Dxh Operator Manual 6r4866

character missing.

Parsing Comment record: trailing carriage return and line feed characters missing.

1. Data incorrectly formatted by the host.

1. the LIS vendor.

Host parsing error: character missing.

Parsing Patient record: trailing carriage return and line feed characters missing.


1. the LIS vendor.


Parsing record: trailing carriage return and line feed characters missing.


1. the LIS vendor.


Parsing Test Order record: trailing carriage return and line feed characters missing.


1. the LIS vendor.

Host parsing error: pair missing.

Parsing Header record: trailing carriage return and line feed characters missing.


1. the LIS vendor.

Troubleshooting Event Messages from the System Manager

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Table 10.6 Info Event Messages (Continued)

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Table 10.6 Info Event Messages (Continued) Detailed Description

Probable Cause

Action

Host parsing error: <ETB>/<ETX> character missing.

Parsing Comment record: end of transmission block <ETB> or end of test <ETX> character missing.


1. the LIS vendor.


Parsing Header record: end of transmission block <ETB> or end of test <ETX> character missing.


1. the LIS vendor.


Parsing Patient record: end of transmission block <ETB> or end of test <ETX> character missing.


1. the LIS vendor.


Parsing record: end of transmission block <ETB> or end of test <ETX> character missing.


1. the LIS vendor.


Parsing Test Order record: end of transmission block <ETB> or end of test <ETX> character missing.


1. the LIS vendor.

Host parsing error: <STX> character missing.

Parsing Header record: start of text <STX> character missing.


1. the LIS vendor.


Parsing Patient record: start of text <STX> character missing.


1. the LIS vendor.


Parsing record: start of text <STX> character missing.


1. the LIS vendor.


Parsing Test Order record: start of text <STX> character missing.


1. the LIS vendor.

Host parsing error: Header record missing in LIS message.

Header record is missing in LIS message.


1. the LIS vendor.

Host parsing error: Header record out of sequence in LIS message.

Header record is not the first record in an LIS message.


1. the LIS vendor.

Host parsing error: Patient record missing in LIS message.

Patient record missing in LIS message.


1. the LIS vendor.


1. the LIS vendor.

Host parsing error: Terminator record missing in LIS message.


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Description

10

629743AE

Description

Detailed Description

Probable Cause

Action

Host parsing error: field delimiter missing.

Parsing Comment record: field delimiter missing.


1. the LIS vendor.


Parsing Header record: field delimiter missing.


1. the LIS vendor.


Parsing Patient record: field delimiter missing.


1. the LIS vendor.


Parsing Terminator record: field delimiter missing.


1. the LIS vendor.


Parsing Test Order record: field delimiter missing.


1. the LIS vendor.

Host parsing error: incorrect CRC.

Parsing Comment record: record contains incorrect CRC.

1. Data incorrectly formatted by the host. 2. Faulty cable connection.

1. the LIS vendor.


Parsing Header record: record contains incorrect CRC.


1. the LIS vendor.


Parsing Patient record: record contains incorrect CRC.


1. the LIS vendor.


Parsing record: record contains incorrect CRC.


1. the LIS vendor.


Parsing Test Order record: record contains incorrect CRC.


1. the LIS vendor.

Host parsing error: invalid escape sequence.

Invalid escape sequence in record field.


1. the LIS vendor.

Host parsing error: invalid sequence number.

Invalid sequence number received in Comment record.


1. the LIS vendor.


Invalid sequence number received in Patient record.


1. the LIS vendor.


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Table 10.6 Info Event Messages (Continued) Detailed Description

Probable Cause

Action


Parsing Terminator record: invalid sequence number.


1. the LIS vendor.


Invalid sequence number received in Test Order record.


1. the LIS vendor.

Host parsing error: missing component delimiter.

Parsing Test Order record: missing component delimiter in Tests field.


1. the LIS vendor.

Host parsing error: record terminator character missing.

Parsing Comment record: record terminator character missing.


1. the LIS vendor.


Parsing Patient record: record terminator character missing.


1. the LIS vendor.


Parsing record: record terminator character missing.


1. the LIS vendor.


Parsing Test Order record: record terminator character missing.


1. the LIS vendor.

Host parsing error: record type not ed.

Parsing LIS record: record type not ed.


1. the LIS vendor.

Host parsing error: start of text <STX> character missing.

Parsing Comment record: start of text <STX> character missing.


1. the LIS vendor.

Host parsing error: terminator character missing.

Parsing Header record: record terminator character missing.


1. the LIS vendor.

Invalid CDATA element in report job result value.

Missing end tag for the CDATA element enclosing the report value string in a report job submitted by the System Manager.

1. Internal software error.

1. Call your Beckman Coulter Representative.

Invalid CDATA elements were found in a report job.

The result value string in a report job from the System Manager contained invalid top-level CDATA elements.

1. Installation problem.


Invalid data for report job.

An invalid XML data string was used in a report job.



Report title: %1 Report name: %2.

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Description

10

Description


Probable Cause

Action

Invalid data set used in report job.

An undefined or invalid data set was used in a report job.



Report name: %1 Report title: %2 Data set: %3. Invalid log on to System Manager.

Invalid log on to System Manager: Operator ID: %1.

1. System Manager logon failed.

1. your lab .

Invalid or missing report file for report job.

An invalid or missing report file was used in a report job.



Report title: %1 Report job name: %2 Report file: %3. Invalid report request received from System Manager.

XML parsing failure for a report job received from System Manager.



Manual backup operation failed.

Error: %1.

1. Attempted backup while instrument was running.

1. Perform backup when the instrument is not busy

Printing error: out of paper.

Printing error: the printer is out of paper.

1. Printer out of paper

1. Fill paper supply.


1. Call Beckman Coulter Representative.


1. Call Beckman Coulter Representative.

Report name: %1, requested time: %2 failed to print. Please insert more paper in the printer or select a different printer. Report data set not defined. Report job creation failed.

The report data set definition %1 could not be found in the database. The report job could not be submitted. Call your Beckman Coulter Representative.

Report failed.

The report failed to print. Report name: %1, requested time: %2 Please check the printer for a paper jam or a printer malfunction.


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Table 10.6 Info Event Messages (Continued) Description


Probable Cause

Action

Report failed.

The report failed to print because of a system error.



1. Invalid bar-code label. 2. Verification read failed.

1. the bar-code label. 2. Perform Bar-code Reader Alignment procedure. 3. Perform Bar-code Read Rate test.

Report name: %1, requested time: %2 Please check the error entry in the general history log. Specimen ID verification failure for a specimen.

The system has determined that an ID verification failure has occurred. Therefore, the specimen (%1 %2) could not be positively identified and specimen processing will be skipped.


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Event Messages from the System Manager that Require No Action Error Messages, Warning Messages and Informational Messages are listed in the following tables. The Error Messages trigger an audible and visual alarm. The Warning Messages trigger a yellow visual alarm. The Informational Messages do not trigger an audible or visual alarm. The tables in this section are: Table 10.7, Error Event Messages, Table 10.8, Warning Event Messages. and Table 10.9, Info Event Messages. In the tables that follow, the % variable will be replaced by actual values when the messages occur on the System Manager. Table 10.7 Error Event Messages Description


Probable Cause

ALARM TEST.

ALARM TEST %1.

None

Added missing operating limit for test.

Test name: %1 low limit: %2 high limit: %3.

None

Attempt to submit specimen order failed. Attempt to submit a specimen order to the System Manager failed for specimen %1.

None

Error code: %2. Communication error with MRC board or SCA DSP.

Communication error while accessing MRC or SCA-DSP resource (Host ID: %1).

1. CAN bus integrity is questionable (Applicable to MRC only) 2. MRC application is corrupted. (Applicable to MRC only). 3. MRC board or COMM I/F card fault. (Applicable to MRC only) 4. SCA-DSP application is corrupted. (Applicable to SCA-DSP only)

Communication error with MRC board or SCA DSP.

Communication error while accessing MRC or SCA-DSP resource (Host ID: %1).

1. CAN bus integrity is questionable (Applicable to MRC only) 2. MRC application is corrupted. (Applicable to MRC only). 3. MRC board or COMM I/F card fault. (Applicable to MRC only) 4. SCA-DSP application is corrupted. (Applicable to SCA-DSP only)

Communications failure transmitting test order for specimen.

Transmission of test order for specimen %1 to the System Manager failed, with error code %2.

None

Controls configuration restore.

Checksum mismatch ignored by registry setting.

None

Created missing System Manager parameter.

Parameter name: %1.

None

Decision rules restore.


None

Delete specimen request failed for specimen.

Delete specimen request command to the System Manager failed for specimen %1.

None

Error code: %2. Event test System Error: Error

%1.

None

Exceeded maximum A/D devices for %1 MRC (Host ID: %2).

This MRC has exceeded the maximum number of A/D devices allowed per MRC.

None

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Table 10.7 Error Event Messages (Continued) Description


Probable Cause

Failed Processing INF File.

System has detected a problem processing INF file: %1 during replay.

1. Corrupted INF/DAT file

Failed to publish specimen order for specimen.

Attempt to publish a specimen order to the System Manager for specimen %1 failed.

None

Error code: %2. Failed to read group definitions file.

Attempt to read the parameter groups definition file failed.

None

Error: %1. General Error test event.

General Error test event.

None

Host error: serial port not initialized.

Error in initializing serial port.

1. Hardware failure.

Incorrect board detected for %1 MRC (Host ID: %2).

An incorrect board was connected to \r\nExpansion Port: %3.

1. SPI cable swapped at MRC.

\r\nExpected board: %4. \r\nDetected board: %5. Invalid label reuse of specimen ID.

The label for specimen %1 contained NOTE: This is a later stage requirement demographic information for a patient ID %2. to accept and handle 2D barcodes with This patient ID did not match the patient ID demographics on the tube. This will not appear in first release defined in the active test order for specimen %1. The specimen could not be processed.

Launch Application Error.

An error occurred launching a Access 2 application: %1.

Maximum number of Tube Position ID No Read events reached.

Maximum number of consecutive Tube Position Id No Read has been reached.

None

Maximum number of consecutive rerun Secondary ID in the first run did not match secondary ID verification errors reached. secondary ID in a rerun.

1. Specimen tube was rerun in a different cassette position. 2. Tube position bar code read error.

PS MRC (Host ID: 31) not responding.

Command sent to PS MRC board was not acknowledged.

One of the following components is disconnected or has experienced a fault:

This can occur during power up or hardware configuration retrieval.

1. 2. 3. 4. 5.

The display name for parameter %1 is incorrect and was replaced.

None

Replaced display name for parameter %1.

CAN cable Module ID board COMM I/F card PS MRC board MRC software application corrupted.

Old name: %2 New name: %3. Solenoid is disconnected.

ActivityID %1, CommandID %2, ResourceID %3.

1. Solenoid or circuit is open (connector unplugged).

Solenoid is shorted.

ActivityID %1, CommandID %2, ResourceID %3.

1. Defective solenoid. 2. Salt bridge on solenoid expansion board connection.

System - Daily Checks test event.

System - Daily Checks test event.

None

System - QA test event.

System - QA test event.

None

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10


Table 10.7 Error Event Messages (Continued) Description


Probable Cause

System - QC test event.

System - QC test event.

None

System - Supplies test event.

System - Supplies test event.

None

System - Xb test event.

System - Xb test event.

None

System Error test event.

System Error test event.

None

Regression Test Event. System Patient test event.

System Patient test event.

None

Tests not available.

Tests ordered for specimen %1 are not installed or not enabled at SPM %2.

None

Tests rejected: %3.

Table 10.8 Warning Event Messages Description


Probable Cause

Automated recovery was not successful. Command %1, SPM %2, Reason: %3.

1. Consumables are depleted.

Automated recovery was not successful. Command %1 on SPM %2 could not start because the SPM was disconnected or not powered up.

1. Power interruption.

Automated recovery was not successful. Command %1 on SPM %2 could not start None because the SPM was in maintenance mode. Automated recovery was not successful. Command %1 on SPM %2 could not start because the command is not available on the SPM.

None

Default test order was used.

None

No test order was defined for specimen %1. The default order for SPM %2 was used to process the specimen.

Event test System Error: Warning

%1.

None

General Configuration restore.


None

High event rate.

Algorithm detected high event rate during Diff analysis on SPM%1.

1. Specimen interference. 2. Sample conditioning issue (mixing, temperature, reagent) 3. Improper probe alignment in mix chamber.

High event rate.

Algorithm detected high event rate during NRBC analysis on SPM%1.

1. Specimen interference. 2. Sample conditioning issue (mixing, temperature, reagent) 3. Improper probe alignment in mix chamber.

High event rate.

Algorithm detected high event rate during Retic analysis on SPM%1.

1. Specimen interference. 2. Sample conditioning issue (mixing, temperature, reagent). 3. Improper probe alignment in mix chamber.

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Table 10.8 Warning Event Messages (Continued) Description


Probable Cause

Label test order used for specimen %1.

No test order was defined for specimen %1.

None

The test order read from the specimen label was used to process the specimen. Low event rate.

Algorithm detected low event rate during Diff analysis on SPM%1.

1. Specimen interference. 2. Sample conditioning issue (mixing, temperature, reagent). 3. Partially obstructed sample line or flow cell.

Low event rate.

Algorithm detected low event rate during NRBC analysis on SPM%1.


Low event rate.

Algorithm detected low event rate during Retic analysis on SPM%1.


Maximum number of Tube Position Id No Read reached.

Maximum number of Tube Position Id no read has reached.

None

Partial INF/DAT export.

The INF/DAT files for %1 of the %2 runs were unavailable.

1. Unavailable INF/DAT files.

One or more runs for the following specimens were not exported: %3. Repair Command Initiation Failed

Initiation of repair command %1 on SPM %2 failed.

None

Reason: %3. System variables (CRC) from SPM cannot be validated.

SPM system variables backup file stored on PI U card is corrupt.

1. NVRAM experienced a fault

Variables have been recovered from workstation. System variables (time stamp) from SPM cannot be validated.

SPM system variables backup file stored on PI U card is corrupt.

1. PI U card replaced

Time stamp mismatch between PI U card and workstation. Variables have been recovered from workstation. The SPM has detected that the waste container is almost full.

1. Waste container is almost full

Description


Probable Cause

%1

%1.

None

%1

%1.

None

Waste container is almost full.

Table 10.9 Info Event Messages

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Probable Cause

A control file has been deleted.

None.

None

A new control file has automatically been created.

None.

None

A report could not be generated: database log on failed.

Could not log on to the database for report %1.

None

The report could not be generated. A report did not contain an expected image table.

The report %1 did not contain the expected image table.

None

One or more images could not be included in the report. Added QC data.

Item %1.

None

Added configuration item.

Item %1.

None

Added patient data item.

Item %1.

None

All XM batches deleted in a group.

All XM batches are deleted on %1, for group %2.

None

An existing order was used for a specimen. Batching is enabled.

Batch mode is enabled and a specimen None (%1 %2) had an existing order in the worklist. The existing order was used instead of the default order.

Auto Configure Control settings changed. None.

None

Auto Stop configuration

None

Automated recovery was successful.

Command %1, SPM %2.

None

BCI default limits restored.

None.

None

Bar code configuration changed on %1 CBC calibration accepted.

None CBC calibration procedure has been accepted with calibration lot %1 (expiration date %2).

None

The specimens were presented in %3 mode. The number of runs = %4. CBC calibration factors were changed.

CBC calibration factors were significantly changed by SPM %1 operator %2.

None

The reference values are WBC=%3 RBC=%4 HGB=%5 MCV=%6 PLT=%7 MPV=%8. CBC calibration run details

CBC calibration procedure has completed with calibration lot %1 (expiration date %2).

None

The specimens were presented in %3 mode. CBC gain calibration status is: CALIBRATED.

For %1, aperture %2.

CBC gain calibration status is: EDITED.


None

Factor was saved. None

Factor was edited and saved.

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Table 10.9 Info Event Messages (Continued) Description CBC gain calibration status is: FAIL.


Probable Cause


None

Quality criteria was not satisfied. Factor was not saved. CBC gain calibration status is: FORCED CALIBRATION.

CBC gain calibration status is: .


None

Factor was saved contrary to recommendation. For %1, aperture %2.

None

Quality criteria was satisfied. Factor update was not necessary. Carryover procedure status.

Carryover procedure on SPM %1 completed on %T(%2).

None

The final status is %R(%3). Changed QC data.

Item %1.

None

Changed configuration item Decision Rule: evaluation order.

New Decision Rule evaluation order: %1.

None

Changed configuration item Patient report.

None.

None

Changed configuration item System Settings: system time.

None.

None

Changed configuration item Test Unit Selection.

None.

None

Changed configuration item.

Item %1.

None

Changed patient data item.

Item %1.

None

Configuration changed for SPM %1. Configuration changed for automatic %1 cycle on instrument %2 .

None Daily Checks or Shutdown maintenance procedure is scheduled to run at a particular time and day(s) of the week.

None

This event logs the changes to current configuration compared to the previously existed configuration. Consensus rules restored.

None.

Consumable on SPM.

None None

Control file modified.

Control file: %1 was modified.

None

Control runs deleted.

Control runs: %1.

None

Copy of event.

Copy of event %1.

None

Could not find required report data.

The report could not be generated because some of the required data could not be found in the database.

1. Data was probably deleted.

The data has probably been deleted. Report job: %1. Daily Checks procedure successful.

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None

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Probable Cause

Data summary Daily Checks - test event. TypeOfCycle: %1 CycleDateTime: %2 Reason: %3 BackgroundCountData: %4 ReagentStatuses: %5 SubsystemStatuses: %6 UseTimeOfLastShutdown: %7.

None

Data summary Reproducibility test event.

Data summary Reproducibility test event:%1.

None

Data summary XB test event.

Data summary XB test event:%1.

None

DataSummary - SystemChecks test event.

TypeOfCycle: %1 CycleDateTime: %2 CycleTime: %3 Reason: %4 BackgroundCountData: %5 ReagentStatuses: %6 SubsystemStatuses: %7 UseTimeOfLastShutdown: %8.

None

Default test order changed on SPM %1.

None

Deleted QC data.

Item %1.

None

Deleted configuration item.

Item %1.

None

Deleted patient data item.

Item %1.

None

Event test Audit Trail: Configuration

%1.

None

Event test Audit Trail: Patient Data

%1.

None

Event test Audit Trail: QC

%1.

None

Event test System Error: Info

%1.

None

Event test System: Maintenance

%1.

None

Event test System: QA

%1.

None

Event test System: QC

%1.

None

Event test System: Service

%1.

None

Event test System: Supplies

%1.

None

Event test System: System Status

%1.

None

Event test System: XB

%1.

None

Event test daily summary: system checks

%1.

None

Event test data summary: consumables

%1.

None

Event(s) were deleted as part of autotrimming process.

Event(s) %1.

None

Event(s) were manually deleted.

Event(s) %1.

None

Eventd test System: Patient

%1.

None

Host data error: duplicate test order.

Duplicate test order received, test order is rejected.

None

Existing test order: Primary ID: %1 Specimen type: %2 Requisition number: %3 Patient ID: %4 Tests: %5 Rejected test order: Primary ID: %6 Specimen type: %7 Requisition number: %8 Patient ID: %9 Tests: %10.

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Probable Cause

Host data error: tests not cancelled.

Specimen not found.

1. Already deleted order was cancelled by LIS.

Primary ID: %1 Specimen type: %2 Requisition number: %3 Patient ID: %4 Tests:%5. Host: test order accepted in place of default test order.

LIS-submitted test order is accepted in place of a default test order.

None

Default test order: Primary ID: %1 Specimen type: %2 Requisition number: %3 Patient ID: %4 Tests: %5 LIS submitted test order: Primary ID: %6 Specimen type: %7 Requisition number: %8 Patient ID: %9 Tests: %10. IQAP export succeeded

IQAP export succeeded.

None

Control type / Lot number %2 SPM: %1. Manual backup failed.

A backup operation was already in progress.

1. Attempted backup while backup was in progress.

Manual backup operation started.

None.

None

Manual selection of flagging limit for test order.

Primary ID: %1.

None

New control file created.

None.

None

New patient demographics created.

Created new patient demographics for (%1, %2, %3) with patient ID (%4).

None

Operator access configuration created.

Operator access configuration created for %1 by %2 First name: %3 Last name: %4 Access level: %5 Active status: %6.

None

Operator access configuration modified.

Operator access configuration modified for %1 by %2 New first name: %3 Previous first name: %4 New last name: %5 Previous last name: %6 New access level: %7 Previous access level: %8 New active status: %9 Previous active status: %10.

None

changed.

changed for %1.

None

reset.

reset for %1 by %2.

None

Patient ID was rectified.

None.

None

Patient demographics deleted.

None.

None

Patient demographics modified.

Patient information was modified for (%1,%2,%3) patient ID (%4) Old: %5 New: %6.

None

Patient demographics were modified.

Type: %1 Patient: %2.

None

Prime procedure was successful. QC Lab limits changed.

None None.

Reagent changed on SPM %1

None None

Remote desktop sharing ended.

RMSID %1.

None

Remote desktop sharing started.

RMSID %1.

None

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Remote management configuration update

Probable Cause None

Remote management enrollment failed.

Remote management enrollment failed for instance %1: error code (%3) RMSID (%2).

None

Remote management enrollment submitted.

Request submitted to enroll SPM %1 with instance number %2.

None

Remote management enrollment was successful. Repeatability run details.

None Repeatability procedure has been accepted.

None

The specimens were presented in %1 mode. Repeatability summary.

Repeatability procedure has been accepted.

None

The specimens were presented in %1 mode. The number of runs is %2. Results summary of Daily Checks.

None

SPM audible alarm setting changed.

None

SPM prime succeeded.

A prime occurs when transitioning from the idle state to an operational state.

None

Scheduled backup operation started.

None.

None

Settings changed on SPM %1.

None

Shutdown procedure cancelled.

None

Shutdown procedure successful.

The cleaner was left in SPM for %1 minutes.

None

Specimen identifier was not submitted on time.

Identifier for manually presented specimen None was not submitted within required 2 minutes.

Specimen was not found. Associated test order cannot be modified.

Specimen: %1 was not found.

None

Its associated test order cannot be modified. Specimen ID: %1 Specimen type: %2 Requisition number: %3 Patient ID: %4 Tests ordered: %5.

Specimen was not presented on time.

Specimen was not placed in the manual station within required 3 minutes.

None

System Manager audible alarm setting changed.

None

System Manager shutdown request.

None

System backup operation successful.

None.

None

System maintenance test event.

System maintenance test event:%1.

None

System recovery operation successful.

System recovery operation successful at %1 on %2.

None

System service test event.

System service test event:%1.

None

Systematic/random review for control.

The following control is reviewed with %1: SPM:%2 Lot number:%3 Type:%4 Level:%5.

None

Test order was collated.

Primary ID: %1.

None

Test order was deleted.

Primary ID: %1.

None

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Probable Cause

Test order was hidden.

Primary ID: %1.

None

Test order was modified.

