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XLTEK NeuroMax User Manual

1. 97 Mair MENU naiean nin 23 Manual USTO Pr 14 Memory 85 Multi Channel 64 Page 117 Xltek NeuroMax Multi Channel Nerve Conductions 65 N Nerve Conduction Study MR MR CC 36 94 94 SEWING Hio eet 34 seng UD SIES 94 Nerve Conduction Tests ABOU de 33 NeuroMax 12 1 OO S 12 CUD OUI 15 operating 15 operating 13 15 transport and 15 P P 300 Test gettibd SIaltet soenoe 65 NNSA FEATURES uiid ia se Dui 67 OPON S 69 terete tre 67 Falient 84 Patient File Ree T 29 Patient Info 87 R Rep Stim Test 37 eatre S cie 43 esen a 38 Report Format 1 87 Report FUNCIONS RA 30 Reports 88
2. 2 lt D UJ TI 120 VAC 60 Hz 1A Frequency and 230 VAC 50 Hz 0 4 A Rated Current Protectively grounded detachable power supply cord 105 dB 2 9 nV VHZ UA 58526950 i T D CO 5 5 o S O Q Page 16 User Manual XLTEK NeuroMax Stimulator Specifications 450 Voltage Maximum Stimulator 100 mA Current Stimulator Current E 1 Accuracy 1 Accuracy Voltage Accuracy on 1 Screen power supervisor circuit shuts off power if insufficient power is present 2 3 WARNINGS AND CAUTIONS The following Warnings and Cautions are marked with a and must be followed very closely to ensure the safety of both the patient and the user of the NeuroMax and the AV Stim It is therefore important to read and observe ALL of the Warnings and Cautions before attempting to use the NeuroMax and the AV Stim If there is any malfunction or perceived malfunction of the system please call an authorized XLTEK service representative immediately at 1 800 303 0306 All internal system checks and or service must only be conducted by an authorized XLTEK service representative IMPORTANT SYSTEM REFERS TO THE NEUROMAX AV STIM AND ALL ACCESSORIES ATTACHED TOIT The NeuroMax and AV Stim carry the ordinary equipment classification as per IEC 529 for the level of protection against ingress of liquids They not
3. 4 4 22 22 4 49 analyzing motor 2 22 2 50 48 SAVING Mc EO 50 triggered features 49 turns amp 48 EMG Notepad Mr rc 87 EMG Suite credin 81 95 ESTER 95 EMG Tests 21916 45 E AT 45 User Manual EOG Protocol rere rete S 72 OO EDO 72 EP Test 51 ERG Protocol c 71 ERG Test IDON sereni a 71 F Files Bb A A 88 CE ER 25 F Wave Test AD OU 40 ANE 43 45 41 IOLA mc 27 H Reflex Response Pieter 44 H Reflex Test SO TING WUD 44 HRV Test ADOT oean eer kare Io IEEE OUR 61 COMOUCHIIG eiit es 61 Seting c o ER rd ve Urs ui deve 61 Incremental Stim Test LOUIE me Tc 58 COMOUCUING TE 60 DEREN DUDEN 58 VAES 60 In Service Cie kllSU osa petet a 90 Mem E 13 K Key Fa 24 bts ibm 96 using
4. am interested in Nerve Conduction Studies EMG Evoked Potentials Both Eq COMMENTS Please Confirm Date Completed Client Name Sales Rep please print please print Signature Signature Page 92 Xltek NeuroMax User Manual 10 APPENDIX 2 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 contact XLTEK Technical Support Phone 1 800 303 0306 Email OT S natus com 10 1 SOFTWARE The following sections show you how to verify the software version on your machine how to update your software and how to install NeuroMax Loader 10 1 1 CHECKING SOFTWARE VERSION ON NEUROMAX 1 Turn on the power to the NeuroMax 2 From the Main Menu screen press ESC and the V key on the keyboard 3 he version number appears in the bottom left corner of the screen 10 1 2 UPDATING SOFTWARE Obtain the newest version of software by contacting Technical Support at 1 800 303 0306 or OT S natus com NOTE ANY CUSTOMIZATION OF TEST DEFAULTS AND REPORT FORMAT WILL NOT BE AFFECTED 10 2 NERVE CONDUCTIONS This section gives you the basic steps for creating a Nerve Conduction Study NCS how to edit it
5. still openandnew If the NeuroMax is turned off the patient file is no cata can be added longer active and must be recalled from the Patient Directory for review 2 9 GENERATING TEST REPORTS Once you have established a patient record you can proceed to the testing stage However it is likely that you will need to record store and distribute the test data Thus you will have to generate reports The following sections show you how to operate the NeuroMax report function and how to design it to your specifications 2 9 1 REPORT FUNCTIONS The first method of reporting is to access the report Besa lon functions while a patient is active eating a Patient Ale Page 30 User Manual XLTEK NeuroMax 1 From the NeuroMax Main Menu screen in an M active patient file press the Report key You can also access the Rot Functions fromwithin any of am thethreetest menus n FUNCTIONS 0 Patient Callback 1 Test Directory 2 Print Report 3 View Report 8 Print Letter 9 Save File to USB 10 Exit Directory Use arrows to highlight choice followed by SELECT enter the Function number or use QWERTY to search for a patient s name To exit select Exit from Patient Directory Figure 2 7 Patient Directory All reporting functions can be completed by highlighting the appropriate patient and selecting the following functions View Report You can view the report on screen before printing to ve
6. 98 SUMU I T 100 97 user adjustments 107 Troubleshooting amp Maintenance 93 U USB saving files to 88 V VEP acquiring fulfield response 78 acquiring hemifield response 79 impedance 78 5 INCUN 77 W 18 Warnings amp Cautions ADON 17 Waveform a 116 NVC ICONS 12 Page 118 natus neurology A Total Service Solution Standing behind every XLTEK product is Natus Medical Incorporated an internationally respected innovator of medical products and services Our Neurology systems are backed up by an in house support team staffed with technical and clinical experts 24 7 support remote support via WebEx or VPN the largest clinical and technical field support network in Neuro Sleep and customized service contracts that include preventative maintenance visits and computer upgrades Natus Medical Incorporated Excel Tech Lid XLTEK 2568 Bristd Orde Qkille Qrtario L6H5S1 Canada T 1 905 829 5300 1 905 829 5304 www nat us com PIN 105352 Rev E
7. External Triggers can be connected to the NeuroMax using the BNC connector on back panel gt Trigger mode and parameters can be selected by X Youcan also pressing the Stimulator key or through the Defaults activate the Dda it setting box by pressing Test Editing page press Default Backspace C 3 1 3 ABOUT THE REP STIM TEST The NeuroMax s Repetitive Stimulation program Rep otim is based upon standard testing protocols The testing protocol includes up to three testing conditions generically named PRE POST and RECOVERY These denote the baseline study PRE the conditioned response study POST and a third test performed two minutes after conditioning of the response RECOVERY The Rep Stim program is divided into two sections 1 SET UP procedure 2 HECORD procedure When Rep Stim is selected from the test menu the screen appears as it does for any MNC or SNC test however the top line of the Acquisition Trace Area displays the title SET UP The first step in the test is to attain a maximal CMAP While you are in the set up mode the maximal CMAP can be attained by Page 37 ThestimJus intensity may aso be cortradled by using the Up Down arrow keys onthestim probe See System Qttions in C 8 User Manual XLTEK NeuroMax delivering a single shot stimulus in exactly the same manner as in an MNC test then changing the stimulus parameters intensity duration etc and then stimulating again until th
8. press the Main Menu key to exit the test Page 47 User Manual XLTEK NeuroMax 4 2 FREE RUN EMG FEATURES 4 2 1 REVIEWING FREE RUN EMG You can review the most recent acquisition you have just completed monitor an audio portion of the test and save waveforms 1 After completing the Notes press the Trace key to open the option box at the bottom of the screen 2 Review is selected as the value so press the Select key to review the acquisition 3 Press the Left Right arrows to move the window box forward or backward 4 Audio Replay is highlighted Press the Select key to play the last 10 seconds of audio 5 Use the Up Down arrows to select any of the other options including the option to save the current sweep 4 2 2 ANALYZING TURNS AND AMPLITUDE You can analyze Turns and Amplitude while you are ec acquiring real time EMG data or after it has been y acquired Qherating instructions are I oe 1 Press the Select key to perform a Turns and of thescrem Amplitude analysis 2 Press the Left Right arrows to move the Analysis Window 3 Press the Trace key to display a Power Spectrum analysis on the screen User Manual XLTEK NeuroMax 4 3 TRIGGERED EMG FEATURES When setting up the EMG test see Section 4 1 choose Triggered Test The Triggered EMG program uses one or two triggers to discriminate and capture various motor unit potentials The first trigger is an amplitude slope trigger and each EMG s
9. WARNING Non medical electrical equipment printers and computers may be attached to the NeuroMax only if those devices pass appropriate safety certifications In the case of printers and computers they should pass IEC 950 or equivalent standard Page 19 User Manual XLTEK NeuroMax WARNING Possible interference with EMG and Nerve Conduction signals may occur in certain situations i e poor grounding in circuitry close proximity to other instrumentation such as an MRI 2 3 2 CAUTIONS Cautions must be noted when using the equipment Cautions apply to conditions which may damage the NeuroMax A A gt gt CAUTION It is recommended that the stimulator probe be disinfected between patients with 70 isopropyl alcohol This is not an appropriate method of Sterilization if the stimulator is used invasively CAUTION Turn off all system power and disconnect the power cord from the system and the wall before attempting to clean the unit The NeuroMax and the AV otim can be wiped clean with a damp cloth using non conductive distilled water electrically non conductive inert surfactants or a cold sterilizing agent It is important to dry off the units quickly Avoid letting liquid seep into any of the internal electronics of the system The screen of the NeuroMax is more sensitive to liquid damage than the other components of the NeuroMax so be careful to wipe off liquid spots immediately Use a soft cloth on the scr
10. 1 Saving Waveforms 1 Cursors 1 Cursors HRV Creating Protocols for EP s Multi Channel EMG IOM Multi Channel NCS 1 Report Menu While in an active patient file press REPORT The following functions should now be available View Report Print Report Edit Report host directory Print Report and Waveforms Interpretation Save Current Patient to USB Accessories Main Contact for ordering Consumable items Please indicate style of Needle currently used Name Disposable Monopolar LJ Phone Disposable Concentric 1 Disposable Injectible Monopolar LJ 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 your current Accessories Supplier L Disposable Electrodes or d Reusable Electrodes for Nerve Conduction Studies Are you currently receiving Preferential Pricing for a Needle Contract Yes No CJ Would you be interested in hearing how Accessories are able to enhance the quality of your studies as well as save you time and money Yes LJ No LJ Page 91 Xltek NeuroMax User Manual XLTEK University 22 Would you be interested in hearinghow XLTEK University is able to give you one on one on site training that can help you in the areas of but not limited fo equipment use basic and advanced clinical training and insight on clinical correlation Yes LJ No LJ
11. 5 efe 25 SEP TOSUscc a 53 54 Site Name List eas 87 Software checking version eese 93 WCAG 93 User Manual Stored Data changing date 87 Studies SGU 96 Sympathetic Skin Respose SSR 63 ODHOFIS 86 Test Menu modifying parameters 80 Test Reports generan e 30 97 SUN ttes 103 electrode impedance 98 electrode type amp placement 99 error 55 0 5 112 large stimulus 109 no electrical stimulus 108 no electrode 108 D ODOWBI UE ct 111 NOIV dala 110 preventative 104 FUTUNA Gases TONO T DOR NS 103 SIGN Al CODING 2 DS 97 skin
12. Amplitude based estimate 24 Means that using amplitude differences the estimate of the number of motor units is 24 Area based estimate 20 Means that using area differences the estimate for the number of motor units is 20 Estimated based on trace 14 and 15 Means that trace 14 presumably the smallest one and 15 presumably the largest one were used for this estimate In the case of amplitude trace 14 Page 60 Tore amp umtotheQhe Tests Menu pressthe Test Menu key User Manual XLTEK NeuroMax should be 24 times smaller than trace 15 if the estimate is 24 NOTE Motor unit estimation should be used only by clinicians who already have an understanding about how it works 5 4 HEART RATE VARIABILITY HRV The HRV test on the NeuroMax is designed to graph the variability in hear rate over the course of a 60 second time trial The parameters obtained at the completion of a 60 second trial with the test are 1 2 4 Maximum Heart rate Max HR Minimum Heart Tate Min HR Mean Heart Rate Mean HR Standard Deviation of the Heart Rate S D HR 5 4 1 SETTING UP HRV STIMULATION TESTS Using the Select arrows select Other Tests from the Main Menu and then press the Select key to open the Other Tests Menu In Section 1 choose the Nerve Muscle using the Select arrows and then press the Select key to continue In Section 2 choose HRV using the Select arrows and then press the S
13. CONFIGURING THE ERG PROTOCOL The ERG protocol must be configured by the user 1 2 n 8 Go to Nerve Conduction from the main menu Go to a blank field Press Backspace and C or the Default key Type ERG and press Select as advised select the ERG test then choose Sensory and Left Right or both and press Select The Screen opens Press the Default key and choose the settings you require For example a low frequency of 1 and a high frequency of 250 a time base of 10 ms div and a gain of 20 uv div select External Stimulator from this panel and trigger out or in as desired Choose Active high Ground on 60 Hz filter on NOTE Other things such as the intensity of the flash are controlled on the photic stimulator you have 71 User Manual XLTEK NeuroMax The above settings will result in the recording of good ERG You will be able to record photic scotopic and flicker fusion with suitable selections 5 9 THE EOG ELECTRO OCULOGRAM TEST 5 9 1 ABOUT THE TEST The electro oculogram records eye movements because of a voltage difference between the cornea and retina As the eye moves the vector of this electric field changes with respect to a reference electrode At least two 2 biopotential channels are required when recording eye movements to assist in distinguishing eye movement potentials from other signal artifacts 5 9 2 CONFIGURING THE E0G PROTOCOL The protocol
14. Portable and mobile RF communications equipment should be used no closer to any part of the NeuroMax 1004 1002 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 150 kHz to 80 MHz E I3OP 61000 4 6 Complies d 124P gw to Radiated RF 3 Vim 80 MHz to 2 5 GHz IEC 61000 4 3 d 234P 0250 where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site should be less than the compliance level in each frequency Interference may occur in the vicinity of equipment marked with the following symbol A NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an
