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Figure 8.4: Archiver Installation

4. Click the Next button to begin opening the files. 5. Select a destination folder for the Unzipped (unpacked)

files. The default folder chosen for you is

Click the Browse button to find new folder or type new folder into test field.

c:\Excel_Tech\lnstall. 6. Click the Finish button to continue and click the Yes button to create the directory.

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~ If you wish to remove previous versions of Archiver, click Yes to All to overwrite existing files.

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7. When the Installation Wizard Welcome dialog box opens, press the Next button to continue.

8. Read the next two text boxes and if you agree with the

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text statements, click the Yes buttons to continue.

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You can remove the disk at this point

9. Type in your Name, Company, and the required Serial

#: and then click the Next button to continue. 10. Archiver asks you once more to confirm the folder

destination. Click the Next button to continue. 11. The computer will have to be shut down and restarted

before you can run Archiver. Select a shut down option and click the Finish button.

8.2.2. STARTING ARCHIVER 1. Double-click the Archiver icon on your desktop. 2. Once in the Archiver screen, click Options on the Menu

bar and then select Set Directory. Click the Browse button and look for the directory that you created as your default patient directory.

8.2.3. TRANSFERRING NEUROMAX FILES TO A PC There are two ways to transfer files from the NeuroMax to a PC. i) _ Manual Disk Transfer: Copy the files to a disk in the NeuroMax disk drive and then load onto the PC. ii) Serial and Parallel Port Transfer: Connect the NeuroMax to a PC using the Serial or Parallel Port connector cable and transfer the files.

8.2.3.1. MANUAL DISK TRANSFER 1. From the NeuroMax Main screen, select istrative Functions and then press the Select key. 2. Choose Patient Directory and then press the Select

key.

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~ Use Windows Explorer to cr~ate a folder to store the archived patient files if the software does not automatically . J create one for yo~

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3. Choose the patient file to be transferred, press the

-...

Select key, and then choose Function #9, Save File to \,_.,

Diskette.

4. After the file has been saved to disk, transfer the disk to the PC and insert into the A: drive.

5. Read files from Archiver. (See Section 8.3.2.)

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8.2.3.2. SERJAUPARALLEL PORT TRANSFER

If there are connection problems, shut down both units, reattach the cables, tum the NeuroMax on, and then tum the PC on.

With the serial/parallel port cable connection, you can transfer files directly from the NeuroMax to the PC. The first thing you need to do is attach the cable.

1. Connect the NeuroMax to the PC with the supplied cable by attaching the small end into the NeuroMax printer

~ lfyouare setting up Archiver for the first time, click Options, click Communications, and select a port. ((Parallel port for Parallel Able or Com 1 for Serial Cable).

port and the large end into the PC's parallel port (usually LPT1).

2. Double-click the Archiver icon on your PC desktop to open the program and then click File on the Menu bar.

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3. Click Connect to NeuroMax and then comply with the

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on-screen instructions asking that NeuroMax be

If there are connection problems and are using a laptop PC, do NOT use battery power but plug the laptop directly into a wall unit.

switched off and then turned on again.

4. Press the Report key on the NeuroMax to display a list of all patients in the NeuroMax directory on the PC screen.

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5. Using the PC keyboard, highlight the file(s) you would like to transfer from the NeuroMax.

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6. To transfer multiple files, depress the Ctrl key on your

If there are connection problems, select a different printer driver for the PC. We suggest the HP320 or the HP340.

PC keyboard while selecting your files to transfer.

7. Select Transfer on the Archiver File Menu bar to transfer the files from the NeuroMax to the PC.

8. To transfer just one file, double right-click it, or click it once and then click Transfer.

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~You can select files for transfer in two ways: 1) Press Select All. 2) Select the first file then toggle down your list to the last file while holding down the Shift key. All files between these two will be selected.

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9. To exit the NeuroMax Directory Screen on the PC, click File on the Menu bar, and then click Close.

8.3. MANAGING THE REPORTS Once you have transferred the reports from the NeuroMax to your PC, you can view them, print them, edit them, and/or discard them. Transferring the files by cable also changes their format into Rich Text Format (RTF), which can be read by a variety of word processing programs.

8.3.1. RICH TEXT FILES (RTF) ing files to a PC by cable will automatically create files with an RTF file extension in the default directory. If modifications are made on an Archiver file, it must then be transferred to RTF format.

1. Open the file to be exported.

2. Choose Save As from the File menu.

~ You can decide how you want to manage the files, whether you want to use them or periodically delete them.

3. Choose Rich Text Format for the file type and press the OK button. A file ending in the .rtf extension is created.

4. Open this file using the word processor of your choice. Consult the documentation on your word processor for more information on importing files in Rich Text Format.

8.3.2. VIEWING PATIENT REPORTS There are two ways to open a patient report file to view.

1. From Archiver, click File on the Menu bar and click

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Local Patient Directory to bring a list of all the patient

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files on the PC onto the screen.

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2. Double-click the patient file to view.

The patient file names are composed of the first 8 characters of the patient's name.

OR 1. From Archiver, click File on the Menu bar, click Open, and then click on a patient file.

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~The file name extension is '.dOO' for new files. Each time a file on the NeuroMax is modified and transferred to a PC, the file extension number incrementally increases by one.

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8.3.3. PRINTING PATIENT REPORTS 1. From Archiver, open the file to print.

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2. Click File on the Menu bar, select Print or Print

insertion cursor using the arrow keys or the mouse.

Preview from the File menu, and then click the OK You can also open a section by pressing the Enter key or by double- clicking the section to edil

button.

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8.3.4. EDITING PATIENT REPORTS Files are edited using the insertion cursor, the flashing vertical bar positioned at the first line of a report section at the left of your screen. 1. From Archiver, open the file and position the insertion point at the top of the section you want to edit. 2. In the Section menu, click Open to open a data box and a waveform window for modifying the section.

opening a bilateral table for modification, you are prompted to choose either the left or the right side. To skip this, hold the Ctrl key when opening the table to jump directly to the left side. Similarly, hold the Shift key down to jump to the right side.

3. Change cursor positions by dragging the desired cursor, or by selecting it and using the arrow keys to move it to a new position. 4. Click the OK button to accept the modifications or click the Cancel button to discard the changes. 5. Click File on the Menu bar and then click Save or Save As from the File menu to save the changes.

8.3.5. EDITING FAST TRIGGERED STUDIES 1. To modify the trigger line, go to the waveform screen for the study and select Superimpose from the Trace

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menu to make the trigger line visible.

ways to move the trigger line: 1) use the mouse or arrow keys. 2) Use the Shift + arrow keys to grow or shrink the trigger

2. Select the trigger line and use the mouse or arrow keys to move it, or use Shift + arrow keys to grow or shrink the trigger line.

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8.3.6. PRINTING THE WAVEFORMS IN ARCHIVER There are three ways to approach the editing and printing of waveforms in Archiver.

8.3.6.1. FIRST: PRINT SCREEN 1. Double-click a NCV test with the left mouse button to open both the waveforms and the results table. 2. Click on a waveform to make the cursors active.

This is simply an editing screen and won't be printed unless you press Print Screen on your keyboard and import the image into a bitmap imaging program such as Paint.

8.3.6.2. SECOND: REMOVING OR DISPLAYING WAVEFORMS Removing 1. To remove the waveforms of a particular test from the

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If Integrate Waveforms is checked, the wavefonns are integrated, otherwise they are displayed at the end of the report.

printed report during a test, select the test. 2. Click Section and then click Hide Waveforms. Displaying 1. To display the waveforms of a particular test from the

printed report during a test, select the test. 2. Click Show Waveforms to display a particular

waveform.

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8.3.6.3. THIRD: PERMANENT WAVEFORMS This useful setting turns on the waveforms permanently. 1. Open a patient file and then click Option on the Menu

bar.

2. Click Style and then click New to access the options which will define the way that your screens will appear. 3. Select New and type in the name of this style. You can create and an unlimited number of styles; however, one must be set as the default style while the other styles may be applied to a specific patient for specific reasons. 4. Click the OK button and then select Modify. 5. Click the arrow next to General to select the other

options.

