Manual Phoenix Gambro (eng) 2u13z

Operator’s Manual

service code revision rev. sw date

6991376 C 3.36 2010-02

Manufactured by: GAMBRO DASCO S.p.A., Via Modenese 66, 41036 MEDOLLA (MO) Italy. Questions or comments about this publication can be directed to your Local Representative. © 2009-2010 GAMBRO LUNDIA AB. All rights reserved. PHOENIX is a trademark of GAMBRO HOSPAL (Schweiz) AG ed in: Australia, Austria, Benelux, Denmark, Estonia, , Georgia, , Italy, Latvia, Lithuania, Norway, Poland, Portugal, Republic of Moldova, Romania, Russian Federation, Slovakia, Slovenia, Sweden, Turkey, United Kingdom, United States and in the European Community. PHOENIX is a trademark of GAMBRO LUNDIA AB ed in Canada. The logo United States.

is a trademark of GAMBRO HOSPAL Schweiz AG ed in the

GAMBRO® is a ed trademark of GAMBRO LUNDIA AB. HOSPAL® is a trademark of GAMBRO HOSPAL Schweiz AG and is ed in Algeria, Austria, Belarus, Benelux, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Finland, , , Greece, Hungary, Italy, Japan, Liechtenstein, Macedonia, Monaco, Morocco, Norway, North Korea, Poland, Portugal, Romania, Russian Federation, San Marino, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States, Vietnam, Yugoslavia. Phoenix ® machine is protected by one or more of the following patents: US4889635; US5276611; US5111683; US5590237; US5228889; US5567320; US5895578; US4784495; US5024756; US4798090; US5041215; US5928177; US5609770; US5394732; US5641144; US6811707; US6881344; US6794194; US5647984; US5733457; US5650071; US5776091; US5624572; US5618441; US5629871; US5685835; US5948251; US6003556; US5620608; US6468427; US6949214; US4740755; EP0243284; EP0403401; EP0428676; EP0418171; EP0465381; EP0467805; EP0501894; EP0658352; EP0813880; EP0900093; EP0330892; EP054702; EP0643301; EP0830155; EP0830156; EP0831945; EP0836486; EP0830153; EP0835493; CA1327022; CA2032156; CA2208931; CA1286284; CA1282012; CA1308569; CA1265403; CA2016863;CA1253919; JP2059115; JP3129326; JP3001235; JP2753242; JP3095223; JP3200594; JP1777042; JP2542728; JP2823513; IT1241624; IT01267416; IT01256865; IT01320264; IT01320247; AU595423; BRPI8800439-2; KR094404; SE467142; SE465404; TW032116; DE-P3620743.8-35; DE4031613; FR9014523; GB2239820; MX5077; Phoenix ® machine is protected by one or more of the following design registrations: US-D446861; US-D446860; US-D464060; US-D462698; US-D462362; US-D462696; DM/051905; DM/055087; IT80564.

Certifications

Indicates that the equipment conforms to Council Directive 93/42/EEC, of 14 June, 1993 relating to Medical Devices. Also indicates that the notified body which has approved the manufacture’s quality system is the British Standards Institution (BSI).

Indicates that the equipment conforms to the rules related to the Safety of Medical Electrical Equipment for U.S. and Canada. The “C” and “US” indicator adjacent to the CSA mark signifies that the product has been evaluated to the applicable ANSI/UL and CSA Standards, for use in the U.S. and Canada.

Only for 115V machine configuration.

REVISION TABLE Revision C SECTION INTRODUCTION SECTION 1 SECTION 2 SECTION 3 SECTION 4 SECTION 5 SECTION 5A SECTION 5B SECTION 5C SECTION 5D SECTION 5E SECTION 5F SECTION 6 SECTION 7 SECTION 8 SECTION 9 WARRANTY APPENDIX A APPENDIX B APPENDIX C

PAGES IN REV. C ------------------------------32, 33 -------

Note The revision corresponds to page. When the modification is related to a table all the pages of the table goes on revision.

I

INTRODUCTION

INTRODUCTION IEC Symbols

WARNING: CONSULT ACCOMPANYING DOCUMENTS

TYPE B APPLIED PART This apparatus provides an adequate degree of protection against electric shock, particularly regarding allowable LEAKAGE CURRENTS and reliability of the protective EARTH connection.

OFF (Main power disconnected)

ON (Main power connected)

ALTERNATING CURRENT

PROTECTIVE EARTH (GROUND)

This symbol indicates that: - the equipment may not be disposed of together with other municipal waste; - the equipment was placed on the market after 13 August 2005.

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II

PHOENIX OPERATOR MANUAL

Keep dry

Year of Manufacturing

Name and address of the Manufacturer

Serial Number

Catalogue Number

Handle with care

This way up

(from IEC 601.1)

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III

INTRODUCTION

Operator Manual Symbols WARNING .......

NOTE ......

Very important information related to patient or operator safety, or given to avoid machine malfunction. Read carefully before operating the machine. Important information related to the correct functioning of the machine. Read carefully before operating the machine.

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IV


INTENDED USE The PHOENIX® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The PHOENIX system is to be used with either high or low permeability dialysers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.

WARNING Fluid balance deviations, even if within the specified Phoenix accuracy, can exceed a level that can be tolerated by low-weight patients.

WARNING The use of procedures not recommended by the manufacturer may result in patient injury or death. The Manufacturer does not assume responsibility for patient safety if the procedures described in this manual are not followed carefully and if staff who perform the procedures have not been appropriately trained and are not qualified.

WARNING It is responsibility of the physician to ensure that the appropriate dialyser and Cartridge Blood Set is selected for the weight of the patient being treated.

WARNING This manual contains a number of references to accessories and disposables for use with the Phoenix machine. The Phoenix machine has been tested and validated for use with the accessories and disposables listed in this manual. The Manufacturer has not validated the use of accessories or disposables other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of accessories or disposable other than those specified in this manual. It is the responsibility of the to validate that other accessories or disposables provide safe and effective performance.

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V

INTRODUCTION

SPARE PARTS Note The Manufacturer will maintain spare parts availability for ten years after the end of production of the PHOENIX. At the end of that time the involved product is considered obsolete and therefore it must be disposed of according to local applicable regulations. The final will be informed about spare parts that are no longer available through the technical service or the commercial representative. For questions, ask for information from the Local Representative.

WARNINGS Introduction WARNING Fluid balance deviations, even if within the specified Phoenix accuracy, can exceed a level that can be tolerated by low-weight patients.

WARNING The use of procedures not recommended by the manufacturer may result in patient injury or death. The Manufacturer does not assume responsibility for patient safety if the procedures described in this manual are not followed carefully and if staff who perform the procedures have not been appropriately trained and are not qualified.

WARNING It is responsibility of the physician to ensure that the appropriate dialyser and Cartridge Blood Set is selected for the weight of the patient being treated.


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VI


Section 1 WARNING To operate the machine correctly, pay careful attention to the messages displayed in the Operator Message Area of the Touch Screen.

WARNING Check that the alarm lights and audible indicators come on for a short time immediately after the machine is powered ON (see Section 5.B - Test Procedures, in this manual). If either signal is not present, one or both signals have malfunctioned. Call for service. Do not operate the machine if the alarm safety system is not functioning. The operator takes full responsibility when a dialysis treatment is carried out in the absence of the audible and visual alarms.

WARNING If the two values, stored by the Protection Module, for the same Safety Relevant parameter are not identical at the time of use, a class Pd alarm is triggered (see Section 08 Alarms and Signals, in this manual). Modification of a Safety Relevant parameter may cause a class Pd alarm, since the machine recognizes a change in the parameter. This alarm is controlled by the machine in the normal way for class Pd alarms, but the audible alarm is automatically disabled for 2 minutes.

WARNING Monitoring of the Venous Pressure could not always detect the disconnection of a venous needle from its access site, which may result in extracorporeal blood loss to the environment. When a venous needle disconnects from its access, pressure at the venous monitoring side may only decrease by the pressure maintained within the patient's access site. This pressure drop may be less than the width of the machine's venous pressure alarm window: in this particular case the disconnection of a venous needle from its access site is not detectable by the machine, even if pressure alarms and alarm windows are properly set. To reduce the risk of needles disconnection: • ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol; • ensure that the patient's access is visible at all times during the dialysis treatment; • inspect frequently the patient's access; • adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms.

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VII

INTRODUCTION

Section 2 WARNING Setting of the Configuration environment must be performed exclusively under the authority of a physician. The physician is solely responsible for clinical adequacy of the parameters setting.

WARNING Before confirming a value for a Safety Relevant parameter (refer to “2.1.2 Parameters in the Parameters List) make List”: the Safety Relevant parameters are marked sure that the value to be confirmed is the same as the value displayed, for that parameter, in the yellow SAFETY BOX. Confirming a value different from that displayed in the yellow SAFETY BOX can cause machine alarms related to that parameter. If you erroneously confirm a value which is different from the value displayed, for that parameter, in the yellow SAFETY BOX, switch OFF the machine, wait 5 seconds, then switch ON the machine again.

WARNING that at least one chemical disinfection process is configured.

WARNING If the INITIAL BOLUS is set from 0-10 ml, at the Heparin Pump start, the heparin quantity set is injected automatically as a bolus after which the linear heparinization starts.

WARNING This feature must exclusively be used under the authority of a physician, who is solely responsible for the use of the information processed by the software.

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VIII


Section 3 WARNING The is responsible for checking compliance of Central Concentrate Systems with the IEC 601.1.1 standard.

WARNING The is responsible for the proper connection of the PHOENIX machine to the Central Concentrate Supply System and to proper functioning of this connection.

WARNING The three internal lines from the Central Supply Ports on the Rear of the PHOENIX to the three Front Concentrate Connectors marked 1, 2, 3 are subject to the same Disinfection requirements as the Central Supply System. The manufacturer is not responsible for the Disinfection of these lines. It is the responsibility of the to carry out Disinfection and Rinse procedures of these lines, and to: • Check the efficiency of Disinfection. • Perform a mandatory Rinse after Disinfection with chemical agents. • Perform a residual test after Rinse.

WARNING It is the responsibility of the to that the proper concentrates are used for the patient. This includes the choice of Acid Concentrate as well as Bicarbonate Concentrate. The machine, while maintaining all the checks (Conductivity, Temperature and pH) of Final Dialysate, disables the check on concentrate dilution that is normally performed when concentrates are provided in containers. The check on concentrate dilution is disabled when Central Concentrate Supply is used in order to prevent the occurrence of ”! Concentrate Cans” #40 alarm. For further information on the concentrate solutions see Section 9 – Specifications, in this manual.

WARNING In case of a switch from Central Concentrate Supply to the use of External Containers, it is the operator’s responsibility to that proper Concentrates are being used.

WARNING In case of a switch from Central Concentrate Supply to the use of External Containers, if the machine has not been correctly calibrated for the liquid Concentrates in the External Containers, the “! Concentrate Cans” #40 Alarm can occur. After carefully ing that the correct concentrates are being used, and that the dialysate Conductivity is correct, the operator may clear the alarm by performing the PA and/or PB Autocalibration Procedure (see Section 5.B - Special Procedures for complete instructions.)

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IX

INTRODUCTION

WARNING Before instilling Cleaning/Disinfecting chemicals into the 3 Central Concentrate Lines, it is advisable to perform a Rinse procedure to avoid chemical reaction or precipitation due to possible incompatibility of the chemical used with any residual Acid or Bicarbonate Concentrate that is left in these lines.

WARNING The efficiency of the Central Bicarbonate Line disinfection process has been tested and can be guaranteed only if the following conditions are satisfied: • The Central Bicarbonate Line connecting the Rear Connector (3) of the PHOENIX (See Figure 3.1) to the Central Concentrate Supply system is a PVC line, maximum 3 metres (118.11 in) in length and with an internal diameter of 3 mm (0.118 in), • Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm)/Bleach is used.

WARNING Before starting a Central Bicarbonate Line disinfection process, it is the operator’s responsibility to that all the Acid and Bicarbonate connectors are correctly placed to ensure the disinfection process is properly performed.

WARNING Before starting a Central Concentrate Rinse process, it is the operator’s responsibility to that all the Acid and Bicarbonate connectors are correctly placed to ensure all the lines involved in the Central Concentrate Rinse process are properly rinsed.

Section 4 WARNING Do not stand on Chemical container shelf.

WARNING Check the continuity and the reliability of the ground connection.

WARNING the quality of the protective earth ground at the time of installation.

WARNING This operation must be performed by authorized personnel. If Service is performed by unauthorized personnel, the manufacturer cannot accept any responsibility for any damage which may occur, and such damage is not covered by the warranty.

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X

PHOENIX OPERATOR MANUAL WARNING Do not use this machine near flammable gas or flammable anaesthetic mixtures with air, with oxygen or with nitrous oxide.

Section 5 WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. The Manufacturer has not validated the use of blood lines other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. It is the responsibility of the to validate that other blood lines provide safe and effective performance.

WARNING It is the responsibility of the physician to ensure that the appropriate Gambro/Hospal Cartridge Blood Set is selected for the weight of the patient being treated. Before installing a Gambro/Hospal Cartridge Blood Set, carefully read the Cartridge Blood Set Instructions for Use.

WARNING Reverse Ultrafiltration of fluid from the dialysate compartment into the blood compartment may occur when High Flux dialysers are used. Because of their high ultrafiltration coefficients, high flux dialysers will quickly transfer fluid across the membrane in response to pressure differences between the dialysate compartment and the blood compartment.

WARNING Never insert fingers in the Venous Line Clamp and in the Arterial Line Clamp (if Single Needle is available on the machine).

WARNING When the cover of the blood pump is open, that the pump is off.

WARNING Improper connections of the extracorporeal circuit may cause potential patient safety hazards, that might not be detected by the machine: for instance, hemolysis caused by kinks, twists, loops, sharp bends, clamps or other restrictions on the blood line, blood loss to the environment/air into the blood circuit due to leakage in the extracorporeal circuit.

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XI

INTRODUCTION

WARNING Before inserting the venous line in the Air Bubble Detector clean and dry it. Fluid and gel substances applied on the Air Bubble Detector may reduced the Air Bubble Detector sensitivity causing patient injury or death. Refer to “6.8.1 External surface cleaning” paragraph, in the Section 06 – Clean/Disinfect, for the description of how to clean the Air Bubble Detector.

WARNING If bicarbonate dialysis is performed: 1. Do not turn off the machine with bicarbonate dialysate in the flow pathway. 2. It is recommended to perform an acetic acid rinse at least twice a week to remove the calcium and any precipitate residues, which may be deposited in the hydraulic pathway. To do this, follow the instructions for the Disinfection process (see Section 6 Clean/Disinfect, in this manual), substituting the chemical disinfectant for an acetic acid solution 30% v/v (add 120 ml of glacial acetic acid to 280 ml of water to obtain 400 ml of solution).

WARNING Ineffective cleaning with acetic acid may cause the machine to malfunction (the lines or the solenoid valves may block and the sensor readings may be affected). It is responsibility of the to check the efficiency of the acetic acid rinsing procedures and to alter the frequency that they are performed, depending on the conditions listed above.

WARNING Check the Expiry date on the BiCart label. Do not refill the BiCart cartridge. If required to replace the BiCart when a dialysis treatment is in progress, follow the “BiCart Change” procedure in the Section 5.A - Special Procedures, in this manual.

WARNING If the machine has detected blood at the Patient Sensor during SETUP, the following message is displayed: If the line has blood in it, press CONFIRM. Or: - Remove venous line from patient sensor - Clean and dry venous line and pt. sensor slot - Put venous line back in the patient Sensor - Press CONFIRM If the patient is already connected to the machine, disconnect the patient from the machine. If there is no patient connected to the machine, this “BLOOD detection” can be to caused by incorrect placement of the venous line. Press the CONFIRM button allow the machine to continue.

Rev. B

XII PHOENIX OPERATOR MANUAL WARNING DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment before dialysate preparation completion, signalled by the appearance of the following Operator Message:

End Of Dialysate Prep, You Can Proceed You Can Now Connect The Dialyser

WARNING When performing dialysis treatment for patients with a body weight of less than 40 kg, special attention should be given to the dialysate flow rate setting. To mitigate the risk of excessive weight removal, it is recommended to set the DIALYSATE FL. parameter to a value lower than or equal to 500 ml/min.

WARNING that fluid is not present in the Waste Handling Option drain port by visual inspection before inserting the Cartridge Blood Set’s priming connector into the port. If fluid is present in the port for more than six seconds after opening the cover, DO NOT USE the WHO.

WARNING Use an aseptic technique when connecting/disconnecting the white priming connector of the arterial line to/from the WHO in order to avoid any potential contamination of the line.

WARNING The Waste Handling Option (WHO) must be cleaned each time blood enters the WHO drain port before continuing with another patient treatments or once per day if the WHO has been in use. (Refer to Section 5.A - Special Procedures, in this manual).

WARNING Hemolysis may occur if blood comes in with disinfectant remaining in the blood pathway of dialysers that have not been completely rinsed. If the dialysers are filled with a chemical disinfectant, special rinsing techniques must be employed to assure the concentration of disinfectant is reduced and maintained at an appropriate level. These rinsing procedures are the responsibility of the medical director. The procedures must include a test of residual disinfectant and techniques to avoid rebound of disinfectant.

WARNING When selecting SETUP , the limits of the Venous Pressure alarm window are automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window limits are set at -400 to +150 mmHg. These values are maintained for the duration of the PRIME mode.

WARNING If performing MANUAL PRIM or PRIME W/O UF , priming of the blood side may be performed before priming the dialysate side. Dialysate side priming may be started before blood side priming is complete.

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XIII

INTRODUCTION

WARNING If using a dialyser that has been filled with a chemical disinfectant, proceed as follows: • that the level of residual chemical disinfectant in the extracorporeal circuit is acceptable according to your facility’s protocol or to the instructions for use of the disinfectant’s manufacturer. • When the residual level is acceptable, discard the rinse saline bag and attach a new bag of saline. If the residual level is unacceptable, proceed according to your facility’s protocol. • Before initiating dialysis flush the istration set and the entire extracorporeal circuit with fresh saline according to your facility’s protocol.

WARNING From the moment that blood is detected in the venous line at the Patient Sensor to the WASHBACK phase, if the operator stops the Blood Pump pressing the ON/OFF button on Blood Pump Control : • The venous pressure alarm window lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 - Configuration Description, in this manual). • The arterial pressure alarm window lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg. These values are maintained for all the time the Blood Pump is OFF and for 30 sec. after the Blood Pump restart.

WARNING Once the patient has been connected, do not open the Blood Pump Cover unless it is required by special procedures described in this manual (i.e., Diaphragm Neutral Position Procedure); in this case strictly follow these procedures. Opening of the Blood Pump Cover without following procedures described in this manual may infuse air to the patient through the arterial line causing patient injury or death.

WARNING The PATIENT CONNECT and WASHBACK MODES have associated safety hazards due to the reduced efficacy of the Protective System; these must be carried out under the control of the and are the responsibility of the .

WARNING When WASHBACK is selected, the limits of the Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure window are set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and +150 mmHg. These values are maintained for the duration of the WASHBACK mode.

WARNING When WASHBACK is selected, the heparin pump is stopped.

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XIV

PHOENIX OPERATOR MANUAL WARNING The FILTER CHANGE Action key must be used only when the dialyser needs to be replaced (Refer to “Dialyser replacement” in the Section 5.A - Special Procedures in this manual).

WARNING Only in the event of the “! Concentrate Cans: A Pump or B Pump or A&B Pumps” (#40) alarm is it possible to perform Autocalibration of PA or PB pump during DIALYSIS (see “Autocalibration procedure for the peristaltic pumps during dialysis” in the Section 5.A - Special Procedures) when the operator accesses the MACHINE view by pressing the MACHINE Navigation key.

WARNING In order to that the patient has been disconnected properly, the following message is displayed when the operator presses the EMPTYING Action key the first time: WARNING! Ensure that the patient has been disconnected. Press CANCEL otherwise. Press CONFIRM to proceed with emptying. Press the CONFIRM button on the Main Control to continue. The blood pump stops and the Protection System is no longer active.

WARNING In bicarbonate dialysis, it is strongly recommended to perform a descaling of the hydraulic circuit with vinegar following every treatment. This can be done using the VINEGAR DESCAL Action key. Its duration may be set with the DESCALING TIME parameter. During this phase the value of the DESCALING TIME parameter is displayed.

WARNING In the case of bicarbonate dialysis, the Acid/Acetate concentrate connector must be left on the machine so that the DESCALING procedure can be performed.

WARNING At the end of WASHBACK, if the does not activate the AutoEmptying procedure, the blue dialysate connector can be reattached to its by port on the machine so that the dialysate side is emptied through the hydraulic circuit (standard EMPTYING).

WARNING Follow facility procedures for proper disposal of used Cartridge Blood Set, dialysers, and other disposables per local regulations.

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XV

INTRODUCTION

WARNING Before starting a new dialysis treatment, ensure that the used Cartridge Blood Set and dialysers have been removed and a new Cartridge Blood Set and dialysers have been installed.

WARNING If, after a bicarbonate dialysis, the DESCALING process is partially or completely skipped by pressing the STOP RINSE Action key, it is strongly recommended to follow the “Precipitate Control (ADR)” recommendations provided in Section 06 – CLEAN/DISINFECT, in this manual.

Section 5.A WARNING Failure to remove the venous line from the Venous Line Clamp can result in rupture of blood lines or dialyser when hand cranking the Blood Pump.

WARNING During a power failure, all safety systems of the machine are disabled or are not operational. It is particularly important to check that all four clamps in the 4 Position Line Clamp, above the Blood Pump, are closed in this situation.

WARNING If a power failure lasts for more than 2 minutes, the patient must be manually disconnected (see Patient Disconnection section in the Manual).

WARNING This emergency procedure for Power Failure is applicable only if your Phoenix machine is equipped with the Battery Backup Kit. Refer to local representative to if your machine is already equipped with the BATTERY BACKUP Kit.

WARNING The use of a Fast Recovery of the Dialysis process procedure must be limited to exceptional cases where the normal recovery procedure can not be performed in accordance with the standard use of the machine, but where the current dialysis treatment must be continued.

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XVI

PHOENIX OPERATOR MANUAL WARNING After pressing the SETUP Action key, DO NOT select a dialysate type (ACETATE/BICARB CONC/BICART) if the patient is still connected to the machine and the Red and Blue Dialysate Connectors are connected to the dialyser.

WARNING The Fast Recovery of an interrupted dialysis treatment can only be performed if TREATMENT has already started (i.e. after PATIENT CONNECT) and has been interrupted before the EMPTYING mode. This procedure can be performed if the Patient Sensor has detected blood in the venous blood line and no service processes (ADR or calibration) have been performed before restarting the dialysis treatment.

WARNING Do not remove the Blood Pump Segment from the Blood Pump. Do not remove the venous line from the Air Bubble Detector/Patient Sensor.

WARNING If the operator erroneously selects a procedure other than “SETUP”, the Fast Recovery of the Dialysis process procedure cannot be performed and the patient must be disconnected.

WARNING During the time between the machine switching OFF and the next restart of the interrupted treatment by the +/- buttons selection, all safety systems of the machine are disabled or are not operational.

WARNING Note that any treatment parameters that were set for the dialysis treatment are transient, i.e. they are lost when a Fast Recovery of the Dialysis process procedure is performed. Therefore, following a Fast Recovery of dialysis, the only treatment parameters that are retained are: − for RX dialysis → the default data values stored in Rx Config − for Standard dialysis → the default data values stored in CONFIG The only exception are: − for RX dialysis → the machine retains the PAT CONN B FLOW parameter value stored in CONFIG instead of the value stored in Rx Config − for Standard dialysis and RX dialysis → the machine retains the DIALYSIS TYPE: ACETATE/BIC CONC/BICART, set for the current treatment instead of the DIALYSIS TYPE stored in CONFIG/Rx Config. NOTE: in case of Computer Prescription of the Treatment (see Section 7 Communication System) the restored treatment parameters are: Dialysis Mode: the last one selected Dialysis Type: the last one performed by the machine.

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XVII

INTRODUCTION

WARNING If during the course of the restarted DIALYSIS, the same problem reoccurs, the cause is not a temporary malfunction. The machine must be turned OFF and the patient manually disconnected. Call for Service.

WARNING It is the responsibility of the to determine the correspondence between the dialysate conductivity, displayed by the machine, and the dialysate solute content, verified by clinical laboratory results, for each dialysate concentrate used for dialysis treatment. This can be done by taking dialysate samples at different conductivity values (e.g. 13,14,15 mS/cm) and sending them to a laboratory for analysis.

WARNING If switching from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate, both in external containers and delivered from the Central Concentrate Supply system, it is the operator’s responsibility to that proper 8.4% bicarbonate concentrate is being used.

WARNING If a switch from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate in external containers, if the machine has not been correctly calibrated for the liquid Concentrate used, the “! Concentrate Cans” #40 Alarm can occur. After carefully ing that the correct concentrates are being used, and that the dialysate Conductivity is correct, the operator may clear the alarm by performing the PB Autocalibration Procedure (see “5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS”, in this section, for complete instructions.)

WARNING Both with Acid/Acetate concentrate container change and with switch from the use of acid in external containers to the use of acid concentratet delivered from the Central Concentrate Supply system, it is the operator’s responsibility to that proper acid/acetate concentrate is being used.

WARNING Both with an Acid/Acetate concentrate formula change and with a switch from Central Concentrate Supply system to the use of acid in external containers, if the machine has not been correctly calibrated for the acid/acetate Concentrate used, the “! Concentrate Cans” #40 Alarm can occur. After carefully ing that the correct concentrates are being used, and that the dialysate Conductivity is correct, the operator may clear the alarm by performing the PA Autocalibration Procedure (see “5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS”, in this section, for complete instructions.)

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XVIII

PHOENIX OPERATOR MANUAL WARNING The CONFIRM button, for Dialyser Change, must be pressed only after having completed the WASHBACK mode.

WARNING In the case of the Acid/Acetate or Bicarbonate Pump Autocalibration, the must always that the correct concentrates are connected to the machine’s concentrate connectors. When the correct concentrates have been verified the CONFIRM button must be pressed on the Main Control . The Autocalibration Process will proceed only after this confirmation. The use of incorrect concentrates may result in an a incorrect dialysate conductivity, that may not be detectable by the Protection System.

WARNING If the “! CONCENTRATE CANS: A PUMP or B Pump or A&B PUMPS” #40 alarm occurs frequently, call for Service.

WARNING The three Autocalibration Action keys are available only before Dialysate Preparation is complete.

WARNING If the Autocalibration Process and the following Test fail, the machine is unable to acquire the relevant value with sufficient accuracy. Autocalibration must be repeated or the pump insert changed and then the autocalibration must be repeated. If the Autocalibration Process fails, but the following Test es, the machine guarantees a degree of accuracy for the value subject to autocalibration. It is recommended that the Autocalibration Procedure be repeated or the pump insert replaced.

WARNING The PA/PB Autocalibration Procedure is mandatory in each of the following cases: • Following a change of the pump insert. • Following a change in the type of concentrate being used. • Following a change from Central Concentrate Supply System to the use of External Concentrate Containers.

WARNING If the Autocalibration Process and the following Test fail, the machine is unable to acquire the relevant value with sufficient accuracy. Autocalibration must be repeated or the pump insert changed and then the autocalibration must be repeated.

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XIX

INTRODUCTION

WARNING The alarm system is inactive or impaired when power to the machine or Touch Screen is off. While manually returning blood, watch the venous line for air. If air is seen, immediately stop returning blood.

WARNING Before performing this procedure, ensure that the Cartridge drip chambers are no more than half full of fluid. Failure to do this may result in patient blood loss.

WARNING The Waste Handling Option (WHO) must be cleaned each time blood enters the WHO Drain Port before continuing with another patient treatment or once per day if the WHO has been in use.

WARNING The patient must not be connected to the machine during this procedure.

WARNING DO NOT USE this priming connector for patient related uses or any sterile connections.

WARNING DO NOT LEAVE undiluted bleach in the flow pathway of the machine.

WARNING Following the WHO bleach procedure, before performing a Chemical Disinfection using a chemical other than Bleach, allow the WHO to rinse at least 3 minutes in the ADR Rinse cycle.

WARNING DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment before dialysate preparation completion, signalled by the appearance of the following Operator Message:

End Of Dialysate Preparation You Can Now Connect The Dialyser

WARNING During OVERRIDE, the operator is responsible for monitoring parameters, which are being overriden.

Rev. B

XX PHOENIX OPERATOR MANUAL WARNING It is the operator’s responsibility to check that the quantity of heparin delivered to the patient is enough to prevent blood clots from forming in the extracorporeal circuit during the transfer of a primed Cartridge Blood Set to another machine.

Section 5.B WARNING It is not advisable to continue treatment, but to notify Service as to which test failed. It is the operator’s responsibility to carefully check the parameters involved in the failed test if the decision is made to continue treatment despite the test failure.

WARNING Notify Service as to which test has failed.

WARNING During the BUZZER AND LAMP test, the presence of a short audible and visual signal must be checked (red and yellow lamps illuminated). If one of the signals is not present, the respective signalling device (buzzer or lamp) is malfunctioning. Call for Service. It is NOT recommended to carry out a dialysis treatment in the absence of the audible and/or visual alarms.

Section 5.C WARNING If the BPM is not factory installed, carefully follow the instructions supplied with the BPM kit.

WARNING The BPM must be used only for patients with a body weight greater than 15 Kg and using a BPM cuff of the appropriate size. Avoid compression or restriction of pressure tubes. Check (e.g. by observing the limb concerned) that operation of the equipment does not result in prolonged impairment of the blood circulation of the patient. The BPM should be tested and calibrated at least once every 4000 hours, or any time irregular performance is suspected or observed. Its composition (insulating material) protects the BPM "Applied Part" (Type BF) against the effect of a defibrillator discharge. In the event of accidental wetting of the cuff or the hydraulic connections, wipe immediately to prevent moisture from entering the machine.

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WARNING In order to be in full conformity with the indications of the European Medical Device Directive 93/42, the manufacturer advises the that the information originating from the BPM cannot be used alone as a unique source of information to induce any therapeutic or pharmacological actions.

Section 5.D WARNING It is the responsibility of the operator to check that the numerical values that represent the Profile (on the bottom of the graph) correspond to the values in the graph.

WARNING The physician is responsible for ensuring that the chosen profiles are appropriate for the patient being treated.

Section 5.E WARNING DIASCAN™ is automatically disabled if: • Dialysate Flow Rate is set to a value lower than or equal to 450 ml/min by the operator Or • Dialysate Flow Rate is set to a value greater than 750 ml/min by the operator Or • The patient connection is performed before the completion of the initial autocalibration. Or • A Fast Recovery of the Dialysis process is performed In such cases DIASCAN™ is inactivated (OFF) for the remainder of the treatment.

WARNING DIASCAN™ measurements are not performed if the blood flow is ≤ 80 ml/min.

WARNING For this software version, the accuracy of the DIASCAN™ Monitoring System is not guaranteed in the SINGLE NEEDLE mode.

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PHOENIX OPERATOR MANUAL WARNING The KT/V computation is based on two parameters: DRY WEIGHT and DISTRIB VOLUME, which must be entered and confirmed by the operator. It is the operator’s responsibility to assess the clinical validity of these parameters.

WARNING The physician is responsible for the clinical adequancy of the parameters set for the correct dialysis dose, based upon the Diascan measurements. Do not use a single Diascan measurement as the only source of clinical information to initiate therapeutic or pharmacologic actions (e.g. change in blood flow rate, dialysate flow rate, dialyser, treatment time, etc...), as unstable operating conditions during a single DIASCAN measurement may result in an artefact in the values computed from the individual reading. Therefore, any changes in the dialysis prescription made on the basis of Diascan analysis should be made in consideration of at least two consecutive readings.

Section 5.F WARNING When the Ultrafilter has been installed, an ADR: RINSING must be performed.

WARNING For the disinfection of the Ultrafilter it is mandatory to use only the chemical agents recommended in the DIACLEAR Instructions for Use. They are also compatible with the PHOENIX Haemodialysis System. The maximum concentration allowed for the disinfectant used is: 6% Sodium Hypochlorite 4% Peracetic acid 40% Formaldehyde 100% Instrunet 100% Steridial Refer to the DIACLEAR Instructions for Use. Some solvents and other chemical products used for cleaning can damage the DIACLEAR Ultrafilter: refer to the DIACLEAR Instructions for Use for the list of prohibited products.

WARNING The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the IDLE view. Following DIACLEAR installation, it is mandatory to perform an ADR: RINSING to prime the DIACLEAR.

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WARNING The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the IDLE view. Following DIACLEAR installation, it is mandatory to perform an ADR: RINSING cycle to prime the DIACLEAR Ultrafilter before entering a DISINFECTION cycle or a DIALYSIS phase.

WARNING The Ultrafilter By connector MUST be installed when the PHOENIX machine is in the IDLE view. When an Ultrafilter By connector has been installed, it is mandatory to perform a disinfection cycle, before entering a DIALYSIS phase.

WARNING The following operations must be performed when the machine is in the IDLE view.

WARNING Avoid tapping the DIACLEAR Ultrafilter too vigorously to remove air as this may cause damage.

WARNING The connection of the DIACLEAR Ultrafilter to the PHOENIX machine must be performed aseptically, so that the fluid pathway is not contaminated. Perform a DISINFECTION procedure before patient connection.

WARNING The DIACLEAR Ultrafilter can only be changed when the PHOENIX machine is in the IDLE view.

WARNING It is imperative that an ADR: RINSING is performed after each DIACLEAR Ultrafilter installation.

WARNING The is responsible for monitoring the DIACLEAR Ultrafilter working time, by resetting the DIACLEAR Ultrafilter installation parameters each time a new DIACLEAR Ultrafilter is installed/replaced, in order to replace the used DIACLEAR Ultrafilter following the maximum dialysis session directions provided in the DIACLEAR Instructions for Use.

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Section 6 WARNING A disinfection process must be followed by a complete RINSING process. If not, on subsequent SETUP the machine will not allow the selection of the DIALYSIS process.

WARNING To be compatible with this feature the PHOENIX machine must be retrofitted with the CWP Adapter kit. Failure to use the CWP Adapter kit may result in damage to components in the PHOENIX machine.

WARNING The temperature of the inlet water to the machine must be lower than 95°C (203°F).

WARNING In the Heat Citric phase, it is important that only citric acid is used and no other disinfectant.

WARNING the absence of residual disinfectant, before connecting a dialyser.

WARNING A disinfection process must be followed by a complete RINSE process.

WARNING For the Touchscreen cleaning use the following disinfectants: • Isopropyl alcohol (70%); • Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm)/Bleach diluted with water at a ratio of 1:50.

WARNING Do not use chemicals which might damage the plastic parts of the machine. Avoid chemicals containing benzene, toluene, xylene, acetone or similar solvents.

WARNING Do not use Sodium hypochlorite to clean the Blood Pump Crank to avoid damaging the metallic parts of this component.

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INTRODUCTION

WARNING Any liquid spilt on the machine must immediately be removed to prevent it from seeping into the machine.

WARNING To prevent cross-contamination problems resulting, for example, from blood leakage from the bloodline or from the dialyser (including blood leak into the hydraulic circuit) the components listed above must be cleaned by immersing them into a disinfectant solution or by exposing them – except the Concentrate Wands - to a steam sterilisation procedure (121°C for at least 30 minutes). Careful attention must be paid to dismounting and re-mounting Dialysate Connectors, Concentrate Connectors and Chemical Connectors in order to avoid damages to those components and leakages from those components.

WARNING To prevent damage to the components listed above, do not leave them immersed in the disinfectant solution for a prolonged period; the proper immersion time is related to the disinfectant dilution used. When the dilution is the same as that used in the machine during DISINFECTION, follow the same time limits: 4 hrs for: Amuchina™, Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength (1:25 dilution); 24 hrs for: Dialox™, Acetoper™, Peresal™, Actril® and Renalin®; 48 hrs for: formaldehyde solution and Steridial™; One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution). (For further information see Section 9 - SPECIFICATIONS, in this Operator’s Manual).

WARNING Stagnant water may contaminate the machine. If machine is stored for more than 7 days, the water line should be disinfected and rinsed.

WARNING After a prolonged period of storage, Service must be called to return the machine to proper working order. Only store at temperatures below 0 °C when the hydraulic circuit has been completely emptied.

Section 7 WARNING PHOENIX makes available the dialysis related data through connection to various external devices for storage and display. The intended use of this information is to the physicians, but it cannot be considered as the sole data to prescribe any therapeutic or pharmacological action for the patient. It is the responsibility of the physician to all data.

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PHOENIX OPERATOR MANUAL WARNING The present software allows information to be gathered about individuals and the must be aware that the use of the information processed or generated by the software is restricted in most countries by legal dispositions such as the Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995. The shall therefore take all necessary measures to ensure the confidentiality of the information which is monitored by means of the software.

WARNING The CentryNet system displays on its treatment screens the concentrations for two conductivity related values (Sodium Level and Bicarbonate Level) in mEq/Liter. As the PHOENIX provides only conductivity information (in mS/cm), the CentryNet entries for Sodium will be approximate values obtained by multiplying the Final conductivity (mS/cm) by 10. A Final conductivity of 13.6 mS/cm will be recorded in CentryNet as a Sodium Level of 136 mEq/Liter. Refer to Section 9 – Specifications of this manual for the exact relation between concentration and conductivity.

WARNING The present SOFTWARE must be used exclusively with the authority of a physician, who is solely responsible for the use of the information processed by the SOFTWARE.

WARNING The PHOENIX machine can be programmed by receiving data through connections to various external devices. As soon as PHOENIX reads the data, it is displayed on the Touch Screen. It is the responsibility of the to all the data before confirming it is correct. Some important parameters relating to the safety of the patient are shown twice, in alternative ways, on the Touch Screen. It is necessary to pay close attention to these values and check their congruency.

Section 8 WARNING If more than one alarm occurs at the same time, the control system automatically prioritizes them, relative to existing alarms. Only those alarms which describe the presumed cause of malfunction are displayed in the alarm window. Alarms that are generated as a result of the original malfunction are not displayed in the alarm window.

WARNING The selection of the OVERRIDE button has effect on all the alarms that are active and can be set to the OVERRIDE state (refer to the “Alarms List” in this section for the list of alarms that can be set to the OVERRIDE state). In the Alarm Area of the screen only two alarm messages can be displayed; if there are more than two alarms active, the additional alarms may be viewed on the Machine view by pressing the Machine Navigation key.

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WARNING During OVERRIDE, the is responsible for monitoring the parameters that are being overridden.

WARNING If the first time the RESTART key is selected, the machine returns to the RESTART condition, wait at least ten seconds before pressing the RESTART key again.

WARNING In some Protection alarms, the audible alarm is active only after DIALYSIS is initiated.

WARNING Press the RESTART key only after having removed the cause requiring the “RESTART”, as described on the Touch Screen. Never press the RESTART key more than 2 or 3 times if the problem has not been identified that will remove the cause of “RESTART”.

WARNING It is the Operator’s responsibility to determine and to correct the cause of the Arterial or Venous Pressure Alarm (#155 and #305) PRIOR to pressing the OVERRIDE Button.

WARNING In each alarm condition critical to the safety of the patient (Class P alarms), the Protection Module checks that the actions relating to the specific safe state are performed correctly by the machine. If this test es, the machine remains in the safe state until the cause of the alarm is removed (as indicated in the Suggested Action). Otherwise, i.e. if the safe state is not correctly configured, the Protection Module generates a > GENERAL SAFE STATE < alarm and the following steps are taken: • The Dialysate Flow through the dialyser is stopped. • The Ultrafiltration Pump is stopped. • The Blood Pump is stopped. • The Venous Clamp is closed. The machine is stopped and the patient isolated. The operator is warned by: •

An alarm window with the message: → > GENERAL SAFE STATE < ←

•

An Operator Message in the help window: You Must Switch Off The Machine

•

A Visual alarm, with a flashing red light of a 6-2 modulation (two flashes lasting 3/8 of a second with an intervening pause of 1/8 of a second)

•

A high volume Audible alarm of 6-2 modulation. Rev. B

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PHOENIX OPERATOR MANUAL •

A numerical code relative to the specific safe state that was not correctly configured (see below).

The GENERAL SAFE STATE is a shutdown alarm and the treatment is stopped. This is a latching alarm and in order to reset it, the machine must be switched OFF. If a General Safe State occurs as a result of a T1 test failure, the following message is displayed: ! T1 TEST FAILED If a General Safe State is due to incorrect voltage, the following message is displayed: ! Voltages Incorrect If a General Safe State is due to a Temperature elevated value alarm, the following message is displayed: ! TEMPERATURE EXCESSIVE VALUE

WARNING When the Blood Pump stops due to an alarm condition: • The venous pressure alarm window lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 - Configuration Description, in this manual). • The arterial pressure alarm window lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg. These values are maintained for all the time the Blood Pump is OFF and for 30 sec. after the Blood Pump restart.

WARNING The machine is supplied with a special device called the Patient Sensor which has the task of setting some class P alarms in an automatic OVERRIDE state when DIALYSIS has not yet started, since the patient’s blood has not yet reached the venous line in the Patient Sensor. Therefore, the relevant safety systems are locked until the presence of blood is detected to allow a smooth start to the process. This condition of the Patient Sensor is indicated by an Icon in the Icon Area on the Touch Screen. The Patient Sensor Icons are: •

No blood has been detected

•

Blood has been detected but the operational test has failed. Not all the relevant safety systems are activated.

•

Blood has been detected and all the relevant safety systems are activated.

For each Class P alarm, the possibility of an automatic OVERRIDE by the Patient Sensor and the related effects are indicated, for each alarm in this section, by symbol in correspondence to the safe requests which are active highlighting the only after either the Patient Sensor has detected blood in the venous line, or after the DIALYSIS Action key has been pressed.

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WARNING 1 Do not open the clamp in between the dialyser and the venous chamber (in DOUBLE NEEDLE mode) or in between the dialyser and the post-dialyser expansion chamber (in SINGLE NEEDLE mode) because the positive pressure at the blood side of the dialyser could push air bubbles to the patient.

WARNING 2 RESUME has no effect if the venous line is not inserted in the Venous Line Clamp (in this case the alarm #205 appears).

WARNING When the patient is connected, if the first selection of the RESTART key doesn’t clear the alarm, re-check carefully all the possible causes of the alarm then press again the RESTART key. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified.

WARNING If the ”!Blood Leakage” # 28 alarm occurs and the identified cause is “Dialyser is leaking blood into the hydraulic circuit”, perform an ADR disinfection before starting a new dialysis treatment. Presence of blood in dialysate might result in a possible contamination of the hydraulic circuit with bacteria or viruses. If the ADR disinfection is not correctly performed before starting a new dialysis treatment, blood into the hydraulic circuit may cause cross-contamination problems resulting in patient injury or death.

WARNING When AC power is interrupted, a continuous audible alarm is turned on.

WARNING Never press the OVERRIDE button, to clear the ! VENOUS PRESSURE HIGH LIMIT #154 alarm, if the problem that is causing the alarm condition has not been identified and removed.

WARNING Never press the OVERRIDE button, to clear the ! Ven Pressure Alarm #155 alarm, if the problem that is causing the alarm condition has not been identified and removed.

WARNING After patient connection this signal becomes #160, a Class P signal (see Class P alarms section), which causes a GENERAL SAFE STATE and consequently stops the machine.

WARNING It is not advisable to continue treatment, but to notify Service as to which test failed. It is the operator’s responsibility to carefully monitor the parameters involved in the failed test if the decision is made to continue treatment despite the test failure.

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PHOENIX OPERATOR MANUAL WARNING If the T1 TESTS DISABLED#203 alarm appears, the machine must not be used for a patient treatment. A Service Technician must re-enable the T1 Tests before using the machine for a patient treatment.

WARNING OVERRIDE has no effect if the venous line is not inserted into the Venous Line Clamp (in which case the alarm number 205: “W! Venous Line Not Fitted “ appears).

WARNING Never press the OVERRIDE button, to clear the ! Art Pressure Alarm #305 alarm, if the problem that is causing the alarm condition has not been identified and removed.

WARNING Never press the OVERRIDE button, to clear the ! Art Pressure Limit #306 alarm, if the problem that is causing the alarm condition has not been identified and removed.

WARNING After the ! UF Mass Balance (#144) recurs 10 times, the TOT. FLUID REMOVED displayed on video is no more reliable. If an external scale is being used, refer to the weight measured by the scale to check the value of the TOT. FLUID REMOVED. If an external scale is not being used, discontinue DIALYSIS.

Section 9 WARNING Storage under 0°C (32°F) is not recommended unless the hydraulic circuit has been emptied (see Maintenance section of the Service Manual).

WARNING The PHOENIX system conforms to IEC 60601-1-2 standard on Electromagnetic Compatibility; thus it has an adequate degree of protection against electromagnetic disturbances. However, to prevent any problems, it is not recommended to use cellular phones (hand-held) in the dialysis room or, at least, to keep a minimum distance of 10 m (33 ft) from the equipment. Refer to, and be compliant with, local standards and guidelines. (For additional information about special precaution regarding EMC, refer to Appendix A in this manual).

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WARNING Possible hazards may arise from equipment (other than the accessories listed below) being connected to machine, which may cause the permitted leakage current to be exceeded.

WARNING The correct installation of a MEDICAL ELECTRICAL SYSTEM requires that each SYSTEM component be individually connected to the main power. It is strongly recommended: NOT TO USE MULTIPLE PORTABLE SOCKET-OUTLETS. However, if using multiple portable socket-outlets, they must comply with the IEC 60601-1-1 Standard and must NOT BE PLACED ON THE FLOOR.

WARNING Wait at least 5 seconds after switching OFF the machine before turning it ON again.

WARNING Do not stand on Chemical Container Shelf.

WARNING The PHOENIX machine is provided with ports for connecting it with an external personal computer or a communication network. All external equipments connected to the PHOENIX machine must be compliant with IEC 60950.

WARNING Before moving the machine, check that the brake is released and remove infusion bags or any other weights or hanging objects from the IV pole or from the concentrate container shelf.

WARNING It is recommended to use concentrates which conform to the requirements of the local standards or of the AAMI RD61 "Concentrates for hemodialysis" standard or of the European Pharmaceutical standards. The control of alarm thresholds and dialysate conductivity precision is of major medical importance in ensuring a safe dialysis treatment.


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PHOENIX OPERATOR MANUAL WARNING Attention must be given to the safety hazards related to incorrect choice of dialysate concentrates.

WARNING When the conductivity of the dialysate exceeds the alarm threshold, the audible and visual alarms are triggered.

WARNING Bicarbonate value in Final Dialysate depends on both the Final conductivity and the Bicarbonate conductivity settings. It is the responsibility of the to set conductivity in accordance with the type of concentrate used to obtain the desired value of bicarbonate in the final dialysate.

WARNING Carefully read the BiCart® Instructions for Use before using the device. BiCart® may only be used by staff, who are specially trained for haemodialysis treatments, using the PHOENIX Operator’s Manual (see Section 5 – Dialysis Operation in this manual).

WARNING When the temperature of the dialysate exceeds the alarm threshold, the audible and visual alarms are triggered.

WARNING When the pressure of the dialysate exceeds the alarm threshold, the audible and visual alarms are triggered.

WARNING When the pH of the dialysate exceeds the alarm threshold, the audible and visual alarms are triggered.

WARNING with cleaning and/or disinfection chemicals may pose a risk of burns, skin irritation or other adverse reactions. Always follow the chemical manufacturer's instructions when handling these products or cleaning spills.

WARNING To prevent damaging the machine, do not leave disinfectant solution in the machine for periods over the following limits: 4 hrs for: Amuchina™, Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength (1:25 dilution); 24 hrs for: Dialox™, Acetoper™, Peresal™, Actril® and Renalin®; 48 hrs for: formaldehyde solution and Steridial™; One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution). Rev. B

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WARNING In the Heat Citric Disinfection phase, it is important that only citric acid is used and no other disinfectants.

WARNING When the Centralized Heat Disinfection System is used, the temperature of the inlet water of the machine must be less than 95°C.

WARNING If the difference between the actual flow of the Ultrafiltration Pump and the set UFR is greater than ±20% with a UF Rate greater than 0.2 kg/h, an audible and visual alarm is triggered. When this alarm is activated the Ultrafiltration Pump is stopped.

WARNING In the "UF only" process or with the hydraulic circuit in BY, the Blood Leak alarm may be delayed, due to the operating conditions and dialyser characteristics.

WARNING Modification of the Blood Flow Rate causes a fluctuation in the Venous Pressure and therefore an alarm may be triggered. Following a change in the Blood Flow Rate, to prevent such an effect, the Alarm Window is automatically set wider for 30 seconds. Its lower value is set to +10 mmHg, while the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 - Configuration Description in this manual).

WARNING Modification of Blood Flow Rate causes a fluctuation in the Arterial Pressure and therefore an alarm may be triggered. Following a change in the Blood Flow Rate, to prevent such an effect, the Alarm Window is automatically set wider for 30 seconds. Its lower value is set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg, while the upper value is set to +150 mmHg.

WARNING Monitoring of the Venous Pressure could not always detect the disconnection of a venous needle from its access site, which may result in extracorporeal blood loss to the environment. When a venous needle disconnects from its access, pressure at the venous monitoring side may only decrease by the pressure maintained within the patient’s access site. This pressure drop may be less than the width of the machine’s venous pressure alarm window: in this particular case the disconnection of a venous needle from its access site is not detectable by the machine, even if pressure alarms and alarm windows are properly set. To reduce the risk of needles disconnection: • ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol; • ensure that the patient's access is visible at all times during the dialysis treatment; • inspect frequently the patient's access; • adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms. Rev. B

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PHOENIX OPERATOR MANUAL WARNING A dedicated warning (W! Low Art Flow For Too Long #204) exists in order to avoid blood loss due to coagulation resulting from interruption of blood flow.

WARNING In WASHBACK (see Section 5 - Dialysis Operation in this manual) the limits of the Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure window are set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and +150 mmHg.

WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. The Manufacturer has not validated the use of blood lines other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. It is the responsibility of the to validate that other blood lines provide safe and effective performance.

WARNING The manufacturer recommends the use of a dialyser with dialysate and blood connections that comply with ISO 8637.

WARNING the absence of disinfectant residuals before connecting the dialyser.


WARNING These diameters have been taken from samples from many countries and are correct at the time of printing. However, the manufacturer cannot be held responsible for changes in syringe dimensions that may occur. The should periodically check the correlation between the stated and the actual diameters.

WARNING The must take precautions against the hazard of cross-contamination between patients by using only extracorporeal circuits with hydrophobic filters on the pressure ports and by disinfecting the accessible surfaces of the equipment.

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WARNING Do not remove the s. If necessary, ask qualified staff to open the s. Disconnect the machine from the main power supply before every cleaning, checking or maintenance operation.

WARNING Do not use this machine near flammable gas or flammable anaesthetic mixtures with air, with oxygen or with nitrous oxide.

WARNING Turn the Blood pump OFF before touching the Blood Pump Rotor. Do not touch the blocking system.

WARNING Carefully move the machine by using the handle on the rear . The machine could be damaged if handled in an improper way.

WARNING Do not assemble, install or use the machine before having read the manual carefully.

WARNING The manufacturer does not accept any responsibility for damage caused by any operation carried out on the machine by unauthorized staff.

WARNING Before replacing or checking any component in the Hydraulic Circuit, a DESCALING Procedure must performed.


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Warranty IMPORTANT NOTE SINCE GAMBRO DASCO S.P.A., THE MANUFACTURER, HAS NO CONTROL OVER THE MANNER IN WHICH SERVICE OR MAINTENANCE WORK IS CONDUCTED BY PERSONS OTHER THAN TRAINED PERSONNEL BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY, OR THE EFFECT OF SUCH WORK ON MACHINE OPERATION AND PERFORMANCE, GAMBRO DASCO S.P.A. DOES NOT ASSUME RESPONSIBILITY OR LIABILITY FOR ANY DAMAGES RESULTING FROM THE OPERATION OR PERFORMANCE OF ANY DEVICE, OR ANY INJURY CAUSED BY SUCH DEVICE AFTER REPAIRS HAVE BEEN ATTEMPTED BY ANYONE OTHER THAN QUALIFIED PERSONS BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY. GAMBRO DASCO S.P.A. DOES NOT RECOGNISE THE OWNER OF A PRODUCT AS AN AUTHORISED SERVICE REPRESENTATIVE. THE WARRANTY ON THIS MACHINE WILL BE VOIDED BY ANY SUCH ATTEMPTED REPAIR AND NO PARTS OR LABOR COSTS INCURRED BY THE OWNER WILL BE REIMBURSED BY THE MANUFACTURER. UNDER NO CIRCUMSTANCES WILL THE MANUFACTURER BE LIABLE FOR INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND, ITS LIABILITY HEREBY BEING LIMITED SOLELY TO REPAIR OR REPLACEMENT. THIS WARRANTY IS IN LIEU OF ANY OTHER EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF SALEABILITY OR SUITABILITY OF USE AND OF ANY OTHER OBLIGATION ON THE PART OF THE MANUFACTURER.


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Tables of contents INTRODUCTION ............................................................................................................................ i IEC Symbols......................................................................................................................... i Operator Manual Symbols ................................................................................................ iii INTENDED USE ................................................................................................................... iv SPARE PARTS ....................................................................................................................... iv WARNINGS.......................................................................................................................... v Introduction ............................................................................................................ v Section 1.................................................................................................................. vi Section 2.................................................................................................................. vii Section 3.................................................................................................................. viii Section 4.................................................................................................................. ix Section 5.................................................................................................................. x Section 5.A.............................................................................................................. xv Section 5.B .............................................................................................................. xx Section 5.C.............................................................................................................. xx Section 5.D ............................................................................................................. xxi Section 5.E............................................................................................................... xxi Section 5.F............................................................................................................... xxii Section 6.................................................................................................................. xxiv Section 7.................................................................................................................. xxv Section 8.................................................................................................................. xxvi Section 9.................................................................................................................. xxx Warranty.................................................................................................................. xxxvi Tables of contens................................................................................................................. xxxvii ADDRESSES .......................................................................................................................... xlv

1. GENERAL DESCRIPTION............................................................................................................ 1-1 1.1 Structure of the machine ............................................................................................ 1-1 1.1.1 Therapies Description ................................................................................ 1-1 1.1.2 Structure of the machine........................................................................... 1-2 1.2 Description of the machine........................................................................................ 1-3 1.2.1 Front view ..................................................................................................... 1-3 1.2.2 Rear view ...................................................................................................... 1-6 1.3 Operator interface........................................................................................................ 1-9 1.3.1 Icons representing processes ................................................................... 1-18 1.3.2 HOME icons................................................................................................. 1-20 1.3.3 Pictograms .................................................................................................... 1-21 1.3.3.1 Background shape..................................................................... 1-21 1.3.3.2 List of Pictograms ...................................................................... 1-21 1.4 Parameter Modification .............................................................................................. 1-26 1.5 Monitoring of Venous Pressure and Venous Needle Dislodgement ............... 1-30

Rev. B

XXXVIII PHOENIX OPERATOR MANUAL 2. CONFIGURATION DESCRIPTION .........................................................................................2-1 2.1 Configuration Environment General Description..................................................2-1 2.1.1 Entering Data on the Configuration Environment ...............................2-4 2.1.2 Parameters List.............................................................................................2-6 2.2 CONFIG Views .............................................................................................................2-18 2.2.1 MACHINE Data Configuration ................................................................2-18 2.2.1.1 OPTIONS.....................................................................................2-18 2.2.1.2 COMMUNICATION.................................................................2-20 2.2.1.3 DATE/TIME..................................................................................2-22 2.2.1.4 WAIT TIME ..................................................................................2-23 2.2.1.5 CLEAN DIAL ...............................................................................2-24 2.2.2 CENTER Data Configuration.....................................................................2-25 2.2.2.1 AUTO ...........................................................................................2-25 2.2.2.2 FUNCTION .................................................................................2-26 2.2.2.3 LIMITS...........................................................................................2-27 2.2.2.4 ALARMS.......................................................................................2-28 2.2.3 ADR Data Configuration ...........................................................................2-29 2.2.3.1 CHEMICAL ..................................................................................2-29 2.2.3.2 HEAT.............................................................................................2-35 2.2.3.3 RINSE ............................................................................................2-39 2.2.3.4 AutoStart......................................................................................2-40 2.2.4 Treatment Data Configuration .................................................................2-42 2.2.4.1 STD HD........................................................................................2-42 2.2.4.2 HEPARIN......................................................................................2-46 2.2.4.3 BPM ..............................................................................................2-47 2.2.5 Profiling Configuration ...............................................................................2-48 2.2.5.1 PROFILE General view .............................................................2-48 2.2.5.2 WLR ..............................................................................................2-49 2.2.5.3 Cond .............................................................................................2-50 2.2.6 KT/V Configuration.....................................................................................2-51 2.3 Rx Config Views............................................................................................................2-52 2.3.1 Rx Config General View ............................................................................2-52 2.3.2 Rx Data Configuration ...............................................................................2-53 2.3.3 Rx Add Configuration.................................................................................2-54 2.3.4 Profiling Configuration ...............................................................................2-55 2.3.4.1 PROFILE General view .............................................................2-55 2.3.4.2 UF ..................................................................................................2-56 2.3.4.3 Cond .............................................................................................2-57 2.3.5 Kt/V Configuration......................................................................................2-58

3. CENTRAL CONCENTRATE SUPPLY ........................................................................................3-1 3.1 Specifications.................................................................................................................3-1 3.2 Connection to the Central Concentrate Supply System .....................................3-2 3.3 Operating Instructions.................................................................................................3-4 3.3.1 Switching from Central Concentrate Supply to the use of External Concentrate Containers .......................................................................3-7 3.4 Central Concentrate Supply Lines Maintenance...................................................3-8 3.4.1 General ..........................................................................................................3-8 3.4.2 Central Bicarbonate Line Disinfection & Rinse: automatic processes .................................................................................................................3-9 3.4.2.1 Disinfection Procedure.............................................................3-9 Rev. B

XXXIX

INTRODUCTION

3.4.2.2 ADR: RINSE following the Central Bicarbonate Line disinfection................................................................................................ 3-14 3.4.3 Acid and Bicarbonate Lines Rinse: automatic process....................... 3-16 3.4.3.1 Rinse Procedure......................................................................... 3-17 3.4.4 Acid and Bicarbonate Lines Maintenance (Disinfection, Rinse and Drain): manual procedure ........................................................................... 3-22 3.4.4.1 Adaptor Setup ............................................................................ 3-22 3.4.4.2 Disinfection Procedure............................................................. 3-23 3.4.4.3 Rinse Procedure......................................................................... 3-23 3.4.4.4 Rinse Verification....................................................................... 3-23 3.4.4.5 Draining of Central Concentrate Lines................................. 3-24 4. INSTALLATION............................................................................................................................. 4-1 4.1 Unpacking instructions................................................................................................ 4-1 4.2 Shipping Carton Contents .......................................................................................... 4-1 4.3 Installation ...................................................................................................................... 4-2 4.4 First service .................................................................................................................... 4-4

5. DIALYSIS OPERATION............................................................................................................... 5-1 5.1 Starting ............................................................................................................................ 5-1 5.1.1 Residual Disinfectant Concentration Test ............................................. 5-1 5.1.2 Checking dialysis parameters configuration ......................................... 5-1 5.2 Extracorporeal Circuit preparation ........................................................................... 5-2 5.2.1 Install dialyser............................................................................................... 5-2 5.2.2 Load the Cartridge Blood Set................................................................... 5-2 5.2.3 Fill and install heparin syringe .................................................................. 5-6 5.2.4 Connect saline ............................................................................................. 5-7 5.3 SETUP selection ............................................................................................................ 5-8 5.3.1 Standard Dialysis Mode (when SETUP has been selected)............... 5-10 5.3.1.1 When Acetate Dialysate is programmed in the Configuration menu................................................................................ 5-10 5.3.1.2 When Liquid Bicarbonate Dialysate is programmed in the Configuration menu .................................................................... 5-11 5.3.1.3 When BiCart Dialysate is programmed in the Configuration Menu ............................................................................... 5-13 5.3.2 RX Dialysis Mode ........................................................................................ 5-17 5.4 Preparing for a patient treatment ............................................................................. 5-23 5.4.1 Dialysate preparation ................................................................................. 5-23 5.4.1.1 Possible operations during the dialysate preparation phase ................................................................................... 5-25 5.4.1.2 Sampling of dialysate ................................................................ 5-25 5.4.2 Priming Mode Selection View ................................................................. 5-26 5.5 Priming of the dialyser................................................................................................. 5-27 5.5.1 Priming with Dialysate Connectors on the Dialyser ........................... 5-27 5.5.1.1 To prime the blood side of the dialyser and the heparin line ............................................................................................... 5-29 5.5.1.2 To fill the dialysate side of the dialyser................................. 5-31 5.5.2 Priming with Dialysate Connectors on the Rinse Ports...................... 5-32 5.5.2.1 To prime the blood side of the dialyser and the heparin line ............................................................................................... 5-33 5.5.2.2 To fill the dialysate side of the dialyser................................. 5-35 5.6 Recirculation.................................................................................................................. 5-36 Rev. B

XL PHOENIX OPERATOR MANUAL 5.6.1 Prepare to perform recirculation .............................................................5-36 5.6.1.1 Unclamp lines .............................................................................5-36 5.6.2 Select Recirculation ....................................................................................5-36 5.7 Level adjustment of the Cartridge chambers .........................................................5-37 5.8 Patient Connection.......................................................................................................5-39 5.8.1 Ready for patient connection...................................................................5-39 5.8.2 Heparinization .............................................................................................5-41 5.8.3 Initiating patient connect...........................................................................5-43 5.8.3.1 Fill the extracorporeal circuit with fresh saline prior to treatment ..............................................................................................5-43 5.8.3.2 Connect patient .........................................................................5-44 5.8.4 Dialysis change mode: Single Needle and Double Needle mode ........................................................................................................................5-47 5.9 Dialysis ............................................................................................................................5-48 5.9.1 Performing Dialysis .....................................................................................5-48 5.10 End of Dialysis.............................................................................................................5-52 5.10.1 Patient disconnection and Emptying dialyser.....................................5-52 5.10.2 Emptying the dialyser...............................................................................5-54 5.10.2.1 Manual Emptying.....................................................................5-54 5.10.2.2 AutoEmptying...........................................................................5-57 5.10.3 Removing the BiCart ................................................................................5-59 5.10.4 End of Treatment ......................................................................................5-60 5.10.5 Quick Access to the Next Dialysis Treatment....................................5-62

5.A. SPECIAL PROCEDURES .........................................................................................................5.A-1 5.A.1 Emergency procedures for Power Failure...........................................................5.A-1 5.A.2 Emergency procedures for Power Failure with the BATTERY BACKUP feature ..................................................................................................................5.A-3 5.A.3 Fast Recovery of the Dialysis process ..................................................................5.A-6 5.A.4 Sampling of water from the machine...................................................................5.A-9 5.A.5 Sampling of Dialysate ..............................................................................................5.A-9 5.A.6 Temporary Disconnection of the Patient : PAUSE THERAPY Procedure ..............................................................................................................................5.A-12 5.A.7 BiCart Change ...........................................................................................................5.A-14 5.A.8 Switching from BiCart Dialysate to the use of Liquid 8.4% Bicarbonate Dialysate.........................................................................................................5.A-16 5.A.9 Acid/Acetate Concentrate Supply Change ........................................................5.A-18 5.A.10 Dialyser Replacement............................................................................................5.A-20 5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS................................................................................................................................5.A-23 5.A.12 Procedure for Standard Autocalibration of the PA, PB, or PUF Pumps during the Dialysate Preparation Process ........................................................5.A-25 5.A.13 Procedure for Automatic Autocalibration of the UF Pump during the Dialysate Preparation Process ...................................................................................5.A-28 5.A.14 Manual Disconnection of the Patient................................................................5.A-29 5.A.15 Diaphragm Neutral Position Procedure ............................................................5.A-30 5.A.16 Manual Cleaning procedure for the Waste Handling Option (WHO) ...................................................................................................................................5.A-32

Rev. B

XLI

INTRODUCTION

5.A.17 Transferring a primed Cartridge Blood Set to another PHOENIX machine for continuation of treatment .......................................................................... 5.A-33 5.A.18 Installation of the Single Needle Holder........................................................... 5.A-36

5.B. TEST PROCEDURES................................................................................................................. 5.B-1 5.B.1 Test procedures.......................................................................................................... 5.B-1 5.C. BLOOD PRESSURE MONITORING SYSTEM................................................................... 5.C-1 5.C.1 General ....................................................................................................................... 5.C-1 5.C.2 Cuff selection............................................................................................................. 5.C-4 5.C.3 Cuff application......................................................................................................... 5.C-5 5.C.4 BPM interface.................................................................................................. 5.C-6

5.D. PROFILE ..................................................................................................................................... 5.D-1 5.D.1 Introduction............................................................................................................... 5.D-1 5.D.1.1 CURVE TYPE Setting .............................................................................. 5.D-2 5.D.2 Dialysis Mode with Profiling not enabled .......................................................... 5.D-4 5.D.2.1 Display UFR and Conductivity graph in Dialysis Mode with Profiling not enabled ............................................................................................ 5.D-4 5.D.2.2 DIALYSIS TIME Setting .......................................................................... 5.D-7 5.D.3 Profiled Dialysis Mode ............................................................................................ 5.D-9 5.D.3.1 General ..................................................................................................... 5.D-9 5.D.3.2 Entering the PROFILE View .................................................................. 5.D-10 5.D.3.3 Progressive Curve Profiles .................................................................... 5.D-11 5.D.3.3.1 Conductivity Progressive Curve Profiles: parameters explanation.......................................................................... 5.D-11 5.D.3.3.2 Ultrafiltration Rate Progressive Curve Profiles: parameters explanation.......................................................................... 5.D-12 5.D.3.3.3 Programming the Progressive Curve ................................ 5.D-13 5.D.3.4 Step Curve Profiles ................................................................................. 5.D-15 5.D.3.4.1 Ultrafiltration Rate Step Curve Profiles ............................ 5.D-15 5.D.3.4.2 Conductivity Step Curve Profiles....................................... 5.D-16 5.D.3.4.3 Programming the Step Curve ............................................. 5.D-17 5.D.3.5 Modify Profile Parameters .................................................................... 5.D-18 5.D.3.6 Activation of Profile................................................................................ 5.D-21 5.D.3.7 Profile during Dialysis ............................................................................ 5.D-23 5.D.3.7.1 Display Profile during DIALYSIS ........................................ 5.D-25 5.D.3.7.2 Modification of a Curve during DIALYSIS....................... 5.D-29 5.D.3.7.3 Profile during WASHBACK ................................................. 5.D-29 5.D.3.8 Deactivation of Profiling ....................................................................... 5.D-30

5.E. MONITORING.......................................................................................................................... 5.E-1 5.E.1 DIASCAN™ Monitoring System............................................................................. 5.E-1 5.E.1.1 General....................................................................................................... 5.E-1 5.E.1.2 Parameters................................................................................................. 5.E-4 5.E.1.3 Initial Auto-Calibration ............................................................................ 5.E-7 5.E.1.4 MEASUREMENTS .................................................................................... 5.E-8 5.E.1.5 Operator Interface................................................................................... 5.E-10

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XLII


5.F. CLEAN DIALYSATE System ....................................................................................................5.F-1 5.F.1 General.........................................................................................................................5.F-1 5.F.2 Ultrafilter information................................................................................................5.F-2 5.F.2.1 DIACLEAR Instruction for Use ..............................................................5.F-3 5.F.3 Installation of the DIACLEAR Ultrafilter on a machine equipped with the Ultrafilter By connector.......................................................................................5.F-4 5.F.3.1 Removal of the Ultrafilter By connector (old version) ...........5.F-5 5.F.3.2 Installation of the DIACLEAR Ultrafilter .............................................5.F-8 5.F.4 Installation of the Ultrafilter By connector on a machine equipped with the DIACLEAR Ultrafilter........................................................................5.F-11 5.F.4.1 Removal of the DIACLEAR Ultrafilter..................................................5.F-11 5.F.4.2 Installation of the Ultrafilter By connector (old version) .........5.F-13 5.F.5 Clean Dialysate...........................................................................................................5.F-16 5.F.5.1 Priming/Rinsing of the DIACLEAR Ultrafilter .....................................5.F-16 5.F.5.2 Dialysate Preparation, Priming/Rinsing of the dialyser and performing the dialysis treatment ......................................................................5.F-16 5.F.5.3 Changing the DIACLEAR Ultrafilter .....................................................5.F-17 5.F.5.3.1 Installation of the new DIACLEAR Ultrafilter....................5.F-17 5.F.5.4 Resetting of the DIACLEAR Ultrafilter Installation parameters...............................................................................................................5.F-17 5.F.5.5 Chemical Disinfection and Descaling..................................................5.F-18 5.F.5.6 Heat/Heat Citric Disinfection................................................................5.F-18 5.F.6 PHOENIX Operator Interface .................................................................................5.F-19 5.F.6.1 Configuration ............................................................................................5.F-19 5.F.6.2 Icons............................................................................................................5.F-20 6. CLEAN/DISINFECT ......................................................................................................................6-1 6.1 Disinfection ....................................................................................................................6-5 6.2 Chemical Disinfection..................................................................................................6-7 6.2.1 Disinfection...................................................................................................6-7 6.2.1.1 HOW TO PROCEED ................................................................6-7 6.2.1.1.1 List of Parameters and their meanings ................ 6-8 6.2.1.2 HOW TO START THE PROCESS ...........................................6-9 6.2.2 Chemical Disinfection Process in progress ...........................................6-11 6.3 Disinfection with heat (not available on 12 A version)........................................6-12 6.3.1 Heat disinfection .........................................................................................6-12 6.3.1.1 HOW TO PROCEED ................................................................6-12 6.3.1.1.1 List of Parameters and their meanings ................ 6-13 6.3.1.2 CENTRALIZED HEAT DISINFECTION SYSTEM..................6-14 6.3.2 Heat Citric disinfection ..............................................................................6-15 6.3.2.1 HOW TO PROCEED ................................................................6-15 6.3.2.1.1 List of Parameters and their meanings ................ 6-17 6.3.3 Heat/Heat Citric Process in Progress (not available on 12 A version).....................................................................................................................6-18 6.4 Rinsing .............................................................................................................................6-19 6.4.1 Rinsing in progress ......................................................................................6-21 6.5 ADR Action Keys availability......................................................................................6-21 6.6 Verification of the Absence of Residual Disinfectant...........................................6-24 6.7 Water Inlet Line Disinfection .....................................................................................6-25 6.7.1 General ..........................................................................................................6-25 6.7.2 Disinfection Procedure ..............................................................................6-25 Rev. B

XLIII

INTRODUCTION

6.8 External Cleaning and Periodic Inspections ........................................................... 6-28 6.8.1 External surface cleaning........................................................................... 6-28 6.8.2 External components Cleaning ................................................................ 6-29 6.8.3 Visual inspection ......................................................................................... 6-31 6.8.4 Storage .......................................................................................................... 6-31 6.8.5 Cartridge Holder O-Rings Inspection and Greasing ........................... 6-32 7. COMMUNICATION SYSTEM................................................................................................... 7-1 7.1 General Description..................................................................................................... 7-1 7.2 Exalis Functional Description ..................................................................................... 7-3 7.3 CONFIGURATION of Communication Environment.......................................... 7-4 7.4 Options of the Communication System.................................................................. 7-8 7.4.1 Patient ................................................................................................ 7-8 7.4.2 PRE POST Dialysis data handling. ........................................................... 7-9 7.4.3 Event/Intervention Marking...................................................................... 7-13 7.4.4 Dialysis Report............................................................................................. 7-15 7.4.5 Dialysis Treatment Data ............................................................................ 7-17 7.5 Prescription with the Exalis System...................................................... 7-18 7.5.1 General Description ................................................................................... 7-18 7.5.2 Functional Specifications........................................................................... 7-18 7.5.3 Error Messages related to Computer Prescription .............................. 7-19 7.6 Communication Libraries............................................................................................ 7-21 7.7 CentryNet System Connection ................................................................................. 7-22 7.7.1 What CentryNet Does............................................................................... 7-23 7.7.2 How CentryNet Communications Work............................................... 7-24 7.7.3 Operator Tasks and Guidelines for CentryNet .................................... 7-25 7.7.4 Configuring the unit with the CentryNet option ................................. 7-26 7.7.5 CentryNet Option Screen Setup Keys ................................................... 7-29 7.7.6 Communication Icons relating to the state of the network link............................................................................................................................. 7-31 7.7.7 Operator Keys relating to the state of the treatment ......................... 7-32 7.7.8 Operator Keys relating to manual data collection .............................. 7-35 7.7.9 Alarm signals relating to CentryNet........................................................ 7-36 7.7.10 CentryNet option activation/deactivation after a Fast Recovery of the Dialysis process ....................................................................... 7-37

8. ALARMS AND SIGNALS ............................................................................................................ 8-1 8.1 Classification and modes of intervention................................................................ 8-1 8.1.1 Operator Guidelines for responding to Alarms on the PHOENIX machine................................................................................................ 8-6 8.1.1.1 OVERRIDING Arterial and Venous Pressure Alarms ........ 8-7 8.1.1.2 Operator Actions required after pressing the OVERRIDE Button for Arterial and Venous Pressure Alarms........ 8-8 8.1.2 Alphabetic List of Alarms........................................................................... 8-8 8.2 Numerical List of Alarms and relevant description............................................... 8-20

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XLIV


9. SPECIFICATIONS .........................................................................................................................9-1 9.1 General specifications .................................................................................................9-1 9.2 Hydraulic section .......................................................................................................... 9-8 9.2.1 Water supply ................................................................................................9-8 9.2.2 Dialysate........................................................................................................9-9 9.2.3 Materials in with dialysate, concentrates and water............9-22 9.2.4 Descaling.......................................................................................................9-22 9.2.5 Disinfection...................................................................................................9-23 9.2.6 Ultrafiltration system...................................................................................9-25 9.2.7 Detection of Extracorporeal Blood Loss ................................................9-26 9.2.8 Operating Modes........................................................................................9-28 9.3 Extracorporeal Circulation ..........................................................................................9-31 9.3.1 Operating Modes........................................................................................9-31 9.3.2 Blood Pumps ................................................................................................9-33 9.3.3 Heparin Pump..............................................................................................9-35 9.3.4 Automatic Functions...................................................................................9-37 9.3.5 Main Surveillance Devices ........................................................................9-38 9.3.6 Safety system actuators .............................................................................9-39 9.4 Protection System.........................................................................................................9-40 9.5 General Safety Controls ..............................................................................................9-41 9.6 Technician Maintenance.............................................................................................9-43 WARRANTY ........................................................................................................................................I

A. APPENDIX A: Guidelines and Manufacturer’s Declaration - Electromagnetic Emissions and Immunity...................................................................................................................A-1

B. APPENDIX B: Special Troubleshooting ..................................................................................B-1

C. APPENDIX C: Ultrafilter By Connector Installation ....................................................C-1 C.1 Disconnection of the three Ultrafilter By connector lines ..........................C-1 C.2 Connection of the Ultrafilter By connector ....................................................C-9

Rev. B

XLV

INTRODUCTION

ADDRESSES Should you require technical assistance, your Local Service Representative as listed below.

USA GAMBRO Renal Products, Inc. 10810 West Collins Avenue Lakewood, CO 80215-4498 Tel. Fax

800 525 2623 303 232 6800 303 231 4032

CANADA : GAMBRO Inc. 9157 Champ d'Eau St Leonard Quebec H1P 3M3 Tel Fax

514 327 16 35 514 327 08 22

KOREA : Gambro Korea Ltd. Head Office 8th Floor, Hanmi Tower 45 Bangee-dong Songpa-Ku KR-SEOUL 138-050 Tel Fax

82 - 2 415 97 72 82 - 2 424 31 25

Rev. B

XLVI


MEXICO : Gambro de Mexico S.A. de CV Vasco de Quiroga 1900, Piso 3 MX-Santa Fe MEXICO D. F. 01210 Tel Fax

52 - 55 52 92 31 00 52 - 55 52 92 31 13

AUSTRALIA : Gambro Pty. Ltd. (Sydney) P.O. Box 6604 BHBC Baulkham Hills AU-NEW SOUTH WALES 2153 Tel Fax

Rev. B

61 - 2 9 680 27 11 61 - 2 9 634 13 75

1 GENERAL DESCRIPTION 1.

SECTION 1 - GENERAL DESCRIPTION

1.1 Structure of the machine PHOENIX is a self-contained, microprocessor-controlled device that provides haemodialysis, hemofiltration and ultrafiltration therapies. The system consists of the Haemodialysis Machine in use with a blood tubing set designed for the machine, a dialyser, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates. The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments.

1.1.1 Therapies Description The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing set properly designed for the machine, through the dialyser where purification takes place, and back to the patient. In the dialyser, the blood and the dialysate fluid flow on opposite surfaces of a thin semi-permeable membrane. As the blood es through the filter, the desired treatment processes take place. Depending upon the therapy in use, the treatment processes can include fluid removal and/or solute clearance. The Phoenix machine can carry out the following therapies: • Ultrafiltration • Hemofiltration • Hemodialysis.

Ultrafiltration In ultrafiltration, the body’s excess fluid is removed through the dialyser membrane by means of a pressure gradient between the blood and dialysate compartments in the dialyser. The entire ultrafiltration process is monitored and controlled by the dialysis machine.

Hemofiltration In hemofiltration, accumulated metabolic products are removed from blood by the process of convective transport as a consequence of ultrafiltration of fluid across a dialyser semi-permeable membrane of high-flux type. The volume of filtered fluid that exceeds the desired weight loss is replaced by sterile pyrogen-free infusion solution infused into the blood flowpath. The replacement solution adds back some or all of the water removed, as well as the prescribed solutes. While the dialysis machine monitors and controls the entire ultrafiltration process, it does not monitor and control infusion of replacement solution.

Rev. B

1-2

PHOENIX

OPERATOR MANUAL

Hemodialysis In hemodialysis, the chemical composition of blood is corrected by removing accumulated metabolic products, normalizing ionic content and adding buffer through the process of diffusive transport. In this case the concentration of solutes unwanted or to be cleared is lower or null in the dialysate with respect to the blood, causing these solutes to diffuse from a compartment of greater concentration (the patient’s blood) to a compartment of lesser concentration (the dialysate solution) across a natural or synthetic semipermeable membrane. The body’s excess fluid is removed through the membrane by means of a pressure gradient created by the dialysis machine. The entire hemodialysis process is managed by the dialysis machine which monitors and controls the total ionic composition of dialysate solution together with the ultrafiltration process.

1.1.2 Structure of the machine PHOENIX has a modular structure. It is made up of five modules that carry out independent functions. The modules are described below.

MASTER MODULE Supervises the functioning of all machine processes. It allows the operator to communicate with the machine via a colour, touch screen graphical interface, through which it is possible to: • select various operations • set parameter values • receive operator and alarm messages

HYDRAULIC MODULE Supervises the dialysate preparation and the measurement and control of ultrafiltration. The PHOENIX is a single- system, i.e. dialysate es through the circuit once. Dialysate preparation is continuous and its conductivity is determined by the parameters selected by the operator.

BLOOD MODULE Manages all the machine processes on the blood side of the extracorporeal circuit. Arterial blood is withdrawn from the patient, may be mixed with heparin to prevent coagulation, ed through the dialyser and then is returned to the patient. The unit consisting of the Master, Hydraulic and Blood Modules is called the Control System.

PROTECTION MODULE Manages all processes related to safe operation of the machine and alarm conditions that occur during dialysis due to unsafe conditions. The machine reverts to a specific safe state when patient safety is in question. The machine is fail-safe in the event of a single point failure occurring during treatment.

BIO MODULE Manages all processes related to Diascan (see Section 5.E – Monitoring, in this manual). Rev. B


1.2 Description of the machine 1.2.1 Front view (For machines with Serial Number greater than PH25160 the Patient Card reader is not available.)

Rev. B

1-3

1-4

PHOENIX

OPERATOR MANUAL

Machine Components – Front View

(A)

Patient Card Reader

(B)

Display/ Touch Screen

Reads the Patient Card. (For machines with Serial Number greater

than PH25160 the Patient Card reader is not available.) Allows the operator to communicate with the PHOENIX Haemodialysis Delivery System via colour Touch Screen and control buttons.

(C)

Main Control

A of buttons whose functions allow the operator to access and modify parameters, mute or reset/override alarms. An additional button, the SAFE button (CURRENTLY NOT AVAILABLE), can be programmed with any combination of the following: stop the blood pump, by the dialyser, or enter minimum UFR. HEART button (initiates a blood pressure measurement), HELP button (CURRENTLY NOT AVAILABLE) and EVENT/INTERVENTION (CURRENTLY NOT AVAILABLE) button.

(D)

Blood Pump Control

A of buttons that allows the operator to control blood pump functions: turn blood pump on/off, resume blood pump speed and decrease/increase blood pump speed.

(E)

4-Position Line Clamp

Plastic assembly that holds the four access lines extending from the top of the Cartridge Blood Set. The four clamps are colour coded for correct line placement as follows: Green-heparin line; Red (right)arterial access line; Red (left)-cartridge saline line; Blue-venous access line.

(F)

Blood Pump Cover and Cover Latch

A plastic cover that protects the blood pump from foreign objects and provides a track inside the cover to hold the pump segment of the Cartridge Blood Set on the pump rollers. The cover latch keeps the blood pump cover closed during operation and the Cartridge securely in place over the arterial and venous pressure sensors. The blood pump will not run unless the door is securely latched.

Blood Pump (G)

Air Bubble Detector Patient Sensor

Pumps blood through the extracorporeal circuit. Ultrasonic sensor that detects macro and micro air in fluid/blood within the venous line. If macro or micro air is detected, an “! AIR & FOAM DETECTOR” alarm (number 4) occurs (blood pump stops and venous line clamp closes). The infra-red Patient Sensor detects the presence of blood in the venous line. When blood is detected the Protection Module is fully activated.

(H) Arterial Line Clip

Secures arterial line to the machine.

(I)

Venous Line Clamp

Occlusive clamp that closes the venous line during certain red-light alarms, some self-tests, and when power is off. Prevents blood flow to the patient.

(J)

WHO™ (Waste Handling Option)

Connects a WHO priming connector on the Cartridge Blood Set to a drain port to dispose of waste fluids produced during priming.

(K)

Acid/Acetate Line (red connector) and Rinse Port

Connects to a container of acid concentrate (for bicarbonate haemodialysis) OR acetate concentrate (for acetate haemodialysis). The acid/acetate line is connected to its red rinse port during rinse and storage.

Rev. B


(L) Bicarbonate Line (blue connector) and Rinse Port

Connects to a container of bicarbonate concentrate. The bicarbonate line is connected to its rinse port when a BiCart is in use, when the machine is used for acetate dialysis, and during rinse and storage.

(M) Disinfectant Line (yellow connector) and Rinse Port

Connects to a chemical container used during the machine chemical processes. During the main machine phases it must be connected to its rinse port.

(N)

Concentrate Container Shelf

Located on bottom front; holds containers of liquid concentrates needed for haemodialysis therapy.

(O)

Locking Brake

(P)

Heparin Syringe Holder

Prevents the machine from moving when in use. Holds the barrel of the heparin syringe.

(Q) Heparin Control

of two buttons that move the plunger clamp to ( ( ) from the syringe plunger.

(R)

Heparin Syringe Plunger Clamp

Holds the plunger of the heparin syringe; moves horizontally to push heparin into the blood flow path at the specified rate.

Heparin Pump (inside machine)

Controls the rate of heparin delivery into the blood flow path. Heparin can be delivered continuously or in bolus amounts.

Blood Leak Detector (inside machine)

Infrared light detector that detects red blood cells in the dialysate leaving the dialyser. Blood in the dialysate indicates a leak or tear in the dialyser membrane. If blood is detected, a Blood Leak alarm (#28) occurs (blood pump stops and venous line clamp closes).

) or away

Houses the BPM cuff when not in use.

(S)

BPM Cuff Holder

(T)

Blood Module Latch

Secures the blood module (middle third of front ). The latch can be opened with a hex key. Only Service technicians should open the latch (to service the internal blood module components).

(U)

Main Power Switch / Circuit Breaker

Turns machine power On/Off. The label “I” means ON and the label “O” means OFF. The switch is also a circuit breaker and shuts off power in the event of an internal electrical overload. The breaker can be reset by turning the machine OFF, then ON.

(V)

BiCart Holder

Holds a BiCart (powdered bicarbonate cartridge) for bicarbonate dialysis. The holder arms open to allow a BiCart to be inserted Note: Bicarbonate concentrate in a container can be used for bicarbonate dialysis instead of BiCart, if desired.

Rev. B

1-5

1-6

PHOENIX

OPERATOR MANUAL

1.2.2 Rear view

Rev. B


Machine Components – Rear View (A)

Solution Bag Hooks

Holds containers of IV solutions for istration through the Cartridge Blood Set.

(B)

IV Pole Adjustment Knob

Loosens/tightens to adjust and hold the IV pole at the desired height.

(C)

IV Pole

(D)

Status Lights Yellow

Adjusts up/down for convenient placement of IV solutions. Illuminate to give a general indication of operating conditions. A flashing yellow light indicates: • one or more alarms have been overridden; • a low priority alarm has occurred, for example, the machine is

operating in By or Minimum UFR. Immediate patient safety is not compromised, but the operator should investigate. Red

(E)

Ultrafilter Detection Switch

(F)

Hour Meter

A flashing red light indicates a high priority alarm has occurred, for example the machine has detected air in the venous line or blood in the dialysate line. A condition of possible patient or machine hazard exists, the operator should intervene immediately. The flashing red light will be displayed in the event of a general safe state condition. Detects the presence of the Diaclear Ultrafilter. Accumulates hours of full power operation. Hours spent in low power are not counted on the meter. Depending on the machine version, the Hour Meter can be located either on the left side of the Ultrafilter By Connector (as shown in the Figure) or in the Computer Interface (see Figure 9.0 in the Section 09 – Specifications).

(G) Computer Interface

Provides ports for PHOENIX options including connection to external networks.

(H)

Ultrafilter By Connector

A connector linking the ultrafilter lines when the Diaclear Ultrafilter is not being used.

(I)

BP Tubing Connector

(J)

Air Vents

(K)

Blood Pump Crank

Crank fits on the blood pump rotor, allowing manual blood return to the patient, if necessary.

(L)

Cable Holder (for storage of equipment)

Holds the power cable when the machine is being moved or not being used.

(M)

Wand Holder

Stores the concentrate wands and the conductivity sampler when they are not being used.

Connects luer lock on tubing of the PHOENIX BP Monitor to the internal electronic module. Provide continuous ventilation of interior components.

(N) Chemical Container Shelf

Holds containers of liquid chemicals needed for ADR procedures.

(O)

Power Cord

The power cord is permanently attached.

(P)

Inlet Water Hose

Connects to the facility’s water supply and carries water to the machine. Rev. B

1-7

1-8

PHOENIX

OPERATOR MANUAL

(Q)

Drain Hose

Connects to the facility’s drainage system and carries away used dialysate, ultrafiltrate, and other waste fluids.

(R)

Dialysate Line From Dialyser (red connector) and By Port

Carries used dialysate from the dialyser. During the hydraulics portion of T1 TEST, ADR procedures, and storage, this line must be connected to its by port.

(S)

Dialysate Line To Dialyser (blue connector) and By Port

Carries fresh dialysate to the dialyser. During the hydraulics portion of T1 TEST, ADR procedures, and storage, this line must be connected to its by port.

(T)

Cartridge Holder

Accepts the Cartridge Blood Set and secures it in position with the Cartridge clip (on the left) and the blood pump rotor (on the right). Has two pressure transducers with sealing cones for pressure monitoring. The red cone connects with the arterial chamber; the blue cone connects with the venous chamber.

(U)

Dialyser Holder

Holds the dialyser. Consists of a movable arm and two grippers attached to the machine.

(V)

Inlet Water Filter

Inlet Water Filter Standard (250 μm).

Rev. B


1.3 Operator interface General description The PHOENIX operator interface consists of: • A colour Touch Screen display that shows: − parameters and commands which the operator can select − alarm messages − operator messages − status icons and pictograms − Navigation keys to access different views on the Touch Screen. During normal operation, the Touch Screen has the following configuration:

8 I C O N

1

2

3

4

TIME AREA

RX /PATIENT NAME AREA

ALARM AREA

STATUS AREA

5

6

7

BPM AREA

OPERATOR MESSAGE AREA

PICTOGRAM AREA

10

9

12

ARTERIAL/VENOUS

PARAMETER AREA

PRESSURE BAR GRAPHS

OPERATION IN PROCESS

ACTION SELECTION KEYS

AND VIEW DISPLAY

A R E A

11 BLOOD PUMP SPEED FLOW AREA 14. HOME

13. NAVIGATION KEYS

1. Time Area: displays the current time of day. 2. Rx/Patient Name Area: displays the therapy or name of the patient selected through personalised dialysis treatment procedures. 3. Alarm Area: in the event of any alarm, an alarm message window, which contains both the name and the number of the alarm, will appear in this area. The alarm messages are the current active alarms that are occurring on the machine or the most significant, if more than 2 are occurring. If there are more than 2 alarms, the additional alarms may be viewed on the Machine view by pressing the Machine Navigation key. 4. Status Area: one message is displayed to describe the current status of the machine.

Rev. B

1-9

1-10 PHOENIX

OPERATOR MANUAL

5. BPM Area: displays the last systolic and diastolic blood pressure and the heart rate as measured by the Blood Pressure Monitor. Moreover it displays the time of the last BPM measurement. 6. Operator Message Area: displays the operations that need to be carried out or messages regarding the status of the machine. 7. Pictogram Area: displays a visual indicator of machine state/operation. (see “Pictograms ” in this section) 8. Icon Area: displays the icons that represent current feature/option enabled. (see “Icons representing processes” in this section) 9. Parameter Area: displays parameters appropriate to the operation in process and view displayed. 10.Arterial/Venous Pressure Bar Graphs: displays current arterial and venous pressures. 11.Blood Pump Speed/Flow Area: displays current blood pump speed and compensated blood flow rate. 12.Action/Selection Key Area: displays Action keys used to start each specific operation and Selection keys for selection menus. 13.Navigation Keys Area: used to access each available Touch Screen view. 14.HOME Navigation Key Area: displays the HOME Navigation Key icon. (see “HOME icon” in this section)

WARNING To operate the machine correctly, pay careful attention to the messages displayed in the Operator Message Area of the Touch Screen.

Note Some Action keys and parameters appearing on the Touch Screen are currently not available. In this manual they are described as “CURRENTLY NOT AVAILABLE”.

Note Format of time representation is settable in Configuration environment. Format of time representation in this manual is only for reference.

• a Main Control below the Touch Screen:

Or

Rev. B


• a Blood Pump Control above the Blood Pump:

• a Heparin Control above the Heparin Pump:

The buttons located on the Main Control are called FUNCTION BUTTONS:

MUTE button used in an alarm condition to silence the audible alarm (see Section Alarms and Signals).

OVERRIDE/RESET button used in an alarm condition to override/reset an alarm (see Section Alarms and Signals).

or

SAFE button allows the to put the machine in the safety state customized by the facility in Configuration. (CURRENTLY NOT AVAILABLE)

HELP button (CURRENTLY NOT AVAILABLE) HEART button: Initiates a BPM measurement outside of the automatic interval. Pressing the HEART button initiates a blood pressure measurement. EVENT/INTERVENTION button: Allows the to mark a patient event/intervention and store it in the system memory. (CURRENTLY NOT AVAILABLE) See Section 7 - Communication System in this manual for a detailed description.

SET button is used to enter the Set Mode set

CONFIRM button. Used to confirm and store the values selected or actions requested.

PLUS and MINUS buttons increase/decrease the parameter values when the parameter has been selected in Set mode and it has a numeric value. The buttons located on the Heparin Pump Control are called HEPARIN PUMP Function buttons: Rev. B

1-11

1-12 PHOENIX

OPERATOR MANUAL

ARROW LEFT and ARROW RIGHT buttons are used to position the heparin syringe plunger clamp against or away from the syringe plunger. Placement of this clamp against the syringe plunger is very important to ensure accurate delivery of heparin. The buttons located on the Blood Pump Control are called BLOOD PUMP Function buttons:

ON / OFF button is used to start the blood pump at the preset start value or to stop it when it is running. Note: When the Blood Pump is stopped due to an alarm condition, the ON / OFF button is not active.

RESUME button is used to restart the blood pump at the previous set value or to restart the blood pump after an ! Air & Foam Detector alarm (#4). PLUS and MINUS buttons are used to change the blood pump speed The green Led on the ON / OFF button can be ON, OFF or flashing depending on the machine operating conditions. The Led is ON: • When the Blood Pump is running; • In SN dialysis, during both the arterial and the venous phases of the cycle; • When the Blood Pump is stopped due to an alarm condition. The Led is OFF: • When the Blood Pump is stopped by using the ON / OFF button; • When a machine phase, in which the Blood Pump is running, is stopped due to an operator intervention (for example Recirculation phase stopped due to the selection of the RECIRC Action key). • When a machine phase, in which the Blood Pump is running, has been correctly completed (for example the programmed RINSEBACK VOLUME value has been reached). The Led is Flashing: • When the Blood Pump speed is controlled by the machine and can not be changed by pressing the PLUS and MINUS buttons (i.e. during the Automatic Gradual Ramping).

Note An audible signal (an high tone followed by a low tone) triggers, following the selection of a button, when: • The machine has not been temporarily able to detect correctly the button previously selected; in this case wait at least 5 seconds before pressing again a button to let the machine recognize the selection made. • A superimposed window is present on the Touchscreen and the selection of that particular button is not requested by the superimposed window. • The PLUS and MINUS buttons are pressed but a manual increment/decrement of the blood pump speed is not possible in that machine phase.

Rev. B


1-13

Operating modes When the machine’s ON/OFF switch is turned ON the software program is loaded. It takes a few minutes for the machine to become fully operational. The progress and the successful completion of the software loading process can be seen on the Touch Screen.

WARNING Check that the alarm lights and audible indicators come on for a short time immediately after the machine is powered ON (see Section 5.B - Test Procedures, in this manual). If either signal is not present, one or both signals have malfunctioned. Call for service. Do not operate the machine if the alarm safety system is not functioning. The operator takes full responsibility when a dialysis treatment is carried out in the absence of the audible and visual alarms.

Note If the Touch Screen turns black or white during the software loading process, a temporary machine malfunction has occurred. Switch OFF the machine, wait 5 seconds and then switch ON the machine again.