The data for the test order was modified.

None

Primary ID: %1. Test order was rejected.

Primary ID: %1.

None

Test order was released.

Primary ID: %1.

None

Test order was restored to release status. Primary ID: %1.

None

The configuration has been successfully restored.

Configuration name: %1, items restored: %2. None

The configuration has been successfully saved.

Configuration name: %1, items saved: %2.

None

The destination printer did not the requested paper source.

The printer %1 does not the paper source %2 requested for report %3.

1. Printer does not paper source.

The default paper source was used. Troubleshooting development test event. Troubleshooting development test event:%1. None Troubleshooting host test event.

Troubleshooting host test event:%1.

None

updated test configuration.

None

Workload history has been cleared

None

XB batches deleted.

None.

None

XB configuration has changed.

None.

None

XM batches deleted.

None.

None

XM configuration has changed.

None.

None

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CHAPTER 11

Quality Assurance

Calibration The calibration procedure consists of comparing instrument measurements to known values for WBC, RBC, HGB, MCV, PLT and MPV. Calibration assures that an instrument's data output accurately reflects sample input. Calibration is performed using materials based on or traceable to known reference preparations or materials. In general, the procedure may indicate that the instrument requires standardization, by first determining the deviation from 'calibrator reference', and then applying recommended correction factors (CAL factors). Your laboratory is responsible for the final calibration of the CBC parameters. Beckman Coulter recommends COULTER S-CAL calibrator, or an exact equivalent, as an acceptable alternative to whole blood calibration. In the normal process of tracking data for an extended period of time, your laboratory can make a specific decision to recalibrate a given parameter. Never adjust to a specific value for an individual sample. For best performance, and calibrate all the CBC parameters. The WBC differential, NRBC and Retic parameters are calibrated by an authorized Beckman Coulter Representative in your laboratory. The VCSn parameters do not require calibration in the laboratory. NOTE Ensure your SPM is properly maintained and the apertures are clean prior to calibration.

When to You should the calibration of your instrument: • As dictated by your laboratory procedures, local or national regulations • When controls begin to show evidence of unusual trends • When controls exceed the manufacturer’s defined acceptable limits • If the average ambient room temperature changes more than 10°F or 12° C from the calibrating temperature. If the procedure indicates you need to calibrate, continue with the calibration procedure.

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11-1

Quality Assurance Calibration

When to Calibrate You should calibrate your instrument: • At installation • After the replacement of any component that involves dilution characteristics (such as the BSV) or the primary measurements (such as the apertures) • When advised to do so by your Beckman Coulter Representative. • If you fail calibration procedure.

Calibrate with COULTER S-CAL Calibrator (Menu > QA > CBC Calibration) NOTE Before you can start or restart the calibration process, the SPM must be offline. Figure 11.1 CBC Calibration Screen

1

11-2

Select Calibration Setup on the CBC Calibration Screen to display the CBC Calibration Setup dialog box.

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Figure 11.2 CBC Calibration Setup Dialog Box

2

Type “10” in the Number of Aspirations text box.

3

Select Cassette Presentation Mode from the drop-down list.

4

Select BCI from the Calibrator Type drop-down list.

5

Select and use the handheld bar-code scanner to scan the 2D bar code on the product insert or type/select the following information: • Lot # • Expiration Date • Reference Values

6

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Select OK and follow the screen prompts.

11-3

11


7

Place the calibrator in a cassette.

8

Place the cassette in the input buffer and select OK.

9

Review the calibration results.

10 Select the Finish button at the bottom of the screen. 11 your calibration with controls. When the calibration procedure is complete, the CBC Calibration (Summary) screen displays. Figure 11.3 CBC Calibration (Summary) Screen

The background color of the Factor %Diff, %CV, and Difference cells change color when the presented value is out of the normal range as follows: • Yellow for Difference indicates that the value is out of range, which means that calibration is recommended. 11-4

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• Red only applies to the %CV and indicates that the statistical value is NOT within range and the system does NOT allow calibration. When all results are acceptable, the Edit System Recommendations button at the bottom right hand corner of the screen is enabled. This button allows to modify the calibration recommended by the system by selecting or deselecting check boxes.

Calibrating with Whole Blood NOTE Before you can start or restart the calibration process, the SPM must be offline.

Sample Requirements For whole blood calibration, use a donor who: • is not receiving medication • has normal hematologic parameters • has normal erythrocyte, leukocyte, and platelet morphology You must draw into and store specimens in the proper amount of EDTA. If you use vacuum collection tubes, ensure they are filled to correct capacity. Obtain 20 normal, fresh whole blood specimens. You need enough of each to cycle three samples on the comparator instrument and three samples on the DxH 800. If not using a comparator instrument, the following reference methods are suggested: • WBC and RBC - A single-aperture impedance cell counter such as a COULTER Z™Series cell counter and the manufacturer’s recommended reagents. Macro dilutions are made using Class A glassware. Both WBC and RBC are corrected for coincidence. • Hgb - Hemoglobincyanide spectrophotometric procedure that follows CLSI Standard H15-A7. This method employs modified Drabkins (Ziljstra) Reagent and is references to NIST-certified filters and ICSH standards. • MCV - Packed cell volume measured by a hematocrit procedure that follows CLSI Standard H7H8. The PCV is not corrected for trapped plasma. MCV is calculated: PCV/RBC x 10. • PLT - Phase-contrast microscopy. • MPV - Reference against latex particles. CAUTION Use a Potassium Salt of EDTA for whole blood calibration. Follow the tube manufacturer’s recommended procedure for the correct volume of anticoagulant.

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11-5

11


CAUTION If you use vacuum collection tubes, fill them to proper capacity according to the tube manufacturer’s recommendations. Calibrating with Whole Blood

1

Select Calibration Setup on the CBC Calibration Screen to display the CBC Calibration Setup dialog box.

2

Type “3” in the Number of Aspirations text box.

3

Select the Cassette Presentation from the drop-down list.

4

Select Whole Blood from the Calibrator Type drop-down list.

5

Select OK to close the Calibration Setup dialog box.

6

Place the 20 samples in cassettes. Place the cassettes in the input buffer and select OK.

7

When the calibration procedure is complete, the CBC Calibration (Summary) Screen displays.

8

Review the calibration results. The System Manager assesses the calibration status, and indicates when calibration is recommended in the check boxes below the data. The background color of the Factor %Diff, %CV, and Difference cells change color when the presented value is out of the normal range as follows: • Yellow for Difference indicates that the value is out of range, which means that calibration is recommended. • Red only applies to the %CV and indicates that the statistical value is NOT within range and the system does NOT allow calibration. When all results are acceptable, the Edit System Recommendations button at the bottom right hand corner of the screen is enabled. This button allows to modify the calibration recommended by the system by selecting or deselecting check boxes.

11-6

9

Select the Finish button at the bottom of the screen.

10

your calibration with controls.

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Quality Assurance Repeatability (Menu > QA > Repeatability > Repeatability)

Repeatability (Menu > QA > Repeatability > Repeatability) Figure 11.4 Repeatability Screen

Sample Requirements For Repeatability studies, ensure the patient has normal erythrocyte, leukocyte, and platelet morphology. You can view a suggested reference range in the Performance Specifications and Characteristics section of the System Overview chapter. NOTE Before you can start or restart the Repeatability process, the SPM must be offline. Repeatability

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1

Ensure you have enough normal whole blood from a single donor for a minimum of 10 cycles.

2

Select Repeatability Setup to display the Repeatability Setup dialog box.

11-7

11


Figure 11.5 Repeatability Setup Dialog Box

Repeatability in Cassette Presentation

1

From the Repeatability Setup dialog box, select a test from the Test drop-down list. NOTE The Repeatability Setup dialog box defaults to Cassette Presentation.

2

Type ‘5’ in the Number of Aspirations text box.

3

Select OK and follow the screen prompts. CAUTION Aspiration probe damage can occur if you pierce a specimen tube more than five times. Do not pierce a specimen tube more than five times.

4

11-8

Select OK to start Repeatability test.

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5

Separate the well mixed normal specimen into two tubes.

6

Place the tubes into consecutive positions in a cassette and place the cassette in the input buffer.

7

Select OK on the DxH dialog box to start the cycle.

8

When the cycle has completed review the results on the Repeatability screen. Use the scroll bar to review results that do not appear in the results .

9

that the CV (Coefficient of Variation) does not exceed the established Repeatability Limits. NOTE Refer to the Repeatability section of the System Overview chapter for Repeatability performance.

10 the results and if satisfied, select Finish. NOTE The Finish button is active only when each parameter has two or more valid results.

Repeatability in Single-tube Presentation Follow the instructions for Cassette Presentation Repeatability, using the Single-tube Presentation station to present each specimen tube. Repeatability Run Details When the Repeatability procedure is complete, the results display on the Repeatability Run Details screen.

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11-9

11


Figure 11.6 Repeatability Run Details Screen

11-10

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Quality Assurance Carryover (Menu > QA > Carryover)

Carryover (Menu > QA > Carryover) NOTE Before you can start or restart the Carryover process, the instrument must be offline. Figure 11.7 Carryover Screen

NOTE The Blood 1, Blood 2, and Blood 3 row headings on the carryover screen represent 3 aspirations of a single blood specimen.

1

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Select Carryover Setup to display the Carryover Setup dialog box.

11-11

11


Figure 11.8 Carryover Setup Dialog Box

11-12

2

Select a test from the Test drop-down list. Select OK and follow the screen prompts.

3

Select OK to start a Carryover procedure.

4

Place a cassette in the input buffer with one blood tube followed by three diluent tubes and select OK to start Carryover.

5

When Carryover is complete, review the results on the Carryover screen.

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Figure 11.9 Carryover Screen (Results)

When performing a Carryover procedure, the calculated % Carryover and/or Background for each parameter is compared to the Carryover and Background limits for acceptability. The status of each parameter is based on the following criteria: a. The status of the parameter is for carryover, if • Diluents 1,2, and 3 are within the Background limits as defined in the Performance section of the System Overview chapter of this manual for WBC, RBC, HGB, PLT, Diff, Retic, or NRBC, as applicable to the . • The calculated % Carryover for the WBC, RBC, HGB, and PLT parameters and the total events for Diluents 1 and 2 for Diff, Retic, and NRBC are within carryover limits. and Diluent 3 sample results for WBC, RBC, HGB, PLT, Diff, Retic, and NRBC are within background limits. b. The status of the parameter is FAIL for carryover if the criteria described above are not met.

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11-13

11


Carryover Messages(Menu > QA > Carryover > Messages) Figure 11.10 Carryover Messages

The Carryover Messages dialog box displays System Status and System Messages. Select Close to close the dialog box.

11-14

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Quality Assurance Exporting Quality Assurance Data

Exporting Quality Assurance Data Select the Export button on the Navigation bar at the bottom of the CBC Calibration, Repeatability and CBC Calibration screens to export Quality Assurance data. Figure 11.11 Export QA Data Dialog Box

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1

Select the Type of file from the drop-down list.

2

Select a Destination and select Start.

11-15

11

Quality Assurance Exporting Quality Assurance Data

11-16

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CHAPTER 12

Cleaning Procedures

When, Why, and How to Perform Each Procedure WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire. Table 12.1 Matrix of Frequency for Cleaning Procedures Procedure

Purpose

Tools/Supplies

Frequency

Clean (Bleach) the Apertures

To address:

• high quality, fragrancefree, gel-free bleach (5 to 6% solution of sodium hypochlorite - available chlorine) • DI (deionized) water • container for bleach solution • container for DI water

As needed.

Clean the Aspiration Probe

To remove buildup.

none

As needed.

Clean the BSV Externally

To remove blood or reagent buildup.

• lint-free tissue • diluent

As needed.

Clean the Pneumatic Supply To prevent damage to the Power Supply. Module Fan Filter

• soap • water

As needed.

Clean the STM

To prevent debris from interrupting the transportation of specimens.


As needed when you discover a problem, or every 6 months.

Clean the Air Mix Temperature Control (AMTC) Module

To remove buildup.


As needed.

Clean the Vacuum Trap

To remove debris that accumulates.

water

As needed.

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• Failure to recover control values. • Decreased cell counts, increased MCV values or increased voteouts.

12-1

Cleaning Procedures Remove the Transport Shield

Table 12.1 Matrix of Frequency for Cleaning Procedures Procedure

Purpose

Tools/Supplies

Frequency

Clean the Optical Sensors

To remove buildup.

• DI water • very fine lint-free swab

As needed.

Clean the Handheld BarCode Scanner

To remove dirt or dust that has accumulated.

• water

As needed,

• detergent • soft cloth or tissue

Remove the Transport Shield For some of the cleaning procedures you need to remove the transport shield.

1

To remove the transport shield: a. Grasp the transport shield behind the tabs on both sides. b. Pull up and out. c. Silence any alarms.

12-2

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Cleaning Procedures Replace the Transport Shield

Replace the Transport Shield

1

To replace the transport shield. a. Locate pins on the shield and the corresponding holes on the front of the SPM. b. Insert the pins into the holes and push the transport shield into place.

Lift the Front Cover 1

Grasp the sides of the front cover and lift upward. .

1 2 3 4 5

9743219A

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12-3

12

Cleaning Procedures Lower the Front Cover

Lower the Front Cover 1

12-4

Grasp the top of the front cover and push downward.

629743AE

Cleaning Procedures Clean (Bleach) the Apertures

Clean (Bleach) the Apertures WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire. NOTE At the completion of this procedure and prior to sample analysis, you must do a Shutdown and run Daily Checks.

1

Prepare a 20 mL solution of bleach and DI water. . In a cuvette, mix together: • 10 mL of high quality, fragrance-free, gel-free bleach (5 to 6% solution of sodium hypochlorite - available chlorine) and • 10 mL of DI water. Label this cuvette “A”.

10 mL

10 mL

A NaClO (5%)

2

DI H2O

Put 20 mL of DI water in a second cuvette labeled “B”.

20 mL

B

3

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DI H2O

At the System Manager, select Menu > Diagnostics > Dx Tools.

12-5

12


4

Select the Maintenance tab to display the Diagnostic Procedures - Maintenance screen.

5

Select Clean Apertures from the drop-down list.

6

Select the Start button. The system places the SAM in safe mode and drains the baths.

7

Remove the Transport Shield and Lift the Front Cover.

8

Locate the bleach probe.

1 2

12-6

3

4 5

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9

When prompted, place the bleach probe in a bleach solution (approximately 20 mL of a 1:1 solution of high quality, fragrance-free, gel-free bleach (5 to 6% solution of sodium hypochlorite - available chlorine) and DI water). The system aspirates the bleach solution and draws it through the apertures and then drains the baths. .

10 A dialog box displays the Time Elapsed as the aperture bleaching takes place. Select Cancel to end the bleaching and continue with the procedure. NOTE A maximum of 15 minutes of aperture bleaching is suggested.

11 When prompted, place the bleach probe in DI water (a cuvette of approximately 20 mL of DI water). The system aspirates the DI water.

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12-7

12


12 Follow the directions on the screen. 13 Lower the Front Cover and Replace the Transport Shield. 14 Run Shutdown. Refer to the Daily Shutdown section in the Shutdown chapter for instructions. NOTE Do not select the Perform Startup (Daily Checks) after Shutdown check box on the Manual Shutdown dialog box.

15 Select the Cancel button on the Navigation bar at the bottom of the screen when you see the timing bar at the lower right-hand side of the screen start to count down.

16 Run Daily Checks. Refer to Run Daily Checks in the Daily Checks chapter.

12-8

629743AE

Cleaning Procedures Clean the Aspiration Probe

Clean the Aspiration Probe NOTE Beckman Coulter recommends that you do the Dispense Diluent procedure after cleaning the aspiration probe to the integrity of the aspiration path.

1

Select Menu > Diagnostics > Dx Tools > Maintenance.

2

In the Fluidic option box, select the Select option button and then select Clean Aspiration Probe from the drop-down list.

3

Select the Start button. The system: • Moves the SAM to a position between the cassette mixer and the AMTC module. • Lowers the probe assembly and extends the aspiration probe, exposing it behind the transport shield. • Flushes the outside of the aspiration probe with diluent as the probe retracts.

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4

Press (F10) Access System Monitor, if necessary, to view the Probe Waste Vacuum sensor’s state on the System Monitor screen.

5

Do the Dispense Diluent procedure. Refer to the Dispense Diluent Procedure (Menu > Diagnostics > Dx Tools > Maintenance) section in the Troubleshooting chapter for instructions.

6

When the procedure is complete, select Finish.

12-9

12

Cleaning Procedures Clean the BSV Externally

Clean the BSV Externally WARNING Risk of personal contamination. The BSV can contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.

WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire. NOTE Clean the outside of the BSV if there is an excessive buildup of dried diluent on the outside. Note that crystallized Beckman Coulter cleaning agent on the outside of the BSV is normal.

12-10

1

Turn off the SPM.

2

Remove the Transport Shield.

3

Lift the Front Cover.

629743AE


4

Locate the BSV.

DxH 800 Hematolgy Analyzer

5

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Dampen a piece of lint-free tissue with DI water and wipe down the outside of the BSV.

12-11

12


12-12

6

Wipe out the drip tray under the BSV with a lint-free tissue dampened with DI water.

7

Lower the Front Cover.

8

Replace the Transport Shield.

9

Turn on the SPM.

629743AE

Cleaning Procedures Clean the Pneumatic Supply Module Fan Filter

Clean the Pneumatic Supply Module Fan Filter WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire.

629743AE

1

Turn off the SPM.

2

Unscrew the power/communications cable from the PSM.

12-13

12


3

Locate the filter on the top of the PSM.

POW ER ON

PULL TO ADJU ST

12-14

PUMP RUNNING PNEUMA TIC FAUL T

4

Using a flathead screwdriver or your hand, loosen the thumbscrews that secure the filter retaining plate and remove the filter from the PSM.

5

Wash the filter in soap and water and rinse and dry completely. If you find a filter that is torn or shredded, discard it and replace it with a new one. Order replacement filters from your Beckman Coulter Representative.

629743AE


6

Return the clean air filter and retaining plate to their original location and fasten the thumbscrews to secure the filter.

7

Connect the power/communications cable connector with the power/communications port on the PSM. a. Line up the holes of the connector with the pins in the port.

b. Push the connector into the port so that the pins in the port are inserted into the connector.

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12-15

12

Cleaning Procedures Clean the STM

c. Fasten the connector by turning the connector clockwise.

8

Turn on the SPM.

Clean the STM WARNING Risk of personal contamination. The STM can contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.

WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire.

12-16

629743AE


1

Turn off the SPM.

2

Remove any cassettes in the input or output buffer.

1 2 3 4 5

000 41

00041 00042 00043 00044

A 00045

3

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12-17

12


12-18

4

Grasp the front of the STM on both sides, lift and pull toward you as if opening a drawer.

5

Examine the drip trays behind the mixer and behind the pending buffer.

6

Use a lint-free tissue dampened with DI water to clean the inside of the STM and drip trays, wiping up any spills or buildup.

629743AE


CAUTION Using bleach to clean the STM drip trays can damage the surface of the drip trays.

CAUTION Discard waste in a biohazard waste container.

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7

Dry the inside of the STM by wiping with a dry lint-free tissue.

8

Grasp the front of the STM on both sides, lift and push to replace the STM.

9


12-19

12


10 Turn on the SPM.

12-20

629743AE

Cleaning Procedures Clean the Air Mix Temperature Control (AMTC) Module

Clean the Air Mix Temperature Control (AMTC) Module WARNING Risk of personal contamination. The AMTC can contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.


1

Turn off the SPM.

2

Remove the transport shield.

3

Dampen a lint-free applicator stick with DI water. NOTE You can use a fabric tipped applicator to clean the top of the AMTC.

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12-21

12

Cleaning Procedures Clean the Air Mix Temperature Control (AMTC) Module

4

Clean the ports of the AMTC. a. Gently pull back the black protective flap in front of the AMTC with one hand. b. With the other hand, carefully use the tip of the applicator stick to wipe debris away from the ports on the AMTC. NOTE It is important to avoid getting debris in the holes at the top of the AMTC during this procedure.

12-22

5

Replace the transport shield.

6

Turn on the SPM.

629743AE

Cleaning Procedures Clean the Vacuum Trap

Clean the Vacuum Trap WARNING Risk of personal contamination. The vacuum trap can contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.


1

Turn off the SPM.

2

Locate the vacuum trap.

POW

PULL TO ADJU ST

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ER ON

PUMP RUNNING PNEUMA TIC FAUL T

12-23

12


12-24

3

Holding the top of the vacuum trap with one hand, use the other hand to unscrew the vacuum trap jar.

4

Empty the vacuum trap jar according to your local environmental regulations and your laboratory’s procedures.

5

Rinse the vacuum trap jar with water, and then shake out the excess water.

6

Use a lint-free tissue to dry the vacuum trap jar.

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7

Dampen a lint-free tissue with DI water and wipe down the black center post inside the vacuum trap assembly. Spin the center post to wipe down the entire surface.

8

Replace the vacuum trap jar. a. Ensure that the black center post is not stuck in the up position.

b. Carefully align the threads on the vacuum trap jar with the threads on the vacuum trap assembly and screw the vacuum trap jar into place.

9

629743AE

Wipe up any spills.

12-25

12

Cleaning Procedures Clean the Optical Sensors

10 Turn on the SPM.

Clean the Optical Sensors WARNING Risk of personal contamination. The optical sensors can contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.


12-26

1

Turn off the SPM.

2

Remove the transport shield and lift the front cover.

629743AE

Cleaning Procedures Clean the Cassettes

3

Locate the optical sensor. Three are located at the input buffer and two at the output buffer. Refer to Figure 1.6, STM Top Level View.

4

Dampen a very fine lint-free swab with DI water.

5

Swab the Optical sensor to remove buildup.

6

Lower the front cover and replace the transport shield.

7

Turn on the SPM.

Clean the Cassettes WARNING Risk of personal contamination. The cassettes can contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.

WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire. Wash the cassettes as needed in warm soapy water and rinse thoroughly. Do not use an abrasive. Keep the cassettes free of dried blood, bleach, or diluent. Be careful not to scratch or deface the barcode labels. Dirt, smears, pencil lead, and grease can affect bar-code label reading.

629743AE

12-27

12

Cleaning Procedures Clean the Handheld Bar-Code Scanner

Clean the Handheld Bar-Code Scanner CAUTION To avoid damaging the handheld scanner, do not submerge the scanner in water and do not use abrasive cloth or tissue on the window. Never use solvents (for example, acetone, benzene, ether, or phenol-based agents) on the housing or window. Solvents can damage the finish or the window. If the scan window is visibly dirty, or if the scanner is not scanning well, clean the scan window with a soft cloth or lens tissue dampened with water (or a mild detergent-water solution). If a detergent solution is used, rinse with a clean lens tissue dampened with water only. The scanner housing can be cleaned the same way.