15. Using the Select arrows select Electromyography from the Main Menu and then press the Select key to open the Electromyography Test Menu User Manual XLTEK NeuroMax 2 In Section 1 choose the appropriate Muscle or Suite using the Select arrows and then press the Select key to continue 3 In Section 2 choose either the Free Run Test or the Triggered Test using the Select arrows and then press the Select key to continue 4 Section choose the side you wish to test and then press the Select key to open the Free Run test screen Figure 4 1 Free Run Acquisition 4 1 2 ACQUIRING AN EMG 1 To start the acquisition press the Start Stop DU Control key Adjust the Audio keys 2 choose different gains use the Up Down avoid excessive arrows vdume levas mE To the acquisition press the Start Stop Control key 4 To classify the results or enter comments press y gt When you sdect the Notes key TEXT entry press the Select key to record a text note Maximum 120 characters User Manual XLTEK NeuroMax 5 Use the Select arrows to change the fields and values in the Notes Box and then press the Select key to record entry 6 Press the Test Menu key to select new muscles 20 05 to test Press the Settings key 7 Repeat Steps 1 5 until you have completed test toreview your Acauisition settings requirements 8 To review the acquisition see section 4 3 or
16. effectively diminishing the current under the prongs forcing you to increase the applied current and causing stimulus artifact problems 10 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 HINT IF YOU SUSPECT THAT THE MUSCLE BENEATH YOUR ELECTRODES IS TENSE TRY TO OBSERVE THIS WITH EITHER A FREE RUNNING SURFACE EMG OR BY INCREASING THE SPEAKER VOLUME USE THIS TO HELP RELAX THE PATIENT 10 5 62 HOW TO STIMULATE NOTE Slow and steady Page 100 Xltek NeuroMax User Manual 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 Remember 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 10 5 6 3 LEAD WIRES NOTE Heduce induced currents With individual unshielded recording lead wires the best results are achi
17. press SETTINGS 3 Change the display settings to Notch Filter OFF LFF 0 1 Hz HFF 15 kHz Gain 10mV div Timebase 5msec div 4 Repeat with other Channel s Note In Dual Channel a 80mV signal be too large to display on the screen Be certain that the display is set at 2Z0mV peak to peak Results The amplitude of this waveform should be 80mV peak to peak 0 8m Page 116 Xltek NeuroMax INDEX A Administrative 83 AEP impedance 77 DI OLOCOIS RR 77 Stim ORDERED QI DE UNS 75 AV SuUIm TODO osse pi tate dva d bat 73 calibration amp maintenance 76 d NR REA MEOS 74 ITO Dal ei de ni dunt 73 73 ebd 75 warnings amp cautions overview 75 B NETTO 86 Blink Reflex Test 57 COMOMCUING N 57 setting UD 57 C Calibrating Tn 115 SUBIT EO ceo I bel e E 115 20 CODIFol KEV S25 vss 24 D Defaults editing NT 81 80 EMG mem sates 46 activating triggers
18. 4 Adjust stimulus mode by pressing the Stimulator key or make changes to defaults by pressing the Default key on the keyboard Fage44 Toreuntothe Test Menu press the Test Menu key User Manual XLTEK NeuroMax 4 EMG TESTS This chapter will deal with the operation of the NeuroMax in its EMG Electromyography Studies mode of operation The NeuroMax has many views of the data on screen to view single traces multiple traces a raster single traces with multiple triggered sweeps captured compressed EMG data in the real time window The NeuroMax incorporates two triggers that may be adjusted independently The first trigger is amplitude slope The second trigger acts as a discriminator that allows you to look at smaller potentials The NeuroMax will store the latest ten seconds of an EMG study You can choose to review it as a compressed EMG or as a real time display with a sweep of 5 ms per division The memory buffer will automatically be cleared after each new test muscle or with a new needle insertion point 4 1 SETTING UP THE EMG TEST MENU Before you begin Electromyography Studies create an active patient to set up the patient information screen and then return to the Main Menu screen The NeuroMax is set to run two EMG test formats Free Run and Triggered Sections 4 2 and 4 3 show you how to perform an EMG acquisition and which test to choose 4 1 1 SETTING UP AN EMG 1
19. AND CONNECTORS SHOULD ONLY BE CLEANED WITH A DRY SOFT LINT FREE CLOTH 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 contact XLTEK service The headbox itself is a completely passive 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 ATTACHED TO THE NEUROMAX WHEN TRANSPORTING THE UNIT 10 8 6 STIMULUS PROBE AND CABLE Page 106 Xltek NeuroMax User Manual 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 10 8 7 PRINTER AND CABLE The NeuroMax must be used with an approved electronic device The approvals should be IEC 950 or equivalent It can also be IEC 601 1 1 1991 A2 1995 EN60601 1 03 96 approved The
20. Electromagnetic compatibility EMC Part 4 11 Testing and measurement techniques Voltage dips short interruptions and voltage variations immunity tests Electromagnetic compatibility EMC Part 3 2 Limits Limits for harmonic current emissions Electromagnetic compatibility EMC Part 3 3 Limits Limitation of voltage changes voltage fluctuations and flicker in public low voltage supply systems Industrial Scientific and Medical ISM Radio Frequency Equipment Electromagnetic Disturbance Characteristics Limits and Methods of Measurement American National Standard for Methods of Measurement of Radio Noise Emissions from Low Voltage Electrical and Electronic Equipment in the Range of 9 KHz to 40 GHz Specification for radio disturbance and immunity measuring apparatus and methods Part 1 1 Measuring Apparatus Specification for radio disturbance and immunity measuring apparatus and methods Part 1 2 Conducted disturbances Federal Communications Commission FCC Unintentional Radiators Page7 User Manual XLTEK NeuroMax DECLARATION OF COMPLIANCE FOR IEC 60601 1 2 Table 1 Electromagnetic Emissions Guidance and manufacturer s declaration electromagnetic emissions The NeuroMax 1004 1002 is intended for use in the electromagnetic environment specified below The customer or the user of the NeuroMax 1004 1002 should assure that it is used in such an environment Emissions Compliance Electromagnetic en
21. NeuroMax 12 The data acquired for the test is automatically analyzed with M and F Wave latencies directly imported into the data table and into the final report If you want you may get an individual test report including waveforms by pressing REPORT and selecting SCREEN COPY 13 To return to the test menu and do another test press TEST MENU 14 To return to the main menu press MAIN MENU F WAVE AND REP STIM TESTS HINTS AND FEATURES gt here are three modes in which potentials can be recorded with the differences between the modes lying in the number of times and frequency at which the patient is stimulated Single Mode a single stimulus applied to a patient each time the Start Stop Control key is pressed This has the advantage of allowing random time intervals between successive stimuli The Inter otimulus Interval is controlled by the user Repetitive Mode set for an unlimited number of stimuli The times between stimuli at a given frequency are pre set and the mode is started and stopped using the Start Stop Control key Train Mode the stimulator will automatically turn off after the set number of stimuli have been delivered If a particular stimulus site has no response use the Cursors key to move the Latency 1 cursor to the O position far left and the report will display NR for the appropriate site While Rep Stim testing there are three sets of responses that may be obtained
22. Non Target Frequency Use the right and left arrows to scroll between the available frequencies 250 500 1000 2000 4000 Hz Then choose the percentage that this tone should be presented These percentages must total to 100 STIMULATOR Rise Fall Time The number of cycles to be used as the ramp up to the tone Page 69 User Manual XLTEK NeuroMax STIMULATOR Duration The length of the tone not including the rise fall time STIMULATOR Inter Stimulus Interval The time between the presentation of tones This interval must be long enough such that the tone can be presented cleanly without cut off and that the entire trace can be displayed before the presentation of a new tone Page 70 User Manual XLTEK NeuroMax 5 8 THE ERG ELECTRORETINOGRAM TEST 5 8 1 ABOUT THE ERG TEST The electroretinogram ERG measures the mass retinal response to a stimulus of light using a corneal electrode and neutral electrodes placed on the skin around the eye The corneal electrode is placed gently behind the lower eyelid and contacts the cornea The patient is kept comfortable with topical anesthesia or in infants general anesthesia may be used A flash of light is shown to the patient and the electrodes record the retinal potentials which develop as a response to the flash This diagnostic procedure may be useful in distinguishing between a variety of retinal disorders such as cone dystrophy and retinitis pigmentosa 5 8 2
23. SOFTWARE 10 2 NERVE CONDUCTIONS 10 2 1 CREATING A NCS Fage4 72 73 73 73 74 75 75 75 76 77 77 77 78 78 79 80 80 81 81 83 93 93 93 93 94 User Manual XLTEK NeuroMax 10 2 2 EDITING AN NCS 10 2 3 SETTING UP STIMULUS AND RECORDING SITES 10 3 ELECTROMYOGRAPHY 10 3 1 CREATING AN EMG SUITE 10 3 2 USING AN EMG SUITE 10 4 ADMINISTRATIVE FUNCTIONS 10 4 1 EDITING STUDIES 10 4 2 INTERPRETATION MACROS 10 5 TROUBLESHOOTING 10 5 1 SIGNAL CLIPPING INNCS AND EMG 10 5 2 STIMULUS ARTIFACT 10 5 3 ELECTRODE IMPEDANCE 10 5 4 SKIN PREPARATION 10 5 5 ELECTRODE TYPE AND PLACEMENT 10 5 6 STIMULATOR 10 6 AV STIM 10 7 PRINTING 10 7 1 NEUROMAX 10 7 2 PRINTER 10 8 RECOMMENDED USER PERFORMED MAINTENANCE 10 8 1 NEUROMAX ENCLOSURE 10 8 2 KEYBOARD 10 8 3 SCREEN 10 8 4 BACK PANEL CONNECTORS 10 8 5 HEADBOX AND CABLE 10 8 6 STIMULUS PROBE AND CABLE 10 8 7 PRINTER AND CABLE 10 8 8 ELECTRODES AND ACCESSORIES 10 9 USER ADJUSTMENTS 10 9 1 NO ELECTRICAL STIMULUS 10 9 2 RESPONSE FROM ELECTRODES 10 9 3 LARGE STIMULUS ARTIFACT 10 9 4 Noisy DATA 10 9 5 UNIT DOES NOT POWER ON 10 9 6 ERROR MESSAGES 10 10 CHECKING CALIBRATION OF NEUROMAX 10 10 1 CHECKING THE STIMULATOR CALIBRATION 10 10 2 CHECKING THE WAVEFORM INDEX Page 5 112 115 115 116 117 User Manual XLTEK NeuroMax NEUROMAX SAFETY AND STANDARDS CONFORMITY STANDARDS COMPLIANCE AND
24. Start in the Main Menu Select Administrative Functions 4 Select Memory Management 2 select Delete All Files 2 Aa WO DN 8 1 3 BATCH PRINT Batch Print collects and prints all the patient files that have not yet been printed 8 1 4 SYSTEM OPTIONS Using the System Options allows you to set a variety of standards for display formats and printed reports You can also enhance the NeuroMax s performance 1 Date Format 2 HeightWeightUnits 3 Printer Type 4 Print Header 5 Stim Probe Remote Switch 6 Gain Timebase Adjustment 7 Artifact Rejection 8 nHL Increase 9 Connection Verification 10 Speaker Option 11 Enable Login 12 Exit from System Options Figure 8 3 System Options User Manual XLTEK NeuroMax 8 1 5 EDIT REPORT FORMAT You can design the report formats to fit your particular requirements The NeuroMax provides five areas to customize i Edit Report Header Places name address and other information on all reports ii Edit Interpretation Macros Provides titles for automatic notes use in history and interpretation fields iii Turn on off Report Fields Selects the fields to be printed in the tables of the report iv Change Report Layout Edits the report format to sort by time test name and Muscle or nerve v Return To Administration Menu Returns you to the main administration menu 8 1 6 EDIT SITE NAME LIST You can change or add the default stimulation site names b
25. The response from the standard tone always appears above the response from the target tone Separate averages for the standard and target tones are maintained Cursors can be applied to each group of traces any combination of 10 latencies 2 amplitudes and 6 inter peak intervals up to a maximum of 14 These can be turned on or off and labeled while editing defaults The typical response mechanism to a target tone is a finger tap or button press The NeuroMax can monitor the patient input from a target tone from a button press Typically for maximal P300 amplitude the patient must acknowledge that they have heard a target or odd tone The patient can either enter their response via a press of the space bar or using the foot switch The NeuroMax keeps track of how many times a response was entered incorrectly i e the space bar was pressed during a standard tone and how many target tones were missed These numbers appear in the command box If a target tone is presented and an acknowledgement is not made the response is not included in either the standard or the target average The current tone being presented is displayed in the command box The NeuroMax ensures that a standard tone is always played first and ensures that a target tone is always followed by a standard tone The type of tone to be played is determined randomly based on the weightings assigned to each tone in the STIMULATOR menu The volume of the tones cannot b
26. are having printing problems try the following 10 7 1 NEUROMAX 1 Shut down NeuroMax and printer and then disconnect all cables 2 Reconnect all cables turn on the printer and then turn on NeuroMax 3 From the Main Menu screen select Administrative Studies and then select Patient Directory 4 Select the patient file and then select Print Report 10 7 2 PRINTER gt Follow the instructions from the printer manufacturer to print a test page gt Does the printer need a new toner cartridge Download files to USB mass storage device and print through Microsoft Word or XLTEK Archiver on a PC Page 103 Xltek NeuroMax User Manual 10 8 RECOMMENDED USER PERFORMED MAINTENANCE Following a regular schedule of general maintenance will help to prolong the lifespan of the NeuroMax Regular maintenance performed by the user 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 XLTEK Service department at 1 800 303 0306 or contact your local XLTEK representative Maintenance performed by the user involves regular inspection and cleaning of all system components including the NeuroMax enclosure keyboard Screen back panel 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
27. 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 Pulse Max Stim Duration 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 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 pre determined value chosen by you To warn you of this situation wnenever 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 ne
28. can be configured in a manner similar to the ERG protocol discussed previously 1 Go to Nerve gt Conduction from the main menu 2 Go to a blank field Press Backspace and C or the Default key 3 Type EOG and press Select as advised 4 Select the test then choose Sensory and Left Right or both and press Select 5 The Screen opens 6 Press the Default key and choose a low frequency of 0 1 and high frequency of 1000 a time base of 500 ms div and a gain of 500 uv div Pre adapted signal is acquired from each eye then dark adapted and lastly light adapted The Arden index is calculated by dividing amplitude of light rise signal by dark adapted eye signal and multiplying that by 100 Page 72 Thegrea power indicator lights uo when AVSTIM 1000 is powered on User Manual XLTEK NeuroMax 6 AV STIM 1000 The AV Stim is used with Evoked Potentials and operates with both the NeuroMax 1002 and the NeuroMax 1004 and with subsequent operating Systems 6 1 AV STIM 1000 FRONT PANEL 6 2 AV STIM 1000 REAR PANEL e Neur AK e 4 gt P E 1004 Audio Out Plug in the calibrated headphones supplied with your AV STIM 1000 Warning Only the XLTEK headphones part number 102610 have been approved for use with your AV Stim Patient isolation in accordance with EN60601 1 is dependent on the approved parts LED Goggles LED goggles generate difficult to reproduce visual evoked potentials due