At the end of the software loading process, the Idle view is displayed on the Touch Screen indicating which procedures are available to run. 12:30

IDLE

PATIENT DATA

SETUP

ADR BPM

REPORT

CONFIG

RX CONFIG

MACHINE

Each view is referred to by its Navigation key name. The pictogram displayed in the upper right hand corner of the touch screen indicates the current status of the machine. The operator can choose which procedures to run as described in the following sections of this Operator’s Manual. For each process/procedure, the specific function of each ACTION key is explained as well as the operations to be carried out. Rev. B

1-14 PHOENIX

OPERATOR MANUAL

At Power ON, information related to the status of the last machine process, correctly completed or interrupted just prior to the machine Power OFF, is displayed on the Touch Screen. Depending on the process, some of the following Icons and relevant Help Messages may appear on the Touch Screen in the Parameter Area, as listed below: (1)

NO ICON

(1)

NO ICON

(1)

NO ICON

Acetate Dialysis Completed

h:min – day/month/year

Bicarbonate Dialysis Completed


BiCart Dialysis Completed


Acetate Dialysis Stop

h:min – day/month/year Phase XX

(See Note 1) or

(1)

Bicarbonate Dialysis Stop


(See Note 1) or

BiCart Dialysis Stop


(See Note 1) Acetate Dialysis Alarm message (if present) or or


(See Note 2)

or

Bicarbonate Dialysis Alarm message (if present)

or

BiCart Dialysis Alarm message (if present)


(1) (See Note 2) h:min – day/month/year Phase XX

(See Note 2) or

(1)

(1)

or Rinsing Performed Correctly


Rinsing not Performed Correctly Stop or Alarm message (if present)


(See Note 3)

(1)

(1)

Chemical Proc. Performed Correctly


Chemical Proc. NOT Performed Correctly Stop or Alarm message (if present)


(See Note 3)

(1)

(1)

Heat Proc. Performed Correctly


Heat Proc. NOT Performed Correctly Stop or Alarm message (if present)


(See Note 3)

Rev. B

Phase XX


(1)

(1)

Heat CWP Proc. Performed Correctly


Heat CWP Proc. NOT Performed Correctly Stop or Alarm message (if present)


(See Note 3)

(1)

(1)

Heat Citric Proc. Performed Correctly


Heat Citric Proc. NOT Performed Correctly Stopor Alarm message (if present)


(See Note 3)

(1)

(1)

Rinse+Bicarb Line Performed Correctly


Rinse+Bicarb Line Not Perf. Correctly Stop or Alarm message (if present)


(See Note 3)

(1)

(1)

CCK Lines Rinse Performed Correctly


CCK Lines Rinse NOT Performed Correctly Stop or Alarm message (if present)


(See Note 3) Chem+Bicarb Line Proc. NOT Perf. Correctly Stop or Alarm message (if present)

(1)


(See Note 3) Process AutoStart Enabled RINSING or HEAT or HEAT CWP or CHEMIC. 1 or CHEMIC. 2 or CHEMIC. 3 or CHEMIC. 4 or H. CITRIC Failure of the…[test failed]…Test New Session Feature not Allowed

(2)

(3)


(See Note 4) Failure of the…[test failed]…Test

(3) (4)


(See Note 5)

NO ICON

SETUP not Allowed. To allow SETUP remove connector from Central bicarb port and reinsert if needed

(See Note 6)

(5)

NO ICON

SETUP not Allowed. A Disinf. Process Must be performed to allow SETUP

(See Note 6)

Rev. B

1-15

1-16 PHOENIX

OPERATOR MANUAL

Note Format of date representation in the Help Messages displayed at the machine power ON is settable in Configuration environment. Format of date representation in the above table is only for reference.

Note 1 This message is displayed in case of dialysis treatment interrupted during dialysate preparation or priming phase due to an operator intervention. Along with the Help message on the type of dialysis interrupted, are also displayed the message informing that an stop caused the dialysis treatment to be interrupted, the time and the machine operating phase in which the dialysis treatment has been interrupted.

Note 2 This message is displayed in case of machine Power OFF following dialysate type selection. Along with the Help message on the type of dialysis interrupted, are also displayed the first alarm message that was displayed in the Alarm Area (if present) before machine Power OFF; the time and the machine operating phase in which the dialysis treatment has been interrupted.

Note 3 This message is displayed in case of ADR process interrupted due to an operator intervention or in case of machine Power OFF during an ADR process. Along with the Help message on the type of ADR process interrupted, are also displayed the reason that caused the ADR process to be interrupted ( intervention or the first alarm message that was displayed in the Alarm Area before machine Power OFF); the time and the machine operating phase in which the ADR process has been interrupted.

Note 4 This message is displayed in case of failure of one of the following T1Tests: Temperature, Cond A, Cond B and BLD.

Note 5 This message is displayed in case of failure of one of the following T1Tests: Board U, EPROM CRC, Comparator, Battery, Voltages (24V), Venous Clamp, Electrovalves, Art/Ven Pressure, Blood Pump, PI/PO Pressures and Ultrafiltration Pump.

Note 6 Refer to Section 3 – Central Concentrate Supply, in this manual, for the detailed description of the CCK Bicarbonate Line Disinfection and of the CCK Acid and Bicarbonate Lines Rinse.

Rev. B


1-17

The above Help Messages appears on the Touch Screen in the Parameter Area, in the following order: 12:30

IDLE

Messages related to the completion of a process. In the above table are indicated as (1) Message related to the Autostart feature. In the above table are indicated as (2) Line Not Used

PATIENT DATA

Line Only for Service use

SETUP

Messages related to the T1Tests failure. In the above table are indicated as (3) Message related to the completion of the Central Bicarbonate Line Rinse. In the above table are indicated as (4) Message related to the completion of the Central Acid and Bicarbonate Lines Rinse. In the above table are indicated as (5) BPM

REPORT

CONFIG

RX CONFIG

ADR

MACHINE

For information about the Dialysis process refer to Section 5 – Dialysis Operation; for information about the ADR Cycle refer to Section 6 – Clean/Disinfect, for information about the CCK Bicarbonate Line Disinfection and about the CCK Acid and Bicarbonate Lines Rinse refer to Section 3 – Central Concentrate Supply in this manual.

Rev. B

1-18 PHOENIX

OPERATOR MANUAL

1.3.1 Icons representing processes The icons relating to particular machine processes or alarms are listed below: The Patient Sensor, positioned on the venous line in the Air Bubble Detector housing, has not detected the presence of blood. The Patient Sensor, positioned on the venous line in the Air Bubble Detector housing, has detected the presence of blood and all machine safety systems are activated. The Patient Sensor, positioned on the venous line in the Air Bubble Detector housing, has detected the presence of blood or there is a failure of the congruency test. Not all machine safety systems are activated. Linear heparinization has been selected. The Heparin Pump is performing a linear heparinization. Automatic bolus heparinization has been selected. The Heparin Pump is performing an automatic bolus heparinization Manual bolus heparinization has been selected. The Heparin Pump is performing a manual bolus heparinization. The Total Fluid Removed is at least 100 g more than the Total Fluid Removed forecasted for that time. The UFR value suggested for recovery is shown in the SET Mode, selecting the UFR parameter. The Total Fluid Removed is at least 100 g less than the Total Fluid Removed forecasted for that time. The UFR value suggested for recovery is shown in the SET Mode selecting the UFR parameter. The BPM device has been activated (automatic mode) A BPM measurement (manual or automatic) is in progress BY-. The machine is in by and dialysate flow is diverted from the dialyser.

Rev. B


1-19

A transmembrane pressure alarm is present and a negative TMP condition exists. Diascan is active and calibrated • Diascan autocalibration in progress • A Diascan measurement (manual or automatic mode) is in

progress Diascan is present but not working

The machine is configured for use of the Patient Card. (This icon is not currently displayed) Conductivity Profiling has been activated.

UF Profiling has been activated.

Conductivity and UF Profiling have been activated

CentryNet option has been deactivated.

CentryNet option is active but communication between the network controller and the machine does not occur. CentryNet is active and effective communication is in progress. When there are records to be taken by the CentryNet network controller this icon flashes until the controller has successfully taken all records. Waiting/reading data.

In the description of each process, these icons will not be not shown. Please refer to this Section for their description.

Rev. B

1-20 PHOENIX

OPERATOR MANUAL

1.3.2 HOME icons The icons displayed in the HOME Navigation key Area are listed below: HOME Navigation key icon selected. HOME Navigation key icon not selected. HOME Navigation key icon selected in Set mode.

Rev. B


1.3.3 Pictograms 1.3.3.1

Background shape Different shapes are used for each pictogram. The shapes and their meanings are listed below: Alert: this shape is used to draw the operator's attention to an alarm or warning situation.

Transitory Status: this shape means the machine has been put in a temporary situation after an operator action. The operator has to respond to exit this status.

Out of Treatment: this shape means "out of treatment process"

In Treatment: this shape means "in treatment process". Treatment starts when the operator initiates the preparation and ends after the FINAL RINSE.

1.3.3.2

List of Pictograms Idle: the machine is waiting for an operator action

Rinsing: the machine is performing a RINSING process.

Rev. B

1-21

1-22 PHOENIX

OPERATOR MANUAL

Heat Disinfection/Heating: the machine is performing a heat disinfection. The heating phase or the temperature sustained phase is in progress.

Heat Disinfection/Cooling: the machine is performing a heat disinfection. The Cooling phase is in progress.

Heat Citric Disinfection/Heating: the machine is performing a Heat Citric disinfection. The heating phase or the temperature sustained phase is in progress.

Heat Citric Disinfection/Cooling: the machine is performing a Heat Citric disinfection. The cooling phase is in progress.

Chemical Disinfection: the machine is performing a Chemical disinfection.

Dialysate Preparation & Test: the machine is performing the dialysate preparation and the functional test is in progress.

Dialysate Preparation & Test completed: the machine is performing the dialysate preparation and the functional test is completed.

Dialysate Preparation & PA or PB or PUF Autocalibration: the machine is performing the dialysate preparation and the PA or PB or PUF Autocalibration.

Rev. B


Dialysate Preparation ended awaiting Priming: the machine has completed the dialysate preparation and is waiting for an operator action to start priming.

Dialysis Priming without UF: the machine is performing dialyser priming without UF; only the blood side priming is started. or Manual Priming: the machine is performing the manual priming of the dialyser. Dialysis Priming with UF: the machine is performing dialyser priming with UF; the blood side and the dialysate side are filled.

Dialysate Priming of dialyser: the machine is rinsing the dialysate compartment first; only the dialysate side is filled. (This pictogram is not currently displayed)

Priming ended awaiting Recirculation: the machine has completed the priming phase and is waiting for an operator action to start Recirculation. (This pictogram is not currently displayed)

Diascan Autocalibration: Diascan autocalibration is in progress.

Dialysate Recirculation: the machine is performing RECIRCULATION.

End Priming, awaiting Patient Connect: the machine has completed priming and is waiting for an operator action to start patient connection.

Rev. B

1-23

1-24 PHOENIX

OPERATOR MANUAL

Patient Connection: patient connection is in progress.

Dialysis: treatment is in progress.

Single Needle Dialysis: Single Needle dialysis is in progress.

Pause Therapy: The PAUSE THERAPY Action key has been selected for a temporary disconnection of the patient during treatment.

WASHBACK: WASHBACK is in progress.

Dialyser Emptying/Autoemptying: The dialyser emptying process is in progress.

Descaling: The machine is performing the DESCALING process with acid or vinegar solution after EMPTYING.

Rinsing: FINAL RINSE is in progress.

Rev. B


Warning: warning yellow lamp.

Alarm: alarm red lamp.

Set: SET MODE.

Select: selection menu.

In the description of each process, these pictograms will be not shown. Please refer to this Section for their description.

Rev. B

1-25

1-26 PHOENIX

OPERATOR MANUAL

1.4 Parameter Modification All significant parameters for the current process appear in the view chosen on the Touch Screen. In order to modify parameter values, the operator must first press the SET button on the Main Control . By pressing the SET button on the Main Control , the SET MODE is activated and a view that has all parameters available for modification will appear as shown below:

12:30

IDLE

Parameter Name

Parameter Name

Parameter Value Unit of Measure Max

Min Parameter Name

Unit of Measure Max

Parameter Name

Unit of Measure Max

Parameter Name

Unit of Measure Max

Min

Unit of Measure Max

Unit of Measure Max

Parameter Name

Unit of Measure Max

Parameter Name

Parameter Value Min

Unit of Measure Max

HOME

(NOTE 1)

Min

Unit of Measure Max

Min

Unit of Measure Max

(NOTE 1)

(NOTE 1)

Parameter Value Parameter Name

Unit of Measure Max


Min Parameter Name

Parameter Value Min

Unit of Measure Max

Min

Parameter Value Min

Unit of Measure Max

Min Parameter Name

Unit of Measure Max

Parameter Name

Parameter Value

Parameter Value

Parameter Value

Parameter Name

Parameter Value Min

Min

Unit of Measure Max

Parameter Name


Parameter Value Min

Min

Parameter Name



Parameter Value Min

Min

Unit of Measure Max

Parameter Name

Parameter Value Min

Parameter Name

Parameter Value


Min Parameter Name

Parameter Value

Parameter Value

Min

Unit of Measure Max

Min

(NOTE 1)

(NOTE 1)

(NOTE 1)

Unit of Measure Max

(NOTE 1)

Note The Navigation keys change according to the Config category selected.

At this point it is possible: • To select a specific parameter to be modified by touching the parameter box on the Touch Screen. • To increase or decrease the value by using the PLUS and MINUS buttons on the Main Control . • To select a different parameter for modification by touching that parameter box on the Touch Screen. Once the desired value for the parameter has been reached, press the CONFIRM button on the Main Control to accept and store the value in memory. Each parameter must be confirmed individually.

Rev. B


A yellow SAFETY BOX appears in the lower right hand corner of the Touch Screen when a Safety Relevant parameter has been selected for modification (refer to Section 02 – Configuration Description, in this manual: the Safety Relevant parameters are marked in the Parameters List). Press the SET button a second time when the parameter modification has been completed to exit the SET MODE and to return to the current process view. The machine will exit the SET Mode automatically if the elapsed time without a key or button being pressed exceeds the value set for the TO VIDEO parameter. The length of this timeout may be programmed in the Configuration menu.

Note 30 seconds is the default interval. The value range is selectable from 10 to 90 seconds (for more details see Section 2 - Configuration Description, in this manual).

The parameter value displayed during normal operating processes is the same as the current value.

Note If the operator selects a Safety Relevant parameter for modification (refer to Section 02 – Configuration Description, in this manual: the Safety Relevant parameters are marked in the Parameters List), the parameter being modified is shown in two places: it appears on the Touch Screen in the usual position and it appears in the yellow SAFETY BOX in the lower right hand corner of the Touch Screen. Carefully check the two values to make sure they are the same. The duplicate image in the yellow SAFETY BOX disappears as soon as the value is confirmed. Pressing CONFIRM allows the Protection Module to accept the value displayed in the yellow SAFETY BOX and store it in two different memory locations.

WARNING If the two values, stored by the Protection Module, for the same Safety Relevant parameter are not identical at the time of use, a class Pd alarm is triggered (see Section 08 Alarms and Signals, in this manual). Modification of a Safety Relevant parameter may cause a class Pd alarm, since the machine recognizes a change in the parameter. This alarm is controlled by the machine in the normal way for class Pd alarms, but the audible alarm is automatically disabled for 2 minutes.

Rev. B

1-27

1-28 PHOENIX

OPERATOR MANUAL

Setting Alarm Limits for ARTERIAL, VENOUS, SN MAXIMUM and SN MINIMUM PRESSURE. The arterial and venous pressures appear on separate pressure bar graphs. An alarm limit window, rather than a specific value, is selected for each pressure and it is displayed on the colour coded (red = arterial, blue = venous) bar graph. The alarm limit window can be selected in the following ways:

ARTERIAL / VENOUS PRESSURE The negative and positive pressure alarm limit window: • can be confirmed by selecting the colour coded area on the graph in Set mode and then pressing the CONFIRM button on the Main Control . • can be adjusted by selecting the colour coded area on the graph in Set mode, by pressing the PLUS (increase high/low limit) and MINUS (decrease high/low limit) buttons to move the alarm limit window to positive/negative pressure values and then by pressing the CONFIRM button on the Main Control . The minimum (low venous pressure) limit of the alarm window corresponds to a value 40 mmHg less than the confirmed venous pressure value. The maximum (high venous pressure) limit of the alarm window corresponds to a value 70 mmHg greater than the confirmed venous pressure value. The minimum (low arterial pressure) limit of the alarm window corresponds to a value 100 mmHg less than the confirmed arterial pressure value. The maximum (high arterial pressure) limit of the alarm window corresponds to a value 100 mmHg greater than the confirmed arterial pressure value. In Single Needle dialysis, the limits are +10 mmHg and the value set for the VEN PRES LIMIT parameter in Config/Centre Conf/Treat.Conf, respectively.

Note In Single Needle dialysis, the value set for the VEN PRES LIMITparameter has to be the same as the value set for the SN Pparameter to avoid the “! Ven Pressure Limit” #154 Alarm occurrence.

SN MAXIMUM and SN MINIMUM PRESSURE (Single Needle transition pressure) The SN P and SN P parameters control the cycling of the single needle transition from the arterial phase to the venous phase. These minimum/maximum pressure values are selected using the PLUS (increase maximum) and MINUS (decrease minimum) buttons. Store values by pressing the CONFIRM button on the Main Control .

Note Following adjustment of the blood pump speed, the machine automatically recognizes the new venous and arterial pressure value, created by the change in the blood pump speed.

Rev. B


Note The venous pressure window limit is automatically set to between -50 and +250 mmHg: • In PRIME and WASHBACK • After the RESUME button selection in case of! Air & Foam Detector alarm (#4). The arterial pressure window has a range of -400 mmHg to +150 mmHg;

Setting BLOOD PUMP SPEED This value is set from the Blood Pump Control , using the PLUS (increase) or MINUS (decrease) buttons on the Blood Pump Control .

Note Adjustment of the blood pump speed may lead to venous and arterial pressure fluctuations and a venous pressure/arterial pressure alarm may be triggered. To prevent this, for 30 seconds following a change in the blood pump speed: • The venous pressure alarm lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 - Configuration Description, in this manual). • The arterial pressure alarm lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg.

Note If the blood pump speed is set to zero by the operator, the machine will automatically set the UFR to its minimum value. When the blood pump speed is reset to a value greater than zero, the UFR returns to the value set by the operator.

Note Calculation of the BLOOD FLOW in SN mode may be done by using the blood pump activation time and the blood pump speed: BLOOD FLOW =

Blood Pump Speed x TART TCYCLE

TART

= Active time of Blood pump

TCYCLE

= Cycle time (activation + deactivation)

Rev. B

1-29

1-30 PHOENIX

OPERATOR MANUAL

1.5 Monitoring of Venous Pressure and Venous Needle Dislodgement The Phoenix hemodialysis machine is provided with a venous pressure monitoring system able to trigger an alarm condition in case that the patient venous pressure falls below the venous pressure alarm threshold set by the operator (Refer to the “Setting Alarm Limits for ARTERIAL, VENOUS, SN MAXIMUM and SN MINIMUM PRESSURE” paragraph in this Section for the description of how to set the alarm limits for venous pressure). has to be aware that venous pressure monitoring system is not always able to detect the pressure drop caused by a venous needle dislodgement. This particular situation is described in the literature1 To reduce the risk related to a Venous Needle Dislodgement event, carefully follow the guidelines below: 1. Ensure that the venous needle and the venous line are adequately fixed to the patient according to your facility's protocol. 2. Make sure that the patient's access is visible at all times during the dialysis treatment. Do not cover the access with clothing, blankets, linens. 3. Visually inspect the patient's access frequently for needle security and site bleeding. Pay a special attention to patients who are moving a lot during the dialysis treatment. 4. Recommend patient to inspect its access site frequently. 5. Properly adjust the venous pressure alarm windows. In particular, it is recommended that the lower venous alarm limit is set as close as possible to the actual value of the patient venous pressure.

WARNING Monitoring of the Venous Pressure could not always detect the disconnection of a venous needle from its access site, which may result in extracorporeal blood loss to the environment. When a venous needle disconnects from its access, pressure at the venous monitoring side may only decrease by the pressure maintained within the patient's access site. This pressure drop may be less than the width of the machine's venous pressure alarm window: in this particular case the disconnection of a venous needle from its access site is not detectable by the machine, even if pressure alarms and alarm windows are properly set. To reduce the risk of needles disconnection: • ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol; • ensure that the patient's access is visible at all times during the dialysis treatment; • inspect frequently the patient's access; • adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms.

1

Sandroni S. Venous needle dislodgement during hemodialysis: An unresolved risk of catastrophic hemorrhage. Hemodialysis International (abstract) 2005; 9: 33-34. Medical Device Safety Reports. Undetected venous line needle dislodgement during hemodialysis. Health Devices 1998; 27: 404-406.

Rev. B

2 CONFIGURATION DESCRIPTION 2.

SECTION 2 - CONFIGURATION DESCRIPTION

2.1 Configuration Environment General Description Before carrying out a dialysis process, the operator can set the parameter values to be used during dialysis entering the Configuration environment. This may be done by selecting, from the IDLE View, the Config Navigation key or the Rx Config Navigation key (in case of individual prescription parameters configuration – Patient/Rx keys will individualize a particular prescription parameters configuration). 12:30

IDLE

BPM

REPORT

KT/V

PROFILE

CONFIG

RX CONFIG

MACHINE

Rev. B

2-2

PHOENIX OPERATOR MANUAL •

When the Config Navigation Key is pressed, the following view is displayed:

12:30

IDLE

CONFIG

Rev. B

MACHINE

CENTRE CONF

ADR

TREATMENTS

PROFILE

KT/V


•

When the Rx Config Navigation Key is pressed, the following view is displayed:

12:30

IDLE

1ST PATIENT 2ND PATIENT 3RD PATIENT 4TH PATIENT 5TH PATIENT 6TH PATIENT 7TH PATIENT RX CONFIG

The can navigate through the views grouping all the configuration parameters of the machine by using the Navigation keys: pressing each Navigation key allows the to access the parameters related to the designated function, allowing customization of machine performance.

Note Both the Config and the Rx Config Navigation Key are only available when the machine is in the IDLE mode.

Rev. B

2-3

2-4


2.1.1 Entering Data on the Configuration Environment WARNING Setting of the Configuration environment must be performed exclusively under the authority of a physician. The physician is solely responsible for clinical adequacy of the parameters setting. In the next paragraphs all the views of the Configuration environment, with corresponding parameters are described. The following procedure must be followed to modify machine parameters: After selecting the Navigation key for the parameters to be modified, a view with the following structure is displayed: 12:30

IDLE

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

NOTE 1

NOTE 1

NOTE 1

NOTE 1

NOTE 1

NOTE 1

NOTE 1

Note 1 The Navigation keys vary depending on the selection made from the Configuration environment.

Note The number of parameters displayed in the Parameter Area can be variable.

A list of all the parameters related to the Navigation key pressed is displayed in this view. Each parameter appears on the parameter area in a double column representation. Rev. B


The operator may modify any parameter value by pressing the SET button on the Main Control . When the SET button is pressed, the SET Mode is activated and the view will change, as shown in the example below: 12:30

IDLE

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER NAME

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

UNIT OF MEASURE MIN MAX PARAMETER NAME




PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE





PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE





PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE





PARAMETER VALUE PARAMETER VALUE PARAMETER VALUE PARAMETER UNIT OF MEASURE UNIT OF MEASURE UNIT OF MEASURE VALUE MAX MIN MAX MIN MAX

MIN

MIN

SAFETY BOX

UNIT OF MEASURE MAX

At this point it is possible: • To select a parameter by touching the parameter box area. • To change a parameter with a “numeric” value by using the PLUS and MINUS buttons on the Main Control . These buttons are used to modify the desired value for a parameter within a fixed range. Once the desired value has been reached, pressing the CONFIRM button on the Main Control accepts the value and stores it in memory. • To change a parameter with a “string” value: after touching the parameter box area, a new view appears with a list of all the values for that parameter. This view has the same form as the previous one: the possible values for the parameter are located in parameter boxes, by touching these areas the operator selects the desired value. The parameter box corresponding to the current value for the parameter selected is yellow highlighted. Once the desired value has been selected, pressing the CONFIRM button on the Main Control accepts the value and stores it in memory. • To move from one parameter to another by pressing a different parameter box area.

Rev. B

2-5

2-6

PHOENIX OPERATOR MANUAL The SAFETY BOX, a yellow second box, appears when a Safety Relevant parameter has been selected (refer to “2.1.2 Parameters List” for a list of all the Safety Relevant in the Parameters List). parameters: the Safety Relevant parameters are marked

WARNING Before confirming a value for a Safety Relevant parameter (refer to “2.1.2 Parameters List”: the Safety Relevant parameters are marked in the Parameters List) make sure that the value to be confirmed is the same as the value displayed, for that parameter, in the yellow SAFETY BOX. Confirming a value different from that displayed in the yellow SAFETY BOX can cause machine alarms related to that parameter. If you erroneously confirm a value which is different from the value displayed, for that parameter, in the yellow SAFETY BOX, switch OFF the machine, wait 5 seconds, then switch ON the machine again. Press the SET button again when parameter modification has been completed: the previous view appears.

Note All the parameters may be seen on the Configuration views, but their values can no longer be modified.

Note The previous parameter selection view may be accessed again by pressing the SET button on the Main Control .

Note After modifying a parameter value in the CONFIGURATION environment and before switching off the machine, wait at least 5 seconds to avoid a failure in the data storage.

Note In the following paragraphs, a list of all the available parameters in their proper view is presented.

2.1.2 Parameters List Below is an alphabetic list of all the parameters, with their respective limits or possible values, which may be verified by the operator.

Note set

The parameters marked may not be changed by the operator. Their values are automatically calculated by the machine.

Note The parameters marked

Rev. B

are Safety Relevant parameters.


PARAMETER

VALUE

1st PROC First process that can be programmed for the Cleaning Autostart.

NONE/RINSING/HEAT/HEAT CWP/CHEMIC. 1/CHEMIC. 2/CHEMIC. 3/CHEMIC. 4/H. CITRIC

2nd PROC Second process that can be programmed for the Cleaning Autostart.


3rd PROC Third process that can be programmed for the Cleaning Autostart.


ACETATE DIAL USE Enables/disables the use of the Acetate Dialysis mode. AUTO OFF Enables/disables automatic Power OFF following RINSE. ART P Arterial pressure alarm threshold.

YES/NO

BPM USE Enables/disables use of BPM (accessory in Patient dialysis mode). YES turns on BPM , NO turns off BPM, AUTOMATIC allows BPM readings to start automatically with the initiation of Dialysis. AUTO OFF Enables/Disables automatic Power OFF following ADR processes. AUTOCHART TIME Sampling time used by the machine to automatically acquire records for CentryNet/Exalis AUTOEMPTYING Enables/disables the use of the Autoemptying procedure at the end of a DIALYSIS. BAUD RATE Speed of the data transmission BEEP ON TOUCH Enables/disables the generation of a loud beep for all actions. BIC 6.6% COND Bicarbonate conductivity value when the 6.6% formulation is used BIC 8.4% COND Bicarbonate conductivity value when the 8.4% formulation is used. BICARB CONC Type of bicarbonate concentrate formulation. BICART DIAL USE Enables/disables the use of the BiCart Dialysis mode. BICART COND BiCart conductivity value.

UNIT

YES/NO

From the value set for the MIN ART PRESSURE parameter increased of 100 to +50 YES/NO/AUTOMATIC

mmHg

YES/NO

00:00 to 01:00 in steps of 00:15

h:min

YES/NO

1200; 2400 ; MEMORY CARD; 9600 YES/NO

4.6 to 6.0 in steps of 0.1

mS/cm


mS/cm

6.6/8.4

%

YES/NO


mS/cm

Rev. B

2-7

2-8

PHOENIX OPERATOR MANUAL PARAMETER BLD SENS Sensitivity level of the Blood Leak Detector to the presence of blood in dialysate. BLOOD FLOW Blood flow value. BOLUS INTERVAL Time interval between each Heparin Bolus. CCM IDENTIF Machine identification number for communication with CCM. CENTR BICARB LINE Selection of the Central Bicarbonate Line Disinfection process. CLEARANCE ALA. Enables/disables clearance alarm. CLEARANCE LEVEL Threshold value for clearance alarm SW COMM SYSTEM Selection of the software system to which the machine will be connected. CON CURVE TYPE Selection of the Conductivity curve type in Profiling. COND STEP Conductivity value for the conductivity step. CONDUCTIVITY Final conductivity value. COOLING Execution of the cooling phase after the heat disinfection. CURVE COEFF Percentage of the rate of change in Cond or UF during Profiling. DATE DISPLAY MODE Format of Date representation.

DAY Current day (calendar context) DAY NAME Name of the current day (calendar context) DELTA WEIGHT Difference between patient weight pre and post dialysis. Depurated Vol Volume of body water purified during DIALYSIS. DESCALING TIME Length of time for rinsing with an acidic solution after EMPTYING (Bicarbonate dialysis). DIAL AUTO PRIME Enables/disables the priming mode selectable during dialysate preparation.

Rev. B

VALUE

UNIT

LOW/HIGH

set

10 to 580 in step of 10

ml/min

00:05 to 02:00 in steps of 00:05

h:min


set

YES

YES/NO 50 to 300 in steps of 5 Exalis/CentryNet /Rims / Other / None PROGRESSIVE/STEP/CONSTANT

set

13.0 to 17.0 in steps of 0.1

mS/cm

13.0 to 17.0 in steps of 0.1

mS/cm

YES/NO


%

dd/mm/yyyy dd/mm/yy mm/dd/yyyy mm/dd/yy dd mmm yyyy dd mmm yy mmm dd yyyy mmm dd yy 1 to 31

dd

Monday/Tuesday/Wednesday/Thu rsday/Friday/Saturday/Sunday 1 to 20 Kg

set

0 to 200

l

03:00 to 10:00 in step of 01:00

min:s

YES / NO


PARAMETER DIALYSATE FL. Dialysate flow rate during DIALYSIS. DIALYSIS TYPE Type of dialysate concentrates configured for DIALYSIS. INIT DIAL B FLOW Blood pump speed at the initiation of DIALYSIS. DIFFUSION TIME Time remaining until the end of DIALYSIS. Time is stopped when the machine is in BY or when the blood pump stops. DIAMETER Heparin syringe diameter DIASCAN Enables/disables use of the Diascan feature in DIALYSIS. DIASCAN USE Use of Diascan as accessory. DISINF TIME Duration of disinfection process.

DRY WEIGHT Patient’s dry weight for the Volume calculation in Diascan. END DIALYSIS End point of the DIALYSIS treatment. END DIA DATA End dialysis data transferring mode END PRE ALARM Enables/disables alarm at the end of dialysate preparation. END PROCESS MODE Enables the ending mode of the Chemical or Heat citric process. END DIA ALARM Enables/disables alarm at the end of DIALYSIS. INCIDENT Patient event occurring during dialysis EXT SYNCHRO Timeout used at the switch on to detect the network presence. EXTERNAL JUG USE Enables/disables use of external jugs for chemical processes. FINAL RINSE TIME Time remaining until the end ofFINAL RINSE.

VALUE 350 to 800 step of 50

UNIT ml/min

ACETATE/BIC CONC/BIC BICART

set


ml/min

From the value set for the DIALYSIS TIME parameter to 00:00

h:min

13.0 to 25.0 in step of 0.1

mm

YES/NO

YES/NO chemical disinfection: 15:00 to min:s 30:00 or 28:00 to 43:00 in steps of 00:10 if END PROCESS MODE is set Bact. heat disinfection (not available on 12A version):18:00 to 36:00 in steps of 18:00 min or 20:00 to 40:00 in steps of 20:00 if the DIACLEAR Ultrafilter is installed. heat citric disinfection: 24 min or 28 min if the DIACLEAR Ultrafilter is installed. 8.0 to 200.0 in steps of 0.5 Kg

TWL/TIME/ T BL/DIFF. TIME set

REQUESTED YES/NO

None/Bact. / Rins.

YES/NO

00:00 to 01:30 in steps of 00:05

min:s

YES/NO

set

From 01:00 to 00:00

min:s

Rev. B

2-9

2-10

PHOENIX OPERATOR MANUAL PARAMETER FINAL VALUE Conductivity at the end of treatment for the COND profiling curve. GATEWAY Parameter for Internal use. GATEWAY 2nd Parameter for Internal use. GATEWAY 3rd Parameter for Internal use. GATEWAY 4th Parameter for Internal use. HEART Rate Measurement of heart rate. HEPARIN BOLUS Volume of bolus injected automatically. PRIMING HEP Enables/disables automatic priming of heparin line duringSETUP. HEPARIN RATE (in linear heparinization mode) HEPARIN ALARM Enables/disables alarm if heparin has not been activated at the start of DIALYSIS. END HEP ALARM Enables/disables alarm at the end of heparin istration PRE STOP TIME Time between the end of heparin istration and the end of DIALYSIS. HEPARIN TYPE Heparin infusion mode in DIALYSIS. HOURS Hours (calendar context) INITIAL BOLUS Initial heparin bolus (before the linear heparinization mode) INITIAL VALUE Initial value for UF Profiling curve INITIAL VALUE Initial value for COND Profiling curve INSTALL TIME Days elapsed from installation of the DIACLEAR Ultrafilter counted from the selection of the CLEAN DIAL Action key. INTAKES Food or fluids given during DIALYSIS. INTERMEASUREM Interval between two clearance measurements. IONIC CLEARANCE The average effective Clearance of ionized substances. KT/V Dialysis Dose (on Monitoring Graphs). Ionic Mass Bal Mass Balance of ionized substances.

Rev. B

VALUE 13.0 to 17.0 in step of 0.1

UNIT mS/cm

0 to 255 in steps of 1 0 to 255 in steps of 1 0 to 255 in steps of 1 0 to 255 in steps of 1 set

40 to 180

pulse

0.0, 0.5 to 10.0 in steps of 0.1

ml

YES/NO

0.5 to 9.9 in step of 0.1

ml/h

YES/NO

YES/NO

00:00 to 04:00 in step of 00:05

h:min

LINEAR/AUTO BOLUS/MAN BOLUS/NONE 0 to 23 0.0 to 10.0 in steps of 0.1

ml

0.10 to 4.00 in step of 0.01

Kg/h

13.0 to 17.0 in step of 0.1

mS/cm

0 to number of days elapsed from DIACLEAR Ultrafilter installation

days

0 to 1000

g

00:00 to 01:00 in steps of 00:15

h:min

set

0 to 300

ml/min

set

0 to 3.00

set

-500 to 800

set

mmol


PARAMETER IP ADDRESS 1st First part of the T/IP Configuration Addresses of the unit in case of Ethernet connection. IP ADDRESS 2nd Second part of the T/IP Configuration Addresses of the unit in case of Ethernet connection. IP ADDRESS 3rd Third part of the T/IP Configuration Addresses of the unit in case of Ethernet connection. IP ADDRESS 4th Fourth part of the T/IP Configuration Addresses of the unit in case of Ethernet connection. BIC LIQUID DIAL USE Enables/disables the use of Liquid Bicarbonate Concentrate. LIQUID INLET Identifies the inlet port location for the disinfectant used in the chemical disinfection process. TOTAL BLOOD Total blood treated during treatment. MANUAL BOLUS Heparin bolus amount for manual bolus istration. MASK ROUTE1

VALUE

UNIT

0 to 255 in steps of 1




YES/NO

FRONT/REAR 1/REAR 2

0.5 to 360.0 in steps of 0.5

l

0.0, 0.5 to 10.0 in steps of 0.1

ml


Parameter for Internal use. MASK ROUTE1 2nd Parameter for Internal use. MASK ROUTE1 3rd Parameter for Internal use. MASK ROUTE1 4th Parameter for Internal use. MAX BLOOD FLOW Maximum Blood Flow. DIAST PRE MAX Maximum diastolic pressure alarm. HEART R. MAX Maximum pulse rate alarm. SYST PRE MAX Maximum systolic pressure alarm. VEN PRES LIMIT Max venous pressure limit. HD SAFE THRE. Alarm threshold on dialyser transmembrane pressure. SAMPLE INTERV (BPM) Time between 2 blood pressure measurements. MED QUANTITY Medicine quantity/dosage istered during DIALYSIS. MEDICATION Medicine/s istered during DIALYSIS. MIN ART PRESSURE Minimum arterial pressure limit.

0 to 255 in steps of 1 0 to 255 in steps of 1 0 to 255 in steps of 1 250 to 580 in steps of 10

ml/min


mmHg


pu/min


mmHg


mmHg

350/450

mmHg

00:05 to 02:00 in step of 00:05

h:min

-400 to -100 in step of 50

mmHg

Rev. B

2-11

2-12

PHOENIX OPERATOR MANUAL PARAMETER DIAST PRE MIN Minimum diastolic pressure alarm. HEART R. MIN Minimum pulse rate alarm. SYST PRE MIN Minimum systolic pressure alarm. TMP THRESHOLD Alarm threshold on dialyser transmembrane pressure. WLR MINIMUM Minimum fluid removal rate. MINUTES (calendar context). MONTH (calendar context). NET ROUTE1 Parameter for Internal use. NET ROUTE1 2nd Parameter for Internal use. NET ROUTE1 3rd Parameter for Internal use. NET ROUTE1 4th Parameter for Internal use. NETWORK TYPE Selection of the hardware network topology. NEW SESSION USE Enables/disables the use of the New Session procedure and a shortened T1 Test. OFFLINE TIMEOUT Timeout initiated when CentryNet/Exalis indicates lack of communication with the machine. JUMP PRIMING Enables/disables priming of a dialyser and Cartridge Blood Set on another machine and then treatment using this machine. PATIENT ID Code that identifies the patient within the communication system. Each patient must have aunique identifier within the system. BLOOD ALARM Enables/disables an alarm when the Patient Sensor detects blood for 5 minutes and the machine is not in DIALYSIS mode. PAUSE THERAPY Enables the use of Pause Therapy Mode. pH Max High alarm threshold for chemical solution pH monitor used in chemical process. pH Min Low alarm threshold for chemical solution pH monitor used in chemical process. pH MONITOR Enables/disables pH monitoring during disinfection processes. pH VALUE Measurement of the pH value of fluid in the hydraulic pathway.

Rev. B

VALUE

UNIT


mmHg


pu/min


mmHg

-100 to +10 in steps of 5

mmHg

0 to 0.300 in steps of 0.100

Kg/h

0 to 59

min

January/…/December

month

0 to 255 in steps of 1 0 to 255 in steps of 1 0 to 255 in steps of 1 0 to 255 in steps of 1 Serial/Ethernet YES/NO

0:01 to 04:15 in steps of 00:01

min:s

YES/NO


YES/NO

YES/NO 7.5 to 14.0 in steps of 0.1

pH units


pH units

YES/NO

set

1.00 to 12.00

pH units


PARAMETER Plasma Conduct Representation of the effective plasma osmolarity. Post Lying Dias Post dialysis diastolic pressure measurement in a lying position. Post Lying Hrat Post dialysis heart rate measurement in a lying position. Post Lying Syst Post dialysis systolic pressure measurement in a lying position. POST SITTING DIAS Post dialysis diastolic pressure measurement in a sitting position. POST SITTING H.RATE Post dialysis heart rate measurement in a sitting position. POST SITTING SYST Post dialysis systolic pressure measurement in a sitting position. Post Stand Dias Post dialysis diastolic pressure measurement in a standing position. Post Stand Hrat Post dialysis heart rate measurement in a standing position. Post Stand Syst Post dialysis systolic pressure measurement in a standing position. POST WEIGHT Patient weight after dialysis. Pre Lying Dias Pre dialysis diastolic pressure measurement in a lying position. Pre Lying Hrate Pre dialysis heart rate measurement in a lying position. Pre Lying Syst Pre dialysis systolic pressure measurement in a lying position. PRE SITTING DIAS Pre dialysis diastolic pressure measurement in a sitting position. PRE SITTING H.RATE Pre dialysis heart rate measurement in a sitting position. PRE SITTING SYST Pre dialysis systolic pressure measurement in a sitting position. Pre Stand Dias Pre dialysis diastolic pressure measurement in a standing position. Pre Stand Hrate Pre dialysis heart rate measurement in a standing position. Pre Stand Syst Pre dialysis systolic pressure measurement in a standing position.

VALUE set

UNIT

13.00 to 17.00

mS/cm

20 to 250

mmHg

30 to 250

pu/min

40 to 270

mmHg

20 to 250

mmHg

30 to 250

pu/min

40 to 270

mmHg

20 to 250

mmHg

30 to 250

pu/min

40 to 270

mmHg

8.0 to 200.0

Kg

20 to 250

mmHg

30 to 250

pu/min

40 to 270

mmHg

20 to 250

mmHg

30 to 250

pu/min

40 to 270

mmHg

20 to 250

mmHg

30 to 250

pu/min

40 to 270

mmHg

Rev. B

2-13

2-14

PHOENIX OPERATOR MANUAL PARAMETER PRE WEIGHT Patient weight before dialysis. PRIME PUMP SPEED Blood pump speed value during the priming phase. PRIME VOLUME Volume of fluid infused during Dialyser Prime. PAT CONN B FLOW Blood pump speed value during PAT CONNECT phase. BLOOD FLOW Blood pump speed in DIALYSIS mode. RAMPING TIME Time period for Automatic Gradual Ramping of the blood pump speed at initiation of DIALYSIS. Ramping is from 50 mL/min to the value set for INIT DIAL B FLOW over the time defined forRAMPING TIME. REAL TREAT TIME Real time of diffusion during DIALYSIS. RECIRC B FLOW Blood pump speed initial value during the Recirculation phase. RECIRCULATION TIME Recirculation time duration. RECIRCULATION UF UF rate value during the Recirculation phase. RINSE TIME Duration of ADR:RINSE process.

VALUE

set

set

RINSING TIME Duration of rinsing for chemical disinfect process. RINSEBACK B FLOW Blood pump speed initial value during the rinseback phase. RINSEBACK VOLUME Volume of saline to be given in WASHBACK prior to alarm. LOW CONSUMPTION Interval between the IDLE view and the blanking of the Touch Screen (machine low power consumption) after an ADR process correctly completed. SINGLE NEEDLE USE Enables/disables use of Single Needle accessory. SN P Single Needle max commutation pressure. SN P Single Needle min commutation pressure.

Rev. B

UNIT

8.0 to 200.0

Kg


ml/min


ml


ml/min


ml/min

0:00 to 10:00 in steps of 00:30

min:s

00:00 to 23:59

h:min


ml/min

01:00 to 55:00 in step of 01:00

min:s

0.100 to 3.000 in step of 0.100

Kg/h

15:00 to 50:00 in steps of 01:00. If the DIACLEAR Ultrafilter is installed: 19:00 to 50:00.

min:s

If performing a Central Concentrate Lines Rinse: 3 (fixed value) 15:00 to 50:00 in steps of 01:00. If the Clean Dialysate system is installed: 19:00 to 50:00. 50 to 200 in step of 10

ml/min


ml

0:00 to 02:00 in steps of 00:15

h:min

min:s

YES/NO

400 to the value SET for the SN Pparameter increased of 40, in steps of 5 100 to the value SET for the SN Pparameter decreased of 40, in steps of 5

mmHg

mmHg


PARAMETER STATION ID Communication code that identifies the placement of the PHOENIX within the room. Each PHOENIX machine must have a unique identifier. STEP UFR UFR value related to the step selected. (Note 3) SUBNET MASK First part of the Subnet Mask for the machine. SUBNET MASK 2nd Second part of the Subnet Mask for the machine. SUBNET MASK 3rd Third part of the Subnet Mask for the machine. SUBNET MASK 4th Fourth part of the Subnet Mask for the machine. SYRINGE TYPE

SYRYNGE TYPES Selection of the heparin syringe volume. TARGET Kt/V Reached Enable/disable alarm for the percentage of KtKt/V TARGET reached. TARGET Kt/V THRESH Threshold for the target Kt\Kt/V alarms. TARGET KT Volume of body water to be purified during DIALYSIS. TARGET KT/V Dialysis Dose to be achieved during DIALYSIS. TOT WEIGHT L Amount of fluid to be removed during DIALYSIS. TEMPERATURE Temperature of the dialysate TIME 1st P Time of the first Autostart process programmed. TIME 2nd P Time of the second Autostart process programmed.

VALUE

UNIT


0.100 to 4.000, from 0.100 to 0.300 in step of 0.100 and then in step of 0.050 0 to 255 in steps of 1

Kg/h


0 to 255 in steps of 1 0 to 255 in steps of 1

ANOTHER 3S BERTONI (30) BD PLASTIPAK (30) PIC LL (30) ICO GAMMA PLUS (30) PENTA (30) DISPOMED (30) TERUMO (30) ICO GAMMA PLUS (20) ICO MONOSTERIL (20) BD PLASTIPAK (20) TERUMO (20) PIC LL (20) PENTA (20) MONOJECT (20) MONOJECT (12) BD PLASTIPAK (10) TERUMO (10) 10 and 20 ml / 20 and 30ml YES/ NO


%


l

0 to 3.00 in steps of 0.05 0.10 to 30.00 in step of 0.05

Kg

34.0 to 39.5 in steps of 0.1

°C

00:00 to 23:59 in step of 00:10

h:min

00:00 to 23:59 in step of 00:10

h:min

Rev. B

2-15

2-16

PHOENIX OPERATOR MANUAL PARAMETER TIME 3rd P. Time of the third Autostart process programmed. TIME DISPLAY MODE Format of Time representation. TMP Transmembrane pressure TMP ALARM Enables/disables Transmembrane pressure alarm (Note 2) TO VIDEO Length of time the machine remains in SET MODE if a selection key is not pressed. TOTAL FLUID REMOVED Total amount of fluid removed during treatment HEPARIN TOTAL Total heparin infused. TREATM NUMBER Number of treatments in which the DIACLEAR Ultrafilter has been used, from the selection of the CHANGE CLEAN DIAL Action key. DIALYSIS TIME (Note 1) Dialysis treatment time duration. CURVE TYPE Selection of the UF curve type in PROFILING. UF PRIMING Ultrafiltration rate during PRIMING. WEIGHT LOSS/H UF rate during DIALYSIS. (Note 3)

ULTRAF PRES Pressure at the outlet of the DIACLEAR Ultrafilter. ULTRAFIL. USE Enables/disables use of the Clean Dialysate system. VEN P Venous pressure alarm threshold. VINEGAR DESCAL Enables/disables use of the Vinegar Descaling feature. DISTRIB VOLUME Total volume of body water for the patient YEAR Current year (calendar context)

Rev. B

VALUE 00:00 to 23:59 in step of 00:10

UNIT h:min

12 h/24 h/AM/PM set

-100 to 450

mmHg

YES/NO

00:10 to 01:30 in steps of 00:05

min:s

set

0 to 32

Kg

set

5 to 30

ml

set

0 to number of treatments in which the DIACLEAR Ultrafilter has been used 00:30 to 08:00 in step of 00:05

h:min

PROGRESSIVE/STEP/CONSTANT 0.100 to 3.000 in steps of 0.100

Kg/h

From the value set for the WLR MINIMUM parameter to 4.00; if WLR MINIMUM=0 the minimum value for WEIGHT LOSS/H is 0.100. 20 to 200 in steps of 10

Kg/h

mmHg

YES/NO

+50 to the value SET for the VEN PRES LIMIT parameter decreased of +70 NO/YES/ALWAYS

mmHg


%

2000 to 2099

year


2-17

Note 1 The remaining DIFFUSION TIME, calculated from the DIALYSIS TIME set, appears on the Touch Screen.

Note 2 The first time the TMP is outside of the range set, the TMP alarm is generated. If NO has been selected in the parameter TMP, the OVERRIDE button will reset this alarm and an audible reminder will be triggered every 5 minutes. The TMP icon always appears in the event of a TMP alarm and may not be reset.

Note 3 Only for the WEIGHT LOSS/H and Step UFR parameters: • once the minimum parameter value is reached, by pressing the MINUS button in SET mode, this button is no more available; • once the maximum parameter value is reached, by pressing the PLUS button in SET mode, this button is no more available.

Rev. B

2-18


2.2 CONFIG Views 2.2.1 MACHINE Data Configuration The machine data configuration parameters may be changed by the operator by selecting the MACHINE Navigation key from the Config view. When MACHINE is pressed the Accessories view is displayed and the following Navigation keys are available: • Communic. • Date/Times • Wait.Times

2.2.1.1 OPTIONS When the MACHINE Navigation key from the Config view is pressed, the following view appears, where the parameters relative to specific functions available on the machine are displayed: 12:30

IDLE

EXTERNAL JUG USE DIASCAN USE SINGLE NEEDLE USE ULTRAFIL. USE HOT CITRIC USE

CONFIG

MACHINE

ACCESSORIE COMMUNIC. S

DATE/TIMES

WAIT.TIMES

CLEAN DIAL.

Note The Clean Dial. Navigation key is available only if the ULTRAFIL. USE parameter is set to YES.

Rev. B


Note The SINGLE NEEDLE USE parameter is visible and can be set only if the arterial clamp is installed.

Note The ULTRAFIL. USE parameter is visible and can be set only if the DIACLEAR Ultrafilter is used.

Note The HOT CITRIC USE parameter is only available if the proper service configuration has been performed in the machine calibrations environment (Refer to Section 8, in the PHOENIX Service Manual for a detailed description of settings necessary to configure the machine for use of the Heat Disinfection processes).

Note Parameters can only be modified when the machine is in the IDLE mode.

Rev. B

2-19

2-20


2.2.1.2 COMMUNICATION The Communic. menu contains the communication parameters. When the Communic. Navigation key is pressed, the following view appears: 12:30

IDLE

CCM IDENTIF

OFFLINE TIMEOUT

BAUD RATE

AUTOCHART TIME

EXT SYNCHRO

STATION ID

SW COMM SYSTEM

IP ADDRESS 1st

NETWORK TYPE

SUBNET MASK GATEWAY NET ROUTE1 MASK ROUTE1

CONFIG

MACHINE

ACCESSORI ES

COMMUNIC.

DATE/TIMES

WAIT.TIMES

CLEAN DIAL.

Some of the above parameters are available only setting a specific value for some other parameters: for further details see Section 7 - Communication System, in this manual.

Note Parameters can only be modified when the machine is in the IDLE Mode. In order to allow a proper configuration of the communication environment, after modifying a communication parameter: -- Wait 5 seconds and then switch OFF the machine; -- Wait 5 seconds and then switch ON the machine.

Note If the parameter EXT SYNCHRO is set to a value different from 0, when the machine is powered on, a window appears advising the operator that the PHOENIX is synchronizing with the Exalis System. This window remains on the Touch Screen for the time set for the EXT SYNCHRO parameter.

Rev. B


Note In order to allow a proper configuration of the communication environment, the values set for the IP ADDRESS 1ST and SUBNET MASK parameters must be entered also in the machine Calibration environment by a service technician (Refer to Section 8, in the PHOENIX Service Manual, for a detailed description of the parameters to be set).

Note If the SW COMM SYSTEM parameter is set toCENTRYNET USE, the STATION ID parameter is displayed in the Config\Mach.Conf\Communic. view but the parameter value is not modifiable in Set mode of this view. See Section 7 - Communication System, in this manual, for a detailed description of the CentryNet relevant parameters setting.

Rev. B

2-21

2-22


2.2.1.3

DATE/TIME

The Date/Times menu contains the parameters relative to the calendar. When the Date/Times Navigation key is pressed, the following view appears: 12:30

IDLE

YEAR

TIME DISPLAY MODE

MONTH

DATE DISPLAY MODE

DAY NAME DAY HOURS MINUTES

CONFIG

MACHINE

ACCESSORI ES

COMMUNIC.

DATE/TIMES

WAIT.TIMES

CLEAN DIAL.

Note Parameters can only be modified when the machine is in the IDLE Mode.

Note After changing the value set for the HOURS and MINUTES parameter, the machine must be switched OFF and then ON to allow the proper updating of those values.

Rev. B


2.2.1.4

WAIT TIME

The Wait.Times menu contains the parameters relative to delays introduced to exit from certain conditions. When the Wait.Times Navigation key is pressed, the following view appears: 12:30

IDLE

TO VIDEO LOW CONSUMPTION

CONFIG

MACHINE

ACCESSORI ES

COMMUNIC.

DATE/TIMES

WAIT.TIMES

CLEAN DIAL.


Note The blanking of the Touch Screen (low machine consumption) can be performed by both setting the LOW CONSUMPTION parameter (blanking at the time interval set) and pressing the SCREEN OFF Action key in Home/MACHINE view (the Touch Screen becomes immediately blanked).

Rev. B

2-23

2-24


2.2.1.5

CLEAN DIAL

The Clean Dial. menu contains the parameters relative to the DIACLEAR Ultrafilter alarm thresholds. When the Clean Dial. Navigation key is pressed, the following view appears: 12:30

IDLE

ULTRAF PRES

CONFIG

MACHINE

ACCESSORI ES

COMMUNIC.

DATE/TIMES

WAIT.TIMES

CLEAN DIAL.


Note The Clean Dial. Navigation key is only available if the ULTRAFIL. USE parameter is set to YES in Config/MACHINE/Accessories.

Rev. B


2.2.2 CENTER Data Configuration The Centre data Configuration parameters may be changed by the by selecting the Centre Conf Navigation key from the Config view. When Centre Config is pressed, the Automation view is displayed and the following Navigation keys are available: • Functions • Treat.Conf • Alarms

2.2.2.1

AUTO

When the Centre Conf Navigation key is pressed, the following view appears: 12:30

IDLE

PRIMING HEP DIAL AUTO PRIME

CONFIG

CENTRE CONF

AUTOMATION

FUNCTIONS TREAT.CONF

ALARMS

Note Pressing the Config Navigation key will return the machine to the Config selection view.


Note The DIAL AUTO PRIME parameter is only settable if the JUMP PRIMING parameter is set to NO in Config/Centre Conf/Functions. When the JUMP PRIMING parameter is changed from YES to NO, the DIAL AUTO PRIME parameter is automatically set to NO.

Rev. B

2-25

2-26


2.2.2.2

FUNCTION

The Functions menu contains the parameters relative to the activation of particular functions during DIALYSIS. When the Functions Navigation key is pressed, the following view appears: 12:30

IDLE

ACETATE DIAL USE

NEW SESSION USE

BIC LIQUID DIAL USE

VINEGAR DESCAL

BICART DIAL USE

AUTOEMPTYING BEEP ON TOUCH JUMP PRIMING PAUSE THERAPY CONFIG

CENTRE CONF

AUTOMATIO N

FUNCTIONS

TREAT.CON F

ALARMS


Rev. B


2.2.2.3

LIMITS

The Treat.Conf menu contains the parameters relative to specific threshold settings. When the Treat.Conf Navigation key is pressed, the following view appears: 12:30

IDLE

WLR MINIMUM VEN PRES LIMIT HD SAFE THRE. TMP THRESHOLD MAX BLOOD FLOW RAMPING TIME MIN ART PRESSURE

CONFIG

CENTRE CONF

AUTOMATIO N

FUNCTIONS

TREAT.CON F

ALARMS


Note Attention should be given to setting the VEN PRES LIMIT and MIN ART PRESSURE parameters consistently with the patient prescription (needle size, blood flow rate) to avoid pressure alarms.

Rev. B

2-27

2-28


2.2.2.4

ALARMS

The Alarms menu contains the parameters relative to some alarm settings. When the Alarms Navigation key is pressed, the following view appears: 12:30

IDLE

END PRE ALARM BLOOD ALARM HEPARIN ALARM END HEP ALARM TMP ALARM END DIA ALARM

TARGET KT/V REACHED CONFIG

CENTRE CONF

AUTOMATIO N

FUNCTIONS

TREAT.CON F

ALARMS


Rev. B


2-29

2.2.3 ADR Data Configuration The ADR data parameters may be changed by the by selecting the ADR Navigation key from the Config view. When ADR is pressed the Chemical view is displayed and the following Navigation keys are available: • Heating • Rinsing • AutoStart

2.2.3.1

CHEMICAL

When the ADR Navigation key is pressed, the following view appears, where the parameters related to the chemical disinfection process may be set: 12:30

IDLE

CHEM PERS 1 CHEM PERS 2 CHEM PERS 3 CHEM PERS 4

CHEM+CENTRAL BICARB LINE

CONFIG

ADR

CHEMICAL

HEATING

Rinsing

AUTOSTART

Note The CHEM+CENTRAL BICARB LINE Action key is only available if the proper service configuration has been performed in the service environment. (Refer to your technical service for information on your machine configuration).

Different types of Chemical processes can be performed by pressing the CHEM PERS 1, CHEM PERS 2, CHEM PERS 3, CHEM PERS 4 or CHEM+CENTRAL BICARB LINE Action keys. The chemical process name may be changed on this view.

Rev. B

2-30


CHEMICAL 1/2/3/4 When a chemical process has been selected pressing one of the Action keys in Chemical view, the following view appears: 12:30

IDLE

CHEM PERS 2

RINSING TIME

DISINF TIME

CHEM PERS 2

END PROCESS MODE pH MONITOR pH Min pH Max AUTO OFF LIQUID INLET CONFIG

ADR

CHEMICAL

HEATING

Rinsing

AUTOSTART

CLOSE

Note When the pH MONITOR parameter is set to YES, two further parameters are accessible: pH Min pH Max


Rev. B


The chemical process name can be changed by pressing the Set button: a view similar to the following appears: 12:30

IDLE

Chem Name Chemical 2 DISINF TIME

END PROCESS MODE

pH MONITOR

AUTO OFF

LIQUID INLET

RINSING TIME

Rev. B

2-31

2-32

PHOENIX OPERATOR MANUAL Pressing the Chem Name parameter box will cause a new view to appear:

NEW NAME Area 1!

2"

3£

4$

5%

6&

7/

8(

9)

0=

Q

W

E

R

T

Y

U

I

O

P

Lock

A

S

D

F

G

H

J

K

L

Shift

Z

X

C

V

B

N

M

comasemicol on

.:

\|

?

ì^

èé[

+*]

òç@

ù§

<>

-_

à°#

BackSpace

<<

Chem NameChemProc 2

Space

>>

AltGr BackSpace

The operator can modify the chemical process name by touching the keypad; the new name is written in the NEW NAME Area and can be confirmed with the CONFIRM button. Pressing UNDO will allow an exit from this view without saving the changes made.

Rev. B


2-33

CHEM+CENTRAL BICARB LINE When the CHEM+CENTRAL BICARB LINE Action key has been selected in the CHEMICAL view, the following view appears: 12:30

IDLE

Chem Name

RINSING TIME

DISINF TIME

CENTR BICARB LINE

END PROCESS MODE pH MONITOR pH Min pH Max AUTO OFF


LIQUID INLET

CONFIG

ADR

CHEMICAL

HEATING

Rinsing

AUTOSTART

CLOSE

Note When the pH MONITOR parameter is set to YES, two further parameters are accessible: pH Min pH Max


Rev. B

2-34

PHOENIX OPERATOR MANUAL The chemical process can be set by pressing the Set button: the following view appears: 12:30

IDLE

DISINF TIME

END PROCESS MODE

pH MONITOR

AUTO OFF

LIQUID INLET

RINSING TIME

Note The following parameters are not accessible in Set Mode: • Chem Name: always set to “Chem + B. Line”; • END PROCESS MODE: always set to Rins.; • CENTR BICARB LINE: always set to YES.

Rev. B


2.2.3.2

2-35

HEAT

The Heating menu contains the parameters relative to the heating processes. When the Heating Navigation key is pressed, the following view appears: 12:30

IDLE

HEAT HEAT WITH CWP HEAT CITRIC

CONFIG

ADR

CHEMICAL

HEATING

Rinsing

AUTOSTART

Note The HEAT Navigation key is only available if the proper service configuration has been performed in the machine calibrations environment (Refer to Section 8, in the PHOENIX Service Manual, for a detailed description of settings necessary to configure the machine for use of the Heat disinfection option).

Rev. B

2-36


HEAT When the HEAT Action key is pressed, the following view appears: 12:30

IDLE

HEAT

DISINF TIME AUTO OFF COOLING

CONFIG

ADR

CHEMICAL

HEATING

Rinsing

AUTOSTART

CLOSE

Note When performing a standard heat disinfection, by selecting the HEAT Action key, the COOLING parameter value is YES.

Rev. B


2-37

HEAT WITH CWP When the HEAT WITH CWP Action key is pressed, the following view appears: 12:30

IDLE

DISINF TIME AUTO OFF

HEAT WITH CWP

COOLING

CONFIG

ADR

CHEMICAL

HEATING

Rinsing

AUTOSTART

CLOSE

Note When using the Centralized Heat Disinfection system, by selecting the HEAT WITH CWP Action key, the COOLING parameter value is NO.

Rev. B

2-38


HEAT CITRIC When the HEAT CITRIC Action key is pressed, the following view appears: 12:30

IDLE

pH MONITOR pH Min pH Max

HEAT CITRIC

AUTO OFF LIQUID INLET

CONFIG

Rev. B

ADR

CHEMICAL

HEATING

Rinsing

AUTOSTART

CLOSE


2.2.3.3

RINSE

The Rinsing menu contains the parameters relative to the rinsing process. When the Rinsing Navigation key is pressed, the following view appears: 12:30

IDLE

RINSING TIME AUTO OFF

CONFIG

ADR

CHEMICAL

HEATING

RINSING

AUTOSTART

Rev. B

2-39

2-40


2.2.3.4

AutoStart

The AutoStart menu contains the parameters relative to the autostart process. When the AutoStart Navigation key is pressed, the following view appears, where the disinfection and rinsing processes may be configured to start automatically: 12:30

IDLE

1ST PROC

TIME 1ST P

2ND PROC

TIME 2ND P

3RD PROC

TIME 3RD P.

Sunday

NONE

--/--

NONE

--/--

NONE

--/--

Monday

NONE

--/--

NONE

--/--

NONE

--/--

Tuesday

NONE

--/--

NONE

--/--

NONE

--/--

Wednesday

NONE

--/--

NONE

--/--

NONE

--/--

Thursday

NONE

--/--

NONE

--/--

NONE

--/--

Friday

NONE

--/--

NONE

--/--

NONE

--/--

Saturday

NONE

--/--

NONE

--/--

NONE

--/--

CONFIG

Rev. B

ADR

CHEMICAL

HEATING

RINSING

AUTOSTART


Each process can be programmed by pressing the SET button, then selecting the process to be configured by touching the parameter box on the Touch Screen. The following view will appear: 12:30

IDLE

NONE

RINSING

HEAT

HEAT CWP

CHEMIC. 1

CHEMIC. 2

CHEMIC. 3

CHEMIC. 4

H. CITRIC

Note If FRONT is selected for the LIQUID INLET parameter in Config/ADR/Chemical or in Config/ADR/HEAT, theCHEMIC. 1, CHEMIC. 2, CHEMIC. 3, CHEMIC. 4 and H. CITRIC parameter are not displayed.

By pressing the CONFIRM button, the selection made is stored in the AutoStart table and the related TIME PROCESS parameter becomes available. To modify the value of the TIME PROCESS parameter press the SET button, select the TIME PROCESS parameter to be configured by touching the parameter box on the Touch Screen and change the value by using the PLUS and MINUS buttons on the Main Control . Press the CONFIRM button to accept the new value for the parameter.

Note If a process is programmed as NONE, the related TIME PROCESS parameter is not modifiable and is displayed as --/-- in the AutoStart view.

Rev. B

2-41

2-42


2.2.4 Treatment Data Configuration The Treatment data parameters may be changed by the by selecting the Treatments Navigation key from the Config view. When Treatments is pressed the Std Dialysis view is displayed and the following Navigation keys are available: • Heparin • BPM

2.2.4.1

STD HD

When the Treatments Navigation key is pressed, the following view appears: 12:30

IDLE

PRIME PUMP SPEED

DESCALING TIME

PAT CONN B FLOW

SN P

INIT DIAL B FLOW

SN P

ACETATE LIQUID BIC BICART

RINSEBACK B FLOW RECIRC B FLOW RECIRCULATION UF RECIRCULATION TIME RINSEBACK VOLUME CONFIG

TREATMENT S

STD DIALYS

HEPARIN

BPM

The parameters relating to the different types of treatments can be programmed by pressing the ACETATE, LIQUID BIC or BICART Action keys.

Rev. B


ACETATE

Note The ACETATE Action key is accessible only if the parameter ACETATE is configured YES on the Config/Centre Conf/Functions view.

When the ACETATE Action key has been pressed the following view is displayed: 12:30

IDLE

DIALYSIS TIME

TOTAL BLOOD

ACETATE

CONDUCTIVITY TEMPERATURE DIALYSATE FL. UF PRIMING PRIME VOLUME END DIALYSIS BLD SENS CONFIG

TREATMENT S

STD DIALYS

HEPARIN

BPM

CLOSE

Note When selecting TOTAL BLOOD for END DIALYSIS in this menu, the TOTAL BLOOD parameter also becomes available.

Rev. B

2-43

2-44


LIQUID BIC

Note The LIQUID BIC Action key is accessible only if the parameter LIQUID BIC is configured YES on the Config/Centre Conf/Functions view.

When the LIQUID BIC Action key has been pressed the following view is displayed: 12:30

IDLE

DIALYSIS TIME

PRIME VOLUME

CONDUCTIVITY

END DIALYSIS

BICARB CONC

BLD SENS

BIC 8.4% COND

TOTAL BLOOD

LIQUID BIC

BIC 6.6% COND TEMPERATURE DIALYSATE FL. UF PRIMING CONFIG

TREATMENT S

STD DIALYS

HEPARIN

BPM

CLOSE


Note When selecting a value of 6.6% for the BICARB CONC parameter, the parameter relative to the bicarbonate conductivity is BIC 6.6% COND. When selecting a value of 8.4% for the BICARB CONC parameter, the parameter relative to the conductivity value is BIC 8.4% COND.

Rev. B


2-45

BICART

Note This Action key is accessible only if the parameter BiCart is configured YES on the Config/ Centre Conf/Functions view.

When the BICART Action key has been pressed the following view is shown: 12:30

IDLE

DIALYSIS TIME

BLD SENS

CONDUCTIVITY

TOTAL BLOOD

BICART COND

BICART

TEMPERATURE DIALYSATE FL. UF PRIMING PRIME VOLUME END DIALYSIS CONFIG

TREATMENT S

STD DIALYS

HEPARIN

BPM

CLOSE


Rev. B

2-46


2.2.4.2

HEPARIN

The Heparin menu contains the parameters relative to all the heparinization modes. When the Heparin Navigation key is pressed, the following view appears: 12:30

IDLE

PRE STOP TIME

DIAMETER

HEPARIN RATE INITIAL BOLUS HEPARIN BOLUS BOLUS INTERVAL MANUAL BOLUS Syringe Type SYRYNGE TYPES CONFIG

TREATMENT S

STD DIALYS

HEPARIN

BPM

WARNING If the INITIAL BOLUS is set from 0-10 ml, at the Heparin Pump start, the heparin quantity set is injected automatically as a bolus after which the linear heparinization starts.

Note Parameters can only be modified when the machine is in the IDLE Mode. In order to allow a proper configuration of the heparinization mode, after modifying the DIAMETER parameter: • Wait 5 seconds and then switch OFF the machine; • Wait 5 seconds and then switch ON the machine.

Rev. B


2.2.4.3

BPM

The BPM menu contains the parameters relative to the BPM measures. When the BPM Navigation key is pressed, the following view appears: 12:30

IDLE

DIAST PRE MIN DIAST PRE MAX SYST PRE MIN SYST PRE MAX HEART R. MIN HEART R. MAX SAMPLE INTERV BPM USE CONFIG

TREATMENT S

STD DIALYS

HEPARIN

BPM

Rev. B

2-47

2-48


2.2.5 Profiling Configuration The Profiling parameters may be changed by the by selecting the PROFILE Navigation key from the Config view. When PROFILE is pressed the PROFILE General view is displayed and also the following Navigation key are available: • WLR • Cond

2.2.5.1

PROFILE General view

When the PROFILE Navigation key is pressed, the following view appears, where the parameters for both the curves, UF and Conductivity, may be set: 12:30

IDLE

DIALYSIS TIME

TOT WEIGHT L

ULTRAFILTRATION CURVE AREA

CURVE TYPE

CONDUCTIVITY CURVE AREA

CONFIG

PROFILE

WLR

CON CURVE TYPE

COND

Note See Section 05.D - Profile, in this manual, for a detailed description of the Profile relevant parameters setting.

Note In case of CONSTANT curve type, the curve displayed Config/PROFILE environment is drawn with default values set by the Manufacturer.

Rev. B


2.2.5.2

WLR

The WLR menu contains all the parameters related to the Ultrafiltration curve. When the WLR Navigation key is pressed, the following view appears: 12:30

IDLE


PARAMETER AREA

◄

Time

CONFIG

PROFILE

CURVE TYPE: STEP

PROGRESSIVE

CONSTANT

CURSOR AREA WLR

UF R

►

COND

PARAMETER AREA:

SET MODE:

TOT WEIGHT L

CURVE TYPE

CURVE TYPE

TOT WEIGHT L

STEP UFR

STEP UFR

TOT WEIGHT L

CURVE TYPE

INITIAL VALUE

TOT WEIGHT L

CURVE COEFF

INITIAL VALUE

CURVE TYPE

CURVE COEFF

CURVE TYPE

CURVE TYPE

Rev. B

2-49

2-50


2.2.5.3

Cond

The Cond menu contains all the parameters related to the Conductivity curve. When the Cond Navigation key is pressed, the following view appears: 12:30

IDLE


PARAMETER AREA

◄

Time

CONFIG

PROFILE

CURVE TYPE: STEP

PROGRESSIVE

CONSTANT

Rev. B

CURSOR AREA WLR

Cond

►

COND

PARAMETER AREA:

SET MODE:

CON CURVE TYPE

CON CURVE TYPE

COND STEP

COND STEP

INITIAL VALUE

CON CURVE TYPE

FINAL VALUE

INITIAL VALUE

CURVE COEFF

FINAL VALUE

CON CURVE TYPE

CURVE COEFF

CON CURVE TYPE

CON CURVE TYPE


2.2.6 KT/V Configuration The kT/V menu contains all the parameters related to the Diascan feature. When the kT/V Navigation key is pressed, the following view appears:

Note The kT/V Navigation key is only available if the parameter DIASCAN USE is configured YES on the Config/MACHINE/Accessories view.

12:30

IDLE

DIASCAN

TARGET KTt

CLEARANCE ALA.

TARGET KT/V THRESH

CLEARANCE LEVEL

TARGET KT/V

DRY WEIGHT DISTRIB VOLUME INTERMEASUREM

CONFIG

KT/V

Note When selecting YES, the CLEARANCE ALA. becomes available and when selecting YES the CLEARANCE LEVEL parameter becomes available.

Rev. B

2-51

2-52


2.3 Rx Config Views WARNING This feature must exclusively be used under the authority of a physician, who is solely responsible for the use of the information processed by the software. Patient/Rx keys will individualize a particular set of prescription parameters. The individualized prescription parameters (Patient/Rx) parameters may be changed by the by pressing the Rx Config Navigation key from the IDLE View.

2.3.1 Rx Config General View When the Rx Config Navigation key is pressed, the following view is displayed: 12:30

IDLE

1st PATIENT 2nd PATIENT 3rd PATIENT 4th PATIENT 5th PATIENT 6th PATIENT 7th PATIENT RX CONFIG

The machine allows 7 customized dialysis sessions to be configured that can be selected by the operator during SETUP for dialysis. By pressing the Action keys, the individualized Treatment Data may be set and the individual dialysis session names can be modified using the same procedure described in the 2.2.3.1 paragraph for the personalization of the chemical process name. When one of the Rx 1/2/3/4/5/6/7 Action keys has been pressed also the following Navigation key are available: • Rx Data • Rx Add • PROFILE • Kt/V

Rev. B


2.3.2 Rx Data Configuration When one of the Patient 1/2/3/4/5/6/7 Action keys has been pressed the following view is shown (Rx Data view): 12:30

IDLE

2nd PATIENT DIALYSIS TIME DIALYSIS TYPE CONDUCTIVITY BIC 8.4% COND BIC 6.6% COND BICART COND TEMPERATURE DIALYSATE FL. END DIALYSIS TOTAL BLOOD BLD SENS PRIME VOLUME UF PRIMING RX CONFIG

INIT DIAL B FLOW RAMPING TIME PRIME PUMP SPEED RECIRCULATION TIME RECIRC B FLOW RECIRCULATION UF PAT CONN B FLOW RINSEBACK VOLUME RINSEBACK B FLOW

RX DATA

RX ADD

PROFILE

Kt/V


Note If NONE is selected for the HEPARIN TYPE parameter, heparinization is not automatically activated during DIALYSIS. If one of the three modes, LINEAR, AUTO BOLUS, MAN BOLUS, is selected, the heparinization is automatically activated.

Rev. B

2-53

2-54


2.3.3 Rx Add Configuration When the Rx Add Navigation key is pressed, the following view appears, where additional treatment data parameters may be set: 12:30

IDLE

HEPARIN TYPE PRE STOP TIME INITIAL BOLUS HEPARIN RATE HEPARIN BOLUS BOLUS INTERVAL MANUAL BOLUS BPM USE DIAST PRE MIN DIAST PRE MAX SYST PRE MIN SYST PRE MAX HEART R. MIN HEART R. MAX SAMPLE INTERV RX CONFIG

Rev. B

RX DATA

RX ADD

PROFILE

Kt/V


2.3.4 Profiling Configuration The patient’s personalised (Rx) Profile parameters may be changed by the by selecting the PROFILE Navigation key from the Rx Config view. When PROFILE Navigation key is pressed the PROFILE General view is displayed and also the following Navigation key are available: • UF • Cond

2.3.4.1

PROFILE General view

When the PROFILE Navigation key is pressed, the following view appears, where the parameters for both the Profile curves, UF and Conductivity, may be set: 12:30

IDLE

DIALYSIS TIME

TOT WEIGHT L


CURVE TYPE


RX CONFIG

PROFILE

UF

CON CURVE TYPE

COND

Note See Section 05.D - Profile, in this manual, for a detailed description of the Profile relevant parameters setting.

Note In case of CONSTANT curve type, the curve displayed Rx Config/PROFILE environment is drawn with default values set by the Manufacturer.

Rev. B

2-55

2-56


2.3.4.2

UF

The UF menu contains all the parameters related to the Ultrafiltration curve. When the UF Navigation key is pressed, the following view appears: 12:30

IDLE


PARAMETER AREA

◄ RX CONFIG

CURVE TYPE: STEP

PROGRESSIVE

CONSTANT

Rev. B

ClkTime

Time PROFILE

UF

UF R

►

COND

PARAMETER AREA:

SET MODE:

TOT WEIGHT L

CURVE TYPE

CURVE TYPE

TOT WEIGHT L

STEP UFR

STEP UFR

TOT WEIGHT L

CURVE TYPE

INITIAL VALUE

TOT WEIGHT L

CURVE COEFF

INITIAL VALUE

CURVE TYPE

CURVE COEFF

CURVE TYPE

CURVE TYPE


2.3.4.3

Cond

The Cond menu contains all the parameters related to the Conductivity curve. When the Cond Navigation key is pressed, the following view appears: 12:30

IDLE


PARAMETER AREA

◄ RX CONFIG

CURVE TYPE: STEP

PROGRESSIVE

CONSTANT

ClkTime

Time PROFILE

UF

Cond

►

COND

PARAMETER AREA:

SET MODE:

CON CURVE TYPE

CON CURVE TYPE

COND STEP

COND STEP

INITIAL VALUE

CON CURVE TYPE

FINAL VALUE

INITIAL VALUE

CURVE COEFF

FINAL VALUE

CON CURVE TYPE

CURVE COEFF

CON CURVE TYPE

CON CURVE TYPE

Rev. B

2-57

2-58


2.3.5 Kt/V Configuration The patient’s personalised (Patient/Rx) Diascan parameters may be changed by the by selecting the Kt/V Navigation key from the Rx Config view. When the Kt/V Navigation key is pressed, the following view appears: 12:30

IDLE

DIASCAN

TARGET KT

CLEARANCE ALA.

TARGET KT/V THRESH

CLEARANCE LEVEL

TARGET KT/V

DRY WEIGHT DISTRIB VOLUME INTERMEASUREM

RX CONFIG

KT/V

RX ADD

PROFILE

KT/V

Note When setting DIASCAN USE to YES, the CLEARANCE ALA. becomes available and when setting CLEARANCE ALA. to YES, the CLEARANCE LEVEL parameter becomes available.

Rev. B


Note When a specific value is selected for some parameters, further new parameters, not listed above, become available. Below is a table with the various possibilities:

PARAMETER

SELECTED VALUE

NEW PARAMETER(S)

DIALYSIS TYPE

BIC CONC

END DIALYSIS HEPARIN TYPE

BIC BICART TOTAL BLOOD LINEAR

BIC 8.4% CONDor BIC 6.6% COND BICART COND TOTAL BLOOD PRE STOP TIME HEPARIN RATE INITIAL BOLUS PRE STOP TIME HEPARIN BOLUS BOLUS INTERVAL MANUAL BOLUS CLEARANCE ALA. DRY WEIGHT DISTRIB VOLUME INTERMEASUREM CLEARANCE LEVEL SAMPLE INTERV SYST PRE MIN SYST PRE MAX DIAST PRE MIN DIAST PRE MAX HEART R. MIN HEART R. MAX DIAL AUTO PRIME

AUTO BOLUS

DIASCAN USE

MAN BOLUS YES

CLEARANCE ALA. BPM USE

YES YES or AUTOMATIC

JUMP PRIMING

NO

Rev. B

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2-60


This page is left intentionally blank

Rev. B

3 CENTRAL CONCENTRATE SUPPLY 3.

SECTION 3 - CENTRAL CONCENTRATE SUPPLY

3.1 Specifications The Phoenix Haemodialysis System, equipped with the Central Concentrate Supply kit, is compatible with Central Concentrate Supply Systems for BICARBONATE DIALYSIS meeting the following requirements: • • • •

Concentrate fluid Temperature : 5 - 30 °C (41-86°F) Concentrate fluid Pressure : 0 - 1 bar (0- 14.50 psi) Bicarbonate Concentrate : 8.4% Acid Concentrate : two different acid concentrate formulas may be used, A1 and A2, whose composition must comply with the specifications described in the Section 9 - Specifications of the Operator’s Manual. • Central Acid Concentrate Supply may be used with either the BiCart or Liquid Bicarbonate Concentrate.

Note The connection to Central Acid Concentrate using BICART will be allowed only if 8.4% for Bicarbonate Concentrate has been selected in the Configuration menu.

WARNING The is responsible for checking compliance of Central Concentrate Systems with the IEC 601.1.1 standard.

Rev. B

3-2


3.2 Connection to the Central Concentrate Supply System In the following figures (fig. 3.1 and 3.2) the positions of the Connectors on the Rear and Front are illustrated with the following numerical and colour-coding: 1 - RED 2 - RED 3 - BLUE

ACID A1 CONCENTRATE for BICARBONATE DIALYSIS ACID A2 CONCENTRATE for BICARBONATE DIALYSIS BICARBONATE CONCENTRATE

Fig. 3.1: Connector positions on the Rear

Fig. 3.2: Connector positions on the Front

Rev. B


The connection to the Central Concentrate Supply must be done by connecting one or more of the three Rear Connectors to the facility’s Concentrate Supply System following the numerical and colour code. Rear Connectors marked 1,2,3 match respectively with the female Concentrate Connectors marked 1,2,3 on the Front .

WARNING The is responsible for the proper connection of the PHOENIX machine to the Central Concentrate Supply System and to proper functioning of this connection.

WARNING The three internal lines from the Central Supply Ports on the Rear of the Phoenix to the three Front Concentrate Connectors marked 1, 2, 3 are subject to the same Disinfection requirements as the Central Supply System. The manufacturer is not responsible for the Disinfection of these lines. It is the responsibility of the to carry out Disinfection and Rinse procedures of these lines, and to: • Check the efficiency of Disinfection. • Perform a mandatory Rinse after Disinfection with chemical agents. • Perform a residual test after Rinse.

Rev. B

3-3

3-4


3.3 Operating Instructions WARNING It is the responsibility of the to that the proper concentrates are used for the patient. This includes the choice of Acid Concentrate as well as Bicarbonate Concentrate. The machine, while maintaining all the checks (Conductivity, Temperature and pH) of Final Dialysate, disables the check on concentrate dilution that is normally performed when concentrates are provided in containers. The check on concentrate dilution is disabled when Central Concentrate Supply is used in order to prevent the occurrence of”! Concentrate Cans” #40 alarm. For further information on the concentrate solutions see Section 9 – Specifications, in this manual.

BICARBONATE DIALYSIS with A1 ACID In this case the male Connector A must be connected to the RED (1) female Connector, and the male Connector B must be connected to the BLUE (3) Connector (see figure 3.3).

fig. 3.3: Connector positions in BICARBONATE DIALYSIS with A1 ACID

Rev. B


BICARBONATE DIALYSIS with A2 ACID In this case the male Connector A must be connected to the RED (2) female Connector, and the male Connector B must be connected to the BLUE (3) Connector (see figure 3.4).

fig. 3.4: Connector positions in BICARBONATE DIALYSIS with A2 ACID

BICART DIALYSIS with A1 ACID In this case the male Connector A must be connected to the RED (1) female Connector, and the male Connector B remains in its Rinse Port (see figure 3.5).

fig. 3.5: Connector positions in BICART DIALYSIS with A1 ACID

Rev. B

3-5

3-6


BICART DIALYSIS with A2 ACID In this case the male Connector A must be connected to the RED (2) female Connector, and the male Connector B remains in its Rinse Port (see figure 3.6).

fig. 3.6: Connector positions in BICART DIALYSIS with A2 ACID

Rev. B


3.3.1 Switching from Central Concentrate Supply to the use of External Concentrate Containers In case of a malfunction of the Central Concentrate Supply System, it is possible to continue the dialysis treatment using External Containers.

BICARBONATE DIALYSIS with A1 or A2 ACID According to the External Containers that will be used, perform the following procedures: • Bicarbonate Container: Disconnect the male Connector B from the BLUE

Connector (3) and connect it to the Wand inserted into a container of the correct Bicarbonate Concentrate. • Acid Container: Refer to Section 05.A – Special Procedures, in this manual for a detailed description of the Acid Concentrate supply change procedure.

BICART DIALYSIS with A1 or A2 ACID • Acid Container: Refer to Section 05.A – Special Procedures, in this manual for a

detailed description of the Acid Concentrate supply change procedure.

WARNING In case of a switch from Central Concentrate Supply to the use of External Containers, it is the operator’s responsibility to that proper Concentrates are being used.

WARNING In case of a switch from Central Concentrate Supply to the use of External Containers, if the machine has not been correctly calibrated for the liquid Concentrates in the External Containers, the “! Concentrate Cans” #40 Alarm can occur. After carefully ing that the correct concentrates are being used, and that the dialysate Conductivity is correct, the operator may clear the alarm by performing the PA and/or PB Autocalibration Procedure (see Section 5.B - Special Procedures for complete instructions.)

Rev. B

3-7

3-8


3.4 Central Concentrate Supply Lines Maintenance 3.4.1 General WARNING The three internal lines, from the Central Concentrate Supply Ports on the Rear of the Phoenix to the three Front Concentrate Connectors marked 1, 2, 3 are subject to the same Disinfection requirements as the Central Concentrate Supply System. The manufacturer is not responsible for Disinfection of these lines. It is the responsibility of the to carry out Disinfection and Rinse procedures of these lines, and to: • Check the efficiency of Disinfection. • Perform a mandatory Rinse after Disinfection with chemical agents. • Perform a residual test after Rinse. If the machine needs to be stored, shipped, or left in Idle for a long period of time, draining these Central Concentrate Lines, after Disinfection and Rinsing, is also recommended. Since these lines are practically integral to the clinic’s piping system, it is recommended to have them disinfected at the same time that the overall system is cleaned/disinfected. The frequency of cleaning these lines can be the same as the frequency of cleaning Clinic’s Supply System, since the fluids are identical.

Note It is the responsibility of the to determine the frequency of the Cleaning/Disinfection procedures of the Central Concentrate Lines; this frequency must be not lower than the frequency of the Cleaning/Disinfection procedures performed for the Clinic’s Supply System.

Note The Acid Lines may not require the same frequency of Cleaning/Disinfecting as the Bicarbonate Line since the Acid formulations typically do not bacterial growth. The Bicarbonate Line is where bacterial growth will occur rapidly thus frequent Cleaning/Disinfecting is recommended. Clinical practices for cleaning other portions of this delivery system can be used as a baseline for the Cleaning/Disinfection frequency.

WARNING Before instilling Cleaning/Disinfecting chemicals into the 3 Central Concentrate Lines, it is advisable to perform a Rinse procedure to avoid chemical reaction or precipitation due to possible incompatibility of the chemical used with any residual Acid or Bicarbonate Concentrate that is left in these lines.

Rev. B


3.4.2 Central Bicarbonate Line Disinfection & Rinse: automatic processes The Central Bicarbonate Line disinfection is a chemical process that allows to disinfect both the hydraulic flowpath of the machine and the central bicarbonate line from the rear of the machine to the male dialysate connector fitting to the Central Concentrate Supply System. To carry out the Central Bicarbonate Line disinfection and the following rinse the following conditions have to be satisfied: •

•

• •

The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be adapted so that the end side of this line (connected to the Central Concentrate Supply port) is a Phoenix Bicarbonate Male Connector; The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be a PVC line, maximum 3 metres (118.11 in) in length and with an internal diameter of 3 mm (0.118 in). The proper service configuration has been performed in the service environment. (Refer to your technical service for information on your machine configuration). Only Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm)/Bleach has to be used.

WARNING The efficiency of the Central Bicarbonate Line disinfection process has been tested and can be guaranteed only if the following conditions are satisfied: • The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system is a PVC line, maximum 3 metres (118.11 in) in length and with an internal diameter of 3 mm (0.118 in), • Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm)/Bleach is used.

3.4.2.1

Disinfection Procedure

1. Disconnect the Bicarbonate Connector from the Bicarbonate Port (B) on the Front and connect it to the BLUE (3) port on the Front . (See Figure 3.7). 2. that the Acid Connector is connected to the Acid Port (A) on the Front . 3. Disconnect the Central Bicarbonate Line on the Rear of the machine from the Central Concentrate Supply system and connect it to the Bicarbonate Port (B) on the Front of the machine. (See Figure 3.7).

WARNING Before starting a Central Bicarbonate Line disinfection process, it is the operator’s responsibility to that all the Acid and Bicarbonate connectors are correctly placed to ensure the disinfection process is properly performed.

Rev. B

3-9

3-10 PHOENIX OPERATOR MANUAL

fig. 3.7: Connector positions in Central Bicarbonate Line Disinfection

4. Place the disinfectant connectors in the correct position. Depending upon the selection of the parameters EXTERNAL JUG USE and LIQUID INLET:

EXTERNAL JUG USE:NO LIQUID INLET:FRONT

• Disconnect the Yellow Connector from its Rinse Port on the lower front of the machine and connect it to the Yellow Wand. Immerse the Yellow Wand into the disinfectant container.

EXTERNAL JUG USE:YES LIQUID INLET:FRONT

• Perform the previous procedure.

EXTERNAL JUG USE:YES LIQUID INLET:REAR 1/REAR 2

• Ensure that the disinfectant connector (present on the rear of the machine) is correctly inserted in the disinfectant container located on the rear of the machine. Also that there is enough liquid to perform a disinfection procedure.

Rev. B


3-11

5. Perform the Bicarbonate Line Disinfection process: • Select the ADR Selection key on the IDLE view and then press the CHEM PROCESS Selection key. • Press the CHEM + CENTR BICARB LINE Action key. The machine will start uptaking of disinfectant to fill an internal tank (approximately 180 ml). The following view is displayed: 12:30

ADR PROGRESS

BPM

REPORT

DISINF TIME

RINSING TIME

min:s

min:s

END PROCESS MODE

AUTO OFF

pH VALUE

LIQUID INLET

MACHINE

CLOSE

Note If the Bicarbonate Connector is not inserted in the BLUE (3) port on the Front (see Figure 3.7), the alarm message “Centr. Bicarb Connector Position” (code #272) is displayed while in the Operator Messages Area the following message will appear: Central bicarb wall connector must be in blue port and blue connector in CCK blue port If the Central Bicarbonate Line is not inserted in the Bicarbonate Port (B) on the Front of the machine (see Figure 3.7), the alarm message “B Connector Position“(code #18) is displayed.

Note If any problems occur while the disinfectant is being taken up into the internal tank, the machine will automatically empty and refill the tank. An Operator Message will appear:

Emptying Disinfectant Tank And Repeat Filling Disinfectant Tank

Note If LIQUID INLET is set to FRONT at the completion of disinfectant uptake, the following alarm message is displayed: Disinf Connector Position with an audible alarm (#47). To clear this alarm and restart the disinfection procedure reinsert the Yellow Connector into its Rinse Port.

Rev. B

3-12 PHOENIX OPERATOR MANUAL 6. Central Bicarbonate Line disinfection stops: • When the time value set for the DISINF TIME parameter is elapsed. • When the machine goes into an alarm condition during the process and the operator takes no action. The machine will automatically turn OFF after 30 minutes following completion of the DISINF TIME. At the next switch on Central Bicarbonate Line disinfection must be performed again to allow the selection of the DIALYSIS process. • When the CLOSE Action key is selected 30 seconds after the disinfection process has been started and before the DISINF TIME has elapsed. In this case the process is not considered complete and the Central Bicarbonate Line disinfection must be performed again to allow the selection of the DIALYSIS process. • When the CLOSE Action key is selected within 30 seconds after the disinfection process has been started. In this case the process selection is cancelled and all the keys that were available before starting the Disinfection process will remain available. 7. When the Central Bicarbonate Line disinfection has been correctly completed, an ADR:RINSE process will automatically start. (See 3.4.2.2 ADR: RINSE , in this section)

Note The Central Bicarbonate Line disinfection can not be programmed by the AutoStart feature.

Rev. B


3-13

List of Parameters and their meanings DISINF TIME: this parameter can be set to a value between 15 min and 30 minutes. The default value for this parameter is the lowest value necessary to ensure disinfection of the machine when an approved disinfectant is used. pH Min and pH Max: these parameters appear only if the parameter pH MONITOR on the Config\ADR\CHEM+CENTRAL.BICARB LINE view is set to YES. During the process an alarm is triggered when the pH value is outside the range selected by the operator for the two parameters. RINSING TIME: this parameter can be set to a value between 15 min and 50 minutes. Once the Central Bicarbonate Line disinfection has been correctly completed, a rinsing phase is automatically performed. AUTO OFF: if NO is selected, the machine returns to the IDLE view after performing the RINSE process, if YES is selected, the machine turns OFF automatically. END PROCESS MODE: this parameter is always set to Rins. and can not be modified; at the end of the chemical disinfection process, the machine performs a RINSE process for the time set for the parameter RINSING TIME parameter. LIQUID INLET: This parameter specifies the line through which the uptake of disinfectant is performed. This parameter can be set to FRONT, REAR 1 or REAR 2, only if the EXTERNAL JUG USE parameter is set to YES in the Config/MACHINE view. When set to YES, the EXTERNAL JUG USE parameter allows the machine to uptake disinfectant from the chemical connector (yellow) on the FRONT of the machine or from REAR 1 or REAR 2 at the back of the machine. When set to NO the internal disinfectant tank is filled by drawing disinfectant from the Yellow Connector on the front of the machine. CENTR BICARB LINE: this parameter is always set to YES and can not be modified. It indicates that a disinfection process will be performed disinfecting both the hydraulic flowpath of the machine and the central bicarbonate line from the rear of the machine to the male dialysate connector fitting to the Central Concentrate Supply System.

Rev. B


3.4.2.2 ADR: RINSE following the Central Bicarbonate Line disinfection The RINSING process described below described allows to rinse both the hydraulic flowpath of the machine and the central bicarbonate line from the rear of the machine to the male dialysate connector fitting to the Central Concentrate Supply System. 1. During the RINSING process, connectors must remain in the same configuration of the Central Bicarbonate Line disinfection. 2. The RINSING process starts automatically once the Central Bicarbonate Line disinfection is completed. During the RINSING process the following view is displayed: 12:30

ADR PROGRESS

RINSING TIME

AUTO OFF

min:s

BPM

REPORT

MACHINE

CLOSE

Note If the Bicarbonate Connector is not inserted in the BLUE (3) port on the Front (see Figure 3.7), the alarm message “Centr. Bicarb Connector Position” (code #272) is displayed while in the Operator Messages Area the following message will appear: Central bicarb wall connector must be in blue port and blue connector in CCK blue port If the Central Bicarbonate Line is not inserted in the Bicarbonate Port (B) on the Front of the machine (see Figure 3.7), the alarm message “B Connector Position“ (code #18) is displayed.

Rev. B


3-15

3. During RINSING, the machine performs the UF Vessel Level Detectors Test. If the UF Vessel Level Detector Test fails, the following operator message will appear: Emptying UF Vessel forced The process time will be increased.

4. Central Bicarbonate Line Rinse process stops: • When the time value set for the RINSING TIME parameter is elapsed. • When the machine goes into an alarm condition during the process and the operator takes no action. The machine will automatically turn OFF after 30 minutes following completion of the RINSING TIME. At the next switch on, Central Bicarbonate Line Rinse process must be performed again to allow the selection of the DIALYSIS process. • When the CLOSE Action key is selected before the RINSING TIME has elapsed. In this case the process is not considered complete and the Central Bicarbonate Line Rinse process (maintaining the same connectors configuration of the Central Bicarbonate Line disinfection) must be performed again to allow the selection of the DIALYSIS process. 5. When the Central Bicarbonate Line Rinse process has been correctly completed, the following Help message will appear on the Touch Screen in the Parameter Area:

To allow SETUP remove connector from Central bicarb port and reinsert if needed 6. To make available the SETUP Action key and delete the above Help message: • Disconnect the Bicarbonate Connector from the BLUE (3) port on the Front . and connect it to the Bicarbonate Port (B) on the Front (See Figure 3.7). • Disconnect the Central Bicarbonate Line from the Bicarbonate Port (B) on the Front of the machine and connect it to the Central Concentrate Supply system (See Figure 3.7).

Note The Central Bicarbonate Line Rinse process can not be programmed by the AutoStart feature.

Rev. B


3.4.3 Acid and Bicarbonate Lines Rinse: automatic process An automatic process can be performed to rinse both the Central Bicarbonate Line and the Central Acid Lines (A1 and/or A2). To carry out the Central Concentrate Lines Rinse process the following conditions have to be satisfied:

Rev. B

•

The proper service configuration has to be performed in the machine calibrations environment (Refer to Section 8, in the Phoenix Service Manual).

•

If Central Bicarbonate Line Rinse has to be performed: The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be adapted so that the end side of this line (connected to the Central Concentrate Supply port) mates to the Female Bicarbonate Connector (B) on the Front of the machine (See Figure 3.2); The Central Bicarbonate Line connecting the Rear Connector (3) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be maximum 3 metres (118.11 in) in length and with a diameter of 3 mm (0.118 in).

•

If Central Acid (A1) Line Rinse has to be performed: The Central Acid (A1) Line connecting the Rear Connector (1) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be adapted so that the end side of this line (connected to the Central Concentrate Supply port) mates to the Female Acid Connector (A) on the Front of the machine (See Figure 3.2); The Central Acid (A1) Line connecting the Rear Connector (1) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be maximum 3 metres (118.11 in) in length and with a diameter of 3 mm (0.118 in).

•

If Central Acid (A2) Line Rinse has to be performed: The Central Acid (A2) Line connecting the Rear Connector (2) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be adapted so that the end side of this line (connected to the Central Concentrate Supply port) mates to the Female Acid Connector (A) on the Front of the machine (See Figure 3.2); The Central Acid (A2) Line connecting the Rear Connector (2) of the Phoenix (See Figure 3.1) to the Central Concentrate Supply system has to be maximum 3 metres (118.11 in) in length and with a diameter of 3 mm (0.118 in).