6. Select MNC to show a list of options and then click Show Waveforms to tum it on. 7. Modify allows you to choose which variable is displayed in all test modalities.

Click the OK button and then select Modify again to repeat the process for the other tests you want this waveforms to appear in.

8. Once you have finished modifying the tests, click Set Default to select this style as your default.

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can modify your Header on the left of the new screen. On the right of the screen, the General option determines how your date will appear and if the waveforms are integrated (appear associated with the results table).

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9. APPENDIX 1: WARRANTIES 9.1. WARRANTY INFORMATION The warranty duration of your XL TEK NeuroMax and associated components is as follows: NeuroMax1 002 /1004 AV Stimulator Medical Cart, Convenience Arm Headbox, 3 Button Stimulator Optical isolator Accessories

3 years 1 year 1 year 1 year 1 year 30 days

9.1.1. NEUROMAX WARRANTY SERVICE Warranty service consists of the following : • Hardware Service • Clinical Service * See XL TEK Warranty Definitions listed below for a full description of the services provided during the warranty period. The and conditions of your warranty of XLTEK REALPATIENT installation are the following:

9.2. EXTENT OF LIMITED WARRANTY XL TEK warrants to the end- customer that XL TEK products will be free from defects in materials and workmanship, for a specified time after the date of receipt by the customer. The duration of this limited warranty is as stated above. XL TEK does not warranty the operation of any product to be uninterrupted or error free. XLTEK does not extend this warranty to any third party owners or s of the product. Warranties are voided on re-sold units. XL TEK limited warranty covers only those defects which arise as a result of normal use of the product, and do not apply if the product has been subjected to: • • • •

Improper or inadequate maintenance Software or interfacing not supplied by XL TEK Unauthorized modification or misuse Improper site preparation or maintenance

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A particular XLTEK component may be void of warranty with accompanying charges such as repair or replacement costs, shipping charges, travel and accommodations costs, etc. being billed to the customer. Whereby XLTEK equipment that has been repaired or replaced because of apparent defective hardware components, and it is evident that the device has been subject to damage due to reasons stated above, the customer will then be billed for all costs associated with its repair or replacement. If XLTEK receives, during the applicable warranty period, notice of a defect in the product which is covered by XL TEK warranty, XLTEK shall either repair or replace the product, at its option, with a product that may be new or like-new, provided that it has functionality at least equal to that of the product being replaced . All correspondence with XLTEK must specify both the model name and/or serial number, as it appears on the product.

9.3. LIMITATIONS OF WARRANTY XLTEK (nor any of its third party suppliers) does not make any other warranties of any kind, whether expressed or implied with respect to XLTEK products. XL TEK and its third party suppliers specifically disclaim the implied warranties of merchantability and fitness for a particular purpose. To the extent that this Limited Warranty Statement is inconsistent with the law of the locality where the customer uses the XLTEK product, this Limited Warranty Statement shall be deemed modified to be consistent with such local law. Under such local law, certain limitations of this Limited Warranty Statement may not apply to the customer. To the extent allowed by local law, the remedies provided in this Limited Warranty Statement are the customer's sole and exclusive remedies.

9.4. LIMITATIONS OF LIABILITY Except for the obligations specifically set forth in this warranty statement, in no event shall XLTEK be liable for any direct, indirect, special, incidental, or consequential damages, whether based on contract, tort, or any other legal theory and whether advised of the possibility of such damages.

XL TEK will make all reasonable efforts to satisfy the customer's needs in of providing a temporary replacement unit for an inadequately functioning XLTEK unit. XL TEK does not assume any responsibility for loss of income due to such an event. It is the customer's responsibility to manage their own patient data base (i.e.: printing or ing patient files to a computer).

9.5. EXTENDED WARRANTY INFORMATION The following services can be purchased in addition to the warranty provided with the purchase of XL TEK equipment, software and services. These items are at no time offered unless otherwise clearly purchased, with a signed quotation or purchase order, and full payment forwarded to XL TEK. Prices are available through your sales representative or an XLTEK Inside Sales Representative.

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9.6. NEUROMAX MAINTENANCE SERVICE NeuroMax Maintenance Service consists of: • Hardware Service • Clinical Service

9.7. 24 HR REPLACEMENT GUARANTEE Includes an on-site loaner guarantee for the duration of the warranty period for any XLTEK acquisition component (price per acquisition component)

9.8. PRICING Warranty pricing is based on the list pricing of a customer's XL TEK installation excluding the cost of training, installation, and discounting. The warranty packages are priced as a percentage of the total list pricing of their hardware.

9.9. XLTEK WARRANTY DEFINITIONS 9.9.1. HARDWARE SERVICE. XL TEK shall use commercially reasonable efforts to repair or replace defective hardware components of the Equipment within 48 hours of reported failure. XLTEK agrees to provide substitute equipment, where available, to enable the client to carry out normal business activity until a repair has been effected. At XL TEK 's option, a defective component is replaced: (i) By XLTEK; or (ii) By forwarding a replacement component to Customer for installation with XL TEK telephone assistance. Replacement parts will be new or reconditioned to perform as new. Replaced parts become the property of XL TEK. XLTEK is not responsible for replacing accessories or consumables including Needles Electrodes or Recording media.

9.9.2. CLINICAL SERVICE. XLTEK shall provide telephone , 5 days a week, 12 hours a day for consultation in solving Equipment Problems. Telephone Service is not for employee training and Customer shall regulate staff use. XLTEK shall be obligated to provide a response to an inquiry as soon as is practically possible

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10. APPENDIX 2: NEUROMAX IN-SERVICE CHECKLIST Name/1 nstitution: Tel: Additional s: Name: Telephone:

Fax:

Email: Position:

10.1. BASIC FUNCTIONS Connections for NeuroMax: D Printer D Headbox 0 Stirn Probe 0 Accessories D To PC D Foot Switch D AVSTIM o External Trig 0 Hot Keys

Keyboard Layout:

Power Supply of NeuroMax:

D Function hardkeys

0 Print:

0 Menu hardkeys 0 Select switch o Arrow keys D Trigger Arrows 0 Stimulus intensity 0 Functions: Opening a Patient File 0 Electrode Impedance Testing

10.2. NERVE CONDUCTION FUNCTIONS 0 0 0 0 0

Asg Waveforms Full Screen Acquisition Trace Cursors Distance

0 Stimulator

Creating Protocols for.

o Notes

o SNC

0 Erase 0 Exponential Decay ("X")

o Rep Stirn

0 F-Wave 0 H-Reflex 0 Normal Values

10.3. ELECTROMYOGRAPHY Basic Functions: 0 Recording (start/stop) 0 Settings (Gain/Timebase) 0 Audio Adjustments 0 Notepad 0 Suites

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Advanced Functions: n Review 0 Turns and Amplitudes

Creating Editing: 0 Defaults 0 Triggered Defaults

o Motor Unit Analysis (1 ,2)

0 EMG Suites 0 Muscles

0 Free Run to Triggered (key function) 0 Free Run to Fast Triggered

Programs: 0 Free Run 0 Triggered

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10.4. ISTRATIVE FUNCTIONS Patient Directory: 0 Search Utility 0 Patient Callback 0 Test Directory n Print Report 0 View Report u Delete File 0 Edit Patient Info o Connect to PC 0 Print Test Screens

Memory Management: 0 Pack Flash 0 Patient Directory 0 Delete all Files 0 Delete all printed files 0 Batch Print:

System Options: 0 1) Report Format o Report Header 0 Interpretation Macros 0 2) Site Name List 0 3) EMG Notepad 0 4) Patient Information Fields