29. document contains confidential or proprietary information of Excel Tech Ltd No part of this document may be reproduced or transmitted in any form or by any means without the written permission of Excel Tech Ltd Excel Tech Ltd makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness of a particular purpose Fage 1 User Manual XLTEK NeuroMax TABLE OF CONTENTS NEUROMAX SAFETY AND STANDARDS CONFORMITY 1 WELCOME TO THE NEUROMAX 1 1 INTRODUCTION 1 1 1 INTENDED USE 1 2 CUSTOMER SERVICE 1 3 USING THE MANUAL 2 THE NEUROMAX 2 1 OPERATING CONDITIONS 2 1 1 ENVIRONMENT PARAMETERS 2 1 2 TRANSPORT AND STORAGE PARAMETERS 2 2 SPECIFICATIONS MATERIALS EXTERNAL CONNECTORS CHANNELS SAMPLING RATE SIZE AND TYPE RESOLUTION CMRR NOISE MAXIMUM SIMULATOR VOLTAGE MAXIMUM STIMULATOR CURRENT STIMULATOR CURRENT ACCURACY STIMULATOR DURATION ACCURACY VOLTAGE ACCURACY ON SCREEN 2 3 WARNINGS AND CAUTIONS 2 3 1 WARNINGS 2 3 2 CAUTIONS 2 4 EXPLANATION OF LABELING SYMBOLS 2 5 MAIN MENU 2 6 KEY PAD 2 7 HOT KEYS 2 7 1 SENSORY NERVE CONDUCTION HOT KEYS 2 7 2 ELECTROMYOGRAPHY HOT KEYS 2 3 EVOKED POTENTIAL HOT KEYS 2 8 CREATING A PATIENT FILE 2 9 GENERATING TEST REPORTS 2 9 1 REPORT FUNCTIONS 3 NERVE CONDUCTION TESTS 3 1 MOTOR AND SENSORY NERVE CONDUCTIONS Page 2 12 13 13 13 14 15 15
30. drip or splash proof Regarding protection against electrical shock the NeuroMax and Stim are classified as Class devices as per EN 60601 1 The NeuroMax Page 17 User Manual XLTEK NeuroMax requires a properly grounded electrical outlet The mode of operation for both the NeuroMax and AV Stim is continuous operation 2 3 1 WARNINGS Warnings MUST be followed when using the equipment Warnings apply to conditions which can injure the patient and or the operator gt gt gt gt gt gt WARNING Care must be taken in the delivery of any level of stimulus If used improperly injury may be caused to the patient The delivery of stimulus to the patient is done through the Start Stop key on the NeuroMax and the stimulus probe WARNING The level of stimulator intensity is controlled by the Up Down arrows on the NeuroMax and the stimulation probe and is displayed on the active test screen in mA Close attention must be paid to the level of stimulus intensity and the duration of the impulse This unit has enough electrical power to harm a patient if used improperly WARNING This system must only be plugged into a properly grounded electrical outlet The internal isolation transformer of the system must not be bypassed under any circumstances WARNING Hazardous voltages are exposed when the lid of the NeuroMax is removed WARNING This system is not suitable for use in the presence of flammable mixtu
31. edit existing information and or make additions to the existing patient information screen 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 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 OR Page 112 Xltek NeuroMax User Manual 2 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
32. electromagnetic site survey should be considered If the measured field strength in the location in which the NeuroMax 1004 1002 15 used exceeds the applicable RF compliance level above the NeuroMax 1004 1002 should be observed to verify normal operation If abnormal operation IS observed additional measures may be necessary such as re orienting or relocating the NeuroMax 1004 1002 ui Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 10 User Manual XLTEK NeuroMax Table 4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the NeuroMax 1004 1002 The NeuroMax 1004 1002 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the NeuroMax 1004 1002 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the NeuroMax 1004 1002 as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter m maximum 150 kHz to80MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the fre
33. per test If more sets are desired and you do not wish to go through the set User Manual XLTEK NeuroMax procedure again press R Repeat The current sets will be saved and you will be returned to the Rep stim record screen with the same set up ready to again acquire responses Press the Trace key to designate a different comparison test response 3 1 7 SETTING UP AN H REFLEX TEST 1 Using the Select arrows select Nerve Conduction Studies from the Main Menu and Tor amp umtothe then press the Select key to open the Nerve T Conduction Test Menu NET 2 Section 1 choose the appropriate Nerve using the Select arrows and then press the Select key to continue 3 In Section 2 choose the H Reflex Test using the Select arrows and then press the Select key to continue 4 Section choose the side you wish to test and then press the Select key to open the H Reflex Test screen 3 1 8 ACQUIRING H REFLEX RESPONSES 1 To begin the train of stimuli and to acquire responses press the Start Stop Control key 2 After each successive sweep increase the The stimulus intensity i may also be contrdlled by stimulation intensity using the Stim Up Down using the Up Down arrows on the Control keypad arrows on the stimprobe See SystenQttions in 3 Once an adequate H Wave has been obtained Ch 8 press the Start Stop Control key to stop
34. printer is attached via a standard USB connector on the NeuroMax DO NOT LEAVE THE PRINTER ATTACHED TO THE NEUROMAX WHEN TRANSPORTING THE UNIT 10 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 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 XLTEK Technical Support at 1 800 303 0306 or your local XLTEK representative 10 9 USER ADJUSTMENTS If you experience any trouble operating the NeuroMax it is possible that many of the problems may be overcome through simple user 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 ar
35. probe and the active recording electrode Page 109 Xltek NeuroMax User Manual 4 f 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 contact 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 turn on the Averager to reduce the influence of the variable noise of the Stimulus artifact 10 9 4 NOISY DATA 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 m
36. 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 contact with blood borne diseases Please take appropriate care 10 5 5 ELECTRODE TYPE AND PLACEMENT Proper electrode to skin connection is vital when attempting to perform a surface recording 10 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 5 0 75 inch 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 10 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 area 0 1 to 0 5 inch Xltek NeuroMax User Manual The Activ
37. save these settings Press START STOP to begin stimulating and AVERAGER to begin acquiring data the response from the standard tone is placed above the response from the target oddball tone Once a sufficient number of averages have been obtained press AVERAGERH to begin acquiring next set of traces Once acquisition of signals is completed press START STOP to end stimulation Press CURSORS to mark signals Press TEST MENU or MAIN MENU to exit the test The patient response can be monitored using the space bar or the external foot switch The external foot switch can be connected to the back of the NeuroMax The type of patient response is set in the STIMULATOR menu under Patient Input 5 7 3 HINTS AND FEATURES There are two different gains available Amplifier gain is the actual input gain of the amplifiers This gain influences the rejection level of the signal Secondly Display sensitivity is used to further scale the signal to better fit the screen This second gain or sensitivity does not affect the amplification of the signal it is simply for display purposes Traces may be moved during acquisition by pressing TRACE entering the trace number and using the UP or DOWN arrow keys Page 67 User Manual XLTEK NeuroMax A single latency cursor is available while the traces are acquiring by pressing CURSOR and is moved using LEFT or RIGHT arrow keys Two sets of traces can be acquired for repeatability
38. 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 remembering 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 set of F 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 to re 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
39. sites Notepad scoring EMG Info Fields the Patient Info screen User Manual XLTEK NeuroMax 8 1 1 PATIENT DIRECTORY The patient directory may be quite extensive because the NeuroMax has the ability to store many files Figure 8 1 Patient Directory 8 Print Letter 9 Save File to USB 10 Exit Directory Use arrows to highlight choice followed by SELECT enter the Function number or use QWERTY keyboard to search for a patient s name To exit select Exit from Patient Directory It outlines which patients are saved on the system the status of those patients Printed Not Printed Transferred the date the patients were saved and gives the user certain functions PATIENT DIRECTORY FUNCTIONS Patient Recall a patient to add to the Callback current file or to begin a new study Test View list of test files along Directory with the date and time they were performed Within this directory tests can be recalled and then edited or deleted Print Report Print the highlighted patient report X View Report View the highlighted patient you sdect the report patient filebefore Delete Patient Delete Patient and tests activating the Edit Patient Edit the selected patient Function options Info information User Manual XLTEK NeuroMax Expansion Print All Test Print all performed test Screens waveforms in condensed format Print Letter Print the history and
40. 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 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 re initialize 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 Page 113 Xltek NeuroMax User Manual 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
41. the Select key to continue lit youwishto begn onthe side Left is the def aut when ro waves have been acquired press the Select key to Switch sides User Manual XLTEK NeuroMax 3 In Section 2 choose Incr Stim using the Select arrows and then press the Select key to continue In Section 3 choose either the Left or the Right side and then press the Select key to open the Incremental Stim screen Page 59 User Manual XLTEK NeuroMax 5 3 2 CONDUCTING INCREMENTAL STIM TESTS Press the Start Stop Control key to begin the stimulation Increase the stimulation intensity until a small response is seen Press the Select key to save response Increase the stimulation slowly and save responses which are different from those on the screen When ten or more waveforms have been Sell neMisss E acquired stop the repetitive stimulation by tocdermremeximd response gain changes pressing the Start Stop Control key to5mVdv Press the M key on the keyboard Press the Start Stop Control key to deliver single stimuli Increase stimulus until response is maximal Press the Select key to save 5 3 3 INCREMENTAL STIM TEST VALUES After you have performed an Incremental Stim test you Will see information similar to the following on your Screen 1 Amplitude based estimate 24 2 Area based estimate 20 3 Estimated based on trace 14 and 15 The meanings of these values are as follows 1
42. the keypad enter the name of the Suite UBI 5 Press the Select key to save the name of your Backspace Suite 6 Use the Left Right arrows to place the yellow highlight over the next muscle you wish to add to the suite and then press the Select key Continue until all muscles have been added 7 Press the Test Menu key twice to save and exit 7 2 EDITING TEST DEFAULTS Many of the test routines and features of the NeuroMax including test protocols and other functions are customizable to allow automation of many routines The NeuroMax1002 1004 is equipped with factory default settings for many tests and these are a good general guide for many of the tests and reporting features However you may wish to change these settings If the changes desired are temporary then the changes should be made using the various keys Settings Stimulator However if you want the new settings to be automatically included each time a particular test is selected then the defaults should be changed Te atka is located at the batom dt of thekeyboard User Manual XLTEK NeuroMax From the NeuroMax Main Menu screen use the select arrows to choose the test menu and then press the Select key Using the Select arrows choose the test you wish change and then press the Select key twice to open the Active Test Screen Press the Default key Use the Select arrows to choose the settings to change and then use the keyboard to enter the ne
43. to the high intensity of the flash We suggest filling the inside of the goggles with cotton balls and asking the patient to have their eyes closed Page 73 X Thered stimulus indicator blinks on whenthe NeuraVax powers up and flashes at the sa stimulus rate CAUTION Beforeusing the headphones and goggles you should themfor any physical damage to the casings If there are any signs of cracking warping or other physica damage DONOT use the equipment Notify an XLTEK Oustorrer Service Hapresertative AN AN VM Thered Stimuus light indicates that theAVSTIMis correctly configured and intiaized User Manual XLTEK NeuroMax Warning Only the XLTEK LED goggles part number 101487 have been approved for use with your AV Stim Patient isolation in accordance with EN60601 1 is dependent on the approved parts Printer An optically isolated printer port that is available only to older NeuroMax users When using the Windows based NeuroMax this is not supported NeuroMax The connector port to which the NeuroMax is attached with the supplied cable VGA Standard D sub video monitor connector The recommended video monitor is a hospital grade VGA or SVGA monitor Warning Only equipment approved to IEC950 EN 60601 1 or a similar safety standard may be connected to the Upgrade Port and VGA ports on the AV Stim 1000 The final system must be configure
44. 1 Press the Stimulator key and then set stim parameters including duration mode maximum 1002 4004 intensity 2 Press the Start Stop Control key to begin the acquisition Press it again to end the acquisition 3 Press the Space Bar to stimulate or to begin repetitive mode 4 Press the Settings key to make changes in settings User Manual XLTEK NeuroMax 5 6 MULTI CHANNEL NERVE CONDUCTIONS Choose Other Test Menu Choose or create Nerve Test Name Choose 4 CH NCS Choose side Hit DEFAULT key for Test Defaults Editing Page Customize your settings i e what channel is used what channel is on test type gains timebases sites etc Hit SELECT and S to save settings Example Median 2CH NCS Active Ch 1 2 Channel 1 On On CV Segments Segmental Total LFF Hz 5 0 30 HFF Hz 2 0k 2 0k Notch Filter Off On Gain uv div 5k 20 Lat take off take off Lat2 neg phase peak Amp bsIn to peak to peak Rec Site APB Index Stim Site1 Wrist Wrist Stim Site2 Elbow Elbow Stim Site3 Axilla Axilla Etc 5 7 THE P300 TEST Please Note This test requires NeuroMax 1004 1002 code version 2 0 available October 99 or above and an AV Stim 1000 code version 5 0 available October 99 or above 5 7 1 GETTING STARTED From the Main Menu the P300 test can be accessed from Other Tests Option 3 Selecta Nerve or Muscle then select P300 and a side The test will run identically for each side The P300 Test