3.4.3.1

3-17

Rinse Procedure

1. Depending on the Central Bicarbonate Lines to be rinsed: • Central Bicarbonate Line: Disconnect the Bicarbonate Connector from the Bicarbonate Port (B) on the Front and connect it to the BLUE (3) port on the Front . Disconnect the Central Bicarbonate Line on the Rear of the machine from the Central Concentrate Supply system and connect it to the Bicarbonate Port (B) on the Front of the machine. Note: If only the Central Bicarbonate Line is rinsed, the Acid Connector is connected to the Acid Port (A) on the Front . (See Figure 3.8 (A)). • Central Acid Line (A1): Disconnect the Acid Connector from the Acid Port (A) on the Front and connect it to the RED (1) port on the Front . Disconnect the Central Acid Line (A1) on the Rear of the machine from the Central Concentrate Supply system and connect it to the Acid Port (A) on the Front of the machine. Note: If only the Central Acid Line (A1) is rinsed the Bicarbonate Connector is connected to the Bicarbonate Port (B) on the Front . (See Figure 3.8 (B)). • Central Acid Line (A2): Disconnect the Acid Connector from the Acid Port (A) on the Front and connect it to the RED (2) port on the Front . Disconnect the Central Acid Line (A2) on the Rear of the machine from the Central Concentrate Supply system and connect it to the Acid Port (A) on the Front of the machine. Note: If only the Central Acid Line (A2) is rinsed the Bicarbonate Connector is connected to the Bicarbonate Port (B) on the Front . (See Figure 3.8 (C)). • Central Acid Line (A1) and Central Acid Line (A2): Disconnect the Acid Connector from the Acid Port (A) on the Front and connect it to the RED (1) port on the Front . Disconnect the Central Acid Line (A1) on the Rear of the machine from the Central Concentrate Supply system and connect it to the RED (2) port on the Front . Disconnect the Central Acid Line (A2) on the Rear of the machine from the Central Concentrate Supply system and connect it to the Acid Port (A) on the Front of the machine. Note: If only the Central Acid Line (A1) and (A2) are rinsed the Bicarbonate Connector is connected to the Bicarbonate Port (B) on the Front . (See Figure 3.8 (D)). • Central Acid Line (A1) and Central Bicarbonate Line: place the connectors as described in the above steps “Central Bicarbonate Line” and in “Central Acid Line (A1)”. (See Figure 3.8 (E)). • Central Acid Line (A2) and Central Bicarbonate Line: place the connectors as described in the above steps “Central Bicarbonate Line” and in “Central Acid Line (A2)”. (See Figure 3.8 (F)). • Central Acid Line (A1), Central Acid Line (A2) and Central Bicarbonate Line: place the connectors as described in the above steps “Central Bicarbonate Line” and in “Central Acid Line (A1) and Central Acid Line (A2)”. (See Figure 3.8 (G)).

Rev. B


(A) Central Bicarbonate Line

(B) Central Acid Line (A1)

(C) Central Acid Line (A2)

(D) Central Acid Line (A1) and Central Acid Line (A2)

fig. 3.8: Connector positions in Central Concentrate Lines Rinse

Rev. B


(E) Central Bicarbonate Line + Central Acid Line (A1)

3-19

(F) Central Bicarbonate Line + Central Acid Line (A2)

(G) Central Bicarbonate Line + Central Acid Line (A1) + Central Acid Line (A2)

fig. 3.8: Connector positions in Central Concentrate Lines Rinse

Rev. B

3-20 PHOENIX OPERATOR MANUAL WARNING Before starting a Central Concentrate Rinse process, it is the operator’s responsibility to that all the Acid and Bicarbonate connectors are correctly placed to ensure all the lines involved in the Central Concentrate Rinse process are properly rinsed. 2. Select the ADR Selection key on the IDLE view and then press the CCK LINES RINSE Action key. The following superimposed window will appear:

CONFIRMATION LAST ACTION MADE ENTER To Confirm By pressing the CONFIRM button, the machine will start the Central Concentrate Rinse process.

Note The CCK LINES RINSE Action key is not available if the ADR processes (Chemical Disinfection or Heat Citric Disinfection) previously performed were not been correctly completed.

3. During all the time the process is in progress the following message will appear in the Operator Messages Area:

To rinse one or more central concentrate lines, ensure they are disconnected from the wall and inserted in rinse ports and the corresponding connectors are in central concentrate ports.

Note The RINSING TIME parameter is automatically set to 3 minutes, this parameter value cannot be modified.

4. Central Concentrate Supply Rinse process stops: • When the RINSING TIME is elapsed. • When the machine goes into an alarm condition during the process and the operator takes no action. The machine will automatically turn OFF after 30 minutes following completion of the RINSING TIME. At the next switch on, all the ADR processes allowed before the CCK LINES RINSE Action key selection are still available except a standard RINSING process. • When the CLOSE Action key is selected before the RINSING TIME has elapsed. In this case the process is not considered complete but all the ADR processes allowed before the CCK LINES RINSE Action key selection are still available except a standard RINSING process.

Rev. B


3-21

5. When the Central Concentrate Supply Rinse process has been correctly completed, the following Help message will appear on the Touch Screen in the Parameter Area:

SETUP not Allowed. A Disinf. Process Must be performed to allow SETUP 6. Restore the previous connectors configuration. 7. To make available the SETUP Action key and delete the above Help message perform a Disinfection process.

Note The Central Concentrate Lines Rinse process can not be programmed by the AutoStart feature.

Rev. B


3.4.4 Acid and Bicarbonate Lines Maintenance (Disinfection, Rinse and Drain): manual procedure Note The Disinfection, Rinse, Verification and Draining procedures, described below, can be applied to any of the 3 Central Concentrate Lines. The Lines may be disinfected simultaneously or independently. It is the responsibility of the to determine the frequency of the Cleaning/Disinfection procedures of these Central Concentrate Lines; this frequency must be not lower than the frequency of the Cleaning/Disinfection procedures performed for the Clinic’s Supply System.

3.4.4.1

Adaptor Setup

Assemble an adaptor that mates to the female Central Concentrate fitting(s) on the Front of the machine: • If the Bicarbonate Line is to be disinfected, use a male Bicarbonate Male Connector as one end of the adaptor. • If the Acid line(s) is to be disinfected, one end of the adaptor would be an Acid Male Connector.

Note The Dialysate Sampling Connector (Universal) can also be used.

This adaptor should be built such that when pressure is applied to the Central Concentrate System, flow should occur through this connector. It is recommended to attach a silicone tube to the outlet side of this adaptor. The length of the tube would depend on whether one wanted to divert the Disinfectant/Rinse flow into a container. The following components can be used to assemble the adaptor: • Dialysate Sampling Connector (Universal) code 6961031. • Acid Male Connector code 6954291. • Bicarbonate Male Connector code 6948996. • 1/8 inch silastic tubing, 95 inch roll.

Two additional components may be required: • A Restrictor: may be needed to reduce flow (depending on the pressure and flow

conditions within the facility’s Central Concentrate System) Disinfection/Rinsing is taking place. • A Check Valve: may be inserted into the line to prevent any back flow.

while

Note For further information on the availability of this adaptor, or the components required to assemble it, your Local Representative.

Rev. B


3.4.4.2

3-23

Disinfection Procedure

1. Turn the machine OFF. 2. Connect the adaptor, described above, to the female Central Delivery Port on the Front of the machine that is to be disinfected. 3. Put the outlet tubing from the adaptor into a container. 4. Disinfect the concentrate lines in the machine and the Central Concentrate Delivery System. the efficacy of the disinfection procedure. Chemical presence can be verified at the outlet of the adaptor.

Note The pressure used within the Central Concentrate System for the Cleaning and Disinfection of the 3 lines must be adequate to push water through this system, for cleaning and disinfection of the lines within the machine. This will depend somewhat upon Drain or Container position. However, the pressure should be limited to prevent disconnection due to excessive pressure. A pressure range of 250-500 mmHg is recommended as an initial estimate for an acceptable pressure.

3.4.4.3

Rinse Procedure

1. Leave the adaptor in the Central Concentrate Port. 2. Rinse the Central Concentrate Supply System with water to remove chemicals introduced during the Cleaning/Disinfection process. 3. Route the Rinse water directly to a container.

3.4.4.4

Rinse Verification

1. the efficacy of Rinsing. Rinsing efficacy for the Central Concentrate Lines within the machine can be verified at the outlet of the adaptor, mentioned above. 2. If draining is not to be done, the adaptor may be removed after this Rinse verification step.

Rev. B


3.4.4.5

Draining of Central Concentrate Lines

Note Draining of Central Concentrate Lines is recommended for machine storage, shipping, or long Idle period.

1. Make certain that the Disinfection, Rinse, and Rinse Verification steps have previously been performed on the Central Concentrate Line(s). 2. Remove Central Concentrate Line(s) at the back of the machine from the Central Concentrate Supply. This line(s) should be open, and exposed to atmosphere. 3. Use the adaptor and attach a syringe to the outlet tubing (the side opposite of the male Concentrate Connector). Attach this adaptor the Central Concentrate Line where fluid is to be drained. Use the syringe to remove all fluid from the Central Concentrate Line. 4. Remove the adaptor.

Alternative Drain Procedure: 1. Make certain that the Disinfection, Rinse, and Rinse Verification steps have previously been performed on the Central Concentrate Line(s). 2. Remove the Central Concentrate Line(s) from the rear of the machine. 3. Turn the machine ON. Enter SETUP. 4. Insert the male Concentrate Connector on the front of the machine into the Central Delivery Port that is to be drained. 5. Let machine run until the lines are empty.

Rev. B

4 INSTALLATION 4.

SECTION 4 - INSTALLATION

4.1 Unpacking instructions • Check that the shipping container is not damaged. • If the shipping container is damaged, notify the transporter before opening. • Carefully take the machine out of its packaging.

Note The PHOENIX shipping carton, foam packing and other packaging materials should be disposed of according to local regulations.

4.2 Shipping Carton Contents The machine packaging contains the following components: • • • • • • • •

PHOENIX Haemodialysis System PHOENIX Operator’s Manual Installation Checklist Water inlet and drain hose Hose clamps Sampling connector Dialysate connectors and tubing IV pole (maximum load: 6 Kg or 13.2 lb)

Note Adjustment of IV pole height must be done without bags on the hooks.

• • • • • •

Concentrate/disinfectant wands Chemical container shelf (maximum load: 16 Kg or 35.3 lb) pH probe assembly Blood pump crank BPM CUFF Single Needle holder (only with machines that have been configured with an Arterial Line Clamp).

WARNING Do not stand on Chemical container shelf.

Rev. B


4.3 Installation Power supply Connect the power cord to a grounded, hospital-grade main power outlet (suitable for continuous operation) according to the voltage and current rating listed on the identification plate at the rear of the PHOENIX machine. Electrical power requirements can be found in Section 9 – Specifications, of the PHOENIX Operator’s Manual.

WARNING Check the continuity and the reliability of the ground connection.

WARNING the quality of the protective earth ground at the time of installation.

Water inlet connection Connect the 8x14 meshed PVC hose to the water inlet port on the rear of the PHOENIX (see fig.4.1). The Water Inlet Port symbol, located on the label on the rear , shows where the inlet water hose is to be connected. Attach the water inlet hose to the treated water for haemodialysis, using a stainless steel hose clamp. Requirements for water for haemodialysis can be found in Section 9 – Specifications, of the PHOENIX Operator’s Manual.

Note Check that the pressure is between 1 Kg/cm2 and 6 Kg/cm2(14.6 to 87.6 psig).

Drain hose connection Connect the 8x14 PVC hose, contained in the shipping carton, onto the drain port on the rear of the PHOENIX machine (see fig.4.1). The Drain Port symbols, located on the label on the rear , show where the drain hose is to be connected. Connect the drain hose to a drainage system that satisfies the following requirements: • • • •

Rev. B

Maximum height above floor level: 1 m (39 inches). Maximum Dialysate flow: 1.1 l/min. Resistant to treated water and chemicals used for disinfection. Resistant to high temperature (~100°C) water, drained during the heat disinfection process.


Make connections as described in the international standards or in the local plumbing and electrical regulations, in respect of separation of devices (drain line and drain itself), back syphonage and the air clearance between the drain connector of the machine and the drain itself.

Drain Port Water inlet Port

Figure 4.1

Dialyser connection Insert the “TO” and “FROM” dialysate lines onto their ports on the left side of the PHOENIX machine. These ports are coloured blue and red appropriately. Insert the dialyser connectors onto the other end of the lines: • Blue connector: TO dialyser line • Red connector: FROM dialyser line Insert the dialysate connectors onto their colour coded by ports.

Rev. B

4-3


4.4 First service WARNING This operation must be performed by authorized personnel. If Service is performed by unauthorized personnel, the manufacturer cannot accept any responsibility for any damage which may occur, and such damage is not covered by the warranty.

General • Open the machine s and visually inspect the hydraulics and electronics for any loose connections or damage from shipment. Mount a pump insert on each of the four peristaltic pumps as follows: • Open the mechanical lock on each peristaltic pump. • Insert the tube connectors in the seats on the collar. • Before mounting, twist the collar and tube backwards. This initially stretches the tube. • Assemble the collar and tube onto each pump. that the collar and tube are mounted correctly onto each pump. that the tubing connector is snug in its mount. Mount the pH Probe as follows: • Remove the plastic cover that protects the pH probe holder • Remove the cap from the hydraulic circuit where the probe will be mounted. • Remove the cover from the probe. • Mount the pH probe using the pH Holder Nut, supplied in the pH probe box. • Attach the pH probe to the using the plastic tie wrap contained in the pH probe box. • Remount the protective plastic cover on the pH probe holder. • Route the wires from the pH probe so that they are secure in their path to the pH circuit board. Connect the probe’s BNC connector to the pH circuit board.

Note Carefully read the instruction sheet in the pH probe box. • Check that all tubing and connection are correct and secure.

Rev. B


Functional Check


Prior to the first patient use, the PHOENIX must be tested by a trained Service technician. • Perform the complete installation procedure found in the PHOENIX Service Manual. • Perform the autocalibration procedure for the concentrate pumps using the concentrate formulas used in the dialysis facility. This is done so that the speed of the pumps for the facility’s concentrates will be stored in the concentrate exchange safety system. The machine is calibrated by the manufacturer to guarantee the operating range described in the Specification Section for the specified concentrates. •

Machine disinfection: Perform the Water Inlet Line Disinfection procedure. Perform a chemical disinfection procedure with the disinfectants that are in use in the dialysis facility. Perform a heat citric disinfection procedure with the disinfectants that are in use in the dialysis facility. The purpose of these procedures is to calibrate the insert in the PS pump, therefore the efficacy of these first disinfections is not guaranteed. Notify the operator that the machine must be disinfected again prior to use. Notify the operator that a post-dialyser dialysate sample should be cultured for machine bioburden levels, as per AAMI and CDC guidelines. Follow your facility protocol for collecting and culturing the sample.

Rev. B

4-5



Rev. B

5 DIALYSIS OPERATION 5.

SECTION 5 - DIALYSIS OPERATION

5.1 Starting 5.1.1 Residual Disinfectant Concentration Test The Residual Disinfectant Concentration Test may be performed in SETUP, prior to using the machine for a patient treatment. Follow the Dialysate Sampling procedure, found in Section 5.A – Special Procedures of this manual, with the machine in the SETUP Mode, prior to connecting the dialyser for priming.

Note It is not necessary to discard liquid before obtaining a sample for the Residual Disinfectant Concentration Test.

5.1.2 Checking dialysis parameters configuration Parameters related to processes configured in the machine are displayed on the Config view. The Config view is only accessible from the IDLE view, prior to pressing the SETUP Action Key.

Rev. B

5-2


5.2 Extracorporeal Circuit preparation WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. The Manufacturer has not validated the use of blood lines other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. It is the responsibility of the to validate that other blood lines provide safe and effective performance.


5.2.1 Install dialyser Place the dialyser into the Dialyser Holder (left side of machine). a. Lift the holder arm and position the dialyser between the arm and the grippers attached to the machine. b. Close the holder arm. (The dialyser is held in position between the holder arm and the grippers.)

WARNING Reverse Ultrafiltration of fluid from the dialysate compartment into the blood compartment may occur when High Flux dialysers are used. Because of their high ultrafiltration coefficients, high flux dialysers will quickly transfer fluid across the membrane in response to pressure differences between the dialysate compartment and the blood compartment.

5.2.2 Load the Cartridge Blood Set To load the Cartridge Blood Set proceed as follows (see Fig 5.1): a. Open the Blood Pump Cover by pressing the cover latch then open the Air Bubble Detector/Patient Sensor cover. b. Place the pump segment of the Cartridge Blood Set around the blood pump rotor.

Note • The blood pump rotor is in a horizontal position. • This is the default position after switching ON the machine. • The blood pump cover can be closed when the blood pump rotor is in the default

position.

c. Insert the tab of the Cartridge Blood Set into the cartridge clip (left side of cartridge holder). Press the Cartridge against the machine. The pressure pods should seat evenly on the pressure transducers. d. Close the Blood Pump Cover. (Cover makes a clicking sound as it latches). Rev. B


e. Route the venous line through the Air Bubble Detector/Patient Sensor and through the Venous Line Clamp. f. Close the Air Bubble Detector/Patient Sensor cover (cover makes a clicking sound as it latches). g. Before attaching the venous and arterial dialyser lines of the Cartridge Blood set to the dialyser blood ports, rotate the dialyser lines counter-clockwise (about 1 full turn); then connect the dialyser lines to the dialyser blood ports. h. Adjust dialyser position to prevent sharp bends in tubing and to prevent tubes from interfering with Phoenix machine or its parts. Ensure that lines are untangled. i. Route the Cartridge access lines into the 4 Position Line Clamp above the blood pump. Route the lines from right to left as follows: Heparin line green clamp Arterial access line

red clamp (right)

Cartridge saline line (with priming connector)

red clamp (left)

Venous access line blue clamp The Arterial access line, Cartridge saline line and Venous access line make a clicking sound when they are firmly inserted in the 4 Position Line Clamp.

If performing a Single Needle dialysis (option): 1. Route the arterial line through the arterial line clamp. 2. Use a Cartridge Blood Set equipped with expansion chambers. 3. Mount the Single Needle holder (see Section 5.A - Special Procedures, in this manual, for the Installation of the Single Needle holder procedure). 4. Insert the pre-dialyser and post-dialyser expansion chambers in their respective holders (with the level adjustment lines pointing upwards). The Single Needle holder is provided of two clip connections to secure the pre and post-dialyser expansion chambers. To mount the pre-dialyser expansion chamber press with the thumb the bottom side to the higher single needle holder arm while levering to the Single Needle holder with the rest of the hand. To mount the post-dialyser expansion chamber press with the thumb the top side to the lower single needle holder arm while levering to the Single Needle holder with the rest of the hand. Both pre and post-expansion chambers must fit properly to the single needle holder arms. 5. Be sure that the clamp above the pre-dialyser expansion chamber and the clamp above the post-dialyser expansion chamber are closed. 6. Before attaching the arterial dialyser line (from the bottom of the pre- dialyser pumping chamber) to the arterial dialyser port (on the top of the dialyser), rotate the arterial dialyser line counter-clockwise (about 1 full turn); then connect the arterial dialyser line to the arterial dialyser port. 7. Before attaching the venous dialyser line (from the bottom of the post- dialyser pumping chamber) to the venous dialyser port (on the bottom of the dialyser), rotate the venous dialyser line counter-clockwise (about 1 full turn); then connect the venous dialyser line to the venous dialyser port. 8. Adjust dialyser position to prevent sharp bends in tubing and to prevent tubes from interfering with Phoenix machine or its parts. Ensure that lines are untangled. 9. Route the venous line into the Air Bubble Detector and through the Venous Line Clamp. 10. Close the Air Bubble Detector cover (cover makes a clicking sound as it latches). 11. Route the Cartridge access lines into the 4 Position Line Clamp above the blood pump. Route the lines from right to left as follows Heparin line green clamp Arterial access line red clamp (right) Rev. B

5-3

5-4

PHOENIX OPERATOR MANUAL Cartridge saline line red clamp (left) Venous access line blue clamp The Arterial access line, Cartridge saline line and Venous access line make a clicking sound when they are firmly inserted in the 4 Position Line Clamp.

Note Clamp all lines except the heparin line. Leave the heparin line unclamped so it can be primed with heparin from the heparin syringe.

WARNING Never insert fingers in the Venous Line Clamp and in the Arterial Line Clamp (if Single Needle is available on the machine).

WARNING When the cover of the blood pump is open, that the pump is off.

WARNING Improper connections of the extracorporeal circuit may cause potential patient safety hazards, that might not be detected by the machine: for instance, hemolysis caused by kinks, twists, loops, sharp bends, clamps or other restrictions on the blood line, blood loss to the environment/air into the blood circuit due to leakage in the extracorporeal circuit.

WARNING Before inserting the venous line in the Air Bubble Detector clean and dry it. Fluid and gel substances applied on the Air Bubble Detector may reduced the Air Bubble Detector sensitivity causing patient injury or death. Refer to "6.8.1 External surface cleaning" paragraph, in the Section 06 - Clean/Disinfect, for the description of how to clean the Air Bubble Detector.

Rev. B


Fig. 5.1 Cartridge Blood Set Loading

Rev. B

5-5

5-6


5.2.3 Fill and install heparin syringe a. Fill a syringe with the desired amount of heparin solution and push the syringe plunger to expel any air. b. that the heparin line of the Cartridge Blood Set is installed in the green clamp of the 4 Position Line Clamp. c. Attach the heparin line to the heparin syringe. (ARROW LEFT) and (ARROW RIGHT) buttons on the Heparin d. With the Control , move the heparin syringe plunger clamp to fit the syringe. Position the wings of the syringe against the syringe holder so that they will fit between the plastic clips. Lock it in place with the clamp and close the syringe holder with the clip (to keep the syringe in place). e. that the heparin line on the Cartridge Blood Set is unclamped.

Rev. B


5.2.4 Connect saline a. Clamp the saline istration line that is connected to the venous line. Remove the cover from the saline istration line and insert the spike into a 1000 ml bag of saline. b. Hang a saline sterile bag on the IV pole.

Rev. B

5-7

5-8


5.3 SETUP selection Overview The dialysate preparation process is started by selecting the SETUP Action key from the IDLE view. The DIAL. CHOICE view appears which displays options for the type of dialysate to be used (ACETATE, BICARB CONC, BICART).

Note If, after the selection of the SETUP Action key, the Cartridge Blood Set has not been installed, the following message will be displayed in the Operator Message Area: Warning: the cassette MUST be installed before starting the preparation. Only after the Cartridge Blood Set installation, the Operator Message will disappear and the ACETATE, BICARB CONC and BICART Action key will become available.

SELECT DIALYSATE VIEW: 12:30

DIAL. CHOICE

ACETATE BICARB CONC BICART

NEW SESSION

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

Note The NEW SESSION Action key appears following the first dialysis treatment of the day. It doesn’t appear if the dialysis treatment has been interrupted and then restarted using the Fast Recovery of the Dialysis process procedure. It disappears at the end of the day.

Rev. B


Connect the appropriate acid and bicarbonate (if applicable) concentrates to the machine. Select the dialysate type Action key to begin uptake of the concentrates into the machine. The following view is then displayed:

SETUP VIEW: 12:30

SETUP

VEN

PRIME TIME

pH VALUE

DIALYSATE FL.

BIC 8.4% COND (Note 1)

PRIME VOLUME

CONDUCTIVITY

PRIME

PATIENT DATA

ART BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

STOP SETUP

Note 1 This parameter changes following the selection made in Config/Treatments for the parameters related to the Action keys ACETATE, BICARB CONC or BICART.

PATIENT DATA (PATIENT DATA/Patient/Rx SELECT): Access this view to select the personalised prescription parameters. Select the name of the desired Patient/Rx prescription by pressing one of the seven Selection keys. The corresponding Patient/Rx parameters are then displayed. Confirm the parameters so that the machine may use them from the beginning of the preparation process or modify the parameters by pressing the Set button.

Note To modify the values of the Patient/Rx parameters press the Set button on the Main Control . Select the desired parameter by touching the parameter box on the Touch Screen and change the value by using the PLUS or MINUS buttons, then press CONFIRM to accept the new value for the parameter. Each parameter must be confirmed individually.

Rev. B

5-9


5.3.1 Standard Dialysis Mode (when SETUP has been selected) 5.3.1.1

When Acetate Dialysate is programmed in the Configuration menu To start the preparation of Acetate dialysate: • Disconnect the white concentrate connector on the lower front of the machine and connect it to the white concentrate wand, and then place the wand into in the acetate concentrate container. • Press the SETUP Action key on the IDLE view. • Select the ACETATE Action key on the DIAL. CHOICE view. The following view is displayed:

12:30

SETUP

VEN

PRIME TIME

pH VALUE

DIALYSATE FL

TEMPERATURE

PRIME VOLUME

CONDUCTIVITY

PRIME

PATIENT DATA

ART BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

STOP SETUP

The dialysate preparation process starts. To stop SETUP, press the STOP SETUP Action key and confirm the operation by pressing the CONFIRM button on the Main Control . The machine will return to the IDLE view.

Rev. B


5.3.1.2 menu

5-11

When Liquid Bicarbonate Dialysate is programmed in the Configuration

Before pressing the SETUP Action key, ensure that the BiCart holder is in the rinsing position, with the arms closed (see Fig 5.3, 1)

Note BICARBONATE 6.6% / 8.4% The type of liquid bicarbonate concentrate is entered in the Configuration menu. If the other type of liquid bicarbonate concentrate is required, the BICARB CONC parameter in the configuration menu must be re-entered

To start the preparation of Liquid Bicarbonate dialysate: • Disconnect the white concentrate connector on the lower front of the machine and connect it to the white concentrate wand and then place the wand into the acid concentrate container. • Disconnect the blue concentrate connector on the lower front of the machine and connect it to the blue concentrate wand and then place the wand into the bicarbonate concentrate container. • Press the SETUP Action key on the IDLE view. • Select the BICARB CONC Action key on the DIAL. CHOICE view.

Note The type of bicarbonate concentrates to be used on the PHOENIX is described in the Section 9 – Specification, in this manual.

If BIC 6.6% is selected in the configuration menu, the following view is displayed: 12:30

SETUP

VEN

PRIME TIME

pH VALUE

DIALYSATE FL.


PRIME VOLUME

CONDUCTIVITY

PRIME

PATIENT DATA

ART BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

STOP SETUP

Rev. B

5-12 PHOENIX OPERATOR MANUAL Note 2 This parameter changes following the selection made in Config/Treatments/BICARB CONC.

To stop setup and to return to the IDLE view, press the STOP SETUP Action key and confirm the operation by pressing the CONFIRM button on the Main Control .

WARNING If bicarbonate dialysis is performed: 1. Do not turn off the machine with bicarbonate dialysate in the flow pathway. 2. It is recommended to perform an acetic acid rinse at least twice a week to remove the calcium and any precipitate residues, which may be deposited in the hydraulic pathway. To do this, follow the instructions for the Disinfection process (see Section 6 Clean/Disinfect, in this manual), substituting the chemical disinfectant for an acetic acid solution 30% v/v (add 120 ml of glacial acetic acid to 280 ml of water to obtain 400 ml of solution).

Twice weekly rinsing with acetic acid is recommended for machines, which carry out two bicarbonate dialysis sessions a day. As required, on the responsibility of the operator, this frequency may be increased or decreased depending on the following conditions: • Number of bicarbonate dialysis sessions a day. • Quality of water. • Quality of the bicarbonate. • Type of solutions used for chemical disinfection.

WARNING Ineffective cleaning with acetic acid may cause the machine to malfunction (the lines or the solenoid valves may block and the sensor readings may be affected). It is responsibility of the to check the efficiency of the acetic acid rinsing procedures and to alter the frequency that they are performed, depending on the conditions listed above.

Rev. B


5.3.1.3

5-13

When BiCart Dialysate is programmed in the Configuration Menu To start the preparation of BiCart dialysate: • Disconnect the white concentrate connector on the lower front of the

machine and connect it to the white concentrate wand, and then place the wand into the acid concentrate container.

Note It is recommended to invert the BiCart before placing it in the BiCart holder.

Note The BiCart cartridge must be inserted into the BiCart holder before selecting the BICART Action key. Pressing theBICART Action key initiates priming of the BiCart cartridge.

• Open both arms (B, C) of the BiCart holder (see Fig 5.2). To fully open the upper arm (B), pull the arm out slightly, then tip it upward. • Place the bottom of the BiCart cartridge (D) into the hole in the lower arm (C). Hold the BiCart in an upright position and press down firmly on the upper arm (B) of the BiCart holder. The spike inside the hole of the upper arm pierces the top port of the BiCart (A). At the same time, the BiCart moves downward and the spike in the lower arm pierces the bottom port. Turn the BiCart by a quarter turn to place it in working order. • When the DIAL. CHOICE view is displayed, press the BICART Action key to initiate priming of the BiCart. The following view appears: 12:30

SETUP

VEN

PRIME TIME

pH VALUE

DIALYSATE FL.


PRIME VOLUME

CONDUCTIVITY

PRIME

PATIENT DATA

ART BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

STOP SETUP

Rev. B

5-14 PHOENIX OPERATOR MANUAL It takes about 1 minute to fill the BiCart with water. If this does not happen, check the position of the BiCart and that both BiCart holder arms are completely pressed into the BiCart ports. To stop SETUP and to return to the IDLE view, press the STOP SETUP Action key and confirm the operation by pressing the CONFIRM button on the Main Control .

A

B

D

C

Fig 5.2 BiCart holder

Rev. B


WARNING Check the expiry date on the BiCart label. Do not refill the BiCart cartridge. If required to replace the BiCart when a dialysis treatment is in progress, follow the “BiCart Change” procedure in the Section 5.A - Special Procedures, in this manual.

IMPORTANT: • Before using the BiCart cartridge, check that it is undamaged. • Store at a temperature lower than 40 °C (104 °F).

Note In the event of a “Bicart Connector Position” #22 alarm, the BiCart priming process will not start.

Rev. B

5-15


1

2

3

Fig 5.3 BiCart connection

Note In bicarbonate dialysis, at the end of EMPTYING, the machine prompts the operator to perform a DESCALING, i.e. rinsing of the hydraulic circuit, using either acid concentrate or vinegar. DESCALING may be performed with the BiCart cartridge in the BiCart holder if a dialysis treatment will follow the DESCALING process or with the BiCart removed and the BiCart holder arms closed.

Rev. B


5-17

5.3.2 RX Dialysis Mode Note This Section contains references to all the communication software systems to which the Phoenix machine can be connected, including the Exalis System.

The PATIENT DATA Selection key in SETUP view, when present, allows the selection of one of the personalised Patient/Rx prescriptions or allows retrieval of the personalised Patient/Rx prescriptions stored in the Exalis database or allows to assign an identifier to the treatment data collected by the Communication System. When the PATIENT DATA Action Key is selected, the PATIENT CHOICE view appears: 12:30

PATIENT CHOICE

PATIENT MACH

PAT NETWORK

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

Note The PAT NETWORK Action key is available only if the SW COMM SYSTEM parameter is set to Exalis or to OTHER in Config/Communic.. • When the the SW COMM SYSTEM parameter is set to Exalis, it indicates that the Exalis Dialysis Management System is active and can send prescriptions. • When the SW COMM SYSTEM parameter is set to OTHER, it indicates that a Communication System, other than Exalis or CentryNet or RIMS, can collect treatment data but cannot send prescriptions. The PAT NETWORK Action key allows to assign a Patient identifier to a treatment, this assignment will be recognized by the Communication System.

Note If the communication between the Exalis System and the machine is interrupted for more than the time set for the OFFLINE TIMEOUT parameter, the PAT NETWORK Action key disappears.

Rev. B

5-18 PHOENIX OPERATOR MANUAL By pressing PAT NETWORK a keypad appears allowing the entry of the Patient Name: • if the SW COMM SYSTEM parameter is set to Exalis, refer to Section 07Communication System, for a detailed description of the prescription with the Exalis System; • if the SW COMM SYSTEM parameter is set to OTHER, the keypad allows to assign a Patient identifier to the treatment that will be collected by the Communication System. By pressing PATIENT MACH the following PATIENT CHOICE view will appear: 12:30

1ST PATIENT 2ND PATIENT 3RD PATIENT 4TH PATIENT 5TH PATIENT 6TH PATIENT 7TH PATIENT BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

Note Before selecting a new personalised Patient (Rx) prescription, deactivate Profiling, if it is has been already activated.

Press the Action key on the Touch Screen to select the desired prescription Patient (Rx). To confirm the selection, press the CONFIRM button on the Main Control as requested by the message on the Touch Screen.

Note If the prescription selected is not consistent with the machine features, a superimposed window appears advising the operator about the error in the patient prescription: …accessory has not enabled in this machine . Press ENTER To Confirm And Proceed The operator must press the CONFIRM button to proceed with the treatment; the portion of the patient prescription related to the accessory that has not been enabled will be ignored.

Rev. B


5-19

Note If at least one of the parameters in the patient prescription can not be accepted by the machine, a superimposed window appears advising the operator about the error in the patient prescription: Prescription Not Valid. Please Access the Machine Page to Check the Wrong Parameter. Press ENTER To Confirm And Proceed.. The operator must press the CONFIRM button to proceed the treatment; after this confirmation: - all of the patient prescription will be discarded; - if the PAT CONNECT Action key does not become available in the WAIT FOR PT. CONNECT view, select the PATIENT DATA Action key and then press the CLOSE Action key to make the PAT CONNECT Action key available. Entering the Machine view, the WRONG PRESC PAR: parameter displays the prescription parameter causing the failure.

Note If the patient prescription selected is not available in the Exalis database, the following superimposed window appears: Patient Not Recognized by Clinical Software Check the Patient Name and retry. Press ENTER To Proceed Press the CONFIRM button and repeat the procedure.

Rev. B

5-20 PHOENIX OPERATOR MANUAL When a Patient is selected, some of the relevant dialysis parameters are displayed, as shown in the following example:

12:30

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

PARAMETER VALUE

SAFETY PARAMETERS

Note • •

Rev. B

When UF PROFILE is active, the DIALYSIS TIME and WEIGHT LOSS/H parameters are not displayed in the Patient/Rx Safety Parameters Area of the screen. When COND PROFILE is active, the DIALYSIS TIME and CONDUCTIVITY parameters are not displayed in the Patient/Rx Safety Parameters Area of the screen.


5-21

When the CONFIRM button on the Main Control is pressed the system will automatically return to the previous view where the PATIENT DATA Selection key was pressed. If it was the IDLE view, the following view will appear, with the selected displayed in the RX/Patient Name Area: 12:30

PATIENT 1

IDLE

PATIENT DATA

SETUP

ADR BPM

REPORT

CONFIG

MACHINE

Rev. B

5-22 PHOENIX OPERATOR MANUAL When programming a Patient treatment: Before pressing the SETUP Action key, to start the preparation of the dialysate: • Attach the concentrate connectors on the lower front of the machine to the appropriate concentrate containers, according to the type of dialysate selected for this Patient. If the type of dialysate is: • ACETATE: follow the instructions in 5.3.1.1 • BIC CONC: follow the instructions in 5.3.1.2 • BIC BICART: follow the instructions in 5.3.1.3 • Press the SETUP Action key.

Note The parameters list displayed, depends on the specific selections made for the Patient

WARNING If the machine has detected blood at the Patient Sensor during SETUP, the following message is displayed: If the line has blood in it, press CONFIRM. Or: - Remove venous line from patient sensor - Clean and dry venous line and pt. sensor slot - Put venous line back in the patient sensor - Press CONFIRM If the patient is already connected to the machine, disconnect the patient from the machine. If there is no patient connected to the machine, this “BLOOD detection” can be caused by incorrect placement of the venous line. Press the CONFIRM button to allow the machine to continue.

Note If the equipment has detected an incorrect pressure during T1Test, due to improper Cartridge positioning, the warning message “W! Wait for Pressure Test Execution” appears and the following message is displayed:

Please Close the Saline Bag and Open the Cassette Chambers to the External Environment By doing this the pressure decreases and the can reposition the Cartridge correctly.

Note When a Patient personalised dialysis is selected, the corresponding Patient name is displayed in the Patient Name Area in the upper left corner of the screen.

Rev. B


5-23

5.4 Preparing for a patient treatment 5.4.1 Dialysate preparation After pressing one of the Dialysate Selection keys on the DIAL. CHOICE view, dialysate preparation starts. During dialysate preparation, the machine carries out the automatic T1 test (see Section 5.B – Test Procedures, in this manual). 12:30

SETUP

VEN

PRIME TIME

pH VALUE

DIALYSATE FL.


PRIME VOLUME

CONDUCTIVITY

PRIME

PATIENT DATA

ART BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

STOP SETUP

Note During the T1 test, appropriate messages are displayed in the operator message window. When no test is occurring, the following message appears:

Wait Dialysate Preparation In Progress... and a progress bar is displayed informing that the dialysate preparation phase is in progress.

Note The parameters on the Touch Screen will differ depending on the type of dialysis therapy previously selected.

Rev. B


WARNING DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment before dialysate preparation completion, signalled by the appearance of the following Operator Message:

End Of Dialysate Prep, You Can Proceed You Can Now Connect The Dialyser

Note During the dialysate preparation phase, the operator may modify some parameters using the SET button on the Main Control .

Rev. B


5.4.1.1

Possible operations during the dialysate preparation phase

Dialysate Preparation may be interrupted by pressing the STOP SETUP Action key to return to the IDLE view. The following message will appear: CONFIRMATION LAST ACTION MADE ENTER To Confirm UNDO

Note If AutoCalibration of the PA and PB concentrate pumps or the UF pump is necessary during the dialysate preparation phase, refer to Section 5.A - Special Procedures, in this manual.

Note If during the dialysate preparation phase, the machine detects a condition that could produce a “! Concentrate Cans: A Pump/B Pump/A+B Pumps” #40 alarm in the dialysis treatment in progress, the following superimposed window will appear: Check the dialysate concentrates to ensure the usage of the correct concentrate type. Press ENTER To Confirm And Proceed Press UNDO to Cancel the Selection By pressing the CONFIRM button the machine will perform the PA/PB pump Autocalibration procedure during the dialysate preparation process, refer to Section 5.A Special Procedures. By pressing UNDO, the machine will proceed with the dialysate preparation process.

Note If during the dialysate preparation phase, the machine detects that the Blood Pump Cover is not properly closed, the following message will be displayed in the Operator Message Area: Arterial Cover is Open Please Close it Only after the Blood Pump Cover has been closed, the Operator Message will disappear and the machine will proceed with the dialysate preparation process.

5.4.1.2

Sampling of dialysate A sample can be obtained after the “End Of Dialysate Prep, You Can Proceed” message appears – refer to “Dialysate Sampling” in the Section 5.A - Special Procedures, in this manual. Rev. B

5-25


5.4.2 Priming Mode Selection View After selecting a dialysate type on the Dialysate Selection view, the following view is displayed where the priming parameters of the dialyser may be selected: 12:30

SETUP

PRIME TIME

DIALYSATE FL. VEN

PRIME

pH VALUE


PATIENT DATA

ART BLOOD FLOW PRIME VOLUME

BPM

REPORT

KT/V

CONDUCTIVITY

PROFILE

HEPARIN

MACHINE

STOP SETUP

Note In Prime mode, the blood pump runs in the reverse direction (clockwise).

Once the PRIME Selection key appears, open the Waste Handling Option (WHO) door and insert the white priming connector attached to the arterial line into the Waste Handling Option drain port (use the pre-connected priming connector).

WARNING that fluid is not present in the Waste Handling Option drain port by visual inspection before inserting the Cartridge Blood Set’s priming connector into the port. If fluid is present in the port for more than six seconds after opening the cover, DO NOT USE the WHO.


WARNING The Waste Handling Option (WHO) must be cleaned each time blood enters the WHO drain port before continuing with another patient treatments or once per day if the WHO has been in use. (Refer to Section 5.A - Special Procedures, in this manual).

Rev. B


5.5 Priming of the dialyser The priming procedure may vary depending on the value set for the DIAL AUTO PRIME parameter in Config\Centre Conf\Automation. •

If the DIAL AUTO PRIME parameter is set to YES, the priming procedure can start immediately after the appearance of the PRIME Action key (Refer to the below section 5.5.1 - Priming with Dialysate Connectors on the Dialyser).

•

If the DIAL AUTO PRIME parameter is set to NO, the priming procedure can start only when the machine is within proper conductivity (Refer to the below section 5.5.2 - Priming with Dialysate Connectors on the Rinse Ports).

WARNING Hemolysis may occur if blood comes in with disinfectant remaining in the blood pathway of dialysers that have not been completely rinsed. If the dialysers are filled with a chemical disinfectant, special rinsing techniques must be employed to assure the concentration of disinfectant is reduced and maintained at an appropriate level. These rinsing procedures are the responsibility of the medical director. The procedures must include a test of residual disinfectant and techniques to avoid rebound of disinfectant.

5.5.1 Priming with Dialysate Connectors on the Dialyser During Dialysate preparation, once the PRIME Action key appears: • Connect the dialysate lines to the dialyser: • Connect the Blue dialysate connector to the inlet dialysate port (blue end) of the dialyser. • Connect the Red dialysate connector to the outlet dialysate port (red end) of the dialyser.

Note The connection of the dialysate lines to the dialyser can be performed during all the dialysate preparation phase except when the following Operator Message is displayed: Do Not change Current position of dialysate connectors until Dialysate Prep. is Complete This message appears immediately before the end of the dialysate preparation phase. Once it disappears the dialysate lines can be still connected to the dialyser, if not yet done.

Rev. B

5-27

5-28 PHOENIX OPERATOR MANUAL • Press the PRIME Action key, the following view is displayed: 12:30

MANUAL PRIM PRIME W/ UF PRIME W/O UF

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

• Select the priming mode. • Select the CLOSE Action key to return to the SETUP PRIME view, if no priming mode has been selected.

WARNING When selecting SETUP, the limits of the Venous Pressure alarm window are automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window limits are set at -400 to +150 mmHg. These values are maintained for the duration of the PRIME mode.

Rev. B


5.5.1.1

5-29

To prime the blood side of the dialyser and the heparin line

Note Before selecting the PRIME Action key, make sure that the saline bag is hanging correctly on the IV Pole.

• Unclamp the saline istration line and the venous and arterial lines. • Depending on the priming mode selected proceed as follows: • if MANUAL PRIM is selected, the following Operator Message is displayed:

Manual Priming is in Progress: the Blood Pump has to be running and the BY has to be deselected. and priming starts as soon as the operator press the ON/OFF button on the Blood Pump Control . During manual priming mode, the blood pump is controlled by the operator, it will not start or stop automatically but is controlled by pressing the blood pump ON/OFF button on the Blood Pump Control . The pump will start at its minimum preset speed. The operator can increase or decrease the blood pump speed using the PLUS or MINUS buttons on the Blood Pump Control . The blood pump must remain ON until at least 120 ml of saline has been infused and an operator message appears that indicates that MANUAL PRIM may be stopped. An operator message will direct the to the required steps in order to complete priming. The UFR is at the UF PRIMING value selected in Config and it is also adjustable in the SET mode.

Note The BY Action key remains activated (yellow) during all the priming of the blood side of the dialyser. To start priming of the dialysate side of the dialyser the BY Action key has to be manually de-activated (grey).

Note If the RESUME button was pressed just before selecting the MANUAL PRIM Action key, the blood pump will start automatically at the selection of the MANUAL PRIM Action key. To manually control the blood pump speed, use the buttons on the Blood Pump Control .

• if PRIME W/ UF is selected, priming will start automatically when the machine is within proper conductivity. The following Operator Message will appear: End Of Dialysate Preparation You Can Now Connect The Dialyser The BY Action Key automatically changes in colour, from yellow to grey, and the blood pump starts automatically. The blood pump will stop when the programmed Dialyser Prime Volume has been infused. The UFR is set at the UF PRIMING value selected in Config and is also adjustable in the SET mode. Rev. B

5-30 PHOENIX OPERATOR MANUAL • if PRIME W/O UF is selected, the blood pump starts automatically immediately after the Action key selection and will stop when the programmed Dialyser Prime Volume has been infused. When the machine is within proper conductivity and the following Operator Message will appear End Of Dialysate Prep, You Can Proceed You Can Now Connect The Dialyser the BY Action Key automatically changes in colour, from yellow to grey. NO UFR is performed.

Note In the Prime mode, the blood pump turns in the reverse (clockwise) direction.

Note A blood pump speed of 150 ml/min is recommended to obtain the best extracorporeal circuit deaereation.

Note If set up for Single Needle and a Single Needle treatment is programmed, perform prime as in Double Needle mode and select Single Needle mode at the end of PAT CONNECT (refer to Dialysis change mode).

• Priming of the heparin line starts automatically at the start of the blood side priming, if the parameter PRIMING HEP is set to YES in the Config screen.

Note To prime the heparin line, access the Heparin view by pressing the Heparin Navigation key. From this view the HEPARIN PR Action key may be pressed to activate priming. An icon indicating the activation of the heparin pump appears on the icon bar. The syringe containing heparin must be correctly installed prior to the time of the HEPARIN PR selection.

• Observe the dialyser and Cartridge Blood Set. • Check/adjust the fluid level in the venous and arterial chambers, refer to “Level adjustment of the Cartridge chambers”.

Rev. B


5.5.1.2

To fill the dialysate side of the dialyser • If MANUAL PRIM has been selected, deselect/deactivate the BY Action key on the SETUP: PRIME/PREPARATION view to prime the dialysate side of the dialyser.

WARNING If performing MANUAL PRIM or PRIME W/O UF, priming of the blood side may be performed before priming the dialysate side. Dialysate side priming may be started before blood side priming is complete.

Note If PRIME W/ UF or PRIME W/O UF has been selected, during dialysate side priming the following message appears: Wait, Priming in progress … and a progress bar is displayed informing that the dialysate side priming phase is in progress.

• The end of the dialysate side priming is signaled by the appearance of the RECIRC Action key. • When priming is complete, the RECIRC Action key will become available to initiate

the recirculation phase prior to patient connection.

Note The selection/activation of the PRIME Action Key allows the operator to re-start priming. If the PRIME Action key is deselected/deactivated before the end of the dialysate side priming, the RECIRC Action key becomes available.

Rev. B

5-31


5.5.2 Priming with Dialysate Connectors on the Rinse Ports When the machine is within proper conductivity, the following Operator Message will appear: End Of Dialysate Prep, You Can Proceed You Can Now Connect The Dialyser

and the following view is displayed: 12:30

SETUP PRIME

VEN

PRIME

PRIME TIME

PH VALUE

DIALYSATE FL.

BIC 8.4% COND (NOTE 1)

ART

PATIENT DATA BY

BLOOD FLOW

PRIME VOLUME

BPM

REPORT

KT/V

CONDUCTIVITY

PROFILE

HEPARIN

PAT CONNECT

MACHINE

STOP SETUP

WARNING When selecting SETUP, the limits of the Venous Pressure alarm window are automatically set at -50 to +250 mmHg and the Arterial Pressure alarm window limits are set at -400 to +150 mmHg. These values are maintained for the duration of the PRIME mode.

Note The PAT CONNECT Action key is available only if the JUMP PRIMING parameter is set to YES in Config/Centre Conf/Functions.

Rev. B


5-33

Note If the machine is connected to the CentryNet system, the PAT CONNECT Action key is available only after the START COLLECT Action key has been pressed.

Connect the dialysate lines to the dialyer. • Connect the Blue dialysate connector to the inlet dialysate port (blue end) of the dialyser. • Connect the Red dialysate connector to the outlet dialysate port (red end) of the dialyser.

5.5.2.1

To prime the blood side of the dialyser and the heparin line

Note Before selecting the PRIME Action key, make sure that the saline bag is hanging correctly on the IV Pole.

• Unclamp the saline istration line and the venous and arterial lines. • When the PRIME Selection key is pressed the following view is displayed: 12:30

MANUAL PRIM PRIME W/ UF PRIME W/O UF

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

Rev. B

5-34 PHOENIX OPERATOR MANUAL • Select the priming mode: • if MANUAL PRIM is selected, the blood pump is controlled by the operator. After the selection of the MANUAL PRIM Action key, the following Operator Message is displayed:

Manual Priming is in Progress: the Blood Pump has to be running and the BY has to be deselected. The blood pump will not start or stop automatically but is controlled by pressing the blood pump ON/OFF button on the Blood Pump Control . The pump will start at its minimum preset speed. The operator can increase or decrease the blood pump speed using the PLUS or MINUS buttons on the Blood Pump Control . The blood pump must remain ON until at least 120 ml of saline has been infused and an operator message appears that indicates that MANUAL PRIM may be stopped. An operator message will direct the to the required steps in order to complete priming. The UFR is at the UF PRIMING value selected in Config and it is also adjustable in the SET mode. • if PRIME W/ UF is selected, the BY Action Key automatically changes in colour, from yellow to grey, and the blood pump starts automatically. The blood pump will stop when the programmed Dialyser Prime Volume has been infused. The UFR is set at the UF PRIMING value selected in Config and is also adjustable in the SET mode. • if PRIME W/O UF is selected, the blood pump starts automatically and will stop when the programmed Dialyser Prime Volume has been infused. NO UFR is performed. • Select the CLOSE Action key to return to the SETUP PRIME view, if no priming mode has been selected.

Note In the Prime mode, the blood pump turns in the reverse (clockwise) direction.

Note A blood pump speed of 150 ml/min is recommended to obtain the best extracorporeal circuit deaereation.

Note If set up for Single Needle and a Single Needle treatment is programmed, perform prime as in Double Needle mode and select Single Needle mode at the end of PAT CONNECT (refer to Dialysis change mode)

Rev. B


5-35

• Priming of the heparin line starts automatically at the start of the blood side priming, if the parameter PRIMING HEP is set to YES in the Config screen.

Note To prime the heparin line, access the Heparin view by pressing the HeparinNavigation key. From this view the HEPARIN PR Action key may be pressed to activate priming. An icon indicating the activation of the heparin pump appears on the icon bar. The syringe containing heparin must be correctly installed prior to the time of the HEPARIN PR selection.

• Observe the dialyser and Cartridge Blood Set. • Check/adjust the fluid level in the venous and arterial chambers, refer to “Level adjustment of the Cartridge chambers”.

5.5.2.2

To fill the dialysate side of the dialyser • If MANUAL PRIM or PRIME W/O UF has been selected, deselect/deactivate the BY Action key on the SETUP PRIME/PREPARATION view to prime the dialysate side of the dialyser.

WARNING If performing MANUAL PRIM or PRIME W/O UF, priming of the blood side may be performed before priming the dialysate side. Dialysate side priming may be started before blood side priming is complete.

Note If PRIME W/ UF or PRIME W/O UF has been selected, during dialysate side priming the following message appears: Wait, Priming in progress … and a progress bar is displayed informing that the dialysate side priming phase is in progress.

• The end of the dialysate side priming is signaled by the appearance of the RECIRC Action key. • When priming is complete, the RECIRC Action key will become available to initiate

the recirculation phase prior to patient connection.

Note The selection/activation of the PRIME Action Key allows to re-start priming. If the PRIME Action key is deselected/deactivated before the end of the dialysate side priming, the RECIRC Action key becomes available.

Rev. B


5.6 Recirculation 5.6.1 Prepare to perform recirculation a. Clamp the heparin line, venous and arterial lines and the saline istration line. b. Disconnect the saline istration line from the venous line and connect it to the Cartridge saline line utilizing the white priming connector on the Cartridge saline line. Ensure the saline istration line is still clamped. c. Remove the arterial line from its priming connector, leaving the priming connector in the WHO drain port.

Note If the arterial line is removed from the Waste Handling Option with the white priming connector attached, there is danger of contaminating the arterial line with fluid that has been in with the Waste Handling Option. To prevent contamination of the arterial line, always disconnect the arterial line from the white priming connector in the WHO drain port.

d. Connect the venous and arterial lines together utilizing the white priming connector on the venous line. e. Remove the white priming connector from the Waste Handling Option drain port and discard it. Close the Waste Handling Option door. If the WHO door remains open at the activation of the RECIRC phase, the alarm message “WHF Door Positioning” (#326) will appear, the Blood Pump will stop. The recirculation timer (RECIRCULATION TIME parameter) will be stopped while the Waste Handling Option door remains open.


5.6.1.1

Unclamp lines Unclamp the venous and arterial lines, the saline istration line, and the Cartridge saline line clamps.

5.6.2 Select Recirculation a. Pressing the RECIRC Action key automatically starts the blood pump. The blood pump will run at the pump speed value previously set for the RECIRC B FLOW parameter. (Refer to Section 02 – Configuration, for details about the RECIRC B FLOW parameter setting). Recirculation continues for the time set in the RECIRCULATION TIME parameter. When the time has elapsed the blood pump continues to run in the forward direction (counter-clockwise) and the UFR stops until Patient Connection.

Note During the Recirculation phase, the PRIME, BY and PAT CONNECT Action keys are not available.

Rev. B


5-37

b. Use the PLUS or MINUS buttons on the Blood Pump Control to adjust the blood pump speed during RECIRC. c. Set a UF PRIMING to greater than 0.1 l/h to prevent saline from flowing backwards into the saline istration line. d. Recirculate according to your facility’s protocol. To stop RECIRC and stop the blood pump, press the RECIRC Action key.

5.7 Level adjustment of the Cartridge chambers Level Adjustment without using syringe in Double Needle Treatment Adjust the fluid level in the venous Cartridge chamber by aseptically opening both the white cap on the venous access line and the blue clamp on the 4 Position Line Clamp, with the blood pump ON in the forward (counter-clockwise) direction. When the target level is reached, close the blue clamp and replace the white cap on the venous access line. During the PRIME mode the fluid level in the arterial Cartridge chamber may be adjusted with the blood pump ON in the reverse (clockwise) direction, by aseptically opening both the white cap on the arterial Cartridge access line and the right red clamp on the 4 Position Line Clamp. When the target level is reached, close the right red clamp and replace the white cap on the arterial access line. To adjust the fluid level in the arterial Cartridge chamber, when not in the PRIME mode, turn the blood pump OFF and then aseptically open both the white cap on the arterial Cartridge access line cap and the right red clamp on the 4 Position Line Clamp. When the target level is reached, close the right red clamp and replace the white end cap.

Note The fluid level in the chambers (arterial or venous) should be stabilized at approximately the bottom of the pressure pod. The target fluid level in the chambers is indicated by a frosted line on the chamber themselves.

Level Adjustment using syringe in Double Needle Treatment To adjust the fluid level in the venous Cartridge chamber open the white cap on the venous access line, connect a sterile syringe to the venous access line and open the blue clamp on the 4 Position Line Clamp. Slowly and cautiously aspirate until the target level is reached, then close the blue clamp, remove the syringe and replace the white cap on the venous access line. To adjust the fluid level in the arterial Cartridge chamber, open the white cap on the arterial Cartridge access line, connect a sterile syringe to the arterial access line and open the right red clamp on the 4 Position Line Clamp. Slowly and cautiously aspirate until the target level is reached, then close the right red clamp, remove the syringe and replace the white cap on the arterial access line.

Rev. B

5-38 PHOENIX OPERATOR MANUAL Note The fluid level in the chambers (arterial or venous) should be stabilized at approximately the bottom of the pressure pod. The target fluid level in the chambers is indicated by a frosted line on the chamber themselves.

Level Adjustment in Single Needle Treatment Adjust the level in the pre and post dialyser expansion chambers and be sure that the clamp above the pre-dialyser expansion chamber and the clamp below the postdialyser expansion chamber are closed. To perform the procedure, follow the instructions in the “Level Adjustment using syringe in Double Needle Treatment” paragraph by operating on the pre and post dialyser expansion chambers.

Note The fluid level in the expansion chambers (pre and post dialyser) should be stabilized at approximately 1/3 of the height of the expansion chambers.

Rev. B


5-39

5.8 Patient Connection 5.8.1 Ready for patient connection After prime is complete the following view is displayed: 12:30

SETUP WAIT PATIENT

RECIRCULATION TIME

PRIME

RECIRCULATION UF

RECIRC DIALYSATE FL. VEN

BIC 8.4% COND (NOTE 1)

ART

PATIENT DATA BY

BLOOD FLOW

PRIME VOLUME

CONDUCTIVITY

PAT CONNECT CHANGES

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

STOP SETUP

Note During the initial DIASCAN Autocalibration, the BY Action key is not available (see Section 5.E – Monitoring, in this manual).

Note If the CURVE TYPE parameter or/and the CON CURVE TYPE parameter is(are) set to STEP or to PROGRESSIVE, the PAT CONNECT Action key becomes available only if the corresponding Profile curve(s) has/have been activated ACTIVATE (UF RATE CURVE or/and the ACTIVATE CONDUCT. CURVE Action key(s) selection). Refer to Section 5.D – Profile, in this manual.

WARNING If using a dialyser that has been filled with a chemical disinfectant, proceed as follows: • that the level of residual chemical disinfectant in the extracorporeal circuit is acceptable according to your facility’s protocol or to the instructions for use of the disinfectant’s manufacturer. • When the residual level is acceptable, discard the rinse saline bag and attach a new bag of saline. If the residual level is unacceptable, proceed according to your facility’s protocol. • Before initiating dialysis flush the istration set and the entire extracorporeal circuit with fresh saline according to your facility’s protocol.

Rev. B


Once all the preparations and settings have been completed and the patient is ready, the operator can select the PAT CONNECT Action key, confirm the selection pressing the CONFIRM button and then proceed to connect the patient.

WARNING When performing dialysis treatment for patients with a body weight of less than 40 kg, special attention should be given to the dialysate flow rate setting. To mitigate the risk of excessive weight removal, it is recommended to set the DIALYSATE FL. parameter to a value lower than or equal to 500 ml/min.

Note If the presence of blood has already been detected at the Patient Sensor the machine automatically goes to the PAT CONNECT view (see Initiating patient connect).

Note When Profiling has not been activated, these parameter values must always be confirmed: − DIALYSIS TIME − TOT WEIGHT L − WEIGHT LOSS/H If these values are not confirmed, a confirmation request is displayed in the Operator Message Area and the PAT CONNECT Action key will not appear. When UFR Profiling has been activated, the TOT WEIGHT L parameter value must always be confirmed in the PROFILE/UF view to make the PAT CONNECT Action Key available. Refer to Section 5.D - Profile.

Note In case of error in the retrieval of the RX prescription from an external communication software system (Refer to Section 7.5.3, Error Messages related to Computer Prescription, for details about the error message displayed in case of failure), the PAT CONNECT Action key might not be displayed. To make the PAT CONNECT Action key available, select the PATIENT DATA Action key and then press the CLOSE Action key.

Note When Profiling is active, the END DIALYSIS parameter can not be modified. Before activating Profiling ensure the END DIALYSIS parameter is correctly set for the current dialysis prescription. The END DIALYSIS parameter becomes again available at Profiling deactivation (Refer to Section 05.D – Profile, for a detailed description of Profiling deactivation conditions).

Note The DIALYSIS TIME, TOT WEIGHT L and WEIGHT LOSS/H parameters have to be confirmed following the listed sequence. To allow the operator to confirm them in the right order, they are automatically selected in sequence.

Note If the machine is connected to the CentryNet system, the DIALYSIS Action key is available only after the START COLLECT Action key has been pressed.

Rev. B


5.8.2 Heparinization By pressing the Heparin Navigation key the following view will appear: 12:30

LINEAR

SYRYNGE TYPES

AUTO BOLUS

VEN

PARAMETER 1 (NOTE 3)




MAN BOLUS

ART

BLOOD FLOW

BOLUS ON HEPARIN PR

BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

Note 3 These parameters are displayed only if the heparin delivery type has been selected by pressing the LINEAR or AUTO BOLUS or MAN BOLUS Action key. In the case of: • LINEAR Parameter 1 = PRE STOP TIME Parameter 2 = HEPARIN RATE Parameter 3 = INITIAL BOLUS Parameter 4 = HEPARIN TOTAL • AUTO BOLUS Parameter 1 = PRE STOP TIME Parameter 2 = HEPARIN BOLUS Parameter 3 = BOLUS INTERVAL Parameter 4 = HEPARIN TOTAL • MAN BOLUS Parameter 1 = MANUAL BOLUS Parameter 2 = HEPARIN TOTAL

If this view is accessed during the PRIME mode, the operator can initiate the priming of the heparin line by pressing the HEPARIN PR Action key. At this point the heparin pump injects a fixed quantity of heparin into the line. Or, priming of the heparin line starts automatically at the start of the blood side priming if the parameter PRIMING HEP is set to YES in Config/Centre Conf/Automation.

Rev. B

5-41

5-42 PHOENIX OPERATOR MANUAL The HEPARIN PR Action key is available only during the dialyser prime and the dialyser change. The volume injected is equivalent to the volume of the heparin line on the Cartridge Blood Set. The heparin delivery type can be selected by pressing one of the following Action keys: LINEAR: heparinization is continual during the treatment at the HEPARIN RATE set. In this mode, a programmable quantity (initial bolus) of heparin can be injected before starting the continual heparinization. To do this, the must set a value for the INITIAL BOLUS parameter before starting the treatment. Pressing the LINEAR Action key disables the AUTO BOLUS and MAN BOLUS Action keys. AUTO BOLUS: a heparin bolus is delivered by the machine at a fixed time interval. The quantity of the bolus corresponds to the value set for the HEPARIN BOLUS parameter, while the timing corresponds to the value set for the BOLUS INTERVAL parameter. Pressing the AUTO BOLUS Action key disables the LINEAR and MAN BOLUS Action keys. MAN BOLUS: a heparin bolus is delivered every time the BOLUS ON Action key is pressed. The quantity of the bolus corresponds to the value set for the MANUAL BOLUS parameter. Pressing the MAN BOLUS Action key disables the LINEAR and AUTO BOLUS Action keys. During treatment, the HEPARIN TOTAL parameter displays the volume of heparin infused to the patient. The HEPARIN TOTAL parameter value for a treatment remains available: -until the machine switch off at the end of treatment; -until the selection of the heparinization delivery type for the next treatment, if the machine is not switched off between two subsequent dialysis treatments. Once the heparinization delivery type is selected and the appropriate Action key pressed, the corresponding heparin icon appears on the left side of the Touch Screen, on the Icon bar, indicating that the mode is activated. The Heparin Pump will start in patient connection. To return to the previous view press the Home icon Navigation key.

Rev. B


5.8.3 Initiating patient connect The machine is ready for patient connection. Press PAT CONNECT, the blood pump stops automatically to allow connection of the patient to the machine. Press the blood pump ON/OFF button to restart the blood pump if the patient is not yet available. The following view appears on selection of PAT CONNECT: 12:30

PATIENT CONNECT

VEN

DIALYSIS TIME

WEIGHT LOSS/H

TOTAL FLUID REMOVED

TOT WEIGHT L

TOTAL BLOOD

CONDUCTIVITY

ART BLOOD FLOW

CHANGES

BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

To access the BPM view press the BPM Navigation key. Proceed with the patient connection to the machine according to the facility’s protocol.

5.8.3.1

Fill the extracorporeal circuit with fresh saline prior to treatment a. Clamp the venous and arterial lines and disconnect them from each other leaving the priming connector on the venous line. b. Place the arterial line over a collecting basin, being careful not to contaminate the line. c. With the blood pump OFF, open the clamps on the saline istration line, Cartridge saline line and the arterial line. d. Allow approximately 60 ml of saline to run out of the saline bag, through the arterial chamber and arterial line into the collecting basin. Clamp the arterial line. e. Being careful not to contaminate the line, connect the arterial line to the patient’s arterial access. Leave both lines clamped.

Rev. B

5-43

5-44 PHOENIX OPERATOR MANUAL f. Insert the priming connector on the venous line into the Waste Handling Option drain port. Press the blood pump ON/OFF button to start the blood pump and immediately open the clamp on the venous line.

Note The Heparin Pump will start after a minimum value (20 ml) of TOTAL BLOOD has been reached.

g. Flush the remaining extracorporeal circuit with enough saline to replace the recirculated saline it contains. DO NOT let air enter the lines. h. When enough saline has been allowed to flush the extracorporeal circuit, press the blood pump ON/OFF button to stop the blood pump and clamp the venous line.

WARNING that fluid is not present in the Waste Handling Option drain port by visual inspection before inserting the Cartridge Blood Set priming connector into the port. If fluid is present in the port more than six seconds after opening the cover, DO NOT USE the Waste Handling Option.

5.8.3.2

Connect patient

Note The steps below give instructions for connecting the patient and discarding the prime. The venous line is still connected to the Waste Handling Option drain port.

a. that there are no active alarms (check the alarm display area of Touch Screen); unclamp the heparin line. b. Clamp the saline istration line and Cartridge saline line. c. Unclamp the arterial line and the patient’s arterial access. Press the blood pump ON/OFF button to start the blood pump (blood begins filling the arterial line and chamber). d. Unclamp the venous line. When blood enters the venous chamber, simultaneously clamp the venous line and press the blood pump ON/OFF button to stop the blood pump. Once the Patient Sensor detects blood in the venous line, an alarm “W! Blood in the Venous Line” will be given and the blood pump will stop. OVERRIDE this alarm to continue. e. Disconnect the venous line from the white priming connector, leaving the white priming connector in the Waste Handling Option. f. Being careful not to contaminate the line, connect the venous line to the patient’s venous access. Unclamp the venous line and the patient’s venous access. g. Remove the white priming connector from the WHO and discard it. Close the Waste Handling Option door.

Note The DIALYSIS Action Key will not appear until the Waste Handling Option door is closed.

Rev. B


Note From the moment that blood is detected in the venous line at the Patient Sensor the Patient Sensor icon appears to indicate the presence of blood.

WARNING From the moment that blood is detected in the venous line at the Patient Sensor to the WASHBACK phase, if the operator stops the Blood Pump pressing the ON/OFF button on Blood Pump Control : • The venous pressure alarm window lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 - Configuration Description, in this manual). • The arterial pressure alarm window lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg. These values are maintained for all the time the Blood Pump is OFF and for 30 sec. after the Blood Pump restart.

WARNING Once the patient has been connected, do not open the Blood Pump Cover unless it is required by special procedures described in this manual (i.e., Diaphragm Neutral Position Procedure); in this case strictly follow these procedures. Opening of the Blood Pump Cover without following procedures described in this manual may infuse air to the patient through the arterial line causing patient injury or death. The DIALYSIS Action Key is displayed: 12:30

PATIENT CONNECT

VEN

DIALYSIS TIME

WEIGHT LOSS/H

TOTAL FLUID REMOVED

TOT WEIGHT L

TOTAL BLOOD

CONDUCTIVITY

DIALYSIS

ART BLOOD FLOW

CHANGES

BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

Rev. B

5-45

5-46 PHOENIX OPERATOR MANUAL Note If a Patient Dialysis is performed and the Communication System is Exalis, once the patient connection has been made, the machine sends to the Exalis database the name of the patient that has been connected. If the name of the patient sent to the Exalis Communication System is not present in the Exalis database, the following superimposed window appears: Patient Not Recognized by Clinical Software. To retrieve the current treatment data, , Link manually the patient in Exalis. Press ENTER To Proceed Press the CONFIRM button to proceed with the treatment. Refer to the Exalis Operator’s Manual for the procedure of how to link manually the patient in the Exalis database.

Once the patient connection has been made, select the DIALYSIS Action key to start the dialysis treatment. The blood pump will start: • at the speed value set for the INIT DIAL B FLOW parameter, if the RAMPING TIME parameter is set to 0. • at 50 ml/min, if the RAMP TIME parameter is set to a value different from 0. In this case the blood pump will automatically reach the pump speed value set for the INIT DIAL B FLOW parameter in a interval time equal to the value set for the RAMPING TIME parameter. During this Automatic Gradual Ramping time period the PLUS and MINUS button on the Blood Control are not active.


Rev. B


5-47

5.8.4 Dialysis change mode: Single Needle and Double Needle mode Pressing the CHANGES Selection key, from the PATIENT CONNECT view, where it is available, allows the to change the operating mode of the blood module. 12:30

CHANGES

DIALYSIS TIME

CHANGE TO SN

WEIGHT LOSS/H

CHANGE TO DN TOTAL FLUID REMOVED VEN

FILTER CHANGE

TOT WEIGHT L

ART

PAUSE BICART

BLOOD FLOW

BICART PRIM. TOTAL BLOOD

CONDUCTIVITY

CHANGE TO LIQ BIC

BLOOD FLOW

BPM

REPORT

CHANGE ACID KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

Note The BICART PRIM. Action key does not appear until the PAUSE BICART Action key has been pressed.

CHANGE TO SN and CHANGE TO DN Action keys are only displayed if Single Needle is set to YES in Config/MACHINE /Accessories. The possible transitions depend on the starting conditions, since in DN only the DN > SN key is enabled, while in SN only the SN > DN key is enabled. From Double Needle From Single Needle

DN SN

> >

SN DN

CLOSE allows the to return to the previous view.

Rev. B


5.9 Dialysis 5.9.1 Performing Dialysis When the DIALYSIS Action key is selected, the following view is displayed: 12:30

TREATMENT

DIALYSIS TIME

BY

DIFFUSION TIME

UF ONLY

VEN

TOTAL FLUID REMOVED

TOT WEIGHT L

WEIGHT LOSS/H

TOTAL BLOOD

WLR MINIMUM

ART BLOOD FLOW

CHANGES

BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

WASHBACK

This view remains until the end of dialysis. CHANGES allows the operator: • to change the operating mode of the blood module as described in the Dialysis Change Mode Section; • to temporarily disconnect the Patient (Refer to Section 05A – Special Procedures, in this manual, for the description of the PAUSE THERAPY procedure); • to change the BiCart if it becomes empty during the treatment (Refer to Section 05A – Special Procedures, in this manual, for the description of the BiCart Change procedure); • to replace the dialyser (Refer to Section 05A – Special Procedures, in this manual, for the description of the Dialyser Replacement procedure); • to switch from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate (Refer to Section 05A – Special Procedures, in this manual, for the description of the CHANGE TO LIQUID BICARB procedure); • to change the Acid/Acetate Concentrate Supply (Refer to Section 05A – Special Procedures, in this manual, for the description of the CHANGE ACID procedure).

Rev. B


5-49

Note When an Patient/Rx Personalised Treatment is performed, the name of the dialysis type in the view above is replaced with the Patient/Rx name.

Note During DIALYSIS, the icons relative to the treatment appear in the Icon bar.

Note In the event of a “! Concentrate Cans: A Pump or B Pump or A+B Pumps” alarm during a treatment, it is possible to carry out a recalibration: refer to Section 5.A - Special Procedures, in this manual.

When a critical condition for the patient arises, the operator can use three emergency functions. • Minimum UF Rate: when selecting the WLR MINIMUM Action key, the hourly ultrafiltration rate is set to the minimum value selected in Config, i.e., a value between 0.0 and 0.3 kg/h. When selected, the Action key is highlighted. • Dialysate Flow in By: when pressing the BY Action key, the flow through the dialyser is interrupted. When selected, the Action key is highlighted: 12:30

TREATMENT

DIALYSIS TIME

VEN

BY

DIFFUSION TIME

TOTAL FLUID REMOVED

TOT WEIGHT L

WEIGHT LOSS/H

TOTAL BLOOD

WLR MINIMUM

ART BLOOD FLOW

CHANGES

BLOOD FLOW

BPM

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

WASHBACK

Rev. B

5-50 PHOENIX OPERATOR MANUAL Note If the operator has selected BY for 7 minutes during the dialysis process, the alarm “! By Wrongly Extended” (#302) appears.

Pressing the BY Action key again will restart the normal dialysis process: • The dialysate flow through the dialyser is restarted. • The BY Action key is no longer highlighted

• Ultrafiltration Only: The dialysate flow through the dialyser may be interrupted by pressing the UF ONLY Action key. The following confirmation request will appear: CONFIRMATION LAST ACTION MADE ENTER To Confirm UNDO

By pressing the Confirm button the Action key becomes highlighted and the BY Action key disappears indicating that the function is no longer selectable.

12:30

TREATMENT

DIALYSIS TIME

DIFFUSION TIME

UF ONLY

VEN

TOTAL FLUID REMOVED

TOT WEIGHT L

WEIGHT LOSS/H

TOTAL BLOOD

WLR MINIMUM

ART BLOOD FLOW

CHANGES

BLOOD FLOW

BPM

Rev. B

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

WASHBACK


By pressing the UF ONLY Action key again, the above confirmation request will appear. After pressing the Confirm button the normal dialysis process restarts: • The dialysate flow through the dialyser is restarted. • The UF ONLY Action key is no longer highlighted. • The BY Action key reappears. To disconnect the patient, select WASHBACK.

Rev. B

5-51


5.10 End of Dialysis 5.10.1 Patient disconnection and Emptying dialyser Select the WASHBACK Action key. In this mode: • The blood pump stops to allow disconnection of the patient and to enable the Washback of blood from the extracorporeal circuit to the patient. • The patient may then be disconnected from the machine according to the facility’s protocol.

WARNING When WASHBACK is selected, the limits of the Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure window are set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and +150 mmHg. These values are maintained for the duration of the WASHBACK mode.

WARNING When WASHBACK is selected, the heparin pump is stopped.

When selecting WASHBACK, the following view is displayed: 12:30

WASHBACK

DIALYSIS TIME

DIFFUSION TIME

EMPTYING

VEN

TOTAL FLUID REMOVED

TOT WEIGHT L

RINSEBACK VOLUME

TOTAL BLOOD

ART BLOOD FLOW

CHANGES

BLOOD FLOW

BPM

Rev. B

REPORT

KT/V

PROFILE

HEPARIN

MACHINE

TREATMENT


Note During WASHBACK, the UFR parameter value is 0.

The different Selection/Action keys available on this view allow access to particular procedures: • EMPTYING Action Key

allows emptying of the dialyser following WASHBACK.

• CHANGES Selection key

gives access to another view where PAUSE BICART, FILTER CHANGE, CHANGE TO LIQ BIC, CHANGE ACID and DIALYSIS MODE CHANGE are available

Note The DIALYSIS MODE on the CHANGES view allows WASHBACK in a different dialysis mode to that that used during dialysis (e.g. Single Needle to Double Needle).

• TREATMENT

allows the operator to return to DIALYSIS. When the RINSEBACK VOLUME value set has been reached, the TREATMENT Action key disappears and it is no longer possible to return to dialysis.

Note When the RINSEBACK VOLUME value set has been reached and the DIALYSIS Action key disappears, the POST STANDING, POST SITTING and POST LYING Action keys becomes available. If selecting one of the three Action keys (POST STANDING/POST SITTING/POST LYING) before the EMPTYING Action key selection, the Dialyser Replacement procedure will be no more allowed for the current dialysis treatment.

WARNING The FILTER CHANGE Action key must be used only when the dialyser needs to be replaced (Refer to “Dialyser replacement” in the Section 5.A - Special Procedures in this manual).

WARNING Only in the event of the “! Concentrate Cans: A Pump or B Pump or A+B Pumps” (#40) alarm is it possible to perform Autocalibration of PA or PB pump during DIALYSIS (see “Autocalibration procedure for the peristaltic pumps during dialysis” in the Section 5.A - Special Procedures) when the operator accesses the Machine view by pressing the Machine Navigation key.


Rev. B

5-53


5.10.2 Emptying the dialyser 5.10.2.1

Manual Emptying At the end of the WASHBACK procedure, the EMPTYING and the AUTOEMPTY (if activated) Action key are available. The selection of EMPTYING acts as a confirmation to the machine that the patient has been disconnected.

WARNING In order to that the patient has been disconnected properly, the following message is displayed when the operator presses the EMPTYING Action key the first time: WARNING! Ensure that the patient has been disconnected. Press CANCEL otherwise. Press CONFIRM to proceed with emptying. Press the CONFIRM button on the Main Control to continue. The blood pump stops and the Protection System is no longer active. After the selection of EMPTYING, the dialysate side of the dialyser is now emptied by the machine and the following view is displayed: 12:30

EMPTYING

TOTAL FLUID REMOVED

TOTAL BLOOD

EMPTYING HEPARIN TOTAL VEN

STOP RINSE

DESCALING TIME

ART

AUTO EMPTYING

BLOOD FLOW

VINEGAR DESCAL BLOOD FLOW

BPM

Rev. B

REPORT

DESCALING KT/V

MACHINE

FINAL RINSE


Note Only after the EMPTYING mode has been completed and if a bicarbonate dialysis has been performed, the descaling function (VINEGAR DESCAL and DESCALING Action key) becomes available. In particular, if the VINEGAR DESCAL parameter in Config is set to NO, the VINEGAR DESCAL Action key is not available; if the VINEGAR DESCAL parameter in Config is set to YES both the VINEGAR DESCAL and the DESCALING Action key are available. If the VINEGAR DESCAL parameter in Config is set to ALWAYS, only the VINEGAR DESCAL Action key is available.

Note Only after the EMPTYING mode has been completed, the STOP RINSE Action key becomes available.

Note Only after the EMPTYING mode has been completed and if an Acetate dialysis has been performed, the FINAL RINSE Action key becomes available.

The AUTO EMPTYING Action key allows to proceed with emptying procedure using the AutoEmptying feature. Refer to “5.10.2.2 AutoEmptying”, in this section, for a detailed description of the AutoEmptying feature. To proceed with EMPTYING without using the AutoEmptying feature: • Rotate the dialyser so that the blue end of the dialyser is up. • Disconnect the blue dialysate connector from the dialysate port of the dialyser and reattach it to its by port on the machine. (This operation is prompted by an operator message). Deselecting EMPTYING allows the EMPTYING process to be interrupted. This Action key disappears when the dialyser has been emptied. • Disconnect the red dialysate connector from the dialysate port of the dialyser and reattach it to its by port on the machine. (This operation is prompted by an operator message).

WARNING In bicarbonate dialysis, it is strongly recommended to perform a descaling of the hydraulic circuit with vinegar following every treatment. This can be done using the VINEGAR DESCAL Action key. Its duration may be set with the DESCALING TIME parameter. During this phase the value of the DESCALING TIME parameter is displayed.

Rev. B

5-55

5-56 PHOENIX OPERATOR MANUAL If another dialysis treatment is going to be performed, the concentrate connectors (Acid and bicarbonate/BiCart) may be left in place on the machine during the DESCALING and FINAL RINSE processes. If another dialysis treatment will not be performed: • Liquid Bicarbonate - remove the blue bicarbonate connector from the blue concentrate wand and reinsert it into its blue rinse port on the machine. • BiCart - remove the BiCart cartridge from its holder and close the BiCart Holder arms. • Remove the Acid/Acetate connector from the white concentrate wand and reinsert it into its red rinse port on the machine.

Note The FINAL RINSE is performed even if the acid connector has not yet been positioned in its rinse port.

Rev. B


5.10.2.2

AutoEmptying To proceed with AutoEmptying: • Leave the blue and red dialysate connectors on the dialyser. • Venous and arterial lines must be connected together in the same configuration as used for RECIRC and the lines unclamped. • Open the left red clamp (on the Cartridge saline line) in the 4-Position Line Clamp. Ensure the saline istration line is not clamped. • Select the AUTO EMPTYING within 20 seconds Action key to start the procedure.

Note The AUTO EMPTYING Action key is only available if the AUTOEMPTYING parameter in Config is set to YES.

Note In the case of bicarbonate dialysis, upon selecting the AUTO EMPTYING Action key, a DESCALING procedure is automatically performed. If the VINEGAR DESCAL parameter in Config is set to ALWAYS, the machine will perform the DESCALING procedure with vinegar.

• • •

If the “End of WashBack Procedure” #332 alarm is present, press the OVERRIDE button to clear the alarm. The blood pump starts automatically at 100 ml/min (this is indicated by the flashing light on the Blood Pump Control ). The blood pump speed can not be modified. Wait until the following Operator Message is displayed:

AutoEmptying Procedure has Been Interrupted and Open in Air the Venous Chamber then open the blue clamp (on the Venous access line) in the 4-Position Line Clamp to allow air to enter the extracorporeal circuit. During AutoEmptying it is possible to stop the procedure by deselecting the AUTO EMPTYING Action key. When the Cartridge Blood Set and blood side of the dialyser are empty, press the AUTO EMPTYING Action key to deactivate it. The AUTO EMPTYING Action key will disappear. The emptying procedure can continue in order to empty the dialysate side; to do this: • When the value set for the DESCALING TIME parameter is elapsed, the following Operator Message is displayed:

You Can Replace The Blue Dialys. Connector All Connectors Must Be Replaced Leave A Connector In Concentrate Disconnect the blue dialysate connector from the dialysate port of the dialyser and reattach it to its by port on the machine. (Do not disconnect the red dialysate connector, which is now at the bottom of the dialyser, from the dialyser.).

Rev. B

5-57

5-58 PHOENIX OPERATOR MANUAL • Rotate the dialyser so that the blue end of the dialyser is up. Deselecting EMPTYING allows the EMPTYING process to be interrupted. • After a short time, when the dialysate side of the dialyser is empty, an operator message will appear on the Touch Screen and the EMPTYING Action key disappears. The red dialysate connector can be disconnected from the dialyser and reattached to its by port on the machine. • Press the FINAL RINSE Action key to initiate this process.

WARNING In the case of bicarbonate dialysis, the Acid/Acetate concentrate connector must be left on the machine so that the DESCALING procedure can be performed.

WARNING At the end of WASHBACK, if the does not activate the AutoEmptying procedure, the blue dialysate connector can be reattached to its by port on the machine so that the dialysate side is emptied through the hydraulic circuit (standard EMPTYING).

Rev. B


5.10.3 Removing the BiCart See Fig 5.4 • Open the upper arm of the BiCart Holder by pulling the arm forward slightly and tipping it up. • Cover the hole on the top of the BiCart (see Fig 5.4, 1). • Pull out the top of the BiCart while leaving the base in place (Fig 5.4, 2). • Disconnect the BiCart and immediately cap the lower end. • Place the holder arms in their original position (see Fig 5.4, 3): a. Close the upper arm by tipping it down; b. Close the lower arm by pulling the arm forward slightly and tipping it up. • Dispose of the empty BiCart per your facility’s practice.

1

2

3

Fig 5.4 Removal of the BiCart®

Rev. B

5-59


5.10.4 End of Treatment When the EMPTYING mode has been completed, the following view is displayed: 12:30

EMPTYING

VEN

TOTAL FLUID REMOVED

TOTAL BLOOD

HEPARIN TOTAL

DESCALING TIME

STOP RINSE

ART BLOOD FLOW

FINAL RINSE TIME

VINEGAR DESCAL BLOOD FLOW

BPM

REPORT

DESCALING KT/V

MACHINE

FINAL RINSE

Note The VINEGAR DESCAL and DESCALING Action keys appear only when a Bicarbonate dialysis was performed; a FINAL RINSE is performed automatically following a DESCALING procedure.

Note The FINAL RINSE Action key appears only when an Acetate dialysis was performed.

The DESCALING Action Key appears if the VINEGAR DESCAL parameter in Config is set to NO or to YES, and if a Bicarbonate dialysis treatment has been performed. If the VINEGAR DESCAL parameter is set to YES or to ALWAYS, the VINEGAR DESCAL Action key is available. In the case of VINEGAR DESCAL, the operator must check that the acid/acetate line is connected to the vinegar container. During the DESCALING process (selection of the VINEGAR DESCAL or the DESCALING Action keys), the DESCALING TIME value will decrease, indicating the time remaining in the DESCALING process. The following message also appears:

Wait, Descaling in progress… and a progress bar is displayed indicating that DESCALING is occurring.

Rev. B


5-61

After the DESCALING or VINEGAR DESCAL Action keys have been pressed they will not be available again until the end of the next dialysis treatment. FINAL RINSE will begin automatically following a DESCALING procedure. If an ACETATE dialysis has been performed the FINAL RINSE Action Key appears immediately after EMPTYING has been completed. Pressing the FINAL RINSE Action Key initiates the Final Rinse process. During the FINAL RINSE process: • The FINAL RINSE TIME value decreases, indicating the time remaining in the Final Rinse process; • The DESCALING TIME value is no longer displayed; • the FINAL RINSE Action key disappears and will not be available until after the next dialysis treatment. The STOP RINSE Action key allows a quick access to the next dialysis treatment skipping partially or completely the DESCALING process and/or the FINAL RINSE process. Refer to “5.10.5 Quick Access to the Next Dialysis Treatment”, in this section, for a detailed description of this procedure. Before starting a new dialysis treatment remove the used Cartridge Blood Set and dialyser.

WARNING Follow facility procedures for proper disposal of used Cartridge Blood Set, dialysers, and other disposables per local regulations.

Note When FINAL RINSE is completed, the machine returns in Idle phase and performs the T1 Tests. Before selecting a new process, wait at least 1 minute to complete the T1 Tests.

Rev. B


5.10.5 Quick Access to the Next Dialysis Treatment When the EMPTYING mode has been completed, the STOP RINSE Action key becomes available and remains available for all the DESCALING process and FINAL RINSE process. It allows the machine to skip partially or completely the DESCALING process and/or the FINAL RINSE process and to return in Idle phase for the next dialysis treatment. After the STOP RINSE Action key is pressed, the following superimposed window will appear:

CONFIRMATION LAST ACTION MADE ENTER To Confirm WARNING: Remove the Cartridge Blood Set and install a new one. By pressing the CONFIRM button, the machine will return in Idle phase and, after T1 tests completion, it is ready for the next dialysis treatment.

WARNING Before starting a new dialysis treatment, ensure that the used Cartridge Blood Set and dialyser have been removed and a new Cartridge Blood Set and dialyser have been installed.

WARNING If, after a bicarbonate dialysis, the DESCALING process is partially or completely skipped by pressing the STOP RINSE Action key, it is strongly recommended to follow the “Precipitate Control (ADR)” recommendations provided in Section 06 – CLEAN/DISINFECT, in this manual.

Rev. B

SECTION 5.A - SPECIAL PROCEDURES

5.A-1

5.A SPECIAL PROCEDURES 5.A SECTION 5.A - SPECIAL PROCEDURES

5.A.1 Emergency procedures for Power Failure In the event of a power failure: − An audible alarm is sounded for at least 2 minutes. − A visual alarm is given with a flashing yellow light. − The duration of the power failure is monitored. Proceed as follows: • Clamp the venous line under the Venous Line Clamp. • Carefully remove the venous line from the Venous Line Clamp by depressing the button on the Venous Line Clamp and pulling the venous line to the left..

WARNING Failure to remove the venous line from the Venous Line Clamp can result in rupture of blood lines or dialyser when hand cranking the Blood Pump. • Remove the arterial line from the Arterial Clamp (if Single Needle is available on the machine). • Remove the Blood Pump Crank from its holder on the rear of the machine and place it in the operating position in the Blood Pump Rotor. • Unclamp the venous line and with the crank manually turn the Blood Pump Rotor counter-clockwise at a flow rate high enough to prevent stagnation or clotting of the blood.

WARNING During a power failure, all safety systems of the machine are disabled or are not operational. It is particularly important to check that all four clamps in the 4 Position Line Clamp, above the Blood Pump, are closed in this situation. Once the power supply has been restored, the Protection System starts the procedure to reset the proper conditions. The machine reverts to one of two specific Safe States depending on the duration of the power failure: − Short Power Failure : less than 20 seconds − Long Power Failure : more than 20 seconds and less than 4 minutes


Rev. B

5.A-2

PHOENIX OPERATOR MANUAL Proceed as follows: • Remove the Blood Pump Crank from the Blood Pump Rotor. • Return the Blood Pump Crank to its holder on the rear of the machine. • Clear the specific Safe State by pressing the OVERRIDE button. The Blood Pump will start at the pre-programmed speed.

Note In the case of a Short Power Failure, if the operator does not press the OVERRIDE button within 30 seconds, the specific Safe State is automatically cleared.

• Reinsert the venous line into the Venous Line Clamp. • If in Single Needle mode, reinsert the arterial line into the Arterial Line Clamp. • Return the clamps on the 4 Position Line Clamp to the appropriate positions for dialysis.

Note If the machine is switched OFF and bicarbonate dialysate remains in the hydraulic pathway for more than 30 minutes, it is recommended that an acetic acid rinse should be performed when the machine is switched back ON.

Rev. B


5.A-3

5.A.2 Emergency procedures for power failure with the BATTERY BACKUP feature WARNING This emergency procedure for Power Failure is applicable only if your Phoenix machine is equipped with the Battery Backup Kit. Refer to local representative to if your machine is already equipped with the BATTERY BACKUP Kit. A BATTERY BACKUP feature is available on Phoenix machine so that, in case of a power failure, the blood module and all the safety systems will remain enabled and operational for approximately 15 minutes. The machine will continue to operate, allowing the operator to rinseback the blood and disconnect the patient. The interruption of the AC supply voltage is signaled by the “NO POWER” #353 alarm. This alarm remains on the Touchscreen for the duration of the power failure.

Note If the interruption of the AC supply voltage occurs when the machine is in IDLE mode, no alarm will be activated.

Note During power failure the heater is turned off.

In case of a power failure, depending on the machine operating conditions, proceed as follows: • In Rinsing or Disinfection: Switch OFF the machine. • In Dialysis, during the Dialysate Preparation phase up until the Patient Connection: Switch OFF the machine. • In Dialysis, during the Treatment phase: perform a Rinseback to return the blood and disconnect the patient. Then Switch OFF the machine. • In Emptying or Descaling: Switch OFF the machine. A message is also displayed in the Operator Message area suggesting the proper action to be performed during each specific machine operating condition.

Note If the power failure lasts for less than 3 minutes, once the AC Power Supply returns: • The “NO POWER” #353 alarm disappears; • The interrupted process automatically restarts and no operator intervention is required.

Rev. B

5.A-4

PHOENIX OPERATOR MANUAL Note In Rinsing or Disinfection, if the “NO POWER” #353 alarm is displayed for more than 3 minutes, the machine will be automatically Switched OFF. A continous audible signal, decreasing in tone, sounds for approximately 5 seconds once the machine is switched OFF.

Note If the machine is switched OFF and bicarbonate dialysate remains in the hydraulic pathway for more than 30 minutes, it is recommended that an acetic acid rinse should be performed when the machine is switched back ON.

Note The Battery, when fully charged, is able to maintain the machine operational during a power failure for approximately 15 minutes before it discharges. Each time a power failure occurs, the Battery loses a quantity of its power and it has to be recharged by leaving the machine switched ON. After a power failure lasting 15 minutes, the time necessary to fully recharge the Battery is 10 hours.

Note When the machine remains switched OFF, the Battery gradually loses its charge. After a long storage (at ambient temperature), before using again the machine, it is recommended to keep it switched ON for a minimum time of 2 hours for each month it has been left switched OFF. If the storage temperature is greater than 25°C, the time necessary to recharge the Battery doubles.

If the BATTERY BACKUP is discharged or becomes discharged during a power failure, a >GENERAL SAFE STATE< alarm is generated and the BATTERY BACKUP feature is no longer active.

Proceed as follows: • Record DIALYSIS TIME, WEIGHT LOSS/H, TOTAL FLUID REMOVED, TOT WEIGHT L, and TOTAL BLOOD, and other treatment data, if possible. • Switch OFF the machine. • Ensure that all four clamps in the 4 Position Line Clamp, above the Blood Pump, are closed. • Clamp the venous line under the Venous Line Clamp. • Carefully remove the venous line from the Venous Line Clamp by depressing the button on the Venous Line Clamp and pulling the venous line to the left.

WARNING Failure to remove the venous line from the Venous Line Clamp can result in rupture of blood lines or dialyser when hand cranking the Blood Pump.

Rev. B


5.A-5

• Remove the arterial line from the Arterial Clamp (if Single Needle is available on the machine). • Remove the Blood Pump Crank from its holder on the rear of the machine and place it in the operating position in the Blood Pump Rotor. • Unclamp the venous line and with the crank manually turn the Blood Pump Rotor counter-clockwise at a flow rate high enough to prevent stagnation or clotting of the blood.


Once the power supply has been restored: Proceed as follows: • Switch ON the machine. • Reinsert the venous line into the Venous Line Clamp. • If in Single Needle mode, reinsert the arterial line into the Arterial Line Clamp. • Return the clamps on the 4 Position Line Clamp to the appropriate positions for dialysis. • Perform the Fast Recovery procedure (See “Fast Recovery of the Dialysis process”, in this Section).

Rev. B

5.A-6


5.A.3 Fast Recovery of the Dialysis process During the course of a dialysis treatment certain conditions may cause the machine to halt: • As a consequence of an alarm condition a General Safe State is generated (see Section 8 - Alarms and Signals). • A problem with the Power Supply reduces the voltage to the machine’s electronics. In both cases it is impossible to continue the dialysis treatment and the machine must be turned OFF. If the machine halt was caused by a temporary malfunction or by unexpected operations, turning the machine OFF and then back ON may clear the incorrect condition.

WARNING The use of a Fast Recovery of the Dialysis process procedure must be limited to exceptional cases where the normal recovery procedure can not be performed in accordance with the standard use of the machine, but where the current dialysis treatment must be continued.

WARNING After pressing the SETUP Action key, DO NOT select a dialysate type (ACETATE/BICARB CONC/BICART) if the patient is still connected to the machine and the Red and Blue Dialysate Connectors are connected to the dialyser. The Fast Recovery of the Dialysis process may, therefore, be attempted without manually disconnecting the patient. This procedure returns the machine to the PATIENT CONNECT mode, so that the Blood Pump is active within a few seconds after the machine is turn ON.

WARNING The Fast Recovery of an interrupted dialysis treatment can only be performed if TREATMENT has already started (i.e. after PATIENT CONNECT) and has been interrupted before the EMPTYING mode. This procedure can be performed if the Patient Sensor has detected blood in the venous blood line and no service processes (ADR or calibration) have been performed before restarting the dialysis treatment.

Note The possibility to restart DIALYSIS using the Fast Recovery of the Dialysis process procedure is allowed if, and only if: − The previous treatment was interrupted after the PATIENT CONNECT mode and before the EMPTYING mode. − At subsequent Power ON, the Patient Sensor has detected blood (the icon is highlighted on the icon bar). − No service processes (rinsing or disinfection or calibration) were performed before restarting the dialysis treatment.

Rev. B


5.A-7

To perform the Fast Recovery of the Dialysis process procedure:

WARNING Do not remove the Blood Pump Segment from the Blood Pump. Do not remove the venous line from the Air Bubble Detector/Patient Sensor.

1. Record DIALYSIS TIME, WEIGHT LOSS/H, TOTAL FLUID REMOVED, TOT WEIGHT L, and TOTAL BLOOD, and other treatment data, if possible. 2. Turn the machine OFF. 3. Clamp the venous line below the ABD and then turn the machine ON. 4. Wait for the software to load.

WARNING If the operator erroneously selects a procedure other than “SETUP”, the Fast Recovery of the Dialysis process procedure cannot be performed and the patient must be disconnected. 5. Press the SETUP Action key. 6. The operation to be performed for a Fast Recovery of the Dialysis process is indicated in the Operator Message Window: Press + and hold, press - and hold, release + then release - to restart interrupted treatment Select these buttons on the Main Control . The machine will immediately go to the PATIENT CONNECT mode. 7. Unclamp the venous line. 8. Press the Blood Pump ON/OFF button to start the Blood Pump.

Note During the time between the machine switching OFF and the next Blood Pump activation, it is possible to manually turn the Blood Pump Rotor counter-clockwise at a flow rate high enough to prevent stagnation or clotting of the blood, by using the Blood Pump Crank. Before manually turning the Blood Pump Rotor: − remove the venous line from the Venous Line Clamp by depressing the button on the Venous Line Clamp and pulling the venous line to the left; − remove the clamp from the venous line below the ABD; − ensure that all four clamps in the 4 Position Line Clamp, above the Blood Pump, are closed. Once the SETUP Action Key appears, reinsert the venous line in the Venous Line Clamp. To restart the interrupted treatment, after the selection of the Blood Pump ON/OFF button to start the Blood Pump, return the clamps on the 4 Position Line Clamp to the appropriate positions for dialysis.