12-28

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CHAPTER 13

Replacement / Adjustment Procedures

When, Why, and How to Perform Each Procedure WARNING Use caution as AC Voltages may be present. Diagnostics procedures (run from Menu> Diagnostics> Dx Tools) automatically place the SPM in safe mode; however, for all other replacement procedures, you must turn off the power switch in front of the SPM. CAUTION Do not attempt to perform any procedure before carefully reading all instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as to how to proceed in any situation, your Beckman Coulter Representative.


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13-1

Replacement / Adjustment Procedures Manage Supplies

Table 13.1 Matrix of Frequency for Replacement Procedures Procedure

Purpose

Tools/Supplies

Frequency

Replace the Aspiration Probe

To replace a defective aspiration probe.

• new aspiration probe As needed. • pliers

Replace the Front Blood Detector To replace a defective Front Blood Detector.

• new Front Blood Detector • screw driver • needle-nose pliers

As needed.

Replace the Count Vacuum Regulator

To replace a defective count vacuum regulator.

• New Count Vacuum Regulator • Flat-head screw driver

As needed.

Replace the Pneumatic Supply Module (PSM)

To replace a defective Pneumatic Supply Module.

• New Pneumatic Supply Module • Phillips-head screwdriver • 1/2 nut driver (in tool box in Accessory kit)

As needed.

Replace Reagent Containers

Reagent container is empty.

New reagent containers.

As needed to replace empty reagent containers. The Supplies alert status icon (see Alert Status Icons) displays the status of the supplies.

Replace the Waste Container

Waste container is full.

New, empty waste containers.

As needed to replace full waste containers.

none

As needed.

Replace the Hand-held Bar-Code To replace a defective Scanner Hand-held Bar Code Scanner.

Manage Supplies The system monitors the supplies status and provides you with a visual indication of their states through the Supplies alert indicator icon. While there is valid reagent usage remaining for all the supplies, the Supplies icon background is beige or neutral. A yellow background indicates a warning condition and a red background indicates an error condition. You can return the color to neutral by replacing the supplies that are low, depleted, or expired.

13-2

629743AE

Replacement / Adjustment Procedures Replace the Aspiration Probe

Replace the Aspiration Probe WARNING Risk of injury and false hardware errors. To avoid injury and false hardware errors, do not remove the transport shield or lift the front cover until otherwise instructed.

WARNING Risk of personal contamination. The aspiration probe and the associated tubing contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.


Removing and Replacing the Aspiration Probe

1

Select Menu > Diagnostics > Dx Tools.

2

Select the Maintenance tab.

3

Select Change Aspiration Probe from the Maintenance drop-down list.

4

Select the Start button.

5

A pop-up window displays the following message: System placing aspiration probe in safe mode. Please wait.

6

629743AE

When the aspiration probe is in safe mode, Remove the Transport Shield and Lift the Front Cover.

13-3

13


7

Locate the aspiration probe.

1 2

8

13-4

3

4 5

Remove the shield.

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9

Disconnect the tubing at the top of the probe. NOTE Use the tips of the pliers to push the tubing up. Do not crimp the tubing.

10 Completely unscrew the knurled nut securing the probe.

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13-5

13


11 Lift the aspiration probe up and out. NOTE The tube must be clear of the probe wipe before lifting out. Use caution so that you don’t bend the probe during replacement.

Installing the New Aspiration Probe

1

13-6

Pick up the new aspiration probe.

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629743AE

2

Orient the probe so that the tab on the top corresponds to the notch in the probe holder.

3

Insert the probe tip into the probe wipe then fit the top section into the holder.

13-7

13


4

Tighten the knurled nut.

5

Reattach tubing to the top of the probe. NOTE Use care so that you don’t crimp the tubing with the pliers.

13-8

629743AE


6

Replace the SAM shield.

7

Lower the Front Cover and Replace the Transport Shield.

8

Perform the Dispense Diluent Procedure (Menu > Diagnostics > Dx Tools > Maintenance).

9

Perform the Aspiration Probe Alignment (Menu > Diagnostics > Dx Tools > Maintenance).

10 Select Finish.

629743AE

13-9

13

Replacement / Adjustment Procedures Replace the Front Blood Detector

Replace the Front Blood Detector WARNING Risk of personal contamination. The front blood detector and the associated tubing can contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.

WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire. NOTE The front blood detector is shipped with the sample line threaded through it; therefore, it is not necessary for you to remove or insert the sample line from the blood detector for this procedure.

13-10

1

Turn off the SPM.

2


3


629743AE


4

Locate the blood detector (physically attached by two screws to the Probe Vertical Drive assembly).

5

Remove the SAM shield. a. Use a Phillips screw driver to remove the two screws at the front of the shield. b. Remove the shield.

629743AE

13-11

13


6

Remove and retain the two screws securing the blood detector at the front of the Probe Vertical Drive assembly.

7

Disconnect the sample line tubing at the top of the aspiration probe. NOTE Use the tip of the pliers to push the tubing up. Use caution so that you don’t crimp the tubing.

13-12

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629743AE

8

Disconnect the sample line from the BSV and pull the tube through and out of the coiled tubing and down and out of the holders. Place the black cone aside for use with the new blood detector.

9

Release the electrical connection wires from the clip.

13-13

13


10 Disconnect the electrical connection at the front of the vertical probe drive

11 Remove and discard the old blood detector assembly. CAUTION Do not discard the black cone. You need it for the new blood detector.

13-14

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12 Install the new blood detector assembly using the black cone and 2 screws retained from the old blood detector.

9743414A

a. Attach the new blood detector assembly to the Probe Vertical Drive assembly.

629743AE

13-15

13


b. Thread the tube through the holders on the side of the Probe Vertical Drive assembly.

c. Thread the tube through the coiled tubing, then thread the tubing through the cone with the narrow end toward the BSV. Attach tubing to the port on the BSV and slide the cone up against the BSV.

13-16

629743AE


d. Connect the tube to the aspiration probe.

e.

629743AE

Connect electrical connector to the board and secure wires in clips.

13-17

13


13 Replace the SAM shield over the Probe Vertical Drive assembly.

14 Lower the Front Cover. 15 Replace the Transport Shield. 16 Turn on the SPM.

17 Run the Blood Detectors Procedure (Menu > Diagnostics > Dx Tools > Maintenance).

13-18

629743AE

Replacement / Adjustment Procedures Replace the Count Vacuum Regulator

Replace the Count Vacuum Regulator WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire. Remove the Old Count Vacuum Regulator

629743AE

1

Turn off the SPM.

2


3


13-19

13


4

Move the SAM to the right to reveal the Count Vacuum Regulator.

p

5

13-20

Disconnect the yellow quick disconnect and the black quick disconnect.

629743AE


629743AE

6

Using a flat-head screw driver, loosen the screw.

7

Remove the old Count Vacuum Regulator and discard.

13-21

13


Installing the New Count Vacuum Regulator

13-22

1

Place regulator on the instrument by lining up the thumbscrew and tab on the bracket with the corresponding holes on the instrument.

2

Using the flat-head screw driver, tighten the thumbscrew.

629743AE


3

Connect the yellow and black quick disconnects. NOTE Be careful not to leave tubing twisted or crimped.

4

Lower the Front Cover.

5


6

Turn on the SPM.

7

Run the Check Count Vacuum Procedure. NOTE Refer to Check Count Vacuum Procedure (Menu > Diagnostics > Dx Tools > Maintenance) in the Troubleshooting chapter for instructions.

629743AE

13-23

13


8

Press (F10) Access System Monitor and select the Volt/Temp button. In the CBC of the System Monitor screen, that Count Vac reads 6.0 +/- 0.1. a. If the vacuum needs to be adjusted, turn the Count Regulator knob clockwise to increase the vacuum or counter-clockwise to decrease the vacuum. b. After you have verified that the vacuum is 6, select the Stop button on the Diagnostic Procedures - Maintenance button to stop the Check Pneumatic Supply procedure.

13-24

629743AE

Replacement / Adjustment Procedures Replace the Pneumatic Supply Module (PSM)

Replace the Pneumatic Supply Module (PSM) Unpack the New PSM

1

Unpack the PSM, remove the plastic sheeting,

2

Using the handles on the PSM, lift it out of the box.

POWE R ON

PULL TO ADJUS T

3

629743AE

PUMP RUNN PNEU MATIC ING FAUL T

Lay the PSM on it’s side.

13-25

13


4

On the bottom of the PSM, use a Phillips screw driver to remove the four Phillips-head screws inside the four socket-head screws, then use the nut driver from your accessory kit to remove the four socket head screws.

5

Set the PSM upright and locate it in the desired location. NOTE If you are using a Floor Stand, you must connect the new PSM before you place it in the floor stand. Refer to Remove and Replace the PSM in this chapter for additional instructions.

13-26

629743AE


Remove and Replace the PSM WARNING Risk of personal contamination. The PSM and the associated tubing can contain residual biohazardous material. Avoid skin . Clean up spills immediately in accordance with your local regulations and acceptable laboratory procedures.


1

Turn off the SPM.

2

Locate the Pneumatic Supply Module. NOTE If your Pneumatic Supply Module is in a floor stand, refer to the Optional Floor Stand section of the System Overview for instructions on locating the Pneumatic Supply Module.

629743AE

13-27

13


3

Unscrew the power/communications cable from the compressor. NOTE If you are using a Floor Stand, remove the PSM from the drawer before disconnecting.

4

Disconnect vacuum and pressure lines. a. Push the vacuum connector rubber sleeve and pull vacuum tube from the connector. b. Press down on the Pressure connector to remove the connector and pressure line.

5

Replace the old compressor with the new compressor. a. Lift the compressor by using the handles on the front and rear of the PSM.

13-28

629743AE


CAUTION Follow your laboratory’s guidelines for lifting to avoid injury.

POW ER ON

PULL TO ADJU ST

6

PUMP RUNNIN PNEUMA G TIC FAULT

Connect the vacuum and pressure lines. NOTE If you are using a Floor Stand, connect everything before placing the new PSM in the floor stand drawer.

a. Insert the vacuum tube into the Vacuum connector.

629743AE

13-29

13


b. Push the Pressure connector into the connecting port until it snaps into place.

7

Connect the power/communications cable connector with the power/communications port on the PSM. a. Line up the holes of the connector with the pins in the port.

b. Push the connector into the port so that the pins in the port are inserted into the connector.

13-30

629743AE


c. Fasten the connector by turning the connector clockwise.

NOTE If you are using a Floor Stand, after connection is complete, the PSM must be centered in the drawer ensuring that the rubber mounts in the drawer align with the holes under the pneumatic module. Avoid touching the inner sides of the drawer (to avoid vibration transfer through the floor stand to the SPM).

629743AE

13-31

13


8

Turn on the SPM.

9

Adjust the Pneumatic Supply Regulator to 25psi. NOTE Wait until the system has completely powered on before doing the adjustment.

Adjust the Pneumatic Supply Regulator

13-32

1

Turn the knob on the Pneumatic Supply Module to adjust the Pneumatic Supply Regulator to 25 psi.

2

Press (F10) Access System Monitor and select the Volt/Temp button to display the Raw Pressure reading.

629743AE

Replacement / Adjustment Procedures Replace Reagent Containers

Replace Reagent Containers WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire.

1

Locate the old Reagent container. NOTE If you are using a floor stand, refer to the Optional Floor Stand section of the System Overview chapter for instructions on locating reagents in the Floor Stand.

2

Place the new reagent box near the old container.

NOTE If you are using a floor stand, lift out the old container and place the new container on the drawer. Make sure that you position the containers correctly in the floor stand so that you do not crimp the tubes when they are inserted.

3

629743AE

Remove any cardboard cutouts from the new container.

13-33

13


13-34

4

Remove the cap and seal from the new reagent container. Be sure to completely remove the foil seal and lift the neck of the container.

5

Remove the plastic collar that secures the pickup tube assembly.

6

Unscrew the pickup tube assembly of the old container and lift it straight up and out.

7

Inspect the pickup tube for damage, and replace it if necessary.

629743AE


8

Carefully insert the pickup tube assembly straight into the new container and tighten the cap. NOTE The pick up tube has several tubes that bend when the assembly is being placed into the new container that can make it difficult to insert. Use a slight twisting motion if you experience difficulty.

IMPORTANT Check the tube for visual leaks or places where the tube is crimped or pinched. If there are leaks you will need to replace the tube. If there are crimped or pinched areas, the container may need to be repositioned.

9

Insert the plastic collar that secures the pickup tubes.

10 Scan the new DxH container’s information on the Setup DxH Supplies dialog box or manually enter information on the Setup Other Supply dialog box. Refer to Set Up Supplies (Menu > Supplies > Setup) in the Setup chapter of this manual.

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13-35

13

Replacement / Adjustment Procedures Replace the Waste Container

11 If you are using a Floor Stand, ensure that you do not tangle the tubing for the various reagents in the upper left drawer of the floor stand. This may make it difficult for reagent replacement in the future.

Replace the Waste Container WARNING Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire. WARNING Possible biohazardous condition. The contents of the old waste container and its associated tubing can include residual biological material and must be handled with care. Check the tubing connection and container location periodically. Avoid skin and clean up spills immediately. Dispose of the contents of the waste container in accordance with your local regulations and acceptable laboratory procedures. CAUTION Waste containers (if used) must be located in a safe place and tubing connection integrity must be verified periodically. Operator must not replace the waste container while the SPM is cycling. CAUTION If the waste line is connected to a drain instead of a waste container, the waste line must be secured into the drain so that the tube cannot accidentally come out of the drain. If using this method of waste removal, Beckman Coulter recommends that you schedule routine maintenance of the laboratory drain pipes.

1

Locate the waste containers. NOTE If your waste containers are located in a Floor Stand, refer to theOptional Floor Stand chapter in the System Overview chapter for instructions on locating the waste containers.

13-36

629743AE


2

Label and uncap an empty waste container and place it near the full one. Save the cap to put onto the full waste container.

NOTE If you are using a Floor Stand, place the empty waste container into the drawer first, and the full container on the floor; then, remove the tubing from the full waste container.

629743AE

3

Ensure that the SPM is not cycling.

4

Slide the collar off the full waste container.

13-37

13


13-38

5

Unscrew the waste tube/level sense assembly cap and lift the assembly straight up and out.

6

Insert the assembly into the empty waste container and screw the cap tightly in place. Cap the full waste container before moving it.

7

Slide the collar into place.

629743AE

Replacement / Adjustment Procedures Replace the Hand-held Bar-Code Scanner

8

that the old container is clearly labeled, add 250 mL of 5% bleach to the 10L old container, then discard according to your laboratory’s standards for biohazardous material.

Replace the Hand-held Bar-Code Scanner

629743AE

1

Disconnect the hand-held bar-code scanner from the USB port at the front of the System Manager U.

2

Install the new scanner by connecting the cable to the USB port at the front of the System Manager U.

13-39

13

Replacement / Adjustment Procedures Replace the Hand-held Bar-Code Scanner

13-40

629743AE

APPENDIX A

Special Equipment

Bar-Code Label Specifications The ed specimen bar-code symbologies are Code 128, Codabar, NW7, Code 39, and Interleave 2 of 5. The number of characters that can be read by the bar-code reader is limited to 22 characters or to that which can be printed in the viewable height, whichever is less. Approximately the bottom 10 mm and the top 10 mm of all tubes is not viewable by the bar-code reader. This is due to the curvature at the bottom of a rounded tube as well as to the cassette barcode window. The top 10mm dimension is measured from the bottom edge of the cap. Table A.1 Printing Parameter’s Specifications 10 uM 3:1 Ratio Recommended Number of Characters by Code Type Minimum Tube Length Required

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Code 128

Code 3 of 9

I 2 of 5

Codabar

55 mm

9

4

12

8

60 mm

11

5

14

9

65 mm

12

6

16

11

70 mm

14

8

18

12

75 mm

16

9

20

14

80 mm

19

10

22

16

85 mm

21

11

—

18

90 mm

22

12

—

19

95 mm

—

13

—

20

100 mm

—

14

—

22

A-1

Special Equipment Tube Specifications

Tube Specifications Tube specifications can be found at www.beckmancoulter.com. NOTE Beckman Coulter does not recommend the use of one tube in preference to another nor guarantee the acceptability of the sample tube to produce quality results. If you need information on a tube not listed here, your Beckman Coulter Representative.

Managing Supplies For information on replacement parts or consumable products, your Beckman Coulter Representative.

A-2

629743AE

APPENDIX B

Operator Access

Operator Roles Operators can be assigned Level I, II, or III on the DxH 800 System, with Level III being Lab access.

Operator Access The following tables list the operator’s access by Operator Role. These lists are not all inclusive.

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B-1

Operator Access Operator Access

Table B.1 Access to Patient Related Functions Privileges to

Level I

Level lI

Level III

Create Patient Demographics

√

√

√

Modify Patient Demographics

√

√

√

Delete Patient Demographics

X

√

√

Rectify Patient Demographics

X

√

√

Review Patient Demographics

√

√

√

Replace Patient Demographics

X

√

√

Edit Patient Results

X

√

√

Review Patient Results

√

√

√

Release Patient Results

X

√

√

Delete Patient Results

X

√

√

Clear Exceptions

√

√

√

Request Rerun/Reflex Tests

X

√

√

Add Comment

√

√

√

Modify Comment

√

√

√

Delete Comment

X

√

√

Modify Specimen Information

√

√

√

Generate Patient Reports

√

√

√

Export Patient Results

X

√

√

Enable/Configure Studiesa

√

√

√

Configure Auto Report Criteria

X

√

√

Configure Batching

X

√

√

Configure Advanced Sort/Filter Criteria in Worklist

X

√

√

Define, Modify and Delete Defined Comments

√

√

√

Patient Functions not identified above

X

X

√

a. If studies mode is enabled, the also has privileges to configure the following settings for the way that studies mode will operate: Auto print for studies specimens, Auto transmit for studies specimens, Number of aspiration per tube for default test order.

B-2

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Table B.2 Access to Quality Control Related Functions

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Privileges to

Level I

Level II

Level III

Configure Controls

X

√

√

Run Control Samples

X

√

√

View QC Results

√

√

√

Delete Results

X

X

√

Delete Controls

X

X

√

Export Control Results

X

√

√

Add Control Comment

X

√

√

Modify Control Comment

X

√

√

Delete Control Comment

X

√

√

Generate Control Reports

√

√

√

Configure XB

on/off

√

√

Configure Extended QC

X

√

√

Configure XM

X

√

√

View XB/XM Results

√

√

√

Delete XB/XM Results

X

X

√

Add XB/XM Comment

X

√

√

Modify XB/XM Comment

X

√

√

Delete XB/XM Comment

X

√

√

Export XB/XM Results

X

√

√

Generate XB/XM Reports

√

√

√

B-3

B


Table B.3 Access to Configuration Privileges to

Level I

Level II

Level III

Configure Primary Identification

X

√

√

Adjust Volume of Audible Alarm

X

√

√

Enable/Disable Audible Alarm

X

X

√

All other system setup items

X

X

√

Configure Operators and Roles

X

X

√

Edit Operators and Roles

X

X

√

Reset

X

X

√

Change

√

√

√

Save/Restore/Print System Configuration

X

√

√

View Bar code Settings

X

√

√

Perform Bar code Discovery Procedure

√

√

√

Configure All Other Bar Code Functions

X

X

√

Logon/Logoff

√

√

√

Configure Tests

X

X

√

Configure Specimen Processing (i.e. Auto Stop)

X

X

√

Configure Printing at Workstation

X

X

√

Enable/Disable All LIS Automatic Transmissions

√

√

√

All Other LIS Configurations

X

X

√

Temporarily Disable Analysis

X

√

√

Table B.4 Access to Test Order Management Privileges to

Level I

Level II

Level III

Create Test Orders

√

√

√

Submit Test Orders

√

√

√

Delete Test Orders

√a

√b

√c

Modify Test Orders

√

√

√

Set Number of Aspirations if Studies is Enabled

√

√

√

All Other Default Test Order Configuration

√

√

√

All Other Test Configuration

X

X

√

a. Deletion only of active test orders where all tests are pending for the entire test order. b. Deletion of any pending or completed test orders, except when a test order is in progress. c. Deletion of any pending or completed test orders, except when a test order is in progress.

B-4

629743AE


Table B.5 Access to Calibration Privileges to

Level I

Level II

Level III

View CBC Calibration

√

√

√

All Other CBC Calibration Functions

X

√

√

Manually Edit CBC Calibration Factors

X

√

√

Perform Non-Routine Calibration (Perform Function)

X

√

√

View Repeatability

√

√

√

All Other Repeatability Functions

X

√

√

Perform Carryover

X

√

√

Export Calibration-Related Results

X

√

√

Generate Calibration-Related Reports

X

√

√

Privileges to

Level I

Level II

Level III

Dispatch Report (print, transmit)

√

√

√

Configure Reports

X

X

√

Export Data

X

√

√

Privileges to

Level I

Level II

Level III

Customer Available Test/Adjust Procedure

X

√

√

Service Available Test/Adjust Procedure

X

√

√

Perform Customer Maintenance Cycles

√

√

√

Perform Service Maintenance Cycles

X

√

√

Device - Configure Desktop Sharing

X

√

√

Device - Allow Desktop Sharing

√

√

√

Information to RMS

X

√

√

Configure Automatic Maintenance Cycles

X

√

√

Privileges To

Level I

Level II

Level III

Viewing Consumable Status

√

√

√

Set Diluent Configuration (1 or 2 diluents)

X

X

√

All Other Consumable Functions

√

√

√

Table B.6 Access to Report Generation

Table B.7 Access to Maintenance/Diagnostics

Table B.8 Access to Consumable Management

629743AE

B-5

B


Table B.9 Access to Workload Privileges to

Level I

Level II

Level III

View Workload Data

√

√

√

Export Workload Data

X

X

√

Workload Data

X

X

√

Generate Workload Report

√

√

√

Privileges to

Level I

Level II

Level III

Consumables Data Summary:

X

X

X

- View, Print, Sort, Filter, Export Logs

√

√

√

- Access Detailed Data

√

√

√

- Add Log Comments

√

√

√


√

√

√

- Delete Logs

X

X

√


√

√

√

- Add Log Comments

√

√

√

Service:

X

X

X


√

√

√

Maintenance:

X

X

X


√

√

√

- Add Log Entries

√

√

√

- Add Log Comments

√

√

√

All Event Logs:

X

X

X


√

√

√

- Delete Logs

X

√

√


X

√

√

- Add Log Comments

√

√

√

Audit Log

X

X

X


√

√

√


√

√

√

- Add Log Comments

√

√

√

Manage Host Log (within Diagnostics)

X

X

X

- Enable, Disable, and Delete

X

X

√

- All other functions

√

√

√

Table B.10 Access to Log Management

B-6

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Table B.11 Access to Manage/Monitor System Privileges to

Level I

Level II

Level III

Backup/Restore System:

X

X

X

- Manual Backup

X

√

√

- Manual Restore

X

X

√

Change Module State (offline, online)

√

√

√

View Status

√

√

√

View Component Configuration Information

√

√

√

Get Help

√

√

√

Error Management

√

√

√

Table B.12 Access to Installation/Upgrade Category Privileges to

Level I

Level II

Level III

Install Software

X

√

√

Upgrade Software

X

√

√

Table B.13 Operator Access to Operating System (OS) Privileges to

Level I

Level II

Level III

Basic OS functions (Wordpad) to create, view and update text files

√

√

√

Basic OS functions (Paint) to capture images

√

√

√

Exit System Manager Application to OS

X

√

√

Access Printer Add/Maintenance*

X

√

√

Access System Recover functions*

X

√

√

* To access these functions, it is necessary to exit from the System Manager application to the OS desktop. When the System Manager application is exited, the OS desktop will be configured to allow access to the Printer Add/Maintenance and system Recover functions, but not other functions.