45. 15 15 16 16 16 16 16 16 16 16 16 17 17 17 17 17 17 18 20 22 23 24 27 27 28 29 30 30 33 34 User Manual XLTEK NeuroMax SETTING UP A NERVE CONDUCTION STUDY CONDUCTING AN NCS ABOUT THE REP STIM TEST PERFORMING A REP STIM TEST ABOUT THE F WAVE TEST PERFORMING AN F WAVE TEST SETTING UP AN H REFLEX TEST ACQUIRING H REFLEX RESPONSES L 0 4 4 1 SETTING UP THE EMG TEST 4 1 1 SETTING UP AN EMG 4 1 2 ACQUIRING AN EMG 4 2 FREE RUN EMG FEATURES 4 2 1 REVIEWING FREE RUN EMG 4 2 2 ANALYZING TURNS AND AMPLITUDE 4 3 TRIGGERED EMG FEATURES 4 3 1 ACTIVATING TRIGGERS 4 3 2 SAVING A TEST 4 3 3 ANALYZING AND REVIEWING MOTOR UNITS 5 OTHER TESTS 5 1 OTHER TESTS 5 1 1 SETTING UP EVOKED POTENTIALS EP 5 1 2 CONDUCTING EVOKED POTENTIALS 5 1 3 SEP TESTS 5 1 4 SUGGESTED SEP PROTOCOLS 5 1 5 DERMATOMAL SEPS 5 2 BLINK REFLEX 5 2 1 SETTING UP A BLINK REFLEX TEST 5 2 2 CONDUCTING BLINK REFLEX TESTS 5 3 INCREMENTAL STIMULATION 5 3 1 SETTING UP INCREMENTAL STIM TESTS 5 3 2 CONDUCTING INCREMENTAL STIM TESTS 5 3 3 INCREMENTAL STIM TEST VALUES 5 4 HEART RATE VARIABILITY HRV 5 4 1 SETTING UP HRV STIMULATION TESTS 5 4 2 CONDUCTING HRV TESTS 5 4 3 SYMPATHETIC SKIN RESPONSE 5 5 MULTI CHANNEL EMG IOM 5 6 MULTI CHANNEL NERVE CONDUCTIONS 5 7 THE P300 TEST 5 7 1 G
46. AV STIM d Functions Opening a Patient File d External Trig Electrode Impedance Testing Hot Keys 1 Power Supply of NeuroMax AVStim Nerve Conduction Functions Assigning Waveforms 1 Stimulator 1 Creating Protocols for Full Screen Acquisition 1 Notes 1 SNC CO Trace Erase 1 MNC Oo Settings 1 1 F Wave d Cursors 1 Exponential Decay X Rep Stim Distance 1 H Reflex d Electromyography Basic Functions Advanced Functions Creating Editing Recording Start Stop 1 1 Defaults Settings Gain Timebase Turns and Amplitudes Triggered Defaults Audio Adjustments Motor Unit Analysis 1 2 EMG Suites Notepad 1 Free Run to Triggered 1 Muscles Suites 1 key function Programs Free Run Triggered 1 Page 90 Xltek NeuroMax User Manual Administrative Functions Patient Directory Memory Management Search Utility Patient Callback CJ Patient Directory LJ Test Directory C Delete All Files O Print Report CJ Delete All Printed files L View Report Delete File System Options Edit Patient Info CJ 1 Report Format Transfer to USB Report Header Report Fields L Print Test Screens Interpretation Macros L3 Report Layout L 2 Site Name List CJ Batch Print L1 3 EMG Notepad O 4 Patient Information Fields LJ Dual Channel Tests Functions Stimulating d BLINKS Stimulating Averaging d Saving Waveforms
47. C study using the Select arrows NCS Test Menu press the Test and then press the Select key to continue Menu key Assigned Trace Area Acquired Trace Area All test screen graphic settings are for demonstration purposes only User Manual XLTEK NeuroMax 4 In Section 3 choose the side you wish to test and then press the Select key to open the Nerve Conductions Studies NCS Test screen 3m WU Pore 19 00 uv m P tow Figure 3 2 NCS Test Screen Acquired Trace Area Shows the most recent acquisition Assigned Trace Area Stores up to eight traces per NCS Test Live Data Box Displays the cursor values for the acquired trace Data Box Shows the cursor and calculated values for the assigned traces Stimulator Box Displays the status of the electrical stimulus stim level mode duration and frequency The Nerve Conductions Studies NCS Test Screen is now active The Acquisition Trace Area displays traces that have just been acquired You can enlarge the Acquisition Trace Area to acquire a waveform 1 Press the Select key to activate Full Screen Mode and then acquire your waveform The stimulus intensity may also be oarttralled by usingthe Up Down arrow keys onthestim probe See System Qxionsin Ch 8 User Manual XLTEK NeuroMax 2 loreturn to standard screen size press the Select key 3 1 2 CONDUCTING AN NCS Make sure that all the electrode connectors are fi
48. ETTING STARTED 5 7 2 RUNNING THE TEST 5 7 3 HINTS AND FEATURES 5 7 4 EXPLANATION OF OPTIONS 5 8 THE ERG ELECTRORETINOGRAM TEST 5 8 1 ABOUT THE ERG TEST 5 8 2 CONFIGURING THE ERG PROTOCOL 5 9 THE EOG ELECTRO OCULOGRAM TEST 5 9 1 ABOUT THE EOG TEST Page 3 User Manual XLTEK NeuroMax 5 9 2 CONFIGURING THE PROTOCOL 6 AV STIM 1000 6 1 AV STIM 1000 FRONT PANEL 6 2 AV STIM 1000 REAR PANEL 6 3 CONNECTING THE AV STIM 1000 6 4 WARNINGS AND CAUTIONS 6 4 1 WARNINGS 6 4 2 CAUTIONS 6 5 CALIBRATION AND MAINTENANCE 6 6 SUGGESTED AEP PROTOCOLS 6 6 1 AEP IMPEDANCE CHECK 6 7 SUGGESTED VEP PROTOCOLS 6 7 1 VEP IMPEDANCE CHECK 6 8 ACQUIRING A FULLFIELD VEP RESPONSE 6 9 ACQUIRING A HEMIFIELD VEP RESPONSE 7 SETTING THE DEFAULTS 7 1 TEST MENU PARAMETERS 7 1 1 CREATING AN ELECTROMYOGRAPHY SUITE 7 2 EDITING TEST DEFAULTS 8 ADMINISTRATIVE FUNCTIONS 8 1 ADMINISTRATIVE FUNCTIONS 8 1 1 PATIENT DIRECTORY 8 1 2 MEMORY MANAGEMENT 8 1 3 BATCH PRINT 8 1 4 SYSTEM OPTIONS 8 1 5 EDIT REPORT FORMAT 8 1 6 EDIT SITE NAME LIST 8 1 7 EDIT EMG NOTEPAD 8 1 8 EDIT PATIENT INFORMATION FIELDS 8 1 9 CHANGING THE DATE ON STORED DATA 8 2 MANAGING THE REPORTS 8 2 1 RICH TEXT FILES RTF 8 3 EXTENDED WARRANTY SERVICES INFORMATION 9 APPENDIX 1 IN SERVICE CHECKLIST 10 APPENDIX 2 TROUBLESHOOTING MAINTENANCE 10 1 SOFTWARE 10 1 1 CHECKING SOFTWARE VERSION ON NEUROMAX 10 1 2 UPDATING
49. Left Right or No Side The EP cursor placement is allocated by sweeps That is each collection of sweeps is considered a set and cursors are placed accordingly This option allows for 4 Page 52 lo can compete four sweep Sets of averages E External Triggers are connected tothe NeuroVax viathe BNC connector on back Trigger mode and parameters are sdected by pressing the Settings key arthrough Defauits Test Editing page press Default arthe Ckey User Manual XLTEK NeuroMax different sets of up to 4 traces each Bilateral Sets are defined by channel not by sweep The first sweep of channel 1 and the second sweep of channel 1 are considered a set and the data table is filled according to this new set definition The bilateral selection first two sweeps one side and final two sweeps the other allows for up to eight sets of two traces each gt There are ten customizable latency cursors two amplitude six inter peak interval distance and conduction velocity calculations are also available Traces may be moved during acquisition by pressing the Trace key entering the trace number and using the Up Down arrows to adjust the trace A single latency cursor is available to you while the traces are acquiring Press the Cursors key and then use the Left Right arrows 5 1 3 SEP TESTS 1 Set stimulator rate between 3 1 and 7 9 Hz but Lower not a multiple of 60 Hz with durati
50. Max offers full featured EMG in a simple easy to use and affordable line of instruments XLTEK NeuroMax is available in two and four channel format and provides you with the highest performance and greatest reliability of any EMG instrument on the market From simple NCS studies through to a complex quantitative EMG the XLTEK NeuroMax is the system you can rely on XLTEK NeuroMax 1002 CE Two channel neurodiagnostic for basic and advanced NCS EMG and EP Incorporates a large 12 1 XGA 1024 x 768 screen Advanced engineering and the latest in technology allow for improved performance and speed advanced NCS capabilities advanced EMG capabilities and advanced Multi Channel Studies XLTEK NeuroMax 1004 CE Four channel neurodiagnostic for basic and advanced NCS EMG and EP Incorporates a large 12 1 XGA 1024 x 768 screen Advanced engineering and the latest in technology allow for improved performance and speed advanced NCS capabilities advanced EMG capabilities and advanced Multi Channel Studies XLTEK Headboxes and Accessories XLTEK provides two and four channel amplifiers AV otimulators and a full range of accessories Page 12 User Manual XLTEK NeuroMax 1 1 INTRODUCTION XLTEK is commitment to continual product improvements and quality design to meet the needs of our clients We thus encourage all feedback and any suggestions you have regarding any aspect of the EMG system the manual our line of acc
51. NORMATIVE REFERENCES EMG System model NeuroMax 1002 and NeuroMax 1004 rated 120 240V 50 60Hz 1 4A 0 7A detachable cord connected Class 1 BF applied parts 1 Type of protection against electric shock Class 2 Degree of protection against electric shock Type BF The NeuroMax and its accessories have been designed to comply with the following national and international standards Table 1 Safety Standard of Compliance and Normative References CAN CSA 22 2 No 601 1 M90 Medical Electrical Equipment part 1 General requirements for Safety adopted IEC 601 1 2ed 90 CSA 601 1 Supplement 1 1994 Supplement 1 94 to CAN CSA 22 2 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for oafet CSA 601 1 Amendment 2 1998 Amendment 2 to CAN CSA C22 2 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety UL Std No 2601 1 2nd Edition Medical Electrical Equipment part 1 General requirements for Safety IEC 601 1 1988 A1 1991 Medical electrical equipment Part 1 General requirements A2 1995 for basic safety and essential performance IEC 60601 2 40 1998 02 Medical Electrical Equipment part 2 40 Particular requirements for the Safety of Electromyographs and Evoked Response Equipment Table 2 EMC Standard of Compliance and Normative References EN 60601 1 2 2001 2nd Edition Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral St
52. Tests Menu press the Test Menu key User Manual XLTEK NeuroMax Press the Start Stop Control key to stimulate 2 Press the Select key to accept waveforms and move to the other side Press the Cursors key to mark the signals Press the Test Menu key or the Main Menu key to exit the test 5 3 INCREMENTAL STIMULATION The incremental stim test provides an indication of the relative sizes of the motor units in a muscle but itcan also be employed to estimate the number of the functioning motor units The muscles which are most suitable for the technique are the EDB extensor digitorum brevis and the median innervated thenar muscles but the technique has also been used routinely for the hypothenar plantar and bicep muscles In each stimulation the active recording electrode is a silver chloride strip which is applied across the muscle belly at the level of the innervation zone a similar surface electrode is positioned over or beyond the distal tendon and serves as a reference The stimulating electrodes are placed over the motor nerve or in some instances the motor point of the muscle It is important that the subject remain relaxed otherwise traces will be rejected 5 3 1 SETTING UP INCREMENTAL STIM TESTS 1 Using the Select arrows select Other Tests from the Main Menu and then press the Select key to open the Other Tests Test Menu 2 In Section 1 choose the Nerve Muscle using the Select arrows and then press
53. and how to set up a stimulus site Page 93 Xltek NeuroMax User Manual 10 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 10 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 10 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 NOTE IF THE SITE YOU NEED IS NOT IN THE SITE NAME LIST GO TO THE MAIN MENU SCREEN AND SELECT ADMINISTRATIVE OPTIONS SELECT EDIT SITE NAME LIST FIND A BLANK POSITION AND THEN ENTER THE REQUIRED SITE NAME 5 To enter normal value
54. andard Electromagnetic Compatibility Requirements and Tests IEC 61000 4 2 1995 EN 61000 4 Electromagnetic compatibility EMC Part 4 2 Testing and 2 2001 measurement techniques Electrostatic discharge immunity test IEC 61000 4 3 2002 EN 61000 4 Electromagnetic compatibility EMC Part 4 3 Testing and 3 2006 measurement techniques Radiated radio frequency electromagnetic field immunity test IEC 61000 4 4 2004 EN 61000 4 Electromagnetic compatibility EMC Part 4 4 Testing and 4 2004 measurement techniques Electrical fast transient burst immunity test Page 6 User Manual IEC 61000 4 5 1995 EN 61000 4 5 2006 IEC 61000 4 6 1996 EN 61000 4 6 2007 IEC 61000 4 8 61000 4 8 IEC 61000 4 11 2004 61000 4 11 2004 61000 3 2 2005 61000 3 2 2006 61000 3 3 1994 61000 3 3 1995 A1 2001 A2 2005 CISPR 11 2004 EN 55011 1998 1 1999 amp A2 2002 ANSI C63 4 2003 CISPR 16 1 1 2003 CISPR 16 2 1 2004 FCC CRF47 Part 15 Subpart B Class A XLTEK NeuroMax Electromagnetic compatibility EMC Part 4 5 Testing and measurement techniques Surge immunity test Electromagnetic compatibility EMC Part 4 6 Testing and measurement techniques Immunity to conducted disturbances induced by radio frequency fields Electromagnetic compatibility EMC Part 4 8 Testing and measurement techniques Power frequency magnetic field immunity test
55. ay 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 Page 110 Xltek NeuroMax User Manual 10 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 panel If the power on LED appears to be lit and the screen is not on call XLTEK service 3 Check the fuse which is located beside the ON OFF switch on the back panel If the fuse needs replacing replac
56. board to scroll to another test screen 12 The data from each of the three test conditions are automatically entered into the data table and the final report If you wish you may get an individual test report including waveforms by pressing REPORT and selecting SCREEN COPY 13 To return to the test menu and do another test press TEST MENU 14 To return to the main menu press MAIN MENU 3 1 5 ABOUT THE F WAVE TEST The F Wave nerve conduction protocol in the NeuroMax has functionality similar to the Repetitive Stimulation protocol previously described Like the Rep Stim program the F Wave study is divided into two sections 1 SET UP procedure 2 RECORD procedure When F Wave is selected from the test menu the screen will appear as it does for any MNC or SNC test however the top line of the Acquisition Trace Area displays the title SET UP The first step in the test is to determine the stimulus characteristics needed for the recording procedure This is done by delivering a single shot stimulus in exactly the same manner as in an MNC test then changing the stimulus parameters intensity duration etc and then stimulating again until the desired M Wave response is obtained Once you have obtained the desired M Wave response and the stimulus parameters are where they should be for the F Wave recording procedure press the SELECT button User Manual XLTEK NeuroMax You will see the screen change slightly in appeara
57. complete 8 2 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 2 1 RICH TEXT FILES RTF Downloading files to a USB device will automatically create files with an RTF file extension in the default directory X You can decide how you wart to manage the files whether you want to use themar periodically ddeaethem Ach Text Format HIP files can beinrported into many dfferent Windows aodications such as Word Xltek NeuroMax User Manual 8 3 EXTENDED WARRANTY SERVICES INFORMATION An extended warranty can be purchased prior to or following the expiration of your NATUS original warranty For further information contact XLTEK s Customer Support at 1 800 303 0306 or Oakville Customer _Service natus com Page 89 Xltek NeuroMax User Manual 9 APPENDIX 1 IN SERVICE CHECKLIST n at 6 NeuroMax In Service Checklist neurology Name Institution Tel Fax Email Additional Contacts Name Position Basic Functions Connections for NeuroMax Keyboard Layout USB Printer 1 Function Hard Keys 1 Headbox 1 Menu Hard Keys oO Stim Probe Select Switch d Accessories Arrow Keys 1 USB Mass Storage 1 Trigger Arrows 1 Foot Switch 1 Stimulus Intensity d