10.5. DUAL CHANNEL TESTS Functions: 0 EP's - Stimulating 0 Averaging D Saving Waveforms 0 Cursors

0 0 0 0

BLINKS • Stimulating Saving Waveforms Cursors HRV

0 Creating Protocols for EP's 0 Multi Channel EMG/IOM 0 Multi Channel NCS

10.6. REPORT MENU While in an active patient file, press REPORT. The following functions should now be available: U View Report 0 Print Report 0 Edit Report (host directory) 0 Print Report and Waveforms n Interpretation 0 Save Current Patient to Diskette

10. 7. ACCESSORIES Main ( for ordering Consumable items): Name: Phone:

Please indicate style currently used U Disposable Monopolar 0 Disposable Concentric 0 Disposable lnjectible Monopolar Please indicate the length and gauge of the needles used: _ _ __ Please indicate the number of EMG's performed monthly: _ _ __ Please indicate if you are using: Please indicate current Accessories Supplier: 0 Disposable Electrodes fro NCS 0 Reusable Electrodes for NCS Are you currently receiving Preferential Pricing for a Needle Contract? 0 YES 0 NO Would you be interested in hearing how XLTEK Accessories are able to enhance the quality of your studies, as well as save you time and money? o YES o NO

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10.8. CONFIRMTION Date Completed: Client Name:

Sales Rep: (please print)

Client Name:

Sales Rep: (please sign)

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(please print)

(please sign)

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11. APPENDIX 3: TROUBLESHOOTING/MAINTENANCE Here you will find information on how to work through trouble spots during the operation of the NeuroMax. If you cannot solve the problem, keep notes on the event so that you can explain them clearly to an XLTEK service technician. If you continue to experience any difficulties in either the set-up or everyday use of your system, please XLTEK Customer Service: Toll Free: 1-800-387-7516 Direct: (905) 829-5300 Fax: (905) 829-5304

11.1. SOFTWARE The following sections show you how to the software version on your machine, how to update your software, and how to install NeuroMax Loader.

11.1.1. CHECKING SOFTWARE VERSION ON NEUROMAX 1. Tum on the power to the NeuroMax. 2. From the Main Menu screen, press Shift and the V key on the keyboard.

3. The version number appears in the bottom-left comer of the screen.

11.1.2. UPDATING SOFTWARE 1. Obtain the newest version of software from either the XLTEK Web site (http://www.xltek.com) or from head office. Call Customer Service at 1-800-387-7516. 2. Ensure that you have a PC (Windows 95, 98, or NT) with Windows Explorer running, the PC

cable, your NeuroMax, and the software. 3. Place the disk into the PC floppy disk drive. Open Windows Explorer and then click the 3Yz inch floppy (A: ) icon in the left window. 4. The contents of the disk will appear in the right window. Select the executable file (.exe) and

double-click the icon.

5. A screen opens asking you to Unzip four files. Choose UNZIP and in a few seconds a message appears confirming that four files have been successfully Unzipped. Click the OK button to continue.

6. Follow the instructions asking you to tum off the NeuroMax.

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7. Connect the NeuroMax to the PC with the cable, tum on the NeuroMax, and then click the OK button on the PC screen. 8. The NeuroMax screen now reads Connected to a PC .... and tells you that the software is being erased and re-written. 9. After the is complete, a window box appear asking you to tum off the NeuroMax and disconnect it from the PC. 10. Tum the NeuroMax off and click the OK button. To ensure that the correct software version is loaded, press Shift and the V key and the latest version of the software appears in the bottom-left corner of the screen. NOTE: ANY CUSTOMIZATION OF TEST DEFAULTS AND REPORT FORMAT WILL NOT BE AFFECTED. PLEASE ENSURE THAT ALL PATIENT FILES ON THE NEUROMAX ARE TRANSFERRED TO PC ARCHIVER OR ARE PRINTED OFF THE NEUROMAX BEFORE THE PROCESS BEGINS.

11.1.3. INSTALLING NEUROMAX LOADER 1. NeuroMax Loader from the XLTEK Web site (http://www.xltek.com). 2. Using Windows Explorer, locate the NeuroMax loader.exe file on your C: drive and doubleclick the icon to place a NeuroMax Loader shortcut icon on your desktop. 3. You can access Loader by clicking the desktop icon. You can also access Loader by clicking Start, selecting Programs, and then clicking NeuroMax Loader.

11.1.4. USING NEUROMAX LOADER 1. Have your PC cable close by. 2. Make sure that you will be ing defaults and ing them onto the same NeuroMax model (1002 to 1002, 1004 to 1004). 3. Double Click the NeuroMax Loader icon. 4. Select the correct NeuroMax model. 5. Choose Upgrade Software (takes approximately 10 minutes). 6. Choose to save defaults (takes less than 3 minutes).

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11.2. NERVE CONDUCTIONS This section gives you the basic steps for creating a Nerve Conduction Study (NCS), how to edit it, and how to set up a stimulus site.

11.2.1. CREATING A NCS 1. From the Main Menu screen, select Nerve Conduction Studies. 2. Find a blank position and press Backspace and C. Edit new name and press Select to save. Now choose new nerve name, choose test, and choose side to go to acquisition screen.

11.2.2. EDITING AN NCS 1. From a NCS Acquisition Screen, press Backspace and C simultaneously (or press the gray Default key on the keyboard) to open the Test Defaults Editing screen. 2. In this screen you can customize the amplifiers, gains, filters, and timebase by using the Up/Down arrows to move through the list and the Left/Right arrows to toggle through the options.

11.2.3. SETTING UP STIMULUS AND RECORDING SITES 1. In the Test Defaults Editing screen, use the Down arrow to highlight Reference Site and press R to designate the reference site as Recording or press S for Stimulation. 2. Press the Down arrow to highlight Site 1. The Site Name List appears in the top-right of the screen. 3. Use the Right and Left arrows to select the site name you want and then press the down Arrow to continue. 4. Press the Down arrow to move down the next site and repeat step 3.

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NOTE: IF THE SITE YOU NEED IS NOT IN THE SITE NAME LIST. GO MENU SCREEN AND SELECT ISTRATIVE OPTIONS. SELECT EDIT SITE NAME LIST, FIND A BLANK POSITION, AND

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THEN ENTE~-TH~-R~QUIRED SITE NAME.

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5. To enter normal values, highlight Normal Values and toggle through latency, amplitude, CV and distance using the Down arrow and enter the normal values that you have established in your lab. Once finished, press the Select key and then press S to save the changes.

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11.3. ELECTROMYOGRAPHY This section gives you the basic steps for creating an electromyography suite and how to use it.

11.3.1. CREATING AN ELECTROMYOGRAPHY SUITE 1. Decide ahead of time the order of the muscles you want to have in the EMG Suite and make

sure that they are in the EMG site name list. 2. From the Main Menu screen, select Electromyography and press the Select key.

3. From the Electromyography Test Menu select the Suite that you wish to rename and then press the C key. 4. Use the keyboard to enter the name of the Suite (e.g. upper limb) and then press the Select

key to save the Suite name. 5. When the Suite Column appears, use the Select arrows to highlight the first muscle in the list

and then press the Select key to save highlighted name.

6. Move to the next muscle in the Suite to select and repeat. 7. Press the Test Menu key to save and exit Suite creation.

11.3.2. USING AN ELECTROMYOGRAPHY SUITE 1. From the Main Menu screen, select Electromyography and press the Select key. 2. Select the Suite you want, the type of EMG test, and then the side. 3. The Suite name list appears in the active screen. Press the Start/Stop Control key to start

recording from the highlighted muscle. 4. When you are ready to move to the next muscle, press the Test Menu key to highlight the

next muscle or use the Up/Down arrows to move to the muscle you want to test. Once highlighted, press the Start/Stop Control key to begin recording . 5. When finished, press the Test Menu key to exit.

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11.4. ISTRATIVE FUNCTIONS The istrative functions are designed to help you prepare the NeuroMax for your specific circumstances and to manage the data you have acquired once the testing is complete.

11.4.1. EDITING STUDIES 11.4.1 .1.

EDITING A PATIENT STUDY WHILE IN ACTIVE PATIENT FILE

1. From Main Menu screen, press the Report key. 2. In the Function column, choose Edit Report.

11 .4.1.2.