629743AE

B-7

B


B-8

629743AE

APPENDIX C

Logs

HIstory Logs (Menu > Logs)

Select the Event Log icon at the top of any screen to display the History Logs screen. The Log Type drop-down list on the History Logs screen allows you to view logs by type.

629743AE

C-1

Logs HIstory Logs (Menu > Logs)

Event Logs (Menu > Logs > Event Logs) Figure C.1 Event Logs -System Status Tab

The History Logs - Event Logs screen displays seven unique tabbed views; however, the options available on the Local Navigation bar at the bottom of the Event Logs screen are the same for each tabbed view. Options on the Event Logs Screen Find Logs Select the Find button on the Event Logs screen to display the Find dialog box. Figure C.2 Find Event Dialog Box

C-2

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Log Details Select the Details button on the History Logs - Event Logs screen to display the Event Details dialog box. Figure C.3 Event Details Dialog Box

Add Comments to Logs Select the Comments button on the Event Logs screen to add comments to an event. Figure C.4 Comments Dialog Box

1

629743AE

Type in the Enter Comment text box.

C-3

C


2

To Log Comment/Event in Maintenance Log select the check box.

3

Select OK.

Filter Logs Select the Filter button on the History Logs - Event Logs screen to filter events. Figure C.5 Filter Dialog Box

1

Select an Operator ID.

2

Select a Date Range.

3

Select Security Settings.

4

Select OK.

Delete Logs Select the Delete button on the History Logs - Event Logs screen to display the Delete dialog box. NOTE The Delete option is not available unless the current filter is set to All Operators, All Entries.

C-4

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Figure C.6 Delete Dialog Box

629743AE

1

Select entries to delete.

2

Select the OK button.

C-5

C


Export Logs Select the Export button on the History Logs- Event Logs screen to display the History Logs Export screen. Figure C.7 History Logs Export Screen

C-6

1

Select Event Logs to export or Select All.

2

Select Data Summary Logs to export or Select All.

3

Select Maintenance Logs to export or Select All.

4

Select Audit Logs to export or Select All.

5

Select All Dates or Specify Date Range.

6

Select a Destination.

629743AE


7

Select OK.

Autoprint Refer to the , Auto Print History Log Configuration section of the Setup chapter for instructions on setting up Autoprint for History Logs. Event Logs - General Figure C.8 History Logs - Event Logs - General Screen

Review Logs From the General Tab, select the Log that you want to mark as reviewed and select the Review button.

629743AE

C-7

C

Logs Data Summary Logs

Data Summary Logs Data Summary Logs Select Data Summary Logs from the Log Type drop-down list. The Data Summary Log screen displays two tabs of History Logs: Supplies and Daily Checks. Figure C.9 History Logs - Data Summary Logs - Daily Checks Screen

C-8

629743AE

Logs Audit Logs

Audit Logs Select Audit Logs from the Log Type drop-down list to display the Audit Logs. Figure C.10 History Logs - Audit Log Screen

629743AE

C-9

C

Logs Maintenance Logs

Maintenance Logs Select Maintenance Logs from the Log Type drop down list to display Maintenance logs. Figure C.11 History Logs - Maintenance Logs - Maintenance Tab Screen

Add a New Maintenance Log

1

C-10

Select the New Entry button to display the New Log Entry dialog box.

629743AE

Logs Maintenance Logs

Figure C.12 New Log Entry

629743AE

2

Type a Message in the text box.

3

Type a Comment in the text box. (Optional)

4

Select the OK button to save the new Maintenance Log.

C-11

C

Logs Print History Logs

Print History Logs Select the Print icon at the top of the History Logs screen to print History Logs. Figure C.13 Print Dialog Box

C-12

1

Select a Print Range.

2

Select the Print Details check box to print details.

3

Select OK.

629743AE

APPENDIX D

Reports

Reports This appendix provides examples of the following reports: • Patient Lab Report • Patient Chartable Report • Patient Cumulative Report • QC Run Details • QC Summary Report • QC Summary Graphical Report • Extended QC Summary Report - HCT • Extended QC Summary Report RBC • Extended QC Summary Report HGB • Extended QC Summary Report - WBC • XB Batch Details • XB Batch Means • XM Batch Details - CBC • XM Batch Means-RETIC CALC • Levey Jennings The first example, Figure D.1, Patient Lab Report, displays footer details that reflect variable flagging sensitivity. The second line of the footer, left hand side, represents the algorithm revision and, in brackets, the variable flagging sensitivity. Here, [333] indicates that all the sensitivities are set to High [3]. Other possible values are shown below. DisabledLowMediumHigh (X _ _)Variant LY123 (_ X _)Left Shift0123 (_ _ X)Immature Granulocytes123

629743AE

D-1

Reports Reports

Figure D.1 Patient Lab Report

D-2

629743AE

Reports Reports

D

Figure D.2 Patient Chartable Report Patient Chartable Report

Specimen ID: 89299430487 Specimen Type: Whole blood Physician: Name: Gender: Location: Comment:

(C) Test WBC UWBC RBC HGB HCT MCV MCH MCHC RDW RDW-SD PLT MPV

CBC Adult Diagnosis:

Priority: Routine

Patient ID: Age:

Unknown

s C

s: Flag Set:

Date

Time

Tube Pos

Instrument

Operator ID

08/11/2008

09:52:10 AM

00220

DxH8001

SYSTEM

Result 5.3 5.3 4.99 14.9 42.9 86.1 30.0 34.8 13.1 38.1 211 8.8

Flags

Units 10^3/uL 10^3/uL 10^6/uL g/dL % fL pg g/dL % fL 10^3/uL fL

Low 4.3 4.3 4.38 13.6 39.5 80.7 27.2 32.7 11.8

High 10.3 10.3 5.77 17.2 50.3 95.5 33.5 35.6 14.3

156 6.9

373 10.8

Comment:

Final Report DevOp

629743AE

Printed 08/11/2008 09:55 AM

Page 1 of 1

D-3

Reports Reports

Figure D.3 Patient Cumulative Report Patient Cumulative Report

Name: Gender: Location: Comment:

Patient ID: Age:

Unknown

Most Recent Whole blood Specimen 89299430487 Specimen ID: Specimen Type: Whole blood Physician:

s: Flag Set:

CBC Adult Diagnosis:

Priority: Routine Most Recent Units

08/11/2008 09:52 AM

Reference Range

Low

High

WBC

5.3

10^3/uL

4.3

10.3

UWBC

5.3

10^3/uL

4.3

10.3

RBC

4.99

10^6/uL

4.38

5.77

HGB

14.9

g/dL

13.6

17.2

HCT

42.9

%

39.5

50.3

MCV

86.1

fL

80.7

95.5

MCH

30.0

pg

27.2

33.5

MCHC

34.8

g/dL

32.7

35.6

RDW

13.1

%

11.8

14.3

RDW-SD

38.1

fL

PLT

211

10^3/uL

156

373

MPV

8.8

fL

6.9

10.8

NE

%

41.4

73.0

LY

%

19.4

44.9

MO

%

5.1

10.9

EO

%

0.9

6.0

BA

%

0.3

1.5

NE#

10^3/uL

2.1

6.1

LY#

10^3/uL

1.3

3.5

MO#

10^3/uL

0.3

0.9

EO#

10^3/uL

0.0

0.5

BA#

10^3/uL

0. 2

NRBC

/100WBC

1.0

NRBC#

10^3/uL

0. 1

RET

%

0.52

3.53

RET#

10^6/uL

0.0200

0.1600

MRV

fL

IRF

Printed 08/11/2008 09:56 AM

D-4

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Figure D.4 QC Run Detail Report Page 1 of 2

QC Run Detail Report

Lot Number: Source: Control Type: Level: Excluded: Presentation:

149021948 BCI COULTER 6C Cell Level 3 No Automatic

Test

Result

WBC RBC

Exp. Date: Instrument: Tube Pos ID: Run Date/Time: Presented By: Reviewed By: Review Date/Time: Units

Upper Limit

8.9

10^3/uL

9.6

5.12

10^6/uL

5.39

HGB

16.2

g/dL

HCT

46.0

%

MCV

89.8

MCH MCHC

8.2

SM Error Diff% 0.00

4.93

4.00

-0.78

16.6

15.2

4.00

1.89

49.9

42.9

5.00

-0.86

fL

94.5

85.5

31.7

pg

32.6

29.0

35.3

g/dL

37.0

31.2

RDW

14.2

%

16.6

11.6

RDW-SD

45.9

fL

58.6

36.6

PLT

227

10^3/uL

266

216

8.50

-5.81

MPV

9.6

fL

11.3

7.3

NE

67.6

H

%

64.0

54.0

LY

15.0

L

%

29.5

19.5

MO

7.6

%

11.7

5.7

EO

9.8

%

11.7

3.7

BA

0.0

%

0.5

0.0

NE#

6.0

10^3/uL

7.2

3.2

LY#

1.3

10^3/uL

3.8

0.6

MO#

0.7

10^3/uL

1.6

0.0

EO#

0.9

10^3/uL

2.1

0.0

BA#

0.0

10^3/uL

0.1

0.0

NRBC

19.9

/100WBC

21.6

15.6

NRBC#

1.8

10^3/uL

1.9

1.3

INF/DAT Filename: 2008-08-11T07-23-13_149021948_00018_121

Printed 08/11/2008 09:01 AM

629743AE

Lower Limit

SM Error Limit (%) 6.50

Comments:

Flags

LIS Status: 09/25/2008 Not Sent Shift: 1 DxH8001 System Messages: 00018 08/11/2008 07:23:13 AM SYSTEM DevOp 08/11/2008 07:29 AM

Page 1 of 2

D-5

Reports Reports

Figure D.5 QC Run Detail Report Page 2 of 2

QC Run Detail Report

Printed 08/11/2008 09:01 AM

D-6

5PD1

5PD2

NRBC1

NRBC2

Page 2 of 2

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D-7

Figure D.6 QC Summary Report QC Summary Report Control Type: Level: Report Filter: Control File Comments: Review Date

Lot Number: Expiration Date: First Run:

COULTER 6C Cell Level 3 None

Operator

Analysis Date

Md. Ex. WBC

Source: Instrument: Last Run:

149021948 09/25/2008 08/07/2008 02:31 PM

BCI DxH8001 08/11/2008 07:23 AM

RBC

HGB

HCT

MCV

MCH

MCHC

RDW

RDW-SD

PLT

MPV 08/07/2008 02:43:16 PM DevOp

08/07/2008 02:31:31 PM C

N

8.8 9.6

5.21

16.3

46.6

89.4

31.3

35.0

14.4

46.4

233

08/08/2008 10:17:28 AM DevOp

08/08/2008 10:07:10 AM C

N

9.0 9.7

5.22

16.2

46.7

89.4

31.1

34.7

14.5

46.4

235

08/11/2008 07:19:39 AM DevOp

08/11/2008 07:17:27 AM C

N

8.9 9.7

5.18

16.2

46.7

90.2

31.3

34.7

14.3

46.4

232

08/11/2008 07:29:47 AM DevOp

08/11/2008 07:23:13 AM C

N

8.9 9.6

5.12

16.2

46.0

89.8

31.7

35.3

14.2

45.9

227

WBC

RBC

HGB

HCT

MCV

MCH

MCHC

RDW

RDW-SD

PLT

4

4

4

4

4

4

4

4

4

4

Diff

0.0

0.02

0.3

0.1

-0.3

0.6

0.8

0.3

-1.3

-9

Mean

8.9

5.18

16.2

46.5

89.7

31.4

34.9

14.4

46.3

232

Summary Statistics: N

2SD

0.2

0.09

0.1

0.7

0.8

0.5

0.6

0.3

0.5

7

%CV

0.92

0.87

0.31

0.72

0.43

0.80

0.82

0.90

0.54

1.47

Target

8.9

5.16

15.9

46.4

90.0

30.8

34.1

14.1

47.6

241

Limit

0.7

0.23

0.7

3.5

4.5

1.8

2.9

2.5

11.0

25

MPV N

4

Diff

0.4

Mean

9.7

2SD

0.1

%CV

0.60

Target

9.3

Limit

2.0

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Printed 08/11/2008 09:02 AM

Page 2 of 2

Reports Reports

Figure D.7 QC Summary Graphical Report

D-8

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Reports Reports

Figure D.8 Extended QC Summary Report - HCT

Extended QC Summary Report - HCT

Parameter Parameter ID: Parameter Name:

Hematocrit

Units: Specimen Type: Instrument ID:

% Whole Blood IMP032_DxH800

Basic Data Lab Information: Target: SM Low Limit: SM High Limit: Statistics First Run Date: Last Run Date: Number of Runs: Minimum: Maximum:

46.4 44.1 48.7

08/07/2008 08/11/2008 4 46.0 46.7

Control Lot Number: Control Name: Manufacturer: Measurement Principle:

149021948 COULTERfi 6C Cell BCI Calculated

Level: Expiration Date:

Level 3 09/25/2008

Limits(%) Random Error: Systematic Error: SM Error:

3.00 3.00 5.00

Mean: SD: CV: Delta Diff%:

46.5 0.34 0.72 0.2

RMSE:

0.31

Additional Information:

Date

Comment

Ex

Operator

Result

08/07/2008 02:31:31 PM

SYSTEM

46.6

0.43

08/08/2008 10:07:10 AM

SYSTEM

46.7

0.65

08/11/2008 07:17:27 AM

SYSTEM

46.7

0.65

08/11/2008 07:23:13 AM

SYSTEM

46.0

-0.86

Printed 08/11/2008 09:03 AM

629743AE

Diff%

44.1

46.4

48.7

Page 1 of 1

D-9

Reports Reports

Figure D.9 Extended QC Summary Report RBC

Extended QC Summary Report - RBC


Red Blood Count


10^6/uL Whole Blood IMP032_DxH800

Basic Data Lab Information: Target:

5.16

SM Low Limit: SM High Limit:

4.95 5.37

Statistics First Run Date: Last Run Date: Number of Runs: Minimum: Maximum:

08/07/2008 08/11/2008 4 5.12 5.22


149021948 COULTER 6C Cell BCI Impedance


Level 3 09/25/2008


2.50 3.00 4.00


5.18 0.045 0.87 0.44

RMSE:

0.05


Date

Comment

Ex

Operator

Result

08/07/2008 02:31:31 PM

SYSTEM

5.21

0.97

08/08/2008 10:07:10 AM

SYSTEM

5.22

1.16

08/11/2008 07:17:27 AM

SYSTEM

5.18

0.39

08/11/2008 07:23:13 AM

SYSTEM

5.12

-0.78

Printed 08/11/2008 09:03 AM

D-10

Diff%

4.95

5.16

5.37

Page 1 of 1

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Figure D.10 Extended QC Summary Report HGB

Extended QC Summary Report - HGB


Hemoglobin Concentration


g/dL Whole Blood IMP032_DxH800


149021948 COULTER 6C Cell BCI Photometric


Level 3 09/25/2008

Limits(%) Random Error: Systematic Error:

2.00 2.00


15.9


15.3 16.5

SM Error:

4.00


08/07/2008 08/11/2008 4 16.2 16.3


16.2 0.05 0.31 2.0

RMSE:

0.33


Date

Comment

Ex

Operator

Result

08/07/2008 02:31:31 PM

SYSTEM

16.3

2.52

08/08/2008 10:07:10 AM

SYSTEM

16.2

1.89

08/11/2008 07:17:27 AM

SYSTEM

16.2

1.89

08/11/2008 07:23:13 AM

SYSTEM

16.2

1.89

Printed 08/11/2008 09:03 AM

629743AE

Diff%

15.3

15.9

16.5

Page 1 of 1

D-11

Reports Reports

Figure D.11 Extended QC Summary Report - WBC

Extended QC Summary Report - WBC


White Blood Count


10^3/uL Whole Blood IMP032_DxH800


8.9


8.3 9.5


08/07/2008 08/11/2008 4 8.8 9.0


149021948 COULTER 6C Cell BCI Impedance


Level 3 09/25/2008


4.00 5.00 6.50


8.9 0.08 0.92 0.0

RMSE:

0.07


Date

Comment

Ex

Operator

Result

08/07/2008 02:31:31 PM

SYSTEM

8.8

-1.12

08/08/2008 10:07:10 AM

SYSTEM

9.0

1.12

08/11/2008 07:17:27 AM

SYSTEM

8.9

0.00

08/11/2008 07:23:13 AM

SYSTEM

8.9

0.00

Printed 08/11/2008 09:03 AM

D-12

Diff%

8.3

8.9

9.5

Page 1 of 1

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Figure D.12 XB Batch Details Report (Example) Page 1 of 2

629743AE

D-13

D

Reports Reports

Figure D.13 XB Batch Details Report (Example) Page 2 of 2

D-14

629743AE

Reports Reports

Figure D.14 XB Batch Means (Example)

629743AE

D-15

D

Reports Reports

D-16 Figure D.15 XM Batch Details Report (Example)

629743AE

629743AE

Figure D.16 XM Batch Means-RETIC CALC Report (Example)

Reports Reports

D-17

D

Reports Reports

D-18 Figure D.17 Example of Levey Jennings on a Report

629743AE

Glossary This glossary is a collection of specialized and their meanings that are either used in this manual or related to the information in it. If a term has more than one meaning, all meanings relevant to this manual are included.

° degrees (temperature only) μ micron ALL axial light loss AMTC Air Mix and Temperature Control Module absolute count Concentration of a cell type expressed as a number per volume of whole blood. accuracy The ability of the instrument to agree with a predetermined reference (true) value. accurate The reported measurement is in agreement, within acceptable limits, of the preferred reference standard. Sometimes specified as the difference of the means of a sample to the assay or expected value (mean difference) or the percent difference of the means of a sample to the assay or expected value (percent mean difference). action limits The limits for a test value, such that if the value is outside of the limits, some future action or review is suggested (for example, repeat test, review blood smear, etc.) active result A result associated with an active test order. active test order Test order for which one or more results for one or more specimens have not been released or released and not yet reported. Somebody whose job is to ister the affairs of a business or organization.

629743AE

Glossary-1

Glossary

advanced operator An operator who has been given authority beyond that of a basic operator. alert A fault condition classification for events occurring on the DxH 800 System. An alert occurs when a condition exists on the system for which corrective actions must be taken in order for specimen results to be reported. This condition has no immediate effect on the system operation as the system does not stop. The system alerts the operator by triggering visual alarms, and if applicable, audible alarms. Alerts are not logged to the Event Log. All alerts require operator review; however, the method of review is specific to the individual event. algorithm A particular procedure for performing an analysis. amended report A patient report that is dispatched subsequent to any change made to the patient’s results if the specific patient report was dispatched previously, prior to the changes. analyze To process a sample to determine the results for a test or tests. analyzer An analytical or preparation unit composed of one or more modules. anticoagulant A substance added to blood to prevent clotting. aperture An opening of a specific size and length through which cells for counting and sizing. application Software SPM or System Manager software that controls and implements the DxH 800 System. aspiration probe Device which pierces the cap and through which the sample is aspirated. assay values Values established for a control by extensive analysis of that material. assembly A replaceable part that comprises more than one component.

Glossary-2

629743AE

Glossary

audit log A general record showing any changes that the operators have made on the system, including configuration, patient, and QC. Data in the Audit log is kept up to a period of 2 years after which the system will “roll over” the log data. audit trail A record of a sequence of events, as actions performed by the operator, from which a history can be reconstructed for a specific area of the system. For example, a patient audit trail will have changes related to patient data. Audit trails are maintained for as long as the data is maintained on the system. auto collation A System Manager feature that automatically combines results of different test modes (CBC/Diff and Retic) analyzed from a sample with an identical patient or sample ID. The different test modes must be performed within a predetermined time. autostop Automatic (for example, without a specific request) stopping of specimen analysis on the SPM because of some condition that was detected by the system. Several conditions can result in an autostop. For the DxH 800 System, the autostop conditions are configurable. available tests All the tests which an instrument is capable of performing. assay values Values for a control established by extensive repeat testing of that control. assembly A specific set of components physically attached together or to a common structure. The components do not have to be related functionally and may not qualify as a sub-system (completeness of functionality). An assembly is modular only when it has the attributes of modularity. BFC Body Fluid Count BSV Body Sampling Valve backup To store data separately from the active data, while leaving the active data in place. Backups can be done completely, meaning that all of the selected data is backed up, or incrementally, meaning that only the changes are backed up. background count Measure of the amount of electrical or particle interference. 629743AE

Glossary-3

Glossary

base test A test that is determined for a method, directly measured by an instrument (for example, WBC, for a CBC analysis), or a test that is derived from the RBC or PLT histogram. basic operator An operator with only limited authority to operate the system. basophil A mature granulocyte WBC with granules that contain heparin and vasoactive compounds. The granules stain purple-blue with Wright’s stain. batch A group or set of results. batch mean The mean or average of a set of examples. bi-directional The capability to send test results to () and receive test results from () the LIS system. board Circuit board not directly connected to a host board or backplane using a card edge connector; typically has a moderate to high density of components. body fluid count The DxH 800 CBC module generates a simple for body fluid specimens composed of RBC and TNC. body fluids Fluids that are excreted, secreted, or derived form the human body. Some examples are: cerebrospinal fluid (brain and spinal cord), pericardial fluid (heart), peritoneal dialysis fluid (abdomen), peritoneal lavage fluid (abdomen), peritoneal tap fluid (abdomen), pleural fluid (lungs), and synovial fluid (ts). CBC Complete Blood Count CD CBC/Diff CLSI Clinical and Laboratory Standard Institute formerly known as the National Committee for Clinical Laboratory Standards (NCCLS).

Glossary-4

629743AE

Glossary

CDR CBC/Diff/Retic CR CBC/Retic CSF Cerebrospinal Fluid CS Common Services calibration The procedure used to set an instrument at a specific value or values using a reference method. calibration factor A numerical factor applied to a result determined by an instrument, in order to establish an agreement between the instrument’s measurement and a reference value. calibrator A substance with values obtained by reference instruments and used to calibrate instruments. card Circuit board with a card edge connector that plugs into a host board or a backplane; typically has a moderate to high density of components. carryover The amount, in percent, of sample remaining in the system and picked up by the next sample cycled. Low-to-high carryover is the amount of sample with low cell concentrations carried over to samples with high cell concentration, such as diluent to blood. High-to-low carryover is the amount of samples with high cell concentrations carried over to samples with low cell concentrations, such as blood to diluent. cassette A type of specimen carrier. cassette presentation The SPM accepts specimens presented at the automatic entry point, delivered by cassette. CBC analytical module A partition of the Specimen Processing module (SPM) that produces CBC raw data. characters All letters A-Z and numbers 0-9.

