XLTEK NeuroMax User Manual Rev E

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User Manual

XLTEK NeuroMax

Publisher’s Notice 105352 Rev E XLTEK NeuroMax User Manual Natus Medical Incorporated Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle

Oakville, Ontario, L6H 5S1 Canada Tel: 905-829-5300 or Fax: Free (US & Canada): Technical Support Email: Customer Service Email:

EUROPEAN AUTHORIZED REPRESENTATIVE: Natus Europe GmbH Robert-Koch-Str. 1 82152 Planegg Germany

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 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.

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XLTEK NeuroMax

TABLE OF CONTENTS NEUROMAX SAFETY AND STANDARDS CONFORMITY

6

1. WELCOME TO THE NEUROMAX

12

1.1. INTRODUCTION

13

1.1.1. INTENDED USE

13

1.2. CUSTOMER SERVICE 1.3. USING THE MANUAL

13 14

2. THE XLTEK NEUROMAX

15

2.1. OPERATING CONDITIONS

15

2.1.1. ENVIRONMENT PARAMETERS 2.1.2. TRANSPORT AND STORAGE PARAMETERS

15 15

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

16 16 16 16 16 16 16 16 16 17 17 17 17 17 17

2.3.1. W ARNINGS 2.3.2. CAUTIONS

18 20

2.4. EXPLANATION OF LABELING SYMBOLS 2.5. MAIN MENU 2.6. KEY PAD 2.7. HOT KEYS

22 23 24 27

2.7.1. SENSORY NERVE CONDUCTION HOT KEYS 2.7.2. ELECTROMYOGRAPHY HOT KEYS 2.7.3. EVOKED POTENTIAL HOT KEYS

27 27 28

2.8. CREATING A PATIENT FILE 2.9. GENERATING TEST REPORTS

29 30

2.9.1. REPORT FUNCTIONS

30

3. NERVE CONDUCTION TESTS

33

3.1. MOTOR AND SENSORY NERVE CONDUCTIONS

34

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3.1.1. SETTING UP A NERVE CONDUCTION STUDY 3.1.2. CONDUCTING AN NCS 3.1.3. ABOUT THE REP STIM TEST 3.1.4. PERFORMING A REP STIM TEST 3.1.5. ABOUT THE F-W AVE TEST 3.1.6. PERFORMING AN F-W AVE TEST 3.1.7. SETTING UP AN H-REFLEX TEST 3.1.8. ACQUIRING H-REFLEX RESPONSES

34 36 37 38 40 41 44 44

4. EMG TESTS

45

4.1. SETTING UP THE EMG TEST MENU

45

4.1.1. SETTING UP AN EMG 4.1.2. ACQUIRING AN EMG

45 46

4.2. FREE RUN EMG FEATURES

48

4.2.1. REVIEWING FREE RUN EMG 4.2.2. ANALYZING TURNS AND AMPLITUDE

48 48

4.3. TRIGGERED EMG FEATURES

49

4.3.1. ACTIVATING TRIGGERS 4.3.2. SAVING A TEST 4.3.3. ANALYZING AND REVIEWING MOTOR UNITS

49 50 50

5. OTHER TESTS

50

5.1. OTHER TESTS

50

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

51 51 53 54 56

5.2. BLINK REFLEX

57

5.2.1. SETTING UP A BLINK REFLEX TEST 5.2.2. CONDUCTING BLINK REFLEX TESTS

57 57

5.3. INCREMENTAL STIMULATION

58

5.3.1. SETTING UP INCREMENTAL STIM TESTS 5.3.2. CONDUCTING INCREMENTAL STIM TESTS 5.3.3. INCREMENTAL STIM TEST VALUES

58 60 60

5.4. HEART RATE VARIABILITY (HRV)

61

5.4.1. SETTING UP HRV STIMULATION TESTS 5.4.2. CONDUCTING HRV TESTS 5.4.3. SYMPATHETIC SKIN RESPONSE

61 61 63

5.5. MULTI-CHANNEL EMG/IOM 5.6. MULTI-CHANNEL NERVE CONDUCTIONS 5.7. THE P300 TEST

64 65 65

5.7.1. GETTING STARTED 5.7.2. RUNNING THE TEST 5.7.3. HINTS AND FEATURES 5.7.4. EXPLANATION OF OPTIONS

65 67 67 69

5.8. THE ERG (ELECTRORETINOGRAM) TEST

71

5.8.1. ABOUT THE ERG TEST 5.8.2. CONFIGURING THE ERG PROTOCOL

71 71

5.9. THE EOG (ELECTRO-OCULOGRAM) TEST

72

5.9.1. ABOUT THE EOG TEST

72

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5.9.2. CONFIGURING THE E0G PROTOCOL