EDITING A PATIENT STUDY NOT IN ACTIVE PATIENT FILE

1. From Main Menu screen, select istrative Functions and then select Patient Directory. 2. Using the Select arrows, choose Patient Directory, highlight patient name, and then select Test Directory in the Functions column. 3. Choose the test to edit and press the Select key, choose Recall and Edit File.

11.4.2. INTERPRETATION MACROS 11.4.2.1.

CREATING A MACRO

1. From the Main Menu screen, select istrative Functions and then select Edit Report Format. 2.

From the Edit Report Format Menu, select Edit Interpretation Macros to view the 30 titles that can be edited. Each title represents one interpretation macro.

3. To edit a title, choose it using the Select arrows. A red cursor appears in the lower box. Next use the keyboard to enter your prepared macro into the highlighted position and then press the Select key to enter the macro. 4. When finished, press the Select key once to move onto the next macro. 5. To exit from the Edit Interpretation Macros screen, highlight EXIT from Interpretation Macros and press the Select key.

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USING A PRE-DEFINED MACRO IN A REPORT

1. From the Main Menu screen, select istrative Functions and then select Patient Directory. 2. Highlight the patient name and press the Select key. 3. Choose Test Directory from the Functions column and press the Select key. 4. From the Test Directory, highlight Interpretation and press the Select key to open the Interpretation window. 5. Type in your entry or enter a macro. 6. To enter a macro, press the Notes key and then the two-digit number that represents the title of the new macro to enter. 7. Press the Select key to exit from the Interpretation screen.

11.5. TROUBLESHOOTING This section answers questions and gives you hints and pointers on how to deal with troublesome situations that may not require a service call.

11.5.1. SIGNAL CLIPPING IN NCS AND EMG There are four possible courses of action. i)_ Swap out recording cables. ii) Try different channels. iii) Check settings such as gain, filter, and notch filter settings. iv) Return to Main Menu screen , select Impedance Test, and then check electrode impedance.

11.5.2. STIMULUS ARTIFACT 11 .5.2.1.

WHAT IS A SHOCK ARTIFACT?

The electrical stimulus pulse and surface electrodes give rise to an artifact consisting of an initial spike and a longer lasting tail which often interferes with the recorded signal. It has 4 sources: i)_ Skin common-mode current escaping through the ground. ii) High filter characteristics of the amplifier.

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iii) Voltage gradient between the recording electrodes caused by a stimulus current flowing through the limb. iv) Capacitance coupling between recording and stimulus leads. The NeuroMax takes care of the first two variables. You can check the following: i) Properly connect the patient to the NeuroMax. ii) Provide a good ground between the stimulator and recording electrodes in order to tie the floating potential of the patient's limb to the machines' ground. iii) Reduce the skin to electrode impedances to reduce common mode voltages, artifacts and 50/60Hz interference. iv) Avoid crossing stimulator and recording cables to eliminate induced currents. v) Keep skin dry between electrodes to prevent bridging of the electrodes.

11.5.3. ELECTRODE IMPEDANCE NOTE: It is important to keep electrode impedance low and balanced. Electrode impedance should be kept below 1Ok (green range) for the best results in recording low amplitude signals (<50uV peak to peak). Higher impedance allows the incursion of power line interference (60Hz or 50Hz) and shock artifacts. Both of these phenomena can obscure your short latency sensory response. At these impedance levels, it becomes necessary to turn on your notch filter. Impedance greater than 1OOK red level with sensory responses below 100 uV peak to peak are invariably difficult to interpret. Unbalanced electrode impedance will produce a specific shock artifact. If the Reference electrode (+)is larger than the Active electrode(-), the shock artifact will start from above the baseline and sweep down. Similarly, if reversed , the shock artifact will start from below the baseline and sweep upwards.

11.5.4. SKIN PREPARATION NOTE: It is important to work with a clean skin surface. The skin is a living tissue. As such it is made of various layers. The top three layers are of crucial importance as they are highly nonconductive. The three layers are the actual dermis, the dead covering of dry scaly dead skin, and a layer of oils, sebum, and dirt.

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Normal SNAPs require no skin preparation. Clients who have callused, greasy, dirty, or dry skin require an extra effort on the part of the Physician/Technologist to obtain good results. Typically washing the skin area of interest (both recording and stimulus sites) with warm soapy water is adequate. For more difficult sites or where washing is difficult or inappropriate, rubbing with of an alcohol swab may be more efficacious. , you are removing these three layers so use of gentle force may be required. We recommend the use of a mild abrasive such as Omni-Prep (pumice suspended in a mild detergent), the hard end of a Q-tip, or rough tissue paper for more difficult situations.

HAZARD WARNING: Rubbing the skin may expose you to blood borne diseases. It is your responsibility to protect yourself and the patient from any with blood borne diseases. Please take appropriate care. 11.5.5. ELECTRODE TYPE AND PLACEMENT Proper electrode to skin connection is vital when attempting to perform a surface recording. 11 .5.5.1.

GROUND ELECTRODE

As a general rule, the larger the better. We recommend a stainless steel electrode with a surface area of at least 5cm2(0.75 inch2). A few drops of a conductive paste should be applied to the skin and the ground plate pressed on top of this. It may be held in place with a piece of tape. Another common solution is the use of a large disposable self adhesive, pre-gelled electrode. Place the ground BETWEEN the stimulator and the recording electrodes. 11 .5.5.2.

RECORDING ELECTRODES

Please be consistent. Always use the same type of electrodes for active and reference, otherwise your results may not be consistent. The most common type of electrodes are either metal discs (with conductive paste) or disposable self-adhesive electrodes. Both are usually about 0.5 to 3 cm2in area (0.1 to 0.5 inch2). The Active electrode (Black- Cathode) is to be placed over the nerve towards the cathode of the stimulator. The Reference electrode (Red+ Anode) is placed 2 to 3cm (distance is set by your procedure) distal to the active electrode (relative to the cathode of the stimulator), again over the nerve. Make sure that the skin surface between all 3 electrodes is dry. In addition, stainless steel clip type electrodes with conductive paste may be used. We do not recommend the use of steel coil electrodes for recordings if you are unfamiliar with their use. Slipping the coils onto the digit will disperse the gel between the two electrodes, usually causing an electrode bridge and subsequent shorting between the electrodes. Also, using spring coils or spring electrodes can increase the surface area and also disperse the signal since part of the surface area is over a silent area of the digit. Stimulus artifact may be reduced in these situations by covering the segment of the clip that is not over the nerve with a piece of gauze or tissue paper.

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NOTE: YOU WILL ONLY UP A SNAP IF YOUR RECORDING ELECTRODES ARE PLACED OVER CORRECT NERVE. BE AWARE OF ANOMALOUS INNERVATIONS.

-

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11.5.6. STIMULATOR Though the NeuroMax can stimulate well by simply pressing the stimulator prongs against the skin, if the message Stimulator impedance high appears on the screen you will be required to add a small drop of conducting gel to the stimulator prongs. Do not spread the gel otherwise the current will spread over a larger skin area, effectively diminishing the current under the prongs forcing you to increase the applied current and causing stimulus artifact problems.

11 .5.6.1.

PATIENT COMFORT

NOTE: A relaxed patient is your friend.

Keep the stimulus current to "just the right amount." Excessive current causes the patient to feel pain and the NeuroMax to pick up excessive stimulus artifact. Furthermore, tense patients contract their muscles and inject EMG activity into the sensory recording. This will make your NCV look very rough making correct interpretation impossible.

SUSPE~T T~

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ELEC~RODES TEN~E~R~

HINT: IF YOU T THE TH YOUR IS TO - OBSERVE THIS WITH EITHER A FREE RUNNING SURFACE EMG OR BY INCREASING THE SPEAKER VOLUME. USE THIS TO HELP RELAX THE PATIENT.

11.5.6.2.

--1

I

HOW TO STIMULATE

NOTE: Slow and steady.