629743AE

Glossary-5

Glossary

cleaning agent A detergent used to flush sample from tubing and eliminate protein buildup. cleared When a specimen has been seen by the system, but it could not be processed, a notification for the specimen is placed on the “Not Processed Filter” of the Worklist. “Cleared” means that one of these notifications has been removed. closed vial The sampling of a specimen by piercing the cap of the container. coefficient of variation (CV or CV%) An expression, in percent (%), of the data spread (variation) as related to the mean value. CV, CV%, and coefficient of variation may be used interchangeably. The standard formula for calculation:

SD CV% = --------------- × 100 Mean coincidence correction Mathematical adjustment of cell count and size for coincidence error. coincidence error Errors produced in counting and sizing by the presence of more than one cell within the aperture sensing area at the same time. The system senses these as one large cell rather than as two distinct cells. common services A functional module that consolidates a set of services and becomes a common source of those services for several other modules. It comprises the Reagent Services, Pneumatic Services, Pneumatic Supply and Electronic Supply. component A subassembly or other constituent part of a module. complete blood count (CBC) In the DxH 800 System, whole blood parameters RBC, WBC -u, WBC -c, HGB, HCT, MCV, MCH, MCHC, PLT, RDW, MPV, PCT, and PDW. computed test A test that is calculated based on the results of one or more discrete tests.

Glossary-6

629743AE

Glossary

configured tests The tests for the SPM that have not been disabled by the operator via the configuration options described in this manual. conforming vial A cap-pierceable vial that can be placed directly into a tube holder or cassette. consensus rules Generally accepted guidelines (rules), developed by the International Consensus Group for Hematology’s (ISLH) Review. The rules can be applied to criteria for review of CBC and differential results from automated hematology analyzers. consumable A component that is required by the physical system during operation and is typically disposed of after a single use or a finite number of usages. This includes such items as calibrators, controls, liquid reagents, etc. control A substance with predetermined values used as a standard to accuracy of instrument results. control file A set of retrieved control results and the expected results associated with them. Each control file contains results from a single instrument and a single control lot or specimen. critical limits The limits for a test value, such that if the value is outside of the limits, the patient’s life may be threatened and immediate action and notification is required. critical result A result considered sufficiently abnormal as to warrant immediate notification of the physician. cyclic redundancy check (CRC) A common technique for detecting data transmission errors. dB Decibel DIFF White Blood Cell Differential DV Distribution Valve

629743AE

Glossary-7

Glossary

dataplot A graphic representation of results. Dataplots present a combined view of population density and hip. Colors represent different types of cells. Shades of colors represent the number of cells--bright colors are the most dense. dead volume The volume of fluid in its container (for example, reagent bottle or specimen tube) that the SPM cannot access. deciliter (dL) A unit of volumetric measurement equal to 0.1 liter. decision rules Typically, -defined “if, then” statements specifying an action to be taken dependent on the outcome (for example, test values, flags) of a test. These are programmed at the System Manager to allow automatic responses. default Original setting in the SPM or System Manager. default test order A test order that is generated when a specimen is presented to the system and a previously submitted test order cannot be found for it. The tests on the order will depend on the method of presentation (Cassette or Single-Tube). default tests The tests that may be assigned to a test order for a specimen that cannot be positively identified, or for which a test order cannot be located. deionized water Water freed of salt and some organisms by an ion-exchange process. This water can be used interchangeably with distilled water in procedures. Also referred to as DI H2O or DI water. deleted A test order, with or without associated results, that has been completely removed from the system. That is, the Test Order is no longer available on either the active or inactive Test Order lists. Furthermore, if there were any results associated with the test order, they are no longer available. delta check A check on sample results that is made by clinical laboratories to determine if the current result on a particular patient is within certain limits of the last result obtained on that same patient.

Glossary-8

629743AE

Glossary

density The number of cells in a particular region, regardless of the type of cell. On dataplots, as more cells appear in a particular region, the color of the region gets brighter. Diff% Used to represent the individual differential % tests, which includes: NE%, LY%, MO%, EO% and BA%. Diff % does not include NRBC. Diff# Used to represent the individual count tests, which includes: NE#, LY#, MO#, EO# and BA#. Diff# does not include NRBC#. differential (Diff) Leukocyte or white blood cell differential. In this manual, a five-part differential. discrete test Refers to either a base test or computed test (for example, WBC which is a base test or HCT which is a computed test). distilled water Water freed of solids and organisms by distillation. This water can be used interchangeably with deionized water in procedures. distribution valve (DV) An electrically driven ceramic face sealing valve in the VCSn functional module that routes sample/reagents between the mixing chambers, the flow cell, and the VCS diluent pump. Data transmitted from an LIS system to a clinical System Manager. down-time Any time the system is not available for testing. DxH 800 System An interacting group of components (SPM, System Manager, and Pneumatic Supply Module). See also, system. EDMA European Diagnostic Manufacturers Association EDTA Ethylene Diamine Tetra Acetic Acid. A common anticoagulant used for hematological testing.

629743AE

Glossary-9

Glossary

entry point The physical place where the specimen first becomes known to the system, for example, at the Manual Station for Single-Tube presentation and at the Input Buffer for Cassette presentation. eosinophil A mature granulocyte WBC that responds to parasitic infections and allergic conditions. Granules stain a bright reddish orange with Wright’s stain. error A fault condition classification for events occurring on the DxH 800 System. An error occurs when a condition exists on the system for which the operator must take corrective action. Operation of the system or a component was affected or may have been halted, and action is required in order to recover the situation. Action may be unrecoverable and may consist of ing your Beckman Coulter Representative. The system alerts you of an error by displaying messages and triggering visual and audible alarms. If an error has an impact on an the SPM’s operation, the an Operational Status Indicator for the SPM will be triggered. Messages related to the event will be posted to the Event Log by filter category. All errors require acknowledgement or review; however, how each error is acknowledged or reviewed is specific to the event. error message A classification of messages that are put into the Event Log. Indicates that messages posted to the Event Log are intended to alert the operator of an error. The Event Log visual indicator is triggered consistent with an error. Audible alarms are also triggered. Error messages post to the Event Log for the General category filter only. The operator is required to review or acknowledge the message in order to clear the Event Log visual indicator. erythrocyte (red blood cell) A biconcave disc, 6 to 8 m, that carries oxygen to the tissues in the body and carries carbon dioxide away from the tissues. ethylenediaminetetraacetic acid (EDTA) A common anticoagulant used for hematological testing. event A noteworthy occurrence; something that needs to be logged. exception A message that indicates why a specimen was not processed or skipped, or a default test order or no match occurred. expiration date A manufacturer’s recommended last day of use for a reagent, control, or calibrator.

Glossary-10

629743AE

Glossary

export To format and store data so that it can be used by external programs (for example, Microsoft Excel or Word). extended differential Includes identification of rare or abnormal white blood cell types not identified in the standard 5-part differential, in addition to the 5-part differential parameters. extended QC Additional QC rules for verification of the following: • Random error or Imprecision • Systematic error or Bias • Total error or Inaccuracy FC Flow Cell feature Any prominent or distinctive aspect, quality or characteristic. femtoliter (fL) Femtoliter, a unit of volumetric measurement equal to 10-15 liter. field replaceable assembly A functional, testable assembly that replaces a portion of a module. This can include such parts as a circuit board, flow cell, laser, etc. flags A flag is a single letter or symbol and will always appear to the right of a result. A flag can be instrument generated (R, P), or laboratory-defined (H, L, c, a). On screens and printouts, the letters, such as H, L, and R appear next to parameter results to indicate specific conditions. field replaceable unit A completely functional tested assembly. This can include such assemblies as a complete Diff Module, MTM, power supply, CBC Module, Sample Aspiration Module, etc. flow cell (FC) A device used to guide particles as they through a laser beam one at a time in a stream of fluid called sheath. This sheath fluid aligns the sample with the center of the flow cell. flow cytometry A process for measuring the characteristics of cells or other biological particles as they through a measuring apparatus in a fluid stream.

629743AE

Glossary-11

Glossary

field replaceable unit (FRU) A completely functional tested assembly. final report Any patient report dispatched subsequent to the entire set of patient’s results being final released. five-part differential Classifying leukocyte cells into five sub-populations (neutrophils, lymphocytes, monocytes, eosinophils and basophils). flagging The ability of a system to identify and alert the operator to the presence of possible anomalies that may affect the accuracy of a test result or require additional work to be performed. functional modules System processes that require inputs and interactions between multiple modules and/or assemblies to produce the required outputs. Gaussian distribution A normal or symmetrical distribution; for example, a bell-shaped curve. giant platelets Platelets above 20 fL in size. gram (g) A unit of weight. ground state The energy level having the least energy of all its possible states and greatest stability. For example, the resting state of an atom is referred to as its ground state. H&H HgB/Hct hardware modules Replaceable, testable units that comprise multiple components and/or assemblies. hematocrit (HCT) Red cell packed volume. The percentage of packed red cells compared to the entire blood sample. hemoglobin (HGB) A protein component of red cells that carries oxygen and carbon dioxide.

Glossary-12

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Hemoglobinometry Measurement of hemoglobin in the blood. hertz (Hz) A unit of frequency. histogram A graphical display of the cell size distribution of a blood sample, where size is on the X-axis and frequency is on the Y-axis. hold When an individual test value, or set of test results is identified as requiring further review and verification prior to release. host A device with customized drivers that receives the SPM patient or control information electronically and formats the data so the LIS can interpret it. host query When a clinical instrument requests test information for a particular specimen from the LIS system. IQAP Inter-Laboratory Quality Assurance Program IQM Intelligent Quality monitoring (IQM) monitors event notification and recovery within the system on an on-going basis. IQM monitors sensor and hardware status in real-time, and also provides tracking and trending of event notifications via the Alert Status icons, alarms and the History Event Log. Events can be addressed as they occur. The availability of IQM optimizes system availability and minimizes possible repeat patient testing for failed QC. IVD In Vitro Diagnostics immature reticulocyte fraction (IRF) The ratio of immature reticulocytes to the total number of reticulocytes. impedance calibrator Beckman Coulter products also known as Latex particles that contain polystyrene beads of uniform and appropriate size to allow standardization of the DC characteristics of Beckman Coulter apertures, and/or the DC and RF characteristics of flow cells for products use VCSn technology. These products are used by service to calibrate SPMs.

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imprecision The degree to which a result will vary due to random error when measured several times on the same instrument. in vitro Outside of a living organism, such as in a laboratory or in an artificial container. in vivo Inside a living organism, associated with the physiological system. inactive result A result associated with an inactive test order. inactive test order Test order for which all results for all specimens have been final released and reported, or test order was removed. indices In hematology, refers to the following calculated values for red cell properties: MCV, MCH, and MCHC. information An information event occurs when a message is logged to the Event Log for tracking and/or troubleshooting purposed. This event has no effect on the system operation and the operator is not alerted. An information event is logged to the Event Log by filter category and does not require operator acknowledgement or review. An action may eventually be needed in order to prevent problems in the future. input buffer Place for loading cassettes. instrument An analytical or preparation unit composed of one or more modules. interfering substances Components within a blood sample that complicate or obstruct the measurement of the desired parameters. Inter-laboratory Quality Assurance Program (IQAP) A program istered by Beckman Coulter, Inc. for s of its hematology instruments and controls. It allows a laboratory to compare its performance to all other laboratories in the program that use the same or similar instrument category and control products.

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LALS Low Angle Light Scatter LIS Laboratory Information System LMALS Lower Median Angle Light Scatter lab An individual who has responsibility for running a laboratory. laminar flow The flow of two liquids side by side in which one does not mix with the other. laser Light amplification by stimulated emission of radiation. leukocyte (white blood cell) Cells that defend the body against disease. linearity The ability of an instrument to accurately produce a test result over the range of possible values for a specific parameter. liter (L) A unit of volumetric measurement. LIS query When a clinical instrument requests test information for a particular specimen from the LIS system. log A record of certain system occurrence or events. lot number An identifier assigned by a manufacturer to identify a control, reagent or calibrator. lymphocyte WBC originating in the lymph system. The key to the body’s immune system, the lymphocyte recognizes and eliminates foreign pathogens in the body. lyse To break apart or dissolve.

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MALS Median Angle Light Scatter MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration MCV Mean Cell Volume MRC Module Resource Controller MTM Multi-Transducer Module manual station The entry point for Single-Tube presentation. mean Arithmetic average of a group of data. mean cell volume (MCV) Average volume of red blood cells expressed in fL. mean corpuscular hemoglobin (MCH) The weight of hemoglobin in the average red blood cell expressed in picograms. mean corpuscular hemoglobin concentration (MCHC) The weight of hemoglobin in the packed red cell volume expressed in g/dL or g/L. mean platelet volume (MPV) Average volume of platelets expressed in fL. mean reticulocyte volume (MRV) Average volume of reticulocytes expressed in fL. mean sphered volume (MSCV) Average volume of red cell population of reticulocyte measuring range Measuring range is the range of values over which the acceptability criteria for the method are defined.

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hip The different types of cells in a particular region, regardless of the number of cells. On dataplots, hip is represented showing different types of cells in different colors. message A classification of messages that are posted to the Event Log that are for informational purposes only. The Event Log visual indicator is not triggered. Audible alarms can be triggered depending on the specific event. Messages can be posted to any of the Event log filter categories. meter (m) A unit of linear measurement. micron (μ) One millionth of a meter. microprocessor The integrated circuitry for electronically controlled devices. milliliter (mL) A unit of volumetric measurement equal to 10-3 liter. millimeter (mm) A unit of linear measurement, equal to one-thousandth of a meter. module A standardized assembly with well-defined interfaces and functionality, that provides a major service to a larger system and can be used together with other modules to form a complete system. monocyte (MO) A large, mononuclear, phagocytic WBC found in the peripheral blood and in the lymphoid system. mononuclear Having only one nucleus. morphology Various conditions that can be seen by examining a blood smear, along with a semi-quantitative estimate of the condition’s severity. The morphology can be related to red cells, white cells or platelets.

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multi-transducer module (MTM) A set of components that produce the DC, Rf, MALS, UMALS, ALL, LALS. and LMALS-Offset signals. It consists of the optical bench, an LALS pre-amp board and the diff pre-amp board. Electrical signals and laser light are ed through the flow cell such that particles flowing through the flow cell will perturb the signals listed above and cause a variety of transducers (antennas, light sensors) to produce other electrical signals which are then measured to produce raw data. nanometer (nm) A unit of linear measurement equal to 10-9 meter. neutrophil A mature granulocytic WBC characterized by a segmented nucleus. The cytoplasm of this phagocyte stains pinkish to beige with faint granules in Wright’s stain. non-conforming vial May not be cap-pierceable vial, or may not fit into cassette or single-tube station cradle. nucleated red blood cell (NRBC) Immature form of the red blood cell characterized by the presence of a nucleus. offline SPM is not participating in specimen scheduling, specimen delivery or specimen processing. online SPM is participating in specimen scheduling, specimen delivery and specimen processing. opacity A transformation of the data derived from the ratio of the RF and DC components obtained during data acquisition. It is calculated for every individual cell measurement or event. Opacity has the effect of removing the size component, yielding a measurement that is more closely related to the internal contents of the cell. RF OP ≈ -------DC

open vial The sampling of a specimen (blood, body fluid, etc.) by removing the cap from the container. operating range The range over which the instrument displays, prints and transmits results. operating system (OS) Operating system files, libraries, drivers, and so forth, required for running the application.

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operating System Core Operating system files, libraries, drivers, etc., required for running the application. operator An individual with authority to operate the system. operator ID Uniquely identifies the processor of the samples. Operator (Level I) Normal operator - has low level privileges to the system software. Operator (Level II) Advanced operator - has medium level privileges to the system software. Operator (Level III) Lab operator - has full level privileges to the system software. Operator (System) Default operator - the system uses this operator when no one is logged in to the system software, but the system is processing specimens. Limited to processing specimens only. Operator (Temp ) Temporary operator - has full level privileges to the system software, to all system service tools and the full operating system for one day only. optical control Beckman Coulter product also known as LATRON -X control that contains stable polystyrene beads of uniform size and appropriate light scattering characteristics to allow monitoring of the light scattering and fluid flow characteristics of products that use VCSn technology. You can use this product to the proper functioning of the VCSn optical bench, much like using 6C controls to the proper recovery of parameter values. Service also uses this product to standardize the characteristics of flow cells. outlier Control results that fall outside the expected or established range. output buffer Where cassettes are unloaded. A grouping of two or more simple s and/or discrete tests that can be ordered on a specimen (for example, CD, CDR, CR, H&H, WHP, etc.).

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parameter Component of blood that the instrument measures and reports. partial voteout An individual aperture count that is not used in the average parameter value. patient ID The System Manager considers this field an optional sample identifier. Your laboratory may use it as a specific identifier for the patient, such as the medical record or Social Security Number. It is intended for laboratories that want to track results of several different samples or tests for the same patient. pericardial fluid The serous fluid that fills the pericardial cavity (the cavity around the heart) and protects the heart from friction. peritoneal dialysis fluid Used in peritoneal dialysis, it is a special solution that is run through a tube into the peritoneum, a thin tissue that lines the cavity of the abdomen, to remove the body’s waste products. peritoneal lavage fluid Fluid instilled into the peritoneal cavity and subsequently withdrawn, for the removal of elements not being excreted by the kidneys. peritoneal tap fluid Fluid obtained from an abdominal tap, which is a procedure in which a needle is inserted through the abdominal wall into the peritoneal cavity to obtain a sample of any fluid that is present. photometric measurement A process where a beam of white light from an incandescent lamp goes through an optical filter and is read by a photocell. This generates a current that can be measured. platelet (thrombocyte) The cytoplasmic fragments of megakaryocytes, circulating as small discs in the peripheral blood, and an essential component for blood clotting. platelet distribution width (PDW) An index of the variation in platelet size. pleural fluid The fluid that encomes the lungs. The name comes from pleura, the serous membrane that enfolds the lungs and is folded back upon the walls of the thorax and upon the diaphragm.

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Plt Histogram The portion of the Plt distribution curve between 0 fL and 36 fL. polynuclear Having many nuclei. positively identified The barcode for the selected primary identifier, either the Specimen ID or Tube Position ID, was successfully read. power down A predefined sequence of events performed at the System Manager to power down the System Manager and the SPM. power off To remove power from an instrument. power on To provide power to an instrument. power up A predefined sequence of events performed at the System Manager to power up the System Manager and the SPM. precision A measure of the ability of the instrument to reproduce similar results when a sample is run repeatedly. May also be referred to as repeatability. precision test The precision test is performed as part of Daily Checks. If any test value exceeds the reference value by 1% or more, the test value appears in red on the Daily Checks screen and is flagged with an H (high) or L (low). predilute Dilution of a sample prior to analysis on the analyzer. preliminary report Any patient report dispatched prior to the entire set of patient’s results being final released. presentation method The method by which the specimen is presented to the SPM. The available methods are Cassette Presentation and Single-Tube Presentation.

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primary identifier The unique identifier that will be used by the system to positively identify a patient specimen. privilege Permission to perform some particular function, for example, enter a test order or review patient results. probe See aspiration probe. processing presentation method The method by which a specimen is presented to the SPM (Cassette Presentation or Single-Tube Presentation). prune To reduce something by deleting whatever is unnecessary or unwanted. pounds per square inch (psi) A unit of pressure measurement. QA Quality Assurance QC Quality Control QA/QC Operator An operator who has authority to perform all QA (calibration) and/or QC (control) related activities. quality control (QC) A set of procedures a laboratory sets up to ensure that an instrument is working accurately and precisely. Ramp Test The ramp test is performed as part of Daily Checks. If any test value exceeds the reference value, the test value appears in red on the System Manager screen and is flagged with an H (high) and L (low). random access The ability to perform different tests on different specimens in random order. The opposite of batch processing, where specimens must be grouped according to tests ordered. random error Imprecision or variance. Glossary-22

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range The difference between the highest and lowest measurement in a series. raw data Unanalyzed data; data not yet subjected to analysis. RBC histogram An RBC distribution curve. The normal curve ranges from 36 to 360 fL. The display starts at 24 fL. RDW (Red Distribution Width) The size distribution spread of the erythrocyte population derived from the RBC histogram. Expressed as coefficient of variation (%). RDW-SD The size distribution spread of the erythrocyte population derived from the RBC histogram. Expressed as a standard deviation in fL. reagent A substance used (as in detecting or measuring a component, or in preparing a product) because of its chemical or biological activity. (Webster) rectify The operator can correct the patient ID if the patient ID was entered incorrectly. red blood cell (RBC) See erythrocyte. red cell indices In hematology, refers to the following calculated values for red cell properties: MCV, MCH, and MCHC. reference range A range of test values determined by statistical analysis of specimens collected from a normal (non-diseased) population. reflex test A different test, or specimen preparation performed as a result of the outcome of an earlier test. Usually performed for confirmation of initial results or to gain a better understanding of a patient’s condition. rejected A test value, or set of results has been reviewed and identified as non-reportable, either automatically because another in another run has been selected for release, or manually because the operator has determined that these tests cannot be reported. 629743AE

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released The test results have been automatically or manually validated and identified as reportable outside the system’s domain, as defined by your laboratory. remote management An application that allows a Beckman Coulter remote to control a System Manager with prior authorization of lab management, allowing pro-active diagnostic . removed A pending test order (no associated test results) that has been manually taken away from the active Test Orders list and has become inactive. repeatability The closeness of agreement between the results of successive measurements of the same substance carried out under the same conditions of measurement. Also known as reproducibility, precision, within-run precision, within-assay, within-run, intra-assay, and intra-run precision. report A formatted printed and/or electronic record of compiled specimen or system data. reportable range The range over which the instrument is accurate. reported The test results have been automatically or manually dispatched to a specified destination. The test results may or may not have been released. rerun The ability to repeat an analysis on a specimen using the same test. reserved control ID A specimen ID that cannot be used for patient specimens because a control has been configured with a lot number that matches the Specimen ID. restore backup To bring backed up data back into the system so that it replaces the active data in the system and becomes the active data itself. result A numerical value or values obtained by performing the analysis for a particular test.