58. d to meet the requirements for safety of medical systems prescribed by EN 60601 1 6 3 CONNECTING THE AV STIM 1000 1 To perform either an auditory or visual evoked potential connect the AV STIM 1000 to the NeuroMax using the supplied connector cable 2 Switch the NeuroMax Off and then insert the male 26 pin connector of the connector cable into the AVStim port at the rear of the NeuroMax 3 Insert the other end also a male 26 pin connector into the AV STIM 1000 NeuroMax port 4 Turn the NeuroMax On and check the AV STIM 1000 to confirm that the green light comes on followed by a brief flash from the red Stimulus light Page 74 User Manual XLTEK NeuroMax 6 4 WARNINGS AND CAUTIONS The following Warnings and Cautions are marked with a A and must be followed very closely to ensure the safety of both the patient and the user of the AV Stim and the NeuroMax It is therefore important to read and observe ALL of the Warnings and Cautions before attempting to use the AV Stim and the NeuroMax If there is any malfunction or perceived malfunction of the system please call an authorized XLTEK service representative immediately at 1 800 303 0306 An authorized XLTEK service representative must only conduct all internal system checks and or service 6 4 1 WARNINGS Warnings MUST be followed when using the equipment Warnings apply to conditions which can injure the patient and or the operator WARNING Exposure to exces
59. de deletes the latest acquisition from the average post processing artifact extraction 2 7 2 ELECTROMYOGRAPHY HOT KEYS FUNCTION TRIGGER go to Triggered from FreeRun 1 2 goto FreeRun from Triggered Page 27 User Manual XLTEK NeuroMax 2 7 3 EVOKED POTENTIAL HOT KEYS FUNCTION A change the Acceptance level of the signal entered as a percentage of the A D converter full scale value cp Display only certain traces F Flip to show the next or previous set of data in the data box L set up the left ear for Audio threshold test Left 15 dB nHL S Axiotess Stimulus Right 0 dB Noise are only valid when set up the right ear for Audio threshold test Left 0 dB Noise Gtimation ode Right 15 dB nHL Stimulus Page 28 User Manual XLTEK NeuroMax 2 8 CREATING A PATIENT FILE An important feature of the NeuroMax is its ability to save multiple patient files and tests This allows you i i 8 E 2 to recall edit and print previously stored data E The first step is to create a patient file Once that is completed you can save tests generate apatient filefirst reports You access the Patient Information screen from the Main Menu and from each of the three Test menus 1 Press the Patient Info key to open the EE in required information SELECT to move to rund beki 2922 eee Patient I
60. e Stimulator box User Manual XLTEK NeuroMax 5 activate the stimulus probe press the START STOP key or the trigger button on the stimulator and obtain a waveform Repeat until the desired waveform is obtained 7 When the desired M Wave response has been obtained press SELECT to enter the RECORD mode Recording Site APB Stimulus Site Wrist SET 1 SET 2 SET 3 mms SET 3 22 1 Press START STOP to begin data acquisition 00mA of 95 92 11 16 58 50 B dur 0 1 ms freq 3 0 Hz train 7 pulses Figure 3 3 Rep Stim Test Screen Record Mode 8 Press the START STOP key to begin data acquisition for the Pre mode The responses will be displayed directly in the trace data area and the amplitudes areas and decrements for the baseline and test traces will automatically be calculated and displayed in the data table 9 f the Pre mode data acquisition is unsatisfactory you may erase the traces and begin again If the response is satisfactory continue to the next phase of the evaluation 10 At the conclusion of the next phase of the test press the START STOP key to begin data acquisition for the Post mode Page 39 User Manual XLTEK NeuroMax 11 After the prescribed recovery time period has elapsed press the the START STOP key to begin data acquisition for the Recovery mode NOTE If your test protocol requires more than three 3 sets press r on the standard key
61. e having please call XLTEK Technical Support or your local XLTEK Hepresentative for service Page 107 Xltek NeuroMax User Manual 10 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 corner 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 headbox 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 Stimu
62. e changed while averaging To ensure that the volume is appropriate press START STOP until the tones can be heard Use the hotkey R to display the raw traces Once satisfied acquisition can begin by pressing AVERAGER User Manual XLTEK NeuroMax To increase the timebase use the right and left arrows Because the P300 event usually occurs 300 msec after the stimulus is presented a timebase of 50 msec is recommended The timebase cannot be changed if the stim in ON or if there are traces on the screen Press R to erase the raw traces ERASE to erase the averaged traces and START STOP to turn off the stimulator The timebase is limited by the inter stim interval so that acquisition ends before the next tone is presented some recommended settings include LFF 0 5 Hz HFF 30 Hz Display Gain 5 uV div Timebase 50 ms Cursors N1 N2 P2 and P3 Inter Stim Interval 2 seconds Standard Frequency 1000 Hz at 80 Target Frequency 2000 Hz at 20 5 7 4 EXPLANATION OF OPTIONS STIMULATOR Number of Stimuli The number of different tones presented to the patient If three tones are being presented the response from Non Target tones is not displayed or included in any averages STIMULATOR Patient Input Indicates if the NeuroMax will keep of patient responses If so the patient can acknowledge a target tone with a tap of the space bar or the press of the external foot switch STIMULATOR Standard Target and
63. e desired CMAP is attained Once you have obtained the maximal CMAP and the stimulus parameters are accurate for the Rep Stim Recording procedure press the SELECT button You will see the screen change slightly in appearance The top of the screen will display RECORD You now simply press the START STOP key for the test to begin The NeuroMax will calculate and display the Amplitude in mV and the area in mVms for both the baseline response and the test response as well as the decrement for both the amplitude and area between the baseline and test responses Post acquisition you can change the test trace number so that a different trace is used as the test trace press TRACE to access this function In the test settings for the Rep Stim test you can set the default trace numbers for both the baseline and test traces 3 1 4 PERFORMING A REP STIM TEST 1 From the main menu highlight Nerve Conduction Studies and then press SELECT or hit 1 2 From the Nerve Conduction Studies test menu choose the nerve you want to test then SELECT Now choose Rep Stim then SELECT and if required choose the side you want to test then SELECT once more 3 he Rep Stim test screen will now appear with the phrase SET UP at the top of the screen NOTE A maximal CMAP must be attained before you can move to the RECORD screen 4 Adjust the stimulus intensity by pressing the STIM UP DOWN arrows E The stimulator levds areshowninth
64. e 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 NOTE YOU WILL ONLY PICK UP A SNAP IF YOUR RECORDING ELECTRODES ARE PLACED OVER THE CORRECT NERVE BE AWARE OF ANOMALOUS INNERVATIONS 10 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
65. e only with two 13 15A 250 V fuse Page 111 Xltek NeuroMax User Manual 10 9 6 ERROR MESSAGES Should any Windows error messages appear on your screen they can always be removed by pressing either ENTER or ESC Pressing ENTER will select the action highlighted Pressing ESC will cause the action to be cancelled We recommend that you always press ESC whenever a Windows error message comes to the screen There are also a few NeuroMax 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 in a test mode If any of these messages are unclear please call your XLTEK 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
66. een Do not use any abrasive cleaner on the system Refer to AV Stim Manual for detailed cleaning instructions for the headphones and goggles used with the Stim CAUTION Method of sterilization or disinfection classification no method CAUTION Inspect all cables and connections especially the power cord often for signs of fraying or other damage Do not operate either the Page 20 User Manual XLTEK NeuroMax gt gt NeuroMax or the AV Stim if you suspect damage to any of the cables or the power cord CAUTION Do not leave any cables attached to the back panel of the NeuroMax AV Stim when transporting the unit this may cause the back panel connections to become loose or malfunction during operation of the unit CAUTION Pay particular attention to the care of the NeuroMax screen Do not attempt to remove the protective cover The screen itself uses a glass panel which may crack or break if it is dropped or bumped on a hard surface Handle with care CAUTION Do not turn on the power to the NeuroMax and or the AV Stim immediately after bringing either unit from a cold environment to room temperature Allow the units to assume ambient environmental temperature one hour warm up Page 21 User Manual XLTEK NeuroMax 2 4 EXPLANATION OF LABELING SYMBOLS A number of symbols appear on the various components of the NeuroMax system Please consult the table below for their meanings and significance Sy
67. elect Impedance Test and then check electrode impedance 10 5 2 STIMULUS ARTIFACT 10 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 Page 97 Xltek NeuroMax User Manual ii High pass filter characteristics of the amplifier ili 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 close to the recording electrodes in order to reduce the common mode potential due to the stimulator 1 the skin to electrode impedances to reduce common mode voltages artifacts and 50 60 2 interference iv Avoid crossing stimulator and recording cables to eliminate induced currents v Keep skin dry between electrodes to prevent bridging of the electrodes 10 5 3 ELECTRODE IMPEDANCE NOTE It is important to keep electrode impedance low and balanced Electrode impedance should be kept below 10k green range for the best results in recording low amplitude signals 50uV peak to peak Higher impedance allows the incursion of powe
68. elect key to continue In Section 3 the Left side is automatically selected by the NeuroMax Press the Select key to continue to the HRV test screen 5 4 2 CONDUCTING HRV TESTS The Heart Rate Variability test on the NeuroMax is designed to graph the variability in heart rate over Page 61 User Manual XLTEK NeuroMax the course of four 60 second time intervals At the completion of each 60 second time trial the following parameters are calculated Page 62 User Manual XLTEK NeuroMax HRV TEST PARAMETERS Maximal Heart Rate Maximal R R interval Minimal Heart Rate Minimal R R interval Mean Heart Rate Mean R R interval Standard Deviation R R Hate interval Min HR 1 Set trigger to appropriate level using the Trigger X Fress the 2 Up Down Control arrows Curse ks io cH Fress the Erase key to 2 Press the Start Stop Control key to begin and the granh area where cede al or apartion d thecalcuations are thedata then press it again to end the acquisition of data paforrred 3 Press the Select key to save the response and then move to next graph 5 4 3 SYMPATHETIC SKIN RESPONSE Involvement of the automatic nervous system recording of the sympathetic skin response SSR is one method of rapid evaluation of the autonomic nervous system The response is also known as either the galvanic skin response or the electrodermal response SSR reflects the voltage changes on the skin due to activation of either the
69. ength 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 10 5 64 WHEN ALL ELSE FAILS sometimes the obvious solution is the right one When all else fails check the following Fage 101 Xltek NeuroMax User Manual 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 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 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 10 Rotate the anode around the cathode This might shunt the shock artifact away from the recordin
70. ep Stim Rate 5 3 NOTE SEE CHAPTER 6 FOR THE AV STIM 1000 EP OPERATIONS AND PROCEDURES 5 1 4 1 MEDIAN C7 TO T1 ULNAR C8 TO T1 NERVES Channe Erb s contra C3 4 Channe Erb s contra T Erb s ipsi User Manual XLTEK NeuroMax SUGGESTED SEP PROTOCOLS Gain LFF 20 Hz 2QuV div Avgs 500 Sweep Stim Rate 5 3 5 1 4 2 POSTERIOR TIBIAL NERVE L5 51 52 Channe Channe Pop fos ipsi We Pop fos contra 2 5 1 4 3 COMMON PERONEAL NERVE 51 S2 Channe Channe Page 55 User Manual XLTEK NeuroMax 5 1 5 DERMATOMAL SEPS DERMATOMAL SEP PROTOCOLS Ae LFF 5 Hz Stim Rate 3 3 Hz Wapping the l Stim Duration 0 2 anian HFF 500 Hz gauze preverts 51 51 MEDIAN DERMATOMAL dermatames C6 Stimulate using ring electrodes places over 15 or 2 digit cathode proximal anode 2cm distal Channe VS Fz Channe VS L3 5 1 5 2 ULNAR DERMATOMAL C8 Stimulate using ring electrodes places over 5 digit cathode proximal anode 2cm distal Channe C3 4 VS Fz Channe Erb s ipsi VS Erb s contra 5 1 5 3 POSTERIOR TIBIAL DERMATOMAL 1 5 Stimulate medial side of the 1 metatarsal ohalangeal joint with a bar electrode anode distal Channe S1 Stimulate lateral side of the 5 metatarsal ohalangeal joint with a bar electrode anode distal Wy Toreuntothe Qher Tests Menu press the Test Menu key U
71. es Mains power quality should be IEC 61000 4 5 differential mode da ope 2 p ospital environment 2 kV common mode Voltage dips short lt 5 Ur Complies Mains power quality should be that interruptions and voltage gt 95 dip in Ur of typical commercial or hospital variations on power supply for 0 5 cycle environment If the user of the input lines 2 m requires continued operation during power IEC 61000 4 11 mains interruption it is recommended that the NeuroMax 1004 1002 be powered from an uninterruptible power supply or a battery Complies 40 Ut 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ut 29596 dip in Ur for 5 sec Power frequency Complies Power frequency magnetic fields 50 60 Hz magnetic field should be at levels characteristic of a typical location in a typical IEC 61000 4 8 commercial or hospital NOTE Ur is the AC supply voltage prior to application of the test level Page 9 User Manual XLTEK NeuroMax Table 3 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and Manufacturer s Declaration Electromagnetic Immunity The NeuroMax 1004 1002 is intended for use in the electromagnetic environment specified below The customer or the user of the NeuroMax 1004 1002 should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level