The amount of current is determined by slowly increasing the stimulus intensity until the SNAP appears. Continue to increase the current until the amplitude of the response ceases to increase. If the patient is obese, has hard, dry skin or has a neuropathy, then you will have to increase the current beyond normal limits. , increasing the current will cause the current to spread and to be shunted in unpredictable ways almost always leading to the formation of a shock artifact.

11 .5.6.3.

LEAD WIRES

NOTE: Reduce induced currents.

With individual unshielded recording lead wires, the best results are achieved when the active and reference lead wires are of the same length and are loosely twisted together up to the point where they have to branch off to reach the electrode placements. They should be kept away from other cables and from the unit's enclosure to minimize interference from power lines and other external sources.

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Similarly, when stimulating with two individual cables from the NeuroMax Stirn Probe, those wires should also be twisted together and kept away from recording lead wires. This will ensure no increase in stimulus artifact due to coupling between cables. In environments with high interference levels, better SNAPs are recorded if you use the NeuroMax shielded acquisition cable. This cable takes advantage of NeuroMax's unique active differential shield drivers producing efficient shielding without compromising on common mode rejection and signal bandwidth. This cable plugs into the 5 pin DIN connector on the headbox and provides alligator clips for active, reference and ground electrodes. XLTEK's design differs from other manufacturer's shielded recording cables that do not differential shield driving technology and instead rely on simply grounding their shields. Cables of this type add common mode capacitance to the input lines causing degradation of high frequency common mode rejection which in tum causes an increase in stimulus artifact and an increased susceptibility to high frequency interference. Depending upon cable length, signal bandwidth may also be compromised. Such cables may reduce power line interference at the expense of an increase in stimulus shock artifact, increased high frequency interference, and reduced bandwidth.

11 .5.6.4.

WHEN ALL ELSE FAILS

Sometimes the obvious solutions is the right one. When all else fails, check the following: 1. Check your impedance. Keep both low and relatively even. HINT: IF BOTH ARE EXACTLY THE SAME, SUSPECT A FAULTY GROUND. UNPLUG THE GROUND, IMPEDANCES SHOULD RISE. IF THEY DO NOT, CHANGE THE GROUND CABLE.

2. Try running a surface EMG with the volume on. The EMG acts as an oscilloscope, if there is noise in the system, you may be able to spot it here. 3. Unplug any other devices on the same circuit such as printers, mechanical beds, vacuum

cleaners, or other potential sources of leakage current. 4. A medical grade ground should be installed in your clinic. Some clinics do not have properly

grounded electrical systems. 5. If the patient is tense, ask her to relax. 6. Frequent inspections of your cables will help prevent recording problems. 7. Always have a backup acquisition cable and a backup ground. 8. Are any of the electrodes touching? If so, they are causing a short circuit and you will develop

an artifact. 9. Try pressing X on the keyboard to mathematically remove the shock artifact from the waveform in the acquisition screen.

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10. Rotate the anode around the cathode. This might shunt the shock artifact away from the recording electrodes. 11. Increase or decrease the pulse duration of the stimulus. 12. Average the sensory response.

11.5.6.5.

REDUCING ELECTRODE IMPEDANCE

1. Use an alcohol prep pad to swab the skin to remove any excess sweat or lotion.

2. Use a mild abrasive paste or pumice tape and gently rub the skin over the stimulation site to remove dead skin and then swab with the alcohol pad. 3. Instruct patients ahead of time to avoid applying lotion to the skin on the morning prior to their test. 4. Make sure that the sticky electrodes are adhering properly to the skin. If they have become loose, replace them with new ones. 5. Make sure that the Stirn probe has some gel on the tips and that there is not gel all over the

patient's skin causing a bridge. 6. Make sure that the patient is properly grounded--good sticky electrode, wet Velcro ground

strap, and good connections in the headbox.

7. When in doubt, try another channel.

11.6. AV STIM 1. Attach the short cable between the NeuroMax and the AV Stirn and then turn on the power to

the NeuroMax. The NeuroMax recognizes the AV Stirn. 2. When the power is turned on, the green power light on the AV Stirn lights up and the red

stimulus light flashes once confirming the initialization of the AV Stirn with the NeuroMax. 3. If you are having problems printing, check the other inputs to the AV Stirn (printer, VGA monitor, headphones). 4. If a printer is hooked up to the AV Stirn but is not plugged into an outlet, power will drain from

the NeuroMax and prevent the acquisition of BAERs and VEPs. Disconnect the printer.

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11.7. PRINTING If you are having printing problems, try the following:

11.7.1. NEUROMAX 1. Shut down NeuroMax and printer and then disconnect all cables. 2. Reconnect all cables, tum on the printer, and then turn on NeuroMax. 3. From the Main Menu screen, select istrative Studies and then select Patient Directory. 4. Select the patient file and then select Print Report.

11.7.2. PRINTER ,_ Try individual test print from the printer itself by disconnecting from NeuroMax and holding down the paper feed and power button. , Swap out printer cable and or Opto cable. ,. Does the printer need a new toner cartridge? ,. files to Archiver and print direct from PC to printer.

11.8. PREVENTATIVE MAINTENANCE Following a regular schedule of preventive maintenance will help to prolong the lifespan of the NeuroMax. Regular preventive maintenance does not involve access to the interior of the NeuroMax; for service problems that require corrective maintenance and/or internal component service, please call the Excel Tech Service department at 1-800-387-7516, or your local Excel Tech representative. Preventive maintenance involves regular inspection and cleaning of all system components, including the NeuroMax enclosure, keypad, Screen, back and connectors, headbox and headbox cable, stimulus probe and cable, printer and printer cable and all electrodes and accessories: Being an extremely portable system, the NeuroMax will probably be subject to increased daily wear and tear as compared to previous, larger EMG systems; this fact has been a very conscious part of the design of all aspects of the NeuroMax and its performance. That being said, taking basic care of the system by avoiding extreme physical will help prolong the lifespan of the NeuroMax.

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CAUTION: DISCONNECT THE POWER CORD FROM THE SYSTEM AND THE WALL BEFORE CLEANING. USE A LINTFREE CLOTH. DO NOT USE ABRASIVE CLEANERS ON ANY SYSTEM COMPONENT( SEE ENCLOSURE BELOW).

Be careful not to allow any excess fluid to seep into the internal electronic components of the system; be especially careful around the grills located both on the front near the top (i.e. the speaker grill) and on the left side of the NeuroMax near the back, as well as around the back connections and the headphone jack on the right side near the front.

11.8.1. NEUROMAX ENCLOSURE The NeuroMax enclosure can be cleaned with a damp cloth, using water, mild detergent or cold sterilizing agent. As above, be careful to avoid allowing excess fluid to seep into any internal components. Since the enclosure is manufactured using a high-grade aluminum metal, there should be no cracks in the case itself; periodic inspection of the enclosure mounting screws is only required to ensure that the screws are not coming loose.

11.8.2. KEYPAD The keypad should be cleaned with a damp cloth (water or mild detergent) only. Do not use any commercial cleaning products, as they may react with the rubber composition of the keypad. Closely inspect the individual keys on a regular basis to ensure no cracks have occurred. Avoiding any sustained exposure to extreme temperatures (above 50° Celsius or below -20° Celsius) will help prolong the integrity of the keypad.

11.8.3. SCREEN The screen itself is protected with a front cover made from a mylar-type material, however the screen uses glass internally, so care should be exercised not to drop or bump the screen, as this may cause the glass to crack or break. The screen can be cleaned in the same fashion as the keypad, by wiping with a damp cloth with no water dripping off or a mild detergent, though a soft lint-free cloth is recommended for cleaning the screen.

11.8.4. BACK PANEUCONNECTORS The back of the NeuroMax contains the headbox connector, the printer connector, the AC power cord connector and the Power ON/OFF switch (and fuses). The itself is made of a heavy grade, reinforced fiberglass material; avoid any excessive physical stress on the itself or any of its components. Check regularly for any cracks that may have developed in the ; Excel Tech service if you suspect any physical damage to the back .