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reticulocyte (Retic) An immature form of red cell that, in the maturation process, falls between a nucleated RBC and a mature RBC. As the nucleated RBC matures, the nucleus shrinks and eventually is shed, and the RNA in the cytoplasm breaks down. The red cell without a nucleus, but still containing remnants of the RNA, is a reticulocyte. Mature RBCs contain no RNA. Stains, such as new methylene blue, precipitate the RNA, differentiating the reticulocytes from mature RBCs and other cells. role A general category associated with the ability to perform some particular function or set of functions, for example, a named set of privileges. root sum squared error (RSSE) Δ =

n----------– 1- ⋅ s 2 + δ 2 n

Measured within a control file Extended QC is enabled, and N is greater than or equal to 15 runs. RSSE is a statistical result that is compared to the limits for Single Measurement Error. run One analysis of a specimen which generates test results. run order The tests ordered for a specific run of specimen, which may require more than one run of the specimen to complete. SAM Sample Aspiration Module STM Specimen Transport Module SPM Specimen Processing Module STAT Superior turn around time, which indicates immediately. sample A fraction of a specimen taken for analysis on an instrument. sample ID One of two possible primary identifiers for sample analysis. The other possible identifier is Tube Position ID.

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sample preparation Requires two services, acquire sample and condition sample. It consists of extracting a sample from a specimen container, segmenting the required sample volume, then combining it with conditioning reagents to enhance specific discrimination characteristics for measuring and analysis. These responsibilities are delegated to an SPM. sample volume The volume of a specimen removed from a specimen container. Also, the volume of a specimen that is conditioned for a specific measuring function. When the volume removed from a specimen container exceeds the conditioning requirement and a portion is discarded, or when portions of the sample are allocated to several conditioning processes, the sample may be called an intermediate sample volume. schistocytes A type of Red blood cell fragments. single measurement error The possible deviation for a single measurement of a result. Single measurement error is flagged when Extended QC is enabled, and the result exceeded the upper or lower limit for Single Measurement Error limits entered by the operator. The Single Measurement Error is measured within the control file as the Root Sum Squared Error (RSSE). screen saver The System Manager has a screen saver that appears when you are not interacting with the System Manager. You can set up the screen saver to appear at specific intervals of non-use. The screen returns to its normal view when the System Manager receives sample data or when you interact with the System Manager by pressing a key on the keyboard. secondary identifier An identifier not configured to be the primary identifier, that can be used by the system to identify a patient specimen in cases where the primary identifier cannot be read. special online Instrument is not participating in specimen delivery and specimen processing for special procedures such as calibration, carryover, etc. This is used for procedures where specific specimens are designated for delivery and no other specimens can be scheduled for delivery during the procedure. specifications An exact statement of particulars, especially a statement prescribing materials, and dimensions for something to be installed. specimen processing module Processes specimens and transmits raw data to the System Manager.

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specimen transport module The specimen delivery module. standard deviation (SD) A measure of deviation from the mean. For example, a measure of the range of channel deviation within a measurement. SD =

∑ ⟨ x – x⟩ 2 -----------------------N–1

sheath A liquid which surrounds and aligns another liquid. shift Consecutive values that abruptly move from one level (mean) to another and then maintain a constant level. specimen The discrete portion of a body fluid or whole blood taken for examination, study, or analysis. status bar A horizontal bar that appears toward the bottom of the screen. It displays the last event message, operator ID, and date and time. study Use of the system to perform an investigation of a subject for which investigation specimens must be analyzed, but the specimen’s results should not be transmitted to the LIS. A study might be used to do things such as validating a new instrument, performing accuracy studies, or evaluating performance, etc. suspect messages Suspect messages appear in a separate area of the screen display, printout, and host transmission. Suspect messages, such as Imm NE 1, Platelet Clumps, etc., are system-generated. Suspect messages appear for sample results based on an abnormal cell distribution or population. The system generates these messages according to an internal algorithm. Abnormalities should be confirmed by microscopic review. synovial fluid The viscid, transparent, albuminous fluid secreted by the synovial membranes at points where lubrication is necessary, as in ts.

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system An individual who has responsibility for istering a DxH 800 System and may perform activities such as configuring the modules and system and performing the more non-routine maintenance activities. system identifier An identifier entered at installation time and used to identify the system when calling your Beckman Coulter Representative. System Manager A personal computer (PC) that: • Provides a graphical interface and input devices (touch screen, keyboard, and mouse) to the operator to interact with the system. This interaction can include, but is not limited to: ordering tests, reviewing test results, reviewing quality control results, making log entries, and responding to system errors. • Communicates with the LIS. • Controls processes such as sample analysis and diagnostic procedures. • Receives and analyzes the raw data from the SPM. • Generates data reports. system message A message that may be given when a system event occurs, to provide a reason for a Review (R) flag generated by the system. systematic error The bias or deviation of the mean from the target value. sweep flow A steady stream of diluent that flows behind the RBC aperture during sensing periods to keep RBCs from swirling back into the sensing zone. TNC Total Nucleated Cells TTM Triple Transducer Module test Individual parameter for which an instrument can determine a value, either directly measured or computed. test order A description of the specimens and what tests per run order are to be performed on each given specimen contained on the test order.

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test An aggregation of selected tests that, when combined, provide results of clinical diagnostic value, but do not necessarily share common analytical technologies. thrombocyte (platelet) the cytoplasmic fragments of megakaryocytes, circulating as small discs in the peripheral blood, and an essential component for blood clotting. throughput A measurement of rate at which an instrument can produce test results, conventionally measured as tests per hour. total nucleated cells The total number of nucleated cells for a body fluid specimen. total voteout A code (-----) that replaces the average parameter result when there is disagreement between the three aperture counts. The aperture counts for the three apertures were too far apart to give a reliable average parameter value. trend Consecutive values that increase or decrease gradually. UMALS Upper Median Angle Light Scatter Uncorrected WBC (UWBC) Uncorrected WBC, labeled “UWBC” is measured directly using the Coulter Principle. UWBC cannot be edited. un-interruptible power supply (UPS) A device with a battery that allows limited continued operation of an instrument or other device during a power outage. Data transmitted from a clinical instrument to an LIS system or other host. interface The display and mechanical devices (keyboard, mouse) used by an operator to interact with the instrument or instruments. VCSn Measurements collected for a cell as it es through the MTM. It consists of values for volume, conductivity, and light scatter for multiple angles.

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validated The test results have been automatically or manually reviewed and confirmed according to laboratory protocols. WHP WBC/Hgb/Plt warning A fault condition classification for events occurring on the DxH 800 System. A warning occurs when a condition exists on the system for which the operator needs to be alerted. This condition has no immediate effect on the system operation, however an action may be needed in order to avoid problems in the future. The system alerts the operator by displaying messages, triggering visible alarms and, if applicable, triggering audible alarms. If the warning could eventually impact the instrument’s operation, then an operational status indicator for the instrument is triggered. Messages related to the event will be posted to the Event Log by filter category. All warning require acknowledgement/review; however, how each one is acknowledged or reviewed is specific to the individual event. warning message A classification of messages that are put into the Event Log. Indicates that messages posted to the Event Log are intended to alert the operator of a warning. Warning messages will be posted to the Event Log for the General category filter only. The operator must acknowledge/review the messages in order to clear the Event Log visual indicator. WBC (White Blood Cell) White Blood Cell count results from the CBC analysis. The WBC count is adjusted for interfering substances when appropriate. No further correction of WBC is required. WBC differential A determination of the types and numbers of leukocytes found in a blood specimen. This may be accomplished by the instrument or by examination of a stained blood smear. white blood cell (leukocyte) Blood cells that defend the body against disease. worklist A listing of specimen analysis status. XB Bull’s Moving Average. A quality control mechanism used by hematology instruments that monitors the stability of the instrument by using the red cell indices MCV, MCH and MCHC. XB batch A set of XB results for up to 20 runs, and the associated XB statistics if there are any.

Glossary-30

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XB current batch The batch of 20 XB results into which results are currently being placed. The batch will remain the current batch until the first specimen after this batch is run, at which time it will become the last XB batch. XB last batch The last XB batch for which results are available, immediately preceding the current XB batch. XB previous batch The XB batch immediately preceding the last XB batch. XB results The parameter results (for example, MCH, MCHC) that have been incorporated into an XB batch. XB run A single analysis of a specimen, the results for which are used as XB results. The run also has ID information associated with it in addition to the results. XB statistics Statistics resulting from the analysis of results in an XB batch, or in a set of XB batches. XM Moving Average. A quality control method that uses the Exponentially Weighted Moving Average (EWMA) to monitor the stability of the instrument using the CBC, Diff, and Retic parameters. XM batch A set of XM results, configured between two to 1,000 runs, and the associated XM statistics, if any. XM batch mean The average value calculated for the batch of XM results. XM current batch The batch of XM results, configured between two to 1000 runs, into which results are currently being placed. The batch remains the current batch until the first specimen after this batch is run, at which time it will become an XM completed batch. XM completed batch The XM batch for which the maximum number of runs for the batch are available. XM group The group (CBC, Diff, Retic and Retic Calc) into which results are placed for XM analysis.

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XM results The parameter results that have been incorporated into an XM batch. XM run A single analysis of a specimen, the results for which are used as XM results. The run also has ID information associated with it in addition to the results. XM statistics Statistics resulting from the analysis of results in an XM batch, or in a set of XM batches.

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References 1. Kjeldsberg C, Knight J. Body Fluids: Laboratory Examination of Cerebrospinal, Seminal, Serous & Synovial Fluids. 3rd Ed., AS Press, Chicago, IL 1993. 2. Miale JB, Laboratory Medicine - Hematology. 3rd Edition 1967, CV Mosby, pages 592-595 3. Steele R, Marmer D, O’Brien M, Tyson S, Steele C. Leukocyte survival in cerebrospinal fluid. J Clin Micro, 198; 23:965-966. 4. Guidelines for the evaluation of blood cell analyzers including those used for differential leucocyte and reticulocyte counting and cell marker applications. International Council for Standardization in Haematology: prepared by the ICSH expert on cytometry. Clin Lab Haematol, 16(2):157-174, 1994. 5. Coulter WH. High speed automatic blood cell counter and cell size analyzer. Paper presented at National Electronics Conference, Chicago, IL, 1956; October 3. 6. Brecher G, Schneiderman M and Williams GZ. Evaluation of electronic red blood cell counter. AM J Clin path, 1956; 26:1439-1449. 7. Brittin GM, Brecher G and Johnson CA. Evaluation of the COULTER COUNTER Model S. Am J Clin Path, 1969,; 679-689. 8. Gottman AW. Multiple hematologic analyses by means of a COULTER COUNTER Model S. Paper presented at International Symposium of Standardization of Hematological Methods, Fondazione, Carlo Erba, Milan, Italy, November 9 and 10. 1970. Symposium proceedings published in Haematologica Latina, 1969. 9. Hamilton PJ and Davidson RL. The interrelationships and stability of Coulter S-determined blood indices. J Clin Path, 1973; 26:700-705. 10. Bessman JD and Johnson RK. Erythrocyte volume distribution in normal and abnormal subjects. Blood, 1975; 46(3): 369-379. 11. Price-Jones C. The diameters of red cells in pernicious anaemia and in anaemia following haemorrhage. J Path Bact, 1922; 25:487-504. 12. England JM, Walford DM and Waters DAW. Re-assessment of the reliability of the haematocrit. Brit J Haemat, 1972; 23:247-256. 13. Bull BS, Scheiderman MA and Brecher G. Platelet counts with the COULTER COUNTER. Am J Clin Path, 1965; 44(6):678-688. 14. Mundschenk DD, Connelly DP, White JG and Brunning RD. An improved technique for the electronic measurement of platelet size and shape. J lab clin Med, 1976; 88(2):301-315. 15. Schultz J and Thom R. Electrical sizing and counting of platelets in whole blood. Med Biol Engr, 1973; 73:447-454. 16. Von Behrens WE. Mediterranean macrothrombocytopenia. Blood, 1975; 46(2):199-208. 17. Paulus JM. Platelet size in man. Blood, 1975; 469(3):321-336. 18. Eckhoff RF. An experimental indication of the volume proportional response of the Coulter Counter for irregularly shaped particles. J Sci Inst, 1967; 44:648-649. 19. Grover NB, Naaman J, Ben-asson S and Dojanski F. Electrical sizing of particles in suspension III. Rigid spheroids and red blood cells. Biophys J, 1972; 12:1099-1116.

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20. Waterman CS, Atkinson EE, Wilkins B, Fischer CL and Kimsey SL. Improved measurement of erythrocyte volume distribution by aperture-counter signal analysis. Clin Chem, 1975; 21:12011211. 21. Kachel V and Ruhenstroth-Bauer G. Methodik and Ergebissne Optiseher Formfatoruntersuchungen bei der Zellvolumenmessung nach Coulter. Micros Acta, 1976; 75:419-423. 22. Gauthier J, Harel P, Belanger C and Fraysse J. Human leukocytes: their size distribution and mean corpuscular volume. Can med Assoc J, 1967; 97:793-796. 23. Hughes-Jones NC, England JM, Norley I and Young JMS. Differential leucocyte counts by volume distribution analysis. Brit J Haemat, 1974; 28(1):148. 24. England JM, Bashford CC, Hewer MG, Hughes-Jines NC and Down MC. A semi-automatic instrument for estimating the differential leucocyte count. Biomed Engr, 1975; 10(8):303-304. 25. Wycherly PA and O’Shea MJ. Abridged differential leucocyte counts provided by a Coulter Channelyzer in a routine haematology laboratory. J Clin Path, 1978. 26. Oberjat TE, Zucker TM and Cassen B. Rapid and reliable differential counts on dilute leukocyte suspensions. J Lab Clin Med, 1970; 76(3):518-522. 27. Hoffman RA and Britt WB. Flow-system measurement of cell impedance properties. J Histochem Cytochem, 1979; 27(1):234-240. 28. Leif RC, Scwartz S, Rodriguez CM, Peel-Fernandez L, Groves M, Leif SB, Cayer M and Crews H. Two-dimensional impedance studies of BSA buoyant density separated human erythrocytes. Cytometry, 1985; 6(1):13-21. 29. Coulter WH et al. Signal modulated apparatus for generating and detecting resistive and reactive changes in a modulated current path for particle classification and analysis. US Patent 3,502,974, March24, 1970. 30. Fulwyler MJ. Electronic separation of biological cells by volume. Science, 1965; 150:910-911. 31. Loken MR, Sweet RG and Herzenberg LA. Cell discrimination by multiangle light scattering. J Histochem Cytochem, 1976; 24(1):284-291. 32. Jovin TM, Morris SJ, Striker G, Schultens HA, Digweed M and Arndt-Jovin DJ. Automatic sizing and separation of particles by ratios of light scattering intensities. J Histochem Cytochem, 1976; 24(1):269-283. 33. Miale JB. Laboratory Medicine: Hematology. CV Mosby Company, St. Louis, MO, 4th ed., 1972; 22. 34. Corash L. Rheinschmidt M, Lieu S, Meers P and Brew E. Fluorescence-activated flow cytometry in the hematology clinical laboratory. Cytometry, 1988; Supplement 3:60-64. 35. Friedman EW. Reticulocyte counts: How to use them, what they mean. Diagnostic Medicine, 1984; 7(6):29-33. 36. Williams WJ, Beutler E, Ersley AJ, and Lichtman MA. Hematology. McGraw-Hill, Inc, New York, NY, 4th ed., 1990; 416. 37. Brecher G. New methylene blue as a reticulocyte stain. Am J Clin Path, 1949; 19:895-896. 38. International Committe for Standardization in Haematology. Recommendations for reference method for haemoglobinometry in human blood (ICSH Standard EP 6/2: 1977) and specifications for international haemiglobincyanide reference preparation (ICSH Standard EP 6/3: 1977). J Clin Path, 1978; 31(2):1390143. 39. Dorsey DB. What can quality control do for hematology? Am J Med Tech, 1965; Mar-Apr:150-153.

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References

40. Bull BS. A statistical approach to quality control. Quality Control in Hematology. Symposium of the International Committee for Standardization in Haematology. Lewis SM and Coster JF, eds, Academic Press, London, England, 1975. 41. Koepke JA and Protextor TJ. Quality assurance for multichannel hematology instruments. Am J Clin Path, 1981; 75(1):28-33. 42. Bull BS. A statistical approach to quality control. Quality Control in Hematology, Symposium of the International Committee for Standardization in Haematology. Lewis SM and Coster JF, eds, Academic Press, London, England, 1975. 43. Bowles K.M., Cook L.J., Richards E.M., Baglin T.P, Platelet size has diagnostic predictive value in patients with thrombocytopenia, Clin. Lab Haem. 27:370–373, 2005. 44. Bancroft A. J., Abel E. W., Mclaern M. . Belch J. J. F. , Mean platelet volume is a useful parameter: a reproducible routine method using a modified Coulter Thrombocytomer, Platelets 11:379–387, 2005.

629743AE

References-3

References

References-4

629743AE

Index

A A control has failed. Auto Stop is not enabled., 10-92 A control has failed. Auto Stop triggered., 10-72 A matching patient specimen was found. Studies mode is enabled., 10-72 A NULL or empty XML string was received for parsing., 10-72 A report could not be generated: No data source found., 10-99 A report could not be generated: Required subreport not found., 10-99 A/D or MRC reference voltage exceeded the operating limits., 10-43 A/D or MRC reference voltage is approaching the operating limits., 10-43 A/D resource busy., 10-72 A/D resource insufficient pairs., 10-72 A/D resource not monitoring., 10-73 A/D resource not ready., 10-73 A/D resource timeout., 10-73 Accuracy, 1-33 Acoustic Noise Level, 1-29 Adding Flagging Limits, 9-35 Locations, 9-62 Physicians, 9-61 Adding a Test Order, 5-6 Automatic from LIS, 5-6 Manual Entry, 5-6 Alarms Setup, 9-14 Alert Status Icons, 1-22 Ambient temperature exceeded the operating limits., 10-41 Ambient temperature is approaching the operating limits., 10-43 An invalid collation ID was received from the System Manager., 10-73

An invalid object type was parsed., 10-73 An invalid primary ID was received., 10-73 An invalid secondary ID was received., 10-73 An unknown attribute was encountered while parsing object., 10-92 An XML parser warning has occurred., 10-92 An XML parsing error occurred., 10-73 An XML parsing error occurred: empty attribute set for object., 10-73 An XML parsing error occurred: invalid attribute value., 10-73 An XML parsing error: unknown start tag in object., 10-92 An XML parsing warning: unknown end tag in object., 10-92 Anticoagulant, 1-32 Application exited while backup was in progress., 10-92 Aspiration, 1-32 Aspiration error., 10-43 Aspiration syringe pump did not sense home., 10-44 Aspiration syringe pump move could not be verified., 10-44 Aspiration syringe pump sensed home after successful recovery., 10-45 Attempt to acknowledge results receipt failed., 10-73 Attempt to perform auto stop failed., 10-74 Attempt to retrieve audible alarm setting failed., 10-74 Attempt to retrieve SPM configuration failed., 10-74 Auto Print, 9-92 Auto report generation error., 10-99 Auto Stop Setup, 9-63 Auto Stop triggered, an SPM has been taken offline., 10-74

Index-1

Index

Group contains undefined parameter., 10-80 Inconsistent database object., 10-81 Invalid flag received., 10-82 Laboratory initialization: no operating limits defined., 10-83 Missing parameter group definition for parameter., 10-85 Operating limit changed for test parameter., 10-86 contains undefined parameter., 10-86 Parameter deleted., 10-87 The control lot you are running has expired., 10-98

B Background Counts, 1-40 Backup and Recovery Setup, 9-7 Backup operation failed., 10-92 Bar-code Labels, 1-27 Bar-code Read Rate Procedure, 10-27 Bar-code Reader Alignment Procedure, 10-28 Bar-code reader did not read specified label., 10-45 Barcode Reader setting up failed, 10-74 Batching, 5-19 BCI Control Setup From Bar Code, 9-87 Blood detector reading exceeded the operating limits., 10-45 Blood detector reading is approaching the operating limits., 10-41 Blood detector variance readings exceeded the operating limits., 10-46 BSV position could not be verified., 10-45 BUSMODEL module A control has failed. Auto Stop is not enabled., 10-92 A control has failed. Auto Stop triggered., 10-72 Auto Stop triggered, an SPM has been taken offline., 10-74 Cannot process QC specimen., 10-92 Conflicting decision rules found., 10-92 Conflicting decision rules were disabled., 10-92 Could not determine unique specimen order., 10-75 Database item validation error., 10-76 Error formatting test values., 10-76 Failed to add test., 10-77 Failed to add/remove a . Exception occurred., 10-77 Failed to add/remove . Mismatched fluid types., 10-78 Failed to add/remove . not available., 10-78 Failed to add/remove . The was already in progress., 10-78 Failed to add/remove . Uned or unknown type., 10-78 Failed to read whole blood limit., 10-79 Failed to remove a . was not requested in the order., 10-79

Index-2

C Calibration, 11-1 With S-Cal, 11-2 With Whole Blood, 11-5 Calibrators Recommended, 1-26 CAN bus impedance not terminated properly for %1 MRC (Host ID: %2), 10-74 CAN bus impedance not terminated properly for %1 MRC (Host ID: %2)., 10-74 Cannot find system path in the system registry., 10-75 Cannot load language library for module., 10-75 Cannot move the cassette into or out of the mix station. OPERATOR MUST TRANSPORT AREA IS CLEAR OF CASSETTES., 10-35 Cannot process QC specimen., 10-92 Carryover, 1-39, 11-11 Cassette Cleaning, 5-4, 12-27 Handling, 5-4 Loading, 5-4 Type D, 1-27 Cassette did not engage the mixer wall. OPERATOR MUST TRANSPORT AREA IS CLEAR OF CASSETTES., 10-35 Cassette mixer did not sense home., 10-35 Cassette mixer missed steps while mixing., 10-36 Cassette not sensed on mixer wall during mix routine., 10-36 Cassettes, 1-27 Type A, 1-27 Type C, 1-27