WARNING During the time between the machine switching OFF and the next restart of the interrupted treatment by the +/- buttons selection, all safety systems of the machine are disabled or are not operational. 9. Reset the TOT WEIGHT L, DIALYSIS TIME and the WEIGHT LOSS/H using the SET mode. Activate Heparin and BPM, if prescribed. If the CentryNet option was activated before the machine halt, refer to Section 07 – Communication System, for a detailed description of the CentryNet option re-activation or deactivation procedure after a Fast Recovery of the Dialysis process. Rev. B

5.A-8

PHOENIX OPERATOR MANUAL Note After a Fast Recovery of the Dialysis process, both the UF Profile curve type and the Conductivity Profile curve type are set automatically to CONSTANT. During the current dialysis treatment it is no longer possible to re-activate UF and Conductivity Profiling.

10. Select the DIALYSIS Action key on the PATIENT CONNECT view. If a “! Blood Leakage” #28 alarm occurs, press the OVERRIDE button.

WARNING Note that any treatment parameters that were set for the dialysis treatment are transient, i.e. they are lost when a Fast Recovery of the Dialysis process procedure is performed. Therefore, following a Fast Recovery of dialysis, the only treatment parameters that are retained are: − for RX dialysis → the default data values stored in Rx Config − for Standard dialysis → the default data values stored in Config The only exception are: − for RX dialysis → the machine retains the PAT CONN B FLOW parameter value stored in CONFIG instead of the value stored in Rx Config − for Standard dialysis and RX dialysis → the machine retains the DIALYSIS TYPE: ACETATE/BIC CONC/BIC BICART, set for the current treatment instead of the DIALYSIS TYPE stored in CONFIG/Rx Config. NOTE: in case of Computer Prescription of the Treatment (see Section 7 Communication System) the restored treatment parameters are: Dialysis Mode: the last one selected Dialysis Type: the last one performed by the machine

WARNING If during the course of the restarted DIALYSIS, the same problem reoccurs, the cause is not a temporary malfunction. The machine must be turned OFF and the patient manually disconnected. Call for Service.

Note Once the patient has been manually disconnected and the following dialysis may be started normally, do not perform the Fast Recovery of the Dialysis process procedure: disconnect manually and the machine OFF. At subsequent power ON, do not select a Fast Recovery of the Dialysis process with the “+/ -” keys. An ADR process must be selected to remove the data related to the Fast Recovery of the Dialysis process from the machine’s memory. Then, select the type of dialysis required (SETUP and proceed as usual with the preparation of the machine.

Rev. B


5.A-9

5.A.4 Sampling of water from the machine If local regulations or the facility’s procedures requires to test the chemical-physical characteristics of water flushing in the hydraulic circuit of the machine or in order to culture the water to be used for dialysis, for microbiological monitoring, a sample of water may be obtained from the machine during SETUP, prior to dialysate concentrate connection. To obtain a sample: • Press the SETUP Action key to start dialysate preparation. • Remove the Blue Dialysate Connector from the machine and hold it over a collection receptacle. This action could generate a flow error evidenced by an alarm and a RESTART condition on the Touch Screen. • While the flow from the Blue Dialysate Connector has stopped because of the RESTART condition, prepare the Dialysate Line Connector, per your facility’s protocol. • Press the RESTART button on the Touch Screen to restart dialysate flow from the Blue Dialysate Line. Continue pressing the RESTART button on the Touch Screen to continue flow from the Blue Dialysate Connector until an appropriate time or flow (as defined by the facility’s protocol, but not less than 2 minutes) has been reached. At this time a sample may be collected. • After the sample has been collected, reconnect the Blue Dialysate Connector to its Blue By port on the machine. Press the RESTART button on the Touch Screen to restore the flow in the hydraulic circuit.

5.A.5 Sampling of Dialysate A sample of dialysate may be taken to carry out laboratory tests.


PERFORMING DIALYSATE SAMPLING Samples for conductivity testing may be obtained at the following times: a. Prior to initiation of treatment, after the appearance of the operator message “End Of Dialysate Prep, You Can Proceed”, and before starting to prime the dialysate side of the dialyser. b. During DIALYSIS.

Note When a dialysate sample is obtained during DIALYSIS using the Sampling Device, the alarm message A Connector Position#2 will appear on the Touch Screen.

Rev. B

5.A-10 PHOENIX OPERATOR MANUAL HOW TO OBTAIN THE DIALYSATE SAMPLE Dialysate sample through the Blue Dialysate Connector Follow this procedure prior to initiation of treatment, only if Priming after Dialysate Preparation is complete is performed (DIAL AUTO PRIME parameter set to NO): • • • • • •

After appearance of the operator message indicating that Dialysate Preparation is Complete, connect the Red Dialysate Connector to the dialyser’s red (outlet) dialysate port, leaving the Blue Dialysate Connector unattached. Hold the Blue Dialysate Connector over a sample collection container. Press the BY Action key to start the flow of dialysate into the sample collection container. Collect the dialysate sample then press the BY Action key to stop the dialysate flow. Connect the Blue Dialysate Connector to the dialyser’s blue (inlet) dialysate port. Press the BY Action key to resume flow of dialysate through the dialyser.

Dialysate sample through the Sampling Device Follow this procedure: • either prior to initiation of treatment, if Priming during Dialysate Preparation is performed (DIAL AUTO PRIME parameter set to YES) • or during TREATMENT. To obtain the dialysate sample proceed as folows: • Insert the Sampling Device in the Rinse Port corresponding to the Acid/Acetate Connector (or the Blue Bicarbonate connector for bicarbonate sampling). • Obtain the sample.

In both the procedures, prior to obtaining a sample, it is recommended to: • Discard the fluid flowing from the Acid/Acetate Rinse Port during the first minute of sampling. • Discard the fluid flowing from the Bicarbonate Rinse Port in the first 2 minutes of sampling. • Obtain the dialysate sample when the conductivity is stable.

Note For reliable sampling, it is important not to change the conductivity of the machine during sampling.

Rev. B


5.A-11

OBTAINING A BICARBONATE SAMPLE WITH BICART DIALYSIS • Open the upper arm of the BiCart Holder. (See Fig..1 (A) ) • Disconnect the Blue Bicarbonate (blue) Concentrate Connector (See Fig.1 (C) ) from its Rinse Port. • Insert the sampling device in the Blue Rinse Port corresponding to the Bicarbonate Connector for bicarbonate sampling. • Obtain the sample.

A

B

C

Fig. 1

Rev. B

5.A-12 PHOENIX OPERATOR MANUAL

5.A.6 Temporary Disconnection of the Patient : PAUSE THERAPY Procedure Note This feature is available only if the PAUSE THERAPY parameter is set to YES in the CONFIG menu. If configured, the PAUSE THERAPY Action key is present in the CHANGES view when accessed during the TREATMENT mode.

Note During the PAUSE THERAPY procedure, appropriate operator’s messages will direct the to the required steps in order to correctly perform the procedure.

In order to temporarily disconnect the patient during TREATMENT: 1. If performing a Single Needle dialysis, select the CHANGES Action key, then the CHANGE TO DN Action key on the CHANGES view. 2. Select the PAUSE THERAPY Action key on the CHANGES view. 3. This selection must be confirmed using the CONFIRM button on the Main Control . 4. The Blood Pump stops automatically. 5. Clamp the arterial and venous lines and the patient’s access sites. 6. Connect the arterial and the venous line together using a sterile priming connector or recirculation device. 7. Unclamp the Cartridge Saline Access Line and the Saline istration Line. 8. Unclamp the arterial and venous lines. 9. Turn the Blood Pump ON using the ON/OFF button on the Blood Pump Control to recirculate the blood in the extracorporeal circuit, per your facility’s protocol. When the patient returns : 1. Turn the Blood Pump OFF using the ON/OFF button on the Blood Pump Control . 2. Clamp the Cartridge Saline Access Line and the Saline istration Line. 3. Clamp the arterial and venous lines. Disconnect the blood lines by removing the sterile priming connector or recirculation device. 4. Reconnect the arterial and venous lines to the patient’s’ access sites. 5. Unclamp the arterial and venous lines and the patient’s access sites. 6. Turn the Blood Pump ON using the ON/OFF button on the Blood Pump Control . 7. Press the PAUSE THERAPY Action key to deselect PAUSE THERAPY. 8. Press the CLOSE Action key on the CHANGES view, the standard treatment view will be displayed.

Note The PAUSE THERAPY Action key is highlighted while the procedure is activated.

Rev. B


5.A-13

Note During the PAUSE THERAPY procedure the alarm “W! STILL IN PAUSE THERAPY“ is displayed to advise the operator that the machine is in a temporary status.

Note The CLOSE and FILTER CHANGE Action keys in the CHANGES view disappear while the PAUSE THERAPY procedure is activated.

Note During the PAUSE THERAPY procedure: • the updating of DIALYSIS TIME, TOTAL FLUID REMOVED and TOTAL BLOOD parameters are interrupted • the WEIGHT LOSS/H is stopped; • the Heparin program is stopped; • Profiling is stopped. When the treatment is restarted, the updating of the parameters is automatically reactivated, and the WEIGHT LOSS/H, Profiling and the Heparin program are resumed. It is not necessary to set the TOT WEIGHT L parameter again.

Note During the PAUSE THERAPY procedure, the limits of the Venous Pressure Alarm Window and Arterial Pressure Alarm Window are set to the wider range. This value is maintained throughout the PAUSE THERAPY procedure.

Rev. B


5.A.7 BiCart Change When the PAUSE BICART Action key is selected, the BiCart may be replaced, once dialyser PRIME is completed and all the preparations and settings have been completed.

BICART CHANGE procedure • Press the CHANGES Action key. • The following view appears: 12:30

CHANGES

DIALYSIS TIME

CHANGE TO SN

WEIGHT LOSS/H


PAUSE THERAPY (See Note 1 below)

TOT WEIGHT L

ART

PAUSE BICART

BLOOD FLOW


CONDUCTIVITY

CHANGE TO LIQ BIC

BLOOD FLOW BPM

REPORT

CHANGE ACID KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

Note 1 Depending on the machine operating phase the FILTER CHANGE Action key or the PAUSE THERAPY Action key is displayed.

Note The BICART PRIM. Action key is available only after the PAUSE BICART Action key has been pressed.

• Press the PAUSE BICART Action key to momentarily stop flow through the BiCart. This helps avoid splashing liquid when the BiCart is removed.

Rev. B


5.A-15

• After the PAUSE BICART Action key has been pressed, the following message will appear: Remove the BICART and insert a new one. Press BICART PRIME to start the procedure. Warning: Pressing BICART PRIME again will stop BICART priming procedure. • Replace the BiCart and then press the BICART PRIM. Action key to start the priming procedure (advice on how to perform the operation will appear in the Operator Messages Area). • The following message will appear in the Operator Messages Area with a warning saying that if the BICART PRIM. Action key is pressed again, priming will be stopped: Wait : BICART Priming in Progress... Warning : if You Push BICART PRIM. Again the BICART Procedure will be Stopped.

Note If the operator stops the priming procedure by pressing the BICART PRIM. Action key, the following message is displayed: Bicart priming interrupted, Press BICART PRIME to complete procedure.

• Priming can be considered finished when the above operator message disappears.

Rev. B


5.A.8 Switching from BiCart Dialysate to the use of Liquid 8.4% Bicarbonate Dialysate If the operator wants to change from BiCart dialysate to liquid bicarbonate dialysate, the CHANGE TO LIQ BIC Action key allows continuing the dialysis treatment using liquid 8.4% bicarbonate from external concentrate containers or delivered from the Central Concentrate Supply system.

Note After switching from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate, both in external containers and from the Central Concentrate Supply system, it is not possible to return to using BiCart dialysate in the current dialysis treatment.

CHANGE TO LIQ BIC procedure • Press the CHANGES Action key. • The following view appears: 12:30

DIALYSIS TIME

CHANGE TO SN

WEIGHT LOSS/H



TOT WEIGHT L

ART

PAUSE BICART

BLOOD FLOW


CONDUCTIVITY

CHANGE TO LIQ BIC

BLOOD FLOW BPM

REPORT

CHANGE ACID KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

Note 1 Depending on the machine operating phase, either the DIALYSER PRIME Action key or the PAUSE THERAPY Action key is displayed.

Rev. B


5.A-17

Note The CHANGE TO LIQ BIC Action key is available only if the BIC LIQUID DIAL USE parameter is set to YES in Config/Centre Conf/Functions view.

• Press the CHANGE TO LIQ BIC Action key. • The following superimposed window will appear:

Confirm the Change from BiCart to Liquid Bic. Press CONFIRM to Proceed Remove Bicart. Connect blue connector to the correct position for the new bicarb source Warning: To avoid compromizing Pt Safety Ensure the proper Bic. Conductivity set • Press the CONFIRM button to allow the machine to proceed in BICARB CONC dialysis mode. • Remove the BiCart and close the BiCart arms. Connector Position” #22 Alarm.

That will clear the “Bicart

• If switching to the use of Liquid Bicarbonate 8.4% in an external container: disconnect the blue concentrate connector on the lower front of the machine and connect it to the blue concentrate wand and then place the wand into the bicarbonate concentrate container. That will clear the “B Connector Position” #18 Alarm. • If switching to the Central Concentrate Supply system: disconnect the blue concentrate connector on the lower front of the machine and connect it to the blue connector dedicated to bicarbonate concentrate delivery from the Central Concentrate Supply system. That will clear the “B Connector Position” #18 Alarm. Refer to section 03 – Central Concentrate Supply, in this manual, for a detailed description of connector positioning in Bicarbonate dialysis. • Press the Set button to enter in Set mode. Check and if necessary adjust the BIC 8.4% COND value set. • Press the CLOSE Action key to exit from the CHANGES view.

WARNING If switching from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate, both in external containers and delivered from the Central Concentrate Supply system, it is the operator’s responsibility to that proper 8.4% bicarbonate concentrate is being used.

WARNING If a switch from the use of BiCart to the use of Liquid 8.4% Bicarbonate concentrate in external containers, if the machine has not been correctly calibrated for the liquid Concentrate used, the “! Concentrate Cans” #40 Alarm can occur. After carefully ing that the correct concentrates are being used, and that the dialysate Conductivity is correct, the operator may clear the alarm by performing the PB Autocalibration Procedure (see “5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS”, in this section, for complete instructions.)

Rev. B


5.A.9 Acid/Acetate Concentrate Supply Change If the operator needs to change acid/acetate concentrate containers, or to change from containers to acid delivered from the Central Concentrate Supply system, or to change from the Central Concentrate Supply system to an acid/acetate container, the CHANGE ACID Action key is used.

CHANGE ACID procedure • Press the CHANGES Action key. • The following view appears: 12:30

DIALYSIS TIME

CHANGE TO SN

WEIGHT LOSS/H



TOT WEIGHT L

ART

PAUSE BICART

BLOOD FLOW


CONDUCTIVITY

CHANGE TO LIQ BIC

BLOOD FLOW BPM

REPORT

CHANGE ACID KT/V

PROFILE

HEPARIN

MACHINE

CLOSE

Note 1 Depending on the machine operating phase, either the FILTER CHANGE Action key or the PAUSE THERAPY Action key is displayed.

Rev. B


5.A-19

• Press the CHANGE ACID Action key. • The following superimposed window will appear:

Change the Acid supply and press CONFIRM to Proceed then press OVERRIDE to resume treatment Warning: To avoid compromizing Pt Safety Ensure the proper CONDUCTIVITY set • Press the CONFIRM button to proceed with the procedure. • If the “Ace Can is Empty” #1 Alarm is present, press the OVERRIDE button to clear the alarm. • When changing the acid/acetate concentrate external container: disconnect the white concentrate connector connected to the white concentrate wand and connect it to the white concentrate wand placed in the new acid/acetate concentrate container. If the “Ace Can is Empty” #1 Alarm is present, press OVERRIDE to clear the alarm and to start uptake of acid/acetate from the new container. • When switching to the Central Concentrate Supply system: disconnect the white concentrate connector connected to the white concentrate wand and connect it to the RED connector dedicated to acid concentrate delivery from the Central Concentrate Supply system. Refer to section 03 – Central Concentrate Supply, in this manual, for a detailed description of connectors positioning in Bicarbonate or BiCart dialysis. f the “Ace Can is Empty” #1 Alarm is present, press OVERRIDE to clear the alarm and to start uptake of acid from the Central Concentrate Supply system. • When switching from Central Concentrate Supply to the use of acid/acetate concentrate in external container: disconnect the white concentrate connector connected to the RED connector dedicated to acid concentrate delivery from the Central Concentrate Supply system and connect it to the white concentrate wand placed in the acid concentrate container. If the “Ace Can is Empty” #1 Alarm is present, press OVERRIDE to clear the alarm and to start uptake of acid from the concentrate container. • Press the Set button to enter in Set mode. Check and if necessary adjust the CONDUCTIVITY value. • Press the CLOSE Action key to exit from the CHANGES view.

Rev. B

5.A-20 PHOENIX OPERATOR MANUAL Note If the acid/acetate concentrate supply change procedure has been performed without the occurrence of “Ace Can is Empty” #1 Alarm, it may appear after completion of the procedure. Press the OVERRIDE button to clear the alarm and to start uptake of acid/acetate.

WARNING Both with Acid/Acetate concentrate container change and with switch from the use of acid in external containers to the use of acid concentratet delivered from the Central Concentrate Supply system, it is the operator’s responsibility to that proper acid/acetate concentrate is being used.

WARNING Both with an Acid/Acetate concentrate formula change and with a switch from Central Concentrate Supply system to the use of acid in external containers, if the machine has not been correctly calibrated for the acid/acetate Concentrate used, the “! Concentrate Cans” #40 Alarm can occur. After carefully ing that the correct concentrates are being used, and that the dialysate Conductivity is correct, the operator may clear the alarm by performing the PA Autocalibration Procedure (see “5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS”, in this section, for complete instructions.)

Rev. B


5.A.10

5.A-21

Dialyser Replacement

Dialyser can be replaced both during the Patient Connection phase and during the dialysis treatment. To replace the dialyser proceed as follows: During the Patient Connection phase: • Stop the Blood Pump and follow facility’s procedures to restitute blood and disconnect the patient. During a dialysis treatment: • Press the WASHBACK Action key on the DIALYSIS view and CONFIRM to perform WASHBACK. • Perform WASHBACK. When the patient has been disconnected: • Press the CHANGES Action key. • Press the FILTER CHANGE Action key. • The following message will appear: PROTECTION SYSTEM Do You Confirm Filter Changing ? Press ENTER To Confirm.

WARNING The CONFIRM button, for Dialyser Change, must be pressed only after having completed the WASHBACK mode. • Press CONFIRM; the following message will appear: Do not remove the Cartridge now Place the dialysate hoses on their rinse ports. • Disconnect the dialysate connectors from the dialysate ports of the dialyser and reattach them to their by ports on the machine.

Note Starting from the above Operator’s message appearance, the dialyser may be replaced.

• Wait until the following message is displayed in the Operator Messages Area: Replace the cartridge and dialyser. After the venous clamp opens, select the desired priming procedure.

Rev. B

5.A-22 PHOENIX OPERATOR MANUAL • Replace the dialyser (if not yet done). • After the Venous Clamp opens, replace the Cartridge Blood set. • After confirming the DIALYSER CHANGE message, the dialyser re-priming view will appear and the priming procedure must be repeated, according to the type of dialyser being used. During the priming procedure the message “Wait, Priming in progress …” will appear on the Operator Messages Area. • When the priming procedure is complete, the PAT CONNECT Action key becomes available. • Press the PAT CONNECT Action key and reconnect the patient to the extracorporeal circuit. • After patient connection, press the TREATMENT Action key to restart the interrupted treatment. • The treatment will automatically restart with the previous TOT WEIGHT L and DIALYSIS TIME, TOTAL FLUID REMOVED and TOTAL BLOOD values retained.

Note During the PAUSE THERAPY and the FILTER CHANGE modes, the updating of DIALYSIS TIME, TOTAL FLUID REMOVED and TOTAL BLOOD are suspended. At the restart of DIALYSIS, the updating of these parameters is automatically reactivated without having to set the TOT WEIGHT L again.

Note If Conductivity Profiling and/or UF Profiling were selected, during the WASHBACK mode, the profiling is stopped. When the treatment is resumed the profiling will restart from the last executed values.

Rev. B


5.A-23

5.A.11 Procedure for Autocalibration of the Peristaltic Pumps during DIALYSIS During DIALYSIS, if a “! CONCENTRATE CANS: A PUMP or B Pump or A+B PUMPS” #40 alarm occurs, an autocalibration of the Peristaltic Pump Inserts may be performed. The autocalibration procedure during DIALYSIS is slightly different from the calibration procedure performed by Service personnel. To prepare the machine for an Autocalibration procedure: • Deactivate Profiling and/or Diascan, in order to have a stable conductivity. • Press the Machine Navigation key. • Select the PA AUTOCALIB or PB AUTOCALIB Action key corresponding to the pump that requires autocalibration. • that the appropriate concentrate is attached. Press the appropriate AUTOCAL Action key. A request to CONFIRM this action will be displayed on a superimposed window on the Touch Screen.


The selected Action keys will remain highlighted and the Autocalibration pictogram is displayed until the start of the Autocalibration process. During Autocalibration, the Action key will disappear but the pictogram will remain on the Pictogram area.

Note The only Action keys that will be displayed are those that are appropriate for the type of dialysate concentrate that is being used, as indicated in this table:

Acid/Acetate PA PB

YES NO

Bic 6.6 % YES YES

Bic 8.4 % YES YES

Bicart YES NO

If the Autocalibration Procedure fails, the “W! .. AUTOCALIBRATION FAILED” alarm message will appear.

Rev. B

5.A-24 PHOENIX OPERATOR MANUAL Note The indication of the relevant pump (PA or PB) appears in the alarm message.

If the Autocalibration Procedure fails, the pump speed calibration values are not saved, the pump autocalibration is not completed and the “! CONCENTRATE CANS: A PUMP or B Pump or A+B PUMPS” #40 alarm may reoccur.

Note The Peristaltic Pump Autocalibration Procedure is an emergency operation intended only to enable completion of the current DIALYSIS treatment. It is recommended to perform the Standard Autocalibration Procedure (see “Procedure for Standard Autocalibration of the PA, PB, or PUF Pumps during the Dialysate Preparation Process” in this section) during SETUP of the machine for the next dialysis treatment.

WARNING If the “! CONCENTRATE CANS: A PUMP or B Pump or A+B PUMPS” #40 alarm occurs frequently, call for Service.

Rev. B


5.A-25

5.A.12 Procedure for Standard Autocalibration of the PA, PB, or PUF Pumps during the Dialysate Preparation Process To prepare the machine for Standard Autocalibration: • Turn the machine ON. • Press the SETUP Action key. • Select the type of dialysate required. • When these operations have been completed, the dialysate preparation will begin and the Standard Pump Autocalibration may be performed. To initiate the autocalibration process: • Press the Machine Navigation key. • Select the PA AUTOCALIB, or PB AUTOCALIB, or PUF AUTOCALIB Action key relating to the pump for which autocalibration is required.

WARNING The three Autocalibration Action keys are available only before Dialysate Preparation is complete. • Press the appropriate Action key to activate the Autocalibration Procedure (it is necessary to CONFIRM this action) • The selected Action key remains highlighted and the Autocalibration pictogram is displayed until the start of the autocalibration process. • At initiation of Autocalibration, a superimposed window displays a request to CONFIRM the appropriate concentrates are attached. • During Autocalibration, the Action key will disappear but the pictogram will remain on the Pictogram area.


Rev. B

5.A-26 PHOENIX OPERATOR MANUAL Note The only Action keys that will be displayed are those that are appropriate for the type of dialysate concentrate that is being used, as indicated in this table:

Acid/Acetate PA PB PUF

YES NO YES

Bic 6.6 % YES YES YES

Bic 8.4 % YES YES YES

Bicart YES NO YES

Autocalibration is performed during the Dialysate Preparation process. When the Autocalibration process is being performed, the following message is displayed in the Operator Message Window: Wait Autocalibration In Progress...

If the process is correctly completed, the machine proceeds with normal operation. No further message appears. The Autocalibration pictogram will disappear from the Pictogram area. If the Autocalibration fails, one of the three following alarm messages appears: • If the process is incorrectly completed because the calculation has not been carried out within the maximum time available: Timeout on ... AutoCalibration • If the process is incorrectly completed because the calculation or the controls provide negative results: W! … AutoCalibration Failed • If the process is incorrectly completed because an error has occurred during the saving of the pump speed calibration values: ...AUTOCALIBRATION FAILED

Note The indication of the relevant pump (PA, PB, or PUF) appears in the alarm message.

If the Autocalibration Procedure fails, the new pump speed calibration values are not saved and the pump autocalibration is not correctly completed. The machine then immediately performs the test relating to the relevant values, using the previous pump speed calibration coefficients: • Acid/Acetate pump • Bicarbonate pump • Ultrafiltration pump

Rev. B

→ → →

Final Conductivity Test Bicarbonate Conductivity Test Ultrafiltration Test


5.A-27

If the Ultrafiltration Pump Test fails, a > GENERAL SAFE STATE < alarm occurs. The machine must be turned OFF. If the Acid/Acetate or Bicarbonate Pump Test fails, the machine proceeds after confirmation. If the Acid/Acetate or Bicarbonate Pump Test es, the machine proceeds with normal operation.

WARNING If the Autocalibration Process and the following Test fail, the machine is unable to acquire the relevant value with sufficient accuracy. Autocalibration must be repeated or the pump insert changed and then the autocalibration must be repeated. If the Autocalibration Process fails, but the following Test es, the machine guarantees a degree of accuracy for the value subject to autocalibration. It is recommended that the Autocalibration Procedure be repeated or the pump insert replaced.

WARNING The PA/PB Autocalibration Procedure is mandatory in each of the following cases: • Following a change of the pump insert. • Following a change in the type of concentrate being used. • Following a change from Central Concentrate Supply System to the use of External Concentrate Containers.

Rev. B


5.A.13 Procedure for Automatic Autocalibration of the UF Pump during the Dialysate Preparation Process The Autocalibration of the UF Pump is automatically performed by the machine if it detects that the pump insert characteristics require this operation. In this case, during the Preparation Process the autocalibration pictogram is dispayed while, in the Machine view, the PUF AUTOCALIB Action key becomes highlighted and the following message appears in the Operator Message Window: Wait Autocalibration In Progress... In case of failure of this Autocalibration Procedure, it is recommended to call for Service.

WARNING If the Autocalibration Process and the following Test fail, the machine is unable to acquire the relevant value with sufficient accuracy. Autocalibration must be repeated or the pump insert changed and then the autocalibration must be repeated.

Rev. B


5.A-29

5.A.14 Manual Disconnection of the Patient During the course of a dialysis treatment certain conditions that make impossible to continue the dialysis treatment may occurs (e.i., display backlight failure, keyboard is not functioning). In these particular situations the manual disconnection of the patient may be performed. To manually disconnect the patient: • Switch OFF the machine. • Clamp the venous line under the Venous Line Clamp. • Remove the venous line from the Venous Line Clamp by depressing the push button and pulling the venous line to the left.

WARNING Failure to remove the venous line from the Venous Line Clamp can result in rupture of blood lines or dialyser when hand cranking the Blood Pump. • If Single Needle mode was chosen, remove the arterial line from the Arterial Line Clamp. • Remove the Blood Pump Crank from the rear of the machine. • Insert the crank through the hole in the Blood Pump Cover and into the Blood Pump Rotor. • that the Cartridge Saline Line and Saline istration Line are clamped. • Clamp the arterial line and the patient’s arterial access site. • Disconnect the arterial line from the patient’s arterial access site. Return the blood in the patient’s access site to the patient according to the facility’s protocol. • Remove the Saline istration Line and priming connector from the Cartridge saline access line. • Attach the Saline istration Line to the arterial line using the priming connector from the Cartridge saline line. • Open the clamps on the arterial line and the saline istration line. • Open the clamps on the venous line and the patient’s venous access site. • When ready, turn the Blood Pump Crank counter clockwise to return blood to the patient.

WARNING The alarm system is inactive or impaired when power to the machine or Touch Screen is off. While manually returning blood, watch the venous line for air. If air is seen, immediately stop returning blood.

Rev. B


5.A.15 Diaphragm Neutral Position Procedure Note In certain conditions, one or both diaphragms of the Cartridge Blood Set may move out of the neutral position. This causes pressure monitoring to become inaccurate and can result in pressure alarms or T1 Test failures. (Neutral position is where the diaphragms fall naturally when not exposed to pressure). The Diaphragm Neutral Position procedure restores both diaphragms to their proper position. This procedure may be required to remedy certain alarms; you may also perform it any time there is fluid/blood in the set and you suspect pressure monitoring to be inaccurate. Part A of this procedure can be tried first, but if the situation is not remedied, then Part B (a longer procedure) must be done.

WARNING Before performing this procedure, ensure that the Cartridge drip chambers are no more than half full of fluid. Failure to do this may result in patient blood loss.

Part A. Expose Diaphragms to Atmospheric Pressure 1. Make sure the Blood Pump is stopped and the Cartridge chambers are no more than half full of fluid/blood. 2. Clamp the venous and arterial lines below the Cartridge; clamp all Cartridge access lines in the 4-position Line Clamp. 3. Disconnect any caps, lines, or syringes connected to the Cartridge venous and arterial access lines. 4. Open the Blood Pump Cover, being careful not to dislodge the pump segment. 5. Open the clamps on the venous and arterial access lines and remove the end caps, if present. (This exposes the blood side of diaphragms to atmosphere) 6. Move the Cartridge slightly to unseat the diaphragms from the Red and Blue Sealing Cones. (This exposes the air-only side of diaphragms to atmosphere) 7. Allow approximately 5 seconds for pressures to stabilize on both sides of the diaphragms. 8. Align the diaphragms with the Sealing Cones; press lightly on the Cartridge to reseat the diaphragms on the cones. 9. Close the Blood Pump Cover. 10. Close the venous and arterial access line clamps; replace end caps, or reconnect previously attached lines/syringes. 11. Unclamp the venous and arterial lines. When ready, restart the Blood Pump.

Part B. Expose Diaphragms to Atmospheric Pressure/Clean Sealing Cones Supplies Needed: 0.5% bleach solution and lint-free cloth

Note To make a 0.5% bleach solution, mix 1 part 5.25% to 6% bleach with 9 parts water.

Rev. B


5.A-31

1. Perform Steps 1 through 5 of Part A of this procedure. 2. Replace the end caps of the venous and arterial access lines (or reconnect lines to previously connected lines/syringes). 3. Remove all Cartridge access lines from the 4-position Line Clamp. Grasp the Cartridge and pull the tab out of the slot. Tilt the Cartridge away from machine so that the Red and Blue Sealing Cones are accessible. 4. Clean the Sealing Cones with a lint-free cloth and the 0.5% bleach solution.

Note Debris on a Sealing Cone prevents an airtight seal between the machine and the diaphragm and causes a diaphragm to lose its neutral position.

5. Replace the Cartridge in the slot, align the diaphragms with the Sealing Cones; press the Cartridge toward machine to seat the diaphragms on the cones. 6. Reroute all Cartridge access lines into the 4-position Line Clamp. Clamp any unused lines in the 4-position Line Clamp. 7. Close the Blood Pump Cover. Unclamp the venous and arterial lines. 8. When ready, restart the Blood Pump.

Rev. B


5.A.16 Manual Cleaning procedure for the Waste Handling Option (WHO) WARNING The Waste Handling Option (WHO) must be cleaned each time blood enters the WHO Drain Port before continuing with another patient treatment or once per day if the WHO has been in use.

Note Non-sterile components can be used to manually clean the WHO.

• •

Open the WHO door by placing the thumb on the middle of the door and gently lifting the WHO door tab. Using a syringe with a priming connector as an adapter, inject 15 cc of undiluted bleach (5.25%-6% sodium hypochlorite) into the WHO when the machine is in IDLE phase.

WARNING The patient must not be connected to the machine during this procedure.

WARNING DO NOT USE this priming connector for patient related uses or any sterile connections.

• •

Remove the syringe and priming connector. Close the WHO door by placing the thumb on the middle of the door and pushing. Immediately begin SETUP for the next treatment or perform an ADR: RINSE procedure to rinse the undiluted bleach from the WHO.

WARNING DO NOT LEAVE undiluted bleach in the flow pathway of the machine.

WARNING Following the WHO bleach procedure, before performing a Chemical Disinfection using a chemical other than Bleach, allow the WHO to rinse at least 3 minutes in the ADR Rinse cycle.

Rev. B


5.A-33

5.A.17 Transferring a primed Cartridge Blood Set to another PHOENIX machine for continuation of treatment WARNING DO NOT transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment before dialysate preparation completion, signalled by the appearance of the following Operator Message:

End Of Dialysate Preparation You Can Now Connect The Dialyser

To transfer a primed Cartridge Blood Set to another PHOENIX for continuation of treatment, the priming process may be skipped by temporarily changing the JUMP PRIMING parameter to YES in the machine’s Config settings. Step 1: Preparing the PHOENIX machine to which you will transfer the patient. 1. Turn the machine ON. 2. From the IDLE view, select Config/Centre Conf/Functions and change JUMP PRIMING to YES. Press CONFIRM. 3. Press the kT/V Navigation key and press SET. Select the Diascan DIASCAN parameter box and select NO. Press CONFIRM. 4. Return to the Home view, then start the preparation process by selecting the SETUP Action key and then select the dialysate type to be used. 5. Place a new Cartridge Blood Set on the machine to allow the T1 test and dialysate preparation to proceed. Do not prime this Cartridge Blood Set. 6. Wait for the PAT CONNECT Action key to appear. This machine is now ready to receive the primed Cartridge Blood Set from the other machine. Step 2: Removing the Cartridge Blood Set from the PHOENIX machine for continuation of treatment on the PHOENIX machine previously prepared. 1. If possible, return the patient’s blood per the WASHBACK procedure. If unable to return blood, make sure the blood pump is stopped, clamp the arterial and venous lines, the arterial and venous dialyser lines, the Saline istration line and the Heparin line (if a heparin syringe is present). 2. Close the 4 access lines on the top of the Cartridge Blood Set using the proper end caps. 3. Open the clamps on the 4 Position Line Clamp, removing the Cartridge access lines from the clamps. 4. Remove the venous line from the Venous Line Clamp and the arterial line from the Arterial Line Clamp (if Single Needle is used). 5. Open the Blood Pump Cover and remove the Cartridge Blood Set from the Blood Pump Rotor and the heparin syringe, if present, from the Syringe Holder. Step 3: Placing the primed Cartridge Blood Set on the PHOENIX machine previously prepared for continuation of treatment: 1. Open the Blood Pump Cover, by pressing the cover latch, then open the Air Bubble Detector/Patient Sensor cover. 2. Remove the unprimed Cartridge Blood Set that had previously been placed on the PHOENIX machine to allow dialysate preparation. 3. the Blood Pump Rotor is in the horizontal position, reposition if necessary. Rev. B

5.A-34 PHOENIX OPERATOR MANUAL Note The Blood Pump cover can be closed only when the rotor is in the horizontal position.

4. Remove the end caps from the venous and arterial access lines of the Cartridge Blood Set: this exposes the blood side of diaphragms to atmosphere. Allow approximately 5 seconds for pressure to stabilize on both sides of the diaphragms. Replace the end caps. 5. Place the pump segment of the Cartridge Blood Set around the Blood Pump Rotor. 6. Insert the tab of the Cartridge Blood Set into the Cartridge Clip (left side of cartridge holder). Press the Cartridge against the machine. The pressure pods should seat evenly on the Red and Blue Sealing Cones. 7. Close the Blood Pump Cover. (Cover makes a clicking sound as it latches). 8. Insert the heparin syringe (if present) into the Heparin Syringe Holder and close the Syringe Holder with the clip to keep it in place. 9. With the ⇐ (ARROW LEFT) and ⇒ (ARROW RIGHT) buttons on the Heparin Control , move the heparin syringe Plunger Clamp to fit the syringe. 10. Place the primed dialyser into the Dialyser Holder. 11. Route the venous line into the Air Bubble Detector/Patient Sensor and through the Venous Line Clamp. 12. Close the Air Bubble Detector/Patient Sensor Cover (cover makes a clicking sound as it latches). 13. Route the arterial line into the Arterial Line Clamp (if Single Needle is used). 14. Route the Cartridge access lines into the 4-Position Line Clamp above the Cartridge Blood Set. Route the lines from right to left as follows: Heparin line

Green clamp

Arterial access line

Red clamp (right)

Cartridge saline line

Red clamp (left)

(with priming connector) Venous access line

Blue clamp

15. Remove the clamps from the arterial and venous lines to the patient, arterial and venous dialyser lines, saline istration line and the heparin line (if a syringe is present). 16. Connect the Dialysate Lines to the dialyser and press BY to reprime the dialysate side of the dialyser. 17. Wait approximately 30 seconds and then press the PAT CONNECT Action key and CONFIRM the selection. 18. Start the Blood Pump by pressing the ON/OFF button on the Blood Pump Control . 19. Override any alarms.

WARNING During OVERRIDE, the operator is responsible for monitoring parameters, which are being overriden. 20. Set the treatment parameters for the remainder of the treatment to be performed. 21. Activate Heparin, BPM, UF or Conductivity Profiling if desired. 22. Press the DIALYSIS Action key to reinitiate the treatment.

Rev. B


5.A-35

WARNING It is the operator’s responsibility to check that the quantity of heparin delivered to the patient is enough to prevent blood clots from forming in the extracorporeal circuit during the transfer of a primed Cartridge Blood Set to another machine.

Following completion of the treatment and return to the IDLE view, before initiating another treatment on this machine, set the following parameters: • The JUMP PRIMING parameter must be changed to NO From the IDLE view, select Config/Centre Conf/Functions and change JUMP PRIMING to NO. Press CONFIRM. • The DIAL AUTO PRIME parameter must be changed to YES, if needed to perform the Priming Procedure with Dialysate Connectors on the Dialyser. From the IDLE view, select Config/Centre Conf/Automation and change DIAL AUTO PRIME to YES. Press CONFIRM.

Rev. B


5.A.18

Installation of the Single Needle Holder

The Single Needle Holder accessory allows SETUP of the Single Needle Cartridge Blood Set.

Note The Single Needle Holder can be left on the machine when a double needle treatment is performed.

The Single Needle holder is provided with a clip connection to latch it to the Dialyser Holder. To mount it to the Dialyser Holder, pull out the Dialyser Holder and then press the Single Needle Holder firmly to the shaft as displayed in Fig. 1. The Holder must stay in the upright position (see Fig. 2).

Fig. 1

Rev. B

Fig. 2

SECTION 5.B - TEST PROCEDURES

5.B-1

5.B TEST PROCEDURES 5.B SECTION 5.B - TEST PROCEDURES

5.B.1 Test procedures The machine automatically carries out a series of tests to check the components and processes that make a dialysis treatment safe. Some tests are carried out in a precise functioning phase, while the remaining can be performed in a different machine status, dependent on manipulations performed. During the T1 test execution, a bar graph is displayed together with an operator ‘s message informing the operator that the T1 test execution is in progress and which specific T1 test the PHOENIX machine is performing. When the machine is powered ON or after the end of the dialysis treatment, the machine goes into IDLE. If the machine detects that it is in IDLE for more than a minute, the T1 Test begins automatically. Normally when the machine is in IDLE after being powered ON, dialysate connectors are on their by ports and dialysate concentrates are not connected. During this time, only the tests that do not involve the conductivity probes are performed. In order to allow the T1 testing to continue, the needs to connect the appropriate concentrates, press the SETUP Action key and choose the dialysate type. The machine will then sequence through each remaining T1 tests automatically. Normally following completion of a dialysis treatment when the machine returns to IDLE, the dialysate connectors are on their by ports and dialysate concentrates may still be connected. From IDLE, the has the opportunity to select the NEW SESSION Action key which will allow the T1 test to be performed without repeating the Dialysate Pressure (Pi & Po), Temperature, Conductivity and UF tests. The is advised with an Operator Message to confirm the use of the NEW SESSION to proceed. If a T1 test es, the machine continues normal operation. If a T1 test fails, an alarm message, T1 TEST FAILED, will appear informing the operator of the failure. An operator ‘s message will inform the operator which specific T1 test failed. After the successful completion of the test, the related test message disappears from the window. Only in the specific case of U test failure, the machine gets stuck without displaying any alarm message. Following successful completion of all the T1 TESTs, the machine continues normal operation. If the T1 TEST fails, one of the four possibilities listed below occurs depending on the seriousness of the condition.

Rev. B

5.B-2 PHOENIX OPERATOR MANUAL

1.

WARNING The operator is advised of the test failure with an alarm message (number 183): W! T1 Test Failed (see Section 8 - Alarms and Signals, in this manual) The machine proceeds with normal operation. The audible and visual alarm is disabled by pressing the OVERRIDE button.

2.

WARNING PLUS CONFIRMATION REQUEST The alarm message (#188) is displayed: W! Wait to Continue (see Section 8 - Alarms and Signals, in this manual) In the Operator Messages Area the following message will appear: ... TEST FAILED. Press OVERRIDE To Proceed

Note On the first line of the message the failed test is indicated. E.g.:” The TEMPERATURE TEST Has Failed"

If the operator decides to continue the dialysis treatment despite this test failure, the OVERRIDE button on the Main Control must be pressed. When the OVERRIDE button is pressed, the following message appears: Press ENTER To Confirm And Proceed Press STOP to Interrupt the Process The CONFIRM button must be selected within 2 minutes (i.e. when the OVERRIDE LED is still lit) to confirm the intention to proceed with the dialysis treatment. If the CONFIRM button is not pressed, the machine remains in a wait state. If the operator decides not to continue the treatment and to return to the IDLE view, the STOP Action key must be pressed.

Note After pressing the STOP SETUP Action key, wait at least 20 seconds before restarting again dialysate preparation.

WARNING It is not advisable to continue treatment, but to notify Service as to which test failed. It is the operator’s responsibility to carefully check the parameters involved in the failed test if the decision is made to continue treatment despite the test failure.

Rev. B


3.

5.B-3

GENERAL SAFE STATE The machine is placed in a GENERAL SAFE STATE: • • • •

Ultrafiltration Pump stops Blood Pump stops Venous Clamp closes. Machine goes into BY

It is impossible to continue with a treatment. The following message appears in the alarm window: > GENERAL SAFE STATE < ! T1 Test Failed In the Operator Message Area the following message will appear: Failure of the ... Test in Progress... You Must Switch Off The Machine

WARNING Notify Service as to which test has failed.

4.

MACHINE STUCK Only in the specific case of U test failure, the machine gets stuck without displaying any alarm message. If this occurs, switch OFF the machine, wait 5 seconds, then switch ON the machine again.

Rev. B

5.B-4 PHOENIX OPERATOR MANUAL The table below lists the individual T1 tests, their execution phase (the 2 conductivity tests can occur outside the normal sequence since they are only executed during dialysate preparation), and the results of a test failure:

Test 1

U Test Process control unit

Execution phase • During loading of the program (when Power is switched ON)

Failure Machine stuck

• In IDLE phase 2

CRC EPR Test System memory check

• During loading of the program (when Power is switched ON) • In IDLE phase

3

Comparator Test Internal comparator


4

RAM IC’s Test Memory units


5

Battery Test

• During loading of the program (when Power is switched ON)

General Safe State General Safe State General Safe State warning

• In IDLE phase 6

Buzzer & Lamp Test Audible and visual alarms


7

free

8

free

9

free

10

24 Volt Test Power supply

• During loading of the program (when Power is switched ON) • At the end of WASHBACK

11

Venous Clamp Test Venous line clamp

• During loading of the program (when Power is switched ON) • At the end of WASHBACK

12

free

13

Electrovalves Test

15

Rev. B

General Safe State General Safe State

• At the beginning of dialysate preparation

General Safe State

Arterial & Venous Pressure Test

• In IDLE phase

Venous & Arterial pressures


General Safe State

Blood Pump Test


Valves command 14

NA (see warning below)

OR

General Safe State


Test 16

PI/PO Pressures Test (Note 2)

5.B-5

Execution phase

Failure


General Safe State

In- & out-let filter pressure. & loss of filter by circuit 17

Temperature Test (Note 2)

• During the dialysate preparation

warning + confirm.

18

Acid/Acetate Conductivity Test


warning + confirm.


warning + confirm.


warning + confirm.


General Safe State

Acid/Acetate conductivity 19

Bicarbonate Conductivity Test (Note 1 & 2) Bicarbonate conductivity

20

BLD Test Blood Leak Detector

21

Ultrafiltration pump Test (Note 2) Ultrafiltration

WARNING During the BUZZER AND LAMP test, the presence of a short audible and visual signal must be checked (red and yellow lamps illuminated). If one of the signals is not present, the respective signalling device (buzzer or lamp) is malfunctioning. Call for Service. It is NOT recommended to carry out a dialysis treatment in the absence of the audible and/or visual alarms.

Note 1 The bicarbonate conductivity test is only carried out if Bicarbonate Dialysis/BiCart has been selected.

Rev. B

5.B-6 PHOENIX OPERATOR MANUAL Note 2 If the dialysis treatment starts with the NEW SESSION mode selected by the , the following T1 Tests are not repeated: • Dialysate (Pi&Po) Pressure • Temperature • Conductivity • Ultrafiltration Pump The is advised with the following operator message when the NEW SESSION key is pressed the first time:

In NEW SESSION Mode The Pi&Po, Temperature, Conductivity and UF T1 Tests won't be Performed. Press ENTER To Confirm And Proceed.

Rev. B

SECTION 5.C - BLOOD PRESSURE MONITORING SYSTEM

5.C-1

5.C BLOOD PRESSURE MONITORING SYSTEM 5.C SECTION 5.C - BLOOD PRESSURE MONITORING SYSTEM

5.C.1 General General description The Blood Pressure Monitoring system (BPM) provides measurement of patient blood pressures using an inflatable pressure cuff. Blood pressure data is derived by the oscillometric method. Once the BPM acquires the pressure data, it analyzes the data to obtain systolic and diastolic pressure values and the heart rate.

WARNING If the BPM is not factory installed, carefully follow the instructions supplied with the BPM kit.

Oscillometric Blood Pressure Measurement Method The BPM uses a blood pressure cuff to apply pressure to the artery. The arterial pressure pulses are coupled in the cuff and result in pulses (oscillations) modulating the cuff pressure. The maximum amplitude of these oscillometric pulses occurs at mean blood pressure. The BPM plots the amplitude of the oscillometric pulses against the cuff pressure. It then interpolates the systolic and diastolic blood pressures from the plot.

Assembly accuracy Meets ANSI/AAMI standards. SP10.

Overall System Accuracy Meets ANSI/AAMI SP 10 clause 4.4.2 and EN 1060-3. The following overall system accuracy values are applied: a. Maximum mean error of measurement: ±5 mmHg b. Maximum experimental standard deviation: 8 mmHg Those accuracy values are obtained with a measurement device with an accuracy of: • ±2% or ±3 mmHg, whichever is greater, over a range of 0 to 260 mmHg

(compliant to ANSI/AAMI SP 10 clause 4.4.1).

Pressure cuff measurement ranges Systolic Diastolic Heart rate

+40 to +270 mmHg +20 to +250 mmHg 30 to 250 beats/min.

Cycle time Typical measurement cycle time is less than 60 seconds. Maximum time is 145 seconds.

Rev. B

5.C-2 PHOENIX OPERATOR MANUAL

Zero setting No manual action is necessary: the assembly automatically sets the pressure transducer channel to zero.

Conformity with international standards The BPM complies with the applicable clauses of the following international standards: IEC 60601-2-30 Medical electrical equipment. Part 2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. EN 1060-1 Non-invasive sphygmomanometers - General requirements EN 1060-3 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electromechanical blood pressure measuring systems.

Composition The inflation bags and the tube in the BPM cuff are made of a latex-free material. The external materials of the inflation bags that are in with the patient are made of Dupont Dacron® Polyester with the hook and loop closures made of Dupont Nylon®. These materials has been tested by NAMSA (North American Science Associates) and are in compliance with bio-compatibility standards for irritation and skin sensitivity.

Cuff cleaning Small soiled or stained areas may be cleaned by gentle scrubbing with a sponge or cloth soaked in mild soap or water solution.

Cuff pressure The maximum pressure is 290 mmHg. In the event of a power failure, the cuff automatically deflates. The inflation rate is less than 80 mmHg/second.

Rev. B


5.C-3

WARNING The BPM must be used only for patients with a body weight greater than 15 Kg and using a BPM cuff of the appropriate size. Avoid compression or restriction of pressure tubes. Check (e.g. by observing the limb concerned) that operation of the equipment does not result in prolonged impairment of the blood circulation of the patient. The BPM should be tested and calibrated at least once every 4000 hours, or any time irregular performance is suspected or observed. Its composition (insulating material) protects the BPM "Applied Part" (Type BF) against the effect of a defibrillator discharge. In the event of accidental wetting of the cuff or the hydraulic connections, wipe immediately to prevent moisture from entering the machine.

WARNING In order to be in full conformity with the indications of the European Medical Device Directive 93/42, the manufacturer advises the that the information originating from the BPM cannot be used alone as a unique source of information to induce any therapeutic or pharmacological actions.

Note Excessive patient movement or speech can interfere with blood pressure measurements. Make sure that the patient is quiet and not moving during the measurements, just as during the manual readings.

Rev. B

5.C-4 PHOENIX OPERATOR MANUAL

5.C.2 Cuff selection Selection of correct cuff size 1. Select the appropriate cuff size as indicated below: Cuff size

Limb circumference (cm)

CHILD

10 – 19

Service code 6975213

(3.9-7.5 in) SMALL ADULT

18 – 26

6975221

(7.1-10.2 in) ADULT

25 – 35

6975239

(9.8-13.8 in) LARGE ADULT

33 - 47

6975247

(12.9-18.5 in) THIGH

46 – 66

6975254

(18.1-25.9 in) 2. Ensure that the rubber cuff bladder wraps at least halfway around the limb.

Note The table above contains a number of references to cuffs for use with the Phoenix Blood Pressure Monitoring System (BPM). The Phoenix machine has been tested and validated for use with the cuffs listed in this table. The Manufacturer has not validated the use of cuffs other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of cuffs other than those specified. It is the responsibility of the to validate that other cuffs provide safe and effective performance.

Common errors in cuff size selection Cuff size

Effect on readings

Too Small

False HIGH

Too Large

False LOW

For correction to blood pressure reading refer to “Correction of blood pressure readings” in this section.

Rev. B

5.C-5


5.C.3 Cuff application Proper cuff application 1. 2. 3. 4.

Select the correct cuff size (see Selection of correct cuff size above). Squeeze air from cuff. Place white arrow on cuff approximately over brachial artery. Wrap cuff snugly, placing upper edge of cuff as high on arm as possible, with lower edge 25 to 50 mm above the antecubital crease. 5. Cuff is applied correctly when white arrow on cuff is placed on the inner surface of the arm (not near antecubital crease).

Common errors in cuff application 1. 2. 3. 4.

Wrong cuff size Cuff full of air when first applied. Cuff too low on arm (lower edge of cuff must not rest on antecubital crease). Cuff too loose.

Correction of blood pressure readings When accurate blood pressure measurements are necessary, arm circumferences should be measured and corrections made using the following table (where SBP and DBP respectively represent the Systolic and the Diastolic Adult Blood Pressure Cuffs) Bladder width (cm)

12 (4.7 in)

15 (5.9 in)

18 (7.1 in)

Ideal arm circumference (cm)

30 (11.8 in)

37.5(14.8 in)

45 (17.7 in)

Arm circumference range (cm)

26 - 33

33 - 41

> 41

(10.2 - 12.9)

(12.9 - 16.1)

> 16.1

Arm circumference (cm)

SBP

DBP

SBP

DBP

SBP

DBP

26 (10.2 in)

+5

+3

+7

+5

+9

+5

28 (11.0 in)

+3

+2

+5

+4

+8

+5

30 (11.8 in)

0

0

+4

+3

+7

+4

32 (12.6 in)

-2

-1

+3

+2

+6

+4

34 (13.4 in)

-4

-3

+2

+1

+5

+3

36 (14.2 in)

-6

-4

0

+1

+5

+3

38 (14.9 in)

-8

-6

-1

0

+4

+2

40 (15.7 in)

-10

-7

-2

-1

+3

+1

42 (16.5 in)

-12

-9

-4

-2

+2

+1

44 (17.3 in)

-14

-10

-5

-3

+1

0

46 (18.1 in)

-16

-11

-6

-3

0

0

48 (18.9 in)

-18

-13

-7

-4

-1

-1

50 (19.7 in)

-21

-14

-9

-5

-1

-1

(inch)

Rev. B

5.C-6 PHOENIX OPERATOR MANUAL For correction of blood pressure readings in individual patients, positive numbers should be added to and negative numbers subtracted from the readings obtained. (The table data is taken from the American Heart Association).

5.C.4 BPM interface When selecting BPM from the Home view, the blood pressure monitoring environment is accessed. After having correctly positioned the cuff on the arm of the patient, a new blood pressure measurement can be taken by: • Selecting the HEART button

on the Main Control . The BPM measurement can be performed in the DISINFECT or RINSING modes, or from the IDLE view, as well as during TREATMENT. Only the pressure values, measured starting from the Patient even throught EMPTYING, are stored in the REPORT screen (see Section 7 - Communication System) on the lines between the Start and the Stop of Acquisition of events.

or • Depending on the operating phase of the machine, pressing one of the following

Action keys: - PRE STANDING - PRE SITTING - PRE LYING - POST STANDING - POST SITTING - POST LYING

The measure taken is linked to the parameter related to the specific type of measure performed, and is stored in the Dialysis Report table (see Section 7 Communication System) in the lines reserved for the PRE/POST DIALYSIS DATA.

Note Only during the time between the Patient event, and the TREATMENT process selection, the following Action keys will be available: PRE STANDING, PRE SITTING,PRE LYING. Only during the time between the DIALYSIS Action key disappearance (after the RINSEBACK VOLUME value set has been reached) and the Patient event for the next dialysis treatment, the following Action keys will be available: POST STANDING, POST SITTING,POST LYING. (See Section 7 - Communication System).

Rev. B

5.C-7


Note When the BPM device is not connected a specific alarm is triggered.

The BPM view has the following form:

12:30

TREATMENT

-- / ---- / --- mmHg

---

pu/min

STOP BPM ON PRE STANDING VEN

ART

PRE SITTING

BLOOD FLOW

PRE LYING

BLOOD FLOW

BPM

<< REPORT

KT/V

TIME

Clk Time

PROFILE

Syst

Dias

H RATE

HEPARIN

>>

MACH.CONF

• A graph is displayed on the BPM view showing the patient’s blood pressure measurements: The last measurement of the systolic pressure (Ps): red line The last measurement of the diastolic pressure (Pd): yellow line. • A graph on the BPM view displays heart rate measurements. The last measurement of the pulse rate (h/r): red line. Three pointers on the graphs mark respectively: • The LOG event: starting when the machine enters the IDLE phase. Under the base line of the graph the time in which the LOG event occurred is displayed. • The INIT event: selection of the DIALYSIS Action key. Under the base line of the graph the time “00:00” is displayed.

Rev. B

5.C-8 PHOENIX OPERATOR MANUAL • The END event: end of the dialysis treatment is indicated either by selecting POST

STANDING/POST SITTING/POST LYING, if pressed before the EMPTYING Action key selection, or by selecting the EMPTYING Action key. Under the base line of the graph the time at which the END event occurred is displayed, measured by the INIT event.

Entering the BPM view a green cursor is positioned on the last BPM measurement. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the patient’s blood pressures and heart rate graphs, in correspondence to the BPM measurements.

Note To prevent problems in the BPM graph visualization, do not press simultaneously the two Function Bar Arrows.

Note The Auto-Repeat feature is active on the Function Bar Arrows: pressing and holding the arrows for more than 2 seconds allows the green cursor to move more quickly on the graph.

The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment ( Time) • The clock time (Clk Time) • The systolic pressure value (Syst) • The diastolic pressure value (Dias) • And the heart rate measurement (H Rat) for the point in time at which the green cursor is positioned on the graph (Time). In the time interval between the INIT event and the END event, the “Time” value displayed in the Function Bar, is calculated starting from the DIALYSIS Action key selection (i.e. INIT event); in the time interval before INIT event and after END event, the “Time” value corresponds with the “Clk Time” value. Both the BPM graphs and the BPM data collected during a treatment and displayed in the Function Bar remains available in the BPM view until the Patient event for the next dialysis treatment is triggered.

Note The BPM area is shown in each view, it displays the last BPM measurement data. Data displayed in this area are not deleted by the Patient event.

Note The base of the graph corresponds to zero and the top to the maximum permitted value.

Select the Home Navigation key to return to the Home view. Press the STOP Action key to stop the measurement.

Rev. B

5.C-9


During the dialysis treatment, press the BPM ON Action key to enable automatic pressure measurements at time intervals corresponding to the value set for the SAMPLE INTERV parameter on the Config/Treatments/BPM screen or on the Rx Config/Rx Add, if using Patient/Rx dialysis. When automatic pressure measurements are enabled, the BPM ON Action key is highlighted and the heart icon appears in the Icon bar. To turn off the automatic pressure measurements, select the BPM ON Action key again. The BPM ON Action key will no longer be highlighted.

Note The HEART icon flashes for a minute before an automatic measurement.

BPM measurements can be performed in the DISINFECT or RINSING modes, or from the IDLE view as well as during TREATMENT. At the start of any process (TREATMENT/DISINFECT/RINSING and on the IDLE view) the machine uses the BPM parameters set in the Config/Treatments/BPM menu.

Note The BPM USE parameter, settable both during STD DIALYSIS and during Patient DIALYSIS, may be programmed in the Configuration menu as follow: NO YES AUTOMATIC

only manual measurements are possible measurements performed by the machine at each “SAMPLE INTERV” time the first measurement is performed by the machine immediately after the selection of the TREATMENT Action key, additional measurements are performed at each “SAMPLE INTERV” time.

Manual BPM measurements may be performed at any time by pressing the

button.

Rev. B

5.C-10 PHOENIX OPERATOR MANUAL By using the SET mode, in the BPM view, the value of the parameters relating to the measurements may be modified: 12:30

TREATMENT

DIAST PRE MIN

DIAST PRE MAX

SYST PRE MIN

HEART R. MIN

HEART R. MAX

SAMPLE INTERV

HOME

BPM

REPORT

KT/V

PROFILE

SYST PRE MAX

HEPARIN

• DIAST PRE MIN– Minimum threshold of the range of values within which the diastolic pressure must fall. • DIAST PRE MAX– Maximum threshold of the range of values within which the diastolic pressure must fall. • SYST PRE MIN– Minimum threshold of the range of values within which the systolic pressure must fall. • SYST PRE MAX– Maximum threshold of the range of values within which the systolic pressure must fall. • HEART R. MIN- Minimum threshold of the range of values within which the pulse rate must fall. • HEART R. MAX- Maximum threshold of the range of values within which the pulse rate must fall. • SAMPLE INTERV- Time interval between two successive automatic BPM measurements.

Note When a diastolic pressure, systolic pressure or heart rate measurement is outside the minimum or maximum thresholds, a corresponding alarm is activated which can be reset with the OVERRIDE button.

Rev. B

SECTION 5.D - PROFILE

5.D-1

5.D PROFILE 5.D SECTION 5.D - PROFILE

5.D.1 Introduction In order to make the dialysis treatment more effective, ultrafiltration rate and final conductivity value can be set so that they follow a predetermined curve during the dialysis treatment in progress. That can be done by entering the PROFILE environment. Three curve types can be set for each parameter: • CONSTANT • STEP • PROGRESSIVE The CONSTANT curve type corresponds to a Dialysis Mode with Profiling not enabled: i.e. ultrafiltration rate and/or conductivity and all the relevant parameters are constant during the patient treatment. By setting the curve type to STEP or to PROGRESSIVE the parameters for conductivity and ultrafiltration may be varied during the treatment following a predetermined profile. (See “5.D.1.1 CURVE TYPE Setting”, in this section, for the description of how to set the CURVE TYPE parameter). Each configured Profile curve can be stored in the machine’s memory as a global Profile curve or it can be stored in the Patient/Rx Action keys as an individualized Profile curve. By selecting a Patient/Rx Action key the pre-programmed Profile that was stored in that Patient/Rx Action key will be activated. (Refer to Section 05 – Dialysis Operation, in this manual, for a detailed description of the Patient/Rx Dialysis). Depending on the values set for the CURVE TYPE parameter in the CONFIGURATION view, the Standard Dialysis Mode may be programmed with or without profiling. (Config/PROFILE/UF and Config/PROFILE/Cond. Each of the Patient Action keys can be programmed in the CONFIGURATION view to different profiles or to different combinations of profiles, depending on the values set for the CURVE TYPE parameter. (Rx Config/PROFILE/UF and Rx Config/PROFILE/COND).

Rev. B

5.D-2


5.D.1.1

CURVE TYPE Setting The CURVE TYPE parameter can be set both in Configuration (Idle phase) and during Dialysis.

IN CONFIGURATION (in Idle phase) Press Config/PROFILE/UF and Config/PROFILE/Cond to gain access to the global profile parameters both for ultrafiltration rate and for final conductivity. Press Rx Config/PROFILE/UF and Rx Config/PROFILE/COND to gain access to the individualized (Patient/Rx) profile parameters, both for ultrafiltration rate and for final conductivity. In each view, press the SET button to allow access to the view where it is possible to modify the parameter value; below is an example of Config\PROFILE\UF view: 12:30

Kg/h Kg/h

4.00

ULTRAFILTRATION

3.00 2.00 1.00 0.00 0:00

2:00

1:00

3:00

4:00

CURVE TYPE

TOT WEIGHT L

INITIAL VALUE

CURVE COEFF

PROGRESSIVE

4Kg

1.4 Kg/h

20%

CONFIG

PROFILE

UF

h:min h:min

COND

Press the CURVE TYPE Parameter Box. The background colour of the entry field will change from gray to yellow and a new view will appear where the three possible selections for the parameter are available: CONSTANT, STEP, PROGRESSIVE. Select the desired value and then press the CONFIRM button to accept the modified value; the profile will change to represent the new value entered. Press the SET button to exit this view. Changes to the CURVE TYPE parameter made in the CONFIGURATION view are retained in the machine‘s memory.

Rev. B


5.D-3

STARTING FROM PREPARATION Press PROFILE/UF and PROFILE/Cond Navigation key to gain access to the global profile parameters both for ultrafiltration rate and for final conductivity. Follow the same procedure described above for the CONFIGURATION view. Changes to the CURVE TYPE parameter made in those pages are only temporary; i.e. they only remain until the end of the current dialysis treatment. The CURVE TYPE parameter value, both for ultrafiltration rate and for final conductivity, can be changed until the PAT CONNECT Action key selection. If the CURVE TYPE parameter and/or the CON CURVE TYPE parameter are set to STEP or PROGRESSIVE the PAT CONNECT Action key will not appear until the profiles have been activated. Select ACTIVATE UF RATE CURVE and/or ACTIVATE CONDUCT. CURVE in the PROFILE view to activate profiles. An operator’s message is displayed at the end of the priming phase stating that Profiling must be activated to make the PAT CONNECT Action key available:

The Profiling Mode has been selected Please activate Profiling to get PAT CONNECT

Rev. B

5.D-4


5.D.2

Dialysis Mode with Profiling not enabled If the CURVE TYPE or/and the CON CURVE TYPE parameter is/are set to CONSTANT, changes to the UFR or/and CONDUCTIVITY value(s) can be done only by an operator intervention.

5.D.2.1 Display UFR and Conductivity graph in Dialysis Mode with Profiling not enabled When selecting PROFILE Navigation key the following view appears. 12:30 -- / ----- / ---mmHg

---

pu/min DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.000 Kg Kg/h ULTRAFILTRATION CURVE TYPE 4.00 CONSTANT 3.00

UFR 1.800 Kg/h

2.00 1.00 0.00

VEN

ART

0:00

1:00

2:00

Time

3:00 h:min

4:00

CONDUCTIVITY

mS/cm

CON CURVE TYPE

17.0

BLOOD FLOW

TOTAL FLUID REMOVED 1.800 Kg/h

16.0

CONSTANT CONDUCTIVITY 14.6 mS/cm

15.0 14.0 13.0 0:00

PUMP SPEED

1:00

Time PROFILE

UF

2:00

3:00 h:min

4:00

COND

Note When the CURVE TYPE parameter is set to CONSTANT, the ACTIVATE UF RATE CURVE Action key is not available in the PROFILE view. When the CON CURVE TYPE parameter is set to CONSTANT, the ACTIVATE CONDUCT. CURVE Action key is not available in the PROFILE view.

Rev. B


•

5.D-5

UF view When selecting PROFILE\UF the following view appears. Both the UFR value set and the achieved UFR values are displayed in the Parameter Area. 12:30 -- / --

--- / --mmHg

---

pu/min

ULTRAFILTRATION Kg/h 4.00 3.00 2.00 1.00

VEN

ART

0.00

0:00

1:00

CURVE TYPE

e

PUMP SPEED

PROFILE

2:00

UF

4:00

3:00

Time

BLOOD FLOW

h:min

CONSTANT

Time

Clock Time

01:90

12:30

UF R 1.4

Curr 1.4

f

COND

Note When the CURVE TYPE parameter is set to CONSTANT, changes to the UFR and TOT WEIGHT L parameter values can be made only from the Home view in Set mode.

The red curve on the graph represents the last value set for the UFR parameter, while the yellow curve represents the achieved UFR values. Entering the PROFILE\UF view a green cursor is positioned on the current UFR value. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the UF Profile graph.

Note To prevent problems in the Profile graph visualization, do not press simultaneously the two Function Bar Arrows.


The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (Clock Time) • The last value set for the UFR parameter (UFR) • The UFR current value (Curr) for the point in time at which the green cursor is positioned on the graph (Time). Press any Navigation key to exit from this view. Rev. B

5.D-6 •

PHOENIX OPERATOR MANUAL COND Profile When selecting PROFILE\Cond, the following view appears. Both the configured Conductivity Profile and the achieved Conductivity values are displayed in the Parameter Area. 12:30 -- / --

--- / ---mmHg

---

pu/min

CONDUCTIVITY

mS/cm 17.0 16.0 15.0 14.0

VEN

13.0

ART

0:00

1:00

Time

4:00

3:00

2:00 h:min

BLOOD FLOW CON CURVE TYPE Plasma Conduct. Ionic Mass Bal

e

PUMP SPEED

PROFILE

UF

CONSTANT 13.5 mS/cm nmol

Time 02:00

Clock Time 12:30

Cond 14.5

Curr 14.5

f

CON

Note When the CON CURVE TYPE parameter is set to CONSTANT, changes to the CONDUCTIVITY parameter value can be made only from the Home view in Set mode.

The red curve on the graph represents the last value set for the CONDUCTIVITY parameter, while the yellow curve represents the achieved CONDUCTIVITY values. Entering the PROFILE\Cond view a green cursor is positioned on the current Conductivity value. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the Conductivity Profile graph.



The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (Clock Time) • The last value set for the CONDUCTIVITY parameter (CON) • The CONDUCTIVITY current value (Curr) for the point in time at which the green cursor is positioned on the graph (Time). Rev. B


5.D-7

The PLASMA CONDUCTIVITY and IONIC MASS BALANCE values are displayed only if the DiascanTMMonitoring System is active and a Clearance measurement has been taken. (See Section 5.E – Monitoring, in this manual, for a detailed description of these parameters). Press any Navigation key to exit from this view.

5.D.2.2

DIALYSIS TIME Setting

When both the CURVE TYPE and CON CURVE TYPE parameters are set to CONSTANT, the DIALYSIS TIME parameter can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\Treatments\Std Dialys view or in the Rx Config\Rx Data view for Patient/Rx Dialysis. Changes to the DIALYSIS TIME parameter during Idle phase are stored in the machine’s memory. STARTING FROM PREPARATION: • by pressing the SET button in the Home view; • by pressing the SET button in the PROFILE view. The value set for the DIALYSIS TIME parameter in the HOME view is automatically displayed in the PROFILE view and vice versa.

Note Change of the DIALYSIS TIME parameter during DIALYSIS affects only the current treatment.

Note Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity graphs in the PROFILEview.

When one of the two parameters CURVE TYPE and CON CURVE TYPE is not set to CONSTANT, the DIALYSIS TIME parameter can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\Treatments\Std Dialys view or in the Rx Config\Rx Data view for Patient/Rx Dialysis; • by pressing the SET button in the Config\PROFILE view or in the Rx Config\PROFILE view for Patient/Rx Dialysis.

Rev. B

5.D-8

PHOENIX OPERATOR MANUAL In STANDARD DIALYSIS: When the Dialysate Selection key is pressed in the SELECT DIALYSATE view, the DIALYSIS TIME parameter in the Config/PROFILE view is automatically changed to the time set in the Config/Treatments/Std Dialys view. The treatment time and the profile time automatically become the same. In PATIENT/RX DIALYSIS: In Patient/Rx Dialysis, the value set for the DIALYSIS TIME parameter in the Rx Config\PROFILE view is automatically displayed in the Rx Config\Rx Data view and vice versa. The treatment time and the profile time automatically become the same.

Note Changes of the DIALYSIS TIME parameter during Idle phase are stored in the machine’s memory.

STARTING FROM PREPARATION: DIALYSIS TIME may be changed before activating UF and/or CON Profiling curve: • by pressing the SET button in the Home view; • by pressing the SET button in the PROFILE view. The value set for the DIALYSIS TIME parameter in the HOME view and the DIALYSIS TIME in the PROFILE view automatically are changed to the same time.

After activating UF and/or CON Profiling curve: by pressing the SET button in the PROFILE view.

•

After deactivating either the UF or the CON Profiling curve and one curve remains active: • by pressing the SET button in the PROFILE view. After deactivating both UF and CON Profiling curve: by pressing the SET button in the Home view.

•

Note Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity graphs in the PROFILE view.

Rev. B


5.D.3

5.D-9

Profiled Dialysis Mode

5.D.3.1

General A Profiled Dialysis can be divided into two different phases: • Configuration phase, i.e. definition of the profile curve. The Configuration phase is accessible from the CONFIG menu when the machine is in IDLE Mode. • Activation phase, accessible from the PROFILE view. In the Activation phase, the Profile attributes can be changed (except during the last 15 minutes of DIALYSIS) and the profile curves can be activated and deactivated.

Note There are only two Profiles configured in the CONFIG menu for both conductivity and ultrafiltration (default Profiles configured by the Manufacturer): a Global Profile and a Patient/Rx Profile.

WARNING It is the responsibility of the operator to check that the numerical values that represent the Profile (on the bottom of the graph) correspond to the values in the graph.

Rev. B

5.D-10 PHOENIX OPERATOR MANUAL

5.D.3.2

Entering the PROFILE View

IN CONFIGURATION (in Idle phase) Press Config/PROFILE/UF or Config/PROFILE/Cond to gain access to the global profile parameters. Press Rx Config/PROFILE/UF or Rx Config/PROFILE/COND to gain access to the Patient/Rx profile parameters. Refer to Section 02 – Configuration Description, in this manual, for a detailed description of the configuration environment. Changes to the profiles parameters made in those pages are retained in the machine‘s memory.

DURING DIALYSIS Select the PROFILE Navigation key to gain access to the profile parameters configured in the machine’s memory; below is an example of PROFILE view with Progressive curves: 12:30 -- / --

--- / --- mmHg

---

pu/min

DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.000 Kg Kg/h ULTRAFILTRATION CURVE TYPE 4.00 PROGRESSIVE 3.00 UFR 0.000 Kg/h 2.00 1.00

VEN

0.00

ART

0:00

1:00

2:00

Time

4:00

UF RATE CURVE

ACTIVATION CONDUCT. CURVE

CONDUCTIVITY

mS/cm

BLOOD FLOW

3:00 h:min


ACTIVATION

CON CURVE TYPE PROGRESSIVE

17.0 16.0

CONDUCTIVITY 0.0 mS/cm

15.0 14.0 13.0 0:00

PUMP SPEED

1:00

Time PROFILE

UF

2:00

3:00 h:min

4:00

COND

Changes to the profiles parameters made from the Profile views are only temporary; i.e. they only remain until the end of the current dialysis treatment. Thus any changes made cannot be saved in memory.

Rev. B


5.D.3.3

5.D-11

Progressive Curve Profiles This type of Profile allows programming the Ultrafiltration Rate and the Conductivity value so that, during the dialysis treatment, they follow a predetermined, continuous progressive graph.

5.D.3.3.1 Conductivity Progressive Curve Profiles: parameters explanation A conductivity profile may be established in the machine’s memory on the Config\PROFILE\Cond view or in the Rx Config\PROFILE\COND view. A conductivity profile may be configured for the current treatment in the PROFILE\Cond view:

INITIAL VALUE: Initial value of Conductivity FINAL VALUE: Final value of Conductivity CURVE COEFF: coefficient of the curvature of the progressive curve. This parameter can range from 20 % to 80 %

DIALYSIS TIME: Length of the dialysis treatment. Set on the PROFILE view or in the Config\PROFILE view or in the Rx Config\PROFILE view. If a Conductivity Progressive curve is set with: INITIAL VALUE= 17 FINAL VALUE= 14 DIALYSIS TIME= 4 h:min CURVE COEFF= 50 % The following graph is shown: 17 mS/cm

CURVE COEFFICIENT= 50 %

INITIAL VALUE = 17

FINAL VALUE = 14

13 mS/cm

4 h:min

Rev. B

5.D-12 PHOENIX OPERATOR MANUAL Increasing the CURVE COEFF, creates the curve as follows:

CURVE COEFFICIENT = 65%

17 mS/cm

INITIAL VALUE = 17 FINAL VALUE = 14 13 mS/cm

4 h:min

The greater the value for the CURVE COEFF (max 80%), the more convex the profile curve will become. If the CURVE COEFF has a value less than 50%, the profile curve will have a concave shape, as shown below:

CURVE COEFFICIENT= 35%

17 mS/cm

INITIAL VALUE = 17 FINAL VALUE = 14 13 mS/cm

4 h:min

5.D.3.3.2 Ultrafiltration Rate Progressive Curve Profiles: parameters explanation An Ultrafiltration Rate Profile may be established in the machine’s memory in the Config\PROFILE\UF view or in the Rx Config\PROFILE\COND view. A conductivity profile may be configured for the current treatment in the PROFILE\UF view:

TOT WEIGHT L: Target Weight Loss (instead of FINAL VALUE). INITIAL VALUE: Initial value of the Ultrafiltration Rate. CURVE COEFF: coefficient of the curvature of the progressive curve. This parameter can range from 20% to 80%

DIALYSIS TIME: Length of dialysis treatment. Set on the PROFILE view or in the Config\PROFILE view or in the Rx Config\PROFILE view. The methods of inserting the UFR parameters are the same as those illustrated for the Conductivity parameters.

Rev. B


5.D-13

5.D.3.3.3 Programming the Progressive Curve


An Ultrafiltration Rate Progressive Profile may be established in the machine’s memory in the Config\PROFILE\UF view or in the Rx Config\PROFILE \UF view. An UFR profile may be configured for the current treatment in the PROFILE\UF view. Press the SET button to allow access to a view where it is possible to modify the profile attributes; below is an example of Config\PROFILE\UF view: 12:30

Kg/h Kg/h

4.00

ULTRAFILTRATION

3.00 2.00 1.00 0.00 0:00

2:00

1:00

3:00

4:00

CURVE TYPE

TOT WEIGHT L

INITIAL VALUE

CURVE COEFF

PROGRESSIVE

4Kg

1.4 Kg/h

20%

CONFIG

PROFILE

UF

h:min h:min

COND

Rev. B

5.D-14 PHOENIX OPERATOR MANUAL A Conductivity Progressive Profile may be established in the machine’s memory in the Config\PROFILE\Cond view or in the Rx Config\PROFILE\COND view. A Conductivity profile may be configured for the current treatment in the PROFILE\Cond view. Press the SET button to allow access to a view where it is possible to modify the profile attributes; below is an example of Config\PROFILE\Cond view: 12:30

Kg/h Kg/h

4.00

CONDUCTIVITY

3.00 2.00 1.00 0.00 0:00

2:00

1:00

3:00

h:min 4:00 h:min

CON CURVE TYPE

INITIAL VALUE

FINAL VALUE

CURVE COEFF

PROGRESSIVE

15.0 mS/cm

13.5 mS/cm

20%

CONFIG

PROFILE

UF

COND

Both for UFR and Conductivity profiles: • Press the Parameter Box to be changed on the Touch Screen. The background colour of the entry field will change from gray to yellow. • To change a parameter with a string value, after touching the parameter box area, another view will appear with the possible selections for that parameter. Select the desired value. • To change a parameter with a numeric value, press the PLUS or MINUS buttons on the Main Control . • Press the CONFIRM button to accept the modified value; the profile will change to represent the new value entered. If another parameter is selected and changed before pressing the CONFIRM button, only the last change is retained in memory. • Press the SET button to return to the view where the profile is displayed. The modified profile is displayed in the “Parameter area”.

Rev. B


5.D.3.4

5.D-15

Step Curve Profiles This type of Profile allows the Ultrafiltration Rate and the Final Conductivity value to be programmed in 15 minute intervals of treatment time.


5.D.3.4.1 Ultrafiltration Rate Step Curve Profiles An Ultrafiltration Rate Step Profile may be established in the machine’s memory in the Config\PROFILE\UF view or in the Rx Config\PROFILE\UF view. An Ultrafiltration Rate Step Profile may be configured for the current treatment in the PROFILE\UF view. Below is an example of Config\PROFILE\UF view in Set mode: 12:30

Kg/h

STEP UF RATE

4.00 3.00 2.00 1.00 0.00

1:00

0:00

CURVE TYPE

3

STEP

CONFIG

2:00

TIME

UF R

0:00

1.7

Time

TOT WEIGHT L

STEP UFR

4 Kg

1.7 Kg/h

PROFILE

UF

3:00

h:min

4:00

4

COND

TOT WEIGHT L: Target Weight Loss. DIALYSIS TIME: Length of dialysis treatment. Set on the PROFILE view or in the Config\PROFILE view or in the Rx Config\PROFILE view. STEP UFR: UFR value for the selected step (a 15 minute segment of the treatment). The Ultrafiltration Rate Step Curve is programmed by selecting and setting each step (15 minute segment) of the treatment. The selected step is red highlighted, all the other steps are yellow highlighted.

Rev. B


5.D.3.4.2 Conductivity Step Curve Profiles A Conductivity Step Profile may be established in the machine’s memory in the Config\PROFILE\Cond view or in the Rx Config\PROFILE\COND view. A Conductivity Step Profile may be configured for the current treatment in the PROFILE\Cond view. Below is an example of Config\PROFILE\Cond view in Set mode:

12:30

mS/cm

STEP COND

17.0 16.0 15.0 14.0 13.0

1:00

0:00

3

2:00 Time

TIME

COND

0:00

14.7

CON CURVE TYPE

COND STEP

STEP

14.7 mS/cm

CONFIG

PROFILE

UF

3:00

h:min

4:00

4

COND

COND STEP: Conductivity value for the step (a 15 minute segment of the treatment). DIALYSIS TIME: Length of dialysis treatment. Set on the PROFILE view or in the Config\PROFILE view or in the Rx Config\PROFILE view. The Conductivity Step Curve is programmed by selecting and setting each step (15 minute segment) of the treatment. The selected step is red highlighted, all the other steps are yellow highlighted.

Rev. B


5.D-17

5.D.3.4.3 Programming the Step Curve To select each bar (a 15 minute segment of the treatment) on the Step curve, press the Function Bar Arrows (located just below the graph), to move the red highlighted area to the right or to the left, as desired. The bar that is red highlighted is the current selection. The Starting Time and the UFR value/Conductivity value for the red highlighted bar is displayed. By selecting the STEP UFR Parameter Box on the PROFILE\UF or Config\PROFILE\UF view or in the Rx Config\PROFILE\UF view, it is possible to change the UFR value for the selected 15 minute Step. Changing the UFR value, for the selected step, also results in a change to the TOT WEIGHT L, which is automatically updated. Changing the DIALYSIS TIME value results in a change to the UF Rate, which is automatically updated, while the TOT WEIGHT L remains constant. Similarly, by pressing the COND STEP Parameter Box on the PROFILE\Cond or Config\PROFILE\Cond view, it is possible to change the Conductivity value for the selected 15 minute Step.

Note In Config\PROFILE, after a Step has been programmed, the following Step is automatically selected. By pressing the CONFIRM button, that Step is programmed to the previously confirmed UF R/Cond value.

Rev. B

5.D-18 PHOENIX OPERATOR MANUAL 5.D.3.5

Modify Profile Parameters Note None of the profile parameters can be changed in the last 15 minutes of DIALYSIS.

DIALYSIS TIME The DIALYSIS TIME parameter can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\Treatments\Std Dialys view or in the Rx Config\Rx Data view for Patient/Rx Dialysis; • by pressing the SET button in the Config\PROFILE view or in the Rx Config\PROFILE view for Patient/Rx Dialysis. In STANDARD DIALYSIS: When the Dialysate Selection key is pressed in the SELECT DIALYSATE view the DIALYSIS TIME parameter in the Config/PROFILE view is automatically changed to the time set in the Config/Treatments/Std Dialys view. The treatment time and the profile time automatically become the same. In PATIENT/RX DIALYSIS: In Patient/Rx Dialysis, the value set for the DIALYSIS TIME parameter in the Rx Config\PROFILE view is automatically displayed in the Rx Config\Rx Data view and vice versa. The dialysis time and profile time automatically become the same.

Note Changes of the DIALYSIS TIME parameter during Idle phase are stored in the machine’s memory.

STARTING FROM PREPARATION: DIALYSIS TIME may be changed before selecting ACTIVATION UF RATE CURVE Action key or/and ACTIVATE CONDUCT. CURVE Action key: • by pressing the SET button in the Home view; • by pressing the SET button in the PROFILE view. The value set for the DIALYSIS TIME parameter in the HOME view and the DIALYSIS TIME parameter in the PROFILE view automatically are changed to the same time. After selecting ACTIVATION UF RATE CURVE Action key or/and ACTIVATION CONDUCT. CURVE Action key: • by pressing the SET button in the PROFILE view. After deselecting both the ACTIVATION UF RATE CURVE Action key and the ACTIVATION CONDUCT. CURVE Action key deselection: • by pressing the SET button in the Home view.

Rev. B


5.D-19

After deselecting either the ACTIVATION UF RATE CURVE or the ACTIVATION CONDUCT. CURVE and one of the curves remains active: • by pressing the SET button in the PROFILE view.

Note Change of the DIALYSIS TIME parameter during DIALYSIS affects only the current treatment.

Note Change of the DIALYSIS TIME parameter affects both the UFR and Conductivity profiles.

Note The minimum DIALYSIS TIME that may be set in the PROFILE view is 30 minutes.

Note If the DIALYSIS TIME parameter value is decreased below the treatment time already elapsed, the UFR measurements will not be recorded by the machine and the UFR Profile graph will not display correct UFR values.

TOT WEIGHT L When the CURVE TYPE is set to STEP or to PROGRESSIVE, the TOT WEIGHT L parameter can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\PROFILE view or in the Rx Config\PROFILE view for Patient (Rx) Dialysis.

Note Changes of the TOT WEIGHT L parameter during Idle phase are stored in the machine’s memory.

STARTING FROM PREPARATION: Before ACTIVATION UF RATE CURVE Action key selection: • by pressing the SET button in the PROFILE\UF view. After ACTIVATION UF RATE CURVE Action key selection: • by pressing the SET button in the PROFILE\UF view.

Note After UFR profile activation, the PAT CONNECT Action Key will not appear until the TOT WEIGHT L parameter value is confirmed in the PROFILE/UF view.

Note After UFR profile activation, if the TOT WEIGHT L parameter is changed during the Pt. Connect phase, the updated TOT WEIGHT L parameter value is not displayed in the Home view until the selection of the DIALYSIS Action key.

After ACTIVATION UF RATE CURVE Action key deselection: • by pressing the SET button in the Home view. Change of the TOT WEIGHT L parameter during DIALYSIS effects only the current treatment. Rev. B

5.D-20 PHOENIX OPERATOR MANUAL INITIAL VALUE (COND), FINAL VALUE (COND), CURVE COEFF (COND), INITIAL VALUE (UFR), CURVE COEFF (UFR), COND STEP and STEP UFR The INITIAL VALUE (COND), FINAL VALUE (COND), CURVE COEFF (COND), INITIAL VALUE (UFR), CURVE COEFF. (UFR), COND STEP and STEP UFR parameters can be changed: IN CONFIGURATION (in Idle phase): • by pressing the SET button in the Config\PROFILE\UF view or in the Config\PROFILE\Cond view, depending on the parameter; • in the Rx Config\PROFILE\UF view or in the Rx Config\PROFILE\COND view, depending on the parameter, for Patient /Rx Dialysis.

Note Changes of those parameters during Idle phase are stored in the machine’s memory.

STARTING FROM PREPARATION: Before and after profiles activation and during the time profiles remain activated: • by pressing the SET button in the PROFILE\UF or in the PROFILE\Cond view, depending on the parameter. (See “5.D.3.3 Progressive Curve Profiles” and “5.D.3.4 Step Curve Profiles” for a detailed description of the profile parameters).

Note After the DIALYSIS Action key selection, when a profile is deactivated, none of the relevant parameters are available in the PROFILE view for the deactivated profile. Those parameters become available in the Home view.

Note Change of those parameters during DIALYSIS effects only the current treatment.

Rev. B


5.D.3.6

5.D-21

Activation of Profile

Activation of UFR or CONDUCTIVITY Profile Press the PROFILE Navigation key to access the PROFILE view: 12:30 -- / --

--- / ---mmHg

---

pu/min DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.000 Kg Kg/h ULTRAFILTRATION CURVE TYPE 4.00 PROGRESSIVE 3.00


1.00 0.00

ART

0:00

1:00

2:00

Time

3:00 h:min

4:00

ACTIVATION

CONDUCTIVITY

mS/cm

CON CURVE TYPE PROGRESSIVE

17.0

BLOOD FLOW

UF RATE CURVE

UFR 0.000 Kg/h

2.00

VEN

ACTIVATION

CONDUCT. CURVE

16.0 CONDUCTIVITY 0.0 mS/cm

15.0 14.0 13.0 0:00

PUMP SPEED

PROFILE

UF

1:00

Time

2:00

3:00 h:min

4:00

COND

Note The ACTIVATION UF RATE CURVE Action key is available only if the CURVE TYPE parameter is set to STEP or to PROGRESSIVE. The ACTIVATION CONDUCT. CURVE Action key is available only if the CON CURVE TYPE parameter is set to STEP or to PROGRESSIVE.

To activate PROFILE, press the ACTIVATION UF RATE CURVE and/or the ACTIVATION CONDUCT. CURVE Action keys. The Action keys are highlighted when profile is activated and the PROFILE icon appears in the Icon Bar on the left side of the Touch Screen. PROFILE must be activated (selection of the ACTIVATION UF RATE CURVE Action key or/and of the ACTIVATION CONDUCT. CURVE Action key) before patient connection phase in order to make the PAT CONNECT Action key available.

Note The ACTIVATION UF RATE CURVE Action key and the ACTIVATION CONDUCT. CURVE Action key are not available in the treatment phase between the PAT CONNECT Action key selection and the following DIALYSIS Action key selection.

Rev. B

5.D-22 PHOENIX OPERATOR MANUAL Once PROFILE has been activated, a change of the CURVE TYPE parameter value will automatically deactivate PROFILE. If the new CURVE TYPE parameter value is STEP or PROGRESSIVE, the action key must be activated again for that PROFILE. If the new CURVE TYPE parameter value is CONSTANT, the ACTIVATION UF RATE CURVE Action key or/and the ACTIVATION CONDUCT. CURVE Action key is/are no longer available.

Note When UFR Profile is activated, the UFR parameter value is not modifiable from the HOME view in Set mode. When CONDUCTIVITY Profile is activated, the CONDUCTIVITY parameter value is not modifiable from the HOME view in Set mode.

Note After UFR profile activation, if the TOT WEIGHT L parameter is changed during the Pt. Connect phase, the updated TOT WEIGHT L parameter value is not displayed in the Home view until the selection of the DIALYSIS Action key.

Note When Profiling is active, the END DIALYSIS parameter can not be modified. Before activating Profiling ensure the END DIALYSIS parameter is correctly set for the current dialysis prescription. The END DIALYSIS parameter becomes available again at Profiling deactivation (See “5.D.3.8 Deactivation of Profiling”, in this section, for the description of a detailed description of Profiling deactivation conditions).

Rev. B


5.D.3.7

5.D-23

Profile during Dialysis Once the DIALYSIS Action key has been selected, only the remaining part of the curve, both PROGRESSIVE and STEP, can be changed. When selecting the PROFILE Navigation key, the following view is displayed.

12:30

TREATMENT

DIALYSIS TIME 04:00 h:min TOT WEIGHT L 4.000 Kg Kg/h ULTRAFILTRATION 4.00 CURVE TYPE PROGRESSIVE 3.00 UFR 0.000 Kg/h 2.00 1.00 0.00

ART

0:00

1:00

Time

VEN mS/cm

2:00

3:00 h:min

4:00

COMPENSATION


ACTIVATION

CONDUCTIVITY CON CURVE TYPE

17.0

BLOOD FLOW

ACTIVATION UF RATE CURVE

16.0

CONDUCT. CURVE

CONDUCTIVITY 0.0 mS/cm

15.0 14.0 13.0 0:00

PUMP SPEED

PROFILE

UF

1:00

Time

2:00

3:00 h:min

4:00

COND

The ACTIVATION UF RATE CURVE and ACTIVATION CONDUCT. CURVE are available to deactivate Profile for a parameter. The COMPENSATION Action key is displayed only if there is a “Error On Total Weight Loss” #60 alarm (difference between theoretical and actual Fluid Removed > 100 grams). It may be displayed at any time during the dialysis treatment except in the last 30 minutes. In addition to the COMPENSATION Action key, an icon is also displayed which represents whether the FLUID REMOVAL ERROR is in the positive or in the negative direction. When pressing the COMPENSATION Action key, the following superimposed window will appear:

Compensation has been request. Press ENTER To Confirm.. Upon pressing the CONFIRM button, a new curve is confirmed and used for the remainder of the DIALYSIS treatment.

Rev. B

5.D-24 PHOENIX OPERATOR MANUAL If the “Error On Total Weight Loss” #60 alarm appears in the last 30 minutes of dialysis treatment or if the alarm has not been cleared before the COMPENSATION Action key disappears (last 30 minutes of dialysis treatment), the following operator’s message is displayed:

The Profiling Mode Cannot Continue Deactivate it and Continue in STD Mode To proceed with the dialysis treatment, deactivate PROFILING.

Rev. B


5.D-25

5.D.3.7.1 Display Profile during DIALYSIS •

UF Profile When selecting PROFILE\UF the following view appears. Both the configured UFR Profile and the achieved UFR values are displayed in the Parameter Area. An example of Progressive UF profile is displayed: 12:30 -- / --

--- / --- mmHg

---

pu/min

ULTRAFILTRATION Kg/h 4.00 3.00 2.00 1.00

VEN

ART

0.00

0:00

1:00

BLOOD FLOW

CURVE TYPE TOT WEIGHT L

e

PUMP SPEED

PROFILE

UF

Time 02:00

2:00

4:00

3:00

Time

h:min

PROGRESSIVE

INITIAL VALUE

4.000 Kg/h

CURVE COEFF

1.500 Kg/h 20%

ClkTime

UF R

Curr

12:30

1.5

0.9

f

COND


The red curve on the graph represents the configured UFR Profile while the yellow curve represents the achieved UFR values. Entering the PROFILE\UF view a green cursor is positioned on the current UFR value. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the UF Profile graph.



Rev. B

5.D-26 PHOENIX OPERATOR MANUAL The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (ClkTime) • The UF rate programmed value (UF R) • The UF rate current value (Curr) for the point in time at which the green cursor is positioned on the graph (Time). Press any Navigation key to exit from this view. By pressing the SET button, a view is displayed where the profile attributes can be modified.

Rev. B


•

5.D-27

COND Profile When selecting PROFILE\Cond, the following view appears. Both the configured Conductivity Profile and the achieved Conductivity values are displayed in the Parameter Area. An example of a Progressive Conductivity Profile is displayed: 12:30 -- / --

--- / ---mmHg

---

pu/min

CONDUCTIVITY

mS/cm 17.0 16.0 15.0 14.0

VEN

13.0

ART

0:00

1:00

Time

4:00

3:00

2:00 h:min

BLOOD FLOW CON CURVE TYPE PROGRESSIVE

INITIAL VALUE

Plasma Conduct.

FINAL VALUE

14.4 mS/cm

CURVE COEFF

25%

Ionic Mass Bal

e

PUMP SPEED

PROFILE

UF

Time 02:00

13.5 mS/cm nmol

16.7 mS/cm

ClkTime

Cond

Curr

12:30

14.0

14.5

f

COND


The red curve on the graph represents the configured Conductivity Profile while the yellow curve represents the achieved Conductivity values. Entering the PROFILE\Cond view a green cursor is positioned on the current Conductivity value. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the Conductivity Profile graph.



Rev. B

5.D-28 PHOENIX OPERATOR MANUAL The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (ClkTime) • The Conductivity programmed value (Cond) • The Conductivity current value (Curr) for the point in time at which the green cursor is positioned on the graph (Time). The Plasma Conduct and Ionic Mass Bal values are displayed only if the DiascanTMMonitoring System is active and a Clearance measurement has been taken. (See Section 5.E – Monitoring, in this manual, for a detailed description of these parameters). Press any Navigation key to exit from this view. By pressing the SET button, a view where the profile attributes can be modified is accessed.

Rev. B


5.D-29

5.D.3.7.2 Modification of a Curve during DIALYSIS Progressive Curve shapes When a change in a Progressive Curve is required during DIALYSIS, the INITIAL VALUE represents the first changeable point on the Profile after the current actual value, i.e. at the next the 5 minute point. Thus the modification will only affect the remaining portion of the Profile. No modifications in a Progressive Curve are allowed in the last 15 min. of DIALYSIS.

Step curve When a change in a Step Curve is required during DIALYSIS, the first changeable Step on the Profile is the Step after the current Step, i.e. the next 15 minute Step. Thus the modification will only affect the remaining portion of the Profile. No modifications in a Step Curve are allowed in the last Step of DIALYSIS.

5.D.3.7.3 Profile during WASHBACK WASHBACK may be carried out without discontinuing Profiling.

Rev. B


5.D.3.8

Deactivation of Profiling

Deactivation by Operator request To deactivate PROFILE for a parameter, the PROFILE view must be accessed. Then press the ACTIVATION UF RATE CURVE and/or the ACTIVATION CONDUCT. CURVE Action key to deactivate the profile; a superimposed window will appear: Confirm last action made. Use -/+ button to modify UF R Press CONFIRM to discontinue UF Profiling. Or Confirm last action made. Use -/+ button to modify Conductivity. Press CONFIRM to discontinue Conductivity Profiling. The UF R/Cond value must be confirmed. The UF R/Cond value that was confirmed in the superimposed window will remain at that value for the reminder of the treatment. If PROFILE is deactivated after the DIALYSIS Action key selection, it is not possible to re-activate it for the current dialysis treatment.