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CAUTION: DO NOT LEAVE ANY CABLES CONNECTED TO THE BACK WHEN TRANSPORTING THE NEUROMAX; DOING SO MAY CAUSE THE CONNECTORS TO COME LOOSE, AND/OR MALFUNCTION. THE BACK AND CONNECTORS SHOULD ONLY BE CLEANED WITH A DRY, SOFT, LINT-FREE CLOTH.

11.8.5. HEADBOX AND CABLE The headbox should only be cleaned with a dry, soft, lint-free cloth. Check regularly to see if any of the electrode connections have become loose; if so, Excel Tech service. The headbox itself is a completely ive electronic device, but care should still be taken to avoid extreme physical stress to the headbox. Check periodically to determine cable integrity. DO NOT LEAVE THE HEADBOX ATIACHED TO THE NEUROMAX WHEN TRANSPORTING THE UNIT.

11.8.6. STIMULUS PROBE AND CABLE The stimulus probe body and cable can be cleaned with a soft, lint-free cloth or a damp cloth soaked in water, mild detergent, or a cold sterilizing agent. Determine cable integrity regularly. The stimulus probe headpieces can be cleaned in the same fashion as the body, but extra care should be taken to remove all electrode gels or pastes that have been used on the headpieces; avoid any long term build-up of gels or pastes on the stimulus probe headpieces, as this may interfere with the optimal performance of the stimulus probe. If the various headpieces do not fit snugly into the probe body, replace them immediately to ensure optimal performance.

11.8.7. PRINTER AND CABLE The NeuroMax must be used with a IEC 601-1 + A1:1991 + A2: 1995\EN60601-1.03.96 printer. The printer is attached via a standard printer cable to an Opto Isolator cable which then connects to the NeuroMax through the 25 pin printer port. DO NOT LEAVE THE PRINTER ATIACHED TO THE NEUROMAX WHEN TRANSPORTING THE UNIT.

11.8.8. ELECTRODES AND ACCESSORIES Regularly clean all surface electrodes and accessories with warm, soapy water or liquid sterilizing agents; ensure that all gels and/or pastes are removed from the electrodes and their cables. Follow the electrode manufacturers' instructions for cleaning and/or sterilizing all electrodes and accessories. While the NeuroMax has been carefully designed and manufactured to be as reliable and durable as possible, regular cleaning and inspection of system components can only help the long term trouble-free operation of the system. As with other types of medical instrumentation, try to avoid

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extremes of physical stress (i.e. dropping the unit, etc...) and sustained exposure to extreme temperatures. If you suspect any problem that might impact on the safety or effectiveness of the NeuroMax, call Excel Tech service at 1-800-387-7516, or your local Excel Tech representative.

11.9. ADJUSTMENTS If you experience any trouble operating the NeuroMax, it is possible that many of the problems may be overcome through simple adjustments. This chapter offers a few suggestions designed to overcome some of the more commonly found difficulties; if you experience any trouble that is not described in this section, or if the suggestions here do not correct the difficulty you are having, please call Excel Tech Ltd. or your local Excel Tech Representative for service.

11.9.1. NO ELECTRICAL STIMULUS The patient does not feel the stimulus pulse, or does not respond to any pulse as expected. The stimulus probe or stimulating electrodes connected to the probe do not deliver any electrical stimulus. Check the following: 1. Check the lower right comer of the screen, in the stimulator status area, to see that the "STIMULATOR ON" message is displayed. If the display reads "OFF", press the START/STOP switch once to activate the stimulator. 2. Check the stimulator status area to determine that the intensity level, in mA, is appropriately set for the current test. 3. Check the connection between the stimulator probe cable and the headbox to ensure that the fit is snug. 4. Check the connection between the headbox and the NeuroMax (at the back on the lower right side of the NeuroMax to ensure that the head box is properly connected - be sure to tighten the thumbscrews so that the headbox cable does not come loose. 5. Check that the skin between the two stimulating electrodes (i.e. anode and cathode) is clean and free from any layer of conducting gel or paste that might create a bridge between the anode and cathode. 6. Press MAIN MENU to exit to the main menu, and then re-enter the current test to reset all software and hardware settings for the stimulus. 7. Check that the "Stimulator Impedance High" error message does not appear when you attempt to stimulate. If it does, clean the stimulus site on the skin and prepare the site with some type of abrasion (e.g. Omni-Prep) to decrease the impedance level.

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11.9.2. NO RESPONSE FROM PATIENT ELECTRODES A. in NCS or EMG Mode - The acquired waveforms are flat, do not appear, or do not correct (or as expected). Check the following:

appear

1. Make sure that the patient electrodes are connected to the correct amplifier channel in the headbox. In all test modes, the screen will display the currently active channel beside the test name in the data table area; check that the active channel corresponds to where the patient electrodes are connected in the headbox. 2. Check that the patient electrodes fit properly into the headbox (not loosely), and also check that there are no apparent breaks in the patient electrode cables. 3. Check the patient electrode impedance levels - if the impedance levels are too high, you may need to replace the electrode, electrode cable, or simply re-prep the recording site on the skin. Make sure that the positive and negative recording electrode sites have similar impedance values. 4. Check the connection between the headbox and the NeuroMax to make sure that it is tight. 5. Check the screen gain and timebase settings to ensure that they are appropriate for the current test. You may also want to check the LFF, HFF, and Notch Filter settings, as well as any sweep or trigger delays being used. 6. Press MAIN MENU to exit to the main menu, and then re-enter the current test to reset all software and hardware settings for the amplifiers B. in Dual Channel Mode, check for all of the above situations, and then check the following : 1. If the current test calls for averaging, check that the "AVERAGER ON" message is displayed on the screen. If it is not shown, press the AVERAGER hardkey. 2. If the AVERAGER is "ON", check the raw data display to ensure that appropriate data is actually being acquired through the amplifiers (Press space bar to display raw data). If the raw data display is flat, then no data is being acquired by the amplifier(s).

11.9.3. LARGE STIMULUS ARTIFACT There appears to be an excessively large stimulus artifact at the beginning of each triggered waveform; this can occur in any NCS or Dual Channel test, and may cover up the actual waveform of interest. Check the following : 1. Check the patient electrode impedance levels - if the impedance levels are too high, you may need to replace the electrode, electrode cable, or simply re-prep the recording site on the skin. Make sure that the positive and negative recording electrode sites have similar impedance values.

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2. Check the integrity of the ground electrode cable. If it appears broken or bent at all, try replacing it. 3. Position the ground electrode between the stimulating electrode (or probe) and the active recording electrode. 4. If you are using a non-disposable, metal ground electrode plate, check that there is no corrosion or build up of gel on either the surface of the plate or the between the plate and the cable. 5. Check that the amplifier gain setting is appropriate for the current test. It is possible that you may be over-amplifying the signal being recorded, and thus over amplifying the stimulus artifact. 6. If you are using single shot stimulus mode, or even if you are using train mode with a low number of pulses per train, try using AVERAGED acquisition (i.e. press the AVERAGER hardkey to tum on the Averager) to reduce the influence of the variable "noise" of the Stimulus artifact.

11.9.4. NOISY OATA The data being displayed on the screen seems excessively noisy. Check the following : 1. Make sure that the patient electrodes are connected to the correct amplifier channel in the headbox. In all test modes, the screen will display the currently active channel beside the test name in the data table area; check that the active channel corresponds to where the patient electrodes are connected in the headbox. 2. Check that the patient electrodes fit properly into the headbox (not loosely), and also check that there are no apparent breaks in the patient electrode cables. 3. Check the patient electrode impedance levels - if the impedance levels are too high, you may need to replace the electrode, electrode cable, or simply re-prep the recording site on the skin. Make sure that the positive and negative recording electrode sites have similar impedance values. 4. Check the connection between the headbox and the NeuroMax to make sure that it is tight. 5. If everything appears prepared and set up as it should be and there still appears to be noise in the data being acquired, try using the other acquisition channel. To switch acquisition channels, put the active and reference recording electrode cables (or the 5 pin D.I.N . cable) into the other channel designated on the headbox, and then press the CHANNEL SELECT button on the keypad to switch recording channels. The data area of the screen will always display which channel is currently being used.