Index

CBC calibrator lot has expired., 10-92 CBC calibrator lot mismatch., 10-99 CBC count vacuum exceeded the operating limits., 10-46 CBC count vacuum is approaching the operating limits., 10-41 CBC diluent temperature exceeded the operating limits., 10-46 CBC diluent temperature is approaching the operating limits., 10-46 CBC lyse pump delivery could not be verified., 10-46 CBC lyse pump did not sense home., 10-47 CBC Module, 1-11 CBC module CBC count vacuum exceeded the operating limits., 10-46 CBC count vacuum is approaching the operating limits., 10-41 CBC diluent temperature exceeded the operating limits., 10-46 CBC diluent temperature is approaching the operating limits., 10-46 CBC lyse pump delivery could not be verified., 10-46 CBC lyse pump did not sense home., 10-47 CBC Module unable to proceed., 10-35 CBC waste chamber drain did not sense empty., 10-47 Hgb blank exceeded the operating limits., 10-53 Hgb blank is approaching the operating limits., 10-54 RBC or WBC aperture voltage exceeded the air limits., 10-63 RBC or WBC aperture voltage exceeded the clog limits., 10-63 RBC or WBC reference voltage exceeded the operating limits., 10-64 RBC or WBC reference voltage is approaching the operating limits., 10-64 RBC or WBC ZAP voltage exceeded the operating limits., 10-62 RBC or WBC ZAP voltage is approaching the operating limits., 10-63 RBC pump delivery could not be verified., 10-64 RBC pump did not sense home., 10-64 Two or more CBC apertures had one or more parameters that exceeded the operating

limits., 10-68 WBC pump delivery could not be verified., 10-71 WBC pump did not sense home., 10-71 CBC Module unable to proceed., 10-35 CBC MRC (Host ID: 10) not responding, 10-74 CBC waste chamber drain did not sense empty., 10-47 Check Pneumatic Supply Procedure, 10-16 Cleaning Cassettes, 5-4, 12-27 When, Why, and How, 12-1 CLR framework error. Call your Beckman Coulter Representative., 10-74 Codes, 6-42 Comments Setup, 9-57 Common Services, 1-11 Common Services unable to proceed., 10-36 Communication timeout with SPM Module ID/ Audio board., 10-75 Conflicting decision rules found., 10-92 Conflicting decision rules were disabled., 10-92 Control Run Details, 4-11 Control specimen not processed., 10-93 Controls Recommended, 1-26 Correct XML parser not installed., 10-75 Could not determine unique specimen order., 10-75 Could not move cassette into or out of pending buffer. OPERATOR MUST TRANSPORT AREA IS CLEAR OF CASSETTES., 10-36 Could not move cassette out of the input buffer. OPERATOR MUST TRANSPORT AREA IS CLEAR OF CASSETTES., 10-36 Could not move the cassette into or out of the output buffer., 10-37 Could not read specimen bar code., 10-75 Could not read specimen ID or cassette bar codes., 10-75 Could not start maintenance procedure., 10-75 COULTER Body Fluid Control, 1-26 COULTER LATRON -X Control, 1-26 Coulter Method, 2-2 Coulter Principle, 2-1 COULTER S-Cal Calibrator, 1-26 CSM module Ambient temperature exceeded the Index-3

Index

operating limits., 10-41 Ambient temperature is approaching the operating limits., 10-43 Common Services unable to proceed., 10-36 Electronic Supply module current exceeded the operating limits., 10-49 Electronic Supply module current is approaching the operating limits., 10-50 Electronic Supply module in service mode., 10-50 Electronic Supply module voltage exceeded the operating limits., 10-51 Electronic Supply module voltage is approaching the operating limits., 10-52 Pneumatic Supply module exceeded the operating limits., 10-57 Pneumatic Supply module is approaching the operating limits., 10-58 Reagent Services hardware failure., 10-64 Unable to read waste status., 10-68 Vacuum chamber detected liquid., 10-71 Vacuum chamber drain did not sense empty., 10-40 Vacuum chamber overflow detected., 10-40 Vent/overflow chamber detected overflow., 10-40 Vent/overflow chamber drain did not sense empty., 10-40 Cycle DV Procedure, 10-24

D Daily Checks, 3-1 NRBC, 3-5 Reviewing, 3-7 Running, 3-2 Daily Checks procedure incomplete., 10-75 Daily Shutdown, 8-2 Data stored on SPM Module ID/Audio board EEPROM is corrupt., 10-76 Data summary Daily Checks: unknown parameter., 10-99 Database Cleanup Setup, 9-8 Database error., 10-76 Database item validation error., 10-76 DATABASE module Database error., 10-76 Database query error., 10-76 Error initializing database., 10-77 Index-4

Expected database object not found., 10-77 Database query error., 10-76 Date and Time Setup, 9-11 DC or RF flow cell voltage exceeded the operating limits., 10-47 DC or RF flow cell voltage is approaching the operating limits., 10-47 Decision Rules Setup, 9-40 Default order contained an invalid test., 10-76 Default Test Order, 5-8, 9-107 Delta Checks Setup, 9-34 Diagnostic Procedures Bar-code Read Rate, 10-27 Bar-code Reader Alignment, 10-28 Check Pneumatic Supply, 10-16 Cycle DV, 10-24 Dispense Diluent, 10-23 Flush Flow Cell, 10-26 HgB Blank Verification, 10-15 Prime Sweep Flow, 10-24 Unlock DV, 10-25 Blood Detectors, 10-25 ZAP Aperture, 10-14 Diagnostics Procedures, 10-6 Diff lyse pump delivery could not be verified., 10-47 Diff lyse pump did not sense home., 10-48 Diff preservative pump delivery could not be verified., 10-48 Diff preservative pump did not sense home., 10-48 Diluent source switched., 10-93 Disconnected expansion board for %1 MRC (Host ID: %2)., 10-76 Dispense Diluent Procedure, 10-23 Disposal of Electrical Instrumentation, 10-4 Distribution valve did not report expected position., 10-48 Distribution valve did not sense home., 10-48 Distribution valve home recovered., 10-48 Distribution valve recovered expected position., 10-49 DMREDUCE module Barcode Reader setting up failed, 10-74 No test order found to process results., 10-86 Writing to barcode reader failed., 10-91

Index

DMSERVICE module Control specimen not processed., 10-93 Multiple conflicting result values produced for a specimen., 10-85 No values supplied for report job., 10-86 Timeout during processing of System Manager message., 10-89 Timeout waiting for shift information retrieval., 10-90 Timeout waiting for unit conversion., 10-90 DMUI module Application exited while backup was in progress., 10-92 Backup operation failed., 10-92 Data summary Daily Checks: unknown parameter., 10-99 Error creating window., 10-76 Error loading language text., 10-77 Failed reading data while trying to save to file., 10-99 Failed to parse Worklist filter XML file., 10-79 Failed to read from the recovery configuration., 10-79 Manual backup operation failed., 10-106 Operator ID was skipped when restoring configuration., 10-96 Restore attempt failed., 10-88 Scheduled backup not performed., 10-97 System backup not performed. SPM was busy., 10-98 System unexpectedly exited while backup was in progress., 10-98 Unexpected framework error. Call your Beckman Coulter Representative., 10-90 received while batching is enabled., 10-93 Duplicate specimen ID., 10-76 DxH Cell Lyse, 1-25 DxH Cleaner, 1-25 DxH Diff Pack, 1-25 DxH Retic Pack, 1-25

E Electronic Supply module current exceeded the operating limits., 10-49 Electronic Supply module current is approaching the operating limits., 10-50 Electronic Supply module in service mode., 10-50

Electronic Supply module voltage exceeded the operating limits., 10-51 Electronic Supply module voltage is approaching the operating limits., 10-52 Empty parameter definitions received., 10-76 Empty test definitions received., 10-76 Error creating window., 10-76 Error formatting test values., 10-76 Error initializing database., 10-77 Error loading language text., 10-77 Event descriptor not found., 10-77 Event Messages, 10-34 EVENTS module Event descriptor not found., 10-77 Failed reading Events Expiration Rules XML file., 10-77 Exception during results processing., 10-77 Expansion ports communication error for %1 MRC (Host ID: %2), 10-77 Expected database object not found., 10-77 Extended QC Setup, 9-90 Additional Comment, 9-91

F Failed reading data while trying to save to file., 10-99 Failed reading Events Expiration Rules XML file., 10-77 Failed to add data to report job. Report job cancelled., 10-99 Failed to add test., 10-77 Failed to add/remove a . Exception occurred., 10-77 Failed to add/remove . Mismatched fluid types., 10-78 Failed to add/remove . not available., 10-78 Failed to add/remove . The was already in progress., 10-78 Failed to add/remove . Uned or unknown type., 10-78 Failed to complete result calculations., 10-78 Failed to connect to System Manager., 10-78, 10-79 Failed to parse Worklist filter XML file., 10-79 Failed to process report., 10-99 Failed to read from the recovery configuration., 10-79 Failed to read IQAP definition file., 10-79 Failed to read whole blood limit., 10-79 Index-5

Index

Failed to remove a . was not requested in the order., 10-79 Failed to restore configuration information., 10-79 Failed to retrieve bar-code configuration., 10-79 Failed to retrieve batch mode., 10-79 Failed to retrieve configuration information., 10-79 Failed to retrieve enabled parameters., 10-80 Failed to retrieve parameter definitions., 10-80 Failed to retrieve report information., 10-80 Failed to retrieve test definitions., 10-80 Failed to save database information., 10-80 File exception error., 10-80 Flagging and Rules Setup, 9-33 Flagging Limits, 9-35 Adding, 9-35 Flagging Sensitivity, 9-39 Flags, 6-41 Setup, 9-33 Floor Stand, 1-12 Flow Cell Volume and Conductivity, 2-9 Flow cell DC voltage exceeded the expected range. Possible full clog., 10-52 Flow-cell clog., 10-93 Flush Flow Cell Procedure, 10-26

G GENERIC module Cannot find system path in the system registry., 10-75 Cannot load language library for module., 10-75 CLR framework error. Call your Beckman Coulter Representative., 10-74 File exception error., 10-80 Language prefix error., 10-83 Load library failed., 10-83 MFC exception occurred., 10-83 OLE disptatch error., 10-86 OLE error., 10-86 SEH (kernel) exception., 10-88 Group contains undefined parameter., 10-80

H Handheld Scanner Cleaning, 12-28 Using, 5-18

Index-6

Handling Alarms, 5-19 Hardware Overview, 1-4 Specimen Transport Module, 1-8 Hgb blank exceeded the operating limits., 10-53 Hgb blank is approaching the operating limits., 10-54 HGB Blank Verification Procedure, 10-15 Home Screen, 1-18 Host data error (Patient record). Invalid data for patient with ID: %1, 10-99 Host data error (Patient record). Invalid patient ID., 10-99 Host data error (Test Order record)., 10-100 Host data error (Test Order record). Invalid data for test order: %1., 10-100 Host data error (Test Order record): invalid data in required field., 10-100 Host data error: cannot create new test order., 10-100 Host data error: comment not associated with patient demographics., 10-100 Host data error: comment not associated with specimen., 10-100 Host data error: duplicate tests cannot be added., 10-100 Host data error: Invalid data received in Comment record., 10-100 Host data error: invalid data received in Header record., 10-100 Host data error: missing primary identifier., 10-100 Host data error: specimen ID is reserved for control ID., 10-101 Host data error: specimen type cannot be changed., 10-101 Host data error: specimen type cannot be modified., 10-101 Host data error: specimen type not ed., 10-101 Host data error: test (s) not ed or enabled., 10-101 Host data error: tests not added., 10-101 Host data error: tests not canceled., 10-102 Host data error: tests not consistent with specimen type., 10-102 Host data error: transmitted patient ID is different., 10-102 Host error: serial port properties not

Index

applied., 10-80 Host error: transmission to LIS failed., 10-80 Host parsing error (Header record): record length invalid., 10-102 Host parsing error: character missing., 10-102 Host parsing error: character missing., 10-103 Host parsing error: pair missing., 10-102 Host parsing error: / character missing., 10-103 Host parsing error: field delimiter missing., 10-104 Host parsing error: Header record missing in LIS message., 10-103 Host parsing error: Header record out of sequence in LIS message., 10-103 Host parsing error: incorrect CRC., 10-104 Host parsing error: invalid escape sequence., 10-104 Host parsing error: invalid sequence number., 10-104, 10-105 Host parsing error: missing component delimiter., 10-105 Host parsing error: Patient record missing in LIS message., 10-103 Host parsing error: record terminator character missing., 10-105 Host parsing error: record type not ed., 10-105 Host parsing error: start of text character missing., 10-105 Host parsing error: terminator character missing., 10-105 Host parsing error: Terminator record missing in LIS message., 10-103

I Icons and Navigation/Status Buttons, 1-21 Incompatible presentation mode for control specimen., 10-95 Incompatible presentation mode for specimen., 10-95 Incompatible specimen type for label order., 10-80 Incompatible specimen type in default order., 10-81 Inconsistent database object., 10-81 Incorrect number of specimens detected during Carryover procedure., 10-81 Incorrect specimen type detected during Carryover procedure., 10-81 Initial Aspiration error., 10-54

Input buffer pushers did not sense home., 10-41 Input buffer pushers missed steps during a sweep., 10-55 Installation Category, 1-29 Intended Use System, 1-1 Inter-Unit Section, 1-4 Introduction, xxxi Invalid bar-code format for specimen ID label [I2of5] digits., 10-81 Invalid CDATA element in report job result value., 10-105 Invalid CDATA elements were found in a report job., 10-105 Invalid collation ID., 10-82 Invalid data for report job., 10-105 Invalid data set used in report job., 10-106 Invalid event log message from System Manager., 10-82 Invalid flag received., 10-82 Invalid IQAP definitions read., 10-81 Invalid label found on a control specimen., 10-82 Invalid log on to System Manager., 10-106 Invalid or missing report file for report job., 10-106 Invalid parameter group definitions., 10-82 Invalid parameter received from System Manager., 10-82 Invalid parameter result generated by the System Manager algorithm., 10-82 Invalid report request received from System Manager., 10-106 Invalid reuse of specimen ID., 10-82 Invalid specimen type in default order., 10-82 Invalid state reported for liquid detector sensor., 10-82 Invalid vector result sent for parameter., 10-83 IQAP Export, 9-93 IQAP export cancelled: system restart., 10-93 IQAP export failed: duplicate transaction., 10-94 IQAP export failed: not enrolled in RMS., 10-94 IQAP export failed: RMS service not available., 10-94 IQAP export failed: RMS transfer not completed., 10-94 IQAP export failed: system error., 10-94

L Label order contained an invalid test., 10-83 Index-7

Index

Laboratory initialization: no operating limits defined., 10-83 Language prefix error., 10-83 Laser Safety, 10-1 Warning Labels, 10-2 Light Scatter Measurement, 2-9 Light scatter offset exceeded the operating limits., 10-55 Light scatter offset is approaching the operating limits., 10-55 Lin-X Linearity Control, 1-26 LIS module received while batching is enabled., 10-93 Host data error (Patient record). Invalid data for patient with ID: %1, 10-99 Host data error (Patient record). Invalid patient ID., 10-99 Host data error (Test Order record)., 10-100 Host data error (Test Order record). Invalid data for test order: %1., 10-100 Host data error (Test Order record): invalid data in required field., 10-100 Host data error: cannot create new test order., 10-100 Host data error: comment not associated with patient demographics., 10-100 Host data error: comment not associated with specimen., 10-100 Host data error: duplicate tests cannot be added., 10-100 Host data error: Invalid data received in Comment record., 10-100 Host data error: invalid data received in Header record., 10-100 Host data error: missing primary identifier., 10-100 Host data error: specimen ID is reserved for control ID., 10-101 Host data error: specimen type cannot be changed., 10-101 Host data error: specimen type cannot be modified., 10-101 Host data error: specimen type not ed., 10-101 Host data error: test (s) not ed or enabled., 10-101

Index-8

Host data error: tests not added., 10-101 Host data error: tests not canceled., 10-102 Host data error: tests not consistent with specimen type., 10-102 Host data error: transmitted patient ID is different., 10-102 Host error: serial port properties not applied., 10-80 Host error: transmission to LIS failed., 10-80 Host parsing error (Header record): record length invalid., 10-102 Host parsing error: character missing., 10-102 Host parsing error: character missing., 10-103 Host parsing error: pair missing., 10-102 Host parsing error: / character missing., 10-103 Host parsing error: field delimiter missing., 10-104 Host parsing error: Header record missing in LIS message., 10-103 Host parsing error: Header record out of sequence in LIS message., 10-103 Host parsing error: incorrect CRC., 10-104 Host parsing error: invalid escape sequence., 10-104 Host parsing error: invalid sequence number., 10-104, 10-105 Host parsing error: missing component delimiter., 10-105 Host parsing error: Patient record missing in LIS message., 10-103 Host parsing error: record terminator character missing., 10-105 Host parsing error: record type not ed., 10-105 Host parsing error: start of text character missing., 10-105 Host parsing error: terminator character missing., 10-105 Host parsing error: Terminator record missing in LIS message., 10-103 Required parameter for generating dataplots missing., 10-87 Load library failed., 10-83 Loading Cassettes, 5-4 Logging On System Manager, 3-1

Index

M Manual backup operation failed., 10-106 Manuals Updating, iii, iv, BACK-1 Material Safety Data Sheets, 1-26 Maximum number of consecutive CBC module errors reached., 10-84 Maximum number of consecutive CSM errors reached., 10-84 Maximum number of consecutive Diff errors reached., 10-84 Maximum number of consecutive duplicate specimen IDs reached., 10-85 Maximum number of consecutive NRBC errors reached., 10-84 Maximum number of consecutive partial voteouts reached., 10-96 Maximum number of consecutive Retic errors reached., 10-85 Maximum number of consecutive SAM errors reached., 10-85 Maximum number of No Match events reached., 10-95 Maximum number of No Match events reached., 10-83 Maximum number of No Read events reached., 10-95 Maximum number of No Read events reached., 10-84 Maximum number of Partial Aspiration events reached., 10-96 Maximum number of Partial Aspiration events reached., 10-84 Maximum number of specimen mismatches reached., 10-85 Maximum number of Total Voteout events reached., 10-96 Maximum number of Total Voteout events reached., 10-84 Measuring and Operating Ranges, 1-37 Menu Bar, 1-19 Messages Appearing with Results, 6-43 Definitive, 6-47 Status, 6-49 Suspect, 6-43 System, 6-44 Method History, 2-1 MFC exception occurred., 10-83

Missing parameter group definition for parameter., 10-85 Mix pressure exceeded the operating limits., 10-55 Mix pressure is approaching the operating limits., 10-56 Motor encoder reported missed steps., 10-85 Motor move to sensor timeout., 10-85 MSDS, 1-26 MTM, 2-8 Multi Transducer Module, 2-8 Multiple conflicting result values produced for a specimen., 10-85

N No pending tests found for specimen., 10-85 No test order and no default order defined., 10-85 No test order could be generated., 10-85 No test order defined for batch processing., 10-86 No test order found to process results., 10-86 No values supplied for report job., 10-86 None module An invalid object type was parsed., 10-73 Attempt to retrieve SPM configuration failed., 10-74 NRBC lyse pump delivery could not be verified., 10-56 NRBC lyse pump did not sense home., 10-56

O Object meta type incorrect., 10-86 OLE disptatch error., 10-86 OLE error., 10-86 One or more Flow cell parameters exceeded operating limits., 10-56 Operating limit changed for test parameter., 10-86 Operating position of STM could not be verified., 10-37 Operation Principles, 2-1 CBC Analysis, 2-4 Coincidence Correction, 2-6 Counting and Sizing, 2-6 Detection and Sensing, 2-5 Hemoglobinometry, 2-7 Histogram Development, 2-7 Pulse Editing, 2-5 Specimen Preparation, 2-4 Sweep Flow, 2-5

Index-9

Index

Voting, 2-6 Dataplot Development, 2-11 Differential Analysis Conductivity Analysis, 2-2 Light Scatter Analysis, 2-3 Volume Analysis, 2-2 VCSn Detection and Sensing, 2-8 Sample Preparation, 2-8 Operator ID was skipped when restoring configuration., 10-96 Output buffer is full., 10-42

P contains undefined parameter., 10-86 Parameter deleted., 10-87 Parameter Measurement, Derivation, and Calculation, 2-14 Parameters System, 1-2 Patient Control New, 9-85 Patient Results, 6-17 Additional Data, 6-22 Dynamic Mode, 6-19 Histogram/Dataplot Description, 6-21 History, 6-37 Navigation, 6-33 Quick Search Mode, 6-20 Reflex, 6-36 Reject, 6-51 Release, 6-51 Rerun, 6-37 Static Mode, 6-20 Performance, 1-32 Persistent object not found., 10-87 Pneumatic Supply, 1-12 Pneumatic Supply module exceeded the operating limits., 10-57 Pneumatic Supply module is approaching the operating limits., 10-58 Polution Degree, 1-29 Possible tube bottom detected before expected., 10-58 Power Consumption, 1-28 Input, 1-28 Precautions and Hazards, 10-1 Index-10

Prime procedure was not successful., 10-96 Prime Sweep Flow Procedure, 10-24 Printer Setup, 9-10 Printing error: out of paper., 10-106 Probe clean valve is not operating properly., 10-59 Probe cleaning pump delivery could not be verified., 10-59 Probe cleaning pump did not sense home., 10-59 Probe vertical drive did not sense home., 10-60 Probe vertical drive move could not be verified., 10-60 Probe vertical drive sensed home after successful recovery., 10-61 Probe waste chamber vacuum error recovered., 10-61 Probe waste chamber vacuum exceeded the operating limits., 10-62 Probe waste drain did not sense empty., 10-62 Processed specimen was not removed on time., 10-96

Q Quality Control Overview, 4-1 Setup Extended QC, 9-90 View Control Files, 4-3

R Radiation Statement, 10-1 RBC or WBC aperture voltage exceeded the air limits., 10-63 RBC or WBC aperture voltage exceeded the clog limits., 10-63 RBC or WBC reference voltage exceeded the operating limits., 10-64 RBC or WBC reference voltage is approaching the operating limits., 10-64 RBC or WBC ZAP voltage exceeded the operating limits., 10-62 RBC or WBC ZAP voltage is approaching the operating limits., 10-63 RBC pump delivery could not be verified., 10-64 RBC pump did not sense home., 10-64 Reagent is depleted., 10-87 Reagent is low., 10-97

Index

Reagent Services hardware failure., 10-64 Reagent should be depleted., 10-87 Reagents Recommended, 1-25 Reagents not available., 10-87 Reference Range Studies, 1-41 Release Rules Setup, 9-60 Repeatability, 1-36, 11-7 Automatic Presentation, 11-8 Manual Presentation, 11-9 Replacing When, Why, and How, 13-1 Report data set not defined. Report job creation failed., 10-106 Report failed., 10-106, 10-107 REPORTS module A report could not be generated: No data source found., 10-99 A report could not be generated: Required sub-report not found., 10-99 Auto report generation error., 10-99 Failed to add data to report job. Report job cancelled., 10-99 Printing error: out of paper., 10-106 Report data set not defined. Report job creation failed., 10-106 Report failed., 10-106, 10-107 Required parameter for generating dataplots missing., 10-87 Rerun secondary ID did not match value in test order., 10-88 Resource concurrent use conflict., 10-88 Restart after unrecoverable exception., 10-88 Restore attempt failed., 10-88 Retic clear pump delivery could not be verified., 10-64 Retic clear pump did not sense home., 10-65 Retic stain pump delivery could not be verified., 10-65 Retic stain pump did not sense home., 10-65 Retic-X Cell Control, 1-26 Revision History, iii RS MRC (Host ID: 30) not responding, 10-87 Rules Triggered, 9-113 Running Samples Cassette Presentation, 5-12 Single-tube Presentation, 5-15