Deactivation at the end of DIALYSIS When the machine reaches the end of the treatment, PROFILE is automatically deactivated and cannot be re-activated.

Deactivation requested by the Protection System During DIALYSIS, the Protection System continuously checks the accuracy of the activated profiles, relative to the current value and the timing. If any problems are detected, the “! Conductivity Profile” #210 alarm or/and the “! ULTRAFILTRATION RATE PROFILE” #212 alarm is/are displayed and the machine automatically deactivates the erroneous profile or profiles. Profile deactivated cannot be re-activated for the current dialysis treatment.

Rev. B

SECTION 5.E - MONITORING

5.E-1

5.E MONITORING 5.E SECTION 5.E - MONITORING

5.E.1 5.E.1.1

DIASCAN™ Monitoring System General The DIASCAN™ Monitoring System allows real time, non-invasive and automatic monitoring of patients and dialyser parameters that can be computed from conductivity measurements on the dialysate side. The clinical purpose of this monitoring is to provide a measure of dialysis efficacy for quality control purposes. The basic principle of this monitoring system is to periodically measure, during the dialysis treatment, the dialysate conductivity at the hemodialyser outlet, following an adjustment of the inlet dialysate conductivity. During the measurement, the inlet conductivity is automatically adjusted by 1.0 mS/cm for 2 minutes. As a result of this increment in conductivity, a mathematical model computes several parameters relevant to the dialysis process: − The IONIC CLEARANCE: Average Clearance of ionized substances; this value is strongly correlated to Urea Clearance. This is a relevant parameter of the clearance actually obtained from the patient, since it includes effects of fistula recirculation and ultrafiltration rate on solute removal during dialysis. − The Plasma Conduct: An expression of the effective plasma ionic concentration. This is a factor that governs the intra/extra cellular fluid shifts. (The Plasma Conduct value is displayed in the PROFILE\Cond view if the DIASCAN USE parameter is set to YES). Three other parameters are derived from the IONIC CLEARANCE: 1) The Depurated Vol: The volume of body water completely cleared of solute during the treatment, with reference to small molecular weight solutes. The computation is based on repeated Clearance measures and on the assessment of the effective dialysis time. This parameter allows the clinician to determine if the prescribed dialysis dose (which is influenced by different factors such as dialysate flow and blood flow, type of dialyser and time) has been achieved. 2) The KT/V: This value is computed by dividing the Depurated Vol by the Volume of Distribution (DISTRIB VOLUME), which is to be established by the clinician, according to the patient’s dry weight and the ratio of the Total Body Water to Patient Weight. This parameter allows the clinician to understand if the dialysis dose that has been achieved is adequate for the patient. 3) The Ionic Mass Bal: This estimation is based on the continuous dialysate outlet conductivity measurement, for each patient. It correlates to the sodium mass balance. (The Ionic Mass Bal value is displayed in the PROFILE\Cond view if the DIASCAN USE parameter is set to YES).

Rev. B

5.E-2

PHOENIX OPERATOR MANUAL WARNING DIASCAN™ is automatically disabled if: • Dialysate Flow Rate is set to a value lower than or equal to 450 ml/min by the operator Or • Dialysate Flow Rate is set to a value greater than 750 ml/min by the operator Or • The patient connection is performed before the completion of the initial autocalibration. Or • A Fast Recovery of the Dialysis process is performed In such cases DIASCAN™ is inactivated (OFF) for the remainder of the treatment.

WARNING DIASCAN™ measurements are not performed if the blood flow is ≤ 80 ml/min.

WARNING For this software version, the accuracy of the DIASCAN™ Monitoring System is not guaranteed in the SINGLE NEEDLE mode.

WARNING The KT/V computation is based on two parameters: DRY WEIGHT and DISTRIB VOLUME, which must be entered and confirmed by the operator. It is the operator’s responsibility to assess the clinical validity of these parameters.

WARNING The physician is responsible for the clinical adequancy of the parameters set for the correct dialysis dose, based upon the Diascan measurements. Do not use a single Diascan measurement as the only source of clinical information to initiate therapeutic or pharmacologic actions (e.g. change in blood flow rate, dialysate flow rate, dialyser, treatment time, etc...), as unstable operating conditions during a single DIASCAN measurement may result in an artefact in the values computed from the individual reading. Therefore, any changes in the dialysis prescription made on the basis of Diascan analysis should be made in consideration of at least two consecutive readings.

Rev. B


DIASCAN™ Characteristics IONIC CLEARANCE

PLASMA CONDUCT

IONIC MASS BAL

13 - 17 mS/cm

-500 - 800 mmol(o)

0 - 200

Measure

50 - 300 ml/min

Accuracy

±7 ml/min

± 0.2 mS/cm

-

2 liters (oo)

-

1 ml/min

0.01

1mmol

0.1 liters

0.01

Range of

DEPURATED VOL

KT/V 0-3

liters

(Std. Err.) Resolution

mS/cm (o) (oo)

Positive values correspond to solutes removed from the patient. Accuracy Standard Error for a 4 hour dialysis.

Rev. B

5.E-3

5.E-4


5.E.1.2

Parameters

Selectable Parameters Unit

Incr.

Max.

Min.

Default

DIASCAN USE

-

-

YES

NO

NO

DIASCAN

-

-

YES

NO

NO

CLEARANCE ALA.

-

-

YES

NO

NO

CLEARANCE LEVEL

ml/min

5

300

50

150

DRY WEIGHT

Kg

0.5

200

8

60

DISTRIB VOLUME

%

1

80

20

55

INTERMEASUREM

h:min

0:15

1:00

0:00

0:30

TARGET KT

l

1

200

0

40

TARGET KT/V

-

0.05

3.00

0

1.30

TARGET Kt/V THRESH

%

5

100

0

0

TARGET Kt/V Reached

-

-

YES

NO

NO

DIASCAN USE Set the DIASCAN USE parameter to YES to enable the DIASCAN™ device. This parameter must be set to YES to utilize DIASCAN. In the IDLE mode, press the Config\Machine\Accessories Navigation keys. Enter the SET Mode and select the DIASCAN USE Parameter Box on the Touch Screen. Then select either the YES or NO Parameter Box and press the CONFIRM button.

DIASCAN Select the DIASCAN parameter to turn the DIASCAN function OFF or ON. It can be set by pressing: • The Config\KT/V Navigation keys, in Standard Dialysis. • Or the Rx Config Navigation keys, then selecting one of the seven personalised dialysis sessions (Patient/RX Action keys), in Patient dialysis, and entering in the Rx Config\kT/V view. The DIASCAN function may be turned OFF also after the start of the treatment in SET Mode. When the DIASCAN parameter is set to YES, the following parameters can be set:

CLEARANCE ALA. This alarm may be programmed ON or OFF. If the CLEARANCE ALA parameter is turned ON, an alarm is triggered if the IONIC CLEARANCE falls below the value set for the CLEARANCE LEVEL parameter. The default setting for the CLEARANCE ALA. is NO.

Rev. B


5.E-5

CLEARANCE LEVEL The CLEARANCE LEVEL parameter may be SET to a value between 50 ml/min to 300 ml/min. If the computed Clearance falls below this value, and if the CLEARANCE ALA. parameter is SET to YES, a CLEARANCE ALA. will occur. The default value for CLEARANCE LEVEL is 150 ml/min.

DRY WEIGHT The DRY WEIGHT value is used in the calculation of KT/V. This value is entered by the clinician within a range of 8 kg to 200 kg. The default value for DRY WEIGHT is 60 kg.

DISTRIB VOLUME (Volume of Distribution) The DISTRIB VOLUME value is used in the calculation of KT/V. The value is entered by the clinician as a percentage of the patient’s DRY WEIGHT. The input range for DISTRIB VOLUME is from 20% to 80%. The default value is 55.

INTERMEASUREM The INTERMEASUREM value defines the time interval between two DIASCAN measurements. Possible SET values are: • 0:00 No automatic measurements are triggered (manual mode) • 0:15 A measurement is performed every 15 minutes (if Profiling mode is set to NO) • 0:30 A measurement is performed every 30 minutes • 0:45 A measurement is performed every 45 minutes (if Profiling mode is set to NO) • 1:00 A measurement is performed once an hour. The default value is 0:30

TARGET KT The TARGET KT value defines the volume of body water to be purified during DIALYSIS. The TARGET KT parameter is available only if the DIASCAN parameter is set to YES. It may be SET to a value between 0 l to 200 l When the FORECAST kT, estimated by the machine, is lower than a percentage of the TARGET KT value, the “Forecast Dial. dose not match Prescrip.”#354 alarm will occur informing the operator that the FORECAST kT will not meet the prescribed Kt. The TARGET Kt/V THRESH may be set to enable the occurrence of the “Forecast Dial. dose not match Prescrip.”#354 alarm by entering the expected percentage of TARGET KT in the TARGET Kt/V THRESH parameter box. Once the Depurated Volume is greater than or equal to a percentage of the TARGET KT value and the TARGET Kt/V Reached parameter is set to YES, the “Kt-Kt/V Target Achieved”#355 alarm will occur. The TARGET KT/V THRESH may be set to enable the occurrence of the “Kt-Kt/V Target Achieved”#355 alarm by entering the minimum accettable percentage of TARGET KT in the TARGET Kt/V THRESH parameter box. The TARGET KT value has to be confirmed/entered to allow the “Kt-Kt/V Target Achieved”#355 alarm occurrence. The default value for TARGET KT is 40 l.

Rev. B

5.E-6


TARGET Kt/V The TARGET KT/V value defines the Dialysis Dose to be achieved during DIALYSIS. The TARGET KT/V parameter is available only if the DIASCAN parameter is set to YES. It may be SET to a value between 0 to 3.00. The TARGET KT/V parameter box will appear after the DRY WEIGHT and DISTRIB VOLUME have been entered and confirmed for the treatment. When the FORECAST kT/V, estimated by the machine, is less than a percentage of the TARGET KT/V value, the “Forecast Dial. dose not match Prescrip.”#354 alarm will occur informing the operator that the FORECAST kT/V will not match the prescribed Kt/V. The TARGET KT/V THRESH may be set to enable the occurrence of the “Forecast Dial. dose not match Prescrip..”#354 alarm by entering the expected percentage of TARGET KT in the TARGET Kt/V THRESH parameter box. Once the KT/V is greater than or equal to the set percentage of the TARGET KT/V value and the TARGET Kt/V Reached parameter is set to YES, the “Kt-Kt/V Target Achieved”#355 alarm will occur. The TARGET Kt/V THRESH may be set to enable the occurrence of the “Kt-Kt/V Target Achieved”#355 alarm by entering the minimum accettable percentage of TARGET KT in the TARGET Kt/V THRESH parameter box. The TARGET KT/V value has to be confirmed/entered to allow the “Kt-Kt/V Target Achieved”#355 alarm occurrence. The default value for TARGET KT/V is 1.30.

TARGET Kt/V THRESH The TARGET Kt/V THRESH parameter is available only if the DIASCAN parameter is set to YES. It may be set to a value between 0 to 100%. This value is set to activate the “Forecast Dial. dose not match Prescrip.”#354 alarm. The default value for TARGET Kt/V THRESH is 0%.

TARGET Kt/V Reached The “Kt-Kt/V Target Achieved”#355 alarm may be programmed ON or OFF. When the TARGET Kt/V Reached parameter is set to YES, the #355 alarm is triggered once the alarm conditions for this alarm occurrence are reached. The default value for TARGET Kt/V Reached parameter is NO.

Note DIASCAN™ can be de-activated at any time, for the current dialysis treatment, by pressing the kT/V Navigation key. Enter the SET Mode and select the DIASCAN Parameter Box on the Touch Screen, then select NO and press the Confirm button. If the DIASCAN Parameter is set to NO, it is not possible to activate DIASCAN again after Dialysate Preparation is complete.

Note The KT/V value will be displayed only if a valid number for DISTRIB VOLUME is present and the DRY WEIGHT of the patient has been confirmed.

Note If the INTERMEASUREM parameter is set to 0:15, 0:30, 0:45 or 1:00, no additional manual measurements are allowed.

Rev. B


5.E.1.3

5.E-7

Initial Auto-Calibration At the beginning of each treatment, at the end of the conductivity T1 TEST phase, DIASCAN™ Monitoring System starts an Auto-Calibration Process, which is indicated by a flashing DIASCAN™ icon. The goal of this Auto-Calibration is to the proper functioning of the conductivity measuring system. The initial Auto-Calibration consists of measuring the outlet conductivity at two different conductivity set points: 14 mS/cm and 16 mS/cm. During Auto-Calibration, the conductivity is increased, first, to 14 mS/cm for 90 seconds (on average) and then is increased to 16 mS/cm again for 90 seconds to complete Diascan autocalibration. The Auto-Calibration Process is signaled by the DIASCAN icon flashing and by the message “DIASCAN Autocalibration in Progress...” displayed on the screen together with a progress bar informing that the DIASCAN autocalibration is in progress.

Note If you disable Diascan during the Auto Calibration procedure, the “Diascan Initial Calibration Failed ” #244 alarm may occur. In this case, switch OFF the machine, wait 5 seconds, then switch ON the machine again.

At the end the Auto-Calibration, two results are possible: − If the alignment is completed successfully, the DIASCAN icon stops flashing and the DIASCAN™ Monitoring System is ready for use. − If the alignment cannot be properly completed, the DIASCAN icon becomes dotted and the message "Diascan Initial Calibration Failed" will be displayed. This message can be canceled by pressing the OVERRIDE button. In case of a failure of the Auto-Calibration, disable the DIASCAN™ Monitoring System by pressing kT/V Navigation key. Enter the SET Mode. Select the DIASCAN Parameter Box on the Touch Screen. Then select NO and press the CONFIRM button.

Note The initial Auto-Calibration Procedure is only required to the correct functioning of the DIASCAN™ Monitoring System. Failure of the procedure does not affect the dialysis treatment.

Note If the “Diascan Initial Calibration Failed” #244 alarm occurs frequently during the initial Auto-Calibration Procedure, call for Service.

Note Following selection of a NEW SESSION Action key, an initial Auto-Calibration Procedure is not repeated. An Auto-Calibration Procedure will only be performed after the NEW SESSION Action Key is selected if the Auto-Calibration failed during the previous dialysis session.

Note If the Patient Sensor detects BLOOD prior to the end of the Auto-Calibration Procedure, the DIASCAN Monitoring System is automatically disabled and its icon becomes dotted.

Rev. B

5.E-8


5.E.1.4

MEASUREMENTS The measurement of Plasma Conduct and IONIC CLEARANCE is automatically triggered at the frequency selected in the INTERMEASUREM parameter. During the entire time of the measurement (about 7 min), the final conductivity is controlled by the DIASCAN™ Monitoring System and the is not allowed to change the conductivity. This measurement phase is indicated by a flashing DIASCAN icon.

Note In order to ensure that DIASCAN™ functions correctly, increases in conductivity of greater than 2 mS/cm should be avoided, both in Manual and PROFILE mode.

Note The DIASCAN™ measurement will fail if there are any modifications to either of the following parameters during the measuring period: − blood flow rate − dialysate flow rate To ensure an accurate measurement it is recommended that modifications in these parameters are not performed within 2 minutes of the next DIASCAN measurement.

Note A DIASCAN™ measurement will also be interrupted by any manual or automatic by condition, such as the BY or UF ONLY key, or the occurrence of an alarm that causes the machine to go into BY.

Note The can stop a measurement in progress or switch OFF the DIASCAN™ Monitoring System at any time without any consequence to the dialysis treatment.

Note If DIASCAN™ is switched OFF in the Config view or in the Rx Config view, the DIASCAN view in the kT/V menu (selected by pressing kT/V Navigation key) will disappear. If DIASCAN™ is switched OFF in the DIASCAN view (selected by pressing kT/V and then the Set button) this will cause the DIASCAN icon to disappear, and measurements will not be executed.

Rev. B


Problem

Possible cause/solution

A manual measurement was requested but the icon did not start to flash.

Proper conditions for a measurement do not exist. that the set-values for blood and dialysate flow rates are within the operating range for the DIASCAN and wait for the correct hydraulic condition.

The icon is dotted.

DIASCAN™ failed the initial auto-calibration. Clean the DIASCAN™ probe by performing a Descaling procedure. The dialysate flow rate is set to a value outside of the proper operating range. Set the dialysate flow rate to a correct value.

All the DIASCAN parameters in the kT/V view are “---”.

No measurements have been performed. Perform at least one manual measurement or wait for the first automatic measurement. No values have been inserted/confirmed for the parameters DRY WEIGHT and DISTRIB VOLUME. Insert/confirm a value for DRY WEIGHT and DISTRIB VOLUME.

DIASCAN parameters are not displayed in SET view even if the Diascan function is enabled (DIASCAN parameter set to YES in CONFIG).

If noticed before starting treatment, when these parameters may have to be modified, switch OFF the machine, wait 5 seconds and switch ON the machine.

Rev. B

5.E-9

5.E-10 PHOENIX OPERATOR MANUAL

5.E.1.5

Operator Interface

DIASCAN Icons If the DIASCAN parameter is set to YES, an icon will appear on the Touch Screen. The possible icons relating to the DIASCAN™ Monitoring System are listed below: • DIASCAN active (IDLE) • DIASCAN calibrated (TREATMENT)

• DIASCAN present but Auto-Calibration failed

Note The DIASCAN active icon flashes during both the initial Auto-Calibration and every measurement.

KT/V MENU In TREATMENT, both during the Standard dialysis and during the Patient/RX dialysis, when the Kt/V Navigation key is selected, the main view of the Kt/V environment is entered. By pressing the Kt/V Navigation keys it is possible to see the Clearance graph.

12:30 -- / ---- / ---mmHg

---

pu/min

DIASCAN MEAS STOP MEASURE

VEN

ART

BLOOD FLOW DEPURATED VOL6.1 L FORECAST KT 26 L TARGET KT 150 l

BLOOD FLOW

KT/V

Rev. B

e

Time

ClkTime

KT/V 0.14 FORECAST KT/V TARGET KT/V Thres

Kurea

B Flow

1.2 2.00

f


5.E-11

Note After confirming the DISTRIB VOLUME and DRY WEIGHT parameter values, the TARGET KT parameter disappears and the TARGET KT/V, KT/V and FORECAST kT/V parameters becomes available in the kT/V view.

If the INTERMEASUREM parameter is set to 0:00, the DIASCAN MEAS Action key is present and allows the manual initiation of a DIASCAN measurement. During every measurement, the STOP MEASURE Action key is present to allow an interruption of the DIASCAN measurement.

Note If the INTERMEASUREM parameter is set to 0:15, 0:30, 0:45 or 1:00 the DIASCAN MEAS Action key is not available.

From the kT/V view is possible to see: • The graph of the CLEARANCE measurements (YELLOW line). • The graph of the B Flow (blood flow value) (BLUE line). • The graph of the CLEARANCE LEVEL alarm threshold (RED line). If the CLEARANCE ALA. parameter is set to YES, so the alarm threshold is active, a “DIASCAN: LIMIT LOW CLEARANCE” #249 alarm occurs when the Clearance value falls below this threshold. The CLEARANCE ALA. parameter can be activated (set to YES) or deactivated (set to NO) for the dialysis treatment; when it is deactivated, the graph of the CLEARANCE LEVEL alarm threshold is shown as a RED line on the “Time” line (CLEARANCE LEVEL low limit line). Entering the kT/V view a green cursor is positioned on the last DIASCAN measurement. Pressing the Function Bar Arrows (positioned on the lower part of the window) moves the position of the green cursor on the Clearance graph, in correspondence to the DIASCAN measurements.

Note To prevent problems in the Clearance graph visualization, do not press simultaneously the two Function Bar Arrows.


The Function Bar displays the following values at the point in time at which the green cursor is positioned on the graph: • The time into treatment (Time) • The clock time (ClkTime) • The CLEARANCE LEVEL alarm threshold (Thres) • The Clearance value (Kurea) • The blood flow value (B Flow) The “Time” value is calculated starting from the DIALYSIS Action key selection.

Rev. B

5.E-12 PHOENIX OPERATOR MANUAL In the kT/V view the following values related to the last DIASCAN measurement, are also displayed: • Depurated Vol. • FORECAST: The volume of body water completely cleared of solute during the treatment, estimated on the current Clearance value and the DIALYSIS TIME set. • TARGET KT: The volume of body water to be purified during the treatment. • KT/V. • FORECAST kT/V: calculated with the following formula: FORECAST Kt/V =

•

FORECAST Kt DISTRIB VOLUME × DRY WEIGHT

TARGET KT/V: Dialysis Dose to be achieved during the treatment.

Note The KT/V, TARGET KT/V and the FORECAST kT/V values are not displayed if the DISTRIB VOLUME and DRY WEIGHT parameters are not confirmed in Set Mode.

After pressing the Set button the following view is displayed, where all the DIASCAN relevant parameters may be set:

12:30

DIASCAN

CLEARANCE ALA.

DISTRIB VOLUME

INTERMEASUREM

TARGET KT

TARGET Kt/V THRESH

CLEARANCE LEVEL

DRY WEIGHT

TARGET KT/V

KT/V

Note If confirming the DISTRIB VOLUME and DRY WEIGHT parameter values, the TARGET KT parameter disappears and the TARGET KT/V parameter becomes available.

Rev. B

5.F-1

SECTION 5.F - CLEAN DIALYSATE SYSTEM

5.F CLEAN DIALYSATE 5.F SECTION 5.F - CLEAN DIALYSATE System

5.F.1 General The purpose of the Clean Dialysate System is to purify the dialysate before its use in the dialyser. The patient’s risk of exposure to bacteria and endotoxin can thereby be minimized. The Clean Dialysate System has been expressly designed to be used with the DIACLEAR Ultrafilter. If any defects in the Ultrafilter are detected, an alarm occurs.

Note It is recommended that the Ultrafilter is replaced following the maximum dialysis session directions provided in the DIACLEAR Instructions for Use.

Note If the machine is stored for more than a week, replace the DIACLEAR Ultrafilter before using the Clean Dialysate feature again.

Note When the DIACLEAR Ultrafilter is used, the temperature in the dialyser may be 0.3 - 0.5°C lower than the displayed temperature.

WARNING When the Ultrafilter has been installed, an ADR: RINSING must be performed.

Rev. B

5.F-2


5.F.2 Ultrafilter information CAUTION This information must be read before the use of the DIACLEAR Ultrafilter. Operational warnings and cautions appear in the appropriate sections of the text to help ensure a safe and effective treatment.

INDICATIONS Bacterial contamination of dialysate has frequently been observed and may induce fever and inflammatory reactions in dialysis patients. Ultrafiltration with the DIACLEAR Ultrafilter is indicated for purification of dialysate to obtain microbiologically high quality dialysate. The risk of exposure to bacteria and endotoxin may therefore be minimized.

SPECIFICATIONS For the Ultrafilter specifications, physical characteristics, materials, performance and limits of use, refer to the DIACLEAR Instructions for Use.

RECOMMENDATIONS

WARNING For the disinfection of the Ultrafilter it is mandatory to use only the chemical agents recommended in the DIACLEAR Instructions for Use. They are also compatible with the PHOENIX Haemodialysis System. The maximum concentration allowed for the disinfectant used is: 6% Sodium Hypochlorite 4% Peracetic acid 40% Formaldehyde 100% Instrunet 100% Steridial Refer to the DIACLEAR Instructions for Use. Some solvents and other chemical products used for cleaning can damage the DIACLEAR Ultrafilter: refer to the DIACLEAR Instructions for Use for the list of prohibited products.

ADVERSE REACTIONS Refer to the DIACLEAR Instructions for Use.

Rev. B

5.F-3


5.F.2.1

DIACLEAR Instruction for Use

CAUTION Make certain that the procedures outlined in this Operator Manual are carefully reviewed before the DIACLEAR Ultrafilter is used on a PHOENIX Haemodialysis System that is equipped with the Clean Dialysate feature. Aseptic technique must be employed when installing the DIACLEAR Ultrafilter to avoid contamination of the fluid pathway. Prime the DIACLEAR Ultrafilter following the Instructions for Use described below, to ensure that the system is completely purged of air. Introduction of air into the DIACLEAR during its use may cause an increased pressure drop and subsequent alarms on the PHOENIX machine. Should the physician in charge decide to use the DIACLEAR for multiple uses, it is imperative to use a chemical disinfectant that is recommended in the DIACLEAR Instructions for Use and that is also compatible with the PHOENIX machine. The instructions supplied by the manufacturer for the chemical disinfectant must be strictly followed. The microbiological quality of the system must be validated by the dialysis facility in order to demonstrate that the disinfection process is effective. Conditions of disinfection and rinsing after the first use are the responsibility of the prescribing physician.

PROCEDURES This section describes the use of the DIACLEAR Ultrafilter when installed on a PHOENIX machine, equipped with the Clean Dialysate feature.

Rev. B

5.F-4


5.F.3 Installation of the DIACLEAR Ultrafilter on a machine equipped with the Ultrafilter By connector WARNING The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the IDLE view. Following DIACLEAR installation, it is mandatory to perform an ADR: RINSING to prime the DIACLEAR.

Note Before installing the DIACLEAR Ultrafilter, that a Rinsing has been performed as latest process in order to avoid the presence of chemical residues in the lines.

Setup Instructions • Before installing the DIACLEAR Ultrafilter, ensure that the ULTRAFIL. USE parameter is set to YES in Config/MACHINE/OPTION view. • Switch Off the machine. • Identify the Ultrafilter By connector version present on the machine. Refer to the figure below to identify the Old or the New version.

Old version

New version

• If the machine is provided with the old version of the Ultrafilter By connector: refer to the “5.F.3.1 Removal of the Ultrafilter By connector (old version)” paragraph, then proceed with the installation of the DIACLEAR Ultrafilter as described in the “5.F.3.2 Installation of the DIACLEAR Ultrafilter” paragraph. • If the machine is provided with the new version of the Ultrafilter By connector: refer to the “Appendix C,” “C.1 Disconnection of the three Ultrafilter By connector lines” section then proceed with the installation of the DIACLEAR Ultrafilter as described in the “5.F.3.2 Installation of the DIACLEAR Ultrafilter” paragraph.

Rev. B

5.F-5


5.F.3.1 Removal of the Ultrafilter By connector (old version) •

Before disconnecting the three Ultrafilter By connector lines, clamp them in order to prevent any possible spillage of water (see Fig. 1).

Fig. 1

Rev. B

5.F-6


Disconnection of the Deaeration Line (line connected to the upper Ultrafilter By connector port) • Disconnect the Deaeration Line (see Fig. 2) from the upper Ultrafilter By connector port by unscrewing the Luer lock from the threaded locking nut (turn the Luer lock counter clockwise while holding the threaded locking nut in place).

Deaeration Line Luer lock

Threaded locking nut

Fig. 2

Disconnection of the Filtrate Outlet Line (line connected to the middle Ultrafilter By connector port) • Press the Filtrate Outlet Line’s pinch safety clip springs (see Fig. 3) then unhook the Filtrate Outlet Line pinch safety clip from the middle Ultrafilter By connector port, keeping firmly the Ultrafilter By connector.

Pinch safety clip springs

Fig. 3

Rev. B

5.F-7


• Disconnect the Filtrate Outlet Line from the middle By connector port (see Fig. 4).

Filtrate Outlet Line

Fig. 4

Disconnection of the Dialysate Inlet Line (line connected to the lower Ultrafilter By connector port) • Disconnect the Dialysate Inlet Line (see Fig. 5) from the lower Ultrafilter By connector port by unscrewing the Luer lock from the threaded locking nut (turn the Luer lock counter clockwise while holding the threaded locking nut in place).


Luer lock Dialysate Inlet Line Fig. 5

Removal of the Ultrafilter By connector • Remove the Ultrafilter By connector from its holder and store it for a further use.

Rev. B

5.F-8


5.F.3.2 Installation of the DIACLEAR Ultrafilter WARNING The DIACLEAR Ultrafilter MUST be installed when the PHOENIX machine is in the IDLE view. Following DIACLEAR installation, it is mandatory to perform an ADR: RINSING cycle to prime the DIACLEAR Ultrafilter before entering a DISINFECTION cycle or a DIALYSIS phase.

Installation of the DIACLEAR Ultrafilter • Remove the DIACLEAR Ultrafilter from the package. • Place the DIACLEAR Ultrafilter in the two fixing clips present on the machine upper rear (the blue cap must be upwards). • Remove the three caps (without throwing them away) from the DIACLEAR Ultrafilter ports corresponding to the Deaeration Outlet Port, to the Filtrate Outlet Port and to the Dialysate Inlet Port (see Fig. 1). Deaeration Outlet Port

Filtrate Outlet Port

Dialysate Inlet Port Fig. 1

Note Do not throw the three DIACLEAR Ultrafilter caps away, because they will be used during the removal of the DIACLEAR Ultrafilter, as described in the 5.F.4.1 “Removal of the DIACLEAR Ultrafilter” paragraph.

Rev. B

5.F-9


Connection of the Deaeration Line • Insert the Deaeration Line’s Luer lock into the Deaeration Outlet Port. • Screw all the way the Deaeration Line’s Luer lock to the Deaeration Outlet Port of the DIACLEAR Ultrafilter. • Ensure that the Deaeration Line is not twisted or kinked (see Fig. 2).

Luer lock

Deaeration Line

Fig. 2

Connection of the Filtrate Outlet Line • Spray the Filtrate Outlet Port of the DIACLEAR Ultrafilter with Ethyl Alcohol. • Fully insert the Filtrate Outlet Line into the Filtrate Outlet Port. • Hook the Filtrate Outlet Line pinch safety clip to the Filtrate Outlet Port (see Fig. 3). Pinch clip

safety


Fig. 3

Rev. B

5.F-10 PHOENIX OPERATOR MANUAL

Connection of the Dialysate Inlet Line • Insert the Dialysate Inlet Line’s Luer lock into the Dialysate Inlet Port. • Screw all the way the Dialysate Inlet Line’s Luer lock to the Dialysate Inlet Port of the DIACLEAR Ultrafilter. • Ensure that the Dialysate Inlet Line is not twisted or kinked (see Fig. 4).

Dialysate Inlet Line Luer lock

Fig. 4 • Ultrafilter After Ultrafilter lines connection, remove the clamps from the three DIACLEAR Ultrafilter lines, if they have been clamped (see Fig. 5).

Fig. 5 • Perform a Rinsing procedure to prime the DIACLEAR Ultrafilter.

Rev. B

5.F-11


5.F.4 Installation of the Ultrafilter By connector on a machine equipped with the DIACLEAR Ultrafilter. WARNING The Ultrafilter By connector MUST be installed when the PHOENIX machine is in the IDLE view. When an Ultrafilter By connector has been installed, it is mandatory to perform a disinfection cycle, before entering a DIALYSIS phase.

Note It is recommended to replace the DIACLEAR Ultrafilter following the dialysis session directions provided in the DIACLEAR Ultrafilter Instructions for Use.

WARNING The following operations must be performed when the machine is in the IDLE view.

5.F.4.1 Removal of the DIACLEAR Ultrafilter Before installing the Ultrafilter By Connector, ensure that the ULTRAFIL. USE parameter is set to NO in Config/MACHINE/OPTION view. Before disconnecting the Ultrafilter lines, clamp the Deaeration Line, the Filtrate Outlet Line and the Dialysate Inlet Line connected to the DIACLEAR Ultrafilter, in order to prevent any spillage of water. Follow the instructions below to disconnect the three Ultrafilter lines:

Disconnection of the Deaeration Line • Disconnect the Deaeration Line from the DIACLEAR Ultrafilter Deaeration Outlet Port, by unscrewing the Deaeration Line’s Luer lock from the DIACLEAR Ultrafilter Deaeration Outlet Port. • Close the DIACLEAR Ultrafilter Deaeration Outlet Port by capping it.

Disconnection of the Filtrate Oulet Line • Press the Filtrate Outlet Line pinch safety clip springs then unhook the pinch safety clip from the DIACLEAR Ultrafilter Filtrate Outlet Port. • Disconnect the Filtrate Outlet Line from the DIACLEAR Ultrafilter Filtrate Outlet Port. • Close the DIACLEAR Ultrafilter Filtrate Outlet Port by capping it.

Disconnection of the Dialysate Inlet Line • Disconnect the Dialysate Inlet Line from the DIACLEAR Ultrafilter Dialysate inlet port, by unscrewing the Dialysate Inlet Line’s Luer lock from the DIACLEAR Ultrafilter Dialysate Inlet Port. • Close the DIACLEAR Ultrafilter Dialysate Inlet Port by capping it.

Rev. B

5.F-12 PHOENIX OPERATOR MANUAL Removal of the DIACLEAR Ultrafilter and Ultrafilter By connector installation • Remove the DIACLEAR Ultrafilter from its holder and throw it away. • Identify the Ultrafilter By connector version to be installed on the machine. Refer to the figure below to identify the Old or the New version.

Old version

New version

• If the old version of the Ultrafilter By connector has to be installed: refer to the “5.F.4.2 Installation of the Ultrafilter By connector (old version)” paragraph for the installation of the old version of the Ultrafilter By connector. • If the new version of the Ultrafilter By connector has to be installed: refer to the “Appendix C”, “C. 2 Connection of the Ultrafilter By connector” section for the installation of the new version of the Ultrafilter By connector.

Rev. B

5.F-13


5.F.4.2 Installation of the Ultrafilter By connector (old version) Follow the instructions below to connect the three Ultrafilter lines to the Ultrafilter By connector.

Connection of the Deaeration Line • Insert the Deaeration Line’s Luer lock into the upper Ultrafilter By connector

port (the Ultrafilter By connector is symmetric, therefore the upper and lower ports are equivalent). • Fix the Deaeration Line’s Luer lock by rotating clockwise the threaded locking nut onto it (see Fig. 1). Deaeration Line


Fig.1

Rev. B


Connection of the Dialysate Inlet Line • Insert the Dialysate Inlet Line’s Luer lock into the lower Ultrafilter By connector

port. • Fix the Dialysate Inlet Line’s Luer lock by rotating clockwise the threaded locking

nut onto it (see Fig. 2).


Dialysate Inlet Line Fig. 2

Connection of the Filtrate Outlet Line • Spray the middle Ultrafilter By connector port with Ethyl Alcohol. • Fully insert the Filtrate Outlet Line onto the middle Ultrafilter By connector

port. • Hook the Filtrate Outlet Line’s pinch safety clip to the middle Ultrafilter By

connector port (see Fig. 3).


Pinch safety clip

Fig. 3 • After having connected the Ultrafilter lines, insert the Ultrafilter By connector

into the lower fixing clip present on the .

Rev. B

5.F-15


• Remove the clamps from the three lines connected to the Ultrafilter By

connector ports (see Fig. 4).

Fig. 4 • Perform a disinfection cycle before starting a dialysis treatment.

Rev. B


5.F.5 Clean Dialysate 5.F.5.1

Priming/Rinsing of the DIACLEAR Ultrafilter After its installation, the DIACLEAR Ultrafilter must be primed by performing an ADR: RINSING cycle. Only after a Rinsing cycle the DIALYSIS treatment can be selected.

Note Rinsing of the DIACLEAR Ultrafilter can only be carried out during an ADR: RINSING cycle of the PHOENIX machine.

• Check that the DIACLEAR Ultrafilter is correctly installed and make sure that the ULTRAFIL. USE parameter is set to YES. • Select ADR: RINSING. Set the RINSING TIME parameter to, at least, 30 min. • In case of alarms during the RINSE cycle, check that the lines are not clamped. • If a line is clamped, unclamp it and perform again the prime (ADR: RINSING) procedure of the DIACLEAR Ultrafilter.

WARNING Avoid tapping the DIACLEAR Ultrafilter too vigorously to remove air as this may cause damage.

WARNING The connection of the DIACLEAR Ultrafilter to the PHOENIX machine must be performed aseptically, so that the fluid pathway is not contaminated. Perform a DISINFECTION procedure before patient connection.

5.F.5.2 Dialysate Preparation, Priming/Rinsing of the dialyser and performing the dialysis treatment • Before selecting DIALYSIS make sure that the DIACLEAR Ultrafilter has been rinsed. • Refer to the Section 5 - Dialysis Operation for instructions on dialysate preparation. Monitoring of the DIACLEAR Ultrafilter related pressures occurs while the PHOENIX machine is operating so that problems may be detected. The alarms, “Ultrafilter Is Packed” (#138) or “Ultrafilter Max Pressure” (#146) occur when there is a high resistance on the dialysate side inside the DIACLEAR Ultrafilter. To correct these conditions, reduce the dialysate flow to 350 ml/min to reduce the pressure. This operation allows the dialysis treatment to be completed (it is necessary to replace the DIACLEAR Ultrafilter at the end of dialysis) when either alarm occurs.

Note The DIACLEAR Ultrafilter can be excluded from the circuit at any time by pushing the BY Action key or the UF ONLY Action key.

Rev. B

5.F-17


5.F.5.3

Changing the DIACLEAR Ultrafilter Note The changing of the DIACLEAR Ultrafilter must be performed following the directions provided in the DIACLEAR Instructions for Use. A new DIACLEAR Ultrafilter must be installed if a “Ultrafilter Max Pressure” alarm or a “Ultrafilter Is Packed” alarm occurs.

WARNING The DIACLEAR Ultrafilter can only be changed when the Phoenix machine is in the IDLE view.

WARNING It is imperative that an ADR: RINSING is performed after each DIACLEAR Ultrafilter installation.

5.F.5.3.1 Installation of a new DIACLEAR Ultrafilter For the installation of a new DIACLEAR Ultrafilter, see paragraph “5.F.3.2 Installation of the DIACLEAR Ultrafilter” in this section.

5.F.5.4 Resetting of the DIACLEAR Ultrafilter Installation parameters Both when installing a new DIACLEAR Ultrafilter and when replacing an used DIACLEAR Ultrafilter, the DIACLEAR Ultrafilter installation parameters must be reset by pressing the CHANGE CLEAN DIAL Action key in the MACHINE view, while the machine is in Idle mode:

CHANGE CLEAN DIAL

POWER DOWN COUNT ABD DIAGNOSTIC ULTRAF PRE INSTALL TIME TREATM NUMBER MACHINE

SERVICE

STATUS

RECORDE CALIBRAT R ION

Rev. B

5.F-18 PHOENIX OPERATOR MANUAL Note The CHANGE CLEAN DIAL Action key is available only in Idle mode and if the ULTRAFIL. USE parameter is set to YES in the Config view.

INSTALL TIME: This parameter totals the days elapsed from the installation of the DIACLEAR Ultrafilter by the operator. After the selection of the CHANGE CLEAN DIAL Action key, the value displayed for this parameter (related to the old DIACLEAR Ultrafilter) is cleared and the machine restarts totalling the days elapsed from the installation of the new DIACLEAR Ultrafilter. • TREATM NUMBER: This parameter totals the number of treatments in which the DIACLEAR Ultrafilter has been used. After the selection of the CHANGE CLEAN DIAL Action key, the value displayed for this parameter (related to the old DIACLEAR Ultrafilter) is cleared and the machine restarts totalling the number of treatments in which the new DIACLEAR Ultrafilter has been used.

WARNING: The is responsible for monitoring the DIACLEAR Ultrafilter working time, by resetting the DIACLEAR Ultrafilter installation parameters each time a new DIACLEAR Ultrafilter is installed/replaced, in order to replace the used DIACLEAR Ultrafilter following the maximum dialysis session directions provided in the DIACLEAR Instructions for Use.

5.F.5.5

Chemical Disinfection and Descaling • Refer to the PHOENIX Operator’s Manual, in Section 6 - Clean/Disinfect, for Disinfection and the Descaling procedures. • Refer to the paragraph “RECOMMENDATIONS” in this section and refer to the

DIACLEAR Instructions for Use for the list of approved disinfection agents.

5.F.5.6

Heat/Heat Citric Disinfection The compatibility of the DIACLEAR Ultrafilter membrane with PHOENIX processes has been validated for both the Heat Disinfect Process and the Heat Citric Disinfect Process. Therefore, each disinfection process that can be executed by the PHOENIX can be executed through the ultrafilter.

Rev. B

5.F-19


5.F.6 PHOENIX Operator Interface 5.F.6.1

Configuration

Parameters Unit

Incr.

Max.

Min.

Default

ULTRAFIL. USE

-

-

YES

NO

NO

ULTRAF PRES

mmHg

10

200

20

100

ULTRAFIL. USE This parameter is used to enable the Clean Dialysate System. The ULTRAFIL. USE parameter must be set to YES in the Config/Machine view in order to allow the other parameters to be displayed. If there is an inconsistency between this parameter and the state of the DIACLEAR Ultrafilter, an alarm will occur.

ULTRAF PRES This parameter measures the difference between the filter inlet and outlet pressures in the ultrafilter membrane during operating conditions. Therefore, in non-operating conditions where fluid es through the membrane, this parameter will be zero since the pressure difference is not significant. This parameter is set in the Config\Machine\Clean Dial. view. When the value set for the parameter is exceeded a warning message appears.

Note The value set for the ULTRAF PRES parameter must be in agreement with the value suggested in the DIACLEAR Instructions for Use.

Note The ULTRAF PRES parameter is displayed on the Machine view, but only if the ULTRAFIL. USE in the Config view is set to YES.

Rev. B


5.F.6.2

Icons If the ULTRAFIL. USE parameter in the Config view is set to YES, a related icon will appear on the icon bar of the Touch Screen. The possible icons relating to the Clean Dialysate process are listed below: Ultrafilter preset and in use.

(Not currently available) Ultrafilter absent or a Switches Error Alarm occurred when ULTRAFIL. USE is set to YES

(Not currently available)

Rev. B

6 CLEAN/DISINFECT 6.

SECTION 6 - CLEAN/DISINFECT

Overview This section contains information about cleaning (internal and external) and disinfection measures that should be performed on the PHOENIX Haemodialysis Delivery System. This information includes: • Description of the ADR (Automatic Disinfection, Rinsing) capabilities of the PHOENIX Haemodialysis Delivery System. • Step-by-step instructions for performing each of the machine’s ADR procedures. • Procedure for cleaning the exterior of the PHOENIX machine and for inspection

and storage of the machine.

Requirements 1. Follow the manufacturer’s instructions when performing ADR procedures. 2. A post-dialyser dialysate sample should be cultured monthly for machine bioburden levels, as per AAMI and CDC guidelines. Follow your facility protocol for collecting and culturing the sample.

Note At the machine installation a post-dialyser dialysate sample should be cultured for machine bioburden levels, as per AAMI and CDC guidelines. Follow your facility protocol for collecting and culturing the sample.

Internal Cleaning and Disinfection Protocol The PHOENIX provides several methods of achieving disinfection of the hydraulic pathway of the system. The choice of which of these methods to use is the responsibility of the facility. The Manufacturer validates the methods suggested based on in-vitro laboratory testing for adequate concentration or temperature distribution to obtain microbial efficacy and hydraulic circuit material compatibility. However, the frequency of disinfection should be based upon allowable bacterial and/or endotoxin limits in water and dialysate, trending of microbiological monitoring results, applicable regulatory requirements and facility practices. Frequency of disinfection or the method used may need to be changed if results do not meet either the facility or regulatory body requirements (if applicable). Testing for residual chemicals must be done prior to patient treatment (see “6.6 Verification of the Absence of Residual Disinfectant” in this section). The PHOENIX can accommodate bleach disinfection as frequently as between each treatment or daily. As a minimum, a daily disinfection (chemical, heat or heat citric) is

recommended. Rev. B

6-2

PHOENIX OPERATOR MANUAL Heat disinfection is also an option, and in addition a deproteinization procedure (for example: bleach) should be done at least two times per week if heat/heat citric disinfection is the primary (between each patient treatment or daily minimum) disinfection method. This is to ensure that any accumulated organic material is periodically removed from the hydraulic pathway. Such material can potentially reduce the effectiveness of a disinfection process. Descaling with vinegar, citric acid or acetic acid is also an important process to periodically perform to remove mineral deposits which can also reduce the effectiveness of the disinfection process. The PHOENIX offers a unique method for protecting the hydraulic pathway from microbial contamination with the preparation of a bacteriostatic level of disinfectant. This can be useful for overnight or weekend storage, and in an acute setting where the time between uses is variable. This procedure is performed by setting the END PROCESS MODE parameter to BACTERIOSTATIC in the Config/ADR/Chemical view and then leaving the machine filled with a dilute (1:750) bleach or sodium hypochlorite solution for a maximum dwell time of one week.

Note It is recommended to alternate the disinfection methods and/or the disinfectants, in order to optimize cleaning, descaling and disinfection of the machine.

Note The test procedure used for verification of the effectiveness of disinfection or sterilisation is available on request.

Rev. B


6-3

Descaling Tables Precipitate Control (Descaling): Following every treatment Chemical Acid Concentrate

White Distilled Vinegar or 5% Acetic Acid

Uptake Concentration ≥ 3 meq/L Acid Content

ADR Cycle Descaling

5% Acetic Acid Content

Descaling

Uptake Site Acid Concentrate connector (white) Acid Concentrate connector (white)

Frequency

Cycle Time

Following every treatment (Bicarbonate dialysis) Following every treatment (Bicarbonate dialysis)

3-5 minutes (Configuration)

3-5 min (Configuration)

Precipitate Control (ADR): Periodic procedures Chemical

Uptake Concentration 5% Acid Content

ADR Cycle Chemical Disinfect

Uptake Site

Frequency

Cycle Time

Rear 1,2, or chemical connector (yellow)

Daily

Chemical Disinfect = 15 min (Configuration)

Acetic Acid

30%

Chemical Disinfect

Twice a week

Citric Acid

See Section Specifications

Heat Citric Disinfect

Rear 1,2, or chemical connector (yellow) Rear 1,2, or chemical connector (yellow)

Chemical Disinfect = 15 min (Configuration) 24 min or 28 min if the DIACLEAR Ultrafilter is installed. (Configuration)

White Distilled Vinegar or 5% Acetic Acid

Daily

Note Cycle Time may be increased for heavy precipitate.

Rev. B

6-4


Disinfection Table Flow Path Disinfection (ADR) Method

Uptake Conc.

Chemical

See the Specifications section.

(See Section Specifications for the disinfectants list)

ADR Cycle Chemical Disinfect

Uptake Site Rear 1,2, or chemical connector (yellow)

Minimum Frequency Daily

Maximum Frequency Following each treatment

Cycle Time

-

Daily (Note 1)

Following each treatment

Daily (Note 1)

Following each treatment

18 min or 36 min if the DIACLEAR Ultrafilter is not installed. 20 min or 40 min if the DIACLEAR Ultrafilter is installed. (Configuration) 24 min or 28 min if the DIACLEAR Ultrafilter is installed. (Configuration)

Heat

-

Heat Disinfect

Citric Acid

See the Specifications section.

Heat Citric Rear 1,2, or Disinfect chemical connector (yellow)

15:00 to 30:00 or 28:00 to 43:00 if END PROCESS MODE is set Bact. (Configuration)

Note 1 A deproteinization procedure (i.e. Bleach) should be performed at least 2 times per week.

Rev. B


6-5

6.1 Disinfection • Select the ADR Selection key on the IDLE view. A new set of Action/Selection keys appear and the ADR schedule is displayed:

12:30

IDLE: SELECT ADR

CHEM PROCESS HEAT

RINSING CCK LINES RINSE

BPM

REPORT

CONFIG

MACHINE

CLOSE

Select CLOSE to return to the IDLE view. The PHOENIX machine is able to perform a variety of ADR procedures. A brief list is as follows:

CHEMICAL DISINFECTION A. Disinfection - front of machine: The uptake of disinfectant is via the Yellow Connector on the front . At completion of the disinfectant tank filling, the Yellow Connector is replaced in its Rinse Port on the front of the machine. This disinfection cycle includes the entire hydraulic circuit. B. Disinfection - rear of machine: Uptake of disinfectant is from the chemical container stored on the rear of the machine. This disinfection cycle includes the entire hydraulic circuit.

Rev. B

6-6


DISINFECTION WITH HEAT (Not available on 12 A version) C. Heat disinfection: Performed by circulating heated water through the hydraulic circuit. D. Heat citric disinfection – front of machine: Performed by using citric acid drawn into the machine via the Yellow Connector attached to the disinfectant container on the front , in combination with circulaton of heated water through the hydraulic circuit. E. Heat citric disinfection – rear of machine: Performed by using citric acid drawn into the machine from the disinfectant container stored on the rear of the machine in combination with circulation of heated water through the hydraulic circuit.

RINSING Fresh RO water flushes the hydraulic circuit.

Rev. B


6-7

6.2 Chemical Disinfection 6.2.1 Disinfection 6.2.1.1 HOW TO PROCEED To perform chemical disinfection: • Press the CHEM PROCESS Selection key. The control of the process continues by displaying the next view: 12:30

SELECT CHEMICAL

CHEM PERS 1 CHEM PERS 2 CHEM PERS 3 CHEM PERS 4


BPM

REPORT

MACHINE

CLOSE

Note CHEM PERS 1 TO 4 represent the four customized chemical disinfection selections available. Selections made in the Config\ Chemical view allow a different set of parameters for each chemical disinfection selection.

Note Selection of the CHEM+CENTRAL BICARB LINE Action key initates the Central Concentrate Lines Disinfection process. Refer to Section 03 - CENTRAL CONCENTRATE SUPPLY, for the complete description of this process. This section describes only the chemical disinfection process when selecting CHEM PERS 1 TO 4.

Rev. B

6-8


6.2.1.1.1

List of Parameters and their meanings

When the customized chemical disinfection type is selected a new view with the corresponding parameters appears.

Note Each customized chemical disinfection type could have a specific set of parameters different from the others.

The number of parameters that appears on this view depends on the selections made in the Config\ CHEM PROCESS \Chemical selection view. A brief list of the possible parameters follows: DISINF TIME: The default value for this parameter is the lowest value necessary to ensure disinfection of the machine when an approved disinfectant is used (see Section 9 – Specifications, in this manual). The operator may therefore accept this time or increase it. pH Min and pH Max: these parameters appear only if the parameter pH MONITOR on the Config\ADR\CHEM PROCESS view is set to YES. During the process an alarm is triggered when the pH value is outside the range selected by the operator for the two parameters. RINSING TIME: when this parameter is set to a value between 15 min and 50 minutes, a rinsing phase is automatically performed, unless the disinfection procedure is stopped. When the END PROCESS MODE parameter is set to Bact. or None, the rinsing process is not performed automatically. AUTO OFF: if NO is selected, the machine returns to the IDLE view at the end of the process, if YES is selected, the machine turns OFF automatically. END PROCESS MODE: this parameter may be set on the Config\ADR\Chemical \Chemical selection view. When this parameter is set to None, at the end of the chemical disinfection process, the machine returns to the IDLE phase. When this parameter is set to Bact., at the end of the chemical disinfection, the machine is left filled with a dilute bleach or sodium hypochlorite solution. In this case a Bacteriostatic Disinfection is performed. When this parameter is set to Rins., at the end of the chemical disinfection process, the machine performs a RINSING process for the time set for the parameter RINSING TIME. LIQUID INLET: This parameter specifies the line through which the uptake of disinfectant is performed. This parameter can be set to FRONT, REAR 1 or REAR 2, only if the EXTERNAL JUG USE parameter is set to YES in the Config/Mach.Conf view. When set to YES, the EXTERNAL JUG USE parameter allows the machine to uptake disinfectant from the chemical connector (yellow) on the FRONT of the machine or from REAR 1 or REAR 2 at the back of the machine. When set to NO the internal disinfectant tank is filled by drawing disinfectant from the Yellow Connector on the front of the machine. To change the parameter selection press the SET button.

Rev. B


6-9

6.2.1.2 HOW TO START THE PROCESS This procedure depends upon the selection of the parameters EXTERNAL JUG USE and LIQUID INLET:

EXTERNAL JUG USE: NO LIQUID INLET: FRONT

• Disconnect the Yellow Connector from its Rinse Port on the lower front of the machine and connect it to the Yellow Wand. Immerse the Yellow Wand into the disinfectant container. • Check that the Concentrate Connectors (white and blue) are in their correct position in their Rinse Ports on the lower front of the machine. The BiCart Holder must be in the rinse position, with the BiCart Holder Arms closed.

EXTERNAL JUG USE: YES LIQUID INLET: FRONT


EXTERNAL JUG USE: YES LIQUID INLET: REAR 1/ REAR 2

• Ensure that the disinfectant connector (present on the rear of the machine) is correctly inserted in the disinfectant container located on the rear of the machine. Also that there is enough liquid to perform a disinfection procedure. • Check that the all connectors (white, blue and yellow) are inserted in their Rinse Ports on the lower front of the machine. The BiCart Holder must be in the rinse position, with the BiCart Holder Arms closed.

Select the appropriate Chemical Action key. The following view is displayed: 12:30

ADR PROGRESS

BPM

REPORT

DISINF TIME

RINSING TIME

min:s

min:s

END PROCESS MODE

AUTO OFF

PH VALUE

LIQUID INLET

MACHINE

CLOSE

Rev. B

6-10 PHOENIX OPERATOR MANUAL Note After selection of the type of chemical disinfection, the corresponding name appears highlighted in the status area.

The machine uptakes approximately 180 ml of disinfectant to fill an internal tank.

Note If any problems occur while the disinfectant is being taken up into the internal tank, the machine will automatically empty and refill the tank. An Operator Message will appear:


If LIQUID INLET is set to FRONT at the completion of disinfectant uptake, the following alarm message is displayed: Disinf Connector Position with an audible alarm (#47). • Reinsert the Yellow Connector into its Rinse Port. The alarm will automatically clear and the disinfection procedure will restart. The current disinfection process begins disinfection of the hydraulic circuit of the machine.

Rev. B


6-11

6.2.2 Chemical Disinfection Process in progress The value of the DISINF TIME parameter automatically decreases as the process proceeds. Disinfection stops: − When the time value set for the DISINF TIME parameter is elapsed. − When the machine goes into an alarm condition during an ADR process and the operator takes no action, the machine will automatically turn OFF after 30 minutes following completion of the DISINF TIME or RINSING TIME. − When the CLOSE Action key is selected. If the CLOSE Action key is pressed before the default time has elapsed, the process is not considered complete.

WARNING A disinfection process must be followed by a complete RINSING process. If not, on subsequent SETUP the machine will not allow the selection of the DIALYSIS process.

Note If the END PROCESS MODE parameter is set to None on the Config\ADR\Chemical view, at the end of the chemical disinfection process, the machine returns to the IDLE phase without performing a RINSING process. • To prevent damaging the machine, do not leave the machine filled with disinfectant solution for a prolonged period: follow the same time limits, for each disinfectant solution, listed in the Section 9 – Specifications, of this manual. • Perform a complete RINSING process before the subsequent SETUP.

Note A disinfection process in progress has priority over a process programmed in the Config/ADR/AutoStart view.

Note At the end of a process programmed by the AutoStart feature, if the AUTO OFF parameter is set to YES, the machine will ignore this selection and will return to the IDLE view.

Note When the machine goes into an RESTART alarm condition during an ADR process programmed by the AutoStart feature, the machine will automatically return to the IDLE view 10 minutes after the alarm appearance. An Operator Message will appear informing the operator than an alarm occurred. No other automatic process will be performed until the operator will successfully complete a disinfection process that has been started manually.

Rev. B


6.3 Disinfection with heat (not available on 12 A version) 6.3.1 Heat disinfection 6.3.1.1 HOW TO PROCEED To perform a Heat Disinfection: • Check that all the connectors (white, blue and yellow) are inserted in their Rinse Ports on the lower front of the machine. The BiCart Holder must be in the rinse position with the Arms closed. • Press the HEAT Selection key on the ADR view. The following view is displayed:

12:30

HEAT SELECTION

HEAT HEAT WITH CWP HEAT CITRIC

BPM

Rev. B

REPORT

MACHINE

CLOSE


6-13

• Select the HEAT Action key. The following view is displayed: 12:30

HEAT PROC. IN PROGRESS

DISINF TIME

AUTO OFF

min:s

COOLING YES

BPM

6.3.1.1.1

REPORT

MACHINE

CLOSE


The default value of the DISINF TIME parameter is the lowest value necessary to ensure disinfection of the machine. The operator can therefore accept this time or increase it. AUTO OFF: If this parameter is set to NO, the machine returns to the IDLE view at the end of the process. If set to YES, the machine turns OFF automatically, 15 minutes after the beginning of the cooling phase, or 1 minute after reaching the threshold temperature of 37°C (98.6°F). COOLING: When performing a standard Heat Disinfection, if the parameter value is YES, the machine will perform the cooling phase at the end of the Heat Disinfection process. When performing a Heat Disinfection using a Centralized Heat Disinfection System, the parameter value should be set to NO, the machine will perform only a brief rinsing/cooling phase (30 sec.) at the end of the Heat Disinfection Process.

Note The COOLING parameter can not be changed by the operator. Its value is automatically set by the machine with the selection of the Heat Disinfection process.

To change the parameter selection, press the SET button.

Rev. B


6.3.1.2 CENTRALIZED HEAT DISINFECTION SYSTEM A Centralized Heat Disinfection System may be used.

WARNING To be compatible with this feature the PHOENIX machine must be retrofitted with the CWP Adapter kit. Failure to use the CWP Adapter kit may result in damage to components in the PHOENIX machine.

WARNING The temperature of the inlet water to the machine must be lower than 95°C (203°F).

To perform a Heat Disinfection using a Centralized Heat Disinfection System: • Check that all the Connectors (white, blue and yellow) are inserted in their Rinse Ports on the lower front of the machine. The BiCart Holder must be in the rinse position with the Arms closed. • Press the HEAT Selection key on the ADR view and then press the HEAT WITH CWP Action key. The following view is displayed: 12:30

HEAT PROC. IN PROGRESS

DISINF TIME

AUTO OFF

min:s

COOLING NO

BPM

REPORT

MACHINE

CLOSE

When a Centralized Heat Disinfection System is used, the selection of the AUTO OFF parameter to YES causes the machine to turn OFF, even if the liquid is not cold, at the end of the brief rinsing/cooling phase (approx. 30 sec.).

Rev. B


6-15

6.3.2 Heat Citric disinfection 6.3.2.1 HOW TO PROCEED This procedure depends upon the selection of the parameters EXTERNAL JUG USE and LIQUID INLET:

EXTERNAL JUG USE: NO LIQUID INLET: FRONT

• Press the HEAT Selection key on the ADR view and then select HEAT CITRIC. • Disconnect the Yellow Connector from its Rinse Port on the lower front of the machine and connect it to the Yellow Wand. Immerse the wand into the citric acid container. • Check that the Concentrate Connectors (white and blue) are in the Rinse Ports on the lower front of the machine. The BiCart Holder must be in the rinse position, with the Arms closed.

EXTERNAL JUG USE: YES LIQUID INLET: FRONT


EXTERNAL JUG USE: YES LIQUID INLET: REAR 1/ REAR 2

• Press the HEAT Selection key from the ADR view and then select HEAT CITRIC. • Ensure that the Disinfectant Connector (present on the rear of the machine) is correctly inserted into the citric acid container located on the rear of the machine and that there is enough liquid to perform a disinfection procedure. • Check that the all Connectors (white, blue and yellow) are inserted in their Rinse Ports on the lower front of the machine. The BiCart Holder must be in the rinse position, with the Arms closed.

Rev. B

6-16 PHOENIX OPERATOR MANUAL Select the HEAT CITRIC Action key. The following view is displayed: 12:30

DISINF TIME

AUTO OFF

min:s

LIQUID INLET

BPM

PH VALUE

REPORT

MACHINE

CLOSE

Note If any problems occur while citric acid is being taken up into the internal tank, the machine will automatically empty and refill the tank. A message is displayed:


At the end of this process, the following message is displayed: DISINF CONNECTOR POSITION with an audible alarm (#47). • Reinsert the Yellow Connector into its Rinse Port. The alarm will automatically clear and the disinfection procedure will restart.

WARNING In the Heat Citric phase, it is important that only citric acid is used and no other disinfectant.

Rev. B


6.3.2.1.1

6-17


pH Min and pH Max: These parameters appear only if the parameter pH MONITOR on the Config/ADR/HEAT/HEAT CITRIC view is set to YES. AUTO OFF: If NO is selected, the machine returns to the IDLE view at the end of the process, if YES is selected, the machine turns OFF automatically. LIQUID INLET: Identifies the line through which the uptake of citric acid is performed. This parameter can be set to FRONT, REAR 1 or REAR 2. To change the parameter selection, press the SET button.

Rev. B


6.3.3 Heat/Heat Citric Process in Progress (not available on 12 A version) The value of the DISINF TIME parameter automatically decreases as the process proceeds. During whole process heat water flows in the Hydraulic circuit. In order to alert the operator the following message appears:

“Don’ t remove any connectors: hot water” Disinfection stops: − When the time value set for the DISINF TIME parameter is elapsed. − When the machine goes into an alarm condition during Disinfection and Rinsing and the operator takes no action, the machine will automatically turn OFF 30 minutes after completion of the DISINF TIME or RINSING TIME. − When the CLOSE Action key is selected.

Note A disinfection process in progress has priority over a process programmed in Config/ADR/AutoStart.


Note When the machine goes into an alarm condition during an ADR process programmed by the AutoStart feature, the machine will automatically return to the Idle view 10 minutes after the alarm appearance. An Operator Message will appear informing the operator that an alarm occurred. No other automatic process will be performed until the operator successfully completes a disinfection process that has been started manually.

Rev. B


6-19

6.4 Rinsing To perform this process: • Select the RINSING Action key on the ADR view: 12:30

IDLE: SELECT ADR

CHEM PROCESS HEAT

RINSING CCK LINES RINSE

BPM

REPORT

CONFIG

MACHINE

CLOSE

Note Selection of the CCK LINES RINSE Action key initates the Central Concentrate Lines Rinse process. Refer to Section 03 - CENTRAL CONCENTRATE SUPPLY, for the complete description of this process. This section describes only the Rinsing process when selecting the RINSING Action key.

• Set the appropriate value for RINSING TIME using the SET button. The default value is the lowest one which will ensure rinsing of the machine. Therefore this time can be accepted or increased. AUTO OFF: If this value is set to NO, the machine will return to the IDLE view at the end of the process; if it is set to YES, the machine will turn OFF automatically. To change the parameter selection, press the SET button. • Check that all connectors (white, blue and yellow) are inserted in their Rinse Ports on the lower front of the machine. The BiCart Holder must be in the rinse position, with Arms closed.

Rev. B

6-20 PHOENIX OPERATOR MANUAL The process now begins and the following view is displayed: 12:30

ADR PROGRESS

RINSING TIME

AUTO OFF

min:s

BPM

REPORT

MACHINE

CLOSE

During Rinsing, the machine performs the UF Vessel Level Detectors Test.

Note When the UF Vessel Level Detector Test fails, the following operator message will appear:

Emptying UF Vessel forced The process time will be increased.

Rev. B


6-21

6.4.1 Rinsing in progress The value of the RINSING TIME parameter automatically decreases as the process proceeds. The process stops: − When the time value set for the RINSING TIME parameter is elapsed. − When the machine goes into an alarm condition during Disinfection and Rinsing and the operator takes no action, the machine will automatically turn OFF 30 minutes after completion of the DISINF TIME or RINSING TIME. − If the CLOSE Action key is pressed. If the CLOSE Action key is selected before the default time has elapsed, the process is not considered complete. When the time value set for the RINSING TIME parameter is elapsed, the machine will perform a tank emptying phase. When this process has been completed, the machine returns to the IDLE view.

WARNING the absence of residual disinfectant, before connecting a dialyser.

Note A rinsing process in progress has priority over a process programmed in Config/ADR/AutoStart.


Note When the machine goes into an RESTART alarm condition during an ADR process programmed by the AutoStart feature, the machine will automatically return to the IDLE view 10 minutes after the alarm appearance. An Operator Message will appear informing the operator than an alarm occurred. No other automatic process will be performed until the operator successfully completes a disinfection process that has been started manually.

6.5 ADR Action Keys availability Depending on the correct or incorrect completion of the last ADR process performed, the following ADR Action keys are available:

Rev. B


Rinsing Performed Correctly Rinsing not Performed Correctly

(See Note 1)

HEAT

HEAT CITRIC

HEAT WITH CWP

CHEM PROCESS


RINSING

CCK LINES RINSE

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Chemical Proc. Performed Correctly

X

Chemical Proc. NOT Performed Correctly

X

(See Note 2) Heat Proc. Performed Correctly Heat Proc. NOT Performed Correctly Heat CWP Proc. Performed Correctly Heat CWP Proc. NOT Performed Correctly Heat Citric Proc. Performed Correctly

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Heat Citric Proc. NOT Performed Correctly

X

(See Note 2) Rinse+Bicarb Line Performed Correctly

X

X

X X

X

X

Rinse+Bicarb Line Not Perf. Correctly

CCK Lines Rinse NOT Performed Correctly

X

X

X

X

X

X

X

X

X

X

X

X

Chem+Bicarb Line Proc. Perf. Correctly Line

Proc.

NOT

X Perf.

X (See Note 3)

Rev. B

X

X

CCK Lines Rinse Performed Correctly

Chem+Bicarb Correctly

X


6-23

Note 1 When a RINSING process has not been correctly completed and the ADR process previously performed was a Chemical Disinfection or a Heat Citric Disinfection not correctly completed, only the RINSING Action key remains available.

Note 2 When the CLOSE Action key is selected within approximately 30 seconds after the Disinfection process selection (Chemical or Heat Citric), the process selection is cancelled and all the keys that were available before starting the Disinfection process will remain available.

Note 3 When a Central Bicarbonate Line disinfection has not been correctly completed, only the Central Bicarbonate Line disinfection can be performed.

Rev. B


6.6 Verification of the Absence of Residual Disinfectant Samples for residual disinfectant concentration testing may be obtained, at the end of RINSING or in SETUP prior to using the machine for a patient treatment, from the following sites: • Dialysate line: remove the inlet dialysate line (blue connector) from its by port on the left side of the machine and collect a fluid sample. • Acid/Acetate Connector. To take a sample from the Acid/Acetate Connector: • Insert the Sampling Connector into the red Acid/Acetate Rinse Port. • Allow liquid to flow from the sampling connector for a few seconds to adequately rinse the sampling connector. • Obtain a sample for testing.

Note Due to the fact that the internal volume of the PHOENIX machine is less than 750 ml and the drain hose may have a volume of between 300 ml and 600 ml, the Residual Disinfectant test performed at the drain hose of the machine does not reflect the quality of the rinsing of the PHOENIX machine and can give a positive result even if the PHOENIX has been rinsed correctly.

Rev. B


6-25

6.7 Water Inlet Line Disinfection 6.7.1 General The segment of the water inlet line between the treated water supply and the end of the hose connected to the inlet port of the heater exchanger is not automatically cleaned/disinfected by the machine. If the machine is stored, switched OFF, or is in IDLE for a long period, it is recommended that the following special cleaning/disinfection procedure is performed.

6.7.2 Disinfection Procedure • Assemble a pump device with the components described in Figure 6.1. your Local Representative for information about where to obtain this device, or the components to assemble it. • Prepare a dilute sodium hypochlorite (bleach) solution (15 ml of 5.25% sodium hypochlorite solution in 500 ml of room-temperature treated water) in a chemicalresistant container. • Turn OFF the treated water supply to the PHOENIX machine. • Disconnect the machine’s water hose from the treated water supply and connect it to the connector on the pump device (on the left side of the device, as shown in Figure 6.1.) • Insert the free end (disinfectant suction line) of the pump device into the disinfectant solution container. • Turn ON the PHOENIX machine and enter the ADR/DISINFECTION mode. Press the CHEM PROCESS Selection key and then select a customized disinfection key that corresponds to the uptake of disinfectant from the Yellow Connector on the lower front of the machine. • Remove Yellow Connector from its Rinse Port and allow it to hang unconnected. • When the machine alarms because of the absence of water, use the syringe on the pump device to pump the disinfectant solution into the inlet water line. • Alternately, completely fill the syringe with the disinfectant solution and then completely empty it into the water inlet line line by firmly pushing in the syringe plunger. • Repeat this operation until the disinfectant solution container is almost empty.

Note Point the syringe downward during the emptying phase to prevent air from entering the water inlet line.

• Turn OFF the machine and leave the water inlet hose filled with the disinfectant solution for a period of time sufficient to achieve microbiocidal efficacy, but not for a period longer than the maximum time recommended in Section 9 – Specifications, in this manual. • Carefully disconnect the end of the inlet water hose from the pump device.

Rev. B

6-26 PHOENIX OPERATOR MANUAL • Switch the PHOENIX machine ON, enter the ADR/DISINFECTION mode, and select RINSING until the machine goes into an alarm condition due to the absence of water.

Note It is recommended to avoid the selection of HEAT DISINFECTION process when disinfectant solution is present in the initial section of the machine’s hydraulic circuit.

Note The purpose of this operation is to empty the end of the water inlet hose to avoid disinfectant from ing the treated water supply flowpath.

• Reconnect the machine’s water inlet hose to the treated water supply system. • Turn on the treated water to the PHOENIX machine. • Insert the Yellow Connector in the Rinse Port on the lower front of the machine. • The RINSING process will restart. Wait until the machine has completed the. RINSING process

WARNING A disinfection process must be followed by a complete RINSING process. • Proceed with the standard procedure to SETUP the machine for DIALYSIS.

Note To perform a test for residual disinfectant concentration, follow the “Verification of the Absence of Residual Disinfectant” Procedure described in this section.

Rev. B


6-27

NO return valves adaptor for the connection to the inlet water line

Disinfectant suction

Silicon “T” connector PVC tube φ 3.5 * 5.5 mm; L = 200 mm

PVC tube φ 4.6 * 6.8 mm; L= 1000 mm

50 ml Syringe

Figure 6.1

Rev. B


6.8 External Cleaning and Periodic Inspections The PHOENIX must be cleaned as often as required by operating conditions and the facility’s protocol. The PHOENIX has been designed to function with a minimum of maintenance. The ambient conditions, as well as frequency and duration of use determine the required cleaning frequency.

6.8.1 External surface cleaning The external surfaces of the machine to be cleaned are: • Blood Pump and the Line Clamp • Air Bubble Detector • Clamp Housings • Heparin Pump Syringe Holder • Arterial and Venous Pressure Sensors • BiCart Holder • Dialyser Holder • Single Needle Holder • the WHO Drain Port and WHO door • the Touchscreen Particles and dust on the external surface of the machine can be removed with a soft cloth or brush. All other deposits can be removed with a soft cloth dipped in a detergent/disinfectant solution. The following detergents/disinfectants are suggested: − Liquid soap. − Ethyl Alcohol (90%). − Isopropyl alcohol (70%). − Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm)/Bleach diluted with water at a ratio of 1:50.

Note If residual detergent/disinfectant remains on the surface of the machine after external cleaning, it has to be removed with a soft cloth dipped in water to avoid damaging or discoloring the plastic parts of the machine. Detergents/Disinfectants have to be removed from the external surface of the machine only after the minimum dwell time for cleaning is elapsed (refer to the detergent/disinfectant instructions for use for the minimum dwell time recommended to guarantee an effective cleaning).

Rev. B


6-29

Note The PHOENIX Touchscreen may also be cleaned when the machine is switched on. Press the Machine Navigation Key, then the CLEANING SCR Action Key. The CLEANING SCR Action Key disables all the Touchscreen functions for 10 seconds, allowing the Touchscreen to be wiped with a soft cloth without activating any Action keys.

WARNING For the Touchscreen cleaning use the following disinfectants: • Isopropyl alcohol (70%); • Sodium hypochlorite solution (active chlorine from 50,000 to 60,000 ppm)/Bleach diluted with water at a ratio of 1:50.

WARNING Do not use chemicals which might damage the plastic parts of the machine. Avoid chemicals containing benzene, toluene, xylene, acetone or similar solvents.

WARNING Do not use Sodium hypochlorite to clean the Blood Pump Crank to avoid damaging the metallic parts of this component.

WARNING Any liquid spilt on the machine must immediately be removed to prevent it from seeping into the machine.

6.8.2 External components Cleaning It is advisable to clean periodically certain external components of the machine, such as: • Dialysate Connectors • Concentrate Connectors • Chemical Connectors • Concentrate Wands by immersing them in a disinfectant solution. The frequency of this cleaning procedure depends on the use of the machine, on the operating conditions and the ambient conditions. After the immersion in the disinfectant solution, the machine components must be thoroughly rinsed with treated water to remove all disinfectant residuals, prior to using them during dialysis. The length of the immersion depends on the disinfectant concentration used.

Rev. B

6-30 PHOENIX OPERATOR MANUAL WARNING To prevent cross-contamination problems resulting, for example, from blood leakage from the bloodline or from the dialyser (including blood leak into the hydraulic circuit) the components listed above must be cleaned by immersing them into a disinfectant solution or by exposing them – except the Concentrate Wands - to a steam sterilisation procedure (121°C for at least 30 minutes). Careful attention must be paid to dismounting and re-mounting Dialysate Connectors, Concentrate Connectors and Chemical Connectors in order to avoid damages to those components and leakages from those components.

WARNING To prevent damage to the components listed above, do not leave them immersed in the disinfectant solution for a prolonged period; the proper immersion time is related to the disinfectant dilution used. When the dilution is the same as that used in the machine during DISINFECTION, follow the same time limits: 4 hrs for: Amuchina™, Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength (1:25 dilution); 24 hrs for: Dialox™, Acetoper™, Peresal™, Actril® and Renalin®; 48 hrs for: formaldehyde solution and Steridial™; One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution). (For further information see Section 9 - SPECIFICATIONS, in this Operator’s Manual).

Rev. B


6-31

6.8.3 Visual inspection The machine must be periodically inspected (at least once a week) to check for: • Broken or damaged switches • Broken or twisted power supply cables • Cracks in the structure • Corroded metal parts • Unattached loose or missing hardware • Blood Pump Rotor damage and that the Rotor surface remains smooth • Damage to the Arterial and Venous Pressure Port seals and that their surface is smooth If any of the damage listed above is noted, avoid using the machine, until the damage has been repaired and the machine is in proper working order.

6.8.4 Storage When not in use, the machine must be kept in a safe place such as a closet free from dust, in ambient conditions, as recommended in the Section 9 – Specifications, in this manual. Avoid storing in busy areas where the machine may be moved or knocked over. Avoid storing in conditions of high humidity. If the machine will be stored for an extended period, it is suggested to carry out a chemical bacteriostatic disinfection at least once per week. To perform chemical disinfection refer to “6.2 Chemical Disinfection” in this section.


WARNING After a prolonged period of storage, Service must be called to return the machine to proper working order. Only store at temperatures below 0 °C when the hydraulic circuit has been completely emptied.

Rev. B


6.8.5 Cartridge Holder O-Rings Inspection and Greasing Every 2 weeks it is necessary to: • Check the four O-rings on the Cartridge holder pressure monitoring sensors for nicks, damage, or wear and replace them if necessary; • Grease the 4 O-Rings to improve the seal to the Cartridge and reduces wear of O-rings. To inspect and grease the O-rings proceed as follows: 1. Remove possible grease in excess using an alcool based solution (refer to the list of chemicals for external cleaning suggested on this section). 2. Check, that the O-Ring surface and the metal stems are free from any extraneous particles and check for nicks, damage or wear. Replace the O-Rings if necessary. 3. Apply a very thin coating of silicon grease (PHOENIX spare part code 6975395) all around the four O-Rings. The silicon grease can be applied either manually or using a grease Dispenser. Refer to the two procedures described below.

Manual Greasing procedure • Place a small quantity of silicon grease

on your finger and apply it uniformly all around the O-Rings. • Pay careful attention to ensure that no grease enters inside the metal stems: grease in the stems may result in false pressure readings. (See Figure 6.2).

Figure 6.2

Rev. B


6-33

Procedure with Grease Dispenser: • Ensure that no grease is present on the

Grease Dispenser (spare part code 6977854) around the Grease Dispenser pin. • Screw the Grease Dispenser to the silicon grease tube and then insert the pin of the Grease Dispenser in the pressure coupling hole (See Figure 6.3).

Figure 6.3 • Press firmly to fit the Grease Dispenser

against the pressure coupling. • Press the silicon grease tube to allow a

thin quantity of grease exits and rotate the tube twice. (See Figure 6.4). • Remove the Grease Dispenser. • that a thin quantity of grease has been applied all around the O-Ring.

Figure 6.4

4. Check, that the front of the couplings and the holes in the metal steams are free from any extraneous particles and exceeding grease.

Rev. B



Rev. B

7 COMMUNICATION SYSTEM 7.

SECTION 7 - COMMUNICATION SYSTEM

7.1 General Description Note This Section contains references to all the communication software systems to which the Phoenix machine can be connected, including the Exalis System.

The communication system is able to transfer to different media the results of data acquired during a dialysis treatment. The system is designed to be compatible with different data acquisition systems running on external networks. Depending on the configuration of the unit, and the type of acquisition system the PHOENIX will be connected to, the output may be as follows: 1. An internal backup memory. This function would be processed by a dedicated PC program (Exalis). 2. A personal computer or network directly connected to the PHOENIX dialysis machine (for example CentryNet or Exalis system). The PHOENIX is also able to display a run-time dialysis report on the Touch Screen, containing the data acquired since the start of the treatment. To view this report, press the Report Navigation key. In addition, the can mark different patient related events that occur during the treatment (incidents, intake, medication and medication dose) in order to highlight them on the dialysis report.

Note The communication system features are linked to an external system able to acquire data from PHOENIX. This chapter refers to programs running on a Personal Computer connected to PHOENIX. The programs able to manage the PHOENIX Communication System and described in this section are: CentryNet system Data Collection software Exalis Dialysis Management Tool Refer to each software’s manual for a detailed description of the program. If the PHOENIX machine is connected to the RIMS system or if programs other than CentryNet system Data Collection software and Exalis Dialysis Management Tool are used, refer to the proper software’s manual for a detailed description of the program features.

Rev. B

7-2

PHOENIX OPERATOR MANUAL WARNING PHOENIX makes available the dialysis related data through connection to various external devices for storage and display. The intended use of this information is to the physicians, but it cannot be considered as the sole data to prescribe any therapeutic or pharmacological action for the patient. It is the responsibility of the physician to all data.

WARNING The present software allows information to be gathered about individuals and the must be aware that the use of the information processed or generated by the software is restricted in most countries by legal dispositions such as the Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995. The shall therefore take all necessary measures to ensure the confidentiality of the information which is monitored by means of the software.

WARNING The CentryNet system displays on its treatment screens the concentrations for two conductivity related values (Sodium Level and Bicarbonate Level) in mEq/Liter. As the PHOENIX provides only conductivity information (in mS/cm), the CentryNet entries for Sodium will be approximate values obtained by multiplying the Final conductivity (mS/cm) by 10. A Final conductivity of 13.6 mS/cm will be recorded in CentryNet as a Sodium Level of 136 mEq/Liter. Refer to Section 9 – Specifications of this manual for the exact relation between concentration and conductivity.

Rev. B


7.2 Exalis Functional Description The information in this section is valid when the PHOENIX unit is configured for Exalis. The operation of the PHOENIX machine when used with the CentryNet Data Collection System is described in the CentryNet System Connection section. The systems use different data acquisition methods. Exalis includes:

Synchronous acquisition The system is able to define a sampling time, typically 5 minutes, and a storage buffer dimension for each machine parameter that can be acquired. The PHOENIX has a default pre-setting for this type of acquisition, which can be personalised via a personal computer.

Asynchronous acquisition The system can be configured to define threshold limits for those machine parameters which can be acquired, i.e. alarms and events. The system acquires the whole machine status at the moment a parameter exceeds its threshold limit. The system also acquires this status when the parameter returns within its threshold limits.

Alarm acquisition The system is able to immediately acquire information regarding alarms active on the equipment. Event recording includes alarm activation and their reset.

Operating phase acquisition The system is able to record the input and the output from the different operating phases of the machine. The records are saved in the backup memory.

Instantaneous acquisition The system is able to transfer the real time machine status.

Data storage The PHOENIX Config environment allows the to select the data storage mode for the records acquired by the acquisition task. The PHOENIX can store up to 3 or 4 treatments, depending upon the acquisition sample time(s).

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Storage on backup memory This mode records all the data in the backup memory of the equipment so that it can be retrieved later by the appropriate PC program (Exalis).

Note This chapter mentions a defined machine operating condition, which is the “data acquisition” state. Thus it refers to start and stop conditions of this state. These events are: Start of acquisition: DIALYSIS phase running after PAT CONNECT. Stop of acquisition: confirmation of the EMPTYING Action key.

7.3 CONFIGURATION of Communication Environment The configuration of the Communication environment is described below. The first choice to be made is the type of acquisition system that will be connected to the PHOENIX: • • • • •

CentryNet system Exalis system RIMS system OTHERS NONE

Note Any modification in the type of acquisition system must be done when no PC is connected to the PHOENIX and the communication between the acquisition system and the PHOENIX has not been activated.

Depending on this selection, the following table will apply:

Rev. B

SECTION 7 - COMMUNICATION SYSTEM Parameter SW COMM SYSTEM

NETWORK TYPE BAUD RATE IP ADDRESS 1st/2nd/3rd/4th SUBNET MASK/ SUBNET MASK 2nd/3rd/4th GATEWAY/GATEWAY 2nd/3rd/4th NET ROUTE1/NET ROUTE1 2nd/3rd/4th MASK ROUTE1/MASK ROUTE1 2nd/3rd/4th CCM IDENTIF STATION ID AUTOCHART TIME OFFLINE TIMEOUT (Note 1)

EXT SYNCHRO

Values • CentryNet • Exalis • RIMS • OTHER • NONE (default NONE) • Ethernet • Seriall • 9600(default); 4800; 2400; 1200 From 0 to 255 for each field (default 10.21.4.250) From 0 to 255 for each field (default 255.255.255.0)

Exalis

CentryNet

Default Ethernet

N.A. (fixed to RS485 Serial communication) N.A. (fixed to 9600 baud for CentryNet)

If NetworkType == Serial If NetworkType == Ethernet If NetworkType == Ethernet

From 0 to 255 for each field (default 10.21.4.31) From 0 to 255 for each field (default 0.0.0.0) From 0 to 255 for each field (default 0.0.0.0) Selectable from 1 to 255 (default 50) Selectable from 1 to 255 (default 50) Selectable from 0 to 1 hour (default 30) Selectable from 00:10 to 04:15 Coordinate with the “Poll Delta Time” min:sec. (default: 1:30 min:sec) setting in Exalis install setup. Recommended minimum value = 1:30 min:sec From 00:00 to 01:30 min:sec in step of 5 sec.

RIMS If NetworkType == Ethernet

OTHERS

NONE

Default Ethernet If NetworkType == Serial If NetworkType == Ethernet If NetworkType == Ethernet

(steps of 15 minute increments) (1:30 min:sec or 5 seconds/station, which ever is larger)

The parameter applies and is enabled (displayed in Config \Communic. view)

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PHOENIX OPERATOR MANUAL SW COMM SYSTEM: Selection of the software system to which PHOENIX will be connected.

Note The choice “OTHER”, for the SW COMM SYSTEM parameter, is dedicated to the PHOENIX machines connected to software systems other than CentryNet, Exalis and RIMS system. The choice “NONE”, for the SW COMM SYSTEM parameter, is dedicated to the PHOENIX machines not connected to communication systems.

NETWORK TYPE: Selection of the hardware network topology. BAUD RATE: Selectable by the depending on the communication speed required by the external software system program (default 9600 BAUD) IP ADDRESS 1st/2nd/3rd/4th: T/IP Configuration Address of the unit - used if the network connection is Ethernet. Each PHOENIX must have a unique identifier. SUBNET MASK/SUBNET MASK 2nd/3rd/4th: Subnet Mask for the machine.

Note In order to allow a proper configuration of the communication environment, the values set for the IP ADDRESS 1ST and SUBNET MASK parameters must be entered also in the machine Calibration environment by a service technician (Refer to Section 8, in the PHOENIX Service Manual, for a detailed description of the parameters to be set).

GATEWAY/GATEWAY 2nd/3rd/4th: parameter for internal use. NET ROUTE1/NET ROUTE1 2nd/3rd/4th: parameter for internal use. MASK ROUTE1/NET ROUTE1 2nd/3rd/4th: parameter for internal use.

Note Certain parameters on the Communic. menu (GATEWAY, NET ROUTE1 and MASK ROUTE1) are required only for some data communication software. a Gambro authorized technician to determine if the parameters are relevant to your software.

CCM IDENTIF: Communication code (CCM) that uniquely identifies the PHOENIX within the network system. Each PHOENIX must have a unique identifier. STATION ID: Code that identifies the placement of the PHOENIX within the clinical network setting. Each PHOENIX must have a unique identifier. If the acquisition system connected to the PHOENIX machine is the Exalis system, the STATION ID parameter configuration allows to display of each PHOENIX location in the Exalis room overview window. If the acquisition system connected to the PHOENIX machine is the CentryNet system, refer to “7.7.5 CentryNet Option Screen Setup Keys”, in this section, for a detailed description of the parameter meaning with the CentryNet communication system.

Rev. B


AUTOCHART TIME: Sampling time used by the PHOENIX to automatically acquire records for CentryNet. OFFLINE TIMEOUT: • CentryNet: Alarm timeout used to signal a lack of communication with the CentryNet software system. • Exalis: Timeout function used to signal a lack of communication with the Exalis software system.

Note 1 The OFFLINE TIMEOUT value, for Exalis, must be calculated using the following formula: Time = 3 x Poll Delta Time x Number of machines Where “Poll Delta Time” is an Exalis configuration parameter and “Number of machines” is the number of machine stations in the network. The recommended minimum value is 1:30 min:sec. The OFFLINE TIMEOUT value, for CentryNet, must be calculated using the following formula: Time = 5 x Number of machine stations

EXT SYNCHRO: Timeout used at the switch ON of the machine to detect the network presence.

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7.4 Options of the Communication System 7.4.1 Patient For the Communication System the Patient is a unique event for each dialysis session, it cannot be re-triggered until the dialysis session is concluded or cancelled. The Patient can be manual or automatic:

Manual Patient In case of Standard Dialysis, after selecting the SETUP Action key, press the Report Navigation key and then press the Action Key. When the Patient is activated, the Action key disappears until the subsequent dialysis session.

Note If a Standard Dialysis has been selected, the Action Key is enabled only after the SETUP Action key has been pressed.

Automatic Patient In case of Patient/Rx Dialysis, after selecting a patient, the Patient event is automatically triggered.

Note If a Standard Dialysis has been selected and the Action Key has not been pressed, the Patient event is triggered automatically after pressing the PAT CONNECT Action Key.

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7.4.2 PRE POST Dialysis data handling. This option allows the to record data (manually or automatically) related to the patient’s weight and blood pressure before and after the dialysis treatment. The values that the acquisition system stores are: • PRE and POST WEIGHT • DELTA WEIGHT • PRE and POST LYING SYST • PRE and POST LYING DIAS • PRE and POST LYING PULSE • PRE and POST SIT SYST • PRE and POST SIT DIAS • PRE and POST SIT PULSE • PRE and POST STAND SYST • PRE and POST STAND DIAS • PRE and POST STAND PULSE

Note This information has no effect on the treatment.

Depending on the operating phase of the equipment, the system allows the to input data.

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7-9

7-10 PHOENIX OPERATOR MANUAL PRE DIALYSIS DATA The time between the Patient event and the DIALYSIS Action key disappearance (after the RINSEBACK VOLUME value set has been reached) is dedicated to the pre-dialysis data input (automatic or manual entry). To enter the pre-dialysis data press the Report Navigation key, then the Summary Navigation key. The following view will be displayed: 12:30

PRE LYING SYST

mmHg

POST LYING SYST

- mmHg

POST LYING DIAS

- mmHg

POST LYING HRAT

- mmHg

POST SITTING SYST

- mmHg

PRE LYING DIAS

mmHg

PRE LYING HRATE -

-mmHg

PRE SITTING SYST-

mmHg

POST SITTING DIAS

- mmHg

PRE SITTING DIAS

mmHg

POST SITTING H.RATE

- mmHg

PRE SITTING H.RATE

mmHg

POST STAND SYST

- mmHg

- mmHg

POST STAND DIAS

- mmHg

POST STAND HRAT

- mmHg

PRE STAND SYST PRE STAND DIAS

mmHg

PRE STAND HRATE

- mmHg

PRE WEIGHT

- Kg

POST WEIGHT

- Kg

DELTA WEIGHT

- Kg

TOTAL BLOOD

- l

TOTAL FLUID REMOVED

HEPARIN TOTAL

- ml

REAL TREAT TIME

REPORT

PRE STANDING PRE SITTING PRE LYING

-l -h:min

SUMMARY

The selection of the Action key related to the value to be stored starts the BPM measurement. The pressure measurement is stored by the acquisition system; it is displayed in the view above and in the REPORT table (See the Dialysis Report section).

Note When the operator selects one of the three Action keys, it becomes highlighted and the others disappear; if the Action key is pressed again, all three Action keys become available again.

If the measurement has been taken by an external device, the value can be manually entered using the SET button. The REPORT table records the time that the measurement was taken, in case of BPM measurement, or the time the measurement was stored, if the value was inserted in SET mode. The pre-dialysis data can be changed any time by using the SET button before the EMPTYING phase.

Rev. B


7-11

POST DIALYSIS DATA The time between the DIALYSIS Action key disappearance (after the RINSEBACK VOLUME value set has been reached) and the Patient for the following dialysis treatment is dedicated to the post dialysis data input. To enter the post-dialysis data press the Report Navigation key, then the Summary Navigation key. The following view will be displayed: 12:30

PRE LYING SYST

- mmHg

POST LYING SYST

- mmHg

PRE LYING DIAS

- mmHg

POST LYING DIAS

- mmHg

PRE LYING HRATE

- mmHg

POST LYING HRAT

- mmHg

PRE SITTING SYST

- mmHg

POST SITTING SYST

-- mmHg

PRE SITTING DIAS

- mmHg

POST SITTING DIAS

- mmHg

PRE SITTING H.RATE

- mmHg

POST SITTING H.RATE

- mmHg

PRE STAND SYST

- mmHg

POST STAND SYST

- mmHg

PRE STAND DIAS

- mmHg

POST STAND DIAS

- mmHg

PRE STAND HRATE

- mmHg

POST STAND HRAT

- mmHg

PRE WEIGHT

-Kg

TOTAL BLOOD

-l

HEPARIN TOTAL

- ml

REPORT

SUMMARY

POST WEIGHT

- Kg

DELTA WEIGHT

- Kg

TOTAL FLUID REMOVED REAL TREAT TIME

POST STANDING

-l - h:min

POST SITTING POST LYING

The selection of the Action key related to the value to be stored starts the BPM measurement. The pressure measurement is stored by the acquisition system and is displayed in the view above and in the REPORT table (See the Dialysis Report section).

Note When selecting one of the three Action keys (POST STANDING/POST SITTING/POST LYING) before the EMPTYING Action key selection, the Dialyser Replacement procedure will no longer be allowed for the current dialysis treatment.

Note When the operator selects one of the three Action keys, it becomes highlighted and the others disappear. If the Action key is pressed again, all three Action keys become available again.

Rev. B

7-12 PHOENIX OPERATOR MANUAL If the measurement has been taken by an external device, the value can be manually inserted using the SET button. The REPORT table records the time that the measurement was taken, in case of BPM measurement, or the time that the measurement was stored, if the value was inserted in SET mode. The data can be changed any time before the Patient event (Patient/Rx key select, ) for the following dialysis treatment.

When the post dialysis data has been specified, the following parameters are displayed as in the view above: • TOTAL BLOOD • HEPARIN TOTAL • TOTAL FLUID REMOVED • REAL TREAT TIME

Note After the insertion of the PRE and POST WEIGHT the DELTA WEIGHT is automatically calculated and displayed in the POST DIALYSIS DATA view.

Rev. B


7-13

7.4.3 Event/Intervention Marking The PHOENIX communication system allows the to record specific patientrelated events, which have occurred during the dialysis treatment. The events recorded are stored by the acquisition system (for example Exalis). This feature is active only when the acquisition is running: starting from the selection of the DIALYSIS Action key (Start of data acquisition) until the confirmation of the EMPTYING Action key (Stop of data acquisition). The data recorded are displayed also in the Report view (see the Dialysis Report section). The can enter the EVENTS environment by pressing the Report Navigation key, then the Events Navigation Key. The following view is displayed:

12:30

INTAKES

MEDICATION

INCIDENT

MED QUANTITY

REPORT

SUMMARY

DATA

EVENTS

Rev. B

7-14 PHOENIX OPERATOR MANUAL By pressing the SET button the operator can store particular events that are related to the patient, including its typology, timing and value. Three main event groups are identified (INTAKES, INCIDENT, MEDICATION) as follows: 12:30

INTAKES

INCIDENT

150

MEDICATION

CRAMPS

NaCl

g

REPORT

MED QUANTITY

10 mEq

SUMMARY

DATA

EVENTS

Note The MEDICATION and the MED QUANTITY parameter are strictly linked and must be inserted in sequence. The medication data and the related medication dose are stored by the communication system only if both the parameters, MEDICATION then MED QUANTITY, have been confirmed.

Rev. B


7-15

7.4.4 Dialysis Report The Dialysis Report contains a “snapshot” of some parameters related to specific machine and patient events. In particular, the report shows: • Pre Dialysis data • Start of Data Acquisition event • BPM measurements • DIASCAN measurements • Selection/deselection of the UF ONLY Action key • Patient events recorded within the PHOENIX interface: SUMMARY and Events view • Start of particular procedures such as: Dialyser Replacement, BiCart Change, Dialysis Mode Change (SN and DN), Acid Concentrate Supply Change, Change to the use of Liquid Bicarbonate dialysate, WASHBACK completion. • Selection/deselection of the Action keys: PAUSE THERAPY, BY,WLR MINIMUM. • Occurrence of particular alarms such as: “No Power”, “No Water” • Selection of the SNAPSHOT Action key in the Report view • Pump speed changes (the values is stored 30 sec. after the last change) • Stop of Data Acquisition event • Post Dialysis data The data collection for a patient starts: • after the Patient confirmation in Patient Dialysis • after PAT CONNECT in Standard Dialysis • when the Action key is pressed

The data collected during a treatment remains available in the REPORT environment until one of the three events listed above occurs. Whenever a new Patient Dialysis is selected and confirmed, is pressed, or PAT CONNECT is selected (in Standard Dialysis), the REPORT table is emptied and is filled in with the data of the current dialysis session.

Rev. B

7-16 PHOENIX OPERATOR MANUAL The can enter the REPORT environment by pressing the ReportNavigation key. The following view is displayed:

Clk Time

Ven P

Art P

BFlow

Time

Syst

Dias

Hrate

Event Descrr

--

--

--

PRE STANDING MEAS

--

--

--

PRE LYING MEAS

--

--

--

PRE SITTING MEAS

Qty

Unit

SNAPSHOT REPORT

SUMMARY

DATA

EVENTS

When the enters this view, the data pointer is placed onto the last event recorded. Using the PAGE UP , PAGE DOWN , UP , DOWN keys the can scroll through the Events list. and Some of the data recorded for each event can be seen only by pressing keys: Ven P (Venous Pressure), Art P (Arterial Pressure), BFlow (Real Blood Flow), PSpeed (Blood Pump speed), TWL (Target Loss), UF R (UF Rate), TMP (only displayed in DN), LP (Liters Processed), Cond (Conductivity), Qd (Dialysate Flow), T Hep (Total Heparin infused), Kurea (Clearance), Kt, Dep V, Pl Con (Plasma Conductivity), Stroke (Stroke Volume in SN).