72. essories and our support services 1 1 1 INTENDED USE The NeuroMax EMG is intended to be used as a clinical electromyograph to acquire display store and archive neurophysiological signals 1 2 CUSTOMER SERVICE XLTEK 16 committed to providing you with support SO you Can operate the NeuroMax with ease and confidence If you need help follow these steps to find a solution Step 1 Document the Incident Carefully document the incident step by step If possible note error messages the type of test and what you did before the problem occurred including the sequence of keystrokes Step 2 Shut Down the NeuroMax sometimes you need to shutdown completely in order to solve a problem Press the MAIN MENU key to return to the Main Menu Turn the power off to the unit Make sure all cables are connected and intact Turn the power back on Step 3 Call or Email Technical Support First write down the serial number located on the back of the computer Then phone XLTEK s Customer Support at 1 800 303 0306 or contact XLTEK Technical Support at OT S natus com Page 13 User Manual XLTEK NeuroMax 1 3 USING THE MANUAL XLTEK is committed to providing you with clear instructions and unqualified support so you can operate our equipment with ease and confidence The manual presents step by step instructions which take you through the testing customizing and operation of the equipment and software so that system meets
73. eved 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 oimilarly when stimulating with two individual cables from the NeuroMax Stim 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 XL TEK s design differs from other manufacturer s shielded recording cables that do not support 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 turn causes an increase in stimulus artifact and an increased susceptibility to high frequency interference Depending upon cable l
74. g electrodes 11 Increase or decrease the pulse duration of the stimulus 12 Average the sensory response 10 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 Page 102 Xltek NeuroMax User Manual 5 Make sure that the Stim 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 doubt try another channel 10 6 AV STIM 1 Attach the short cable between the NeuroMax and the AV Stim and then turn on the power to the NeuroMax When the NeuroMax recognizes the AV Stim it will provide power to it 2 When the power is turned on the green power light on the AV Stim lights up and the red stimulus light flashes once confirming the initialization of the AV otim with the NeuroMax 3 he printer port of the AV Stim is not active with this version of the NeuroMax 10 7 PRINTING If you
75. hted muscle 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 When finished press the Test Menu key to exit Page 95 Xltek NeuroMax User Manual 10 4 ADMINISTRATIVE FUNCTIONS The administrative 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 10 4 1 EDITING STUDIES 10 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 10 4 1 2 EDITING A PATIENT STUDY NOT IN ACTIVE PATIENT FILE 1 From Main Menu screen select Administrative 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 10 4 2 INTERPRETATION MACROS 10 4 2 1 CREATING A MACRO 1 From the Main Menu screen select Administrative 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 edita title choose it us
76. ill already be chosen This automatic setting is called a default setting and the NeuroMax comes to you with a full complement of default settings designed to meet the greatest variety of requirements 7 1 TEST MENU PARAMETERS On any given test menu you can change add the name of a nerve Nerve Conductions Test Menu muscle Electromyography Test Menu or protocol Other Tests Menu CAUTION This will permanently change the Test Menu 1 From the NeuroMax Main Menu screen use the select arrows to choose the Test Menu and then press the Select key to open the Test Menu 2 Use the Left Right arrows to place the yellow highlight over the position to be changed 3 Press the Default key to open the Default gt You can also Settings box edivatethe setting box by pressing 4 Using the keypad enter the name of the new Badd C nerve muscle protocol 5 Press the Select key to exit The Defauit key is located at the bottom lat d thekeyboard User Manual XLTEK NeuroMax 7 1 1 CREATING AN ELECTROMYOGRAPHY SUITE You can set the default parameters to create a personalized EMG suite that fits your specifications 1 From the NeuroMax Main Menu use the Select arrows to choose Electromyography and then press the Select key 2 Use the Left Right arrows to place the yellow highlight over the Suite name you wish to edit 3 Press the Default key ull activatethe Defaut 4 Using
77. ing 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 Xltek NeuroMax User Manual 10 4 2 2 USING A PRE DEFINED MACRO IN A REPORT 1 From the Main Menu screen select Administrative 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 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 T Press the Select key to exit from the Interpretation screen 10 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 10 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 s
78. interpretation in a letter format with the referring doctor s name Save File to Moves highlighted files to USB USB device See section 8 1 2 for details 8 1 2 MEMORY MANAGEMENT The Memory Management Option shows you the available memory and how to clear the memory to allow for more patient files You should monitor the memory on the NeuroMax regularly and archive the reports you wish to store Figure 8 2 Memory Management ADMINISTRATION MENU 1 PATIENT DIRECTORY 3 BATCH PRINT TTT 7 EDIT EMG Notepad 8 EDIT PATIENT INFO Fields 9 Change password 10 Login user manager 11 Software update 12 Backup Restore 4 SYSTEM OPTIONS 5 EDIT Report Format 6 EDIT Sita Name list 7 EDIT EMG Nolepad IMPORTANT Deleting patient files from the NeuroMax moves the information from live file memory which is shown as a yellow bar to deleted file memory which is shown as a red bar Both types of file memory will increase to fill the total maximum amount of memory available User Manual XLTEK NeuroMax To free up more memory on the NeuroMax you must archive backup all deleted files by 1 Saving the files to another computer via USB or 2 By printing hard copies of the files Once you have backed up all the files use these steps to permanently delete the deleted files and free more memory TAKE NOTE THAT THE PERMANENT DELETION OF FILES PERTAINS TO ALL DELETED FILES OR NONE OF THE DELETED FILES
79. lator 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 10 9 2 NO RESPONSE FROM ELECTRODES A In NCS or EMG Mode The acquired waveforms are flat do not appear or do not appear correct or as expected 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 Page 108 Xltek NeuroMax User Manual 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 a
80. libration 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 amplitude and duration The accuracy of the waveform acquisition section 15 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 10 10 1 CHECKING THE STIMULATOR CALIBRATION 1 Place 1Kohm 1 resistor across the leads of the stimulator 2 Access atest routine and temporarily reset its parameters As an example SELECT Nerve Conduction Studies gt Next SELECT Median gt Next SELECT a Test gt Select any side and press SELECT to enter the Test Screen 3 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 100mA by pressing the STIMULUS UP arrow key Page 115 Xltek NeuroMax User Manual 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 10 10 2 CHECKING THE WAVEFORM 1 Puta 80mV peak to peak 1KHz waveform into Channel 1 using a calibrated signal generator 2 From within the Blue Test Screen
81. mbol IEC Publication 384 ATTENTION Consult j Accompanying Documents 417 5019 Protective Earth Ground 878 02 02 Type BF Equipment 878 03 01 Dangerous Voltage 417 5032 Alternating Current 417 5008 Power Off Medical Device Directive CE Mark 93 42 EEC Canadian Standards Not Applicable Association indicates safety approval by Page 22 User Manual XLTEK NeuroMax 2 5 MAIN MENU The NeuroMax opens to the Main Menu screen and lists the five menu choices available to you MAIN MENU 2 Electromyography 3 Other Tests 4 Administrative Functions 5 Impedance Test Figure 2 1 Main Menu Choices 1 3 are the studies available on the NeuroMax 1 Nerve Conduction Test motor nerve conduction sensory nerve conduction F Wave Rep Stim and H reflex 2 Electromyography Test muscle activity with FreeRun EMG and Triggered EMG 3 Other Tests Includes Evoked Potentials Blink Reflex Incremental Stim and Heart Rate Variability Multi Channel EMG and Multi Channel NCS Page 23 User Manual XLTEK NeuroMax 2 6 KEY PAD The keypad is divided into four sections each with its own set of functions Alphanumeric Keyboard Figure 2 2 Key Pad Alphanumeric Keyboard Follows the familiar QWERTY pattern used on most computer keyboards Control Keys Operate audio stimulation and trigger levels Page 24 User Manual XLTEK NeuroMax d wndlel di ARUS ITOT Fig
82. natus neurology XLTEK NEUROMAX User Manual User Manual XLTEK NeuroMax Publisher s Notice 105352 RevE XLTEK NeuroMax User Manual Natus Medical Incorporated Excel Tech Ltd XLTEK 2568 Bristol Circle Oakville Ontario L6H 551 Canada Tel 905 829 5300 or Fax 905 829 5304 Toll Free US amp Canada 800 303 0306 Technical Support Email OTS natus com Customer Service Email Oakville Customer_Service natus com Website www natus com Natus Europe GmbH Robert Koch Str 1 82152 Planegg Germany CE 0086 rer EUROPEAN AUTHORIZED REPRESENTATIVE EC ONLY Copyright 2012 by Excel Tech Ltd XLTEK The information in this publication is provided for reference only All information contained in this publication is believed to be correct and complete Excel Tech Ltd shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this material All product specifications as well as the information contained in this publication are subject to change without notice This publication may contain or reference information and products protected by copyrights or patents and does not convey any license under the patent rights of Excel Tech Ltd nor the rights of others Excel Tech Ltd does not assume any liability arising out of any infringements of patents or other rights of third parties All rights reserved This
83. nce The top of the data area now displays RECORD and the screen is divided into two areas The left side of the screen has the same sensitivity factor as the F Wave set up routine while the right side of the screen has a separate F Wave sensitivity By default the F Wave gain will be 10 of the M Wave gain from the set up routine The two gain areas are separated by a vertical red line drawn on the screen The whole screen is continuous in timebase Once you have pressed SELECT to enter the RECORD mode simply press the START STOP key to begin the train of stimuli and recording of the M and F Wave responses By default the NeuroMax assumes that the stimulus used will be single shot stimulation for the set up and then change to train stimulation for the record mode but these defaults can easily be changed if required The F Wave protocol allows for the acquisition of up to 20 responses on one screen If you want to repeat a test you can either erase the existing traces and then acquire new data or you can save the existing test by going back to the test menu and re selecting F Wave once again 3 1 6 PERFORMING AN F WAVE TEST 1 From the main menu highlight Nerve Conduction Studies and then press SELECT or hit 1 2 From the Nerve Conduction Studies test menu choose the nerve you want to test then SELECT Choose F wave then SELECT 4 If required choose the side you want to test then SELECT once more 5 5 F Wave
84. nd 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 10 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 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
85. nformation screen Figure 2 6 Patient Information TTA 2 Enter the patient s information in each of the Ay P fields The yellow bar marks the field you are Up Down arrows the ina i Bett key andthe working in and the Select key takes you to keyboard keys to the next field othe Entry fidd User Manual XLTEK NeuroMax 3 When all relevant information has been entered While a patient is press the Patient Info key to exit to the Main actives thapatiat Menu information can be edited and or a new patient filecan 4 Press the Patient Info key to open the Patient be created Information screen to the patient s data 5 Atthe bottom of the screen you can choose A whether to edit the existing patient information or The Edt Curert Fariert to create a new patient file sattingis hidtigtted for you by the NeurdViax 6 To edit the current patient file press the Select 7 Tocreate new patient file press the Right arrow to highlight New Patient and then press the Select key Once a test is completed and you have returned to either the Main Menu screen or to any of the three Test Menus that particular test will be saved and ui filed under the active patient name These tests can The Patient 5 be recalled and edited at any time from the Patient Bretay isfondin the Administrative An Activefileisa Directory Functions See Ch 8 patient filethat is for more
86. ng conditions gt For the sound level pressure reading to be valid only XLTEK approved headphones are to be used gt The AV STIM 1000 does not at present support NTSC video monitors gt The visual stimulator must be calibrated by the user This involves dedicating a monitor for the purpose of presenting the visual stimulus collecting normal values and then fixing the brightness contrast and distance to the patient Do not alter these values gt The interior surface of the LED goggles should be inspected before and after an examination and cleaned with a soft cloth Remove any oil or dust from both the interior and exterior surfaces Page 76 User Manual XLTEK NeuroMax Periodically check to be certain that all LEDs are functioning 6 6 SUGGESTED AEP PROTOCOLS SUGGESTED AEP PROTOCOLS LFF 150 Gain 2uV div Pulse Frequency Hz 11 1 Hz HFF 2 0 Sweep kHz 1ms div Channe Channe 6 6 1 AEP IMPEDANCE CHECK 1 Press the I Impedance key while testing to check impedance levels 2 Press the Select key to return to test screen 6 7 SUGGESTED VEP PROTOCOLS SUGGESTED VEP PROTOCOLS Hz 5uV Div 1 1 Hz HFF 100 Sweep KHz 25ms div One Channel Channe Two Channel Channe Channe Page77 E Theused a jumper cadle is recommended to comect the reference leacs Also use dectrode toFzasagoaud E heused a jumper cable is recomended to connec
87. on of 0 2 0 3 stimdus durations are better tolerated but MSEC will preferentially 2 Place stimulator electrode over the nerve with excite rotor nears ova Sensory cathode negative black proximal and cathode positive red distal 3 To set stimulus Intensity press the Start Stop Control key and use the stimulus controls to increase the current level to approximately 3 times that at which the patient first felt the shocks Make sure that the correct muscles are visibly twitching 4 Press the Averager key to begin acquiring data User Manual XLTEK NeuroMax 5 When sufficient number of averages have 7 Sect key to togde been obtained press the Averager key to through each trace in succession The acquire the next set of traces 6 Once acquisition of signals is complete press move the red vertical cursor the Start Stop Control key to end stimulation across screen The Down arrows T Press the Trace key and then use the togdebawea the Move Superimpose features to overlay o or ame waveforms 8 Press the Cursors key to mark signals 9 calculate a conduction velocity press the Distance key 10 To exit the test press the Test Menu key or the Main Menu key 5 1 4 SUGGESTED SEP PROTOCOLS The tables below give you the suggested SEP protocols and the protocols for specific location acquisitions SUGGESTED SEP PROTOCOLS Gain LFF 20 Hz 20uV div Avgs 500 Swe