S Safety, v SAM horizontal drive assembly did not sense home., 10-65 SAM horizontal drive assembly move could not be verified., 10-65 SAM horizontal drive assembly sensed home after successful recovery., 10-65 SAM module Aspiration error., 10-43 Aspiration syringe pump did not sense home., 10-44 Aspiration syringe pump move could not be verified., 10-44 Aspiration syringe pump sensed home after successful recovery., 10-45 Bar-code reader did not read specified label., 10-45 Blood detector reading exceeded the operating limits., 10-45 Blood detector reading is approaching the operating limits., 10-41 Blood detector variance readings exceeded the operating limits., 10-46 BSV position could not be verified., 10-45 Initial Aspiration error., 10-54 Possible tube bottom detected before expected., 10-58 Probe clean valve is not operating properly., 10-59 Probe cleaning pump delivery could not be verified., 10-59 Probe cleaning pump did not sense home., 10-59 Probe vertical drive did not sense home., 10-60 Probe vertical drive move could not be verified., 10-60 Probe vertical drive sensed home after successful recovery., 10-61 Probe waste chamber vacuum error recovered., 10-61 Probe waste chamber vacuum exceeded the operating limits., 10-62 Probe waste drain did not sense empty., 10-62 SAM horizontal drive assembly did not sense home., 10-65 SAM horizontal drive assembly move could

Index-11

Index

not be verified., 10-65 SAM horizontal drive assembly sensed home after successful recovery., 10-65 SAM unable to proceed., 10-37 Stripper vertical drive did not sense home., 10-67 Stripper vertical drive sensed home after successful recovery., 10-67 Transport shield was opened., 10-39 Tube was detected after a successful recovery., 10-67 Tube was detected earlier than expected., 10-67 Tube was not detected., 10-67 SAM MRC (Host ID: 40) not responding., 10-88 SAM unable to proceed., 10-37 Sample Analysis, 5-1 Placing Bar-code Label on the Tube, 5-3 Sample Aspiration Module, 1-10 Aspiration Probe, 1-10, 1-11 Bar-code Reader, 1-11 Blood Detectors, 1-10 BSV, 1-10 Sample Collection, 5-1 Sample or sheath pressure exceeded the operating limits., 10-66 Sample or sheath pressure is approaching the operating limits., 10-66 Sample Stability and Storage, 1-45 Body Fluids, 1-47 Predilute, 1-47 Whole Blood, 1-46 Samples Running Analysis, 5-12 SAX COM error., 10-88 Scheduled backup not performed., 10-97 Scheduled procedure skipped., 10-97, 10-98 Search Icon, 1-23 Secondary ID did not match the value in test order., 10-89 SECURITY module Invalid log on to System Manager., 10-106 SEH (kernel) exception., 10-88 Setup, 9-1 Auto Stop, 9-63 Batching Enables, 9-110 BCI Control Manual Entry, 9-87 BCI Control from Bar Code, 9-87

Index-12

Comments, 9-57 Communications, 9-100 Container Configuration, 9-2 Low Level Condition, 9-3 Daily Checks, 9-104 Automatic Cycling, 9-104 Decision Rules, 9-40 Delta Checks, 9-34 Demographics, 9-76 Flagging and Rules, 9-33 Flagging Sensitivity, 9-39 Flagging/Rules Collation, 9-64 Flags, 9-33 Install/Upgrade Software, 9-101 Locations, 9-62 Operators and Roles, 9-27 Physicians, 9-61 Quality Assurance, 9-102 Carryover, 9-102 CBC Calibration, 9-102 QA Auto Report, 9-103 Repeatability, 9-102 Quality Control, 9-83 New Patient, 9-85 Shifts, 9-98 XB, 9-93 XM, 9-96 Release Rules, 9-60 Reporting, 9-65 Auto Report, 9-70, 9-75 Lab Information, 9-66 Label Names, 9-69 Units Format, 9-67 System, 9-6 Sheath or sample tank did not indicate full condition., 10-66 Shutdown Daily, 8-2 Overview, 8-1 SPM, 8-2 System Manager, 8-1 Shutdown procedure incomplete., 10-98 Shutdown procedure incomplete., 10-89 Single tube station home position or tube cradle status could not be verified., 10-39 Single tube station recovered while extending or retracting., 10-66 Single-tube Presentation Icon, 1-21

Index

Specimen ID verification failed., 10-89 Specimen ID verification failure for a specimen., 10-107 Specimen Transport Module, 1-8 Input Buffer, 1-9 Mixer Wall and Aspiration Probe, 1-9 Output Buffer, 1-10 Pending Buffer, 1-9 SPM Dimensions, 1-29 Icons, 1-24 SPM alarm command failed., 10-88 SPM prime did not succeed., 10-88 SPM serial number undefined, 10-89 SPM Specifications, 1-28 Status Bar, 1-22 Status Mode Area, 1-21 STM, 1-8 STM module Cannot move the cassette into or out of the mix station. OPERATOR MUST TRANSPORT AREA IS CLEAR OF CASSETTES., 10-35 Cassette did not engage the mixer wall. OPERATOR MUST TRANSPORT AREA IS CLEAR OF CASSETTES., 10-35 Cassette mixer did not sense home., 10-35 Cassette mixer missed steps while mixing., 10-36 Cassette not sensed on mixer wall during mix routine., 10-36 Could not move cassette into or out of pending buffer. OPERATOR MUST TRANSPORT AREA IS CLEAR OF CASSETTES., 10-36 Could not move cassette out of the input buffer. OPERATOR MUST TRANSPORT AREA IS CLEAR OF CASSETTES., 10-36 Could not move the cassette into or out of the output buffer., 10-37 Input buffer pushers did not sense home., 10-41 Input buffer pushers missed steps during a sweep., 10-55 Operating position of STM could not be verified., 10-37 Output buffer is full., 10-42 Single tube station home position or tube cradle status could not be verified., 10-39

Single tube station recovered while extending or retracting., 10-66 STM unable to proceed., 10-38 STM XY truck did not sense home on the Xaxis., 10-37 STM XY truck did not sense home on the Yaxis., 10-38 STM XY truck recovered from missed steps on the X-axis., 10-38 STM XY truck recovered from missed steps on the Y-axis., 10-38 Unexpected cassette at mix station moved to output buffer., 10-39 Unexpected cassette at pending buffer moved to the output buffer., 10-68 STM MRC (Host ID: 50) not responding., 10-89 STM unable to proceed., 10-38 STM XY truck did not sense home on the Xaxis., 10-37 STM XY truck did not sense home on the Yaxis., 10-38 STM XY truck recovered from missed steps on the X-axis., 10-38 STM XY truck recovered from missed steps on the Y-axis., 10-38 Stripper vertical drive did not sense home., 10-67 Stripper vertical drive sensed home after successful recovery., 10-67 Studies, 5-19 Surface Plots, 6-29 System backup not performed. SPM was busy., 10-98 System Manager Logging On, 3-1 System Setup, 9-6 Audible Alarms, 9-14 Backup and Recovery, 9-7 Bar Code, 9-13 Database Cleanup, 9-8 Date and Time, 9-11 Printer Setup, 9-10 Studies, 9-16 System Configuration, 9-17 System unexpectedly exited while backup was in progress., 10-98

T Temporarily Disable Analysis, 9-20 Index-13

Index

Termperature Humidity, 1-28 Test definition contains an unrecognized specimen type., 10-98 Tests ordered could not be run., 10-89 The control lot you are running has expired., 10-98 The database object was not found., 10-89 The replacement of the consumable on SPM %1 was interrupted., 10-89 Throughput, 1-40 Timeout during processing of System Manager message., 10-89 Timeout waiting for shift information retrieval., 10-90 Timeout waiting for unit conversion., 10-90 Transmit Released Results, 6-13 Transport shield was opened., 10-39 Triple Transducer Module, 2-3 Troubleshooting, 10-1 TTM, 2-3 Tube position ID no read, 10-90 Tube was detected after a successful recovery., 10-67 Tube was detected earlier than expected., 10-67 Tube was not detected., 10-67 Two or more CBC apertures had one or more parameters that exceeded the operating limits., 10-68

U Unable to access PI U NVRAM, 10-98 Unable to communicate with bar-code reader., 10-90 Unable to install SAX handler during XML parsing., 10-90 Unable to read waste status., 10-68 Unexpected cassette at mix station moved to output buffer., 10-39 Unexpected cassette at pending buffer moved to the output buffer., 10-68 Unexpected CDATA during XML parsing., 10-90 Unexpected CDATA received during XML parsing., 10-98 Unexpected character data during XML parsing., 10-90 Unexpected characters during XML parsing., 10-98 Unexpected document end during XML Index-14

parsing., 10-90 Unexpected end tag during XML parsing., 10-90 Unexpected framework error. Call your Beckman Coulter Representative., 10-90 Unexpected start tag during XML parsing., 10-90 Unlock DV Procedure, 10-25 Unprocessed specimen was not removed on time., 10-98 Uned result type received from System Manager., 10-90 USM module A matching patient specimen was found. Studies mode is enabled., 10-72 A/D resource busy., 10-72 A/D resource insufficient pairs., 10-72 A/D resource not monitoring., 10-73 A/D resource not ready., 10-73 A/D resource timeout., 10-73 An invalid collation ID was received from the System Manager., 10-73 An invalid primary ID was received., 10-73 An invalid secondary ID was received., 10-73 Attempt to acknowledge results receipt failed., 10-73 Attempt to perform auto stop failed., 10-74 Attempt to retrieve audible alarm setting failed., 10-74 CAN bus impedance not terminated properly for %1 MRC (Host ID: %2), 10-74 CAN bus impedance not terminated properly for %1 MRC (Host ID: %2)., 10-74 CBC calibrator lot has expired., 10-92 CBC calibrator lot mismatch., 10-99 CBC MRC (Host ID: 10) not responding, 10-74 Communication timeout with SPM Module ID/ Audio board., 10-75 Could not read specimen bar code., 10-75 Could not read specimen ID or cassette bar codes., 10-75 Could not start maintenance procedure., 10-75 Daily Checks procedure incomplete., 10-75 Data stored on SPM Module ID/Audio board EEPROM is corrupt., 10-76 Default order contained an invalid test., 10-76 Diluent source switched., 10-93 Disconnected expansion board for %1 MRC (Host ID: %2)., 10-76 Duplicate specimen ID., 10-76 Empty parameter definitions received., 10-76

Index

Empty test definitions received., 10-76 Exception during results processing., 10-77 Expansion ports communication error for %1 MRC (Host ID: %2), 10-77 Failed to complete result calculations., 10-78 Failed to connect to System Manager., 10-78, 10-79 Failed to process report., 10-99 Failed to read IQAP definition file., 10-79 Failed to restore configuration information., 10-79 Failed to retrieve bar-code configuration., 10-79 Failed to retrieve batch mode., 10-79 Failed to retrieve configuration information., 10-79 Failed to retrieve enabled parameters., 10-80 Failed to retrieve parameter definitions., 10-80 Failed to retrieve report information., 10-80 Failed to retrieve test definitions., 10-80 Failed to save database information., 10-80 Flow-cell clog., 10-93 Incompatible presentation mode for control specimen., 10-95 Incompatible presentation mode for specimen., 10-95 Incompatible specimen type for label order., 10-80 Incompatible specimen type in default order., 10-81 Incorrect number of specimens detected during Carryover procedure., 10-81 Incorrect specimen type detected during Carryover procedure., 10-81 Invalid bar-code format for specimen ID label [I2of5] digits., 10-81 Invalid CDATA element in report job result value., 10-105 Invalid CDATA elements were found in a report job., 10-105 Invalid collation ID., 10-82 Invalid data for report job., 10-105 Invalid data set used in report job., 10-106 Invalid event log message from System Manager., 10-82 Invalid IQAP definitions read., 10-81 Invalid label found on a control specimen., 10-82 Invalid or missing report file for report job., 10-106

Invalid parameter group definitions., 10-82 Invalid parameter received from System Manager., 10-82 Invalid parameter result generated by the System Manager algorithm., 10-82 Invalid report request received from System Manager., 10-106 Invalid reuse of specimen ID., 10-82 Invalid specimen type in default order., 10-82 Invalid state reported for liquid detector sensor., 10-82 Invalid vector result sent for parameter., 10-83 IQAP export cancelled: system restart., 10-93 IQAP export failed: duplicate transaction., 10-94 IQAP export failed: not enrolled in RMS., 10-94 IQAP export failed: RMS service not available., 10-94 IQAP export failed: RMS transfer not completed., 10-94 IQAP export failed: system error., 10-94 Label order contained an invalid test., 10-83 Maximum number of consecutive CBC module errors reached., 10-84 Maximum number of consecutive CSM errors reached., 10-84 Maximum number of consecutive Diff errors reached., 10-84 Maximum number of consecutive duplicate specimen IDs reached., 10-85 Maximum number of consecutive NRBC errors reached., 10-84 Maximum number of consecutive partial voteouts reached., 10-96 Maximum number of consecutive Retic errors reached., 10-85 Maximum number of consecutive SAM errors reached., 10-85 Maximum number of No Match events reached., 10-95 Maximum number of No Match events reached., 10-83 Maximum number of No Read events reached., 10-95 Maximum number of No Read events reached., 10-84 Maximum number of Partial Aspiration events reached., 10-96 Maximum number of Partial Aspiration events Index-15

Index

reached., 10-84 Maximum number of specimen mismatches reached., 10-85 Maximum number of Total Voteout events reached., 10-96 Maximum number of Total Voteout events reached., 10-84 Motor encoder reported missed steps., 10-85 Motor move to sensor timeout., 10-85 No pending tests found for specimen., 10-85 No test order and no default order defined., 10-85 No test order could be generated., 10-85 No test order defined for batch processing., 10-86 Prime procedure was not successful., 10-96 Processed specimen was not removed on time., 10-96 Reagent is depleted., 10-87 Reagent is low., 10-97 Reagent should be depleted., 10-87 Reagents not available., 10-87 Rerun secondary ID did not match value in test order., 10-88 Resource concurrent use conflict., 10-88 Restart after unrecoverable exception., 10-88 RS MRC (Host ID: 30) not responding, 10-87 SAM MRC (Host ID: 40) not responding., 10-88 Scheduled procedure skipped., 10-97, 10-98 Secondary ID did not match the value in test order., 10-89 Shutdown procedure incomplete., 10-98 Shutdown procedure incomplete., 10-89 Specimen ID verification failed., 10-89 Specimen ID verification failure for a specimen., 10-107 SPM alarm command failed., 10-88 SPM prime did not succeed., 10-88 SPM serial number undefined, 10-89 STM MRC (Host ID: 50) not responding., 10-89 Test definition contains an unrecognized specimen type., 10-98 Tests ordered could not be run., 10-89 The replacement of the consumable on SPM %1 was interrupted., 10-89 Tube position ID no read, 10-90 Unable to access PI U NVRAM, 10-98 Unable to communicate with bar-code reader., 10-90

Index-16

Unprocessed specimen was not removed on time., 10-98 Uned result type received from System Manager., 10-90 VCSn MRC (Host ID: 20) not responding., 10-91 Verification bar code read was not successful., 10-91 VME POST failed for CBC SCA card., 10-91 VME POST failed for Comm I/F card., 10-91 VME POST failed for VCSn SCA card., 10-91 Waste container is full., 10-91 Utility Icons, 1-23

V Vacuum chamber detected liquid., 10-71 Vacuum chamber drain did not sense empty., 10-40 Vacuum chamber overflow detected., 10-40 VCS diluent pump delivery could not be verified., 10-68 VCS diluent pump did not sense home., 10-69 VCS temperature exceeded the operating limits., 10-69 VCS temperature is approaching the operating limits., 10-70 VCS waste chamber drain did not sense empty., 10-70 VCSn Acquisition Time was longer than expected., 10-71 VCSn Module, 1-11 VCSn module A/D or MRC reference voltage exceeded the operating limits., 10-43 A/D or MRC reference voltage is approaching the operating limits., 10-43 DC or RF flow cell voltage exceeded the operating limits., 10-47 DC or RF flow cell voltage is approaching the operating limits., 10-47 Diff lyse pump delivery could not be verified., 10-47 Diff lyse pump did not sense home., 10-48 Diff preservative pump delivery could not be verified., 10-48 Diff preservative pump did not sense home., 10-48 Distribution valve did not report expected position., 10-48 Distribution valve did not sense

Index

home., 10-48 Distribution valve home recovered., 10-48 Distribution valve recovered expected position., 10-49 Flow cell DC voltage exceeded the expected range. Possible full clog., 10-52 Light scatter offset exceeded the operating limits., 10-55 Light scatter offset is approaching the operating limits., 10-55 Mix pressure exceeded the operating limits., 10-55 Mix pressure is approaching the operating limits., 10-56 NRBC lyse pump delivery could not be verified., 10-56 NRBC lyse pump did not sense home., 10-56 One or more Flow cell parameters exceeded operating limits., 10-56 Retic clear pump delivery could not be verified., 10-64 Retic clear pump did not sense home., 10-65 Retic stain pump delivery could not be verified., 10-65 Retic stain pump did not sense home., 10-65 Sample or sheath pressure exceeded the operating limits., 10-66 Sample or sheath pressure is approaching the operating limits., 10-66 Sheath or sample tank did not indicate full condition., 10-66 VCS diluent pump delivery could not be verified., 10-68 VCS diluent pump did not sense home., 10-69 VCS temperature exceeded the operating limits., 10-69 VCS temperature is approaching the operating limits., 10-70 VCS waste chamber drain did not sense empty., 10-70 VCSn Acquisition Time was longer than expected., 10-71 VCSn Module unable to proceed., 10-39 VCSn phase alignment did not complete successfully., 10-42 VCSn temperature was not in operating range limits. Try again in 10 minutes., 10-42 VCSn Module unable to proceed., 10-39

VCSn MRC (Host ID: 20) not responding., 10-91 VCSn phase alignment did not complete successfully., 10-42 VCSn temperature was not in operating range limits. Try again in 10 minutes., 10-42 Vent/overflow chamber detected overflow., 10-40 Vent/overflow chamber drain did not sense empty., 10-40 Verification bar code read was not successful., 10-91 Blood Detectors Procedure, 10-25 VME POST failed for CBC SCA card., 10-91 VME POST failed for Comm I/F card., 10-91 VME POST failed for VCSn SCA card., 10-91

W Waste container is full., 10-91 Waste Disposal Warning, 10-5 WBC pump delivery could not be verified., 10-71 WBC pump did not sense home., 10-71 Worklist Custom, 6-15 Advanced Search, 6-15 Screen, 6-1 Tabs, 6-1 Not Processed, 6-7 Pending, 6-3 Released, 6-11 Review, 6-9 Workload, 7-1 Writing to barcode reader failed., 10-91

X XB, 4-24 Setup, 9-93 XM, 4-32 Setup, 9-96 XML is missing the format specification., 10-91 XML module A NULL or empty XML string was received for parsing., 10-72 An unknown attribute was encountered while parsing object., 10-92 An XML parser warning has occurred., 10-92 An XML parsing error occurred., 10-73 An XML parsing error occurred: empty attribute set for object., 10-73

Index-17

Index

An XML parsing error occurred: invalid attribute value., 10-73 An XML parsing error: unknown start tag in object., 10-92 An XML parsing warning: unknown end tag in object., 10-92 Correct XML parser not installed., 10-75 Object meta type incorrect., 10-86 Persistent object not found., 10-87 SAX COM error., 10-88 The database object was not found., 10-89 Unable to install SAX handler during XML parsing., 10-90 Unexpected CDATA during XML parsing., 10-90 Unexpected CDATA received during XML parsing., 10-98 Unexpected character data during XML parsing., 10-90 Unexpected characters during XML parsing., 10-98 Unexpected document end during XML parsing., 10-90 Unexpected end tag during XML parsing., 10-90 Unexpected start tag during XML parsing., 10-90 XML is missing the format specification., 10-91 XML parsing error., 10-91 XML parsing error: duplicate start tag in object., 10-91 XML parsing error: no attributes found., 10-91 XML parsing warning., 10-98 XML parsing error., 10-91 XML parsing error: duplicate start tag in object., 10-91 XML parsing error: no attributes found., 10-91 XML parsing warning., 10-98

Z ZAP Aperture Procedure, 10-14

Index-18

Beckman Coulter, Inc. Customer End License Agreement This Product contains software that is owned by Beckman Coulter, Inc. or its suppliers and is protected by United States and international copyright laws and international trade provisions. You must treat the software contained in this Product like any other copyrighted material. This license and your right to use the Product terminate automatically if you violate any part of this agreement. This is a license agreement and not an agreement for sale. Beckman Coulter hereby licenses this Software to you under the following and conditions: You May: 1. Use this software in the computer supplied to you by Beckman Coulter; 2. Maintain one copy of this software for backup purposes (the backup copy shall be supplied by Beckman Coulter); 3. After written notification to Beckman Coulter, transfer the entire Product to another person or entity, provided you retain no copies of the Product software and the transferee agrees to the of this license agreement. You May Not: 1. Use, copy or transfer copies of this Software except as provided in this license agreement; 2. Alter, merge, modify or adapt this Software in any way including disassembling or decompiling; 3. Loan, rent, lease, or sublicense this Software or any copy. Limited Warranty Beckman Coulter warrants that the software will substantially conform to the published specifications for the Product in which it is contained, provided that it is used on the computer hardware and in the operating system environment for which it was designed. Should the media on which your software arrives prove defective, Beckman Coulter will replace said media free of charge within 90 days of delivery of the Product. This is your sole remedy for any breech of warranty for this software. Except as specifically noted above, Beckman Coulter makes no warranty or representation, either expressed or implied, with respect to this software or its documentation including quality, performance, merchantability, or fitness for a particular purpose. No Liability for Consequential Damages In no event shall Beckman Coulter or its suppliers be liable for any damages whatsoever (including, without limitation, damages for loss of profits, business interruption, loss of information, or other pecuniary loss) arising out of the use of or inability to use the Beckman Coulter Product software. Because some states do not allow the exclusion or limitation of liability for consequential damages, the above limitation might not apply to you.

629743AE

WARRANTY-1

Beckman Coulter, Inc. Customer End License Agreement

General This agreement constitutes the entire agreement between you and Beckman Coulter and supersedes any prior agreement concerning this Product software. It shall not be modified except by written agreement dated subsequent to the date of this agreement signed by an authorized Beckman Coulter representative. Beckman Coulter is not bound by any provision of any purchase order, receipt, acceptance, confirmation, correspondence, or otherwise, unless Beckman Coulter specifically agrees to the provision in writing. This agreement is governed by the laws of the State of Florida.

WARRANTY-2

629743AE

Trademarks The BECKMAN COULTER logo , COULTER, UniCel, Erythrolyse, StabiLyse, LATRON, and S-CAL are trademarks of Beckman Coulter, Inc.

All other trademarks, service marks, products, or services are trademarks or ed trademarks of their respective holders.

629743AE

TRADEMARKS-1

Related Documents Your DxH 800 documentation can be found on our website at www.beckmancoulter.com. Instructions for Use PN 629743 •

System Overview

•

Operation Principles

•

Daily Checks

•

Quality Control

•

Sample Analysis

•

Data Review

•

Workload

•

Shutdown

•

Setup

•

Troubleshooting

•

Quality Assurance

•

Cleaning Procedures

•

Replacement Procedures

•

Appendices

•

Abbreviations

•

Glossary

•

References

Host Transmission Manual PN 773765

www.beckmancoulter.com

© 2009 Beckman Coulter, Inc. All Rights Reserved

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