Note Modifications in the Blood Pump Speed are stored in the Report view only 30 seconds after the last change in the Pump Speed value.

The time in which each event has occurres, is displayed in two different ways: • the “Time” column displays the time of the event recorded as time elapsed from the Start of Acquisition event; • the “Clk Time” column displays the clock time of the event. The SNAPSHOT Action key allows recording a generic event, it is a “reminder” for the operator.

Rev. B


7-17

7.4.5 Dialysis Treatment Data This view displays a list of some relevant dialysis parameters. The can enter the Data environment by pressing the Report Navigation key, then the Data Navigation Key. The following view is displayed:

12:30

DIALYSIS TIME

h:min

TEMPERATURE

DIFFUSION TIME

h:min

pH VALUE

TOTAL FLUID REMOVED

Kg

TOT WEIGHT L

Kg TMP

WEIGHT LOSS/H

DIALYSATE FL.

mmHg TWL

l BLD SENS

HIGH

CONDUCTIVITY

mS/cm STROKE VOLUME

BICART COND

mS/cm

SUMMARY

ml/min

Kg/h END DIALYSIS

TOTAL BLOOD

REPORT

°C

DATA

ml

EVENTS

Note The STROKE VOLUME parameter is displayed only if performing a Single Needle dialysis.

Rev. B


7.5 Prescription with the Exalis System WARNING The present SOFTWARE must be used exclusively with the authority of a physician, who is solely responsible for the use of the information processed by the SOFTWARE.

7.5.1 General Description The PHOENIX machine allows the to start a dialysis treatment with a treatment prescription received from a Personal Computer (Exalis software).

7.5.2 Functional Specifications If the PHOENIX is connected to the Exalis System, which is configured for transfer of the patient prescription, the PAT NETWORK Action key selection (in the PATIENT CHOICE view) starts the procedure described below: 1) A keypad appears allowing the entry of the Patient Name: NEW NAME Area Q

W

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Rev. B

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7-19

2) The PHOENIX displays a message to signal that it is waiting for an external prescription. 3) The external Computer System retrieves the prescription assigned to that Patient Name from its database and sends it back to the PHOENIX. 4) PHOENIX displays the prescription received to the for confirmation (it may be modified on the PHOENIX before starting the treatment)

Note The Parameters not managed by the computer prescription are set with a default value.

7.5.3 Error Messages related to Computer Prescription In the event of an error during the transfer of the prescription, the PHOENIX warns the with a specific superimposed window. •

If the Patient Name entered is not available in the Exalis database:

Patient Not Recognized by Clinical Software Check the Patient Name and retry. Press ENTER To Proceed Press the CONFIRM button and repeat the Patient Name entry procedure. •

If at least one of the parameters in the patient prescription can not be accepted by the machine:

Prescription Not Valid. Please Access the Machine Page to Check the Wrong Parameter. Press ENTER To Confirm And Proceed. In the Machine view, the WRONG PRESC PAR: prescription parameter causing the failure. •

parameter displays the

If an error occurred when trasferring prescription data from a personal computer:

Timeout on Data Receiving. Press ENTER To Confirm And Proceed •

If the connection between the PHOENIX machine and the personal computer is interrupted while transferring prescription data:

Connection lost with Clinical SW. Press CONFIRM to Proceed

Rev. B

7-20 PHOENIX OPERATOR MANUAL The operator must press the CONFIRM button to proceed the treatment; all of the patient prescription will be discarded.

WARNING The PHOENIX machine can be programmed by receiving data through connections to various external devices. As soon as PHOENIX reads the data, it is displayed on the Touch Screen. It is the responsibility of the to all the data before confirming it is correct. Some important parameters relating to the safety of the patient are shown twice, in alternative ways, on the Touch Screen. It is necessary to pay close attention to these values and check their congruency.

Rev. B


7-21

7.6 Communication Libraries Some information libraries (e.g. Patient Events) are stored in a dedicated memory section of the PHOENIX system. This data can be either ed or ed to/from the PHOENIX with dedicated application software. The file transmission can be performed only when the PHOENIX is in the IDLE state. During this transmission, the PHOENIX control is disabled and the is informed accordingly on the Touch Screen. The modifications to the library apply when the PHOENIX machine is subsequently powered ON.

Rev. B


7.7 CentryNet System Connection The CentryNet network consists of a series of CentryNet capable dialysis machines (PHOENIX, Centrysystem 3) with RS485 Network Interface Cards. The RS485 interface cards contain the necessary circuitry to receive incoming information from and transmit dialysis treatment data back to the network controller. Understanding the CentryNet system involves understanding what the CentryNet controller does, how it performs, how it communicates, and how the collection of treatment data is managed when using the CentryNet software.

PHOENIX

Host Computer (Optional)

Network 1 (Max 32 Machines)

CentryNet Wall Outlet


Network 2 (optional) Network Controller

Centrysystem 3


Printer (Optional)

Termination Assembly

Typical CentryNet Network Configuration

Rev. B


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7.7.1 What CentryNet Does With the CentryNet option, PHOENIX machines are cabled together for communication with a network controller, a specially configured computer that collects, sorts and stores data generated by the PHOENIX machine during the dialysis treatment. This data is organized into a Treatment Record run sheet format and can be sent to a printer, a host computer system, or both. After the operator presses the START COLLECT Action key, treatment data is collected (as taken) for the following information: •

Machine SETUP parameters, e.g., at START COLLECT, and whenever the machine enters DIALYSIS.

•

Changes that may occur in the machine SETUP.

•

Machine status changes, i.e., when a PHOENIX machine goes ONLINE or OFFLINE, or when the CentryNet controller is started up or shut down.

•

All REPORTS and BPM data.

Several functions initiate a reading of PHOENIX machine data: •

Blood pressure readings taken at selected timed intervals.

•

The blood pressure monitor fails to record a requested reading.

•

The Heart ♥ button on the Main Control is pressed.

•

The machine is taken into or out of the DIALYSIS mode.

•

Automatic readings taken at selected timed intervals.

•

The CHARTS Action key is pressed.

During DIALYSIS, the CentryNet controller automatically collects data without operator assistance or intervention. The end data collection event takes place either when the operator presses the STOP COLLECT Action key or automatically at the Patient event for the following treatment. At the end data collection event the CentryNet controller stops collecting data for that treatment and the treatment is summarized and “closed out” on the network controller. If for any reason the operator does not press the START COLLECT and STOP COLLECT Action keys on the PHOENIX machine in the required sequence, or if data collection is interrupted for any mechanical reason, the treatment data collection may be prematurely concluded. The CentryNet-collected data for such a treatment will be incomplete, e.g., the treatment will be “broken”. When the PHOENIX machine is between treatments, the CentryNet controller collects no treatment data. Therefore, the operator should not to perform any therapy-related, data-generating tasks between treatments.

Rev. B


7.7.2 How CentryNet Communications Work When using the CentryNet option with PHOENIX system, the PHOENIX collects and stores treatment data and ultimately transfers the data to the network controller along the cabling that links the network controller and the dialysis machines. A series cable connects all the PHOENIX machines on a network. In this type of network the network controller can only “communicate” with, or “poll”, one machine at a time. The physical location (the STATION ID) of a PHOENIX machine within a clinic determines the order for communication between the CentryNet controller and the PHOENIX units. The CentryNet controller collects data based upon the following: •

The ID SET: Unique data identifiers (per machine) that include theSTATION ID, CCM IDENTIF, PATIENT ID, and a sequence number to identify data with a specific treatment.

•

The START COLLECT and STOP COLLECT Action keys initiate and close out the sequence number, which identifies specific treatment information with a particular machine (ID Set).

Note The sequence number - invisible to the operator - corresponds to the chronological sequence of treatment data and will change only when a new treatment is started.

When the operator presses the START COLLECT Action key on the PHOENIX machine, and after the PATIENT ID value is confirmed, all four data identifiers (STATION ID, CCM IDENTIF, PATIENT ID, and the sequence number) are sent to the network controller and logged in. All treatment data generated for this treatment will contain these four data identifiers. If any of these identifiers are changed during a treatment, the network controller considers the treatment “broken,” or prematurely ended. If the CentryNet controller does not poll the PHOENIX machine at least once during the time established by the OFFLINE TIMEOUT setting, the PHOENIX machine will display an alarm indication,CentryNet Station Offline. The operator may not start or end data collection when this message is displayed, however, treatment data already collected in the network controller will be retained.

Note The installation technician sets the CCM IDENTIF and the OFFLINE TIMEOUT limit within the PHOENIX machine at installation.

Rev. B


7-25

7.7.3 Operator Tasks and Guidelines for CentryNet The basic tasks the operator performs directly at the PHOENIX machine are: •

the physical location of the PHOENIX machine (theSTATION ID)

•

Perform the Patient ( Action key selection).

•

Press the START COLLECT Action key on the PHOENIX machine to start data collection for a treatment.

•

Enter a unique PATIENT ID using the alpha-numeric keypad, and confirm.

Note The PATIENT ID value cannot be inserted prior to the Patient event.

•

Conclude the treatment ∗ Press the STOP COLLECT Action key to manually end data collection for a treatment. ∗ the next patient, i.e., select and confirm a new Patient/RX Dialysis, press , or select PAT CONNECT (in Standard Dialysis).

Note Post Treatment measurements can be taken until the next Patient event.

A few simple rules aid the clinician when using the CentryNet option: 1. Perform only those tasks between treatments for which data is neither required nor expected. 2. Always press the Action key and enter a new PATIENT ID for each patient to start the collection of data for a treatment. 3. Always conclude the treatment in the normal fashion (see above).

Note Do NOT return to the IDLE view from SETUP after entering the PATIENT ID without first pressing STOP COLLECT. Doing so will cause the treatment in CentryNet to be broken. Any data acquired will be transferred to Broken Treatments and unavailable in the Treatmens database in CentryNet.

Note When data collection for a treatment terminates, the CentryNet network controller begins collecting data again for that machine only when the operator presses the PATIENT ID Action key.

Note Switching the CentryNet option Off ends data collection - breaking the treatment.

Rev. B


7.7.4 Configuring the unit with the CentryNet option To configure the PHOENIX machine for operation with CentryNet, from the Home view (in IDLE view) press the Config Navigation key. The following view will be displayed:

12:30

IDLE

CONFIG

Rev. B

MACHINE

CENTRE CONF

ADR

TREATME NTS

PROFILE

KT/V


7-27

Press the MACHINE Navigation key, the Communic. Navigation key, then press the SET button on the Main Control to access the SET Mode. The following view will be displayed: 12:30

IDLE

CCM IDENTIF

50 SW COMM SYSTEM

AUTOCHART TIME

CentryNet

OFFLINE TIMEOUT

00:30

01:30 min:s

IP ADDRESS 1st t

IP ADDRESS 2nd

50

20

SUBNET MASK

SUBNET MASK 2nd

50

10

IP ADDRESS 3rd

min:s

IP ADDRESS 4th

10

50

SUBNET MASK 3rd

SUBNET MASK 4th

10

20

For CentryNet, the important items to are: • • • •

CCM IDENTIF SW COMM SYSTEM OFFLINE TIMEOUT AUTOCHART TIME

Machine Identifier System type Polling Timer Automatic interval

CCM IDENTIF CCM IDENTIF is used to set the Machine Identifier for CentryNet. The CCM IDENTIF for each PHOENIX machine in a clinic must be a unique three-digit number, between 1 and 250. Pressing this parameter box activates the PLUS and MINUS buttons on the Main Control , and allows the to increase or decrease the CCM IDENTIF. The PHOENIX CCM IDENTIF must be set at installation - without it, the CentryNet system will not communicate with the machine. This ID does not normally change throughout the use of the machine. A record of CCM IDENTIF’s for each clinic should be kept so that new CCM IDENTIF’s do not duplicate any existing ones.

Rev. B


SW COMM SYSTEM This parameter box activates a sub-view with several selections on it. These items allow the to select a destination for the data. It must be set to CentryNet for the CentryNet system to communicate with this machine.

OFFLINE TIMEOUT The Polling Timer: A defined period of time during which the CentryNet network controller must communicate with each machine. Pressing this parameter box activates the Plus and Minus buttons on the Main Control , allowing the to select an appropriate timeout setting. Use the following formula: Time = 90 or (Number of stations x 5), whichever is greater Example 1: There are 15 machine stations in the network. Insert this value (15) into the formula. The timeout setting calculates to be (15 x 5), or 75. 75 is the value that would normally be used for all machines on the network. However, a minimum of 90 is recommended, therefore, use 90 in each. Example 2: There are 30 machine stations in the network. Insert this value (30) into the formula. The timeout setting calculates to be (30 x 5), or 150. 150 is the value to be used in all machines on this network.

Note Do not set the polling timer to a value lower than the recommended default setting of 90. You may, however, set the polling timer to a higher value allowing more time before the Station Off-line alarm occurs. If you set it at too short of a time span, it may cause the PHOENIX to go into alarm as it goes off-line and online. The polling time must be set in the machine at installation to avoid unnecessary alarms.

AUTOCHART TIME The AUTOCHART TIME parameter box allows the to select when readings will be taken automatically for CentryNet; the time between REPORT readings. REPORT readings are a snapshot of the machine’s operation at that moment. Pressing this parameter box activates PLUS and MINUS buttons on the Main Control , allowing the to select an appropriate time interval setting.

Note The system also takes a REPORT reading according to the Blood Pressure Module sample interval. See the Section 5.C - Blood Pressure Monitoring, in this manual, for the procedure to configure the SAMPLE INTERV.

Rev. B


7-29

7.7.5 CentryNet Option Screen Setup Keys The CentryNet option, when active, is accessed by first pressing the Report Navigation key, and then pressing the CentryNet Navigation key. 12:30

PATIENT ID

STATION ID

0

0

CENTRYNET USE

CCM IDENTIF

YES

50

REPORT

CENTRYNET

Press the SET button on the Main Control to enter the SET Mode. 12:30

IDLE

CENTRYNET USE

YES

STATION ID

0

Rev. B

7-30 PHOENIX OPERATOR MANUAL CENTRYNET USE The CENTRYNET USE parameter box allows the operator to activate or deactivate the CentryNet option. When the option is set to YES (ON), the CentryNet data collection function is active and begins immediately when the START COLLECT Action key is pressed. When the CENTRYNET USE option is set to NO (OFF), data collection does not take place and all CentryNet alarm signals are deactivated. The CentryNet option can be switched OFF at any time during the treatment. Switching from ON (YES) to OFF (NO) abruptly interrupts data collection relating to the treatment in progress. The CentryNet option can be switched ON at any time except when the machine is in the Dialysis mode, i.e., activating the CentryNet option during Dialysis is disallowed.

STATION ID The STATION ID parameter box allows adjustment of the STATION ID for the machine. Pressing this box activates the PLUS and MINUS buttons on the Main Control . These buttons allow the to increase or decrease the STATION ID. Values from 1 to 255 may be selected. The STATION ID is typically the number assigned to the physical location (the station) within the facility. The value entered into the PHOENIX must correspond to this location. If the unit is moved within the facility, a new STATION ID must be entered to allow the system to correctly proceed with the station assignment. Upon power up, the PHOENIX machine always assumes the value previously assigned for the STATION ID. Station assignment for the PHOENIX machine is automatic with CentryNet - the STATION ID must be present as one of the active stations in the network controller. If the PHOENIX machine has a valid STATION ID present in memory, when CentryNet polls that station the PHOENIX machine will respond automatically, no operator action is required. The STATION ID parameter box may not be present when first entering the SET Mode. To activate the parameter box, switch the CENTRYNET USE parameter box from YES to NO. The STATION ID key will now be present. The STATION ID may only be changed when the CentryNet option is Off; CENTRYNET USE=NO.

CCM IDENTIF CCM IDENTIF is used to set the Machine Identifier for CentryNet. The CCM IDENTIF for each PHOENIX machine in a clinic must be a unique three-digit number, between 1 and 250. The PHOENIX CCM IDENTIF is accessed (from the IDLE view) by pressing the Config Navigation key, then the MACHINE Navigation key, and then the Communic. Navigation key. Finally, press the SET button on the Main Control to enter the SET Mode.

PATIENT ID The PATIENT ID can be a number from 0001 to 9999. Each patient should have his or her own unique ID. Once the desired PATIENT ID is entered it is possible to start data collection. The PATIENT ID may not be changed after start of data collection. It may be changed only after the treatment has been terminated. The PATIENT ID entry keypad may be accessed through the REPORT screen.

Rev. B


7-31

7.7.6 Communication Icons relating to the state of the network link Several icons are associated with CENTRYNET USE. The following icons indicate the state of the CentryNet option: Use = NO

Use = YES

Use = YES

CentryNet is Off

CentryNet = On Station = Offline

CentryNet = On Station = Online (When data is available, icon is yellow and flashes)

CENTRYNET OFF The CENTRYNET OFF icon appears when the CentryNet option has been deactivated. While this message is displayed, no communication with CentryNet takes place, and, all CentryNet alarms are deactivated. When the option is activated the CENTRYNET OFF icon is replaced by one of the following.

CENTRYNET ON / STATION OFFLINE The STATION OFFLINE icon appears when CentryNet is active but communication between the network controller and PHOENIX does not occur, or when the PHOENIX machine has not received a communication within the established time limit for the Offline Timeout (polling timer). This icon warns the operator that there is no communication and data is not being collected by the network controller.

CENTRYNET ON / STATION ONLINE The STATION ONLINE icon appears when the CentryNet option is active and effective communication is in progress. The icon indicates that the machine’s STATION ID and CCM IDENTIF are accepted by CentryNet. When there are records to be taken by the CentryNet network controller, this icon is yellow and flashes until the controller has successfully taken all records.

Note A machine assignment must take place when a specific machine ID does not match the list in CentryNet. This must be accomplished before data collection can begin. The assignment function takes place automatically when the PHOENIX machine and the CentryNet network controller begin communicating after (the machine has just been turned on and) a STATION ID has been entered. Data from an incorrectly assigned station is not collected. The PATIENT ID Action key is disabled until the station is successfully assigned.

Rev. B


7.7.7 Operator Keys relating to the state of the treatment There are several Action keys that control when data is being collected. •

•

START COLLECT/PATIENT ID entry keypad

•

STOP COLLECT

The Report screen provides access to these Action keys.

Clk Time

VEN P

ART P

BFlow

Time

Syst

Dias

HRAT E

EVENT DESCR

--

--

--

PRE STANDING MEAS

--

--

--

PRE LYING MEAS

--

--

--

PRE SITTING MEAS

QTY

UNIT

PATIENT ID STOP COLLECT CHARTS

REPORT

SUMMARY

DATA

EVENTS

This action key (event) performs several functions for the communication system.

Rev. B

•

It initiates the Patient event and clears previous data in the Report screen.

•

It enables the PRE-/POST- data-handling feature of the BPM system.

•

If not already concluded, it closes out (ends) the current treatment ed in CentryNet (as if the STOP COLLECT Action key had been pressed).

•

It allows the to initiate a new treatment in CentryNet by activating the START COLLECT Action key and the PATIENT ID entry keypad.


7-33

Note The Patient event is triggered automatically by pressing an PATIENT DATA Selection key in Patient/Rx dialysis, or by pressing the Action Key in a Standard dialysis. . If an Rx selection key has been pressed the Action key is not displayed – the START COLLECT Action key will be displayed.

START COLLECT Pressing the START COLLECT Action key activates the PATIENT ID entry keypad. It is normally available in all modes exceptIDLE, TREATMENT and ADR PROGRESS. However, the START COLLECT Action key is not available for the following: •

The Patient event has not been triggered.

•

The STOP COLLECT Action key has not been pressed.

•

If any CentryNet alarms exist on the PHOENIX system.

PATIENT ID Keypad After pressing the START COLLECT Action key, a keypad appears allowing the entry of the PATIENT ID. 123

<<

Clear

>>

7

8

9

4

5

6

1

2

3

BackSpace

0

Enter the ID number through the keypad and press the CONFIRM button on the Main Control to confirm. The PATIENT ID can be any number from 0001 to 9999. Once the PATIENT ID is entered data collection begins. Pressing CONFIRM clears the treatment database in PHOENIX machine, begins the collection of treatment data to the network controller, and assigns the data to the PATIENT ID for that treatment.

Note The PATIENT ID may not be changed after the start of dialysis. It may, however, be changed before dialysis has been initiated. If a new PATIENT ID is required press the STOP COLLECT Action key, the Action key, the PATIENT ID Action key, and then enter the new ID through the keypad and press confirm. The PATIENT ID may also be changed after the treatment has been terminated, i.e., data collection has been ended, for this patient - follow the standard procedure for setting up a new patient.

Rev. B


STOP COLLECT The STOP COLLECT Action key stops data collection and ends the treatment in CentryNet. It appears after the PATIENT ID has been entered and data collection has begun. It is not available if any CentryNet alarms exist on the system. This key may be pressed to manually conclude collecting data for a particular treatment (PATIENT ID), or the operator may conclude the treatment automatically by setting up for the next patient, i.e., by pressing an Patient/Rx Management patient selection key, pressing the Action key, or pressing the PAT CONNECT Action key.

Note Do NOT turn OFF the machine without first pressing STOP COLLECT. Doing so will cause the treatment in CentryNet to be broken. Any data acquired prior to the power-off will be transferred to Broken Treatments and unavailable in the Completed Treatments database in CentryNet..

Note Do NOT return to the IDLE view from SETUP after entering the PATIENT ID without first pressing STOP COLLECT. Doing so will cause the treatment in CentryNet to be broken. Any data acquired prior to returning to IDLE will be transferred to Broken Treatments and unavailable in the Completed Treatments database in CentryNet.

Note After STOP COLLECT and before PATIENT ID the PHOENIX is considered “between” dialysis treatments. Whenever the CentryNet option is turned OFF, the machine is also “between” treatments. The CentryNet controller does not collect treatment data from a machine when it is in this mode

Note The STOP COLLECT Action key is made available if certain conditions in the treatment are met. One condition includes a successful polling (status response) communication between the PHOENIX machine and the CentryNet software. Another requires that all records from the treatment in progress have been collected by CentryNet. As a consequence, the availability of the STOP COLLECT Action key may be delayed under some conditions, for example, the STOP COLLECT Action key might become available only after the completion of the CentryNet polling loop and the ing of all charts and related records from the PHOENIX machine.

Rev. B


7-35

7.7.8 Operator Keys relating to manual data collection There is one additional Action key that controls when data is collected. •

CHARTS

CHARTS Pressing the CHARTS Action key triggers a chart record to be generated and sent to CentryNet. This chart record is identical to those automatically generated by the machine, as defined by the time established in the AUTOCHART TIME interval.

Note The system also takes a CHART reading according to the Blood Pressure Module sample interval. See the Blood Pressure Monitoring section of this manual for configuring the SAMPLE INTERV.

Rev. B


7.7.9 Alarm signals relating to CentryNet Several alarms may be generated regarding the CentryNet option. •

The CentryNet Station Offline (#322) alarm indicates a communication problem in the network, i.e., PHOENIX machine cannot detect communications.

•

The CentryNet: Incomplete Data Collection (#323) alarm may occur if the CentryNet network controller has not received all records from the PHOENIX machine and an attempt to end the treatment has been made.

•

The CentryNet: Duplicate Station (#321) alarm will occur whenever one of the STATION IDs is duplicated on more than one machine in the network.

•

The CentryNet: Station ID Error (#325) alarm indicates that a problem exists with the STATION ID assignment for a particular machine.

Note See Section 8 - Alarms and Signals in this manual for a detailed description of these alarms: Reason for Alarm, Machine Actions, Possible Causes/Suggested Action.

Whenever the PHOENIX machine displays any CentryNet-related alarms during a treatment, data collection is suspended. However, data is not lost if the alarm-causing situation is corrected without breaking the treatment.

Background Information for Investigating CentryNet Alarms Communication in the CentryNet network occurs as following: 1. Initial Reception - consists solely of the PHOENIX machine being able to detect communication on the network. When the PHOENIX machine successfully detects communication the CENTRYNET STATION OFFLINE message is masked. 2. Machine Assignment - consists of the PHOENIX machine being able to send out an assignment request and correctly interpret the network controller's response. If received successfully, the station assignment is accepted and the PHOENIX machine automatically comes Online. At that point the STATION ONLINE icon will display and the STATION ID ERROR message is masked. 3. Data Collection - consists of full interaction, with the network controller requesting specific data from the PHOENIX machine and acknowledging the transmissions. It provides detailed information about status, parameters, and current charts data. For additional information see the CentryNet Operator’s Guide.

Rev. B


7-37

7.7.10 CentryNet option activation/deactivation after a Fast Recovery of the Dialysis process In case of dialysis treatment interrupted and then restarted with a Fast Recovery of the Dialysis process procedure, the operator can • either start a new treatment data collection session for the same patient • or deactivate the CentryNet option and continue the dialysis treatment without recording treatment data. Starting a new data collection session Perform the following procedure to start a new treatment data collection session for the same patient and to restart the interrupted treatment: • •

Press the SETUP Action key Follow the directions in the Operator Message Window: Press + and hold, press - and hold, release + then release - to restart interrupted treatment

• • • •

The machine will immediately go to the PATIENT CONNECT mode. Press the Blood Pump ON/OFF button to start the Blood Pump. Reset the TOT WEIGHT L, DIALYSIS TIME and the WEIGHT LOSS/H using the SET mode. From the Report\CentryNet view, press the PATIENT ID Action key and enter thePATIENT ID. Press the Confirm button. Select the DIALYSIS Action key on the PATIENT CONNECT view.

Note After a Fast Recovery of the Dialysis process, if the CENTRYNET USE parameter value is set to YES, the DIALYSIS Action key becomes available only after properly entering the PATIENT ID.

Deactivating the CentryNet option Perform the following procedure to deactivate the CentryNet option and to restart the interrupted treatment without recording treatment data: • •

Press the SETUP Action key Follow the directions in the Operator Message Window: Press + and hold, press - and hold, release + then release - to restart interrupted treatment

• • • •

The machine will immediately go to the PATIENT CONNECT mode. Press the Blood Pump ON/OFF button to start the Blood Pump. Reset theTOT WEIGHT L, DIALYSIS TIMEand the UFR using the SET mode. From the Report\CentryNet view, enter in Set mode and set the CENTRYNET USE parameter value to NO. Press the Confirm button. Select the DIALYSIS Action key on the PATIENT CONNECT view.

Rev. B

7-38 PHOENIX OPERATOR MANUAL Note After a Fast Recovery of the Dialysis process, the DIALYSIS Action key becomes available only after setting the CENTRYNET USE parameter to NO.

Re-activating the CentryNet option during the same dialysis treatment If the CentryNet option has been deactivated, it can be reactivated, during the same dialysis treatment by performing the following procedure: • • • •

Press the WASHBACK Action key on the TREATMENT view and then press the

Confirm button. Enter in the Report\CentryNet view and press the SET button on the Main Control to enter the SET Mode. Select the CENTRYNET USE parameter box and set the parameter to YES, then press the Confirm button. From the WASHBACK view, press the TREATMENT Action key to continue the dialysis treatment with a new treatment data collection session for the same patient.

Note When the RINSEBACK VOLUME value set has been reached, the DIALYSIS Action key disappears from the WASHBACK view and it is no longer possible to return to dialysis.

Rev. B

8 ALARMS AND SIGNALS 8.

SECTION 8 - ALARMS AND SIGNALS

8.1 Classification and modes of intervention The machine has been designed to recognize and control various types of malfunctions and faults. There are three ways in which the operator is advised of an alarm condition: • Modulated audible alarm, high or low tone. • Visual alarm with a flashing light at the top of the machine. • Message in the alarm window on the Touch Screen with a description of the alarm. The alarms are classified according to the part of the machine affected and the type of intervention required from the operator. All the alarms are indicated in the alarm window on the Touch Screen, while the type of visual and audible alarm depends on the class of alarm.

Note Depending on the version of the buzzer installed on the machine, the tone of the audible alarms may be: • High or Low: for machines in which the Standard buzzer is installed; • Only High: for machines in which the Magnetic buzzer is installed. To install and configure the machine for the use of the Magnetic buzzer a service intervention is required. Refer to “CLASSES OF ALARMS” in this section, for the detailed description of the audible alarm type depending both on the class of the alarm and on the version of the buzzer.

WARNING If more than one alarm occurs at the same time, the control system automatically prioritizes them, relative to existing alarms. Only those alarms which describe the presumed cause of malfunction are displayed in the alarm window. Alarms that are generated as a result of the original malfunction are not displayed in the alarm window. The classes of Alarms will be described in decreasing order of importance, i.e the first is the most serious type of alarm.

CLASSES OF ALARMS

P

Alarms related to the safety of the patient, which may be controlled by the machine or by the intervention of the operator as described below. They may be identified by: • A Visual alarm with a flashing Red light of 4-4 modulation (one flash of 4/8 second, followed by a 4/8 second pause). • An Audible alarm with a 4-4 modulation that has a high pitch, modulated tone. • A Message on top of the Touch Screen preceded by an exclamation (!) mark.

Rev. B

8-2

PHOENIX OPERATOR MANUAL Note Some class P alarms have a descriptive "attribute", which specifies the type of fault.

Pd

Alarms not related to the safety of the patient, which are due to an error in the reading of process data contained in the memory of the Protection Module. These require operator intervention as described below. They may be identified by: • A Visual alarm with a Red light with a flashing pattern of 4-4 modulation (one flash of 4/8 second, followed by a 4/8 second pause). • An Audible alarm with a 4-4 modulation that has a high pitch, modulated tone. • A Message on the top of the Touch Screen preceded by an exclamation (!) mark and followed by the words: “data error”.

A

Alarms not related to the safety of the patient, caused by internal machine processes, requiring operator intervention to remove the cause, returning the process data to the operating limits. They may be identified by: • A Visual alarm with a Red light with a flashing pattern of 4-4 modulation (one flash of 4/8 second, followed by a 4/8 second pause). • An Audible alarm with a 4-4 modulation that has a high pitch, modulated tone. • A Message on the top of the Touch Screen.

B

Alarms not related to the safety of the patient, caused directly by an operator error on the machine controls or caused by machine conditions requiring operator intervention. These require operator intervention. They may be recognized by: • A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second followed by a pause of 7/8 second). • An Audible alarm with a 1-7 modulation that has a low pitch if the Standard buzzer is installed or that has a high pitch if the Magnetic buzzer is installed, modulated tone. • A Message on the top of the Touch Screen.

W

E

Rev. B

Indication of disturbances not related to the safety of the patient and due to conditions not recognized by the Protection Module. These disturbances may revert to normal without operator intervention. They may be identified by: • A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second followed by a pause of 7/8 second). • An Audible alarm with a modulation of 1-7 and a high pitch, modulated tone. • A Message on the top of the Touch Screen, preceded by W! Alarms which are not related to the safety of the patient, and are caused by control errors that may revert to normal without the need for operator intervention. They usually require the intervention of a Service technician. They may be identified by: • A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second and followed by a pause of 7/8 second). • Audible alarm with a modulation of 1-7 and a high pitch, modulated tone. • A Message indication on the top of the Touch Screen.


8-3

D

Indication related to a machine state requiring the attention of the operator. These are not related to the safety of the patient or to an error condition. They may be identified by: • A Visual alarm with a Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second followed by a pause of 7/8 second). • An Audible alarm with a modulation of 1-7 and a low pitch if the Standard buzzer is installed or that has a high pitch if the Magnetic buzzer is installed, modulated tone. • A Message on the top of the Touch Screen.

C

Alarms which are not related to the safety of the patient and are due to transitory control errors which usually revert to normal without operator intervention. If these errors persist, the machine is probably not functioning properly and Service must be notified. They may be identified by: • A Visual alarm with Yellow light with a flashing pattern of 1-7 modulation (a flash of 1/8 second followed by a pause of 7/8 second). • A Message on the top of the Touch Screen.

The operator can therefore identify the class of alarm with the aid of the three types of indicators available and then take appropriate action.

Note All the alarms are coded numerically. The relevant code is displayed on the Touch Screen with the alarm message.

Note The PHOENIX machine is able to send a signal to a remote alarm device, to indicate an audible alarm, only in case of occurrence of alarms in the classes P, Pd, A, W, E.

LEVELS OF OPERATOR INTERVENTION When an alarm condition occurs, the operator may be able to manually deal with the problem, depending on its class. The specific actions to take are described for each individual alarm. Three types of intervention are possible:

1) OVERRIDE When an alarm is activated, the operator can try to solve the problem by stopping the autonomous operations being carried out by the machine and reaching a specific safe state. This can be done by pressing the OVERRIDE button on the Main Control . When the LED on the OVERRIDE button comes on, release the OVERRIDE button. During the OVERRIDE state, the LED is on.

Rev. B

8-4

PHOENIX OPERATOR MANUAL The OVERRIDE state lasts 2 minutes. During this period: • Some of the safety mechanisms are disabled (as pointed out in the description of each alarm). • The Audible alarm stops. • The Visual alarm remains ON as long as the fault persists. • The Message remains on the Touch Screen with the description of the cause of the alarm. • The Message is preceded by the icon representing the OVERRIDE condition: ! Venous Pressure • Every 20 seconds the Audible and Visual alarms are repeated. If one or more additional faults cause an alarm during the OVERRIDE state, the description relative to each fault is added to the superimposed window. In this case the operator can intervene with the OVERRIDE button. All the new alarms are set to the OVERRIDE state. The timer relative to the duration of the OVERRIDE state is reset to zero each time the button is pressed so this state remains for 2 minutes from the last time the button was pressed. OVERRIDE is removed: • Automatically when the time has elapsed. • Manually before the time has elapsed, by pressing the OVERRIDE button until the LED goes off and then releasing the button. When the OVERRIDE state has been removed, any remaining alarms are reactivated, along with their respective descriptive messages.

Note In some specific alarm cases, the OVERRIDE button has different effects. The alarm condition is RESET and the alarm message disappears from the screen. These cases are marked with in the following list.

Note The selection of the OVERRIDE button has no effect on the alarms that occur while the machine is performing one of the following T1Tests: Board U, EPROM CRC, Comparator, Board RAM, Battery, Buzzer Lamp, Voltages (24V), Venous Clamp.

WARNING The selection of the OVERRIDE button has effect on all the alarms that are active and can be set to the OVERRIDE state (refer to the “Alarms List” in this section for the list of alarms that can be set to the OVERRIDE state). In the Alarm Area of the screen only two alarm messages can be displayed; if there are more than two alarms active, the additional alarms may be viewed on the Machine view by pressing the Machine Navigation key.

Rev. B


8-5


2) MUTE By pressing the MUTE button on the Main Control , the operator can temporarily (2 min) deactivate the audible alarm. During the MUTE state: • The LED on the MUTE button remains on. • The Audible alarm is deactivated. • The Visible alarm remains. • The message remains on the Touch Screen with the description of each alarm. The MUTE state is removed: • Automatically when the time has elapsed. • Manually by pressing the MUTE button until the LED starts to flash. • When a new alarm is activated.

3) RESTART In certain alarm conditions, the view relative to the current phase of the process disappears from the Touch Screen and the RESTART key becomes available to allow an exit from the alarm condition. A suggestion on how to solve the problem appears in the Operator Message area. When the fault has been removed and RESTART pressed, normal operation is resumed. The current view reappears on the Touch Screen.

WARNING If the first time the RESTART key is selected, the machine returns to the RESTART condition, wait at least ten seconds before pressing the RESTART key again.

WARNING In some Protection alarms, the audible alarm is active only after DIALYSIS is initiated.

WARNING Press the RESTART key only after having removed the cause requiring the “RESTART”, as described on the Touch Screen. Never press the RESTART key more than 2 or 3 times if the problem has not been identified that will remove the cause of “RESTART”.

Rev. B

8-6


8.1.1 Operator Guidelines for responding to Alarms on the PHOENIX machine In case of an alarm condition, the Operator should perform the following actions: 1. Press the MUTE Button to silence the Audible Alarm, if desired. 2. Observe the Alarm Message in the Alarm Area at top of the Touchscreen. Alarms are referenced by number. The number is located on the Right Side of the Alarm Message. 3. Determine the cause of the Alarm. If uncertain about the cause or appropriate response to the alarm, refer to Alarms Troubleshooting, in this section, for possible causes and solutions. 4. Correct the cause of the Alarm and then press the OVERRIDE Button. The Alarm or Alarms that are present will be overridden for 2 minutes. 5. In some cases it may be necessary to restore the previous operating conditions to properly troubleshoot an Alarm. In these cases the OVERRIDE Button may be pressed prior to correcting the cause of the Alarm.


Note For some Alarm Conditions a RESTART Key will appear on the Touchscreen. These Alarms are cleared by pressing the RESTART Key, rather than pressing the OVERRIDE Button.

Note If the Overridden Alarms reoccur during the 2-minute OVERRIDE period they will not cause a new Alarm.

Note If other new Alarms occur during the OVERRIDE period, the PHOENIX machine will generate audible and visual alarms.

Note Each time the OVERRIDE Button is pressed the OVERRIDE period is reset to 2 minutes.

Rev. B


8.1.1.1

8-7

OVERRIDING Arterial and Venous Pressure Alarms Following an Arterial or Venous Pressure Alarm (code #155 and #305), pressing the OVERRIDE Button will restart the Blood Pump at the previous speed. During the OVERRIDE period, the overridden Arterial and/or Venous Pressure Alarms will not recur until the 2-minute period has elapsed. However, after 30 seconds the previously memorized alarm windows will be displayed on the Pressure Bar Graphs. If the Pressure Pointers move outside of the alarm windows, the corresponding alarm messages and the Override Icon will be displayed in the Alarm Area. The Blood Pump will continue to operate because the Alarms are in an Override condition. An audible alarm will also occur, if it has not been previously muted. When the Pressure Pointers return within the alarm windows the alarm messages will no longer appear. Additional, supplementary Arterial and Venous Pressure Limit Alarms are always present and active: • “! ART PRESSURE LIMIT” (code #306), which occurs when the pressure reaches the value set for the MIN ART PRESSURE parameter. • “! VEN PRESSURE LIMIT” (code #154), which occurs when the pressure reaches the value set in the Configuration Menu for the VEN PRES LIMIT parameter. However the Operator must consider that during the time when the Arterial or Venous Pressure Alarms are OVERRIDDEN and before an ! ART PRESSURE LIMIT#306 alarm, or a ! VEN PRESSURE LIMIT #154 alarm occurs: • The patient’s vascular access may be exposed to pressure extremes. • Restriction of blood flow to the Arterial Chamber may result in emptying of the Chamber prior to the Redundant Alarm occurring.

WARNING It is the Operator’s responsibility to determine and to correct the cause of the Arterial or Venous Pressure Alarm (#155 and #305) PRIOR to pressing the OVERRIDE Button.

Note Pressing the OVERRIDE button will “spread the alarm windows” for 30 sec.

Rev. B

8-8


8.1.1.2 Operator Actions required after pressing the OVERRIDE Button for Arterial and Venous Pressure Alarms After pressing the OVERRIDE Button the Operator should remain at the machine and observe the Arterial and Venous Pressure Pointers. The Operator should also wait for the memorized Arterial and Venous Pressure Alarm Windows to reappear around the Pressure Pointers and then determine if the needle position, the Blood Pump speed or the alarm windows are appropriate. If required, the Arterial or Venous Alarm Windows may be adjusted by pressing the SET Button and then highlighting the appropriate Pressure Bar Graph. The CONFIRM Button is then pressed to adjust the Alarm Windows, followed by pressing the SET button to return to the Home Screen. The newly memorized alarm widows will appear around the pressure pointers. If the pressures are stable and within the alarm windows the Operator may press and hold the OVERRIDE Button until the orange LED to the right of the button is no longer illuminated. This will cancel the Override condition. Alternatively the Operator may observe the machine until the 2-minute Override period is completed.

8.1.2 Alphabetic List of Alarms Below is a list of all the alarms in alphabetic order, indicating: • The message that appears on the Touch Screen. • The Attribute (if any) • The Numerical Code • The Class • The OVERRIDE button availability

Rev. B

8-9


ALARM MESSAGE ! AIR & FOAM DETECTOR

CODE 4

! ART PRESSURE ALARM

305

! ART PRESSURE LIMIT

306

! ARTERIAL PUMP

10

! AUTOEMPTYING: MAX ACTIVATION TIME

294

! BIC CONDUCTIVITY

23

! BLOOD DETECTED DURING PRIME

ATTRIBUTE AIR BUBBLE T0 FAILURE MAXIMUM MINIMUM UNDEFIN MAXIMUM MINIMUM UNDEFIN LINE PRES

CLASS

OVERRIDE

P P

YES PARTIAL YES

P

NO

P

YES

P MAXIMUM MINIMUM

YES

P

NO

342

P

NO

! BLOOD LEAKAGE

28

P

YES

! BLOOD PUMP DIRECTION

340

P

! BY WRONGLY EXTENDED

302

P

NO

! CONCENTRATE CANS

40

P

NO

! CONDUCTIVITY PROFILE

210

! CONTROL SYSTEM OUT OF ORDER

274

! DIALYSATE FLOW

44

! DIASCAN MEASUREMENT FAILED :

251

! FINAL CONDUCTIVITY

62

! PI PO MAX

HIGH PH LOW PH A PUMP B PUMP A+B PUMPS CURVE TIMING SET VAL

P

YES

YES

P

NO

P

YES

P

YES

P

NO

114

P

NO

! PI PO MIN

115

P

NO

! PROTECTIVE CARD COMM. TIMEOUT

120

P

NO

! PROTECTIVE MSG TRANSFER ERROR

39

PD

NO

! SN COMMUTATION

125

P

! T1 TEST FAILED

133

P

NO

! TEMPERATURE

134

P

NO

MAXIMUM MINIMUM UNDEFIN MAXIMUM MINIMUM

MAXIMUM MINIMUM UNDEFIN

YES

Rev. B

8-10

PHOENIX OPERATOR MANUAL ALARM MESSAGE

CODE

! TEMPERATURE EXCESSIVE VALUE

136

! UF MASS BALANCE

144

! UF RATE ERROR

145

! VEN PRESSURE ALARM

155

! VEN PRESSURE LIMIT

ATTRIBUTE

VALVES D1-2/P2 NO CALIB LOW HIGH VESSEL MAXIMUM MINIMUM UNDEFIN

CLASS

OVERRIDE

P

NO

P

YES

P

YES

P

YES

154

P

! VOLTAGES INCORRECT

160

P

YES PARTIAL SEE NOTE 2 NO

! WEIGHT LOSS RATE PROFILE

212

!ART PRESSURE DATA ERROR

307

PD

NO

!AUTOEMPTYING DATA ERROR

277

PD

NO

!BICARB 6.6% COND DATA ERROR

19

PD

NO

!BICARB 8.4% COND DATA ERROR

20

PD

NO

!BICART COND DATA ERROR

263

PD

NO

!BLD DATA ERROR

26

PD

NO

!BLOOD FLOW DATA ERROR

27

PD

NO

!BY ALARM DATA ERROR

36

PD

NO

!CONDUCTIVITY DATA ERROR

41

PD

NO

!DATA ERROR

43

PD

NO

!DIALYSAT FLOW DATA ERROR

45

PD

NO

!DIALYSIS TIME DATA ERROR

239

PD

NO

!DIASCAN FREQ. DATA ERROR

257

PD

NO

! LONG POWER FAILURE

80

P

!MAX BLOOD FLOW DATA ERROR

312

PD

NO

!PAUSE THERAPY DATA ERROR

313

PD

NO

!S/N MAX PRESSURE DATA ERROR

209

PD

NO

!S/N MIN PRESSURE DATA ERROR

208

PD

NO

! SHORT POWER FAILURE

124

P

Rev. B

CURVE TIMING SET VAL

P

YES

YES

YES


ALARM MESSAGE

CODE

ATTRIBUTE

8-11

CLASS

OVERRIDE

!TEMPERATURE DATA ERROR

135

PD

NO

!TOT WEIGHT L DATA ERROR

240

PD

NO

!UF DATA ERROR

143

PD

NO

!VEN PRES LIMIT DATA ERROR

152

PD

NO

!VENOUS PRES DATA ERROR

150

PD

NO

!WLR MINIMUM DATA ERROR

164

PD

NO

> GENERAL SAFE STATE <

64

P

NO

A CONNECTOR POSITION

2

B

NO

ACE CAN IS EMPTY

1

A

YES

ART PRESSURE LIMIT

11

A

NO

ART PUMP POSITION

13

C

ART SENSOR ERROR

6

A

NO

ARTERIAL CLAMP POSITION

7

A

NO

ARTERIAL COVER IS OPEN

8

B

NO

B CONNECTOR POSITION

18

B

NO

BAD BLOOD LINE POSITION

219

A

YES

BAD HYDRAULIC CONDITION

14

E

NO

BICARB CAN IS EMPTY

24

A

YES

BICART CONNECTOR POSITION

22

B

NO

BICART IS EMPTY

21

A

YES

BIOSLAVE MSG TRANSFER ERROR

297

C

NO

BIOSLAVE CARD COMM. TIMEOUT

296

E

NO

BLOOD CARD COMMUNICATION TIMEOUT

295

E

NO

BLOOD CARD MSG TRANFER ERROR

130

C

NO

BLOOD MODULE<->MASTER DISK MISMATCH

259

A

YES

BLOOD PUMP JAMMED

12

C

YES

BLOOD PUMP NOT IN START POSITION

29

E

YES

BPM NOT CONNECTED

255

A

YES

See warning at end of section.

YES

Rev. B

8-12


CODE

ATTRIBUTE

CLASS

OVERRIDE

BPM: AID REQUEST

30

A

YES

BPM: MEASUREMENT NOT MADE

32

A

YES

BPM: SYSTEM FAILURE

31

A

YES

BT1 LEVEL ERROR

33

E

NO

BT1 MALFUNCTIONING

299

C

NO

BT2 LEVEL ERROR

34

E

NO

BT2 MALFUNCTIONING

268

C

NO

BTP LEVEL ERROR

35

E

NO

CENTR. ACID CONNECTOR POSITION

271

B

NO

CENTR. BICARB CONNECTOR POSITION

272

B

NO

CENTRYNET STATION OFFLINE

322

D

NO

CENTRYNET: DUPLICATE STATION

321

D

NO

CENTRYNET: INCOMPLETE DATA COLLECTION

323

E

YES

CENTRYNET: STATION ID ERROR

325

D

NO

D1 OUT OF ORDER

300

C

NO

D2 OUT OF ORDER

301

C

NO

DIAL CONNECTOR POSITION

65

B

NO

DIALYSER SAFETY PRESSURE

68

D

NO

DIASCAN INITIAL CALIBRATION FAILED

244

B

YES

DIASCAN: INCORRECT MEASUREMENT

246

C

YES

DIASCAN: LIMIT LOW CLEARANCE

249

B

YES

DIASCAN: MEAS. IMPOSSIBLE (ALARM)

270

B

YES

DIASCAN: MEASUREM. IMPOSSIBLE (SET)

269

B

YES

DIASTOLIC PRESSURE ALARM

46

A

DISINF CONNECTOR POSITION

47

B

NO

E2PROM BIOSLAVE ERROR

50

E

NO

E2PROM BLOOD ERROR

48

E

NO

E2PROM HYDR ERROR

49

E

NO

END DIA - TOTAL WL

53

B

NO

Rev. B

YES


ALARM MESSAGE

CODE

ATTRIBUTE

8-13

CLASS

OVERRIDE

END DIA - DIFF TIME REACHED

339

B

NO

END DIA - TIMEOUT

51

B

NO

END DIA - TOTAL BLOOD

52

B

NO

END HEPARIN

55

A

NO

END OF DIALYSATE PREPARATION

57

D

NO

END OF HEPARIN TIME

58

B

NO

END OF WASHBACK PROCEDURE

332

C

ERROR ON CALIBRATION TOOL

279

B

NO

ERROR ON HEATER PROTECTION

59

A

NO

ERROR ON TOTAL WEIGHT LOSS

60

B

NO

FIXED DATA

63

C

NO

FORECAST DIAL. DOSE NOT MATCH PRESCRIP.

354

E

YES

>> GENERAL SYSTEM FAILURE << System Blocking

xxx

/

/

HEART RATE ALARM

66

A

YES

HEATING SYSTEM NOT STARTED

67

B

NO

HEPARIN PUMP DIRECTION ERROR

69

E

NO

HEPARIN SPEED ERROR

70

C

NO

HEPARINISATION NOT STARTED

71

B

HIGH LEVEL IN DIS TANK

72

E

NO

HIGH LEVEL IN UF VESSEL

73

E

NO

HYD CARD MSG TRANSFER ERROR

131

C

NO

HYDRAULIC CARD COMM. TIMEOUT

304

E

YES

KT-KT/V TARGET ACHIEVED

355

LOW LEVEL IN DIS TANK

82

E

NO

LOW LEVEL IN UF VESSEL

83

E

NO

LOW PRESSURE IN DEGASSER

84

E

NO

LOW TEMPERATURE LIMIT REACHED

81

C

NO

MAX PI PRESSURE

87

A

NO

MAX PO PRESSURE

88

A

NO

YES

YES

YES

Rev. B

8-14


CODE

ATTRIBUTE

CLASS

OVERRIDE

MAX TEMPERATURE LIMIT

90

B

NO

MIN PI PRESSURE

94

A

NO

MIN PO PRESSURE

95

A

NO

NO POWER

353

A

NO

NO WATER

100

A

NO

OUTPUT OVERPRESSURE

206

A

NO

P1 PUMP OUT OF ORDER

104

E

NO

P2 PUMP OUT OF ORDER

106

B

NO

PA AUTOCALIBRATION NOT PERFORMED

107

E

NO

PA PUMP OUT OF ORDER

108

B

NO

PB AUTOCALIBRATION NOT PERFORMED

109

E

NO

PB PUMP OUT OF ORDER

110

B

NO

PC PUMP FAILURE

111

E

NO

PH MAXIMUM ALARM

112

E

NO

PH MINIMUM ALARM

113

E

NO

PI PRESSURE SENSOR ERROR

116

E

NO

PO PRESSURE SENSOR ERROR

118

E

NO

PRIME VOLUME COMPLETED

54

C

PUF AUTOCALIBRATION NOT PERFORMED

121

E

NO

PUF PUMP OUT OF ORDER

122

B

NO

S/N: VEN PRESSURE NOT CHANGING

351

A

YES

S/N: VENOUS PRESSURE UNRELIABLE

352

B

NO

START DIALYSIS DELAYED

129

B

NO

SYSTOLIC PRESSURE ALARM

132

A

TIME OUT PROC

190

E

NO

TIMEOUT ERROR ON PROCESS CLOSING

335

C

NO

TIMEOUT ERROR ON PROCESS SELECTION

333

C

NO

TIMEOUT ON PA AUTOCALIBRATION

139

E

NO

TIMEOUT ON PB AUTOCALIBRATION

140

E

NO

Rev. B

YES

YES


ALARM MESSAGE

CODE

ATTRIBUTE

8-15

CLASS

OVERRIDE NO

TIMEOUT ON PUF AUTOCALIBRATION

141

E

TOTAL HEPARIN INFUSED ERROR

338

B

TRANSMEMBRANE PRESSURE

142

C

ULTRAFILTER : TMP TOO HIGH

237

B

NO/YES SEE NOTE 1 YES

ULTRAFILTER IS PACKED

138

B

NO

ULTRAFILTER MAX PRESSURE

146

C

NO

ULTRAFILTER PRESSURE SENSOR

147

C

NO

ULTRAFILTER: LOWER SWITCH

61

B

NO

ULTRAFILTER: UPPER SWITCH

38

B

NO

VEN PRESSURE OUT OF RANGE

153

A

NO

VEN SENSOR ERROR

159

A

NO

VENOUS CLAMP POSITION

148

A

NO

W! STILL IN MINIMUM UF

189

W

YES

W! AD CONVERTER

165

W

YES

W! AIR & FOAM DETECTOR

264

W

YES

W! ANALOG HIVAR

166

W

YES

W! ART PRESSURE SENSOR ERROR

317

W

YES

W! BLD CALIBRATION PHASE

167

W

YES

W! BLD FAST RECOVERY

168

W

YES

W! BLD LED EXCESSIVE VALUE

169

W

YES

W! BLD RECEIVER EXCESSIVE VALUE

170

W

YES

W! BLOOD IN THE VENOUS LINE

308

W

YES

W! BLOOD PUMP STOPPED BY ABD

318

W

YES

W! BLOOD SENSED IN VENOUS LINE

359

W

YES

W! COMMUNICATION CRC ERROR

327

W

YES

W! DAC EXCURSION

172

W

YES

W! DRIFT ON FLOWMETERS

343

W

YES

W! E2PROM CRC

173

W

YES

W! LOW ART FLOW FOR TOO LONG

204

W

YES

YES

Rev. B

8-16


CODE

ATTRIBUTE

CLASS

OVERRIDE

W! MASS BALANCE NOT RELIABLE

309

W

YES

W! PA AUTOCALIBRATION FAILED

176

W

YES

W! PATIENT SENSOR SATURATION

273

W

YES

W! PB AUTOCALIBRATION FAILED

177

W

YES

W! PDR PRESSURE SENSOR ERROR

252

W

YES

W! PI PRESSURE SENSOR

178

W

YES

W! PO PRESSURE SENSOR

179

W

YES

W! PUF AUTOCALIBRATION FAILED

180

W

YES

W! PV PRESSURE SENSOR

181

W

YES

W! RAM ERROR

175

W

YES

W! SET VALUE OUT OF RANGE

250

W

YES

W! STILL IN BY

171

W

YES

W! STILL IN PAUSE THERAPY

329

W

W! T1 TEST FAILED

183

W

W! T1TESTS DISABLED

203

W

W! TEMPERATURE SENSOR

184

W

YES

W! U.F. CALCULATION NOT RELIABLE

220

W

YES

W! UNKNOWN MESSAGE TYPE

185

W

YES

W! UNRECOGNIZED SOFTWARE EXEC

182

W

YES

W! VENOUS LINE NOT FITTED

205

W

YES

W! VOLTAGES INCORRECT

187

W

YES

W! WAIT FOR PRESSURE TEST EXECUTION

319

W

YES

W! WAIT TO CONTINUE

188

W

WAIT FOR CONFIRMATION

283

E

YES SEE NOTE 3 YES

WHF DOOR POSITIONING

326

B

NO

YES YES NO

Note 1 If the parameter TMP ALARM is set to NO in the Config menu, the alarm cannot be overridden; if the parameter is set to YES, the alarm can be reset.

Rev. B


8-17

Note 2 OVERRIDE only has an effect if the measured venous pressure is less than +450 mmHg, otherwise the safety activation is not removed.

Note 3 To RESET the alarm condition, press the OVERRIDE button then press the CONFIRM button.

Rev. B

8-18

PHOENIX OPERATOR MANUAL WARNING In each alarm condition critical to the safety of the patient (Class P alarms), the Protection Module checks that the actions relating to the specific safe state are performed correctly by the machine. If this test es, the machine remains in the safe state until the cause of the alarm is removed (as indicated in the Suggested Action). Otherwise, i.e. if the safe state is not correctly configured, the Protection Module generates a > GENERAL SAFE STATE < alarm and the following steps are taken: • The Dialysate Flow through the dialyser is stopped. • The Ultrafiltration Pump is stopped. • The Blood Pump is stopped. • The Venous Clamp is closed. The machine is stopped and the patient isolated. The operator is warned by: • An alarm window with the message:

→> GENERAL SAFE STATE < ←

• An Operator Message in the help window: You Must Switch Off The Machine • A Visual alarm, with a flashing red light of a 6-2 modulation (two flashes lasting 3/8 of a second with an intervening pause of 1/8 of a second) • A high volume Audible alarm of 6-2 modulation. • A numerical code relative to the specific safe state that was not correctly configured (see below). The GENERAL SAFE STATE is a shutdown alarm and the treatment is stopped. This is a latching alarm and in order to reset it, the machine must be switched OFF. If a General Safe State occurs as a result of a T1 test failure, the following message is displayed: ! T1 Test Failed If a General Safe State is due to incorrect voltage, the following message is displayed: ! Voltages Incorrect If a General Safe State is due to a Temperature elevated value alarm, the following message is displayed:

! Temperature Excessive Value

WARNING When the Blood Pump stops due to an alarm condition: • The venous pressure alarm window lower limit is automatically set to +10 mmHg and the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 - Configuration Description, in this manual). • The arterial pressure alarm window lower limit is automatically set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and the upper limit is set to +150 mmHg. These values are maintained for all the time the Blood Pump is OFF and for 30 sec. after the Blood Pump restart.

Rev. B


8-19

WARNING The machine is supplied with a special device called the Patient Sensor which has the task of setting some class P alarms in an automatic OVERRIDE state when DIALYSIS has not yet started, since the patient’s blood has not yet reached the venous line in the Patient Sensor. Therefore, the relevant safety systems are locked until the presence of blood is detected to allow a smooth start to the process. This condition of the Patient Sensor is indicated by an Icon in the Icon Area on the Touch Screen. The Patient Sensor Icons are: • • •

No blood has been detected Blood has been detected but the operational test has failed. Not all the relevant safety systems are activated. Blood has been detected and all the relevant safety systems are activated.

For each Class P alarm, the possibility of an automatic OVERRIDE by the Patient Sensor and symbol the related effects are indicated, for each alarm in this section, by highlighting the in correspondence to the safe requests which are active only after either the Patient Sensor has detected blood in the venous line, or after the DIALYSIS Action key has been pressed.

Note In this section the state.

icon is used to indicate the possibility to set the alarm to the OVERRIDE

Rev. B

8-20


8.2 Numerical List of Alarms and relevant description Below is a description, in numerical order, of all the alarms listed in the previous table.

ACE CAN IS EMPTY 1 Reason for Alarm

In DIALYSIS: The Acid/Acetate Pump (PA) has been driven at maximum speed for over 25 seconds due to the conductivity not reaching the set value. In DESCALING: The Acid/Acetate Pump PA has been driven at maximum speed for over 25 seconds and the wrong solution has been detected for DESCALING to be performed.

Machine Actions

The Acid/Acetate Pump PA stops.

Possible Cause

Suggested Action

1. Acid/Acetate Concentrate container is empty.

1. Supply appropriate concentrate to the relevant inlet connector following the Acid/Acetate Concentrate Container Change procedure (see Section 5.A – Special Procedures, in this manual). 2. Check and if necessary change the Acid/Acetate Concentrate Wand. Press OVERRIDE to continue. 3. Supply appropriate vinegar solution to the relevant inlet connector and press the OVERRIDE button to restart uptake of vinegar into the machine. 4. Supply appropriate concentrate/vinegar to the relevant inlet connector and press the OVERRIDE button to restart uptake of concentrate to the machine. 5. the correct solution, depending on the DESCALING procedure selected.

2. Massive air leak from the Acid/Acetate Concentrate Wand. 3. If the VINEGAR DESCAL Action key has been selected, the vinegar container is empty. 4. If the DESCALING Action key has been selected the Acid/Acetate container is empty. 5. The correct DESCALING procedure has not been selected for the descaling solution in use. 6. Acid/Acetate Concentrate connector not connected to the Concentrate Wand.

Rev. B

6. the Concentrate connector is well fitted into the proper Wand. Press OVERRIDE to continue. Call for Service if the problem persists.


8-21

A CONNECTOR POSITION 2 Reason for Alarm

The Acid/Acetate Concentrate connector is not in the correct location for the phase of the machine.

Machine Actions

In ADR: the machine will stop and wait for the connector position to be corrected. In DIALYSIS: during the preparation phase, the machine will not proceed: during the treatment phase, the machine will automatically go into By.

Possible Cause

Suggested Action

1. the right connector position in 1. Acid/Acetate Concentrate Connector is in relation to the machine phase. the wrong position, or not fully inserted into its Rinse Port. Call for Service if the problem persists.

Rev. B

8-22


!

AIR & FOAM DETECTOR 4

Attribute

1. Air Bubble 2. T0 Failure

Reason for Alarm

Air Bubble The presence of air is detected in the venous line at the Air Bubble Detector. T0 Failure The T0 Test, related to the ABD sensor, has failed.

Machine Actions

Stops the Blood Pump. Closes the Venous Line Clamp. Ultrafiltration Pump is reduced to its minimum value.

Possible Cause

Suggested Action

1. #4 with Attribute Air Bubble.

1. Procedure to clear the alarm. a. Press the MUTE button to silence the alarm. b. Manually clamp the venous line below the venous line clamp and any visible air bubbles. c. Clamp the venous dialyser line between the dialyser and the venous chamber. (If in SINGLE NEEDLE mode, clamp the venous dialyser line between the dialyser and the expansion chamber.) d. Open the white cap on the venous access line of the Cartridge and attach a sterile 10-20 ml syringe to the venous access line of the Cartridge. Open the venous access line clamp. e. Aspirate until the venous pressure is between –50 and -150 mmHg. Avoid a negative pressure over -150 mmHg. Close the venous access line clamp. (If in SINGLE NEEDLE mode connect the syringe to the access port on the post dialyser expansion chamber) Remove the syringe and replace the white cap on the venous access line. f. Press the OVERRIDE button to open the Venous Line Clamp. The Venous Line Clamp and the Air Bubble Detector will deactivate for 30

Air or foam in the venous line (inside or below the Air Bubble Detector).

Rev. B


g.

h.

i.

j.

8-23

seconds.(See Note 1 and Warning 1). Slowly open the clamp on the venous line. Air is drawn automatically into the venous chamber. If air bubbles remain, repeat the procedure from step b. Remove the clamp on the venous dialyser line between the dialyser and the venous chamber. (or in between the dialyser and the post-dialyser expansion chamber for SINGLE NEEDLE.) Press the RESUME button to restart the blood pump at the previous value. (See Warning 2) If needed, adjust the blood level in the Cartridge chambers

2. #4 with AttributeAir Bubble. Venous Line is scratched under the Air Bubble Detector.

2. Proceed as follows: a. Move the venous line position a few centimeters. b. Follow the procedure to clear the alarm described above.

3. #4 with Attribute Air Bubble. Air Bubble Detector door is open.

3. Proceed as follows: a. Close the door of the Air Bubble Detector. b. Follow the procedure to clear this alarm described above.

4. #4 with Attribute Air Bubble. Decreased Sensitivity of the Air Bubble Detector.

4. Proceed as follows: a. Re-position the venous line. b. Follow the procedure to clear this alarm described above. If the problem persists call for Service

5. #4 with Attribute T0 Failure. Failure in the electronic board.

5. Proceed as follows: a. Follow the procedure to clear this alarm described above. If the problem persists call for Service Call for Service if the problem persists. When the alarm #4 occurs, take note of the values displayed for the parameters ABD DIAGNOSTIC in the MACHINE view: this information could be helpful for the service technician.

Note 1 The Venous Line Clamp is not automatically opened if the venous pressure is not lower than +10mmHg.

Rev. B

8-24

PHOENIX OPERATOR MANUAL WARNING 1 Do not open the clamp in between the dialyser and the venous chamber (in DOUBLE NEEDLE mode) or in between the dialyser and the post-dialyser expansion chamber (in SINGLE NEEDLE mode) because the positive pressure at the blood side of the dialyser could push air bubbles to the patient.

WARNING 2 RESUME has no effect if the venous line is not inserted in the Venous Line Clamp (in this case the alarm #205 appears).

Note Check for Air bubbles starting from PATIENT CONNECT, even if the Patient Sensor has not detected blood.

Note To prevent an !AIR IN BLOOD (#4) alarm, follow the guidelines below: • Follow the priming procedure carefully. • Ensure arterial line is connected securely and leak-free. • Carefully manage the extracorporeal accesses when istrating medication. • Ensure the blood levels in the Cartridge chambers are at the target level.

Rev. B


8-25

ART SENSOR ERROR 6 Reason for Alarm

The control system has detected a large spike or a large rapid change while monitoring the Arterial Pressure Sensor.

Machine Actions

The Blood Pump is stopped. The Ultrafiltration Pump speed is reduced to its minimum value.

Possible Cause

Suggested Action

1. Temporary problem.

1. Wait a few seconds for the alarm to be cleared. Call for Service if the problem persists.

Rev. B

8-26


ARTERIAL CLAMP POSITION 7 Reason for Alarm

The optical switch on the Arterial Line Clamp indicates that the clamp is open when it should be closed or it is closed when it should be open. This alarm only applies to single needle machines.

Machine Actions

The Blood Pump stops. The Ultrafiltration Pump speed is reduced to its minimum value.

Possible Cause

Suggested Action

1. Arterial Line Clamp obstructed.

1. the Arterial Line Clamp is free from obstruction. Only the arterial line should be inserted into the clamp. 2. Carefully clean the Arterial Line Clamp with a cloth dipped in a disinfectant solution. Call for Service if the problem persists.

2. Arterial Line Clamp dirty.

Rev. B


8-27

ARTERIAL COVER IS OPEN 8 Reason for Alarm

The Blood Pump Cover is open.

Machine Actions

The Blood Pump is stopped. The Ultrafiltration Pump speed is reduced to its minimum value. Closes the Venous Line Clamp.

Possible Cause

Suggested Action

1. Blood Pump Cover is open.

1. Close the Blood Pump Cover. Be sure the Blood Pump Cover is securely latched. 2. Carefully clean the magnet placed behind the Blood Pump Door with a cloth dipped in a disinfectant solution. Call for Service if the problem persists.

2. The magnet is dirty.

Note The check for the front cover of the Blood Pump is enabled at the beginning of PRIME.

Rev. B

8-28


!

ARTERIAL PUMP 10

Attribute

1. Minimum 2. Maximum 3. Undefin 4. Line Pres

Reason for Alarm

Minimum The actual flow of the Blood Pump is less than the set value or the minimum permitted value. Maximum The actual flow of the Blood Pump is higher than the set value or the maximum permitted value. Undefin There is an error in the reading from the encoder on the Blood Pump or the rotor position sensors. Line Pres The venous line is not inserted inside the Air Bubble Detector housing.

Machine Actions

Stops the Blood Pump. Closes the Venous Line Clamp. Ultrafiltration Pump is reduced to its minimum value.

Possible Cause

Suggested Action

1. The Blood Pump speed is different from the 1. Press OVERRIDE to restart the Blood Pump. set value. 2. The venous line is not inserted inside the Air 2. Check the venous line position. Bubble Detector housing. Call for Service if the problem persists.

Rev. B


8-29

ART PRESSURE LIMIT 11 Reason for Alarm

The arterial pressure is beyond the upper or lower limit of the sensor.

Machine Actions


Possible Cause

Suggested Action

1. Restriction of blood flow from the arterial access or in the arterial line.

1. Check for restriction of blood flow in the arterial line, i.e. kinks, clamps, clotted arterial needle, poor flow from the patient’s arterial access. The alarm clears when the arterial pressure is in the proper range. 2. Attention should be given to re-evaluating needle size, blood flow rate, anticoagulant dosage.

2. Arterial pressure decreased somewhat during a treatment due to hemoconcentration and/or inadequate heparinization of the patient and a resulting pressure drop increase for a given needle at a fixed blood flow rate.

Call for Service if the problem persists.

Rev. B

8-30


BLOOD PUMP JAMMED 12 Reason for Alarm

The Blood Pump Rotor is jammed and will not turn or the blood slave board does not see the signal from the Blood Pump board.

Machine Actions


Possible Cause

Suggested Action

1. Cartridge Blood Set Pump segment is jamming the Rotor of the Blood Pump.

1. the correct placement of the Cartridge. Press OVERRIDE to restart the Blood Pump. 2. the Blood Pump Rotor is not obstructed. Press OVERRIDE to restart the Blood Pump. Call for Service if the problem persists.

2. The Blood Pump Rotor is jammed.

Rev. B


8-31

ART PUMP POSITION 13 Reason for Alarm

The Blood Pump Rotor could not be positioned by the Blood Board while in IDLE, or the machine is not sensing a Cartridge Blood Set.

Machine Actions

None.

Possible Cause

Suggested Action

1. The venous and arterial lines are not in their 1. the Cartridge position. The arterial proper position. line should be placed in the Arterial Line Clamp (if present), the venous line into the Air Bubble Detector and the Venous Line Clamp. Press OVERRIDE to clear the alarm. 2. The Blood Pump Rotor is jammed. 2. the Blood Pump Rotor is not obstructed. Manually position the Blood Pump Rotor to a horizontal position. Press OVERRIDE to clear the alarm. Call for Service if the problem persists.

Rev. B

8-32


BAD HYDRAULIC CONDITION 14 Reason for Alarm

Problem or configuration issue with the hydraulic portion of the machine. See the operator message box for more details.

Machine Actions

The machine goes into a RESTART condition.

Possible Cause

Suggested Action

1. No water.

1. adequate water supply to machine. Press RESTART to continue. 2. Drain Line is kinked or occluded. 2. that the Drain Line is not kinked or occluded. Press RESTART to continue. 3. Dialysate Connectors in the wrong position. 3. the Dialysate Connectors are well connected in the correct position for the current operation of the machine. Press RESTART to continue. 4. Dialysate Lines kinked. 4. that the Dialysate Lines are not kinked. Press RESTART to continue. Call for Service if the problem persists.


Rev. B


8-33

B CONNECTOR POSITION 18 Reason for Alarm

The Bicarbonate Concentrate Connector is not in the correct position for the phase of the machine.

Machine Actions

In ADR: the machine will stop and wait for the connector position to be corrected. In DIALYSIS: during the preparation phase, the machine will not proceed; during the treatment phase, the machine will automatically go into by.

Possible Cause

Suggested Action

1. Bicarbonate Concentrate Connector is in the wrong position or not fully inserted into its rinse port.

1. the right connector position in relation with the machine phase. Call for Service if the problem persists.

Rev. B

8-34


!

BICARB 6.6% COND DATA ERROR 19

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the BIC 6.6% COND parameter.

Machine Actions

None

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protective System in the Main Board, for the BIC 6.6% COND parameter.

1. In Set mode, restore the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B


!

8-35

BICARB 8.4% COND DATA ERROR 20

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the BIC 8.4% COND parameter.

Machine Actions

None

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the BIC 8.4% COND parameter.


Rev. B

8-36


BICART IS EMPTY 21 Reason for Alarm

The Bicarbonate Pump is being driven to maximum speed for greater than 25 seconds, due to the conductivity not reaching the set value.

Machine Actions

The Bicarbonate Pump stops.

Possible Cause

Suggested Action

1. BiCart cartridge is almost empty.

1. Replace the BiCart according to the directions in the operator manual. Press OVERRIDE to restart uptake of bicarbonate. 2. the correct position of the BiCart in its holder. Press OVERRIDE to restart uptake of bicarbonate. Call for Service if the problem persists.

2. BiCart cartridge in wrong position.

Rev. B


8-37

BICART CONNECTOR POSITION 22 Reason for Alarm

The BiCart Holder Arms are not in the required position for the current operating phase.

Machine Actions

In ADR: The machine stops and waits for both Holder Arms to be moved to the correct position. In DIALYSIS: During the dialysate preparation phase, the machine will not proceed. During the treatment phase, the machine will go into by when one of the two Holder Arms is in the incorrect position.

Possible Cause

Suggested Action

1. BiCart Holder Arms are in the wrong position, or not closed securely.

1. the correct position of the BiCart Holder Arms in relation to the machine phase. Call for Service if the problem persists.

Rev. B

8-38


!

BIC CONDUCTIVITY 23

Attribute

1. Minimum 2. Maximum

Reason for Alarm

Minimum Value of Bicarbonate Conductivity is lower than the value set by the operator or the permitted minimum. Maximum Value of Bicarbonate Conductivity is higher than the value set by the operator or the permitted maximum.

Machine Actions

During a dialysis treatment, the machine will go into BY.

Possible Cause

Suggested Action

1. Bicarbonate Concentrate container or BiCart are almost empty.

1. adequate levels of Concentrates. If BiCart, replace as directed in the Operator’s Manual. 2. the connector is well fitted to the proper wand. 3. Change Bicarbonate Concentrate Wand.

2. Bicarbonate Concentrate Connector not well fitted to the Concentrate Wand. 3. Massive air leak from the Bicarbonate Concentrate Wand. 4. BiCart not well positioned in its holder.

Rev. B

4. Ensure the BiCart is securely placed in its holder. Call for Service if the problem persists.


8-39

BICARB CAN IS EMPTY 24 Reason for Alarm

The Bicarbonate Pump has been driven at the maximum speed for greater than 30 seconds due to a loss in Bicarbonate Conductivity.

Machine Actions

The Bicarbonate Pump is shut off.

Possible Cause

Suggested Action

1. Bicarbonate Concentrate Container is empty.

1. Supply appropriate concentrate to the relevant inlet connector and press OVERRIDE to restart uptake of bicarbonate. 2. the connector is well fitted to the proper wand. Press OVERRIDE to continue. 3. Change Bicarbonate Concentrate Wand. Press OVERRIDE to continue. Call for Service if the problem persists.

2. Bicarbonate Concentrate Connector not well fitted to the Concentrate Wand. 3. Massive air leak from the Bicarbonate Concentrate Wand.

Rev. B

8-40


!

BLD DATA ERROR 26

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the BLD SENS parameter.

Machine Actions

None

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the BLD SENS parameter.


Rev. B


!

8-41

BLOOD FLOW DATA ERROR 27

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the BLOOD FLOW parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the BLOOD FLOW parameter.

1. Re-enter a different blood flow rate, then restore the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B

8-42


BLOOD LEAKAGE 28

!

Reason for Alarm Machine Actions

The machine has detected a blood leak into the hydraulic circuit either at a level of 0.30 ml/min or at a rate of 0.45 ml/min (HIGH or LOW sensitivity set value). Stops the Blood Pump. Closes the Venous Line Clamp. Ultrafiltration Pump is reduced to its minimum value.

Possible Cause

Suggested Action

1. Dialyser is leaking blood into the hydraulic circuit.

1. Test the dialysate for the presence of blood. If the results are positive, replace the dialyser and the Cartridge Blood Set. Follow the correct procedure to replace the extracorporeal circuit. Before starting a new dialysis treatment perform an ADR disinfection. 2. Test the dialysate for the presence of blood. If the results are negative consider reducing the sensitivity of the sensor to its low value to complete the treatment (BLD SENS parameter). Press OVERRIDE. 3. If the dialysate tested negative for the presence of blood, the Blood Leak Sensor parameter is set to LOW and the alarm persists, stop the treatment. As soon as possible perform a chemical disinfection to clean the Blood Leak Sensor. 4. the Dialysate Connectors do not leak. Put the machine in BY and that the Dialysate Connectors are well fitted to the dialyser. Remove from BY. Press OVERRIDE. Call for Service if the problem persists.

2. The Blood Leak Sensor is dirty.

3. The Blood Leak Sensor is dirty and the sensitivity is set to LOW.

4. Massive air leak from the Dialysate Connectors.

WARNING If the ”!Blood Leakage” # 28 alarm occurs and the identified cause is “Dialyser is leaking blood into the hydraulic circuit”, perform an ADR disinfection before starting a new dialysis treatment. Presence of blood in dialysate might result in a possible contamination of the hydraulic circuit with bacteria or viruses. If the ADR disinfection is not correctly performed before starting a new dialysis treatment, blood into the hydraulic circuit may cause crosscontamination problems resulting in patient injury or death.

Rev. B


8-43

BLOOD PUMP NOT IN START POSITION 29 Reason for Alarm

A problem was encountered during the initial reset phase that would not allow the Blood Pump to position itself correctly.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Blood Pump Cover is open or not completely closed.

1. the Blood Pump Cover is closed, press OVERRIDE to clear the alarm or restart the machine. Call for Service if the problem persists.

Rev. B

8-44


BPM: AID REQUEST 30 Reason for Alarm

Incorrect calibration of the BPM device.

Machine Actions

Blood pressure monitoring is stopped and the measurement is not available.

Possible Cause

Suggested Action

1. Temporary blockage of the device

1. Press OVERRIDE to clear the alarm. Do not perform any other measurements. In DIALYSIS, wait for the end of the treatment, turn OFF the machine, wait a few seconds and turn it ON again. From the IDLE view try a blood pressure measurement. Call for Service if the problem persists.

Rev. B


8-45

BPM: SYSTEM FAILURE 31 Reason for Alarm

The BPM is not taking measurements because of high or low pressure detected in the cuff.

Machine Actions


Possible Cause

Suggested Action

1. Tubing is kinked or disconnected.

1. that the external tubing is connected and there are no leaks or kinks. Press OVERRIDE and retry the measurement. 2. Press OVERRIDE and retry the measurement.

2. The patient moved his arm too many times during the measurement. The BPM was unable to measure the blood pressure. 3. The external Blood Pressure Cuff tubing or 3. Replace the cuff tubing and the cuff with a the cuff itself is leaking. new one. 4. There is a communication problem between 4. Repeat the measurement. the cuff and the machine. Call for Service if the problem persists

Rev. B

8-46


BPM: MEASUREMENT NOT MADE 32 Reason for Alarm

The blood pressure monitor was unable to take a blood pressure measurement.

Machine Actions


Possible Cause

Suggested Action

1. The patient moved during the measurement. 1. Press OVERRIDE and retry the The BPM was unable to detect the systolic measurement. or diastolic pressure. 2. Incorrect position of the cuff. 2. Check the position of the cuff. Press OVERRIDE and retry the measurement. 3. The external blood pressure cuff tubing or 3. Replace the cuff tubing and the cuff with a the cuff itself is leaking. new one. Press OVERRIDE to clear the alarm. 4. Tubing is kinked or disconnected. 4. that all of the external tubing is connected and there are no leaks or kinks. Press OVERRIDE and retry the measurement. Call for Service if the problem persists

Rev. B


8-47

BT1 LEVEL ERROR 33 Reason for Alarm

LD1 Level Sensor failed its test during dialysis preparation or an ADR process. The level sensor may have detected air, failed or needs to be cleaned.

Machine Actions

In ADR: The Time Out Proc (#190) alarm is generated which causes the machine to stop the procedure and to go to a RESTART condition. In DIALYSIS: None.

Possible Cause

Suggested Action

1. Massive air leak from an empty concentrate 1. Check for empty Acid/Acetate, BiCart or container. Bicarbonate Container. The alarm clears before patient connection. 2. Dirty LD1 Level Detector. 2. Perform a RINSE or a Chemical Disinfection to clean the sensor of deposits. 3. proper placement of the Concentrate 3. Concentrate Line is not in the proper Line for the current phase of the machine. position for the current phase of the machine. 4. BiCart Holder Arms are not in the fully 4. Place the BiCart Holder Arms in the closed closed position. position. Call for Service if the problem persists.

Rev. B

8-48


BT2 LEVEL ERROR 34 Reason for Alarm

LD2 Level Sensor failed its test during dialysis preparation or a cleaning process. The Level Sensor may have detected air, failed or needs to be cleaned.

Machine Actions

In ADR: None. In DIALYSIS: None.

Possible Cause

Suggested Action

1. Massive air leak from an empty Concentrate 1. Check for empty Acid/Acetate, BiCart or Container. Bicarbonate Container. The alarm stays until the end of the treatment. 2. Dirty LD2 Level Detector. 2. Perform a RINSE or a Chemical Disinfection to clean the sensor of deposits. 3. that the Concentrate Lines are in the 3. Concentrate Line is not in the proper proper position for the current phase of the position for the current phase of the machine. machine. 4. BiCart Holder Arms are not in the fully 4. Move the BiCart Holder Arms to the closed closed position. position to clear this alarm and to allow cleaning of the complete circuit. Call for Service if the problem persists.

Rev. B


8-49

BTP LEVEL ERROR 35 Reason for Alarm

LP Level Sensor failed its test during dialysis preparation or an ADR process. The level sensor may have detected air, failed or needs to be cleaned.

Machine Actions

In ADR: the Time Out Proc (#190) alarm is generated which causes the machine to stop the procedure and to go to a RESTART condition. In DIALYSIS: None.

Possible Cause

Suggested Action

1. Dirty LP Level Detector.

1. Perform a RINSING or a Chemical Disinfection to clean the sensor of deposits. Call for Service if the problem persists.

Rev. B

8-50


!

BY ALARM DATA ERROR 36

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the BY ALARM parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protective System in the Main Board, for the BY ALARM parameter.

1. Return to IDLE view, in Configuration menu restore the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B


8-51

ULTRAFILTER: UPPER SWITCH 38 Reason for Alarm

The Ultrafilter Upper Microswitch (SWFS) located on the rear of the machine is indicating a problem condition.

Machine Actions

In ADR: The machine goes into the RESTART condition. In Dialysate preparation: The machine will not continue until the microprocessor sees the correct signal from the switch. In DIALYSIS: The machine byes the dialyser.

Possible Cause

Suggested Action

1. In Dialysate preparation: incorrect position of the Ultrafilter or By fitting.

1. Carry out the following operations: • If an ultrafilter is installed, that it is correctly mounted covering both micro switches. • If an ultrafilter is not installed, that the clean dialysate by fitting is installed correctly on the lower bracket. 2. that the correct ULTRAFIL. USE parameter value is in memory. Call for Service if the problem persists.

2. Incorrect ULTRAFIL. USE parameter.

Rev. B

8-52


!

PROTECTIVE MSG TRANSFER ERROR 39

Reason for Alarm

A communication problem has been detected in the transmission of data between the Master Module and the Protection Module.

Machine Actions

None.

Possible Cause

Suggested Action

1. A communication problem has been detected in the transmission of data between the Master Module and the Protection Module.

1. Wait for a few seconds for the alarm to clear. • If it does not clear, enter the last safety related parameter which failed to restore the communication. • If it does not clear, turn the machine off, then back on and continue with the procedure being performed. Call for Service if the problem persists.

Rev. B


8-53

CONCENTRATE CANS 40

!

Attribute

Reason for Alarm

1. LOW PH 2. HIGH PH 3. A Pump 4. B Pump 5. A+B PUMPS LOW PH The measured pH is lower than the permitted value. HIGH PH The measured pH is higher than the permitted value. A PUMP;B PUMP; A+B PUMPS A discrepancy is indicated between the conductivity of the dialysate both for the dialysate flow and the rotation speed of the associated Pump/Pumps. The actual Pump(s) speed does not match with the actual concentrate(s) used.

Machine Actions

Byes the dialyser.

Note Autocalibration of the Pumps is possible from the beginning of dialysate preparation to phase 8, and from phase 9 on, each time the alarm occurs with the A Pump, B Pump or A+B Pumps attribute.

Note PB autocalibration is only available with liquid bicarbonate.

Possible Cause

Suggested Action

1. Machine has run out of concentrates. 2.

3. 4. 5.

1. Replace the empty container, then wait a few seconds for the machine to stabilize. If the attribute is A Pump or B Pump or A+B 2. that the correct concentrate type is connected to the machine. that the Pumps, concentrate type was/were changed conductivity is stable, then perform a and the PA/PB/PA+PB PA/PB/PA+PB autocalibration/ autocalibration/autocalibrations was/were autocalibrations. not performed. Air leak from a Concentrate 3. there are no air leaks from the Connector/BiCart. Concentrate Connectors/BiCart. The Concentrate Connector has 4. Rinse accumulated debris from the accumulated debris or salt crystals. Connector. The Concentrate Line is not properly 5. that the Concentrate Lines are connected to the Concentrate Container securely connected and that no air bubbles are being draw into the lines.

Rev. B

8-54


6. The solution in the Concentrate Container is 6. Stop the dialysis preparation and replace the Cartridge Blood Set and the dialyser with a not a solution correct for haemodialysis new Cartridge Blood Set and a new dialyser. treatments (see Section 9 – Specification, in Run a complete RINSE procedure. Replace this manual). the solution with the correct solution and then restart the dialysis preparation. 7. The solution in the Concentrate Container is 7. that the solution is the correct not correct or is dilute. concentrate and/or replace the solution with the correct solution. 8. that the Acid Connector is securely 8. The Acid Concentrate Connector is not connected to its Rinse Port. securely connected to its Rinse Port. (If using concentrate from a central delivery system) 9. Ensure that the correct type of dialysate has 9. In SETUP, select the correct concentrate been selected on the Dialysate Select view. type. Call for Service if the problem persists.

Rev. B


!

8-55

CONDUCTIVITY DATA ERROR 41

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the CONDUCTIVITY parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protective System in the Main Board, for the CONDUCTIVITY parameter.


Rev. B

8-56


!

DATA ERROR 43

Reason for Alarm

A difference was detected when data was stored in the Protection Module.

Machine Actions

None.

Possible Cause

Suggested Action

1. A difference was detected when data was stored in the Protection Module.

1. In Config the operator must restore the parameters not related to the safety of the patient. If not cleared, turn the machine OFF, then back ON and continue with the procedure being performed. Call for Service if the problem persists.

Rev. B


!

8-57

DIALYSATE FLOW 44

Attribute

1. Minimum 2. Maximum 3. Undefin

Reason for Alarm

The actual flow of the dialysate is different from the set value. MINIMUM The actual flow of the dialysate is lower than the set flow or minimum permitted flow. MAXIMUM The actual flow of the dialysate is higher than the set flow or maximum permitted flow. UNDEFIN The machine is unable to measure dialysate flow.

Machine Actions

Machine byes the dialyser.

Possible Cause

Suggested Action

1. Unstable dialysate flow has been detected by the machine. 2. There are deposits or debris inside the flowmeters of the machine.

1. Press OVERRIDE to continue with the treatment. 2. Perform a Descaling or a Chemical Disinfection. Call for Service if the problem persists.

Rev. B

8-58


!

DIALYSAT FLOW DATA ERROR 45

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the DIALYSATE FL. parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the DIALYSATE FL. parameter.

1. In Set mode, restore the parameter to the correct value.


Rev. B


8-59

DIASTOLIC PRESSURE ALARM 46 Reason for Alarm

The diastolic pressure measurement made by the BPM device is outside the limits set by the operator in configuration.

Machine Actions

None.

Possible Cause

Suggested Action

1. The diastolic pressure is out of the range set 1. Press OVERRIDE to reset the alarm. Retry in configuration. the measurement and compare it with a manual blood pressure cuff. Refer to your internal policy and consider changing the Maximum or Minimum limit of this alarm in SET mode for this patient. 2. The cuff is improperly applied. 2. Check cuff application, repeat measurement. 3. The patient moved during the reading. 3. Retry measurement. 4. The blood pressure cuff is not working 4. Take a comparison blood pressure properly. measurement with a correctly calibrated manual sphygmomanometer. Call for Service if the problem persists.

Rev. B

8-60


DISINF CONNECTOR POSITION 47 Reason for Alarm

The Disinfectant Connector is not in the proper position for the phase of the machine.

Machine Actions

In ADR: the machine will stop and wait until the connector is put in the proper position. In DIALYSIS: none

Possible Cause

Suggested Action

1. The Disinfectant or Concentrate Connector 1. the connector is in the proper position in relation to the machine phase. is in the wrong position, or not fully inserted into its Rinse Port. Call for Service if the problem persists.

Rev. B


8-61

E2PROM BLOOD ERROR 48 Reason for Alarm

Problem detected with the calibration coefficients in the Blood board EEPROM. Default coefficients will be used to run the machine.

Machine Actions

None.

Possible Cause

Suggested Action

1. Error with calibration parameters in the Blood board EEPROM.

1. Discontinue the treatment. Call for Service if the problem persists.

Rev. B

8-62


E2PROM HYDR ERROR 49 Reason for Alarm

Problem detected with the calibration coefficients in the Hydraulic board EEPROM. Default coefficients will be used to run the machine.

Machine Actions

None.

Possible Cause

Suggested Action

1. Error with calibration parameters in the Hydraulic board EEPROM.

1. Discontinue the treatment. Call for Service if the problem persists.

Rev. B


8-63

E2PROM BIOSLAVE ERROR 50 Reason for Alarm

Problem detected with the calibration coefficients in the Bioslave board EEPROM. Default coefficients will be used to run the machine.

Machine Actions

None.

Possible Cause

Suggested Action

1. Error with calibration parameters in the 1. Discontinue the treatment. Bioslave board EEPROM. Call for Service if the problem persists.

Rev. B

8-64


END DIA - TIMEOUT 51 Reason for Alarm

This message signals the operator that the DIALYSIS TIME is complete. This is only used if TIME has been selected as the condition to end the dialysis treatment (END DIALYSIS parameter).

Machine Actions

None.

Note This alarm doesn’t occur when Profiling is active, even if the alarm condition has been reached.

Note If the DIALYSIS TIME is increased following the occurrence of this alarm, the DIFFUSION TIME parameter will not be updated.

Possible Cause

Suggested Action

1. DIALYSIS TIME is complete. 2. Additional DIALYSIS TIME may be needed.

1. Disconnect patient. 2. Increase the set DIALYSIS TIME to lengthen the treatment.

Rev. B


8-65

END DIA - TOTAL BLOOD 52 Reason for Alarm

This message signals the operator that the amount of the blood selected to be dialysed is complete. This is only used if “T BL” has been selected as the condition to end the dialysis treatment (END DIALYSIS parameter).

Machine Actions

None.


Possible Cause

Suggested Action

1. The total blood has been processed. 2. Additional dialysis is needed even though the blood volume has been processed.

1. Disconnect patient. 2. Increase the set blood volume to lengthen the treatment.

Rev. B

8-66


END DIA - TOTAL WL 53 Reason for Alarm

This message signals the operator that the patient’s weight removal has been completed. This is only used if TWL has been selected as the condition to end the dialysis treatment (END DIALYSIS parameter).

Machine Actions

The hourly weight loss of the patient is automatically set to the minimum value.


Possible Cause

Suggested Action

1. The TOT WEIGHT L programmed is complete. 2. Additional dialysis is needed even though the TOT WEIGHT L programmed has been removed.

1. Disconnect patient.

Rev. B

2. Increase the set TOT WEIGHT L to lengthen the treatment, then deselect the WLR MINIMUM key.


8-67

PRIME VOLUME COMPLETED 54 Reason for Alarm

The Blood Pump has finished priming. The quantity of physiological solution, which has ed through the dialyser, is equal to that selected by the operator during the PRIME process.

Machine Actions

Blood Pump stops.

Possible Cause

Suggested Action

1. Priming is complete.

1. Press OVERRIDE to clear the alarm and proceed with set up. 2. Repress PRIME and select a priming procedure.

2. Additional priming is required.

Rev. B

8-68


END HEPARIN 55 Reason for Alarm

The heparin syringe is at the end of its travel. Heparin Line Clamp is not open.

Machine Actions

Stops the Heparin Pump.

Possible Cause

Suggested Action

1. Heparin syringe is empty.

1. Turn off the heparin program, refill the syringe, place it back on the pump. the Heparin Line Clamp is open, perform a manual bolus if desired. Restart the program. 2. the Heparin Line Clamp is closed on the heparin line of the 4 position line clamp. Turn off the heparin program and use the RIGHT arrow button on the Heparin Control to decrease pressure then use the LEFT arrow button to ensure the heparin syringe plunger clamp is in with the syringe plunger. Open the Heparin Line Clamp, perform a manual bolus if desired. Restart the program and the machine is delivering the correct heparin quantity. 3. Turn off the heparin program, refill a new syringe, place it back on the pump. the Heparin Line Clamp is open, perform a manual bolus if desired. Restart the program. 4. Ensure that the syringe is properly placed in the syringe holder. Call for Service if the problem persists.

2. Blocked heparin line.

3. Defective syringe.

4. Incorrect position of the syringe.

Rev. B


8-69

END OF DIALYSATE PREPARATION 57 Reason for Alarm

The dialysate preparation process is complete.

Machine Actions

The machine waits for the dialyser to be primed.

Possible Cause

Suggested Action

1. Dialysate preparation is complete.

1. Machine is ready to prime a dialyser. Select the appropriate keys to prime the dialyser.

Note In CONFIGURATION of the machine it is possible to turn this ALARM OFF (END PRE ALARM parameter). If set to OFF, this alarm will not occur.

Rev. B

8-70


END OF HEPARIN TIME 58 Reason for Alarm

The programmed PRE STOP TIME has been reached.

Machine Actions


Possible Cause

Suggested Action

1. Heparin infusion is complete.

1. Select the HEPARIN view. Deactivate the heparin program to clear the alarm. 2. Set a new value for the PRE STOP TIME, lower than the previous one.

2. The patient needs more heparin.

Note In CONFIGURATION of the machine it is possible to turn this ALARM off. If set to OFF, this alarm will not occur.

Rev. B


8-71

ERROR ON HEATER PROTECTION 59 Reason for Alarm

The alarm appears if the Heater malfunctions or if there is a problem in the protection circuit of the heater.

Machine Actions

The Heater is turned off.

Possible Cause

Suggested Action

1. Error in the heating system.

1. Turn the machine OFF, perform a Fast Recovery of the Dialysis process (see Section 5.A - Special Procedures, in this manual) if in treatment. Call for Service if the problem persists.

Rev. B

8-72


ERROR ON TOTAL WEIGHT LOSS 60 Reason for Alarm

There is greater than a 100 gram difference between the actual total fluid removed and the programmed TOT WEIGHT L.

Machine Actions

None.

Possible Cause

Suggested Action

1. The UF Rate has not been confirmed after the TOT WEIGHT L has been set.

1. Confirm the UF Rate by selecting SET from the HOME view, selecting UF Rate and pressing CONFIRM (the machine calculates the UF Rate for the TIME and TOT WEIGHT L values). 2. To match the current dialysis treatment with the Target Loss, enter SET mode and CONFIRM the UF Rate calculated.

2. There is a difference between the actual Total Fluid Removed and the programmed TOT WEIGHT L. The operator changed the TOT WEIGHT L, but forgot to CONFIRM the new UF Rate. 3. Interruption in the operation of the DIALYSIS mode. Alarms or operations set the Minimum UF Rate for too long.

4. Operator placed the machine in Minimum UF for too long or the machine remained in PATIENT CONNECT, after blood detection, for too long.

Rev. B

3. To match the current DIALYSIS treatment with the TOT WEIGHT L, enter the SET mode and CONFIRM the new UF Rate calculated. If UF Profiling is activated, a COMPENSATION Action key will appear in PROFILE view. Select the COMPENSATION Action key for a new profile rate to be established so that the TOT WEIGHT L may be achieved. 4. To match the current DIALYSIS treatment with the TOT WEIGHT L, enter the SET mode and CONFIRM the new UF rate calculated. If UF Profiling is activated, a COMPENSATION Action key will appear in PROFILE view. Select the COMPENSATION Action key for a new profile rate to be established so that the TOT WEIGHT L may be achieved. Call for Service if the problem persists.


8-73

ULTRAFILTER: LOWER SWITCH 61 Reason for Alarm

The ultrafilter lower microswitch (SWBY) is indicating a problem condition.

Machine Actions

In ADR: The machine goes into the RESTART condition. In Dialysate preparation: The machine will not continue until the microprocessor sees the correct signal from the switch. In DIALYSIS: The machine byes the dialyser.

Possible Cause

Suggested Action

1. In Dialysate preparation: incorrect position of the Ultrafilter or by fitting located behind the machine.

1. If an Ultrafilter is installed, that it is correctly mounted covering both microswitches. If an Ultrafilter is not installed, that the clean dialysate by fitting is installed correctly on the lower bracket. 2. that the correct ULTRAFIL. USE parameter value is entered in Config. Call for Service if the problem persists.

2. Incorrect ULTRAFIL. USE parameter.

Rev. B

8-74


!

FINAL CONDUCTIVITY 62

Attribute

1. Minimum 2. Maximum

Reason for Alarm

The conductivity of the dialysate is above or below the allowed limit.

Machine Actions

In DIALYSIS: the machine will by the dialyser.