88. ows to highlight the next cursor 5 Press the Cursors key to exit the editing cursor mode 5 OTHER TESTS The NeuroMax conducts several other tests including Evoked Potentials Blink Reflex Incremental Stim Heart Rate variability and P 300 5 1 OTHER TESTS Before you select any of the Other Tests you need to set up the patient information screen to create an active patient file and then return to the Main Menu screen X You can save ether thehighigtted ar averaged waveform average of all the restered wavefors The Up Down arrows sdect the waveforms to highlight User Manual XLTEK NeuroMax 5 1 1 SETTING UP EVOKED POTENTIALS EP 1 Using the Select arrows select Other Tests from the Main Menu and then press the Select A EE key to open the Other Tests Menu Toreumtothe aher 2 Section 1 choose the appropriate test using Tests Menu press the Test Menu key the Select arrows and then press the Select key to continue 3 Section 2 choose EP Evoked Potentials using the Select arrows and then press the Select key to continue 4 Section choose the side you wish to test and then press the Select key to open the EP Test screen Figure 5 1 EP Test 5 1 2 CONDUCTING EVOKED POTENTIALS The Evoked Potentials test screen is similar to that of the Nerve Conductions The gains for all channels and timebase are shown on the top of the acquisition box and the cu
89. palmar or plantar sweat glands in response to a variety of stimuli In this case electrical The SSR is a multi segmental somatosympathetic reflex arc terminating with a final efferent pathway passing through preganglionic and postganglionic sudomotor fibers Though intimidating to conceptualize it is straight forward to perform The patient must be relaxed and recumbent Normal recording parameter are not consistent through the literature We suggest that you use variations of the below given parameters LFF 0 5 to 2 0 Hz HFF 500 to 5 000 Hz Gain 500 uV div Timebase 1 sec div otimulate single irregular intervals with long interstimulus intervals between one 1 to three 3 minutes to avoid habituation Record from the side contralateral to the site of stimulation Page 63 User Manual XLTEK NeuroMax Hand Reference electrode placed on the back of the hand active electrode placed on palm Stimulate the median nerve at a supramaximal level 0 1 msec Cathode is proximal Foot Reference electrode placed on dorsum active electrode placed on sole Stimulate the tibial nerve at a supramaximal level 0 1 msec Cathode is proximal Latencies are measured form the stimulus artifact to the onset of the first negative OR positive peak Amplitude is measured peak to peak A typical recording session will consist of collecting up to ten 10 responses from each nerve and recording the mean value 5 5 MULTI CHANNEL EMG IOM
90. quency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people DECLARATION OF COMPLIANCE FOR FCC Note This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense Warning Changes or modifications not expressly approved by the manufacturer could void the user s authority to operate the equipment Page 11 User Manual XLTEK NeuroMax 1 WELCOME TO THE NEUROMAX Congratulations you have purchased the NeuroMax from XLTEK one of the world s top manufacturers of neurodiagnostic equipment and software The Neuro
91. r 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 100K 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 Xltek NeuroMax User Manual 10 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 layer of oils sebum and dirt 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 Remember you are
92. res The system is not AP or APG rated WARNING Do not turn the system on until all cable connections are made and their integrity is checked Page 18 User Manual XLTEK NeuroMax A A A gt gt WARNING The proper use of this device for its intended purpose can only be assured once all instructions have been read and understood If there are any questions regarding the operation of this device contact your XLTEK representative at once WARNING The sale distribution or use of this device is restricted to by or on order of a licensed medical practitioner WARNING The NeuroMax and the AV Stim are Type BF devices as per EN 60601 1 regarding degree of protection against electrical shock The BF device is an applied part isolated from other parts of the EQUIPMENT to such a degree that that no current higher than the PATIENT LEAKAGE CURRENT allowable in SINGLE FAULT CONDITION flows if an intended voltage originating from an external source is connected to the PATIENT and thereby applied between the APPLIED PART and the ground All of the patient connections of the NeuroMax are electrically isolated however these connections are not intended for direct cardiac contact WARNING The NeuroMax provides sufficient electrical isolation for the patient through its own internal isolation barrier Please ensure that a printer attached to the NeuroMax through the USB port passes an appropriate safety certification
93. rify or inspect the data Edit Report You can edit the tests and the data within a test to customize the report Interpretation Gives you a free text area to type a summary of the data interpret what will be printed on the final report Print Report Prints the report Only Print Report Prints the report and a and condensed version of the Waveforms waveforms If a patient is not active then the reporting functions must be accessed through the Patient Directory in the Administration Menu User Manual XLTEK NeuroMax 1 From the NeuroMax Main Menu screen select Administrative Menu and then press the Select 2 From the Administrative Functions Menu select Patient Directory and then press the Select 3 Select the function and press the Select key Page 32 User Manual XLTEK NeuroMax 3 NERVE CONDUCTION TESTS This chapter will deal with the operation of the NeuroMax in its Nerve Conduction Studies mode of operation The most important function to become familiar with is the ASSIGN function The Assign function has been designed to streamline the process of acquiring Motor and Sensory Nerve Conductions responses The Assign function will enable the user to peruse many acquired responses and relevant data values i e latency amplitude etc on the same screen at the same time enabling them to efficiently choose the best response without having to SAVE EACH INDIVIDUAL response during the course of the
94. rmly in place 1 Adjust the stimulus intensity by pressing the Stim Up Down arrows on the Control 1 TreSimiads arerecorded inthe keypad amp imda o box at the bottomright of your To activate the stimulus probe press the screen Start Stop Control key the center button on the hand held stimulator to obtain the waveform or press and release the footswitch Repeat until desired waveform is obtained Number the waveform and assign waveform to trace position using appropriate number key 1 8 The waveform will be placed the Assigned Trace area Move to next stimulus site and then repeat procedure To save the test data and to exit the test press the Test Menu key or the Main Menu key Page 36 User Manual XLTEK NeuroMax MNC SNC STUDY HINTS AND FEATURES gt f a particular stimulus site has no response use the Cursors key to move the Latency 1 cursor to the 40 position far left and the report will display NR for the appropriate site Pressing the Averager key will automatically average successive traces and the averaged trace will be displayed in the acquisition box Once the desired response is obtained the averaged waveform may be assigned to the appropriate position and the number of averages will return to zero to begin the next stimulus site This feature may be used in conjunction with repetitive or train stimulus mode to quickly average more than one response gt
95. rsor data and stimulator boxes are located to the right of the screen Page 51 User Manual XLTEK NeuroMax 1 Press the Start Stop Control key to begin stimulating Press the Averager key to begin acquiring data Once a sufficient number of averages has been obtained press the Averager key to begin acquiring the next set of traces 4 Once acquisition of signals is completed press MU due the Start Stop Control key to end the Use Sdedt arrows to stimulation move cursor andto sdect new cursors Press the Cursor key to mark signals See instructions battamright screen Press the Test Menu key to exit and set up new test or press the Main Menu key to exit the test EVOKED POTENTIALS HINTS AND gt There are two different gains available i Amplifier Gain the actual input gain of the amplifiers This gain influences the rejection level of the signal Display Gain sensitivity magnifies the signal to better fit the screen This second gain or sensitivity does not affect the amplification of the signal it is simply for display purposes gt Ifthe amplifier gain is set too high there is a chance that the amplifier will blocked or saturated Thus since Evoked Potentials are very small magnitude signals you may wish to reject more signals than the set 99 of the amplifier limit Using A Acceptance Level the user can choose the specific threshold for acceptance rejection Choosing Sides i
96. rve 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 Page 114 Xltek NeuroMax User Manual 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 15 highlighted As an example if you choose RADIAL nerve and then highlight 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 move to the RECORD screen at least 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 10 10 CHECKING CALIBRATION OF NEUROMAX The factory ca
97. s 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 Xltek NeuroMax User Manual 10 3 ELECTROMYOGRAPHY This section gives you the basic steps for creating an electromyography suite and how to use it 10 3 1 CREATING AN EMG 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 From the Main Menu screen select Electromyography and press the Select key From the Electromyography Test Menu select the Suite that you wish to rename and then press the C key 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 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 10 3 2 USING AN EMG 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 Suite name list appears in the active screen Press the Start Stop Control key to start recording from the highlig
98. s made up of discrete keys and cannot be easily cleaned If any material were to slip between the keys the NeuroMax can be held upside down to allow those pieces to drop Also individual keys can be cleaned carefully with Q tips Avoiding any sustained exposure to extreme temperatures above 50 Celsius or below 20 Celsius will help prolong the integrity of the keyboard 10 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 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 10 8 4 BACK PANEL CONNECTORS The back panel of the NeuroMax contains the headbox connector the printer connector the AC power cord connector and the Power ON OFF switch and fuses The panel itself is made of a heavy grade reinforced fiberglass material avoid any excessive physical stress on the panel itself or any of its components Check regularly for any cracks that may have developed in the panel contact XLTEK service if you suspect any physical damage to the back panel CAUTION DO NOT LEAVE ANY CABLES CONNECTED TO THE BACK PANEL WHEN TRANSPORTING THE NEUROMAX DOING SO MAY CAUSE THE CONNECTORS TO COME LOOSE AND OR MALFUNCTION THE BACK PANEL
99. screen is similar to that of Evoked Potentials The gains for all four channels and Page 65 User Manual XLTEK NeuroMax timebase are shown on the top of the acquisition box and the cursor data and stimulator boxes are located on the right of the screen The stimulator box shows the two different tones to be presented to evoke the P300 response Their frequency and weighting can be changed using the STIMULATOR hard key The data box contains the active cursors and once placed on a waveform their values These cursors can be set and labeled by editing the test s defaults For the first set of waveforms cursor data will be placed in Standard Set 1 or Target Set 1 depending on whether the data was collected from a target or standard response The command box shows the current tone that is being presented to the patient as well as the number of traces that are either included in the averages or have been rejected Different averages are kept for target and standard responses If the NeuroMax is to keep track of patient input the command box also shows the number of times the button was pressed during a standard tone Press on Stand and how many targets tones were missed by the patient Missed Targets User Manual XLTEK NeuroMax 5 7 2 RUNNING THE TEST Enter a patient name and data by pressing PATIENT INFO while in the Test Menu or Main Menu Enter the desired settings by pressing STIMULATOR or use DEFAULT to set and
100. ser Manual XLTEK NeuroMax Channe 9 1 5 4 SURAL DERMATOMAL 51 Stimulate under the lateral malleolus anode distal Channe 5 2 BLINK REFLEX The Blink Reflex test as designed on the NeuroMax is an easy to use protocol for the evaluation of the R1 and R2 Compound Muscle Action Potentials recorded from the orbicularis oculi muscle in response to stimulation of either the supraorbital or infraorbital branch of the trigeminal nerve The Blink Reflex test allows for the complete examination to be performed on one test screen with the flexibility in setting up the default configuration to allow you to run your own specific protocol 5 2 1 SETTING UP A BLINK REFLEX TEST 1 Using the Select arrows select Other Tests from the Main Menu and then press the Select key to open the Other Tests Test Menu 2 In Section 1 choose the Facial setting using the Select arrows and then press the Select key to continue 3 In Section 2 choose Blink using the Select arrows and then press the Select key to continue 4 In Section 3 the Bilateral side is defaulted Press the Select key to open the Blink Test screen 5 2 2 CONDUCTING BLINK REFLEX TESTS Page 57 X Thesdections for aBirktest are limited by the nature of thetest thusthe NeuroMex notifies you if the wrong nerve is sdected Thereareten customizable cursors Six inte peakinterval Calculations are also availade WM a Toreumtothe Gher
101. sive sound can cause temporary and even permanent hearing loss WARNING Long term exposure to excessive light can cause temporary and even permanent changes in visual acuity WARNING Patient electrical isolation BS EN 60601 1 is ensured when all peripherals Headphones Printer Goggles Monitor attached to the Audio Visual Stimulator are XLTEK approved The final system configuration must meet the requirements of EN 60601 1 for safety of medical systems WARNING Use of the AV STIM 1000 is not compatible with defibrillators or electrocautery devices gt 6 4 2 CAUTIONS Page 75 User Manual XLTEK NeuroMax Cautions must be noted when using the equipment Cautions apply to conditions which may damage the NeuroMax and other equipment CAUTION If you choose to attach a VGA display other than the model supplied by XLTEK it MUST either meet IEC 601 1 or the leakage current requirements for your jurisdiction CAUTION The AV STIM 1000 provides signals to the headphones the LED goggles and to the video stimulator Otherwise signals are provided by the NeuroMax 6 5 CALIBRATION AND MAINTENANCE The AV STIM 1000 requires minimal maintenance The supplied headphones are factory calibrated to the specific NeuroMax you are using If for any reason the headphones require replacement or re calibration both the headphones and the AV STIM 1000 unit must be returned to XLTEK Please observe the followi