72

6. AV STIM 1000

73

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

73 73 74 75

6.4.1. W ARNINGS 6.4.2. CAUTIONS

75 75

6.5. CALIBRATION AND MAINTENANCE 6.6. SUGGESTED AEP PROTOCOLS

76 77

6.6.1. AEP IMPEDANCE CHECK

77

6.7. SUGGESTED VEP PROTOCOLS

77

6.7.1. VEP IMPEDANCE CHECK

78

6.8. ACQUIRING A FULLFIELD VEP RESPONSE 6.9. ACQUIRING A HEMIFIELD VEP RESPONSE

78 79

7. SETTING THE DEFAULTS

80

7.1. TEST MENU PARAMETERS

80

7.1.1. CREATING AN ELECTROMYOGRAPHY SUITE

81

7.2. EDITING TEST DEFAULTS

81

8. ADMINISTRATIVE FUNCTIONS

83

8.1. ADMINISTRATIVE FUNCTIONS

83

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

84 85 86 86 87 87 87 87 87

8.2. MANAGING THE REPORTS

88

8.2.1. RICH TEXT FILES (RTF)

88

8.3. EXTENDED WARRANTY SERVICES INFORMATION

89

9. APPENDIX 1: IN-SERVICE CHECKLIST

90

10. APPENDIX 2: TROUBLESHOOTING/MAINTENANCE

93

10.1. SOFTWARE

93

10.1.1. CHECKING SOFTWARE VERSION ON NEUROMAX 10.1.2. UPDATING SOFTWARE

93 93

10.2. NERVE CONDUCTIONS

93

10.2.1. CREATING A NCS

94

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10.2.2. EDITING AN NCS 10.2.3. SETTING UP STIMULUS AND RECORDING SITES

94 94

10.3. ELECTROMYOGRAPHY

95

10.3.1. CREATING AN EMG SUITE 10.3.2. USING AN EMG SUITE

95 95

10.4. ADMINISTRATIVE FUNCTIONS

96

10.4.1. EDITING STUDIES 10.4.2. INTERPRETATION MACROS

96 96

10.5. TROUBLESHOOTING

97

10.5.1. SIGNAL CLIPPING IN NCS 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

97 97 98 99 99 100

10.6. AV STIM 10.7. PRINTING

103 103

10.7.1. NEUROMAX 10.7.2. PRINTER

103 103

10.8. RECOMMENDED USER PERFORMED MAINTENANCE

104

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

105 106 106 106 106 106 107 107

10.9. USER ADJUSTMENTS

107

10.9.1. NO ELECTRICAL STIMULUS 10.9.2. NO 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

108 108 109 110 111 112

10.10. CHECKING CALIBRATION OF NEUROMAX

115

10.10.1. CHECKING THE STIMULATOR CALIBRATION: 10.10.2. CHECKING THE W AVEFORM

115 116

INDEX

117

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NEUROMAX SAFETY AND STANDARDS CONFORMITY STANDARDS COMPLIANCE AND NORMATIVE REFERENCES EMG System, model "NeuroMax 1002" and “NeuroMax 1004"; rated 120/240V, 50/60Hz, 1.4A/0.7A; detachable cord connected; Class I;Type BF applied parts. 1. Type of protection against electric shock: Class I 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 C22.2 No 601.1-M90 CSA 601.1 Supplement 1:1994

CSA 601.1 Amendment 2:1998

UL Std No 2601-1 (2nd Edition)

Medical Electrical Equipment part 1: General requirements for Safety adopted IEC 601-1 2ed (90) Supplement No 1-94 to CAN/CSA C22.2 601.1-M90 Medical Electrical Equipment Part 1: General Requirements for Safety Amendment 2 to CAN/CSA C22.2 601.1-M90 Medical Electrical Equipment Part 1: General Requirements for Safety Medical Electrical Equipment part 1: General requirements for Safety

IEC 601-1:1988 + A1:1991 + A2:1995

Medical electrical equipment - Part 1: General requirements 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 Standard: Electromagnetic Compatibility - Requirements and Tests

IEC 61000-4-2:1995 / EN 61000-42:2001

Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test

IEC 61000-4-3:2002 / EN 61000-43:2006

Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test

IEC 61000-4-4:2004 / EN 61000-44:2004

Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test

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XLTEK NeuroMax

IEC 61000-4-5:1995 / EN 61000-45:2006

Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test

IEC 61000-4-6:1996 / EN 61000-46:2007

Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields

IEC 61000-4-8 / EN 61000-4-8

Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test

IEC 61000-4-11:2004 / EN 61000-411:2004

Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests

IEC 61000-3-2:2005 / EN 61000-32:2006

Electromagnetic compatibility (EMC) - Part 3-2: Limits Limits for harmonic current emissions

IEC 61000-3-3:1994 / EN 61000-33:1995 +A1:2001 +A2:2005

Electromagnetic compatibility (EMC) - Part 3-3: Limits Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems

CISPR 11:2004 / EN 55011:1998+A1:1999 & A2:2002

Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Electromagnetic Disturbance Characteristics Limits and Methods of Measurement