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11.9.5. UNIT DOES NOT POWER ON The unit does not power on when the "on" switch is pressed. Check the following: 1. Check both ends of the AC power cord to ensure they are connected to the unit and the wall properly (use only an approved hospital grade, 3 pronged outlet for AC connection). 2. Check that the green LED for "power On" is lit up (this can be found below the screen on the left side of the front screen ). If the power on LED appears to be lit and the screen is not on, call Excel Tech service. 3. Check the fuse which is located beside the ON/OFF switch on the back . If the fuse needs replacing, replace only with a 1.6 A, 250 V, slow-blow fuse.

11.9.6. ERROR MESSAGES There are a few error messages which may appear from time to time when you are using the NeuroMax EMG system. Most of these messages have simply been designed to warn you that less than perfect testing conditions exist, or that you must do something to continue on in a test mode. If any of these messages are unclear, please call your Excel Tech Ltd. representative. The following messages are presented in alphabetical order.

"Are you sure(Y/N)? If yes, current waveforms will be lost" This message only appears when you have existing information in the patient information screen (i.e. the active or current patient file) and you select NEW PATIENT. When the system has been turned on and you are testing a patient (with patient info already entered), you may decide to press PATIENT INFO to enter the patient information screen. When you do this there are two choices shown - 1. Edit Current Patient, and 2. New Patient. If you SELECT the first option (Edit Current Patient), the cursor will move to the first patient information field and you can now edit existing information and/or make additions to the existing patient information screen. If you have finished testing the current patient and now have a new patient, this error message is simply warning you that the WAVEFORMS will be lost. It is important to know that you will not lose the existing patient file, the existing final report or the existing test files complete with all of the numeric data; only the actual waveforms will be lost. If required , you can exit the patient info screen, press REPORT and choose STORE REPORT WITH WAVEFORMS. However, if you simply select new patient, the complete patient file, minus only the actual waveforms, is automatically stored.

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"Erase Trace(s) to Acquire more data" The NeuroMax can acquire up to eight traces per dual channel test screen, and up to twenty stored traces for all F-wave and H-reflex tests. Once you have acquired a complete set of data for any one of these tests (i.e. all trace locations have waveforms), you cannot acquire any more data for the current test. If you try to acquire more data in this instance, the screen will display the error message shown above. There are two ways to acquire more data in this case: 1. You may choose to erase a particular trace or set of traces -OR2. Press TEST MENU, and re-select the current test to acquire a new set of data while automatically storing the old set of data. Once again this error message appears simply to let you know that you must proceed in a particular fashion, so that no test data is ever inadvertently erased.

"WARNING: the flash memory is almost full" The permanent storage capacity of the NeuroMax is almost full. There will not be enough memory available to store all data and waveforms for the current patient if the test is too large. To proceed with the current test, you must first make additional memory available by deleting some patient final reports from the patient directory, ing that reports stored with waveforms require substantially more memory than reports only.

"Previous data will be erased. To accept, press Y. Any other key to keep present data and not start stimulator." You are in the RECORD mode of the F wave test modality. You have already acquired a setofF wave responses which are displayed on screen, with the associated data values in the data table. When you press the START/STOP switch to begin another train of stimuli or deliver a single shot stimulus, this error message appears. If the existing data set on screen is inadequate and you wish to erase them and acquire a new set, press Y and then START/STOP to erase the existing trace set and acquire a new set. If you wish to keep the existing set and acquire a second set for comparison later on, press N, and then press TEST MENU tore-select the F wave study and acquire a new set of responses. By going through the TEST MENU, you are in essence doing a "new" test, and once completed the patient file will have both F wave tests, with their associated test times, in storage. In this manner, you can do a couple of tests, and then at some later time edit or delete one of the tests, keeping the other one for your final report.

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"Printer Error" This message only appears when you attempt to either print a screen copy or a final report. The printer is either not connected to the NeuroMax, or it is not powered on. When the NeuroMax is initially powered on, AC power is immediately supplied to the printer; however, if for some reason the printer is turned off during testing, you must press the printer's POWER ON button to reinitialize the printer.

"Printer Out Of Paper" This message only appears when you attempt to either print a screen copy or a final report. The printer is simply out of paper, and you must feed either a single sheet into the drive mechanism or load the sheet feeder with more paper.

"Out of Range" You have either entered an invalid number for the number of pulses in the train or You have entered an invalid number for the stimulus frequency. The maximum number of pulses allowed in any single train is 60 pulses; the minimum number is 2 pulses. Therefore the number of pulses that can be entered is between 2 and 60 pulses. The stimulus frequency range is nominally 0.0 Hz to 50.0 Hz; the number entered must be lower than 50.0. You may choose any value below 50.0, accurate to one decimal place (i.e. 27.8 Hz is acceptable). For patient safety and comfort however, the maximum stimulus frequency is also dependent upon the pulse duration chosen, such that at higher stimulus pulse durations, the maximum frequency available is decreased (see Table 9.1 below). Table 9.1 -Maximum Stimulus Frequencies at all Pulse Durations

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Pulse Duration

Max. Stirn Frequency

0.05 ms

50.0 Hz

0.10 ms

50.0 Hz

0.20 ms

25.0 Hz

0.30 ms

16.6 Hz

0.50 ms

10.0 Hz

1.00 ms

5.0 Hz

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"Stimulus Impedance High" The NeuroMax has been designed to deliver a constant current stimulus pulse throughout a wide range of skin impedances; the current will be constant as long as the impedance is below 4,000 Ohms. Above this level, the actual current being delivered to the patient may be less than the predetermined value chosen by you. To warn you of this situation, whenever you try to deliver a stimulus pulse and the impedance level is over 4.0 kOhms, the system will deliver the pulse and display the error message superimposed above the trace that was acquired. The best course of action is to improve the skin preparation of the site used for stimulating. Alternately, you may wish to check the integrity of any electrode or electrode cable you are using to deliver the stimulus pulse to the patient.

"This test is not yet defined for the selected nerve" You are in the Nerve Conduction Studies TEST MENU, and have already selected a nerve to test. The selected nerve appears in the menu as a highlighted selection. For a particular nerve, only certain tests have been defined, and you currently have highlighted a test which is NOT defined. If you continue on by pressing the SELECT switch, the default NCS test screen will appear. Press the left or right arrows of the SELECTOR SWITCH and see that as you highlight different tests for the selected nerve, the error message will appear and disappear, depending on which test is highlighted. As an example, if you choose RADIAL nerve and then highlight "H Reflex", the error message appears, because no H reflex test has been defined for the radial nerve. If you now press the left arrow three times to move to SNC, this test has been defined, so the error message will disappear.

"To move to the RECORD screen, at least one M wave must be obtained." You are currently in the SET UP mode of either the F wave or Repetitive Stimulation test, and you have pressed the SELECT switch to move to the RECORD mode. In the SET UP mode of these two tests, the first step is to acquire an appropriate M wave response before proceeding to the RECORD mode. The system requires that you have at least one M wave on screen before moving to the RECORD mode. Press the START/STOP switch to acquire an M wave response before pressing SELECT to move to the RECORD mode.

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11 .1 0. CALIBRATING THE NEUROMAX The factory calibration is digitally stored on the unit and should NOT be modified outside the factory. External checking of the calibration may be performed. The accuracy of the stimulator is better than 1% in both ampl~ude and duration. The accuracy of the waveform acquisition section is also better than 1% in both amplitude and time. A calibrated oscilloscope and a calibrated signal generator are required to calibrate the unit. Attach the Headbox to the NeuroMax; insert the stimulator into the headbox and proceed with the calibration.