102. st collecting waveforms onthe sare menu screen switch eyes and repeat 51605 3 6 LEethesetaldesto sc your Montage levds User Manual XLTEK NeuroMax 6 9 ACQUIRING A HEMIFIELD VEP RESPONSE The setup for the Hemifield VEP Response is completed in the Choose Side section of the Other Tests test screen 1 In the Choose Side section select Bilateral and then press the Select key to continue Press the Stimulator key and set the Stimulator to Left Field Stimulus and Right Field Nothing Montage for Right eye Left covered Channe B 1 Channe 10cm lateral to VS Fpz 2 O1 Montage for Left eye Right covered Channe Channe 10cm lateral to VS Fpz 2 O2 3 Have subject cover the Right eye and fixate towards the center of the checkerboard field Press the Start Stop Control key and begin acquisition 5 Press the Averager key to begin averaging 6 Once a set is completed press the Averager key again to collect the next set Page 79 Toswitchto the ather side cover theldt eye sat the simulator to Hght Fad Stimulus and Left Nothing VM lt TreDdait keyis located at the bottom let of the keyboard User Manual XLTEK NeuroMax 7 SETTING THE DEFAULTS The setting on all of your tests can be designed to suit your particular needs Thus whenever you activate the NeuroMax to do a particular test your specific settings w
103. study When a stimulus pulse is delivered the response will be displayed in the box at the top left hand corner of the screen in the Acquisition Trace Area Once you have acquired a satisfactory trace response you must ASSIGN it to the Assigned Trace Area by assigning that trace a number using the numeric keypad Refer to figure 3 2 fora diagram of the screen trace areas As with other testing modes on the NeuroMax you can create custom testing protocols and have them saved for immediate selection without having to change all of the stimulating and recording parameters each time you do a particular test Test Menu Parameters are covered in chapter seven 7 User Manual XLTEK NeuroMax 3 1 MOTOR AND SENSORY NERVE CONDUCTIONS Before you begin the Motor and Sensory Nerve Conduction Studies set up the Patient Information screen to create an active patient file and then return to the Main Menu screen 3 1 1 SETTING UP A NERVE CONDUCTION STUDY 1 Using the Select arrows select Nerve Conduction Studies from the Main Menu and then press the Select key to open the Nerve anduction Studies TEST MENU Median ot Med Uln Rad Conduction Test Menu Figure 3 1 NCS Test Menu Screen 2 In Section 1 choose the appropriate Nerve using the Select arrows then press the SELECT 3 In Section 2 choose either the Motor Nerve Conduction study or Sensory Nerve Tor amp umtothe Conduction SN
104. 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 contact will help prolong the lifespan of the NeuroMax CAUTION DISCONNECT THE POWER CORD FROM THE SYSTEM AND THE WALL BEFORE CLEANING USE A LINT FREE CLOTH DO NOT USE ABRASIVE CLEANERS ANY SYSTEM COMPONENT SEE NEUROMAX 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 panel 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 panel connections and the headphone jack on the right side near the front Page 104 Xltek NeuroMax User Manual 10 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 ABS resin 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 Page 105 Xltek NeuroMax User Manual 10 8 2 KEYBOARD The keyboard i
105. t the reference leads Also use an AectrodetoFzas a ground Inaunlateral study 4 sets of 2 chamas canbe cdlectedin this reme User Manual XLTEK NeuroMax 6 7 1 VEP IMPEDANCE CHECK 1 Press the I Impedance key while testing to check impedance levels 2 Set impedance levels 3 Press the Select key to return to test screen 6 8 ACQUIRING A FULLFIELD VEP RESPONSE The setup for the Fullfield VEP Response is completed in the Choose Side section of the Other Tests test screen 1 Choose the eye to test To begin with the left eye choose the Left side and then press the Select key to continue Press the Stimulator Control key and then set the Stimulator to Left Field Stimulus and or Right Field Stimulus Have the test subject cover the right eye and fixate towards the center of the checkerboard field with the left eye Press the Start Stop Control key and begin the acquisition 5 Press the Averager key to begin averaging 6 Once a set is completed press the Averager key again to collect the next set To test the Right side press the Test Menu key select the Right side in the Choose Side section of the Test Screen and then press the Select key to continue Cover left eye and repeat steps 2 6 Page 78 E Inqpedances of about 5 kChrre are recommended for dear resuts If youare conga Blatera test start withtheldt eye andfalow the steps x If youare conga Blateral te
106. test screen will now appear with Thestirnuus intensity the phrase SET UP at the top of the screen 54 Thestimiata also be cortrolled levds are snowninthe by using the Up Down Stinuator box arrow keys onthestim probe See System Qsxionsin C 8 Fage41 User Manual XLTEK NeuroMax NOTE A proper M Wave response must be obtained before you can move to the RECORD screen 6 Adjust the stimulus intensity by pressing the STIM UP DOWN arrows 7 activate the stimulus probe press the START STOP key or the trigger button on the stimulator and obtain a waveform Repeat until the desired waveform is obtained 9 When the desired M Wave response has been obtained press SELECT to enter the RECORD mode A in Fave testing the acqusition areais dvidedirto a split screen by a vertical redline The 61 side hasthe same gan factor as the set up routine while the right side has an independent F Wave sensitivity The dd aut sattingof ths sensitivity is 10 of the Mave gain Figure 3 4 F Wave Test Screen Record Mode 10 Press the START STOP key to begin data acquisition 11 Press CURSORS to adjust the F Wave latency cursor To calculate F Wave amplitude you must first superimpose all traces TRACE function NOTE If response is absent scroll latency cursor to 0 far left and report will display response as Page 42 Fress the aimuatar key to set mode operation User Manual XLTEK
107. unctions 2 1 OPERATING CONDITIONS The NeuroMax is designed for optimum performance under safe conditions To ensure the safety of the operator and of the patient please read the following sections carefully 2 1 1 ENVIRONMENT PARAMETERS Temperature Range 10 to 40 degrees Celsius Relative Humidity Range 30 96 to 75 96 Atmospheric Pressure Range 700 hPa to 1 060 hPa Altitude To a maximum of 4600 meters above sea level 2 1 2 TRANSPORT AND STORAGE PARAMETERS Ambient Temperature Range 40 to 70 degrees Celsius Relative Humidity Range 10 to 100 including condensation Atmospheric Pressure Range 500hPa to 1 060hPa Page 15 User Manual XLTEK NeuroMax 2 2 SPECIFICATIONS pecification imensions 4 x 13 W x 13 D eight olour Materials Injection moulded PC ABS chassis Headbox Headphones Printer Footswitch pneumatic 4 NeuroMaxCE 1004 Channels 2 NeuroMaxCE 1002 Sampling Rate 60 kHz Display Size and Type 12 1 active matrix colour LCD screen Resolution 1024 x 768 Input Power eat Loss Maximum Supply 10 for either 50 Hz or 60 Current Tolerance Hz transformer Electrical Supply 10 for either 50 Hz or 60 0 x o O D x o c D 2 lt x cO O N m x SY gt o x 3 D M 1 n 5 RV N 2 2
108. ure 2 3 Control Keys Select Keys The Select arrows control the option selections and the Select key is main entry key Figure 2 4 Select Keys Function Keys Perform and customize neurological tests Page 25 User Manual XLTEK NeuroMax Figure 2 5 Function Keys The Function key operations are listed below TRACE FUNCTION KEY superimpose traces SETTINGS FUNCTION KEY Low frequency high frequency and notch filters Amplifier and Display Gain timebase and sweep delay Trigger delay slope CURSORS FUNCTION KEY Latency and amplitude cursors Adjust position and add cursors DISTANCE FUNCTION KEY segment distances in mm Conduction velocity calculated STIMULATOR FUNCTION KEY Pulse duration stim frequency mode and max intensity Number of pulses train Page 26 User Manual XLTEK NeuroMax AV Stimulator parameters NOTES FUNCTION KEY Needle EMG notepad Enter test comments Edit site names ERASE FUNCTION KEY Erase single or multiple traces Erase sets of data AVERAGER FUNCTION KEY Turn Averager On Off Acquire EP responses SELECT FUNCTION KEY Choose highlighted menu selection 2 HOT KEYS The Hot Keys activate functions during an acquisition providing a quick and immediate response They will be noted in the Notes and Tips when applicable 2 7 1 SENSORY NERVE CONDUCTION HOT KEYS FUNCTION Space Bar if in full screen mode averaging and single acquisition mo
109. vironment guidance RF emissions Group 1 The NeuroMax 1004 1002 uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment RF emissions Class A The NeuroMax 1004 1002 is suitable for use in all establishments other CISPR 11 than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Class A emissions IEC 61000 3 2 Voltage Complies fluctuations flicker emissions IEC 61000 3 3 Page 8 User Manual XLTEK NeuroMax Table 2 Electromagnetic Immunity Guidance and Manufacturer s Declaration Electromagnetic Immunity The NeuroMax 1004 1002 15 intended for use in the electromagnetic environment specified below The customer or the user of the NeuroMax 1004 1002 should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic test level level environment guidance Electrostatic Discharge 6 kV contact Floors should be wood concrete or ESD ceramic tile If floors are covered with 38 kV air synthetic material the relative humidity IEC 61000 4 2 should be at least 3096 Electrostatic fast 2 kV for power Complies Mains power quality should be transient burst supply lines that of a typical commercial or IEC 61000 4 4 hospital environment input output lines Surge 1 kV Compli
110. w values These values become the new default settings Press the Select key to open the Save and Exit dialog box Press Sto save ar Dto discard changes Torestorefactary defaults press R To cortinue editing defauits press E Figure 7 1 Save and Exit Dialog Box 6 Select one of the options and continue Note that you can always return to the factory default settings that came with the NeuroMax Page 82 x You can also activate the Def auit sating box by pressing Space Bar C User Manual XLTEK NeuroMax 8 ADMINISTRATIVE FUNCTIONS The NeuroMax Administrative Functions are designed to help you customize the NeuroMax and to manage the information acquired by the tests This chapter shows you how to customize reports store data and transfer files 8 1 ADMINISTRATIVE FUNCTIONS The Administrative Functions menu allows you to customize the reports functions and memory of the system Data entered on these menus makes permanent changes to the system The following chart lists the administrative functions REPORT FUNCTIONS Patient Recall print and edit stored Directory patient files Memory Delete files and erase Management memory Print all non printed reports System oet global options including Options date time units of measure printer type artifact rejection external stimulator and more Edit Report Edit macros select fields included in the report and report layout List stimulation
111. weep which crosses the trigger will be copied to the raster area The second trigger is an exclusion trigger Figure 4 2 Triggered EMG 4 3 1 ACTIVATING TRIGGERS The NeuroMax is automatically set to Trigger 1 The active trigger levels are shown at the bottom of the left screen See Figure 4 2 1 To adjust trigger amplitude levels press the Trigger Up Down Control arrows 2 activate Trigger 2 press the Trigger 1 2 Control key 3 To adjust Trigger 2 amplitude levels press the Trigger Up Down Control arrows Page 49 JJ When the Trigger Sone is negative Trigger 2 the exclusion trigger negative value is greater higher onthe screen than Trigger 1 When trigger slope is positive Trigger 2 positive value is greater lower onthe screen than Triggert See dhada on Test Recall Procedures User Manual XLTEK NeuroMax 4 3 2 SAVING A TEST 1 When number of rastered traces are on the screen press the Select key to save the test 2 adjust the number of waveforms to raster press the Trace key 3 adjust the cursors in the selected and the averaged waves press the Cursors key 4 3 3 ANALYZING AND REVIEWING MOTOR UNITS 1 Recall the test file from Patient Directory 2 Use Left Right arrows to highlight red box containing the motor unit to be edited 3 Press the Cursors key and then use the Left Right arrows to move the highlighted green cursor 4 Press the Up Down arr
112. y selecting an existing name and then deleting and entering a new name A reren cannot be nore than 12 cheracters long 8 1 7 EDIT EMG NOTEPAD You can edit the standard Notes format available when acquiring EMGs to reflect your requirements 8 1 8 EDIT PATIENT INFORMATION FIELDS You can customize the fields you would like to appear on the patient information section of the reports 8 1 9 CHANGING THE DATE ON STORED DATA On pre stored files 1 Turn On the NeuroMax or be certain that there is currently no selected patient 2 From the Main Menu select Administration Functions then Patient Directory Page 87 User Manual XLTEK NeuroMax 3 Choose the Patient Choose 0 Patient Callback into Current Study 4 Choose Main Menu followed by Administration Functions followed by SYSTEMS OPTIONS 5 You are now going to change the date to suite your needs 6 Choose Edit Date or Edit Time and set to the required needs 7 Exit from this screen go to Main Menu and press Patient info And choose Edit Current Patient 8 You must now rename the patient suggest that you simply add aaa to the beginning of the patient name 9 Press Patient Info When done 10 Patient is now stored under the new date 11 You must now press Patient Info again and remove the aaa from the patient name Press Patient info o exit this screen 12 Repeat steps 4 to 6 to change the date back to the current date 13 You are now
113. your specific needs It will guide you through the acquisition of a patient record and its review storage and recall You will learn how to develop a report and to archive studies for future reference For your convenience a thorough Table of Contents is provided which details the topics covered in each chapter An Index is also available at the back of the manual The in depth procedures describe the detailed operation and customization of the EMG system The procedures which are accompanied by detailed graphics are designed to tailor the system to your specific circumstances We encourage all users to explore the manual and to take advantage of everything that XLTEK has designed the EMG system to do When going through the procedures we recommend that you read the whole section before Starting the sequence Please follow the instructions carefully We have also placed TIPS and NOTES alongside the instructions These will list Hot Keys operation tips shortcuts and testing information Page 14 User Manual XLTEK NeuroMax 2 THE XLTEK NEUROMAX The NeuroMax is designed to conduct a range of tests including Nerve Conduction Studies 5 Electromyography Studies EMG and other tests such as Evoked Potentials Blink Reflex Incremental Stimulation and Heart Rate Variability This chapter takes you through the Warnings and Cautions you need to observe while operating the NeuroMax and introduces you to its basic f

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