Possible Cause

Suggested Action

1. Acid/Acetate or Bicarbonate Concentrate Container is empty.

1. Supply appropriate concentrate to the relevant inlet connector. Wait for stability of the dialysate flow. 2. the Connector(s) are properly positioned to the proper wand(s). Wait for stability of the dialysate flow. 3. Change Concentrate Wand. Wait for stability of the dialysate flow. 4. Rinse accumulated debris from the Connector(s).

2. Acid/Acetate or Bicarbonate Concentrate Connector(s) are not properly positioned to the concentrate Wand(s). 3. Massive air leak from the Concentrate Wand. 4. The Acid/Acetate or Bicarbonate Connector(s) has accumulated debris or salt crystals. 5. Inappropriate solution in the Acid/Acetate Concentrate Container. 6. When using Central Delivery Acid, the Acid/Acetate or Bicarbonate Connector is not securely connected to its Rinse Port.

Rev. B

5. that the solution is the correct concentrate and dilution. 6. that the Acid/Acetate or Bicarbonate Connector is properly positioned in its Rinse Port. Call for Service if the problem persists.


8-75

FIXED DATA 63 Reason for Alarm

This alarm will display if the operator selects Disinfection (HEAT or CHEMICAL) or RINSE modes and does not start the mode.

Machine Actions

The machine will not proceed.

Possible Cause

Suggested Action

1. The operator did not start the process to be performed.

1. Turn OFF the machine and turn it ON. Repeat the process to perform.

Rev. B

8-76


> GENERAL SAFE STATE < 64 Reason for Alarm

THIS IS A SPECIAL ALARM. A FULL DESCRIPTION APPEARS IN THE WARNING AT THE END OF THE PRECEDING SUB-SECTION. SEE THE POSSIBLE CAUSE FOR DIFFERENT INDICATIONS.

Machine Actions

1. 2. 3. 4. 5.

Byes the dialyser. Stops the Ultrafiltration Pump. Stops the Blood Pump. Closes the Venous Line Clamp. Audible alarm cannot be muted or overridden.

Possible Cause

Suggested Action

1. A safety condition has not been satisfied when an alarm occurred.

1. Turn off the machine. See the Fast Recovery of the Dialysis process in the Section 5.A - Special Procedures. If the alarm reoccurs, disconnect the patient and turn off the machine. 2. that the dialysate Connectors are well fitted to the machine. the Cartridge is not blocking the Blood Pump Rotor. Turn the machine OFF, then try again to start up. Call for Service if the problem persists.

2. A T1 Test failed during preparation.

Note If this alarm occurs during a treatment, the operator restarts the machine and the Patient Sensor detects blood, the machine will allow the operator to do a Fast Recovery of the Dialysis process (See the Fast Recovery of the Dialysis process procedure in the Section 5.A - Special Procedures). This enables the to by many of the T1 tests so that the machine can continue the treatment from Patient Connect.

Rev. B


8-77

DIAL CONNECTOR POSITION 65 Reason for Alarm

The flow sensor (LFD) has detected an incorrect flow through the Dialysate Connectors for the current phase.

Machine Actions

The machine will go to a RESTART condition.

Possible Cause

Suggested Action

1. Dialysate Connectors in the wrong position.

1. Correctly connect the dialyser Connectors to the By Connectors or to the dialyser depending upon the phase of the machine at that time, then press RESTART. 2. the Dialysate Connectors are properly positioned to the dialyser or to the machine, depending upon the phase of the machine at that time. Press RESTART to restart the current operation of the machine. 3. the presence of air in the external Dialysate line (TO/FROM). Press RESTART to restart the current operation of the machine. Call for Service if the problem persists.

2. Dialysate Connectors not properly positioned.

3. Massive air leak.

Rev. B

8-78


Heart Rate Alarm 66 Reason for Alarm

The BPM heart rate measurement is outside the limits set by the operator.

Machine Actions

None.

Possible Cause

Suggested Action

1. The BPM heart rate measurement is outside the limits set by the operator.

1. Press OVERRIDE to clear the alarm. the heart rate with a manual measurement, compare it with the BPM heart rate. If both readings are close, consider changing the heart rate limits for this patient in the SET mode from the BPM view. 2. Check cuff application, repeat measurement. 3. Retry measurement.

2. The cuff is improperly applied. 3. The patient moved during the measurement. 4. The blood pressure cuff is not working properly or has a leak.

Rev. B

4. Take a manual pulse rate. Replace the tubing and cuff if necessary. Call for Service if the problem persists.


8-79

HEATING SYSTEM NOT STARTED 67 Reason for Alarm

This alarm displays if the hydraulic flowpath temperature falls below 90°C for 5 minutes during HEAT Disinfection.

Machine Actions

The machine will go to a RESTART condition.

Possible Cause

Suggested Action

1. The hydraulic flowpath temperature falls below 90°C for 5 minutes during HEAT Disinfection.

1. Press RESTART to reset to normal operating conditions. If the alarm occurs again, turn OFF the machine and then ON. Repeat the ADR procedure. Call for Service if the problem persists.

Rev. B

8-80


DIALYSER SAFETY PRESSURE 68 Reason for Alarm

The transmembrane pressure difference of the blood side to the dialysate side is larger than the value set by the operator for the HD SAFE THRE.

Machine Actions

None.

Possible Cause

Suggested Action

1. The HD SAFE THRE. is incorrect for the dialyser used.

1. that the correct HD SAFE THRE. value was selected and entered in Config for the dialyser used. 2. the correctness of the patient prescription (ultrafiltration rate). Consider decreasing the blood flow if this operation is not in disagreement with the patient prescription to decrease the venous pressure and avoid hemoconcentration. 3. the correctness of the patient prescription (ultrafiltration rate). 4. Consider increasing the dialysate flow to increase the dialysate pressure. 5. Check the extracorporeal circuit for clotting. Refer to your internal policy. Call for Service if the problem persists.

2. The blood flow rate is too high for the current dialyser in the current operating condition.

3. The ultrafiltration is too high for the current dialyser in the current operating condition. 4. The transmembrane pressure is too high. 5. The extracorporeal circuit is clotting (low flux dialyser).

Rev. B


8-81

HEPARIN PUMP DIRECTION ERROR 69 Reason for Alarm

The Heparin Pump motor is rotating in the wrong direction.

Machine Actions


Possible Cause

Suggested Action

1. The Heparin Pump motor is rotating in the wrong direction.

1. Deactivate the heparin program. Activate it again. If the problem persists deactivate the heparin program. Call for Service if the problem persists.

Rev. B

8-82


HEPARIN SPEED ERROR 70 Reason for Alarm

Actual Heparin Pump infusion rate is incorrect.

Machine Actions


Possible Cause

Suggested Action

1. Actual Heparin Pump infusion rate is incorrect.

1. Deactivate the heparin program. Activate it again. If the problem persists, deactivate the heparin program. 2. that the heparin clamp on the 4 Position Line Clamp is open and the heparin line is open. Call for Service if the problem persists.

2. Blocked heparin line or the clamp is closed.

Rev. B


8-83

HEPARINISATION NOT STARTED 71 Reason for Alarm

The machine is in DIALYSIS, sensing blood at the Patient Sensor and the Heparin Pump has not been turned ON.

Machine Actions

None.

Possible Cause

Suggested Action

1. Heparin infusion was not started at the beginning of the treatment. 2. No heparin program is needed.

1. In heparin view, start the heparin program and press OVERRIDE to clear the alarm. 2. Press OVERRIDE to clear the alarm.

Note In Config, the HEPARIN ALARM parameter can be configured to NO or YES. If set to NO, the Heparinisation Not Started alarm is turned off and will not appear.

Rev. B

8-84


HIGH LEVEL IN DIS TANK 72 Reason for Alarm

The state of the high level sensor in the disinfectant tank is not as required for the current phase.

Machine Actions

In ADR: The Time Out Proc (#190) alarm is displayed and the machine stops. In Dialysis: None.

Possible Cause

Suggested Action

1. In ADR: the disinfectant container is empty.

1. Check the level of the disinfectant container. Press RESTART to proceed with the current process. 2. the Disinfectant Connector is properly positioned to the Disinfectant Wand. Press RESTART to proceed with the current process. 3. Run a complete RINSE procedure.

2. In ADR: disinfectant connector not attached to the Disinfectant Wand.

3. In dialysis preparation: the machine had been shut off when the tank was full or not completely rinsed out. 4. In dialysis preparation: the Level Sensor is dirty or defective. 5. In DIALYSIS: If the Visual and Audible alarms are triggered press OVERRIDE.

Rev. B

4. Stop the dialysis preparation and run a complete RINSE procedure. If the problem persists call for Service. 5. Wait for the end of the treatment. After WASHBACK, try to perform a RINSE procedure. Call for Service if the problem persists.


8-85

HIGH LEVEL IN UF VESSEL 73 Reason for Alarm

Problem indicated with the High Level Sensor in the UF burette.

Machine Actions


Possible Cause

Suggested Action

1. In ADR: Error detected by the High Level Sensor in the UF burette.

1. Press RESTART to restart the process. Call for Service if the problem persists.

Rev. B

8-86


LONG POWER FAILURE 80

!

Reason for Alarm

An interruption of the AC supply voltage for more than 20 seconds.

Machine Actions

Stops the Blood Pump. Closes the Venous Line Clamp. Ultrafiltration pump is reduced to its minimum value. Byes dialyser.

Note This alarm occurs only if the Battery Backup Kit is not installed.

WARNING When AC power is interrupted, a continuous audible alarm is turned ON.

Possible Cause

Suggested Action

1. Loss of AC power.

1. When power is restored, press OVERRIDE to restart the dialysis treatment. 2. the plug is properly positioned in the socket and the switch is turned on. Press OVERRIDE to restart the dialysis treatment. Call for Service if the problem persists.

2. The plug has been disconnected, or the main switch (beside the socket) has been turned off.

Rev. B


8-87

LOW TEMPERATURE LIMIT REACHED 81 Reason for Alarm

This alarm appears if, in Chemical Disinfection with heating, the hydraulic flowpath temperature falls below 33°C.

Machine Actions

The process time will stop until the temperature measured in the hydraulic circuit reaches 36°C.

Possible Cause

Suggested Action

1. Temporary drop of the temperature.

1. No Action is required. The machine should heat automatically. Call for Service if the problem persists.

Rev. B

8-88


LOW LEVEL IN DIS TANK 82 Reason for Alarm

The state of the Low Level Sensor in the Disinfectant Tank is not as required for the current phase.

Machine Actions

In ADR: The Time Out Proc (#190) alarm is displayed and the machine stops. In Dialysis: None

Possible Cause

Suggested Action

1. In ADR: the Disinfectant Container is empty.

1. Check that an adequate amount of disinfectant is present in the Disinfectant Container. Press RESTART to proceed with the current process. 2. that the Disinfectant Connector is properly connected to the Disinfectant Wand and that the Wand is submerged in the disinfectant. Press RESTART to proceed with the current process. 3. Run a complete RINSE procedure.

2. In ADR: the Disinfectant Connector is not attached to the Disinfectant Wand or the Wand is not positioned properly for the level of disinfectant present. 3. In dialysis preparation the machine was shut off when the tank was full or not completely rinsed out. 4. In dialysis preparation: the Level Sensor is dirty or defective. 5. In DIALYSIS: If the Visual and Audible alarms occur, press OVERRIDE.

Rev. B

4. Stop the dialysis preparation and run a complete RINSE procedure. If the problem persists call for Service. 5. Wait for the end of the treatment. After WASHBACK, try to perform a RINSE procedure. Call for Service if the problem persists.


8-89

LOW LEVEL IN UF VESSEL 83 Reason for Alarm

Problem indicated with the Low Level Sensor in the UF Burette

Machine Actions


Possible Cause

Suggested Action

1. In ADR: Error detected by the low level sensor in the UF burette.


Rev. B

8-90


LOW PRESSURE IN DEGASSER 84 Reason for Alarm

Low flow as seen by LFP (for more than 6 seconds) is indicated in the degassing portion of the hydraulics.

Machine Actions

The heater is turned OFF, the machine stops and goes into a RESTART condition.

Possible Cause

Suggested Action

1. Problem in the degassing loop.



Rev. B


8-91

MAX PI PRESSURE 87 Reason for Alarm

The hydraulic pressure sensor PI has detected a higher pressure than what is allowed at the dialyser inlet connector.

Machine Actions

In DIALYSIS: If the pressure is greater than 450 mmHg, the UF Pump is driven at the current value. If the pressure is greater than 500 mmHg, the UF Pump is driven at the current value and the machine goes into the RESTART phase. In ADR: If the pressure is greater than 500 mmHg the machine will stop the hydraulic module pumps and the UF Pump. The machine goes into the RESTART.

Possible Cause

Suggested Action


1. Dialysate Connectors are in the proper position for the current phase of the machine, then press RESTART. 2. Dialysate Connectors are well fitted to the dialyser or to the machine, depending upon the phase of the machine at that time, then press RESTART. 3. external Dialysate Lines are not kinked, then press RESTART. 4. the presence of air in external Dialysate Line, then press RESTART. 5. the correctness of the patient prescription (ultrafiltration rate). Consider reducing the blood flow if this operation is not in disagreement with the patient prescription. 6. Check for clotting or clogging in the blood side of the dialyser. Change the dialyser if necessary 7. Consider reducing the dialysate flow rate.

2. Dialysate Connectors in the proper position, but not well inserted.

3. External Dialysate Lines are kinked. 4. Massive presence of air inside the hydraulic circuit. 5. The blood flow is too high, producing a overpressure on the hydraulic side of the machine.

6. Clotting or clogging in the blood side of the dialyser. 7. The dialysate flow rate is not correct for the current dialyser. 8. Incorrect placement of the diaphragm between the Cartridge Blood Set and the venous seal.

8. Perform a diaphragm Neutralization procedure (See Section 5.A – Special Procedures, in this manual). Call for Service if the problem persists.

WARNING When the patient is connected, if the first selection of the RESTART key doesn’t clear the alarm, recheck carefully all the possible causes of the alarm then press again the RESTART key. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified.

Rev. B

8-92


MAX PO PRESSURE 88 Reason for Alarm

The pressure sensor Po has detected a higher pressure than what is allowed at the dialyser outlet connector.

Machine Actions

In DIALYSIS: If the pressure is greater than 450 mmHg, the UF Pump is driven at the current value. If the pressure is greater than 500 mmHg, the UF Pump is driven at the current value and the machine goes into the RESTART phase. In ADR: If the pressure is greater than 500 mmHg the machine will stop the hydraulic module pumps and the UF Pump. The machine goes into the RESTART.

Possible Cause

Suggested Action


1. Dialysate Connectors are in the proper position for the current phase of the machine, then press RESTART. 2. Dialysate Connectors are well fitted to the dialyser or to the machine, depending upon the phase of the machine at that time, then press RESTART. 3. external dialysate lines are not kinked, then press RESTART. 4. the presence of air in the external dialysate line, then press RESTART. 5. the correctness of the patient prescription (ultrafiltration rate). Consider reducing the blood flow if this operation is not in disagreement with the patient prescription. 6. Check for clotting or clogging in the blood side of the dialyser. Replace the dialyser if necessary. 7. Consider reducing the dialysate flow rate.


3. External dialysate lines are kinked. 4. Massive presence of air inside the hydraulic circuit. 5. The blood flow is too high, producing a overpressure on the hydraulic side of the machine.

6. Clotting or clogging in the blood side of the dialyser. 7. The dialysate flow rate is not correct for the current dialyser. 8. Incorrect placement of the diaphragm between the Cartridge Blood Set and the venous seal.


WARNING When the patient is connected, if the first selection of the RESTART key doesn’t clear the alarm, recheck carefully all the possible causes of the alarm then press again the RESTART key. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified.

Rev. B


8-93

MAX TEMPERATURE LIMIT 90 Reason for Alarm

The temperature measured by TP is greater than the following maximum values: 1. In DIALYSIS ⇒ 46°C (114.8°F) 2. In Chemical Disinfection ⇒ 42°C (107.6°F) 3. In Heat or Heat Citric Disinfection⇒ 110°C (230°F)

Machine Actions

The heater is turned OFF.

Possible Cause

Suggested Action

1. The machine had a RESTART condition.

1. patient safety. a previous RESTART condition. Wait for the temperature to drop; the heater is automatically turned on. 2. Discontinue DIALYSIS and call for Service. 3. Check the incoming water temperature (See the Specifications section). Call for Service if the problem persists.

2. The machine has malfunctioned. 3. Incoming water temperature is too high.

Rev. B

8-94


MIN PI PRESSURE 94 Reason for Alarm

The pressure sensor Pi has detected a lower pressure (approximately -350 mmHg) than what is allowed at the inlet of the dialyser.

Machine Actions

In DIALYSIS: When the Dialysate flow is greater than 400 ml/min and the pressure is lower than -350 mmHg, the UF Pump is stopped. When the Dialysate flow is lower than or equal to 400 ml/min and the pressure is lower than -250 mmHg, the UF Pump is stopped and the machine goes into by. If the pressure is lower than -450 mmHg, the UF Pump is stopped and the machine goes into the RESTART condition. In ADR: The pumps in the hydraulic module are stopped and the machine goes into the RESTART condition.

Possible Cause

Suggested Action


1. the Dialysate Connectors are in the proper position for the current phase of the machine, then press RESTART. 2. the Dialysate Connectors are well fitted to the dialyser or to the machine, depending upon the phase of the machine at that time, then press RESTART. 3. the external dialysate lines are not kinked, then press RESTART. 4. the presence of air in the external dialysate line, then press RESTART. 5. Check the proper UF Rate for the dialyser used. Consider reducing the blood flow if this operation is not in disagreement with the patient prescription then press RESTART. 6. Check for clotting or clogging in the blood side of the dialyser. Replace the dialyser if necessary. 7. Consider reducing the dialysate flow rate.


3. External dialysate lines are kinked. 4. Massive presence of air inside the hydraulic circuit. 5. The UF Rate is too high for the dialyser used.

6. Clotting or clogging in the blood side of the dialyser. 7. The dialysate flow is not correct for the current dialyser.



Rev. B


8-95

MIN PO PRESSURE 95 Reason for Alarm

The pressure sensor Po has detected a lower pressure (approximately -350 mmHg) than what is allowed at the outlet of the dialyser.

Machine Actions

In DIALYSIS: When the Dialysate flow is greater than 400 ml/min and the pressure is lower than -350 mmHg, the UF Pump is stopped. When the Dialysate flow is lower than or equal to 400 ml/min and the pressure is lower than -250 mmHg, the UF Pump is stopped and the machine goes into by. If the pressure is lower than -450 mmHg, the UF Pump is stopped and the machine goes into the RESTART condition. In ADR: The pumps in the hydraulic module are stopped and the machine goes into the RESTART condition.

Possible Cause

Suggested Action


1. the Dialysate Connectors are in the proper position for the current phase of the machine, then press RESTART. 2. the Dialysate Connectors are well fitted to the dialyser or to the machine, depending upon the phase of the machine at that time, then press RESTART. 3. the external dialysate lines are not kinked, then press RESTART. 4. the presence of air in the external dialysate line, then press RESTART. 5. Check the proper UF Rate for the dialyser used. Consider reducing the blood flow if this operation is not in disagreement with the patient prescription, then press RESTART. 6. Check for clotting or clogging in the blood side of the dialyser. Replace the dialyser if necessary. 7. Consider reducing the dialysate flow rate.


3. External dialysate lines are kinked. 4. Massive presence of air inside the hydraulic circuit. 5. The UF Rate is too high for the dialyser used.

6. Clotting or clogging in the blood side of the dialyser. 7. The dialysate flow rate is not correct for the current dialyser.


WARNING When the patient is connected, if the first selection of the RESTART key doesn’t clear the alarm, re-check carefully all the possible causes of the alarm then press again the RESTART key. Never press the RESTART key more than 2 or 3 times if the problem that is causing the “RESTART” condition has not been identified. -

Rev. B

8-96


NO WATER 100 Reason for Alarm

No water in the hydraulic circuit. Water pressure is low.

Machine Actions

All hydraulic module pumps are stopped. In DIALYSIS: the machine byes the dialyser.

Possible Cause

Suggested Action

1. Pressure drop in the RO distribution system. 2. The inlet water is disconnected.

1. that there is adequate water pressure in the RO distribution system 2. Connect the inlet water to proper water valve. 3. the water valve is open. 4. Check the water filter in the machine for clogging. A clogged filter will decrease the amount of water flowing through the system. Call for Service if the problem persists.

3. The water valve is closed. 4. The incoming water filter is clogging.

Note In DIALYSIS press RESTART to continue the treatment after the problem is fixed. In ADR the machine restarts automatically.

Rev. B


8-97

P1 PUMP OUT OF ORDER 104 Reason for Alarm

The encoder on P1 does not indicate the proper response to the command to run P1, or P1 pump does not guarantee the dialysate flow set value, thus indicating malfunctioning.

Machine Actions

In ADR: The machine stops and goes into a RESTART condition. In DIALYSIS: None.

Possible Cause

Suggested Action

1. In DIALYSIS: P1 pump does not work properly in order to guarantee the dialysate flow set value.

1. Consider completing the treatment by setting the dialysate flow to 500 ml/min if this operation is not in disagreement with the patient prescription; at the end of the treatment call for Service. If it is not possible to modify the patient prescription, stop the treatment and call for Service. 2. If the alarm does not clear see the Fast Recovery of the Dialysis process procedure in the Special Procedures section. 3. Press RESTART to restart the current operation of the machine. 4. Turn OFF the machine, wait a few seconds, turn it ON again and repeat the procedure to perform. Call for Service if the problem persists.

2. In DIALYSIS: failure on the command that drives the pump P1. 3. In ADR: failure on the command that drives the pump P1. 4. In ADR: if the machine does not restart.

Rev. B

8-98


P2 PUMP OUT OF ORDER 106 Reason for Alarm

The encoder on P2 does not indicate the proper response to the command to run P2, thus indicating malfunctioning.

Machine Actions


Possible Cause

Suggested Action

1. In DIALYSIS: failure of the command that drives the P2 Pump.

1. If the alarm does not clear see the Fast Recovery of the Dialysis process procedure in the Section 5.A Special Procedures. 2. Press RESTART to restart the current operation of the machine. 3. Turn OFF the machine, wait a few seconds, turn it ON again and repeat the procedure to perform. Call for Service if the problem persists.

2. In ADR: failure of the command that drives the P2 Pump. 3. In ADR: if the machine does not restart.

Rev. B


8-99

PA AUTOCALIBRATION NOT PERFORMED 107 Reason for Alarm

The self calibration of the PA pump has not been performed due to a problem in the EEPROM of the Protective board.

Machine Actions

None.

Possible Cause

Suggested Action

1. The autocalibration of the Acid/Acetate Pump failed.

1. Repeat the PA autocalibration. Call for Service if the problem persists.

Rev. B


PA PUMP OUT OF ORDER 108 Reason for Alarm

The PA Pump does not respond to commands.

Machine Actions


Possible Cause

Suggested Action

1. In ADR, Acid/Acetate Pump failed.

1. In ADR, press RESTART to restart the current operation of the machine. 2. Turn OFF the machine, wait a few seconds, turn it ON again and repeat the procedure to perform. Call for Service if the problem persists.

2. Acid/Acetate Pump failed but RESTART does not fix the problem.

Rev. B


8-101

PB AUTOCALIBRATION NOT PERFORMED 109 Reason for Alarm

The self calibration of the PB Pump has not been performed due to a problem in the EEPROM of the protective board.

Machine Actions

None.

Note This alarm only occurs when using liquid bicarbonate concentrate.

Possible Cause

Suggested Action

1. The autocalibration of the Bicarbonate Pump failed.

1. Repeat the PB autocalibration. Call for Service if the problem persists.

Rev. B


PB PUMP OUT OF ORDER 110 Reason for Alarm

The PB Pump does not respond to commands.

Machine Actions


Possible Cause

Suggested Action

1. Bicarbonate Pump failed.

1. In ADR, press RESTART to restart the current operation of the machine. 2. Turn OFF the machine, wait a few seconds, turn it ON again and repeat the procedure to perform. Call for Service if the problem persists.

2. Bicarbonate Pump failed but RESTART does not fix the problem.

Rev. B


8.

8-103


PC PUMP FAILURE 111 Reason for Alarm

The encoder on the PC does not indicate the proper response to the command to run the PC, thus indicating a malfunction.

Machine Actions


Possible Cause

Suggested Action

1. In DIALYSIS: failure of the command that drives the PC Pump.

1. If the alarm does not clear see the Fast Recovery of the Dialysis process procedure in the Section 5.A - Special Procedures. 2. Press RESTART to restart the current operation of the machine. 3. Turn OFF the machine, wait a few seconds, turn it ON again and repeat the procedure. Call for Service if the problem persists.

2. In ADR: failure of the command that drives the PC Pump. 3. In ADR: if the machine does not restart.

Rev. B


PH MAXIMUM ALARM

112

Reason for Alarm

This alarm only occurs during Chemical or Heat Citric Disinfection. The pH value measured is greater than the maximum SET in the parameters.

Machine Actions

In Chemical or Citric Disinfection, the machine will go to a RESTART condition.

Possible Cause

Suggested Action

1. The pH value measured is greater than the maximum SET in the parameters.

1. that the chemical is the correct type to be used. Press RESTART to restart the current operation of the machine. If the problem persists, discontinue the process. 2. Consider changing the pH Max parameter value in relation to the chemical being used for that process. Call for Service if the problem persists.

2. The pH Max parameter value is not correct for the chemical being used.

Rev. B


PH MINIMUM ALARM

8-105

113

Reason for Alarm

This alarm only occurs during Chemical or Heat Citric Disinfection. The pH value measured is less than the minimum SET in the parameters.

Machine Actions

In Chemical or Citric Disinfection, the machine will go to a RESTART condition.

Possible Cause

Suggested Action

1. The pH value measured is lower than the maximum SET in the parameters.

1. that the chemical is the correct type to be used. Press RESTART to restart the current operation of the machine. If the problem persists, discontinue the process. 2. Consider changing pH Min parameter value in relation to the chemical being used for that process. Call for Service if the problem persists.

2. The pH Min parameter value is not correct for the chemical used.

Rev. B


PI PO MAX

!

114

Reason for Alarm

The dialyser inlet/outlet pressure has exceeded the maximum limit of +480 mmHg.

Machine Actions

None.

Note In case of high pressure detected by Pi or by Po, the #87 alarm (in case of high pressure detected by Pi) or the #88 alarm (in case of high pressure detected by Po) often occurs just before the #114 alarm appearance. Moreover, if the pressure detected becomes highter than +500 mmHg, the machine goes into RESTART condition and the RESTART window becomes available. Refer also to the #87 or #88 alarm description to exit from the alarm condition.

Possible Cause

Suggested Action

1. Dialysate Connectors not in the proper position or not well inserted.

1. the Dialysate Connectors are in the proper position and are well fitted to the dialyser or to the machine, depending upon the phase of the machine at that time. 2. the external Dialysate Lines are not kinked. 3. the presence of air in the external Dialysate line. the Dialysate Connectors are well fitted to the dialyser or to the machine. 4. the correctness of the patient prescription (ultrafiltration rate). Consider reducing the Blood Pump speed if this operation is not in disagreement with the patient prescription. 5. Check for clotting or clogging in the blood side of the dialyser or in the Cartridge Blood Set. Change the dialyser and the Cartridge Blood Set if necessary. 6. Consider reducing the dialysate flow rate.

2. External Dialysate Lines are kinked. 3. Massive presence of air inside the hydraulic circuit.

4. The UF Rate is too low.

5. Clotting or clogging in the dialyser and/or Cartridge Blood Set.

6. The dialysate flow rate is not correct for the current dialyser. 7. Incorrect placement of the diaphragm between the Cartridge Blood Set and the venous seal.

Rev. B



PI PO MIN

!


8-107

115

The dialyser inlet/outlet pressure is below the minimum limit of -350 mmHg.

Ultrafiltration is stopped.

Note In case of low pressure detected by Pi or by Po, the #94 alarm (in case of low pressure detected by Pi) or the #95 alarm (in case of low pressure detected by Po) often occurs just before the #115 alarm appearance. Moreover, if the pressure detected becomes lower than -450 mmHg, the machine goes into RESTART condition and the RESTART window becomes available. Refer also to the #94 or #95 alarm description to exit from the alarm condition.

Possible Cause

Suggested Action

1. Dialysate Connectors not in the proper position or are not inserted well.

1. the Dialysate Connectors are in the proper position and are well fitted to the dialyser or to the machine, depending upon the phase of the machine at that time. 2. the external Dialysate Lines are not kinked. 3. the presence of air in the external Dialysate Lines. the Dialysate Connectors are well fitted to the dialyser or to the machine. 4. the correctness of the patient prescription (ultrafiltration rate). Consider increasing the Blood Pump speed if this operation is not in disagreement with the patient prescription. 5. Check for clotting or clogging in the blood side of the dialyser or in the Cartridge Blood Set. Replace if necessary. 6. Consider increasing the dialysate flow rate.

2. External Dialysate Lines are kinked. 3. Massive presence of air inside the hydraulic circuit.

4. The UF Rate is too high for the dialyser used.

5. Clotting or clogging in the dialyser or the Cartridge Blood Set. 6. The dialysate flow rate is not correct for the current dialyser.


Rev. B


PI PRESSURE SENSOR ERROR

116

Reason for Alarm

A problem was detected with the Inlet Dialyser Pressure Sensor due to an unplugged Sensor or to an out of range reading.

Machine Actions

None.

Possible Cause

Suggested Action

1. Problem detected with the Inlet Sensor of the dialyser.

1. No action is required. Call for Service if the problem persists.

Rev. B


PO PRESSURE SENSOR ERROR

8-109

118

Reason for Alarm

A problem was detected with the Outlet Dialyser Pressure Sensor due to an unplugged Sensor or to an out of range reading.

Machine Actions

None.

Possible Cause

Suggested Action

1. Problem detected with the Outlet Sensor of the dialyser.

1. No action is required. Call for Service if the problem persists.

Rev. B


PROTECTIVE CARD COMM. TIMEOUT 120

!

Reason for Alarm

The Protection System is not able to communicate with the Main computer Board.

Machine Actions

Byes the dialyser. Stops the Ultrafiltration Pump. Stops the Blood Pump. Closes the Venous Line Clamp.

Note The Audible alarm, which signals the #120 alarm condition, can not be silenced by pressing the MUTE button.

Note This alarm is usually followed by a > GENERAL SAFE STATE < alarm.

Possible Cause

Suggested Action

1. Temporary instability of the communication system. 2. The machine blocks and goes into > GENERAL SAFE STATE <.

1. Wait few seconds for stability of the communication system. 2. See the Fast Recovery of the Dialysis process procedure in the Section 5.A Special Procedures. If the condition persists, stop DIALYSIS. Call for Service if the problem persists.

Rev. B


8-111

PUF AUTOCALIBRATION NOT PERFORMED 121 Reason for Alarm

The Ultrafiltration Pump Autocalibration was not performed due to a problem in the EEPROM of the Protective board.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Autocalibration of the Ultrafiltration Pump failed.

1. Repeat the PUF Autocalibration. If necessary, turn OFF the machine. Call for Service if the problem persists.

Rev. B


PUF PUMP OUT OF ORDER

122

Reason for Alarm

The Ultrafiltration Pump does not respond to commands.

Machine Actions


Possible Cause

Suggested Action

1. Ultrafiltration Pump failed.

1. In ADR: press RESTART to restart the current operation of the machine. 2. Turn OFF the machine, wait a few seconds, turn it ON again and repeat the procedure. Call for Service if the problem persists.

2. Ultrafiltration Pump failed but RESTART does not fix the problem.

Rev. B


SHORT POWER FAILURE

!

8-113

124

Reason for Alarm

A drop in AC voltage for less than 20 seconds.

Machine Actions

Byes the dialyser.

Note This alarm occurs only if the Battery Backup Kit is not installed.

WARNING When AC power drops out, a continuous audible alarm is turned on.

Possible Cause

Suggested Action

1. Loss of AC power less than 20 seconds.

1. Press OVERRIDE to restart the dialysis treatment. 2. that the plug is properly positioned in the socket and the switch is turned on. Press OVERRIDE to restart the dialysis treatment. Call for Service if the problem persists.

2. The plug has been disconnected, or the breaker switch (beside the socket) has been turned off.

Rev. B


!

SN COMMUTATION


125

The maximum run time for a cycle in Single Needle mode has elapsed.

Stops the Blood Pump. Closes the Venous Line Clamp. Ultrafiltration is reduced to its minimum value.

Possible Cause

Suggested Action

1. The expansion chambers may be leaking air, causing the stroke to be too long. The chamber will fill up over time. 2. A previous alarm stopped the Blood Pump.

1. the expansion chambers are not leaking. Adjust the levels inside the expansion chambers. 2. Press OVERRIDE to restart the Pump and clear the alarm. 3. Increase the Blood Pump speed, or consider changing the venous limits. 4. the venous line is not kinked.

3. The Blood Pump speed is too low for the venous limits set by the operator. 4. The venous line is kinked. The machine cannot reinfuse the blood to the patient after clamp commutation. 5. Clotting is occuring in the Cartridge Blood Set. 6. The patient is moving around. 7. The blood levels in the arterial and venous chambers were adjusted while the Blood Pump was running. 8. A combination of Blood Pump speed, venous high and low trip points, and UF RATE has caused the SN cycle time to exceed the allowed cycle time. 9. Arterial and/or venous lines are not in their clamps. 10. A change was made to the UF RATE.

Rev. B

5. that there is no clotting in the Cartridge Blood Set. 6. Press OVERRIDE to restart the pump and clear the alarm. 7. Press OVERRIDE to restart the pump and clear the alarm. Slowly adjust the arterial and venous chamber blood levels, using a syringe. 8. Increase the Blood Pump speed, change the venous trip points, or decrease the UF RATE to reduce the SN cycle time to within the allowed time limit. 9. Press OVERRIDE to restart the pump and clear the alarm. Place the line(s) in the clamp(s). 10. Press OVERRIDE to restart the pump and clear the alarm. Call for Service if the problem persists.


8-115

START DIALYSIS DELAYED 129 Reason for Alarm

The Patient Sensor has detected blood for at least 5 minutes and the DIALYSIS Action key on the PATIENT CONNECT view has not been pressed.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Patient Sensor has detected blood for at least 5 minutes and the DIALYSIS Action key on the PATIENT CONNECT view has not been pressed. 2. Problems during patient connection postponed the start of dialysis.

1. Select the DIALYSIS Action key.

2. Fix problems in patient connection, then start the treatment.

Rev. B


BLOOD CARD MSG TRANFER ERROR 130 Reason for Alarm

The Main computer and the Blood Slave Board are not communicating.

Machine Actions

None.

Possible Cause

Suggested Action

1. Temporary communication problem.

1. Wait a few seconds for the alarm to be cleared. 2. See the Fast Recovery of the Dialysis process procedure in the Section 5.A - Special Procedures. Call for Service if the problem persists.

2. If alarm does not clear and the machine stops functioning.

Rev. B


HYD CARD MSG TRANSFER ERROR

8-117

131

Reason for Alarm

The Main computer Board and the hydraulic modules are not communicating.

Machine Actions

None.

Possible Cause

Suggested Action


1. Wait a few seconds for the alarm to be cleared. 2. See the Fast Recovery of the Dialysis process procedure in the Section 5.A Special Procedures. Call for Service if the problem persists.


Rev. B


SYSTOLIC PRESSURE ALARM 132 Reason for Alarm

The systolic pressure measurement taken by the BPM device is outside the limits set by the operator in the Configuration view.

Machine Actions

None.

Possible Cause

Suggested Action

1. The patient’s systolic pressure is out of the range set in configuration.

1. Press OVERRIDE to reset the alarm. the measurement with a manual blood pressure cuff. Refer to your internal policy. Retry the measurement. 2. Check and/or reapply the cuff on the patient’s extremity. Press OVERRIDE to reset the alarm. Retry the measurement. 3. Press OVERRIDE to reset the alarm. Retry the measurement. 4. Replace the cuff and tubing and retry the measurement. Take a comparison blood pressure reading with a correctly calibrated manual sphygmomanometer. If the readings are not similar, call for Service. Call for Service if the problem persists.

2. The cuff is improperly applied.

3. Patient moved during the measurement. 4. The blood pressure cuff is not working properly.

Rev. B


!

8-119

T1 TEST FAILED 133

Reason for Alarm

One of the automatic T1 tests of the machine’s components and processes has failed.

Machine Actions

GENERAL SAFE STATE

Possible Cause

Suggested Action

1. A T1 test failed during preparation.

1. that the Dialysate Connectors are properly positioned to their By Ports. Repeat Dialysate preparation. If the T1 test fails again, note the T1 test failed and call for Service. 2. The venous line must stay inside the Air Bubble Detector. A new Fast Recovery of the Dialysis process procedure is required. If the blood is clotting, disconnect the patient. Call for Service if the problem persists.

2. A Fast Recovery of the Dialysis process was performed, but the venous line was out of the Air Bubble Detector.

Rev. B


!

TEMPERATURE

134

Attribute

MINIMUM MAXIMUM UNDEFIN

Reason for Alarm

Minimum The measured temperature is -2°C lower than the set value or the minimum permitted value (34°C). Maximum The measured temperature is +2°C above than the set value or the maximum permitted value (39.5°C). Undefin The machine is unable to measure the temperature.

Machine Actions

Byes the dialyser.

Possible Cause

Suggested Action

1. A temporary instability of dialysate flow due to a previous RESTART condition. 2. The temperature of the dialysate has exceeded safe limits. 3. The machine has recently been turned on and has not yet reached operating temperature. 4. The machine has an internal malfunction

1. Wait for stability of the system.

Rev. B

2. Check the incoming water temperature (See the Section 9 - Specifications). 3. If the machine temperature remains high or low for more than 10 minutes, discontinue dialysis. 4. Discontinue dialysis. Call for Service if the problem persists.


!

TEMPERATURE DATA ERROR

8-121

135

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the TEMPERATURE parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the TEMPERATURE parameter. 2. The machine has an internal malfunction.

1. In SET mode, restore the parameter to the correct value. If the alarm persists, restart the machine. 2. Discontinue DIALYSIS. Call for Service if the problem persists.

Rev. B


!

TEMPERATURE EXCESSIVE VALUE

136

Reason for Alarm

In DIALYSIS: The protection probe (TPS) temperature was greater than 50°C for at least 30 seconds. Not in DIALYSIS: The protection probe (TPS) temperature was greater than 105°C for at least 30 seconds. The temperature measured by the Hydraulic Probe was greater than 107°C for at least 5 minutes. The temperature measured by the Hydraulic Probe was greater than 80°C with a variation of less than 0.1°C for at least 5 minutes.

Machine Actions

GENERAL SAFE STATE

Possible Cause

Suggested Action

1. In dialysis: a previous RESTART condition made the dialysate flow rate unstable.

1. See the Fast Recovery of the Dialysis process procedure in the Section 5.A Special Procedures. If the problem persists disconnect the patient. 2. Check the incoming water temperature. (See the Section 9 - Specifications). 3. Discontinue DIALYSIS. Call for Service if the problem persists.

2. The temperature of the dialysate has exceeded safe limits. 3. The machine has an internal malfunction.

Rev. B


ULTRAFILTER IS PACKED

8-123

138

Reason for Alarm

The pressure drop across the Clean Dialysate Ultrafilter is higher than the maximum permitted value.

Machine Actions

In DIALYSIS and ADR: The machine goes into a RESTART condition.

Possible Cause

Suggested Action

1. The Clean Dialysate Ultrafilter is plugged.

1. If treatment has started, the dialysis process in progress can be continued by decreasing the dialysate flow rate. When the treatment is complete, replace the Ultrafilter according to the procedure. Call for Service if the problem persists.

Rev. B


TIMEOUT ON PA AUTOCALIBRATION

139

Reason for Alarm

The PA Pump Autocalibration has failed due to the timeout of the Main Board.

Machine Actions

None.

Possible Cause

Suggested Action

1. Concentrates were changed during the Autocalibration or the machine has run out of concentrates.

1. Wait a few seconds for stability of the machine, check for the correct Acid/Acetate Container, and then repeat the PA Autocalibration. If needed reboot the machine and repeat the PA Autocalibration. 2. the Acid/Acetate Connector is well inserted in the proper Wand, the stability of Acid/Acetate conductivity, then repeat the PA Autocalibration. If needed reboot the machine and repeat the PA Autocalibration. 3. Turn the machine OFF and then back ON and perform PA Autocalibration again. Call for Service if the problem persists.

2. Conductivity is not stable during the Autocalibration.

3. Power failure during PA Pump Autocalibration.

Rev. B


8-125

TIMEOUT ON PB AUTOCALIBRATION 140 Reason for Alarm

The PB Pump Autocalibration has failed due to the timeout of the Main Board.

Machine Actions

None.

Note This alarm will only occur if Liquid Bicarbonate is being used.

Possible Cause

Suggested Action


1. Wait a few seconds for the machine to stabilize, check for the correct Bicarbonate Concentrate, and then repeat the PB Autocalibration. If needed, turn the machine OFF and then back ON and repeat the PB Autocalibration. 2. the Bicarbonate Connector is well inserted in the proper Wand, the stability of the Bicarbonate Conductivity, then repeat the PB Autocalibration. If needed turn the machine OFF and then back ON and repeat the PB Autocalibration. 3. Turn the machine OFF and then back ON and perform the PB Autocalibration again. Call for Service if the problem persists.

2. Conductivity is not stable during the Autocalibration.

3. Power failure during PB Pump Autocalibration.

Rev. B


TIMEOUT ON PUF AUTOCALIBRATION

141

Reason for Alarm

The PUF Pump Autocalibration has failed due to the timeout of the Main Board.

Machine Actions

None.

Possible Cause

Suggested Action

1. The tubing segment in the PUF Peristaltic Pump is new, and needs to be stretched. 2. In a previous RESTART condition the Autocalibration failed. 3. Power failure during PUF Pump Autocalibration.

1. Perform a RINSING procedure, and then repeat the PUF Autocalibration. 2. From IDLE view, restart the Dialysis preparation and the PUF Autocalibration. 3. Turn the machine OFF and then back ON and perform the PUF Autocalibration again. Call for Service if the problem persists.

Rev. B


8-127

TRANSMEMBRANE PRESSURE 142 Reason for Alarm

The difference between the venous pressure and the Pi Pressure Transducer has reached the TMP THRESHOLD parameter set by the .

Machine Actions

None.

Note If the parameter TMP ALARM is set to NO in the configuration process, when the alarm appears once, it can be reset and then does not appear again; if the parameter is set to YES, it is not possible to override the alarm, it will be displayed on the Touch Screen as long as the alarm condition persists. The TMP icon and visual alarm are displayed if the TMP ALARM is set YES or NO.

Note The Transmembrane Pressure alarm is not active if the machine is in Single Needle mode.

Possible Cause

Suggested Action

1. Dialyser not correct for the current treatment.

2. 3. 4. 5. 6.

1. the correctness of the patient prescription (ultrafiltration rate). Consider increasing the Blood Pump speed if this operation is not in disagreement with the patient prescription. Comply with the specifications of the dialyser. TMP THRESHOLD parameter does not 2. Consider changing the limit of this comply with the specification of the dialyser. parameter in the Config menu. Blood Pump is stopped. 3. Correct the action which caused the Blood Pump to stop and restart the Blood Pump. The Dialysate Lines are blocked. 4. Check that the Dialysate Lines are not kinked or clamped. The Alarm limit is set too close to the actual 5. Readjust the alarm limit. TMP. The Cartridge Blood Set is not well 6. If the alarm condition persists, the positioned or a pressure pod diaphragm has Cartridge Blood Set position. that the collapsed. The Pressure Sensor cannot read pressure pod diaphragm are not collapsed. properly. Perform the Diaphragm Neutral Position Procedure (See Section 5.A Special Procedures) if required. Call for Service if the problem persists.

Rev. B


!

UF DATA ERROR 143

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the WEIGHT LOSS/H parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protective System in the Main Board, for the WEIGHT LOSS/H parameter.

1. In SET mode, confirm the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B


UF MASS BALANCE

!

8-129

144

Attribute

8. 9. 10. 11.

Reason for Alarm

VALVES: Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect valves control. D1-D2: Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect flowmeter reading. P2 Pump: Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect P2 Pump flow or P2 reading. NO CALIB: The machine could not perform an alignment of the D2 flowmeter during the treatment, and the Ultrafiltration Mass Balance could be incorrect.

Machine Actions

Valves D1-D2 P2 Pump No Calib

Byes the dialyser.

Note This alarm will only be displayed after the Patient Sensor detects blood or the DIALYSIS Action key is pressed.

Possible Cause

Suggested Action

1. A RESTART condition has resulted in the machine detecting a Ultrafiltration Mass Balance error. 2. If the attribute is D1-D2 or P2 Pump the machine needs to be descaled.

1. Press OVERRIDE to clear the alarm.

2. If the problem persists disconnect the patient. As soon as possible perform DESCALING. 3. If the attribute is No Calib, the machine has 3. Press OVERRIDE. The machine not performed a flowmeter alignment for 25 automatically will perform a flowmeter minutes. alignment. Call for Service if the problem persists.

Rev. B


UF RATE ERROR

!

145

Attibute

1. LOW 2. HIGH 3. VESSEL

Reason for Alarm

1. LOW: The measured ultrafiltration is lower than the rate set by the operator or the permitted limit. 2. HIGH: The measured ultrafiltration is higher than the rate set by the operator or the permitted limit. 3. Vessel: There was an error detected in the calculation of the volume or the emptying time of the UF burette.

Machine Actions

Ultrafiltration Rate is set to zero.


Possible Cause

Suggested Action

1. The operator changed the Ultrafiltration Rate of the machine too often. This is a temporary acquiring error.

1. Press OVERRIDE to restart the Ultrafiltration Pump. The Total Weight Loss calculation may be affected by this error. If the alarm persists disconnect the patient, as the Total Fluid Removal value may not be reliable. 2. Press OVERRIDE to restart the Ultrafiltration Pump.

2. Pi and Po pressures are high. The machine adds approximately 2 liters/hour to the UF Rate to lower the pressure. If this occurs often the alarm could be triggered.


Rev. B


ULTRAFILTER MAX PRESSURE

8-131

146

Reason for Alarm

The PFS Pressure Sensor (PFS Sensor is related to the Clean Dialysate Ultrafilter) has ed a measurement which exceeds the maximum permitted value.

Machine Actions

In DIALYSIS and ADR: The machine goes into a RESTART condition.

Possible Cause

Suggested Action

1. The Clean Dialysate Ultrafilter is plugged.

1. If in treatment, the dialysis process in progress can be continued by decreasing the dialysate flow rate. When the treatment is complete, replace the Ultrafilter according to the procedure. 2. Dialysate Connectors in the wrong position. 2. Correctly connect the dialyser Connectors to the By Connectors or to the dialyser depending upon the phase of the machine at that time, then press RESTART. 3. Dialysate Connectors not properly 3. the Dialysate Connectors are properly positioned. positioned to the dialyser or to the machine, depending upon the phase of the machine at that time. Press RESTART to restart the current operation of the machine. Call for Service if the problem persists.

Rev. B


ULTRAFILTER PRESSURE SENSOR

147

Reason for Alarm

A problem was detected with the Pre Ultrafilter Pressure Sensor (PFS) due to an unplugged connector or to an out of range reading.

Machine Actions

None.

Possible Cause

Suggested Action

1. Problem detected with the Pre Ultrafilter Sensor.

1. Press RESTART to restart the current operation of the machine. Call for Service if the problem persists.


Rev. B


VENOUS CLAMP POSITION

8-133

148

Reason for Alarm

The Optical Switch in the Venous Line Clamp indicates that the clamp is open when it should be closed, or it is closed when it should be open.

Machine Actions

None.

Possible Cause

Suggested Action

1. Venous Line Clamp is obstructed.

1. the Venous Line Clamp is free from obstruction. Only the venous line should be inserted into the clamp. 2. Carefully clean the Venous Line Clamp (see Section 6 - Clean/Disinfect, in this manual). 3. Call for service if the problem persists. Call for Service if the problem persists.

2. Venous Line Clamp is dirty. 3. The machine has an internal malfunction.

Rev. B


!

VENOUS PRES DATA ERROR

150

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the VEN P parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the VEN P parameter.

1. Return to IDLE view, in Config restore the parameter to the correct value. If the alarm persists, and turn the machine OFF, then back ON again. Call for Service if the problem persists.

Rev. B


!

VEN PRES LIMIT DATA ERROR

8-135

152

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the VEN PRES LIMIT parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protective System in the Main Board, for the VEN PRES LIMIT parameter.

1. In SET mode, restore the parameter to the correct value. If the alarm persists, turn the machine OFF, then turn it ON again. Call for Service if the problem persists.

Rev. B


VEN PRESSURE OUT OF RANGE

153

Reason for Alarm

The measured venous pressure is outside the range of values permitted by the Sensor.

Machine Actions

Stops the Blood Pump. Closes the Venous Line Clamp. Ultrafiltration is reduced to the minimum value.

Possible Cause

Suggested Action

1. Restriction of blood flow to the patient’s venous access or in the venous line.

1. Check for restriction of blood flow in the venous line, i.e. kinks, clamps, clotted venous needle, poor flow to the patient’s venous access. The alarm clears when the venous pressure is in the proper range. 2. Attention should be given to re-evaluating needle size, blood flow rate and anticoagulant dosage.

2. Venous pressure has increased somewhat during a treatment due to haemoconcentration and/or inadequate heparinization of the patient, resulting in a pressure increase for a given needle at a fixed blood flow rate.


Rev. B


!

VEN PRESSURE LIMIT

8-137

154

Reason for Alarm

The Venous Pressure Sensor measured a value that is greater than the VEN PRES LIMIT value set by the operator in the Configuration menu.

Machine Actions

Stops the Blood Pump. Closes the Venous Line Clamp. see Note

Ultrafiltration is reduced to the minimum value.

Note The following message appears in the window: Decrease the Venous Pressure ! Override will only open the Venous Line Clamp if the venous pressure is > VEN PRES LIMIT but lower than +450 mmHg. When this is the case, the following message is displayed: Push OVERRIDE To Open The Venous Clamp.

Possible Cause

Suggested Action

1. Restriction of blood flow to the patient’s venous access or in the venous line.

1. Check for restriction of blood flow in the venous line, i.e. kinks, clamps, clotted venous needle, poor flow to the patient’s venous access. Press OVERRIDE to open the Venous Clamp. The alarm clears when the venous pressure is in the proper range. 2. Attention should be given to re-evaluating needle size, blood flow rate and anticoagulant dosage. Press OVERRIDE to open the Venous Clamp. The alarm clears when the venous pressure is in the proper range. Call for Service if the problem persists.

2. Venous pressure has increased somewhat during a treatment due to haemoconcentration and/or inadequate heparinization of the patient, resulting in a pressure increase for a given needle at a fixed blood flow rate.

WARNING Never press the OVERRIDE button, to clear the ! VENOUS PRESSURE HIGH LIMIT #154 alarm, if the problem that is causing the alarm condition has not been identified and removed.

Rev. B


VEN PRESSURE ALARM

!

155

Attribute

1. MINIMUM 2. MAXIMUM 3. UNDEFIN

Reason for Alarm

1. MINIMUM: The Venous Pressure Sensor has measured a pressure value that is lower than +10 mmHg or which is lower than the minimum range selected by the operator and displayed in the pressure graph. 2. MAXIMUM: The Venous Pressure Sensor has measured a pressure value that is higher than the maximum permitted range selected by the operator and displayed in the pressure graph. 3. UNDEFIN: Error in venous pressure acquisition.

Machine Actions

Stops the Blood Pump. Closes the Venous Line Clamp. Ultrafiltration is reduced to the minimum value.

Note The following message appears in the Operator Messages Area: Check blood line and patient's access. Press Override to restart the Pump. If needed select in SET the graph of the pressure causing the alarm and press CONFIRM

Possible Cause

Suggested Action

1. If <10 mmHg, venous line may have become disconnected from the patient. 2. If high venous pressure, check for kinked venous line. 3. Incorrect placement of the diaphragm between the Cartridge Blood Set and the venous seal.

1. Carefully check patient’s line connections. Press OVERRIDE to restart the Blood Pump. 2. Carefully check patient’s line connections. Press OVERRIDE to restart the Blood Pump. 3. Perform a Diaphragm Neutral Position Procedure (See Section 5.A – Special Procedures, in this manual). Press OVERRIDE to restart the Blood Pump. 4. In SET mode, select the venous pressure graph and press CONFIRM. Press OVERRIDE to restart the Blood Pump. Call for Service if the problem persists.

4. The venous pressure window needs to be set.

WARNING Never press the OVERRIDE button, to clear the ! Ven Pressure Alarm #155 alarm, if the problem that is causing the alarm condition has not been identified and removed.

Rev. B


VEN SENSOR ERROR

8-139

159

Reason for Alarm

The control system has detected a large spike or a large rapid change while monitoring the Venous Pressure Sensor.

Machine Actions

Stops the Blood Pump. Closes the Venous Line Clamp. Ultrafiltration is reduced to its minimum value.

Possible Cause

Suggested Action



Rev. B


!

VOLTAGES INCORRECT

160

Reason for Alarm

The Protection Module detects a difference between the reference values and the Power Supply voltages after Patient Connection.

Machine Actions

GENERAL SAFE STATE

Possible Cause

Suggested Action

1. Difference between the Protection references and the Power Supply voltages.

1. See Fast Recovery of the Dialysis process procedure in the Section 5.A - Special Procedures. Discontinue treatment if the problem persists. Call for Service if the problem persists.

Rev. B


!

WLR MINIMUM DATA ERROR

8-141

164

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the WLR MINIMUM parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the WLR MINIMUM parameter.

1. Return to IDLE view, in Config menu restore the parameter to the correct value. If the alarm persists, turn the machine OFF, then ON again. Call for Service if the problem persists.

Rev. B


W!

AD CONVERTER

165

Reason for Alarm

Malfunction of analog/digital converter on the Protective Board.

Machine Actions

None.

Possible Cause

Suggested Action

1. Temporary acquiring problem.

1. Press OVERRIDE to clear the alarm. Call for Service if the problem persists.

Rev. B


W!

ANALOG HIVAR

8-143

166

Reason for Alarm

Protection Module unable to monitor the Temperature or Pressure Sensors.

Machine Actions

None.

Possible Cause

Suggested Action


1. Press OVERRIDE. Wait a few seconds for the alarm to be cleared. If the alarm persists, discontinue the treatment, and turn the machine OFF. Call for Service if the problem persists.

Rev. B


W!

BLD CALIBRATION PHASE

167

Reason for Alarm

The calibration of the Optical Sensor for the Blood Leak Detector did not occur at the correct time.

Machine Actions

None.

Possible Cause

Suggested Action

1. The calibration of the Blood Leak Detector did not occur at the correct phase. This alarm usually occurs during a Fast Recovery of the Dialysis process.

1. Press OVERRIDE to clear the alarm. The Blood Leak Detector will calibrate.

Rev. B


W!

BLD FAST RECOVERY

8-145

168

Reason for Alarm

A Fast Recovery of the Dialysis process procedure has been performed by the operator and the EEPROM calibration value for the Blood Leak Detector has not been set.

Machine Actions

None.

Possible Cause

Suggested Action

1. After a Fast Recovery of the Dialysis process, the value of the Blood Leak Detector has not been set.

1. Press OVERRIDE to clear the alarm. The Blood Leak Detector will use a default parameter.

Rev. B


W!

BLD LED EXCESSIVE VALUE

169

Reason for Alarm

Excessive control voltage at the Blood Leak Detector transmitter Optical Sensor.

Machine Actions

None.

Possible Cause

Suggested Action

1. An excessive control voltage at the Blood Leak Detector transmitter Optical Sensor is present, because of deposits on the detector.

1. Perform a Chemical Disinfect procedure to clean the Sensor.


Rev. B


W!

BLD RECEIVER EXCESSIVE VALUE

8-147

170

Reason for Alarm

An excessively high value is present at the receiver of the Optical Sensor, resulting in loss of Blood Leak Detector sensitivity.

Machine Actions

None.

Possible Cause

Suggested Action

1. An excessively high value is present at the receiver of the Optical Sensor, due to deposits on the detector.

1. Press OVERRIDE to clear the alarm. Perform a Chemical Disinfect procedure to clean the Sensor. Call for Service if the problem persists.

Rev. B


STILL IN BY

W!

171

Reason for Alarm

The machine has been in PATIENT CONNECT for more than 7 minutes or in the WASHBACK phase for more than 8 minutes.

Machine Actions

None.

Note This message remains on the Touch Screen for a few seconds and then disappears automatically.

Possible Cause

Suggested Action

1. The machine remained in PATIENT CONNECT for too long. 2. The machine remained in WASHBACK for too long.

1. Proceed with DIALYSIS.

Rev. B

2. Press OVERRIDE or continue the treatment by pressing the DIALYSIS Action key.


W!

DAC EXCURSION

8-149

172

Reason for Alarm

Protection Module unable to monitor Temperature or Pressure Sensors.

Machine Actions

None.

Possible Cause

Suggested Action



Rev. B


W!

E2PROM CRC

173

Reason for Alarm

The control memory CRC test performed by the Protection System for the correct number related to the calibration data has failed. The calibration data has been lost and standard defaults are used.

Machine Actions

None.

Possible Cause

Suggested Action

1. The calibration parameters of the EEPROM have been lost.

1. Turn the machine OFF and then ON again. Retry dialysis preparation. Call for Service if the problem persists.

Rev. B


W!

RAM ERROR

8-151

175

Reason for Alarm

Error in reading Protection Module memory.

Machine Actions

None.

Possible Cause

Suggested Action

1. Protection Slave Board memory problem.

1. Turn the machine OFF and then ON again. Retry Dialysate preparation. Call for Service if the problem persists.

Rev. B


W!

PA AUTOCALIBRATION FAILED

176

Reason for Alarm

Acid/Acetate Pump Autocalibration by the Protection System has failed.

Machine Actions

None.

Possible Cause

Suggested Action

1. Concentrates were changed during the Autocalibration procedure or the machine has run out of concentrates.

1. Press OVERRIDE to clear the alarm. Wait a few seconds for the machine to stabilize, the correct Acid/Acetate Concentrates are being used, and then repeat the PA Autocalibration. If needed, turn the machine OFF and then ON again and repeat the PA Autocalibration. 2. the Acid/Acetate Connector is inserted well to the proper Concentrate Wand. When the Acid/Acetate conductivity is stable, repeat the PA Autocalibration. If needed turn the machine OFF and then ON again and repeat the PA Autocalibration. 3. Turn the machine OFF and then ON again and repeat the PA Autocalibration. Call for Service if the problem persists.

2. Conductivity is not stable during the PA Autocalibration procedure.

3. Power failure during PA Autocalibration.

Rev. B


W!

PB AUTOCALIBRATION FAILED

8-153

177

Reason for Alarm

Bicarbonate Pump Autocalibration by the Protection System has failed. (This alarm will only occur when Liquid Bicarbonate is used.)

Machine Actions

None.

Possible Cause

Suggested Action


1. Press OVERRIDE to clear the alarm. Wait a few seconds for the machine to stabilize, the correct Bicarbonate Concentrate is being used, and then repeat the PB Autocalibration. If needed turn the machine OFF and then ON again, and repeat the PB Autocalibration. 2. the Bicarbonate Connector is inserted well to the proper Concentrate Wand. When the Bicarbonate conductivity is stable, repeat the PB Autocalibration. If needed, turn the machine OFF and then ON again and repeat the PB Autocalibration. 3. Turn the machine OFF and then ON again and repeat the PB Autocalibration. Call for Service if the problem persists.

2. Conductivity is not stable during PB Autocalibration.

3. Power failure during PB Autocalibration.

Rev. B


W!

PI PRESSURE SENSOR

178

Reason for Alarm

A large pressure spike or a large rapid change were detected from the Pi Pressure Sensor.

Machine Actions

None.

Possible Cause

Suggested Action



Rev. B


W!

PO PRESSURE SENSOR

8-155

179

Reason for Alarm

A large pressure spike or a large rapid change were detected from the Po Pressure Sensor.

Machine Actions

None.

Possible Cause

Suggested Action



Rev. B


W!

PUF AUTOCALIBRATION FAILED

180

Reason for Alarm

Ultrafiltration Pump Autocalibration by the Protection System has failed.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Ultrafiltration Pump has failed the PUF Autocalibration.

1. Return to IDLE view, restart Dialysate preparation and repeat the PUF Autocalibration. 2. Turn the machine OFF and then ON again and repeat the PUF Autocalibration. Call for Service if the problem persists.

2. Power failure during the PUF Autocalibration.

Rev. B


8.

8-157


W!

PV PRESSURE SENSOR

181

Reason for Alarm

A large pressure spike or a large rapid pressure change was detected by the Venous Pressure Sensor.

Machine Actions

None.

Possible Cause

Suggested Action


1. Press OVERRIDE. Wait a few seconds for the alarm to be cleared. Call for Service if the problem persists.

Rev. B

8-158


W!

UNRECOGNIZED SOFTWARE EXEC

182

Reason for Alarm

Execution error in program management of the Protection Module.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Protection module detects an error in execution of the software.


Rev. B


W!

T1 TEST FAILED

8-159

183

Reason for Alarm

Failure of one of the T1 tests which does not stop the machine (see Section 5.B Test Procedures, in this manual).

Machine Actions

None.

Possible Cause

Suggested Action

1. A T1 test related to: Temperature, Acid/Acetate or Bicarbonate Conductivity, or Blood Leak Detector failed during preparation. 2. The T1 test failed following turning the machine OFF, then back ON and restarting Dialysis preparation.

1. Turn the machine OFF, then back ON, and restart Dialysis preparation to recheck the failed T1 test. 2. It is NOT advisable to continue treatment. It is the operator’s responsibility to carefully check the parameters involved in the failed test if the decision is made to continue treatment despite the test failure. Call for Service if the problem persists.

Rev. B

8-160


W!

TEMPERATURE SENSOR

184

Reason for Alarm

A large temperature spike or a large rapid temperature change was detected by the TPS Temperature Sensor.

Machine Actions

None.

Possible Cause

Suggested Action


1. Press OVERRIDE. Wait a few seconds for the alarm to be cleared. Call for Service if the problem persists.

Rev. B


W!

UNKNOWN MESSAGE TYPE

8-161

185

Reason for Alarm

The Protection Module does not recognize the data sent.

Machine Actions

None.

Possible Cause

Suggested Action


1. Press OVERRIDE. Wait a few seconds for the alarm to be cleared. If the alarm persists, discontinue treatment, turn the machine OFF and then back ON. Call for Service if the problem persists.

Rev. B

8-162


W!

VOLTAGES INCORRECT

187

Reason for Alarm

The Protection Module detects a difference between the reference values and the supply voltages.

Machine Actions

None before Blood detection (patient not connected). In DIALYSIS: Alarm 160 occurs causing a GENERAL SAFE STATE.

WARNING After patient connection this signal becomes #160, a Class P signal (see Class P alarms section), which causes a GENERAL SAFE STATE and consequently stops the machine.

Possible Cause

Suggested Action

1. Power supply failure during preparation.

1. If the alarm persists until the end of the preparation, do not proceed into DIALYSIS. Call for Service.

Rev. B


W!

WAIT TO CONTINUE

8-163

188

Reason for Alarm

Failure of a machine control test (T1 test) with a request for the operator to confirm if normal operation is to be continued despite T1 test failure (see Section 5.B - Test procedures, in this manual).

Machine Actions

None.

Possible Cause

Suggested Action

1. T1 test failed.

1. Press OVERRIDE then CONFIRM to proceed despite failure of T1 test. Call for Service if the problem persists.

WARNING It is not advisable to continue treatment, but to notify Service as to which test failed. It is the operator’s responsibility to carefully monitor the parameters involved in the failed test if the decision is made to continue treatment despite the test failure.

Rev. B

8-164


STILL IN MINIMUM UF

W!

189

Reason for Alarm

The machine has been in WLR MINIMUM for longer than 4 minutes.

Machine Actions

None.

Note This message remains on the Touch Screen for a few seconds and then disappears automatically. It is displayed every 4 minutes if the condition remains.

Possible Cause 1. WLR MINIMUM Action key selected for longer than 4 minutes.

Suggested Action

1. Deselect the WLR MINIMUM Action key to reset the Ultrafiltration Rate to its set value. The TOT WEIGHT L or UFR may need to be adjusted to avoid Fluid Removal alarms. 2. An alarm condition sets WLR MINIMUM for 2. Correct the alarm condition to continue the longer than 4 minutes. treatment.

Rev. B


TIME OUT PROC

8-165

190

Reason for Alarm

Service processes are stopped due to a time out.

Machine Actions

In ADR: Machine stops and goes to the RESTART phase.

Possible Cause

Suggested Action

1. An alarm has occurred that stopped the procedure.

1. Press the RESTART key after correcting the alarm condition. Call for Service if the problem persists.

Rev. B

8-166


W!

T1TESTS DISABLED

203

Reason for Alarm

T1 Test has been hardware disabled.

Machine Actions

The T1 Test will not be executed.

Note This message remains on the Touch Screen for 5 seconds and then disappears automatically. It is displayed every 5 minutes for all the dialysis treatment, starting from the selection of the Dialysate Type until the end of the FINAL RINSE process.

WARNING If the W! T1Tests Disabled #203 alarm appears, the machine must not be used for a patient treatment. A Service Technician must re-enable the T1 Tests before using the machine for a patient treatment.

Possible Cause

Suggested Action

1. The machine is being serviced and the T1 test has been temporarily disabled.

1. Press OVERRIDE to use the machine in vitro for service testing. A Service Technician must re-enable the T1 Test before using the machine for a patient treatment. Call for Service if the problem persists.

Rev. B


LOW ART FLOW FOR TOO LONG

W!

8-167

204

Reason for Alarm

Operator has set the Blood Pump to a value less than 50 ml/min for more than 4 minutes.

Machine Actions

None.

Note This message remains on the Touch Screen for a few seconds and then disappears automatically. It is displayed every 4 minutes if the condition remains.

Possible Cause

Suggested Action

1. Blood Pump speed is less than 50 ml/min for more than 4 minutes.

1. Press OVERRIDE to clear the alarm. Increase Blood Pump speed to more than 50 ml/min.

Rev. B

8-168


W!

VENOUS LINE NOT FITTED

205

Reason for Alarm

The venous line has been incorrectly inserted in the Venous Line Clamp or inside the Air Bubble Detector housing.

Machine Actions

None. If an “! AIR & FOAM DETECTOR” #4 alarm occurs when the venous line is not correctly placed in the Air Bubble Detector, it is not possible to clear the alarm. When the RESUME key is pressed the Blood Pump doesn’t start and the Venous Line Clamp closes.

Possible Cause

Suggested Action

1. Venous line is not inserted correctly into the 1. Remove and correctly re-insert the venous Venous Line Clamp. line into the Venous Line Clamp. 2. Venous line is not inserted correctly into the 2. Check the venous line position. Air Bubble Detector housing. Call for Service if the problem persists.

Rev. B


OUTPUT OVERPRESSURE

8-169

206

Reason for Alarm

The Hydraulic Module Drain Pressure Switch (SWP1) is sensing HIGH pressure in the drain.

Machine Actions

The machine goes into By and all Hydraulic Module Pumps are stopped, including the Ultrafiltration Pump.

Possible Cause

Suggested Action

1. Obstruction or kinking in the drain hose.

1. the drain hose is not kinked or obstructed in any way. Call for Service if the problem persists.

Rev. B

8-170


!

S/N MIN PRESSURE DATA ERROR

208

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the SN P parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the SN P parameter.


Rev. B


!

S/N MAX PRESSURE DATA ERROR

8-171

209

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the SN P parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the SN P parameter.


Rev. B

8-172


CONDUCTIVITY PROFILE

!

Reason for Alarm

210

CURVE: The Conductivity Profile has caused a Protection Module data error. TIMING: The Conductivity Profile timing has caused a Protection Module data error. SET VAL: The Conductivity Curve scanning set value has caused a Protection Module data error.

Machine Actions

Machine goes into By. Disables Conductivity Profiling.


Possible Cause

Suggested Action

1. The Protection Module detected an incoherent condition in the Conductivity Profiling execution.

1. Press OVERRIDE to clear the alarm. Before starting the following dialysis treatments, check and if necessary re-set the profiling curves in Config/PROFILE.

Rev. B


WEIGHT LOSS RATE PROFILE

!

Reason for Alarm

8-173

212

CURVE: The Ultrafiltration Profile has caused a Protection Module data error. TIMING: The Ultrafiltration Profile timing has caused a Protection Module data error. SET VAL: The Ultrafiltration Curve scanning set value has caused a Protection Module data error.

Machine Actions

Ultrafiltration is reduced to the minimum. Ultrafiltration Rate profiling is disabled.


Possible Cause

Suggested Action

1. The Protection Module detected an incongruent condition in the UF Profiling execution.

1. Press OVERRIDE to clear the alarm. Before starting the following dialysis treatments, check and if necessary re-set the profiling curves in Config/PROFILE.

Rev. B

8-174


BAD BLOOD LINE POSITION

219

Reason for Alarm

The machine detects an incorrect configuration of the Cartridge Blood Set during the Autoemptying Procedure.

Machine Actions

Stops the Blood Pump.

Possible Cause

Suggested Action

1. The operator has clamped one of the lines 1. that clamps are open on the Cartridge on the Cartridge Blood Set. Blood Set. 2. The Cartridge Blood Set is not correctly 2. the Cartridge Blood Set is correctly configured for the Autoemptying Procedure. configured for the current phase of the machine. Call for Service if the problem persists.

Rev. B


W!

U.F. CALCULATION NOT RELIABLE

8-175

220

Reason for Alarm

The “! UF RATE ERROR: VESSEL” #145 alarm has occurred too many times during DIALYSIS.

Machine Actions

None.

Possible Cause

Suggested Action

1. The “! UF RATE ERROR: Vessel” alarm has occurred too many times during DIALYSIS.

1. Press OVERRIDE to clear the alarm. The Fluid Removed data displayed may not be accurate. Disconnect the patient. Refer to alarm number 145 for further troubleshooting information. 2. Perform PUF Autocalibration. See the directions for this procedure in Section 5.A Special Procedures. Call for Service if the problem persists.

2. The Ultrafiltration Pump (PUF) Autocalibration is required.

Rev. B

8-176


ULTRAFILTER : TMP TOO HIGH

237

Reason for Alarm

Transmembrane Pressure has reached 90% of the maximum value set by the operator.

Machine Actions

In DIALYSIS: None.

Possible Cause

Suggested Action

1. The ultrafilter is approaching its expected end of life. 2. The operator set a value lower than the correct ULTRAF PRES parameter.

1. Press OVERRIDE to clear the alarm. The ultrafilter needs to be replaced. 2. Press OVERRIDE to clear the alarm. From IDLE view, on Config menu, the correct value for the ULTRAF PRES parameter. Call for Service if the problem persists.

Rev. B


!

DIALYSIS TIME DATA ERROR

8-177

239

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the DIALYSIS TIME parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the DIALYSIS TIME parameter.

1. In Set Mode, restore the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B

8-178


!

TOT WEIGHT L DATA ERROR

240

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the TOT WEIGHT L parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the TOT WEIGHT L parameter.

1. In Set Mode, restore the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B


DIASCAN INITIAL CALIBRATION FAILED Reason for Alarm

Initial DIASCAN Autocalibration has failed.

Machine Actions

In DIALYSIS: None. DIASCAN Monitoring System is disabled.

8-179

244

Possible Cause

Suggested Action

1. An conductivity alarm or intervention caused Autocalibration to fail.

1. During Autocalibration avoid alarms and modifications to Dialysate conductivity and flow rate in SET. The DIASCAN Monitoring System is not available for the current treatment. 2. Check if DIASCAN performs two autocalibrations during the next treatment. The DIASCAN Monitoring System is not available for the current treatment. Call for Service if the problem persists.

2. The Autocalibration was out of range. The DIASCAN conductivity measuring system is not able to measure the correct conductivity.

Rev. B

8-180


DIASCAN: INCORRECT MEASUREMENT Reason for Alarm

A DIASCAN measurement could not be completed.

Machine Actions

None.

246

Possible Cause

Suggested Action

1. An alarm or intervention cancelled the Diascan measurement. 2. The Diascan conductivity measuring system is not properly working.

1. Avoid interventions or conductivity alarms during Diascan measurement. 2. Switch off the DIASCAN Monitoring System in the Kt/V view. Call for Service if the problem persists.

Rev. B


DIASCAN: LIMIT LOW CLEARANCE

8-181

249

Reason for Alarm

The last measured value of the Clearance is lower than the fixed threshold.

Machine Actions

None.

Possible Cause

Suggested Action

1. The blood flow rate was changed.

1. Let the blood flow rate stabilize before performing other procedures to clear the alarm. 2. Determine reason for clotting and replace the dialyser. 3. Check patient’s access for correct needle placement.

2. The Dialyser is clotting. 3. Problem with patient’s access or needle placement. The level of recirculation is increased. 4. Clearance threshold incorrect for this patient.

4. Change the clearance threshold alarm level.

Rev. B

8-182

W!


SET VALUE OUT OF RANGE

250

Reason for Alarm

The Protection System has detected a control set-value that is out of range.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Protection System has detected a control set-value that is out of range.

1. Press OVERRIDE to clear the alarm.

Rev. B


DIASCAN MEASUREMENT FAILED :

!

Reason for Alarm

Machine Actions

8-183

251

The Protection System has detected a violation of a DIASCAN safety criterion. 1. SET VALUE: Conductivity Step amplitude too high or too low. 2. Duration: Conductivity Step duration too long. 3. Frequen: Too many repetitions of the Conductivity Step. Machine goes into By.


Possible Cause 1. The DIASCAN conductivity measuring system has failed.

Suggested Action 1. Press OVERRIDE to clear the alarm. DIASCAN is not reliable for the current treatment. Switch off the DIASCAN Monitoring System in the kT/V view. Call for Service if the problem persists.

Rev. B

8-184


W!

PDR PRESSURE SENSOR ERROR

252

Reason for Alarm

A large pressure spike or a large rapid change in pressure was detected by the Drain Pressure Sensor.

Machine Actions

None.

Possible Cause

Suggested Action



Rev. B


BPM NOT CONNECTED

8-185

255

Reason for Alarm

The BPM is disconnected inside the machine.

Machine Actions

None.

Possible Cause

Suggested Action

1. The machine does not detect the BPM.

1. Press OVERRIDE to clear the alarm. During DIALYSIS the BPM is not available. From IDLE, turn the machine OFF then back ON again and retry a measurement. Call for Service if the problem persists.

Rev. B

8-186


!

DIASCAN FREQ. DATA ERROR

257

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the INTERMEASUREM parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the INTERMEASUREM parameter.

1. In the Config/PROFILE/kT/V view, in SET Mode, restore the INTERMEASUREM parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B


BLOOD MODULE<->MASTER DISK MISMATCH

8-187

259

Reason for Alarm

An incongruent condition has been detected between the Blood board configuration and the dialysis mode during a Fast Recovery of the Dialysis process.

Machine Actions

The dialysis process is not available.

Possible Cause

Suggested Action

1. During a Fast Recovery of the Dialysis process the machine detected an incongruent condition between the Blood Board configuration and the Dialysis mode.

1. The Fast Recovery of the Dialysis process is not available, discontinue the treatment. Perform a RINSE to reset the alarm. Call for Service if the problem persists.

Rev. B

8-188


!

BICART COND DATA ERROR

263

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the BICART COND parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the BICART COND parameter.

1. From Home view, in SET Mode, restore the parameter to the correct value. If the alarm persists, turn the machine OFF then back ON again. Call for Service if the problem persists.

Rev. B


W!

AIR & FOAM DETECTOR


8-189

264

During Dialysate preparation, the Patient Sensor has detected blood in the venous line and the Air Bubble Detector has detected air in the venous line. Stops the Blood Pump.

WARNING OVERRIDE has no effect if the venous line is not inserted into the Venous Line Clamp (in which case the alarm number 205: “W! Venous Line Not Fitted“ appears).

Note If the alarm is displayed only for a few seconds before the machine detects blood, ignore it. If the alarm persists, refer to the troubleshooting procedure described below.

Possible Cause

Suggested Action

1. Air in venous line or Patient Sensor dirty or wet.

1. Stop Dialysate preparation and return to the IDLE view. Remove the venous line from the Air Bubble Detector and carefully clean the Patient Sensor and the surface of the Air Bubble Detector around the Patient Sensor using a soft cloth. Carefully clean the venous line using a soft cloth. Reinsert the venous line in the Air Bubble Detector and restart the Dialysate preparation. Call for Service if the problem persists.

Rev. B

8-190


BT2 MALFUNCTIONING

268

Reason for Alarm

LD2 Level Sensor malfunctioning. It appears only if a certain sequence of “! UF Mass Balance” alarms (code number 144) occur.

Machine Actions

None. This alarm is only triggered during treatment. (Patient connection forward).

Possible Cause

Suggested Action

1. Dialysate Connectors are in the wrong position.

1. the Dialysate Connectors are well connected in the correct position and that there are no air leaks. Call for Service if the problem persists.

Rev. B


DIASCAN: MEASUREM. IMPOSSIBLE (SET)

8-191

269

Reason for Alarm

The set-value for blood or dialysate flow rate has been changed during the measurement.

Machine Actions

None.

Possible Cause

Suggested Action

1. The blood or dialysate flow rate was changed during the measurement.

1. Press OVERRIDE to clear the alarm. A DIASCAN measurement will not be obtained at this interval. Avoid changing blood or dialysate flow rates during DIASCAN readings.

Rev. B

8-192


DIASCAN: MEAS. IMPOSSIBLE (ALARM)

270

Reason for Alarm

During the measurement, an alarm occurred and the machine went into By.

Machine Actions

None.

Possible Cause

Suggested Action

1. Machine went into By due to an alarm, or the operator put the machine into By.

1. Press OVERRIDE to clear the alarm. A DIASCAN measurement will not be obtained at this interval. Avoid placing the machine in BY during DIASCAN readings.

Rev. B


CENTR. ACID CONNECTOR POSITION

8-193

271

Reason for Alarm

The Central Acid Inlet Connector is not in the correct position for the current operating phase of the machine.

Machine Actions

In ADR: The machine stops and waits for the Connector to be correctly positioned. In DIALYSIS: The machine stops during the preparation phase. The machine goes into By during the treatment phase.

Possible Cause

Suggested Action

1. The Central Acid Inlet Connector is not in the correct position for the current operating phase of the machine.

1. the correct configuration of the machine. Call for Service if the problem persists.

Note If the machine has stopped during an ADR procedure when the alarm occurs, the SETUP Action key is not available. Perform a complete ADR procedure in order to have the SETUP Action key displayed in the IDLE view.

Rev. B

8-194


CENTR. BICARB CONNECTOR POSITION 272 Reason for Alarm

The Central Bicarbonate Inlet Connector is in the incorrect position required for the current operating phase of the machine.

Machine Actions

In ADR: The machine stops and waits for the Connector to be correctly positioned. In DIALYSIS: The machine stops during the preparation phase. The machine goes into By during the treatment phase.

Possible Cause

Suggested Action

1. The Central Bicarbonate Inlet Connector is not in the correct position required for the current operating phase of the machine.

1. the correct configuration of the machine. Call for Service if the problem persists.

Note If the machine has stopped during an ADR procedure when the alarm occurs, the SETUP Action key is not available. Perform a complete ADR procedure in order to have the SETUP Action key displayed in the IDLE view.

Rev. B


W!

PATIENT SENSOR SATURATION

8-195

273

Reason for Alarm

The Protection System detects the maximum allowed value for the Patient Sensor.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Patient Sensor is malfunctioning.

1. Service is required. Call for Service.

Rev. B

8-196


CONTROL SYSTEM OUT OF ORDER

!

274

Reason for Alarm

The Control System is not able to communicate with the Protection System.

Machine Actions

GENERAL SAFE STATE

Note The Audible alarm, which signals the #274 alarm condition, can not be silenced by pressing the MUTE button.

Possible Cause

Suggested Action

1. The control system is no more working correctly.

1. Turn the machine OFF. See the Fast Recovery of the Dialysis process procedure in the Section 5.A - Special Procedures, in this manual. Call for Service if the problem persists.

Rev. B


!

AUTOEMPTYING DATA ERROR

8-197

277

Reason for Alarm

A data difference was detected inside the double image of the Protection System in the Main Board, for the AutoEmptying parameter.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected inside the double image of the Protection System in the Main Board, for the AutoEmptying parameter.

1. In Config, restore the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B

8-198


ERROR ON CALIBRATION TOOL

279

Reason for Alarm

The machine has detected a problem during the P2 Autocalibration. This alarm can occurr only during Service calibration.

Machine Actions

The machine does not proceed with the P2 Autocalibration.

Possible Cause

Suggested Action

1. The machine has detected a problem during the P2 Autocalibration.

1. No troubleshooting is required, this alarm can occurr only in calibration environment.

Rev. B


WAIT FOR CONFIRMATION

8-199

283

Reason for Alarm

The machine is waiting for the operator to confirm an Autocalibration of the PA or PB Pump.

Machine Actions

The machine stops and waits for confirmation.

Possible Cause

Suggested Action

1. The machine is waiting for the operator to confirm an Autocalibration of the PA or PB Pump.

1. Check for correct concentrates and press CONFIRM to proceed.

Rev. B

8-200


!

AUTOEMPTYING: MAX ACTIVATION TIME


294

The maximum volume of blood has ed through the Blood Pump during the AutoEmptying procedure. Stops the Blood Pump. Venous Line Clamp closes.

Possible Cause

Suggested Action

1. The Patient Sensor detects blood during the 1. The Autoempting procedure is stopped after Autoempting procedure. 400 ml. Press OVERRIDE then an additional 100 ml will be infused. 2. The venous line is not correctly positioned 2. the position of the venous line in the in the Patient Sensor. Patient Sensor. 3. The Patient Sensor is dirty. 3. Carefully clean the Patient Sensor, using a soft cloth. Call for Service if the problem persists.

Rev. B


BLOOD CARD COMMUNICATION TIMEOUT

8-201

295

Reason for Alarm

There was a communication problem detected between the Blood Slave Board and the Main board.

Machine Actions

None.

Possible Cause

Suggested Action

1. Temporary data overload of the Blood Slave 1. Wait a few seconds for the alarm to clear. Board. Too much information is going to the See the Fast Recovery of the Dialysis Blood Slave Microprocessor at one time. process procedure in the Section 5.A Special Procedures. Call for Service if the problem persists.

Rev. B

8-202


BIOSLAVE CARD COMM. TIMEOUT

296

Reason for Alarm

There was a communication problem detected between the Bio Slave Board and the Main Board.

Machine Actions

None.

Possible Cause

Suggested Action

1. Temporary data overload of the Bio Slave Board. Too much information is going to the Bio Slave Microprocessor at one time.

1. Wait a few seconds for the alarm to clear. See the Fast Recovery of the Dialysis process procedure in the Section 5.A - Special Procedures. Call for Service if the problem persists.

Rev. B


BIOSLAVE MSG TRANSFER ERROR

8-203

297

Reason for Alarm

The Main computer and the Bio Slave Board are not communicating.

Machine Actions

None.

Possible Cause

Suggested Action


1. Wait a few seconds for the alarm to be cleared. 2. See the Fast Recovery of the Dialysis process procedure in the Section 5.A Special Procedures. Call for Service if the problem persists.


Rev. B

8-204


BT1 MALFUNCTIONING Reason for Alarm

LD1 Level Sensor Failure.

Machine Actions

None.

299

Possible Cause

Suggested Action

1. Dirty LD1 level detector.

1. Perform a RINSING or a Chemical Disinfection to clean the sensor of deposits. Call for Service if the problem persists.

Rev. B


D1 OUT OF ORDER

8-205

300

Reason for Alarm

The D1 flowmeter does not respond to changes in the dialysate flow.

Machine Actions

None.

Possible Cause

Suggested Action

1. Debris has clogged the gears in the flow meter.

1. Perform a DESCALING. If the flowmeter is completely blocked, ADR cannot start. Call for Service if the problem persists.

Rev. B

8-206


D2 OUT OF ORDER

301

Reason for Alarm

The D2 flowmeter does not respond to changes in the dialysate flow. Possible Mass Balance alarms may precede this alarm.

Machine Actions

None.

Possible Cause

Suggested Action

1. Debris has clogged the gears in the flow meter.

1. Perform DESCALING. If the flowmeter is completely blocked, ADR cannot start. Call for Service if the problem persists.

Rev. B


!

BY WRONGLY EXTENDED

8-207

302

Reason for Alarm

The machine is in By for more than 6 minutes, either automatically or the operator has selected BY.

Machine Actions

None. In DIALYSIS: The alarm is active when the machine is in DIALYSIS mode with blood detected in the venous line. The alarm will be displayed on the Touch Screen 6 minutes after the machine is in BY.

Possible Cause

Suggested Action

1. By has been selected and not cleared during the treatment. 2. The machine is stuck in by.

1. Take the machine out of By by pressing the BY Action key. 2. See the Fast Recovery of the Dialysis process procedure in the Section 5.A Special Procedures.

Rev. B

8-208


HYDRAULIC CARD COMM. TIMEOUT

304

Reason for Alarm

There was a communication problem detected between the Hydraulic Slave Board and the Main Board.

Machine Actions

None.

Possible Cause

Suggested Action

1. Temporary data overload of the Hydraulic Slave Board. Too much information is going to the Hydraulic Slave Microprocessor at one time.

1. Wait a few seconds for the alarm to clear. See the Fast Recovery of the Dialysis process procedure in the Section 5.A Special Procedures. Call for Service if the problem persists.

Rev. B


ART PRESSURE ALARM

!

8-209

305

Attribute

1. MINIMUM, 2. MAXIMUM, 3. UNDEFIN

Reason for Alarm

MINIMUM: The Arterial Pressure Sensor has measured a pressure value which is lower than the minimum range selected by the operator and displayed on the Arterial Pressure Bar Graph. MAXIMUM: The Arterial Pressure Sensor has measured a pressure value which is higher than the maximum permitted range selected by the operator and displayed on the Arterial Pressure Bar Graph. UNDEFIN: Error in the arterial pressure acquisition.

Machine Actions

Stops the Blood Pump. Reduces the Ultrafiltration Rate to its minimum. Venous Line Clamp closes.

Note The following message appears in the operator messages area: Check blood line and patient's access. Press Override to restart the Pump. If needed select in SET the graph of the pressure causing the alarm and press CONFIRM

Possible Cause

Suggested Action

1. The arterial pressure window needs to be set.

1.

2. The arterial line may have become disconnected from the patient.

2.

3. Arterial line is kinked, clamped or restricted. 3.

In SET Mode, select the Arterial Pressure Bar Graph and press CONFIRM. Press OVERRIDE to restart the Blood Pump. Carefully check Cartridge connections and the patient’s access site. Press OVERRIDE to restart the Blood Pump. Check the arterial line and the patient’s arterial access for kinks, clamps or other restrictions, i.e. clotted arterial needle, poor flow from the patient’s arterial access. Press OVERRIDE to restart the Blood Pump. Consider slowly increasing the blood flow, observing the arterial pressure, if this operation is not in disagreement with the patient prescription. Rev. B

8-210


4. 4. Loss of diaphragm pressure between the Cartridge Blood Set and the arterial pressure cone.

Perform a Diaphragm Neutral Position Procedure, see the Section 5.A - Special Procedures. Press OVERRIDE to restart the Blood Pump. Call for Service if the problem persists.

WARNING Never press the OVERRIDE button, to clear the ! Art Pressure Alarm #305 alarm, if the problem that is causing the alarm condition has not been identified and removed.

Rev. B


!

ART PRESSURE LIMIT

8-211

306

Reason for Alarm

Arterial pressure is lower than the MIN ART PRESSURE value set by the operator in the Configuration menu.

Machine Actions

Stops the Blood Pump. Reduces the Ultrafiltration Rate to its minimum. Venous Line Clamp closes.

Possible Cause

Suggested Action

1. The arterial line may have become disconnected from the patient.

1.

2. Blood Pump speed is too fast.

2.

3. Arterial line is kinked, clamped or restricted. 3.

4. Arterial pressure decreased somewhat during a treatment due to haemoconcentration and/or inadequate heparinization of the patient, resulting in a reduced pressure for a given needle at a fixed blood flow rate.

4.

Carefully check Cartridge connections and the patient’s access site. Press OVERRIDE to restart the Blood Pump. Consider decreasing the blood flow if this operation is not in disagreement with the patient prescription. Press OVERRIDE to restart the Blood Pump. Check the arterial line and the patient’s arterial access for kinks, clamps or other restrictions, i.e. clotted arterial needle, poor flow from the patient’s arterial access. Press OVERRIDE to restart the Blood Pump. Attention should be given to re-evaluating needle size, blood flow rate, anticoagulant dosage. Press OVERRIDE to restart the Blood Pump. Call for Service if the problem persists.

WARNING Never press the OVERRIDE button, to clear the ! Art Pressure Limit #306 alarm, if the problem that is causing the alarm condition has not been identified and removed.

Rev. B

8-212


!

ART PRESSURE DATA ERROR

307

Reason for Alarm

A data difference was detected for the ART P parameter inside the double image of the Protection System in the Main Board.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected for the ART P parameter inside the double image of the Protection System in the Main Board.

1. From Set Mode, restore the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B


BLOOD IN THE VENOUS LINE

W!

8-213

308

Reason for Alarm

The Patient Sensor detected blood in the venous line.

Machine Actions


Note If the Standard buzzer is installed on the machine, the Audible alarm, which signals the #308 alarm condition, has a low pitch modulated tone.

Possible Cause

Suggested Action

1. The Patient Sensor detected blood in the venous line.

1. that the venous line is appropriately attached to the patient’s access. Press OVERRIDE to continue. 2. If the alarm occurs during Dialysate preparation and the Blood Pump is running, it is not possible to proceed. Switch the machine OFF, remove the venous line from the Air Bubble Detector and carefully clean the Patient Sensor and the surface of the Air Bubble Detector around the Patient Sensor using a soft cloth. Reinsert the venous line in the Air Bubble Detector and then switch the machine ON. If the alarm occurs during PRIME or RECIRCULATION, the machine is forced to the PATIENT CONNECT view. At the end of the current dialysis treatment, before starting a new dialysis session, clean the Patient Sensor following the procedure described above. Call for Service if the problem persists.

2. The Patient Sensor is dirty or wet.

Note In case of blood detected in the venous line during PRIME, also the #342 alarm occurs together with the #308 alarm. Refer also to the #342 alarm description to exit from the alarm condition.

Rev. B

8-214


W!

MASS BALANCE NOT RELIABLE

309

Reason for Alarm

The “! UF Mass Balance” #144 alarm has occurred too many times during the dialysis treatment.

Machine Actions

After the ! UF Mass Balance #144 alarm recurs 10 times, this alarm is displayed. Each time thereafter this alarm will display along with the “! UF Mass Balance” #144 alarm.

Possible Cause

Suggested Action

1. The ! UF Mass Balance #144 alarm has occurred 10 times or continues to display during a treatment.

1. Determine the cause of the ! UF Mass Balance alarm (#144) then press OVERRIDE to continue. Refer to Alarm number 144 for additional troubleshooting information. Call for Service if the problem persists.

WARNING After the ! UF Mass Balance (#144) recurs 10 times, the TOTAL FLUID REMOVED displayed on video is no more reliable. If an external scale is being used, refer to the weight measured by the scale to check the value of the TOTAL FLUID REMOVED. If an external scale is not being used, discontinue DIALYSIS.

Rev. B


!

MAX BLOOD FLOW DATA ERROR

8-215

312

Reason for Alarm

A data difference was detected for the MAX BLOOD FLOW parameter inside the double image of the Protection System in the Main Board.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected for the MAX 1. From IDLE view, in Config, restore the BLOOD FLOW parameter inside the double parameter to the correct value. If the alarm image of the Protection System in the Main persists, restart the machine. Board. Call for Service if the problem persists.

Rev. B

8-216


!

PAUSE THERAPY DATA ERROR

313

Reason for Alarm

A data difference was detected for the PAUSE THERAPY parameter inside the double image of the Protection System in the Main Board.

Machine Actions

None.

Possible Cause

Suggested Action

1. A data difference was detected for the PAUSE THERAPY parameter inside the double image of the Protection System in the Main Board.

1. From IDLE view, in Config, restore the parameter to the correct value. If the alarm persists, restart the machine. Call for Service if the problem persists.

Rev. B


W!

ART PRESSURE SENSOR ERROR

8-217

317

Reason for Alarm

A large pressure spike or a large rapid change in pressure was detected by the Arterial Pressure Sensor.

Machine Actions

None.

Possible Cause

Suggested Action


1. Press OVERRIDE. Wait a few seconds for the alarm to clear. Call for Service if the problem persists.

Rev. B

8-218


W!

BLOOD PUMP STOPPED BY ABD

318

Reason for Alarm

The Blood Pump has not been restarted for 30 seconds following an ! Air & Foam Detector #4 alarm.

Machine Actions

Blood Pump is off.

Possible Cause

Suggested Action

1. The Blood Pump has not been restarted for 30 seconds following an ! Air & Foam Detector #4 alarm.

1. Restart the Blood Pump by performing the procedure to clear the alarm (instructions are found in the description for the ! Air & Foam Detector #4 alarm, in this section).

Rev. B


W!

WAIT FOR PRESSURE TEST EXECUTION

8-219

319

Reason for Alarm

The machine cannot proceed with the Arterial and Venous T1 Test because the pressures are not close to 0 mmHg.

Machine Actions

The machine will stop at this point and not proceed any further into the test.

Possible Cause

Suggested Action

1. If the Cartridge Blood Set is filled with saline, 1. Clamp the Cartridge saline line, arterial and it is possible to have a pressure different venous lines. Open the arterial and venous from 0 mmHg. access lines to the atmosphere. The pressures displayed on the Touch Screen should decrease toward 0 mmHg. 2. The Cartridge Blood Set was installed 2. The venous line must be inserted in the Air incorrectly during the Venous/Arterial Bubble Detector and the door closed. The Pressure Test during the T1 test. Blood Pump Cover must be closed. Reposition the Cartridge Blood Set and restart the T1 test. 3. Blood Pump Cover is open. 3. Close the Blood Pump Cover. Be sure the Blood Pump Cover is securely latched. 4. The magnet is dirty. 4. Carefully clean the magnet located behind the Blood Pump Cover, using a soft cloth dipped in Ethyl Alcohol (90%) or in Isopropyl Alcohol (70%). Call for Service if the problem persists.

Rev. B

8-220


>> GENERAL SYSTEM FAILURE << System Blocking Reason for Alarm

THIS IS A SPECIAL ALARM. Main Board blockage.

Machine Actions

GENERAL SAFE STATE.

XXX

Touchscreen blocked.

Note In the alarm name, "xxx" means the internal code related to the alarm condition.

Possible Cause

Suggested Action

1. Main Board internal error.

1. If this alarm occurs during ADR, IDLE, SETUP and PRIME, switch the machine OFF and then back ON. 2. If this alarm occurs during DIALYSIS, perform a Fast Recovery of the Dialysis process. See the Fast Recovery of the Dialysis process Procedure in Section 5.A – Special Procedures. Call for Service if the problem persists.

2. Main Board internal error.

Rev. B

8-221


CENTRYNET: DUPLICATE STATION

321

Reason for Alarm

The station number entered into the machine is in use(duplicated) by another machine on the network.

Machine Actions

None to the patient system. Automatically resets when the error condition is corrected. The “CentryNet: Station ID Error“ alarm also appears.