11.10.1. CALIBRATING THE STIMULATOR: 1. Place a 1Kohm 1% resistor across the leads of the stimulator 2. Access a test routine and temporarily reset its parameters. As an example: SELECT Nerve Conduction Studies -+ Next SELECT Median MNC 3.

-+

Next SELECT a Test

-+ Select any side and press SELECT to enter the Test Screen

Once in the Blue Test Screen, press STIMULATOR. Set the stimulator to 1.0msec pulse duration, and 100mA Max Intensity. Press STIMULATOR to exit

4. Increase current to 1OOmA by pressing the STIMULUS UP arrow key 5.

Measure the voltage generated across the resistor using a calibrated oscilloscope. Results: The voltage should be 100 +/- 1 Volt, duration should be 1 +/- 0.01 msec.

'-

11.10.2. CHECKING THE WAVEFORM 1.

Put a 80mV peak to peak 1KHz waveform into Channel 1 using a calibrated signal generator

2. From within the Blue Test Screen, press SETIINGS 3. Change the display settings to Notch Filter OFF LFF 0.1 Hz HFF 15 kHz Gain 1OmV/div Timebase 5msec/div 4. Repeat with other Channel(s) Note: In Dual Channel, a 80mV signal may be too large to display on the screen. Be certain that the display is set at 20mV peak to peak Results: The amplitude of this waveform should be 80mV peak to peak +/- O.Bm

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12 XL TEK DIAGNOSTIC ACCESSORIES 12.1 INTRODUCTION XL TEK manufactures high-end, technologically advanced neuromuscular and neurophysiological instruments for the complete spectrum of diagnostics and has been recognized as one of Canada's Top 50 Best Managed Private Companies XL TEK has encomed yet another segment of medical diagnostic products. Our Accessories Division comprises quality EMG and EEG supplies at competitive prices. We are dedicated to sourcing superior products that enhance patient well being while improving recording characteristics.

Our Accessories Representatives would be pleased to discuss maximizing your savings through our Preferential Pricing Agreements and Promotional Discounts please call 1-800-387-7516.

12.2 HOW TO ORDER ACCESSORIES CALL

Toll Free

ONUNE

FAX

Toll Free

1·800-387-7516

1·888-404·2992

www.llltak.com

Monday through Friday 8:00 a.m. to 6:00 p.m. (EST)

24 Hours a Day 7 Days a week

24 Hours a Day

XLTEK DIAGNOSTIC ACCESSORIES For Information Regarding: ~

Preferential Pricing Programs

~

Product information and pricing

~

Sales and Service

~

Warranty Programs

XlTEK~

Call Us at:

1-800-387.7516 And ask for our Diagnostic Accessories Representative Or Email us at : [email protected]

115

NeuroMax

Manual

12.4 ORDER FORM FAX TO 905-829-5304, OR 888-404-2992

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~ ~&§"" ~~ 1 J BILL TO:

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P URCHASE O RDER No:

L..-_ _ _ _ _ _ _ ___. 1

SHIP TO IF DIFFERENT THAN BILLING:

NAME

NAME

INST/D EPT

INST/D EPT

BILLING A DDRESS

S HIPPING A DDRESS

C ITY

C ITY

STATE/PROVINCE

S TATE/P ROVINCE

Z IP/POSTAL C ODE

Z IP/P OSTAL CODE

PHONE

EXT.

FACSIMILE

P HONE

EXT.

FACSIMILE

METHOD OF PAYMENT:

INVOICE NET 30 DAYS

D

VI S A

D

M.C.

D

I C REDIT CARD NUMBER

NAME PRINTED ON CARD

EXP. DATE

SIGNATURE

SPECIAL INSTRUCTIONS:

ACCESSORY ORDER: ITEM NUMBER

PART DESCRIPTION

QUANTITY

•Taxes will be applied to Canadian customers. If you are PST exempt please submit forms to XL TEK via fax at 1-888-404-2992. **Please Choose One of The Following Shipping Options: .:1 UPS Regular Delive ry: $10.00 .:1 2 nd Day A ir Delive ry: $20.00 .::::J N ext Day Air D e livery: $30.00

=xLTEK ~

COST/ITEM

TOTAL AMT.

Taxes* SHIPPING** Order Total

121

NeuroMax

Manual

INDEX 24 Hour Replacement, 87 Accessories, Diagnostic, 115 design & quality, 117-119 order form for, 121 ordering, 115 inistrative Functions, 73 AEP impedance check, 65 protocols, 65 Archiver about, 78 installing, 78 starting, 79 AV Stirn cautions, 64 AV Stirn 1000, 61 calibration & maintenance, 64 connecting, 62 front , 61 rear , 61 warnings, 63 warnings & cautions overview, 63 Batch Print, 76 Blink Reflex Test about, 51 conducting, 51 setting up, 51 Calibrating NeuroMax, 114 stimulator, 114 Cautions, 16 Clinical Service, 87 Control Keys, 20 Defaults editing test, 70 setting test, 69 EMG acquiring, 38 activating triggers, 40 analyzing motor units, 41

_, XlTEK

fast triggered features , 42 free run, 39 review & edit fast triggered , 42 saving a test, 41 triggered features , 40 turns & amplitude, 39 EMG Notepad edit, 77 EMG Suite creating, 69, 96 using, 96 EMG Tests about, 37 setting up, 37 EP Test conducting, 46 setting up, 45 Fast-Triggered Studies editing, 82 Files manual disk transfer, 79 RTF, 81 serial/parallel port transfer, 80 transferring to PC, 79 Function Keys, 21 F-Wave & Rep Stirn Tests recording , 35 setting up, 33 Hot Keys, 23 H-Reflex Response acquiring, 36 H-Reflex Test setting up, 36 HRV Test about, 53 conducting, 54 setting up, 53 Incremental Stirn about, 52 setting up, 52 Incremental Stirn Test conducting, 52

123

NeuroMax

Manual

In-Service Checklist, 89 Introduction, 10 Key Pad , 19 Liability limitations, 86 Macro creating, 97 using pre-defined, 98 Main Menu , 18 Maintenance Service, 87 Manual using, 10 MCD calculating, 43 Memory Management, 74 Multi-Channel EMG/IOM, 55 Multi-Channel Nerve Conductions, 56 M-Wave Response obtaining, 34 Nerve Conduction Study conducting, 32 creating, 95 editing, 95 setting up, 30 setting up sites, 95 Nerve Conduction Tests about, 29 NeuroMax 1002,9 1004,9 about, 13 operating conditions , 13 operating environment, 13 transport and storage, 13 NeuroMax Loader installing, 94 using, 94 P 300 Test getting started, 56 hints & features, 58 options, 59 running , 57 Patient Directory, 73

124

Patient File creating , 24 Patient Info edit, 77 Publisher's Notice, 7 Report Format edit, 76 Report Functions, 26 Reports editing, 82 managing, 81 printing, 82 viewing patient, 81 Select Keys, 20 SEP Test, 47 protocols, 48 Site Name List edit, 77 Software checking version , 93 updating, 93 Stored Data changing date on, 77 Studies editing, 97 Sympathetic Skin Respose (SSR), 54 System Options, 76 Test Menu modifying parameters, 69 Test Reports generating, 25 Troubleshooting, 98 AVStim , 103 electrode impedance, 99 electrode type & placement, 100 error messages, 11 0 large stimulus artifact, 108 no electrical stimulus, 107 no electrode response , 108 no power, 110 noisy data, 109 preventative maintenance, 104 printing, 104 signal clipping , 98 skin preparation, 99

XLTEK

Manual

NeuroMax

stimulator, 101 stimulus artifact, 98 adjustments, 107 Troubleshooting & Maintenance, 93 VEP acquiring fulfield response, 67 acquiring hemifield response, 68 impedance check, 66 protocols, 66 Warnings, 14 Warnings & Cautions about, 13

= XlTEK

Warranty, 10 definitions, 87 duration, 85 extended info, 86 extent of limited, 85 limitations, 86 service, 85 Waveform checking, 114 Waveforms printing in archiver, 83 Welcome, 9

125

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