ANSI C63.4:2003

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

CISPR 16-1-1: 2003

Specification for radio disturbance and immunity measuring apparatus and methods. Part 1-1: Measuring Apparatus

CISPR 16-2-1:2004

Specification for radio disturbance and immunity measuring apparatus and methods. Part 1-2: Conducted disturbances

FCC CRF47 Part 15, Subpart B Class A

Federal Communications Commission (FCC) - Unintentional Radiators

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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 test RF emissions

Compliance

Electromagnetic environment - guidance

Group 1

The NeuroMax 1004/1002 uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment

Class A

The NeuroMax 1004/1002 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 RF emissions CISPR 11

Harmonic Class A emissions IEC 61000-3-2 Voltage Complies fluctuations/ flicker emissions IEC 61000-3-3

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Table 2 - Electromagnetic Immunity

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 test level

Electrostatic Discharge (ESD)

±6 kV contact

Compliance level Complies

±8 kV air

IEC 61000-4-2 Electrostatic fast transient/burst

±2 kV for power supply lines

IEC 61000-4-4

±1 kV for input/output lines

Surge

±1 kV differential mode

IEC 61000-4-5

Complies

IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle

Mains power quality should be that of a typical commercial or hospital environment.

Complies

Mains power quality should be that of a typical commercial or hospital environment. If the user of the NeuroMax 1004/1002 requires continued operation during power mains interruption, it is recommended that the NeuroMax 1004/1002 be powered from an uninterruptible power supply or a battery.

Complies

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles

Power frequency (50/60 Hz) magnetic field

<5% UT (>95% dip in UT) for 5 sec 3 A/m

IEC 61000-4-8 NOTE: UT is the AC supply voltage prior to application of the test level.

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Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

Complies

±2 kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines

Electromagnetic environment - guidance

User Manual

XLTEK NeuroMax

Table 3 - Electromagnetic Immunity – for EQUIPMENT and SYSTEMS that are not LIFESUPPORTING

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

Compliance Electromagnetic environment - guidance level

IEC 60601 test level

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 IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

150kHz to 80MHz

Complies 80MHz to 800MHz

Radiated RF

3 V/m 80 MHz to 2.5 GHz

IEC 61000-4-3

800MHz to 2.5GHz

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 sitea should be less than the compliance level in each frequencyb. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the NeuroMax 1004/1002 is 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.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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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 maximum output power of transmitter (W)

Separation distance according to frequency of transmitter (m) 150 kHz to80MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

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 frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: 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.

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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 NeuroMax offers full-featured EMG in a simple, easy to use, and affordable line of instruments. XLTEK NeuroMax is available in two and fourchannel 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 MultiChannel 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 MultiChannel Studies.

XLTEK Headboxes and Accessories XLTEK provides two and four-channel amplifiers, AV

Stimulators, and a full range of accessories.

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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 accessories, 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 is 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 [email protected].

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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 our system meets 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. TIPS

NOTES

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2. THE XLTEK NEUROMAX The NeuroMax is designed to conduct a range of tests, including Nerve Conduction Studies (NCS), 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 functions.

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 % to 75 % 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

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2.2. SPECIFICATIONS Specification

Value General Description Dimensions 4” (H) x 13” (W) x 13” (D) Weight 11.4lbs (5.2kg) Colour White Injection moulded PC ABS Materials chassis External Connectors Headbox, Headphones, Printer, Footswitch (pneumatic) 4 (NeuroMaxCE 1004) Channels 2 (NeuroMaxCE 1002) 60 kHz Sampling Rate Size and Type Resolution

Display 12.1” active matrix colour LCD screen 1024 x 768

Electrical Specifications Maximum Rated 92 VA Input Power Heat Loss 92 Watts Maximum Supply ± 10% for either 50 Hz or 60 Current Tolerance Hz transformer* Electrical Supply ± 10% for either 50 Hz or 60 Frequency Tolerance Hz transformer* Insulation Class and Class 1, Type BF Type Power Input Voltage, 120 VAC, 60 Hz, 1A Frequency, and 230 VAC, 50 Hz, 0.4 A Rated Current Mains Connection Protectively grounded detachable power supply cord ~105 dB CMRR Noise

~2.9 nV / √Hz

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Stimulator Specifications Maximum Simulator ~450 V Voltage Maximum Stimulator 100 mA Current Stimulator Current Accuracy

± 1%

Stimulator Duration Accuracy

± 1%

Voltage Accuracy on ± 1% Screen * A 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 1-800-3030306. 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 TO IT.

The NeuroMax and AV Stim carry the ordinary equipment classification (as per IEC 529) for the level of protection against ingress of liquids. They are not drip or splash proof. Regarding protection against electrical shock, the NeuroMax and AV Stim are classified as Class I devices (as per EN 60601-1). The NeuroMax

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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.

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 mixtures. 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.

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