Possible Cause

Suggested Action

1. The same STATION ID number has already been assigned to another machine.

1. Check that the STATION ID on the machine matches the posted STATION ID in the clinic. the other stations. Change the STATION ID for the machine that is incorrect, correcting any duplication.

Note This alarm is not functional if the CentryNet option is not installed, or when the CentryNet option is turned OFF (CentryNet = NO).

Note If the alarm persists, the CentryNet option must be switched OFF. The is responsible for manually collecting data until the cause of the alarm can be corrected.

Note A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Duplicate Station has cleared. If a treatment is in progress, the network controller will retain any data that it has collected until the station comes back online.

Rev. B

8-222


CENTRYNET STATION OFFLINE

322

Reason for Alarm

The network controller has failed to successfully poll a particular station on the network (the machine did not receive a poll within the expected polling time).

Machine Actions

None to the patient system. Automatically resets when the error condition is corrected. START COLLECT/STOP COLLECT keys are not active. The icon changes to indicate Off-Line.

Possible Cause

Suggested Action

1. A configuration setting is incorrect.

1. all configuration items relating to CentryNet. 2. Add the station to the network (see the Communication section) for instructions. 3. Polling timer limit may need changing to accommodate the number of machines and quantity of data being collected. Call for Service if the problem persists.

2. The CentryNet Network Controller is not programmed for this station. 3. The Offline Timeout (polling timer) limit has been exceeded.



Note A treatment cannot be started or ended on the Phoenix machine until the CentryNet Station Offline error has cleared. If a treatment is in progress, the network controller will retain any data that it has collected until the station comes back online.

Rev. B


CENTRYNET: INCOMPLETE DATA COLLECTION

8-223

323

Reason for Alarm

An attempt to end a treatment (STOP COLLECT) has been made before all records in the database have been collected by the network controller.

Machine Actions

None to the patient system. Automatically resets when error condition is corrected.

Possible Cause

Suggested Action

1. The treatment has ended in the normal fashion (WASHBACK, DESCALE, FINAL RINSE, etc.) and all data from that treatment has not yet been collected by the Network Controller. 2. The STOP COLLECT Action key has been pressed and all data from the current treatment has not yet been collected by the Network Controller. 3. The network controller is polling another machine. 4. CentryNet is unable to collect a number of records for this treatment due to an internal Phoenix problem.

1. Wait a few minutes until data collection is complete. all cable connections are intact; the network controller is collecting data. 2. Wait a few minutes until data collection is complete and then press STOP COLLECT again.

3. Wait for the network controller to finish polling other machines. 4. Switch the CentryNet option OFF and take records manually for that treatment. Turn CentryNet back ON for the next treatment and determine if the problem has corrected itself. 5. The station is off-line; the STATION OFFLINE 5. Switch the CentryNet option OFF. Continue alarm condition will eventually occur. using the machine without CentryNet. Refer to the CentryNet Station Offline #322 alarm message and troubleshooting advice. Call for Service if the problem persists.



Note A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Incomplete Data Collection error has cleared. If a treatment is in progress, the network controller will retain any data that it has collected until the station comes back online.

Rev. B

8-224


CENTRYNET: STATION ID ERROR

325

Reason for Alarm

A poll has been received by Phoenix, but the network controller machine ID does not match the Phoenix machine ID for that station, or the machine has not been assigned to that station (awaiting assignment).

Machine Actions

None to the patient system. Automatically resets when error condition is corrected.

Possible Cause

Suggested Action

1. A configuration setting is incorrect. 2.

3.

4.

5.

1. all configuration items relating to CentryNet. A new STATION ID is currently being 2. No action necessary. Wait for processed. communication process to be completed. The alarm will self-clear. Either the machine, or the CentryNet option, 3. No action necessary. Wait for has just been turned on and communication communication process to be completed. is being established The alarm will self-clear. Two stations have the same STATION ID; 4. Check that the STATION ID on the alarming the CentryNet: Duplicate Station (Alarm machine matches the posted STATION ID in #321) message appears on screen. the clinic. Change the STATION ID for one machine, correcting any duplication STATION ID assignment has been lost at 5. Make sure the STATION ID matches the CentryNet, or has changed. physical location in the clinic. If not in a treatment, reboot the Phoenix to reinitialize the STATION ID assignment. Call for Service if the problem persists.


Note If the alarm persists, the option must be switched OFF. The is responsible for manually collecting data until the cause of the alarm can be corrected.

Note A treatment cannot be started or ended on the Phoenix machine until the CentryNet: Station ID Error has cleared. If a treatment is in progress, the network controller will retain any data that it has collected until the station re-links with CentryNet.

Rev. B


WHF DOOR POSITIONING

8-225

326

Reason for Alarm

The Waste Handling Option Door is open during an operational phase that requires the WHO Door to be closed.

Machine Actions

The machine stops and waits for the WHO Door to be closed.

Possible Cause

Suggested Action

1. The Waste Handling Option Door is open when it should be closed.

1. that the Door is closed. Call for Service if the problem persists.

Rev. B

8-226


W!

COMMUNICATION CRC ERROR

327

Reason for Alarm

The Protection test for the correct reading of the message sent by the Control System has failed. The message has been lost and the last correct message is used.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Protective system detected an incorrect 1. Press OVERRIDE to clear the alarm. Confirm message from the Control system. the data using the selection procedure.

Rev. B


STILL IN PAUSE THERAPY

W!

8-227

329

Reason for Alarm

The operator has maintained the selection of PAUSE THERAPY for more than 5 minutes (approx).

Machine Actions

None.

Note This message remains on the Touch Screen for a few seconds and then disappears automatically.

Possible Cause

Suggested Action

1. The operator has maintained the selection of PAUSE THERAPY for more than 5 minutes.

1. Press OVERRIDE to clear the alarm. Deselect PAUSE THERAPY to continue the treatment.

Rev. B

8-228


END OF WASHBACK PROCEDURE

332

Reason for Alarm

The quantity of physiological saline solution that has ed through the dialyser is equal to the RINSEBACK VOLUME set by the operator.

Machine Actions

The Blood Pump stops.

Possible Cause

Suggested Action

1. The quantity of physiological saline solution 1. Press OVERRIDE to continue, or end the that has ed through the dialyser is equal treatment. Consider changing in Config the to the RINSEBACK VOLUME SET by the quantity of physiological solution for operator. WASHBACK (RINSEBACK VOLUME parameter).

Rev. B


TIMEOUT ERROR ON PROCESS SELECTION

8-229

333

Reason for Alarm

Failure of the communication between BOM and the machine. This alarm can occur only during the manufacturer tests.

Machine Actions

NONE. The alarm will be used only during the manufacturer tests.

Possible Cause

Suggested Action

1. Failure of the communication between BOM and the machine.

1. No troubleshooting is required, this alarm can occur only during the manufacturer tests.

Rev. B

8-230


TIMEOUT ERROR ON PROCESS CLOSING

335

Reason for Alarm

Internal communication error.

Machine Actions

The machine doesn’t transfer data to the On Board Calibration environment.

Note This alarm can occurr only during the machine Calibration procedures.

Possible Cause

Suggested Action

1. Internal communication error.

1. No troubleshooting is required, this alarm can occur only during the machine calibration procedures.

Rev. B


TOTAL HEPARIN INFUSED ERROR

8-231

338

Reason for Alarm

The Heparin Pump is malfunctioning or it is not delivering the correct amount of heparin.

Machine Actions

None.

Possible Cause

Suggested Action

1. The Heparin Pump is malfunctioning.

1. the total amount of heparin delivered. that the machine has delivered the correct initial bolus if required. Press OVERRIDE to clear the alarm. 2. Deactivate the Heparin program to clear the alarm. Call for Service if the problem persists.

2. The Heparin Pump is still malfunctioning.

Rev. B

8-232


END DIA - DIFF TIME REACHED

339

Reason for Alarm

This message signals the operator that the DIFFUSION TIME is complete. This alarm will occur only if DIFFUSION TIME has been selected as the treatment end point for the END DIALYSIS parameter.

Machine Actions

None.


Possible Cause

Suggested Action

1. DIFFUSION TIME is complete.

1. Disconnect patient.

2. Additional DIALYSIS TIME may be needed.

2. Increase the set DIALYSIS TIME to lengthen the treatment.

Note The alarm will self-clear if the DIALYSIS TIME parameter value is increased.

Note If the DIALYSIS TIME is increased following the occurrence of this alarm, the DIFFUSION TIME parameter will not be updated.

Rev. B


BLOOD PUMP DIRECTION

8-233

340

Reason for Alarm

During DIALYSIS, when all the machine safety systems are activated, the Blood Pump is not turning in the correct direction for the current machine operating phase.

Machine Actions

GENERAL SAFE STATE

Possible Cause

Suggested Action

1. The blood pump is not turning in the correct 1. The > GENERAL SAFE STATE < 64 alarm will direction due to an internal malfunction. occur. Refer to alarm number 64 for further troubleshooting information. Call for Service if the problem persists.

Rev. B

8-234

!


BLOOD DETECTED DURING PRIME

342

Reason for Alarm

During PRIME, The Patient Sensor detected blood in the venous line.

Machine Actions

Stops the Blood Pump. Ultrafiltration Rate is set to zero. Venous Line Clamp closes.

Possible Cause

Suggested Action

1. The Patient Sensor is dirty or wet.

1. The machine is forced to the PATIENT CONNECT view. At the end of the current dialysis treatment, before starting a new dialysis session, clean the Patient Sensor and the surface of the Air Bubble Detector around the Patient Sensor using a soft cloth. Call for Service if the problem persists.

Note If blood is detected in the venous line during PRIME, the #308 alarm will also occur together with the #342 alarm. Also refer to the #308 alarm description to exit from the alarm condition.

Rev. B


DRIFT ON FLOWMETERS

W!

8-235

343

Reason for Alarm

The D1/D2 flowmeter test, performed during the dialysis preparation phase, has failed due to a drift of the flowmeters.

Machine Actions

None.

Note The following message appears in the Operator Messages Area: Flow Balance alarm MAY occur during Tx Recommend Descale at the end of Tx. for the maximum amount of time, or perform acid based chemical disinfect now.

Possible Cause

Suggested Action

1. There are deposits or debris inside the flowmeters of the machine.

1. Press OVERRIDE to clear the alarm. Stop the dialysis preparation and return to IDLE view. Perform a DESCALING or a Chemical Disinfection to clean the flowmeters of deposits, then restart the dialysis preparation. If the problem persists, turn the machine OFF and call for Service. 2. Press OVERRIDE to clear the alarm. Stop the dialysis preparation and return to IDLE view. Restart the dialysis preparation. If the problem persists, turn the machine OFF and call for Service. Call for Service if the problem persists.

2. Test failed due to a problem on the flowmeter(s).

Rev. B

8-236


S/N: VEN PRESSURE NOT CHANGING

351

Reason for Alarm

In Single Needle Mode, the venous pressure remains stable during the arterial cycle.

Machine Actions

Stops the Blood Pump. Closes the Venous Line Clamp.

Note OVERRIDE has no effect if the machine doesn’t detect a variation in the venous pressure value.

Possible

Suggested

Cause 1. The Blood lines are kinked, clamped or restricted.

Action 1. Check the Blood lines and the patient’s access for kinks, clamps or other restrictions. Press OVERRIDE to restart the Blood Pump and clear the alarm. 2. that there is no clotting in the Cartridge Blood Set. Press OVERRIDE to restart the Blood Pump and clear the alarm. 3. Press OVERRIDE to restart the Blood Pump and clear the alarm. 4. Perform a Diaphragm Neutral Position Procedure (See Section 5.A – Special Procedures, in this manual). Press OVERRIDE to restart the Blood Pump and clear the alarm. 5. Press OVERRIDE to restart the Blood Pump and clear the alarm. Place the line(s) in the clamp(s). Call for Service if the problem persists.

2.

Clotting is occurring in the Cartridge Blood Set.

3.

The patient is moving around.

4.

Incorrect placement of the diaphragm between the Cartridge Blood Set and the venous seal.

5.

Arterial and/or venous lines are not in their clamps.

Rev. B


S/N: VENOUS PRESSURE UNRELIABLE

8-237

352

Reason for Alarm

The “S/N: Ven Pressure Not Changing” #351 alarm has occurred 3 times during the dialysis treatment.

Machine Actions

None.

Note This message remains on the Touch Screen for all the dialysis treatment until the EMPTYING Action key confirmation.

Possible

Suggested

Cause Action 1. The “S/N: Ven Pressure Not Changing” 1. Determine the cause of the alarm then #351 alarm has occurred 3 times during the press OVERRIDE to continue. Refer to dialysis treatment. Alarm number 351 for additional troubleshooting information. Call for Service if the problem persists.

Rev. B

8-238


NO POWER

353

Reason for Alarm

The AC supply voltage has been interrupted in a machine equipped with the BATTERY BACKUP KIT.

Machine Actions

In RINSE: None. In DISINFECTION and in DIALYSIS: the heater is turned off.

Possible Cause

Suggested Action

1. Interruption of the AC supply voltage in RINSE or DISINFECTION. 2. Interruption of the AC supply voltage in DIALYSIS, during the Dialysate Preparation phase until Patient Connection. 3. Interruption of the AC supply voltage in DIALYSIS, during the treatment phase. 4. Interruption of the AC supply voltage in DIALYSIS, during EMPTYING or DESCALING.

1. Switch OFF the machine. 2. Switch OFF the machine.

3. Perform WASHBACK to return blood to the patient and then switch OFF the machine. 4. Switch OFF the machine.

Note If the power failure lasts for less than 3 minutes, once the AC Power Supply returns: - The “No Power #353" alarm disappears; - The interrupted process automatically restarts and no operator intervention is required.

Note In Rinsing or Disinfection, if the “No Power #353" alarm is displayed for more than 3 minutes, the machine will be automatically switched OFF.

Rev. B


FORECAST DIAL. DOSE NOT MATCH PRESCRIP.

8-239

354

Reason for Alarm

The Forecast Kt/V (or Kt), estimated by the machine, is lower than the TARGET Kt/V THRESH Percentage. (The parameter TARGET Kt/V THRESH is SET in the IDLE mode in the Config\kT/V view.)

Machine Actions

None.

Note The following message appears in the Operator Messages Area: Check Clearance/Blood Flow R. consistency Check Treat. Time/Prescription consistency Enter SET Mode to modify the Target; then Press OVERRIDE to cancel the message

Note The “FORECAST DIAL. DOSE NOT MATCH PRESCRIP.”#354 alarm will occur only if the TARGET Kt/V THRESH parameter is set to a value different from 0 and the TARGET KT or the TARGET KT/V parameter value has been confirmed/entered.

Possible Cause

Suggested Action

1. The Dialyser is clotting.

1. Determine reason for clotting and replace the dialyser. Press OVERRIDE to clear the alarm. 2. Check patient’s access for correct needle placement. Consider decreasing the blood flow if this operation is not in disagreement with the patient prescription. Press OVERRIDE to clear the alarm. 3. that the dialyser selected is adequate to deliver the Prescribed dialysis dose. Press OVERRIDE to clear the alarm. 4. that the patient prescription is correct. Consider increasing the blood flow rate if this operation is not in disagreement with the patient prescription. Press OVERRIDE to clear the alarm. 5. Correctly connect the dialysate connectors. Press OVERRIDE to clear the alarm.

2. Problem with patient’s access or needle placement. The level of recirculation is increased.

3. Dialyser is not providing sufficient Clearance to meet Target Dose. 4. The blood flow rate is not consistent with the TARGET KT and/or the TARGET KT/V programmed.

5. Dialysate connectors are reversed (blue dialysate connector is not connected to the inlet dialysate port of the dialyser). 6. The DIALYSIS TIME set is not consistent with 6. that the patient prescription is correct. the TARGET KT/V programmed. Consider increasing the DIALYSIS TIME if this operation is not in disagreement with the patient prescription. Press OVERRIDE to clear the alarm.

Rev. B

8-240


7. The TARGET KT and/or the TARGET KT/V 7. that the patient prescription is correct. Consider changing the TARGET KT and/or the programmed is not consistent with the patient TARGET KT/V value programmed or consider prescription. setting a lower value for the TARGET Kt/V THRESH parameter. Press OVERRIDE to clear the alarm.

Rev. B


KT-KT/V TARGET ACHIEVED

8-241

355

Reason for Alarm

If DISTRIB VOLUME and DRY WEIGHT parameter values have not been confirmed: The Depurated Vol is greater than or equal to the TARGET KT value. If DISTRIB VOLUME and DRY WEIGHT parameter values have been confirmed: The KT/V is greater than or equal to the TARGET KT/V value.

Machine Actions

None.

Note In Config, the TARGET Kt/V Reached parameter can be configured to NO or YES. If set to NO, the Kt-Kt/V Target Achieved alarm is turned off and will not appear. If set to YES, when the alarm appears once, it can be reset by pressing the OVERRIDE button and then it does not appear again during the same dialysis treatment. The Kt-Kt/V Target Achieved alarm will appear again during the same dialysis treatment only after a modification of at least one of the following parameter values: - TARGET KT - TARGET KT/V - DIALYSIS TIME - DRY WEIGHT - DISTRIB VOLUME.

Possible Cause

Suggested Action

1. The Depurated Vol is greater than or equal to 1. Press OVERRIDE to clear the alarm. the fixed percentage of the TARGET KT value. 2. The KT/V is greater than or equal to the fixed 2. Press OVERRIDE to clear the alarm. percentage of the TARGET KT/V value.

Rev. B

8-242

W!


BLOOD SENSED IN VENOUS LINE

359

Reason for Alarm

The Patient Sensor detected blood in the venous line during priming of the blood side of the dialyser and the Blood Pump was running.

Machine Actions


Note When the alarm appears also the following superimposed window is displayed: If the line has blood in it, press CONFIRM. Or: - Remove venous line from patient sensor - Clean and dry venous line & pt. sensor slot - Put venous line back in the patient sensor - Press CONFIRM

Possible Cause

Suggested Action

1. The Patient Sensor detected blood in the 1. that the venous line is appropriately venous line. attached to the patient’s access. Press CONFIRM to clear the alarm. 2. The Patient Sensor is dirty or wet. 2. Follow the instructions given in the superimposed window: remove the venous line from the Air Bubble Detector and carefully clean the venous line, the Patient Sensor and the surface of the Air Bubble Detector around the Patient Sensor using a soft cloth. Then reinsert the venous line in the Air Bubble Detector. that the “No blood detected” Patient Sensor Icon is displayed in the Icon Area on the Touch Screen and then press CONFIRM to clear the alarm. Call for Service if the problem persists.

Note If the Patient Sensor continues to detect blood after performing the cleaning and drying procedure described in the superimposed window, the W! Blood sensed in venous line #359 alarm message will reoccur together with the superimposed window. The operator is allowed to remove the venous line from the Air Bubble Detector to clean and dry the Patient Sensor and the venous line for a maximum of three times.

Rev. B

9 SPECIFICATIONS 9.

SECTION 9 - SPECIFICATIONS

9.1 General specifications Name PHOENIXTM Haemodialysis Equipment.

Equipment Classification • • • •

Class I, Applied Part Type B (EN 60601-1) Class IIb (MDD 93/42/EEC) Protection Class: IPX1 (drip-proof equipment) Not suitable for use in the presence of flammable anesthetics, or anesthetic mixtures with air or with oxygen or nitrous oxide. • Continuous operation.

Note The Phoenix machine is classified as Class I APPLIED PART B device, according to the IEC 60601-1 international electrical safety standard. As a result the Phoenix machine is not recommended for use in direct cardiac applications.

Version The machine can be installed according to one of the following power supply versions: N°

Zone

Power supply

1

Europe

220 V

50/60 Hz

2

Europe, South America

230 V

50/60 Hz

3

UK

240 V

50/60 Hz

4

North America, US

115 V

60 Hz

Dimensions Parameter Height

Dimension 1440 mm (56.7 in) 1970 mm (77.4 in) with “IV Pole”

Width

610 mm (24.0 in) with “Dialyser holder” in working position

Depth of base

710 mm (27.9 in) 930 mm (36.5 in) with “Chemical Container Shelf”

Total floor surface covered by base

433100 mm² (671.3 in²) 567300 mm² (879.3 in²)

Dry weight

120 kg (264.5 lb)

Non-combustible plastic materials for external s and electronic keyboard cover (in compliance with CSA standard C22.2 no. 6 "self-extinguishing"). Rev. B

9-2


Ambient requirements and storage conditions State

Temperature

Humidity

Operational

+10°C to +40°C (50°F to 104°F)

30 to 85 % rh

Storage

-20°C to +70°C (-4°F to 158°F)

10 to 95 % rh (non-condensing)

Atmospheric pressure range State

Pressure

Operational

700 to 1060 hPa

Storage

500 to 1060 hPa

WARNING Storage under 0°C (32°F) is not recommended unless the hydraulic circuit has been emptied (see Maintenance section of the Service Manual).

Electromagnetic Environment Requirements The PHOENIX machine needs specials precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Appendix A, in this manual.

WARNING The PHOENIX system conforms to IEC 60601-1-2 standard on Electromagnetic Compatibility; thus it has an adequate degree of protection against electromagnetic disturbances. However, to prevent any problems, it is not recommended to use cellular phones (hand-held) in the dialysis room or, at least, to keep a minimum distance of 10 m (33 ft) from the equipment. Refer to, and be compliant with, local standards and guidelines. (For additional information about special precaution regarding EMC, refer to Appendix A in this manual).

Automatic turn-off Can only be enabled for rinsing and disinfection phases.

CE Marking The PHOENIX machine has been developed to conform to the requirements of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. The CE marking by the manufacturer GAMBRO DASCO S.p.A. covers the equipment. The compatibility of the PHOENIX machine with the other accessories and disposables listed in this Operator Manual has been verified during product validation.

Rev. B


Conformity with international rules The PHOENIX machine has been developed to conform to the following electrical safety standards: IEC 60601-1 VDE 0750-1

MEDICAL ELECTRICAL EQUIPMENT Part 1. General Requirements for Safety (Equivalent to EN 60601-1)

CEI 62/5 BS 5724-1 UL 2601-1 IEC 60601-2-16 VDE 0750-206

MEDICAL ELECTRICAL EQUIPMENT Part 2. Particular requirements for safety of haemodialysis equipment.

CEI 62/98

(Equivalent to EN 60601-2-16)

BS 5724-2-16 IEC 60601-1-2

MEDICAL ELECTRICAL EQUIPMENT Part 1. General Requirements for Safety. 2. Collateral standard: Electromagnetic compatibility Requirements and tests (Equivalent to EN 60601-1-2)

IEC 60601-1-1

MEDICAL ELECTRICAL EQUIPMENT Part 1. General Requirements for Safety. 1. Collateral standard: Safety Requirements for Medical Electrical System. (Equivalent to EN 60601-1-1)

IEC 60601-1-4

MEDICAL ELECTRICAL EQUIPMENT Part 1. General Requirements for Safety 1. Collateral standard: Programmable electrical medical systems (Equivalent to EN 60601-1-4)

CSA C22-2 N° 601-1-M90

MEDICAL ELECTRICAL EQUIPMENT. General Requirements for Safety

CAN/CSA C22-2N°601-2-16-92

MEDICAL ELECTRICAL EQUIPMENT Part 2. Particular requirements for safety of haemodialysis equipment.

UL 2601-1

MEDICAL ELECTRICAL EQUIPMENT. General Requirements for Safety

Independent internationally recognized experts have rigorously checked conformity with these standards.

Leakage current and dielectric strength Earth Leakage Current: <300uA as required by the UL 2601-1 Standard (typically between 80 and 130 uA) (115V); <300uA as required by the UL 2601-1 Standard (typically between 170 and 220 uA) (230V). Patient Leakage Current (normal condition): max 5uA (115V), max 10 uA (230/240V). Dielectric strength: verified in compliance with clause 20 of IEC 601-1 (UL 2601-1).

Rev. B

9-3

9-4

PHOENIX OPERATOR MANUAL Note The above measurements are applicable when all standard and optional accessories designed for the PHOENIX are connected.

WARNING Possible hazards may arise from equipment (other than the accessories listed below) being connected to machine, which may cause the permitted leakage current to be exceeded.

WARNING The correct installation of a MEDICAL ELECTRICAL SYSTEM requires that each SYSTEM component be individually connected to the main power. It is strongly recommended: NOT TO USE MULTIPLE PORTABLE SOCKETOUTLETS. However, if using multiple portable socket-outlets, they must comply with the IEC 60601-1-1 Standard and must NOT BE PLACED ON THE FLOOR.

Electrical Power Supply – two standard versions: N°

Volts

% Range

Hertz

Amps

1

230/240

±10

50/60

10

Note 1

2

115

±10

60

16

or 12 (without heat disinfection)

Note 1 It is possible to operate the machine with a 220 or 240 volt power supply. However, selection of voltage requires an internal service configuration.

Note Both versions are fitted with a three-pin plug which includes a Ground.

WARNING Wait at least 5 seconds after switching OFF the machine before turning it ON again.

Power failure If there is a power failure, an audible alarm is triggered and the yellow lamp is illuminated. The values programmed and the modes set remain in the machine’s memory for 4 minutes.

Rev. B


Shipping List The machine packaging contains a shipping list with the following components: • • • • •

Water Inlet Hose and Drain Hose Connection Set Sampling Connector Dialysate Connectors and Lines Intravenous Pole (maximum load: 6 Kg or 13.2 lb)

Note The telescopic pin adjustment must be done without bags on the hooks

• Concentrate/Disinfectant Wands • Chemical Container Shelf (maximum load: 16 Kg or 35.3 lb)

WARNING Do not stand on Chemical Container Shelf. • • • • • •

pH Probe Assembly Blood Pump Crank BPM Cuff Single Needle Holder Operator’s Manual Installation Checklist

Accessories • • • • • • • • •

BPM (Blood Pressure Monitoring System) Central Concentrate Supply Kit DIASCAN Kit Single Needle Kit CentryNet serial interface board (RS 485) CWP Adapter Kit Clean Dialysate Remote Alarm Battery Backup Kit

Note Refer to your local representative to if your machine is already equipped with the BATTERY BACKUP Kit.

Rev. B

9-5

9-6


Interface connectors See Fig 9.0. The machine is supplied with a standard 10 Base T Ethernet connection. The Computer Connection Accessories may be used to connect the machine to a Personal Computer to interface with the Communication System (see Section 7 – Communication System in this manual). The BPM port is the pneumatic connection used for the BPM option (see Section 5.C - Blood Pressure Monitoring System in this manual). The other connectors are currently not used.

WARNING The PHOENIX machine is provided with ports for connecting it with an external personal computer or a communication network. All external equipments connected to the PHOENIX machine must be compliant with IEC 60950.

Wheels and portability The PHOENIX system is maneuvered by 4 double wheels and one brake which is at the front of the concentrate container shelf. The brake is foot-operated: to brake, press the left side of the pedal completely down; to release the brake, press the right side of the pedal completely down. To avoid jolting, move the machine carefully using the rear handle.

Note A two-color plate status indicator, fitted behind the brake pedal, indicates whether the brake is ON or OFF. When red is visible, the brake is ON, when green is visible, the brake is released.

WARNING Before moving the machine, check that the brake is released and remove infusion bags or any other weights or hanging objects from the IV pole or from the concentrate container shelf.

Software revision This manual revision is related to the software revision root 3.36.

Rev. B


9-7

Hour Meter

(Depending on the machine version, it may be present or not in the Interface Connectors )

Computer Connection

Remote alarm

External water valve

(not used)

Fig 9.0 Interface Connectors

Rev. B

9-8


9.2 Hydraulic section 9.2.1 Water supply Incoming water Water treated for the haemodialysis process should be obtained using purification processes. Examples include: reverse osmosis, deionization, ion exchange or any other system approved by the person responsible for the dialysis facility.

Water Quality Requirements. Refer to the local standards or to the AAMI RD62 "Water treatment equipment for hemodialysis applications" standard.

Main requirements Incoming water

Required value

Pressure

100 to 600 kPa (14.5 to 87.0 psig)

Flow

1.1 l/min

Temperature

10°C to 32.2 °C (50°F to 90 °F)

Filtration (by internal filter)

250 μm RMS

Maximum height above floor level:

1 m (39.4 in)

Maximum distance to the drain

3 m (118.1 in)

Drain flow :

1.1 l/min max.

Temperature:

+95 °C max (203 °F max)

Drain

Make the connection, as described in applicable local and international standards, with an external pressure connector to avoid back flow. Mantain an air clearance between the drain connector of the machine and the drain itself.

Color Code Concentrate Connectors Front: Bicarbonate Connector Acetate/Acid Connector Disinfectant Connector

: Blue : White/Red : Yellow

Rear: Two permanent lines :Yellow/No-Coloured containers on the back of the machine.

Rev. B

connected

to

disinfectant


9.2.2 Dialysate WARNING It is recommended to use concentrates which conform to the requirements of the local standards or of the AAMI RD61 "Concentrates for hemodialysis" standard or of the European Pharmaceutical standards. The control of alarm thresholds and dialysate conductivity precision is of major medical importance in ensuring a safe dialysis treatment.


Note For the dialysate concentrates listed in this manual, some graphs and tables are given as examples of the correspondence between dialysate conductivity and dialysate solute content of those particular dialysate concentrates.

WARNING Attention must be given to the safety hazards related to incorrect choice of dialysate concentrates.

Note Concentrate is drawn into the machine by a peristaltic pump. The concentrate supply pressure range at which the machine operates is 0 to 1 bar (0 to 14.5 psi). The concentrate temperature must be between 5 °C (41°F) and 30 °C (86°F).

Total conductivity of the dialysate Permitted values

13 - 17 mS/cm

Average accuracy

± 1.5% of the selected value

Alarms

± 5% of the selected value

Protection system type

Monitoring of the dialysate electrical conductivity

Note When the Final Conductivity value set is changed, the Protection System verifies the congruency of the variation during the transition period.

Rev. B

9-9


Conductivity of the Bicarbonate Solution Both BiCart® (sodium bicarbonate cartridge - see specific instruction sheet) and a solution of sodium bicarbonate can be used with the PHOENIX machine. Two different types of solution of sodium bicarbonate, namely BIC 8.4% and BIC 6.6%, will be described in the following tables.

Note If the bicarbonate concentrate, selected for a BIC 8.4% dialysis treatment contains only NaHCO3 (sodium bicarbonate), the NaHCO3 concentration must be at least of 70.00 g/l so that the machine reaches a correct value of dialysate conductivity.

Type 1: BIC 8.4% • Bicarbonate Concentrate Nominal composition of 8.4% Bicarbonate Concentrate type: Ion NaHCO3 (Sodium bicarbonate)

Concentrate (g/l) 84.00

Concentrate (mEq/l) 1000

• Acid Concentrate Four different types of acid concentrate are considered: (a) Nominal composition of 1:34 (35X) Acid Concentrate type (containing 4mEq/l acetic acid when properly diluted to make dialysate): Salt

Concentrate (g/l)

Concentrate (mEq/l)

NaCl (Sodium chloride)

204.54

3500

KCl (Potassium chloride)

5.22

70

CaCl2 2H2O (Calcium chloride)

7.72

105

MgCl2 6H2O (Magnesium chloride)

2.67

26.25

CH3COOH (Acetic acid)

8.41

140

Table (a) The following graphs and the related tables (Figs. 9.1 and Fig. 9.3) and Table (f) refer to this acid composition.

Rev. B


(b) Nominal composition of 1:44 (45X) Acid Concentrate type (containing 4mEq/l acetic acid when properly diluted to make dialysate):

Salt

Concentrate (g/l)

Concentrate (mEq/l)


262.98

4500


6.71

90


9.92

135


3.43

33.75


10.81

180

Table (b) The following graphs and the related tables (Figs. 9.1 and Fig. 9.3) and Table (f) refer to this acid composition.

(c) Nominal composition of 1:34 (35X) Acid Concentrate type (containing 3mEq/l acetic acid when properly diluted to make dialysate): Salt

Concentrate (g/l)

Concentrate (mEq/l)


204.54

3500


5.22

70


7.72

105


2.67

26.25


6.31

105

Table (c)

Rev. B

9-11

9-12 PHOENIX OPERATOR MANUAL (d) Nominal composition of 1:44 (45X) Acid Concentrate type (containing 3mEq/l acetic acid when properly diluted to make dialysate):

Salt

Concentrate (g/l)

Concentrate (mEq/l)


262.98

4500


6.71

90


9.92

135


3.43

33.75


8.11

135

Table (d)

Note For Acid Concentrate selection, these are the minimum quantities of acetic acid recommended for use in a solution, to reduce the possible formation of bicarbonate precipitates.

Conductivity values of between 2.7 and 3.7 mS/cm, with steps of 0.1 mS/cm, may be selected.

Average accuracy:

±0.1 mS/cm

Alarms:

±5% of set value


WARNING Bicarbonate value in Final Dialysate depends on both the Final conductivity and the Bicarbonate conductivity settings. It is the responsibility of the to set conductivity in accordance with the type of concentrate used to obtain the desired value of bicarbonate in the final dialysate.

Rev. B


Type 2: BiCart® Use of BiCart®: For the nominal composition of Acid Concentrate Type refers to the tables (a) and (b) above, for Type 1: BIC 8.4%.

WARNING Carefully read the BiCart® Instructions for Use before using the device. BiCart® may only be used by staff, who are specially trained for haemodialysis treatments, using the PHOENIX Operator’s Manual (see Section 5 – Dialysis Operation in this manual).

Type 3: BIC 6.6 % • Bicarbonate Concentrate Nominal composition of 6.6% Bicarbonate Concentrate type: Ion

Concentrate (g/l)

Concentrate (mEq/l)

NaHCO3 (Sodium bicarbonate)

65.95

785.11


23.53

402.64

• Acid Concentrate Nominal composition of 1:35.83 (36.83X) Acid Concentrate type: Salt

Concentrate (g/l)

Concentrate (mEq/l)


172.190

2946.44


5.490

73.63


9.480

128.96


3.740

36.79


8.850

147.38

Table (e) The following graphs and the related tables (Figs. 9.2 and Fig. 9.3) and Table (g) refer to this acid composition.

Rev. B

9-13

9-14 PHOENIX OPERATOR MANUAL Note For Acid Concentrate selection, these are the minimum quantities of acetic acid recommended for use in a solution, to reduce the possible formation of bicarbonate precipitates.

Conductivity values of between 4.6 and 6.0 mS/cm, with steps of 0.1 mS/cm, may be selected. Average accuracy:

±0.1 mS/cm

Alarms

±5% of set value


Selection Guide for Bicarbonate Concentrate: Bicarbonate Concentrate Type BIC 8.4%

Acid Concentrate Type 1:34 (35X) 1:44 (45X)

BiCart

1:34 (35X) 1:44 (45X)

BIC 6.6%

1:35.83 (36.83X)

Examples of Correspondence between Conductivity Settings and Dialysate Solute Content The following graphs and tables are given as examples of the correspondence between dialysate conductivity and dialysate solute content for some of the particular dialysate concentrates listed in this section. Changes in the concentrate formula will result in changes of the dialysate solute content so if a different formula is used these graphs and tables may not be representative.

Rev. B

9-15


How to set Conductivity to get a desired Bicarbonate value in Final Dialysate

Bicarbonate Conductivity mS/cm

3.7 3.6 3.5 3.4 3.3 3.2 3.1 3 2.9 2.8 2.7 28.0

29.0

30.0

31.0

32.0

33.0

34.0

35.0

36.0

37.0

38.0

39.0

40.0

41.0

Bicarbonate value in Final Dialysate mEq/l

Bicarbonate value need 30 (mEq/l) 35 (mEq/l) 40 (mEq/l) Fig 9.1

Bicarbonate Conductivity 2.8 (mS/cm) 3.2 (mS/cm) 3.6 (mS/cm)

Final Conductivity

13.0 mS/cm

Bicarbonate value in Final Dialysate versus Bicarbonate Conductivity when the BIC. 8.4% solution is used (with Acid Concentrate of the type containing 4mEq/l acetic acid when properly diluted to make dialysate). The above graph and table show the effects on Bicarbonate value in Final Dialysate following adjustments in Bicarbonate Conductivity. They represent typical values obtained setting Final conductivity to 13.0 mS/cm when the acid concentrate used are the acid concentrate listed in Table(a) and Table (b).

Note Bicarbonate values displayed in the above graph/table are calculated with an approximation of ± 1 mEq/l.

Note If Final conductivity is set to 17.0 mS/cm, bicarbonate value in final dialysate will be reduced by approximately 1.5 mEq/l from the above graph/table.

Note If the Acid Concentrate used is of the type containing 3mEq/l acetic acid (when properly diluted to make dialysate), the Bicarbonate value in Final Dialysate will be increased by approximately 1 mEq/l. For example, using this concentrate and setting the Bicarbonate Conductivity to 3.7 mS/cm and the Final Conductivity to 13 mS/cm, the bicarbonate value in final dialysate will be approximately 42 mEq/l.

Rev. B


How to set Conductivity to get a desired Bicarbonate value in Final Dialysate 6.00

Bicarbonate Conductivity mS/cm

5.90 5.80 5.70 5.60 5.50 5.40 5.30 5.20 5.10 5.00 4.90 4.80 4.70 4.60 30.0

31.0

32.0

33.0

34.0

35.0

36.0

37.0

38.0

39.0

40.0

41.0

Bicarbonate value in Final Dialysate mEq/l

Bicarbonate value need 30 (mEq/l) 35 (mEq/l) 40 (mEq/l) Fig 9.2

Bicarbonate Conductivity 4.6 (mS/cm) 5.3 (mS/cm) 5.9 (mS/cm)

Final Conductivity

13.0 mS/cm

Bicarbonate value in Final Dialysate versus Bicarbonate Conductivity when the BIC. 6.6% solution is used. The above graph and table show the effects on Bicarbonate value in Final Dialysate following adjustments in Bicarbonate Conductivity. They represent typical values obtained setting Final conductivity to 13.0 mS/cm and when the acid concentrate used is the acid concentrate listed in Table(e).

Note Bicarbonate values displayed in the above graph/table are calculated with an approximation of ± 1 mEq/l.

Note If Final conductivity is set to 17.0 mS/cm, bicarbonate values in final dialysate will be reduced by approximately 1.5 mEq/l from the above graph/table.

Rev. B


9-17

How to set Conductivity to get a desired Sodium value in Final Dialysate

Final Conductivity mS/cm

17.0 16.5 16.0 15.5 15.0 14.5 14.0 13.5 13.0 130.0

135.0

140.0

145.0

150.0

155.0

160.0

165.0

170.0

Sodium value in Final Dialysate mEq/l

Sodium value need 135 (mEq/l) 140 (mEq/l) 145 (mEq/l) 150 (mEq/l) 155 (mEq/l) 160 (mEq/l) Fig 9.3

Bic 8.4% / Bic 6.6% Bicarbonate conductivity 3.7 mS/cm (Bic 8.4%)/ 6.0 mS/cm (Bic 6.6%)

Final Conductivity 13.3 (mS/cm) 13.8 (mS/cm) 14.3 (mS/cm) 14.9 (mS/cm) 15.4 (mS/cm) 15.9 (mS/cm)

Sodium value in Final Dialysate / Final Dialysate Conductivity. The above graph and table show the effects on Sodium value in Final Dialysate following adjustments in Final Dialysate Conductivity. They represent typical values obtained when is used: • The acid concentrate listed in Table(a) or in Table (b) (for Bic 8.4% or BiCart) and setting Bicarbonate conductivity to 3.7 mS/cm; or • The acid concentrate listed in Table(e) (for Bic 6.6%) and setting Bicarbonate conductivity to 6.0 mS/cm.

Note Sodium values displayed in the above graph/table are calculated with an approximation of ± 2 mEq/l.

Rev. B

9-18 PHOENIX OPERATOR MANUAL Note If the bicarbonate concentrate of the 8.4% type is used, when setting the Bicarbonate conductivity to 2.7 mS/cm, sodium values in final dialysate will be reduced by approximately 3 mEq/l from the above graph/table. If the bicarbonate concentrate of the 6.6% type is used, when setting the Bicarbonate conductivity to 4.6 mS/cm, sodium values in final dialysate will be reduced by approximately 3 mEq/l from the above graph/table.

Note If the Acid Concentrate used is of the type containing 3mEq/l acetic acid (when properly diluted to make dialysate), the Sodium value in Final Dialysate will be increased by approximately 1 mEq/l.

Rev. B


9-19

Ca++, K+ and Mg++ ions concentration in the Final dialysate Both when varying the Bicarbonate Conductivity and when varying the Final Conductivity, the Ca++, K+ and Mg++ ions concentration varies in the Final dialysate as shown in the following tables: BIC 8.4% concentrate type The following table shows the effects on Ca++, K+ and Mg++ values in Final Dialysate following adjustments in Bicarbonate Conductivity when using a BIC 8.4% concentrate: Final Conductivity

13.0 mS/cm

15.0 mS/cm

17.0 mS/cm

Bicarbonate Conductivity

Ca++ (mEq/l)

K+ (mEq/l)

Mg++ (mEq/l)

2.7 mS/cm 3.1 mS/cm 3.7 mS/cm 2.7 mS/cm 3.1 mS/cm 3.7 mS/cm 2.7 mS/cm 3.1 mS/cm 3.7 mS/cm

2.9 2.8 2.6 3.5 3.4 3.2 4.1 4.0 3.8

2.0 1.9 1.8 2.3 2.2 2.1 2.7 2.6 2.5

0.73 0.71 0.66 0.88 0.85 0.80 1.02 0.99 0.95

Table (f) BIC 6.6% concentrate type The following table shows the effects on Ca++, K+ and Mg++ values in Final Dialysate following adjustments in Bicarbonate Conductivity when using a BIC 6.6% concentrate: Final Conductivity

13.0 mS/cm

15.0 mS/cm

17.0 mS/cm

Bicarbonate Conductivity

Ca++ (mEq/l)

K+ (mEq/l)

Mg++ (mEq/l)

4.6 mS/cm 5.3 mS/cm 6.0 mS/cm 4.6 mS/cm 5.3 mS/cm 6.0 mS/cm 4.6 mS/cm 5.3 mS/cm 6.0 mS/cm

3.5 3.2 2.9 4.3 4.0 3.7 5.1 4.8 4.5

2.0 1.8 1.6 2.4 2.3 2.1 2.9 2.7 2.6

0.98 0.90 0.82 1.22 1.14 1.05 1.45 1.37 1.29

Table (g)

Note Ca++, K+ and Mg++ values displayed in the above tables are calculated with an approximation of ± 0.2 mEq/l.

Rev. B

9-20 PHOENIX OPERATOR MANUAL Dialysate Temperature Range:

+34 °C (93.2°F) to +39.5 °C (103.1°F)

Accuracy:

+1.0 °C (+1.8°F)/-1.5°C (-2.7°F)

Alarms:

±2 °C (3.6°F); +32 °C (89.6°F) min; +41 °C (105.8°F) max.

Protection system type:

monitoring of the dialysate temperature

WARNING When the temperature of the dialysate exceeds the alarm threshold, the audible and visual alarms are triggered.

Dialysate Flow Possible values: 350 to 800 ml/min with steps of 50 ml/min Accuracy: ±5%

Dialysate Pressure Permitted values:

-350 to +450 mmHg

Accuracy:

±25 mmHg

WARNING When the pressure of the dialysate exceeds the alarm threshold, the audible and visual alarms are triggered.

Dialysate Deaeration Method of Deaeration:

heating in combination with vacuum pumping.

Partial pressure of Oxygen:

less than 100 mmHg at 40 °C (104°F) or dissolved gas in dialysate less than 4.5 mg/l (ppm) .

Rev. B


9-21

Dialysate pH The pH of the dialysate is displayed on the screen. Accuracy:

±0.3 pH units

Range in Bicarbonate mode:

6.5 to 7.6 or 7.8 (depending on service configuration) pH units

Range in Acetate mode

6.0 to 8.2 pH units

Note The range for pH is 6.5 to 8.2 pH units only during the preparation phase in BiCart dialysis.

WARNING When the pH of the dialysate exceeds the alarm threshold, the audible and visual alarms are triggered.

Dialysate Pump Monitoring for Concentrate Exchange The reference values for the speed of the acid/acetate and bicarbonate peristaltic pumps are defined during the corresponding calibration processes and represent the 100% functioning point. A safety system is present to prevent concentrate exchange errors, by generating an alarm in case the pumps speeds are measured outside a range of -10% to +30% of the reference value.

Rev. B


9.2.3 Materials in with dialysate, concentrates and water Ceramic Ethylene Propylene Diene Monomer (EPDM) Ethylene Propylene Monomer (EPM) Fiberglas Reinforced Polyamide (PA + GF -Glass Fiber-) Fiberglas Reinforced Polypropylene (PP + CF -Carbon Fiber-) Fluoroelastomer (FKM) Glass (GLA) Graphite (C) High Density Polyethylene (HDPE) Liquid Cristal Polymer (L) Nitril Butil Rubber (NBR) Polyester Thermoplastic Elastomer (PTE -Santoprene- ) Polyetheretherketone (Peek) Polyetheretherketone and Carbon Fiber (Peek + CF) Polyetheretherketone and Glass Fiber (Peek + GF) Polyfluorovinylidene (PVDF) Polyphenysulphide (PPS) Polypropylene (PP) Polysulfone (PSU) Polytetrafluoro Ethylene (PTFE) Polyvinil Cloruro (PVC) Silicon Rubber (SI) Stainless Steel (AISI SS316) Titanium (Ti)

9.2.4 Descaling Machine descaling can be carried out using: • • •

Rev. B

The same concentrate solution used for the dialysis procedure (in case of Bicarbonate Dialysis). A Vinegar Solution containing at least a 5% concentration of Acetic Acid. A 5% Acetic Acid Solution.


9.2.5 Disinfection WARNING with cleaning and/or disinfection chemicals may pose a risk of burns, skin irritation or other adverse reactions. Always follow the chemical manufacturer's instructions when handling these products or cleaning spills.

Disinfectants that may be used for chemical disinfection The machine can withstand different chemical solutions, which can be classified by their active ingredient. Oxidating Chlorine Active ingredient: Sodium Hypochlorite with active chlorine from 50,000 to 60,000 ppm, chlorine dioxide or active chlorine. Some commercial products are e.g.: • Bleach® • Instrunet HD™ (*) • Amuchina™ Peracetics Active ingredient: Peracetic Acid from 0.06% to 4% Some commercial products are e.g.: • Actril® (*) • Dialox™ (*) • Renalin™ (*) • Acetoper™ (*) • Peresal™ (*) Aldehydes Active ingredient: Formaldehyde Solution at 37-40% or association of different aldehydes. Some commercial products are e.g.: • Steridial™

WARNING To prevent damaging the machine, do not leave disinfectant solution in the machine for periods over the following limits: 4 hrs for: Amuchina™, Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength (1:25 dilution); 24 hrs for: Dialox™, Acetoper™, Peresal™, Actril® and Renalin®; 48 hrs for: formaldehyde solution and Steridial™; One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution).

Rev. B

9-23


Note Chemicals marked with the symbol (∗) carry out a combined action of disinfection and descaling.

Note If Bicarbonate Dialysis is carried out, an Acetic Acid cleaning must be performed at least twice a week (in the case of two normal dialysis sessions per day) to remove the calcium and magnesium carbonate residuals which may have precipitated in the hydraulic circuit. To do this, follow the instructions for the disinfection process and automatic rinsing (see Section 6 – Clean/Disinfect in this manual), substituting Acetic Acid solution at 30% v/v (add 120 ml of pure Acetic Acid to 280 ml of water to obtain 400 ml of solution) for the chemical disinfectant.

Chemical agents that can be used for Heat Citric Disinfection The machine can withstand the following chemical solutions: • Citric Acid at a concentration of 50% Citric Acid

WARNING In the Heat Citric Disinfection phase, it is important that only citric acid is used and no other disinfectants.

your Local Representative to determine if other chemical agents may be used for disinfection.

Centralized Heat Disinfection System The Centralized Heat Disinfection System may be used.

WARNING When the Centralized Heat Disinfection System is used, the temperature of the inlet water of the machine must be less than 95°C.

Rev. B


9.2.6 Ultrafiltration system Total Target Weight Loss The maximum Total Programmable Target Weight Loss is 30 kg to be obtained in a linear Treatment Time of up to 8 hours.

UF Flow Rate The minimum UF Rate can be configured (see Section 2 - Configuration Description in this manual), to 0.0, 0.100, 0.200, or 0.300 kg/h. The maximum UF Rate is 4.0 kg/h.

Note If the WLR MIN ALARM parameter is set to 0.0 Kg/h, the minimum value that can be set for the WEIGHT LOSS/H parameter is 0.100 Kg/h.

The UF Flow Rate accuracy is ±2%. Protection System Type: monitoring of ultrafiltration volume.

WARNING If the difference between the actual flow of the Ultrafiltration Pump and the set UFR is greater than ±20% with a UF Rate greater than 0.2 kg/h, an audible and visual alarm is triggered. When this alarm is activated the Ultrafiltration Pump is stopped.

Flow Balance System Dialysis fluid flowing into the dialyser and dialysis fluid flowing out from the dialyser are balanced in order to guarantee that the only fluid removed from the patient is equal to what is pumped by the UF Pump. The Flow Balance System (per hour) accuracy is: • ±35 g/h at a dialysate flow=350 ml/min • ±50 g/h at a dialysate flow=500 ml/min • ±80 g/h at a dialysate flow=800 ml/min

Maximum Weight Loss Error (g/h) The maximum Weight Loss Error (per hour) can be calculated with the following formula: WLE = WLEUFR + WLEFBS where: WLE = maximum Weight Loss Error WLEUFR = UFR error related to the UF Flow Rate accuracy WLEFBS = Flow Balance System error related to the Flow Balance System accuracy Example: at dialysate flow=500 ml/min and UFR= 0.5 Kg/h WLEFBS=±50 g/h WLEUFR=±10 g/h WLE=±60 g/h Rev. B

9-25


9.2.7 Detection of Extracorporeal Blood Loss Blood Loss Detection in the event of membrane rupture (Blood Leak Detector) Elapsed Time before an alarm:

less than 1 min.

Conditions:

Dialysate Flow of about 800 ml/min (max specified dialysate flow).

High Sensitivity:

• Normalized Blood Loss: 0.35 ml/min of fresh whole human or bovine blood with a hematocrit of 25%. • Normalized Blood Loss: 0.30 ml/min of fresh whole human or bovine blood with a hematocrit of 32%.

Low Sensitivity:

• Normalized Blood Loss: 0.45 ml/min of fresh whole human or bovine blood with a hematocrit of 25%. • Normalized Blood Loss: 0.38 ml/min of fresh whole human or bovine blood with a hematocrit of 32%.

Detection Method:

Optical Infrared System.

Automatic electronic compensation is performed before starting the DIALYSIS mode. Operating range of the sensitivity controlled by setting the BLD SENS. Parameter. A Safety Test of the Blood Leak Detector System is automatically performed each time the machine enters the Dialysate Preparation phase.

WARNING In the "UF only" process or with the hydraulic circuit in BY, the Blood Leak alarm may be delayed, due to the operating conditions and dialyser characteristics.

Blood Loss to the Environment (Venous Pressure Monitoring) Venous Pressure Sensor

Accuracy: ± 20 mmHg or ±10% of set value, whichever is greater

Venous Pressure Alarms

-40, +70 mmHg with respect to set value, in Double Needle mode. Operating range: +10 to the value set for the VEN PRESS LIMIT parameter. Tolerance: ±10 mmHg. Delay time: about 2 s.

Out of Range Alarms

• Note: in Single Needle mode only the Out of Range

Alarms are active Minimum

Threshold: +10 mmHg Delay time: about 1 s.

Maximum

Threshold: value set for the VEN PRESS LIMIT parameter Delay time: about 1 s.

A Safety Test of the Venous Pressure Monitoring System is automatically performed each time the machine enters the Dialysate Preparation phase

Rev. B


WARNING Modification of the Blood Flow Rate causes a fluctuation in the Venous Pressure and therefore an alarm may be triggered. Following a change in the Blood Flow Rate, to prevent such an effect, the Alarm Window is automatically set wider for 30 seconds. Its lower value is set to +10 mmHg, while the upper limit is set to the VEN PRES LIMIT parameter value decreased of 50 mmHg (see Section 2 - Configuration Description in this manual).

WARNING Modification of Blood Flow Rate causes a fluctuation in the Arterial Pressure and therefore an alarm may be triggered. Following a change in the Blood Flow Rate, to prevent such an effect, the Alarm Window is automatically set wider for 30 seconds. Its lower value is set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg, while the upper value is set to +150 mmHg.

WARNING Monitoring of the Venous Pressure could not always detect the disconnection of a venous needle from its access site, which may result in extracorporeal blood loss to the environment. When a venous needle disconnects from its access, pressure at the venous monitoring side may only decrease by the pressure maintained within the patient’s access site. This pressure drop may be less than the width of the machine’s venous pressure alarm window: in this particular case the disconnection of a venous needle from its access site is not detectable by the machine, even if pressure alarms and alarm windows are properly set. To reduce the risk of needles disconnection: • ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol; • ensure that the patient's access is visible at all times during the dialysis treatment; • inspect frequently the patient's access; • adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms.

WARNING A dedicated warning (W! Low Art Flow For Too Long #204) exists in order to avoid blood loss due to coagulation resulting from interruption of blood flow.

WARNING In WASHBACK (see Section 5 - Dialysis Operation in this manual) the limits of the Venous Pressure alarm window are automatically set to -50 and +250 mmHg and the limits of the Arterial Pressure window are set to the value set for the MIN ART PRESSURE parameter increased of +50 mmHg and +150 mmHg.

Rev. B

9-27


9.2.8 Operating Modes WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. The Manufacturer has not validated the use of blood lines other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. It is the responsibility of the to validate that other blood lines provide safe and effective performance.

Note Further information on suitable blood lines can be obtained by ing your local representative.

WARNING The manufacturer recommends the use of a dialyser with dialysate and blood connections that comply with ISO 8637.

Note Do not use plate-type dialyser.

Dialysis • Acetate • Bicarbonate with Liquid Concentrates or BiCart

Disinfection

Heat

Hot water:

>85°C (185°F)

Process Time:

may be set to 18, 36 min or 20, 40 min if the Clean Dialysate system is installed (with the DISINF TIME parameter in Config, see Configuration).

After the Time, the Hydraulic Circuit is cooled with fresh water. Therefore the total duration of the Heat Disinfection Process is about 10 minutes more than the Disinfection Time selected.

Rev. B


Heat Citric

Hot water:

>80°C (176°F)

Process Time:

24 min or 28 min if the Clean Dialysate system is installed

9-29

Automatic filling with citric acid (about 180 ml). Automatic verification of the volume of Citric Acid pumped by the device. After the Time, the Hydraulic Circuit is rinsed and cooled with fresh water. The total duration of the Heat Citric Disinfection Process is about 30 minutes. Chemical

Disinfection Time:

may be set from 15 to 30 min or from 28 to 43 min if END PROCESS MODE is set to Bact. (with the DISINF TIME parameter in Config, see Section 2 – Configuration Description).

Automatic filling with Disinfectant (about 180 ml). Automatic verification of the volume of disinfectant pumped by the device. An Automatic Rinsing Process, performed after the Chemical Disinfection, may be set by selecting Rins. for the END PROCESS MODE parameter in Config. The value may be Set to None or Bact. if an Automatic Rinsing is not required. A Bacteriostatic Disinfection Process may be set: select Bact. for the END PROCESS MODE parameter in the Config view. The effectiveness of rinsing to obtain the maximum permitted levels of disinfectant residuals (measured at a point in the hydraulic circuit just prior to the dialyser connection) was tested by Gambro Dasco Quality Control and it conforms to international standards.

Note It is recommended to alternate the disinfection methods and/or the disinfectants, in order to optimize cleaning, descaling and disinfection of the machine. For additional information your local representative.

Rev. B


Rinsing This phase is mandatory after Chemical Disinfection. The effectiveness of Rinsing (measured at a point in the hydraulic circuit just prior to the dialyser connection) conforms to international standards for residual concentrations of disinfectant: • Formaldehyde • Sodium Hypochlorite

less than 1.0 ppm less than 0.5 ppm

Time may be set at a value between 15 and 50 minutes or between 19 and 50 minutes if the Clean Dialysate system is installed (RINSING TIME parameter , see Section 2 – Configuration Description in this manual).

Note The test procedures for the measurement of disinfection and rinsing efficiency are available, upon request, from the manufacturer’s quality control department.

WARNING the absence of disinfectant residuals before connecting the dialyser.

Rev. B


9.3 Extracorporeal Circulation 9.3.1 Operating Modes Blood Circulation in Dialysis Mode • Double Needle • Single Needle (optional)

Blood Lines The blood lines are positioned in a way designed to ensure a simple and effective system. Refer to Chapter 5.0 - Dialysis Operation, in this manual for the mounting procedure for the Cartridge Blood set.

Cartridge Blood Set The Gambro/Hospal Cartridge® Blood Sets are the only extracorporeal blood circuit for hemodialysers that may be used with the Phoenix® Hemodialysis Delivery System. The following is the current list of Gambro/Hospal Cartridge® Blood Set models that have been validated for use with the Phoenix® Hemodialysis Delivery System.

Rev. B

9-31

9-32 PHOENIX OPERATOR MANUAL Code

Application

6032536

Single Needle Conversion Kit

6184071

Double Needle

6186803

Double Needle (with prime line attached)

6186886

Double Needle

6187439

Single Needle

6187660

Double Needle

6187686

Single Needle (with prime line attached)

6187694

Double Needle

6188320

Double Needle

6280598 003409-410

Double Needle (with prime line attached) Single Needle (with prime line attached)

003410-500

Double Needle

003410-510

Double Needle (with prime line attached)

003410-710

Double Needle (with prime line attached and injection port on prime line)

003412-500

Double Needle - Low Weight

003429-500

Single Needle Conversion Kit


Note your Local Service Representative for the Gambro/Hospal Cartridge Blood Sets technical data in order to choose the most appropriate Gambro/Hospal Cartridge Blood Set for your usage.

Rev. C


WARNING The use of the Gambro/Hospal Cartridge Blood Set designed for Phoenix machine has been tested and validated to provide safe and proper functioning of the system. The Manufacturer has not validated the use of blood lines other than those specified in this manual. The Manufacturer does not assume responsibility or liability for use of blood line other than the Gambro/Hospal Cartridge Blood Set. It is the responsibility of the to validate that other blood lines provide safe and effective performance.

9.3.2 Blood Pumps Blood Pump The Blood Module has one pump specifically designed for dialysis. It is peristaltic and it is comprised of: • An Electronic Speed Control System to keep the speed constant, independent of load variations. • A light on the Blood Pump Control is illuminated when the Pump is turning (or when it is about to turn, for example, after an automatic stop caused by an alarm). • A Pump Direction Monitor. • Blood Pump stop and automatic closure of the Venous Line Clamp if air or foam is detected while blood is sensed. • A Safety Control when the Blood Pump Door is open. • A handle for manual turning of the blood pump. • A Protective System to prevent overloads.

Technical characteristics of the Blood Pump Speed of Pump Head:

0 to 70 rpm approx.

Max Blood Flow (at 70 rpm):

580 ml/min (with Gambro/Hospal Cartridge Blood Set models that have been validated for use)

Rev. C

9-33

9-34 PHOENIX OPERATOR MANUAL Blood Flow Accuracy (Double Needle Mode) The machine display shows: •

The blood flow set value (displayed as “BLOOD FLOW”),

•

The blood flow actual value (displayed as “BLOOD FLOW”).

The blood flow set value represents the theoretical blood flow rate in the extracorporeal circuit calculated from the speed of the blood pump rotor and the geometric characteristics of the pump segment. The blood flow actual value is the actual blood flow rate in the extra-corporeal circuit. The actual value is usually lower than the set value due to the negative pressure in the access line at the inlet to the pump. The negative pressure is caused by the rotation of the pump itself and pressure drop linked to the motion of blood in the line. The actual value coincides with the set value when the pump inlet pressure (arterial pressure) is zero. The blood flow actual value is estimated by means of a mathematical algorithm taking into the pump segment characteristics of HOSPAL/GAMBRO Cartridge Blood Set, the current pump speed and the pressure values in the extracorporeal circuit. The accuracy on the estimate, using HOSPAL/GAMBRO Cartridge Blood Set, is typically within ±10% in the following conditions: •

the pressure before the pump, given by the pressure in the arterial chamber of the cartridge, is higher (less negative) than –150 mmHg.

Note Due to a natural decrease of the pump segment performance during the dialysis treatment, if the pressure before the pump, given by the pressure in the arterial chamber of the cartridge, is lower (more negative) than -150 mmHg, the ±10% accuracy on the blood flow actual value estimation may not be guaranteed.

Blood Flow Accuracy (Single Needle Mode) The machine display shows: • The blood flow set value (displayed as “BLOOD FLOW”), • The blood flow actual value (displayed as “BLOOD FLOW”). The blood flow set value represents the theoretical blood flow rate in the extracorporeal circuit calculated from the speed of the blood pump rotor and the geometric characteristics of the pump segment. The blood flow actual value is the actual blood flow rate in the extra-corporeal circuit. The actual value is usually lower than the set value due to the negative pressure in the access line at the inlet to the pump. The negative pressure is caused by the rotation of the pump itself and pressure drop linked to the motion of blood in the line. The blood flow actual value is calculated by using the blood pump activation time and the blood pump speed value (refer to the “Parameter modification” paragraph, in the Section 01 for a detailed description of how to calculate the blood flow actual value in Single Needle Mode). The accuracy of the blood flow actual value is typically within ±16% in the following conditions: • the pressure before the pump, given by the pressure in the arterial chamber of the cartridge, is higher (less negative) than –150 mmHg. Rev. B


9-35

Note Due to a natural decrease of the pump segment performance during the dialysis treatment, if the pressure before the pump, given by the pressure in the arterial chamber of the cartridge, is lower (more negative) than -150 mmHg, the ±16% on the blood flow actual value calculation may not be guaranteed.

Note In Single Needle mode, the blood recirculation rate at the level of the vascular access is influenced by the needle type or catheter used. The blood recirculation rate is not due to the single needle Cartridge Blood Set characteristics.

Blood Flow set Double Needle

10 to 580 ml/min

Single Needle (option)

10 to 580 ml/min.

(Istantaneous flow)

In Single Needle mode the stroke volume for each cycle is approximately 60 ml.

Alarms

•

If the set value is > 300 ml/min ± 10%

•

If the set value is <= 300 ml/min ± 30 ml/min in Double Needle ± 105 ml/min in Single Needle

Note Data relating to haemolysis is available upon request.

9.3.3 Heparin Pump The PHOENIX machine can be supplied with a syringe type infusion pump which delivers heparin with either a standard 10 to 20 ml or a 20 to 30 ml syringe.

Heparin Pump Specifications • • • • •

Maximum Capacity Maximum Delivery Rate in Linear Mode Possible Delivery Rate in Linear Mode Accuracy Maximum pressure

30 ml 10 ml/h 0/0.5 to 9.9 ml/h in steps of 0.1 ml/h ±5 % or ±0.2 ml/h +900 mmHg

The delivery of heparin (see Heparinization Section) may be: Linear: 0/0.5 to 10 ml/h Automatic Bolus: bolus quantity and internal time are programmed. Manual Bolus: bolus quantity programmed. The bolus is injected when the MAN BOLUS Action key is pressed.

Rev. B

9-36 PHOENIX OPERATOR MANUAL Note If the HEPARIN PR Action key is selected before blood is detected, 0.4 ml of heparin is injected into the Cartridge to prime the heparin line. This will happen regardless of the type of heparin programming selected.

Syringes that may be used for Heparin Infusion Syringe name

Volume (ml)

Internal diameter

TERUMO

30

23.1 mm (0.909 in)

3S (BERTONI)

30

23.9 mm (0.941 in)

BD 30 PLASTIPAK

30

21.6 mm (0.850 in)

PIC 30 LL

30

23.6 mm (0.929 in)

ICO GAMMA PLUS

30

23.9 mm (0.941 in)

DISPOMED

30

22.3 mm (0.878 in)

PENTA 30

30

21.7 mm (0.854 in)

ICO GAMMA PLUS

20

19.1 mm (0.752 in)

ICO MONOSTERIL

20

19.1 mm (0.752 in)

BD 20 PLASTIPAK

20

19.1 mm (0.752 in)

TERUMO 20

20

20.0 mm (0.787 in)

PIC 20 LL

20

19.6 mm (0.770 in)

PENTA 20

20

20.0 mm (0.787 in)

MONOJECT 20

20

20.1 mm (0.831 in)

MONJECT 12

12

15.7 mm (0.618 in)

BD 10

10

14.4 mm (0.567 in)

TERUMO 10

10

15.8 mm (0.622 in)

WARNING These diameters have been taken from samples from many countries and are correct at the time of printing. However, the manufacturer cannot be held responsible for changes in syringe dimensions that may occur. The should periodically check the correlation between the stated and the actual diameters.

Note It is possible to define a syringe that is not present on the list, by setting, in Config, first ANOTHER for the Syringe Type parameter, then setting the DIAMETER parameter.

Note The syringe infusion pump described above must be used only for the infusion of heparin.

Rev. B


9.3.4 Automatic Functions 1. Single Needle - One Pump (optional): arterial/venous cycles occur through automatic blood pump transition when preprogrammed venous pressure thresholds are reached. 2. Linear or Bolus heparinization, through programming of the rate and timing of heparinization. 3. Heparin Bolus Injection Characteristics. 4. Patient Sensor before the Venous Line Clamp Before blood detection by the Patient Sensor or before the selection of the DIALYSIS Action key, the class P alarms are byed (see Section 8 - Alarms and Signals in this manual) to allow easier filling of the extracorporeal and dialysate circuits.

Rev. B

9-37


9.3.5 Main Surveillance Devices 1) Monitoring of Arterial Pressure. The arterial pressure sensor is used to measure pre-pump arterial pressure. Monitoring the pre-pump arterial pressure is required to protect the patient from high negative arterial pressures between the patient and the blood pump. If the pressure falls below a set value, an arterial pressure alarm is triggered. The alarm threshold can be fixed between the value set for the MIN ART PRESSURE parameter and +150 mmHg on the Touch Screen. Accuracy: ±20 mmHg or ± 10%, whichever is greater.

2) Monitoring of Venous Pressure. See Subsection “Blood Loss to the Environment”.

3) Ultrasonic Air Bubble Detector. The blood module has an Air Bubble Detector consisting of: • An Ultrasonic Device located in the Air Detector Housing. • A Transducer which carries out the auto-test approximately every 250 ms. • A Visual and an Audible alarm which is activated if air is detected. An ultrasonic wave band crosses the fluid in the blood line. When air is present in the line, the signal received by the detector is modified in proportion to the volume of air present. When the signal goes above a fixed threshold, the microprocessor triggers a signal, which causes the Venous Line Clamp to close and the Blood Pump to stop. Accuracy: Able to detect a single bubble with a volume approximately of 20 μl, with the blood flow at the maximum allowed value.

4) Monitoring of the Commutation Pressure in Single Needle mode (optional) The Venous Pressure Sensor is used to measure the blood pressure in the Venous Chamber for blood pump activation and deactivation in Single Needle mode, according to set venous pressure values: • Normal operating conditions: from 100 to 400 mmHg • Safety Alarm: over +450 mmHg

WARNING The must take precautions against the hazard of cross-contamination between patients by using only extracorporeal circuits with hydrophobic filters on the pressure ports and by disinfecting the accessible surfaces of the equipment.

Rev. B


9.3.6 Safety system actuators 1) Arterial Clamp - Optional with Single Needle Feature 2) Venous Line Clamp The Venous Line Clamp, located below the air bubble detector, performs the following tasks: • Automatic closure when required by an alarm as part of a specific safety state (see Section 8 - Alarms and Signals, in this manual). • Closure in Single Needle to reduce recirculation. The Venous Line Clamp is fitted with a position sensor to ensure proper functioning of the clamp, and to assure that the Blood Pump is stopped.

Rev. B

9-39


9.4 Protection System The Protection System has the function of controlling fault conditions which may be dangerous for the patient, by placing the machine in a Safe State, as required by international regulations. For each of these conditions, an independent safety chain is implemented. The conditions controlled are: • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Final Dialysate Conductivity Blood Pump Bicarbonate Dialysate conductivity Presence of blood in the Hydraulic Circuit Concentrate Container Error Dialysate Flow Error in the Single Needle mode (optional) Maximum Dialyser Pressure at the Dialyser Inlet and Outlet Minimum Dialyser Pressure at the Dialyser Inlet and Outlet Heater Protection Voltage Drop of greater than 20 seconds and less than 4 minutes Voltage Drop of less than 20 seconds Presence of Air in the Venous Line Profiling of Final Conductivity Activity Profiling of Ultrafiltration Rate Activity Temperature of the Dialysate Ultrafiltration Flow Ultrafiltrate Mass Balance Venous Pressure higher than the maximum permitted Venous Pressure outside the interval selected or less than the minimum permitted Arterial Pressure lower than the minimum permitted Arterial Pressure outside the interval selected or more than the maximum permitted Incorrect Voltage Activity in Profiling Mode. Activity of Diascan system Control System Communication checking Correct Sequence of T1 Tests Power Failure Long By Autoemptying

If, on encountering a fault, the relevant safety state is not correctly configured, the protection system places the machine in a General Safe State: 1 2

Rev. B

The Venous Line Clamp is activated. The Power Supply to all other actuators, except those for visual and audible alarms, is turned OFF.


9.5 General Safety Controls Use

The PHOENIX Haemodialysis System must be used under the supervision of a physician.

Earth

Check that the PHOENIX machine is properly grounded.

Electrical Protection

WARNING Do not remove the s. If necessary, ask qualified staff to open the s. Disconnect the machine from the main power supply before every cleaning, checking or maintenance operation.

Risks of Explosion


Moving Parts

WARNING Turn the Blood pump OFF before touching the Blood Pump Rotor. Do not touch the blocking system.

Handling and Transport

WARNING Carefully move the machine by using the handle on the rear . The machine could be damaged if handled in an improper way.

Use and Maintenance Read this manual carefully, paying special attention to the notes and observations.

WARNING Do not assemble, install or use the machine before having read the manual carefully.

Disposal of Energy Cells The PHOENIX machine contains energy cells (batteries). components, follow local regulations for proper disposal.

When replacing these

Rev. B

9-41


Disposal of discarded equipment Discarded electromedical equipment may not be disposed of together with municipal waste but must be collected separately in order to guarantee ecologically correct disposal to prevent dispersion of potential pollutants into the environment. Pay attention to the fact that some components of the machine (display, batteries, circuit boards, etc.) may contain toxic substances which, if released into the environment, pose a risk to the health of living organisms and the environment itself. When discarding electromedical equipment used at or through healthcare facilities, it may be returned directly to the local representative/distributor who has supplied it. When discarding electromedical equipment used in private households, it may be: - returned free of charge to the distributor at the time of purchasing new equipment - sent to the specialized collection centres free of charge. s who return electromedical equipment to the subjects identified above actively contribute to reuse, recycling and recovery of potentially still useable materials and components and to reduction of the potential risks to the environment and human health. Abusive disposal of discarded equipment may be punishable by law.

Rev. B


9-43

9.6 Technician Maintenance WARNING The manufacturer does not accept any responsibility for damage caused by any operation carried out on the machine by unauthorized staff. To keep the machine in good and safe working order, preventive maintenance must be performed by authorized service technicians. The ambient conditions, as well as frequency and duration of use determine the maintenance frequency; however when a maximum of 4,000 hours of use has elapsed (or at least once a year) technical preventive maintenance is required. The Manufacturer makes available Preventive Maintenance Kits, including Preventive Maintenance Checklists, to complete the Technical Preventive Maintenance. Below is a list of the main operations and verifications required during the Technical Preventive Maintenance program, updated at the date of printing of this manual. For a complete description of all the components to be replaced and the calibrations and checks to be performed refer to the Preventive Maintenance Checklist provided with each Preventive Maintenance kit and to the calibration/test procedures described in the Phoenix Service Manual.

Operation

Frequency

Change the O-rings

Every 4000 hours

Change the BIC/ACE/Sterilant/Dialysate connectors

Every 4000 hours

Change the Safety valve

Every 4000 hours

Replace the UF, air, hydraulic Filters

Every 4000 hours

Replace the O-rings in the BiCart holder arms

Every 4000 hours

Change the Peristaltic Pump Inserts and recalibrate the machine.

Every 4000 hours

Change the Pressure Ports gaskets

Every 4000 hours

EVC and EVD valve body

Every 4000 hours

Replace the WHO Connector Cap

Every 4000 hours

HLS and LLS level sensors

Every 4000 hours

pH sensor

Every 4000 hours

During these operations the technician should the following: • Leakage in the hydraulic circuit • Leakage in the blood circuit • Correct grounding and hearth leakage current • Power Supply voltages • Correct closing of the clamps • Blood Pump Rotor occlusion • ABD alarm simulation • Power failure simulation • Arterial and Venous Pressure pods • WHO door

Rev. B


Periodic Safety Inspection A safety inspection of the PHOENIX machine is required at least once a year, or as stipulated by local requirements. Only trained and qualified technicians are approved to perform the safety inspection procedures. The inspection consists of the following tests: Parameter

Performance

Conditions

Earth leakage current Low voltage model

< 300 uA (typically < 130 uA)

Normal condition

High voltage model

< 300 uA (typically < 220 uA)

Normal condition

0.2 ohm maximum

Between earth ground in mains plug and any accessible conductive part.

Ground Integrity Test per IEC 601.1, para 18f

WARNING Before replacing or checking any component in the Hydraulic Circuit, a DESCALING Procedure must performed.


Rev. B

WARRANTY

WARRANTY WARRANTY

All products manufactured by Gambro Dasco S.p.A. are warranted against defects in workmanship and materials. While the unit is within the stated warranty period, no service repairs on this machine should be attempted. Any unauthorized work will immediately void the warranty. If additional information or assistance is required or the information provided is not sufficient, the Service Representative in your country and request additional information or assistance. If any information in this manual is found to be in error, or if there are any additions or deletions that you feel will improve the manual, please forward your comments to the Service Representative in your country. GAMBRO DASCO S.p.A. and/or its s accept responsibility for the safety, reliability, and performance of this equipment only if: -- Operational procedures, calibrations, and repairs are carried out by appropriately qualified persons, -- All equipment modifications are authorized in writing by GAMBRO DASCO S.p.A. and carried out by appropriately qualified persons, -- The electrical installation of the relevant room complies with all applicable local electrical codes and IEC requirements, and -- The equipment is used in accordance with the published instructions for use.

IMPORTANT NOTE SINCE GAMBRO DASCO S.P.A., THE MANUFACTURER, HAS NO CONTROL OVER THE MANNER IN WHICH SERVICE OR MAINTENANCE WORK IS CONDUCTED BY PERSONS OTHER THAN TRAINED PERSONNEL BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY, OR THE EFFECT OF SUCH WORK ON MACHINE OPERATION AND PERFORMANCE, GAMBRO DASCO S.P.A. DOES NOT ASSUME RESPONSIBILITY OR LIABILITY FOR ANY DAMAGES RESULTING FROM THE OPERATION OR PERFORMANCE OF ANY DEVICE, OR ANY INJURY CAUSED BY SUCH DEVICE AFTER REPAIRS HAVE BEEN ATTEMPTED BY ANYONE OTHER THAN QUALIFIED PERSONS BELONGING TO THE SERVICE REPRESENTATIVE IN YOUR COUNTRY. GAMBRO DASCO S.P.A. DOES NOT RECOGNISE THE OWNER OF A PRODUCT AS AN AUTHORISED SERVICE REPRESENTATIVE. THE WARRANTY ON THIS MACHINE WILL BE VOIDED BY ANY SUCH ATTEMPTED REPAIR AND NO PARTS OR LABOR COSTS INCURRED BY THE OWNER WILL BE REIMBURSED BY THE MANUFACTURER. UNDER NO CIRCUMSTANCES WILL THE MANUFACTURER BE LIABLE FOR INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND, ITS LIABILITY HEREBY BEING LIMITED SOLELY TO REPAIR OR REPLACEMENT. THIS WARRANTY IS IN LIEU OF ANY OTHER EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF SALEABILITY OR SUITABILITY OF USE AND OF ANY OTHER OBLIGATION ON THE PART OF THE MANUFACTURER.

Rev. B

I

II

PHOENIX OPERATOR MANUAL NOTE The PHOENIX Haemodialysis machine was designed and has been built to comply with the product specifications listed in this manual (See Section 09 – Specifications, in this manual). Gambro Dasco S.p.A is committed to continuously improving this product. The improvement process may result in modifications to both the product specifications and consequently to the equipment produced in the future. These changes or improvements may or may not be applicable or usable with previously produced equipment. Where possible, improvements will be made available at reasonable prices. Any such improvement shall not be construed as corrections of any perceived deficiency.

NOTE This manual contains a number of references to spare parts for use with PHOENIX. The PHOENIX has been tested and validated for use with spare parts listed in this manual. The Manufacturer does not assume responsibility or liability for use of not genuine spare parts and for use/mounting of those components not in accordance with the official Instruction for Use accompanying those components. Depending on the circumstances, use of not genuine spare parts and use/mounting of those components not in accordance with the above mentioned Instruction for Use may reduce the Manufacturer’s warranties for the Phoenix Hemodialysis System.


NOTE This publication contains information which is the property of Gambro Dasco S.p.A. Whoever receives this manual accepts that drawings and information contained herein must not be disclosed to others without the express written permission of Gambro Dasco S.p.A. Do not attempt to assemble, install, or operate the machine until all the contents of this manual are thoroughly understood.

Rev. B

A APPENDIX A: Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity Appendix A: Guidelines and Manufacturer’s Declaration – Electromagnetic Emissions and Immunity

Guidance and manufacturer’s declaration – electromagnetic emissions The PHOENIX is intended for use in the electromagnetic environment specified below. The customer or the of the PHOENIX should assure that it is used in such an environment.

Emission test

RF emission CISPR 11

RF emission CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations / flicker emissions

Compliance

Group 1

Class B Not applicable

Not applicable

IEC 61000-3-3

Electromagnetic environment - guidance The PHOENIX uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The PHOENIX is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

For PHOENIX equipment with a rated mains voltage less than to 220V.

Rev. B

A-2


Guidance and manufacturer’s declaration – electromagnetic emissions The PHOENIX is intended for use in the electromagnetic environment specified below. The customer or the of the PHOENIX should assure that it is used in such an environment.

Emission test

RF emission CISPR 11

RF emission CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations / flicker emissions IEC 61000-3-3

Compliance

Group 1

Class B Class A

Complies

Electromagnetic environment - guidance The PHOENIX uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The PHOENIX is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

For PHOENIX equipment with a rated mains voltage greater than or equal to 220V.

Rev. B

APPENDIX A: GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS AND IMMUNITY

A-3

Guidance and manufacturer’s declaration – electromagnetic emissions The PHOENIX is intended for use in the electromagnetic environment specified below. The customer or the of the PHOENIX should assure that it is used in such an environment. Electrostatic

±6 KV

± 6 KV

±8 KV air

± 8 KV air

±2 KV for power supply lines

± 2 KV for power supply lines

IEC 61000-4-4

±1 KV for input / output lines

± 1 KV for input / output lines

Surge

±1 KV line(s) to line(s)

± 1 KV differential mode

IEC 61000-4-5

±2 KV lines(s) to earth

± 2 KV common mode

<5 % UT

<5 % UT

(>95 % dip in UT)

(>95 % dip in UT)

for 0.5 cycle

for 0.5 cycles

40 % UT

40 % UT

Voltage dips, short interruptions and voltage variations on power supply input lines

(60 % dip in UT)

(60 % dip in UT)

for 5 cycles

for 5 cycles

70 % UT

70 % UT

IEC 61000-4-11

(30 % dip in UT)

(30 % dip in UT)

for 25 cycles

for 25 cycles

<5 % UT

<5 % UT

(>95 % dip in UT)

(>95 % dip in UT)

for 5 s

for 5 s

discharge (ESD) IEC 61000-4-2

Electrical fast transient / burst

Power frequency (50/60 Hz) magnetic field

3 A/m

3 A/m

IEC 61000-4-8

Electrostatic discharge (ESD) IEC 61000-4-2

±6 KV

± 6 KV

±8 KV air

± 8 KV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the of the PHOENIX requires continued operation during power mains interruptions, it is recommended that the PHOENIX be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

NOTE UT is the a.c. mains voltage prior to application of the test level.

Rev. B

A-4

PHOENIX OPERATOR MANUAL Guidance and manufacturer’s declaration – electromagnetic immunity The PHOENIX is intended for use in the electromagnetic environment specified below. The customer or the of the PHOENIX should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the PHOENIX including cables, than the recommended separation distance calculated from the equation applicable to frequency of the transmitter. Recommended separation distance

d = 1.2 P

Conducted RF

3 Vrms

IEC 61000-4-6

150 KHz to 80 MHz

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

3 Vrms

3 V/m

d = 1.2 P

80 MHz to 800 MHz

d = 2.3 P

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To asses the electromagnetic environment due to fixed transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PHOENIX is used exceeds the applicable RF compliance level above, the PHOENIX should be observed to normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the PHOENIX. b

Rev. B

Over the frequency range 150 KHz to 80 MHz, field strength should be less than 3 V/m.

APPENDIX A: GUIDELINES AND MANUFACTURER’S DECLARATION

A-5

– ELECTROMAGNETIC EMISSIONS AND IMMUNITY

Recommended separation distances between portable and mobile RF communications equipment and the PHOENIX The PHOENIX is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the of the PHOENIX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PHOENIX as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W

Separation distances according to frequency of transmitter 150 KHz to 80 MHz d = 1.2

P

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2

d = 2.3

P

0,01

0.12

0.12

0.23

0,1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

P

For transmitters rated at maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 applies.

At 80 MHz and 800 MHz, the separation distance for the higher frequency range

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, object and people.

Rev. B

A-6



Rev. B

B APPENDIX B: Special Troubleshooting

The situations described below are exceptional events. This table provides instructions in order to solve these problems and prevent them (when possible) from occurring again.

1. GENERAL EVENTS Situation Remedy Machine stuck during software loading Switch OFF the machine, wait 5 seconds and and/or Action keys not available in switch ON the machine again. IDLE. Machine stuck after selecting Action keys in a fast sequence.

Action key not responding at first touch.

Switch OFF the machine, wait 5 seconds and switch ON the machine again. To prevent this situation, do not press the Action keys too quickly. Select the Action key again.

2. IDLE Situation Machine stuck in IDLE.

Remedy Switch OFF the machine, wait 5 seconds then switch ON the machine. To prevent this situation, at the machine switch ON, do not touch the screen until the IDLE view is displayed.

Audible buzzer and flashing red light active in IDLE.

Switch OFF the machine, wait 5 seconds, then switch ON the machine again.

3. SETUP SELECTION Situation “W! SET VALUE OUT OF RANGE” # 250 alarm occurs after the selection of the SETUP Action key.

Remedy Press OVERRIDE to clear the alarm.

Machine stuck after the selection of the SETUP Action key.

Switch OFF the machine; wait 5 seconds, then switch ON the machine.

Rev. B

B-2


4. PRIME Situation Machine stuck when starting a second priming with the “PRIME VOLUME COMPLETED” # 54 alarm displayed on the screen.

Remedy Perform another prime.

5. PATIENT CONNECTION Situation PAT CONNECT Action key present even if Profile curves have not been activated.

Remedy Activate the profile curves.

With CentryNet communication system activated, PATIENT ID Action key still present in Report Page, after patient ID has been already entered.

Do not touch the Action key; any data entered will not be effective.

6. TREATMENT Situation Remedy “END OF HEPARIN TIME” # 58 alarm To clear the alarm, activate the heparin displayed even if the heparin program is not program and then deactivate it. activated. DIALYSIS TIME parameter not shown in SET environment (when Profiling is activated).

If DIALYSIS TIME s to be modified, deactivate Profiling.

Blood pump running at minimum rate instead of at the prescribed rate at the beginning of treatment.

Manually increase the BLOOD FLOW to the prescribed value.

“!WEIGHT LOSS RATE PROFILE (TIMING)” # 212 and “!CONDUCTIVITY PROFILE (TIMING)” # 210 alarms displayed after the deactivation of the related profile.

Press OVERRIDE to clear the alarm. If the alarm persists, switch OFF the machine, wait 5 seconds, then switch ON the machine again.

Rev. B

C APPENDIX C: Ultrafilter By Connector Installation This section describes: 1. Disconnection of the three Ultrafilter By connector lines (section C.1); 2. Connection of the Ultrafilter By connector (section C.2).

Material / Instruments needed for the installation • • •

Ethyl Alcohol Clamp A pair of gloves

q.ty 5 ml q.ty 3 q.ty 1

C.1 Disconnection of the three Ultrafilter By connector lines Setup instructions 1. 2. 3.

4.

Put on the gloves. Switch On the machine, the software program is loaded. At Power ON, information related to the status of the last machine process appear on the Touch Screen display (see Fig. 1). Perform a Rinse process, if one of the following messages appears: - “Rinsing NOT Performed Correctly”. - “Chemical Proc. Performed Correctly”. - “Chemical Proc. NOT Performed Correctly”.

WARNING Fig. 1

Before disconnecting any component in the hydraulic circuit, ensure that the hydraulic circuit is not containing chemicals. If chemicals in the hydraulic circuit come in with skin, they might cause chemical injuries.

Rev. B

C-2

PHOENIX

OPERATOR MANUAL

5. 6.

Deaeration Line

7. 8.


Dialysate Inlet Line Ultrafilter By connector Fig. 2

Rev. B

Switch Off the machine. Unplug the power cord from power supply. Close the water inlet. Follow the instructions below to disconnect the three Ultrafilter By connector’s lines from the Ultrafilter By connector (see Fig. 2).

APPENDIX C: ULTRAFILTER BY CONNECTOR INSTALLATION

C-3

Disconnection of the Deaeration Line from the Ultrafilter By connector 9.

Press the Deaeration Line‘s snap safety clip springs then unhook the snap safety clip from the upper Ultrafilter By connector port (see Figures 3 and 4).

10.

Slide the Deaeration Line’s snap safety clip along the Deaeration Line and insert the snap safety clip into the grey Deaeration Line ring (see Fig. 5 and Fig. 6).

Deaeration Line

Snap safety clip

Fig. 3 Snap safety clip springs

Upper Ultrafilter By connector port

Fig. 4

Grey Deaeration Line ring

Fig. 5

Fig. 6

Rev. B

C-4

PHOENIX

OPERATOR MANUAL

11.

Clamp the Deaeration Line to avoid water spillage (see Fig. 7).

12.

Disconnect the Deareation Line from the upper Ultrafilter By connector port by pulling upwards the Deaeration Line’s Luer lock (seeFig. 8).

Deaeration Line

Fig. 7

Luer lock

Fig. 8

Rev. B


C-5

Disconnection of the Dialysate Inlet Line from the Ultrafilter By connector 13.

Press the Dialysate Inlet Line ‘s snap safety clip springs then unhook the snap safety clip from the lower Ultrafilter By connector port (see Figures 9 and 10).

14.

Slide the Dialysate Inlet Line’s snap safety clip along the Dialysate Inlet Line and insert the snap safety clip into the grey Dialysate Inlet Line ring (see Fig. 11 and Fig. 12).

Dialysate Inlet Line

Snap safety clip

Fig. 9

Snap safety clip springs

Fig. 10

Grey Dialysate Inlet Line ring

Fig. 11

Fig. 12

Rev. B

C-6

PHOENIX

OPERATOR MANUAL

15.

Clamp the Dialysate Inlet Line to avoid water spillage (see Fig. 13).

16.

Disconnect the Dialysate Inlet Line from the lower Ultrafilter By connector port pulling downwards the Dialysate Inlet Line’s Luer lock (see Fig. 14).


Fig. 13

Luer lock

Fig. 14

Disconnection of the Filtrate Outlet Line from the Ultrafilter By connector

17.


Fig. 15

Rev. B

Clamp the Filtrate Outlet Line to avoid water spillage (see Fig. 15).


C-7

18.

Press the Filtrate Outlet Line’s pinch safety clip springs (Fig. 16) then unhook the pinch safety clip from the middle Ultrafilter By connector port (see Fig. 17).

19.

Disconnect the Filtrate Outlet Line from the middle Ultrafilter By connector port. (see Fig. 18).

Pinch safety clip springs

Fig. 16

Pinch safety clip

Fig. 17


Fig. 18

Rev. B

C-8

PHOENIX

OPERATOR MANUAL

Removal of the Ultrafilter By connector Upper fixing clip

20.

Lower fixing clip

Fig. 19

Rev. B

Remove the Ultrafilter By connector from the lower fixing clip (see Fig. 19).


C-9

C.2 Connection of the Ultrafilter By connector Connection of the Deaeration Line to the Ultrafilter By connector New Ultrafilter By connector

1.

Take the new Ultrafilter By connector (see Fig. 1).

2.

Do not insert the new Ultrafilter By connector into the lower fixing clip (see Fig. 2), since it is necessary to handle the Ultrafilter By connector.

3.

Spray the upper Ultrafilter By connector port (see Fig. 3) with Ethyl Alcohol (the Ultrafilter By connector is symmetric, therefore the upper and lower ports are equivalent).

Fig. 1

Lower fixing clip

Fig. 2


Fig. 3

Rev. B

C-10

PHOENIX

OPERATOR MANUAL

Deaeration Line

4.

Luer lock

Insert completely the Deaeration Line’s Luer lock into the upper Ultrafilter By connector port (see Figures 4 and 5).

Note Ensure that the Deaeration Line is not twisted or kinked.

Fig. 4


Fig. 5

5. Deaeration Line

Fig. 6

Rev. B

Unclamp the Deaeration Line (see Fig. 6).


Snap safety clip

C-11

6.

Disconnect the snap safety clip from the grey Deaeration Line ring (see Fig. 7).

7.

Position each of the two Deaeration Line’s snap safety clip springs in the housing between the two ribs of the Ultrafilter By connector (see Fig. 8).

8.

Hook the snap safety clip to the Ultrafilter By connector and make sure to hear a “click” sound when it is firmly inserted (see Fig. 9).

Fig. 7

Snap safety clip

Ribs

Ribs

Fig. 8

Snap safety clip

Fig. 9

Rev. B

C-12

PHOENIX

OPERATOR MANUAL

9.

GOOD

BAD

Fig. 10-A

Fig. 10-B

Ensure that the snap safety clip is properly hooked to the Ultrafilter By connector: The Deaeration Line’s snap safety clip has to be fully inserted in its housing in order to avoid line disconnection. (Fig. 10-A shows a good installation Fig. 10-B shows a bad installation due to the gap between the Deaeration Line’s snap safety clip and the Ultrafilter By connector.)

Connection of the Dialysate Inlet Line to the Ultrafilter By connector

10. Spray the lower Ultrafilter By connector port (see Fig. 11) with Ethyl Alcohol (the Ultrafilter By connector is symmetric, therefore the upper and lower ports are equivalent).

Fig. 11

Rev. B

Lower Ultrafilter By connector port


C-13

11. Insert completely the Dialysate Inlet Line’s Luer lock (see Fig. 12) into the lower Ultrafilter By connector port (Fig. 13).

Note Ensure that the Dialysate Inlet Line is not twisted or kinked. Luer lock


Fig. 12

Lower Ultrafilter By connector port

Fig. 13

12. Unclamp the Dialysate Inlet Line (see Fig. 14).


Fig. 14

Rev. B

C-14

PHOENIX

OPERATOR MANUAL

13. Disconnect the snap safety clip from the grey Dialysate Inlet Line ring (see Fig. 15).

Snap safety clip

Fig. 15

Ribs

Ribs

Snap safety clip

spring

Fig. 16

Rev. B

14. Position each of the two Dialysate Inlet Line’s snap safety clip springs in the housing between the two ribs of the Ultrafilter By connector (see Fig. 16).


C-15

15. Hook the snap safety clip to the Ultrafilter By connector and make sure to hear a “click” sound when it is firmly inserted (see Fig. 17).

Snap safety clip

Fig. 17

GOOD

BAD

Fig. 18-A

Fig. 18-B

16. Ensure that the snap safety clip is properly hooked to the Ultrafilter By connector: The Dialysate Inlet Line’s snap safety clip has to be fully inserted in its housing in order to avoid line disconnection. (Fig. 18-A shows a good installation. Fig. 18-B shows a bad installation due to the gap between the Dialysate Inlet Line’s snap safety clip and the Ultrafilter By connector.)

Connection of the Filtrate Outlet Line to the Ultrafilter By connector Middle Ultrafilter By connector port

17. Spray the middle Ultrafilter By connector port (see Fig. 19) with Ethyl Alcohol.

Fig. 19

Rev. B

C-16

PHOENIX

OPERATOR MANUAL

18. Fully insert the Filtrate Outlet Line onto the middle Ultrafilter By connector port (see Fig. 20). Filtrate Outlet Line

Fig. 20

Pinch safety clip

Fig. 21

Rev. B

19. Hook the pinch safety clip to the middle Ultrafilter By connector port (see Fig. 21)


Pinch safety clip

C-17

20. Ensure that the pinch safety clip is securely inserted onto the middle Ultrafilter By connector port in order to avoid line disconnection (see Fig. 22).

Fig. 22

21. Unclamp the Filtrate Outlet Line (see Fig. 23). Filtrate Outlet Line

Fig. 23

Rev. B

C-18

PHOENIX

OPERATOR MANUAL

22. Insert the Ultrafilter By connector in the lower fixing clip present on the machine (see the yellow arrow in Fig. 24).

Lower fixing clip

Fig. 24

Machine disinfection 23. Plug the Power Cord to power supply. 24. Open the water inlet. 25. Switch On the machine. 26. Perform a Rinse procedure to check for leaks in the hydraulic circuit. (Please refer to the Operator’s Manual, Section 06 for a detailed description of the Rinse procedure). During the Rinse process complete the “Final Check” checklist as described at page 19 of this Appendix C. 27. In case a fluid leakage occurs during the Final Check, switch Off the machine and repeat the connection procedure of the improper connections. 28. Perform a Heat Disinfection procedure. Only if the Heat Disinfection is not available, perform a Chemical Disinfection procedure to disinfect the hydraulic circuit prior to performing a dialysis treatment (Please refer to Section 06 in this manual for a detailed description of the Heat and Chemical Disinfection procedures).

Rev. B


C-19

Final Check Fill in the checklist below to if the Ultrafilter By connector replacement procedure has been correctly performed. To correctly perform the installation procedure all the flags must be checked.

1. Refer to Figure 25

…Check

that the Ultrafilter By connector is properly installed into the lower fixing clip located on the machine as shown in Fig. 25.

Lower fixing clip

Fig. 25


…Check

that no leaks are present in the Deaeration Line (see Fig. 26, point A).

…Check

that the snap safety clip is correctly hooked to the Ultrafilter By connector (see Fig. 26, point A).

A

…Check that the Deaeration Line is not

twisted or kinked (see Fig. 26, point A).

Fig. 26

Rev. B

C-20

PHOENIX

OPERATOR MANUAL


…Check

that no leaks are present in the Dialysate Inlet Line (see Fig. 27, point B).

…Check

that the snap safety clip is correctly connected to the Ultrafilter By connector (see Fig. 27, point B).

…Check that the Dialysate Inlet Line is B

not twisted or kinked (see Fig. 27, point B).

Fig. 27


…Check

that no leaks are present in the Filtrate Outlet Line (see Fig. 28, point C).

…Check

that the pinch safety clip is correctly connected to the Ultrafilter By connector(see Fig. 28, point C) .

C

Fig. 28

Rev. B

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