Neurosoft Neuro-MEP Manual de usuario

Technical Manual

Neuro-MEP

Neuro-ERG

Digital Neurophysiological Systems

TM006.01.005.00

(27.08.2013

)

5, Voronin str., Ivanovo, 153032, Russia

P.O. Box 10, Ivanovo, 153000, Russia

Phone: +7 (4932) 24-04-34 Fax: +7 (4932) 24-04-35

E-mail: com@neurosoft.ru Internet: www.neurosoft.ru

Contents

Introduction............................................................................................................... 4

1. Description and Operation................................................................................ 5

1.1. Function........................................................................................................ 5

1.2. Specifications ...............................................................................................6

1.3. Delivery Set................................................................................................ 10

1.4. Arrangement and Operation ....................................................................... 16

1.5. Connectors and Indicators Function............................................................ 19

1.6. Synchronization with Stimulators of Third-party Manufacturers................... 22

1.7. Synchronization Use with Neuro-MEP.NET Software ................................. 23

2. Mounting and Setting...................................................................................... 24

2.1. Personnel Requirements Conducting Mounting and Setting....................... 24

2.2. Room Selection and Placement.................................................................. 25

2.3. Unpacking and Check of Delivery Set......................................................... 27

2.4. Mounting and Connection to Computer....................................................... 28

3. Proper Use....................................................................................................... 32

3.1. Safety Measures When Using Digital System............................................. 32

3.2. Setting-Up Procedures................................................................................ 32

3.3. Troubleshooting.......................................................................................... 33

3.4. Exams Performing Using Digital System..................................................... 39

3.5. Actions in Emergency................................................................................. 39

4. Servicing.......................................................................................................... 40

4.1. General Requirements................................................................................ 40

4.2. Digital System Servicing............................................................................. 40

4.3. Conservation .............................................................................................. 40

5. Current Repair ................................................................................................. 41

5.1. General Requirements................................................................................ 41

5.2. Cables, Adapters and Linkers Repair.......................................................... 41

5.3. Amplifier Interface Cable Repair (USB Cable) ............................................ 41

5.4. Auditory Stimulator Repair.......................................................................... 42

5.5. LED Goggles Repair................................................................................... 42

5.6. LED Penlights Repair ................................................................................. 43

5.7. Ganzfeld Stimulator Repair......................................................................... 44

5.8. Electro Stimulating Electrode Repair (Stimulus Probe) ............................... 44

6. Packing and Transportation ........................................................................... 45

7. Utilization......................................................................................................... 45

8. Delivery Set and Package Data....................................................................... 45

9. Acceptance Certificate.................................................................................... 46

10. Delivery Certificate.......................................................................................... 46

11. Storage Data .................................................................................................... 46

12. Warranty........................................................................................................... 47

13. Reclamation Data ............................................................................................ 48

14. Repair Data ...................................................................................................... 50

Appendix 1. Electromagnetic Emissions and Immunity ...................................... 51

Neuro-MEP, Neuro-ERG (Technical Manual)

Introduction

This technical manual (further "manual") is the combined document describing opera-

tion and servicing of multifunctional digital neurophysiological systems for EMG, EP,

ERG and OAE Neuro-MEP-4, Neuro-MEP-8 and Neuro-ERG digital systems (here-

inafter referred to as "digital systems").

The document certifies technical parameters of digital systems, which are guaranteed

by the manufacturer.

Do not start working with the digital system before you have

read this document!

You can send your responses and recommendations to the following address:

P.O. Box 10, Ivanovo, 153000, Russia

or by e-mail:

[email protected].

You can find additional information on Neurosoft products on our website:

www.neurosoft.ru

or ask questions by phone:

+7 (4932) 24-04-37 (Service Department)

+7 (4932) 24-04-34

You can also contact SAS Neuromed Company, Authorized European Representa-

tive of Neurosoft Company (to Mr. Pierre Scholl) by the following address:

Chemin du tomple

84330 Le Barroux, France

Phone: +490-650-470, +622-748-384

Fax: +490-650-470

E-mail: bscho[email protected]

Description and Operation

1. Description and Operation

1.1. Function

Digital system Neuro-MEP-4 is intended for study of electrical activity of muscles and

nerves and also somatosensory, visual, auditory evoked potentials (EP), magnetic

EP, electroretinogram (ERG), otoacoustic emission (OAE) by 1-4 channels and

Neuro-MEP-8 is by 1-8 channels. It is done by biopotentials acquision and input into

PC, and measurement, calculation and analysis of its parameters.

Digital system Neuro-ERG is based on Neuro-MEP digital system and intended for

electroretinography, flash and reversal pattern visual evoked potentials (VEP) and

EOG studies.

The digital systems can be used in the patient care institutions, diagnostics centers,

neurosurgical hospitals and experimental laboratories of the research institutions for:

•brain functional state study;

•neuromuscular system study (Neuro-MEP digital system);

•study of auditory (Neuro-MEP digital system) and visual tracts.

The general properties, when carrying out the exams:

•1-4/8 channel biopotentials recording in any unshielded room;

•Photic-, auditory (Neuro-MEP digital system), electrical stimulation (Neuro-MEP

digital system) and stimulation carrying out with the use of checkerboard reversal

pattern;

•Long-, middle-, short-latency flash and reversal pattern visual, auditory

(Neuro-MEP digital system), cognitive (P300, MMN, CNV) (Neuro-MEP digital sys-

tem), somatosensory (Neuro-MEP digital system) evoked potentials recording;

•Skin galvanic responses recording (Neuro-MEP digital system);

•Surface EMG recording (Neuro-MEP digital system);

•Stimulation EMG recording (Neuro-MEP digital system);

•Repetitive stimulation (Neuro-MEP digital system);

•Needle EMG recording (Neuro-MEP digital system);

•Electroretinogram study;

•Otoacoustic emission study (Neuro-MEP digital system);

Neuro-MEP, Neuro-ERG (Technical Manual)

•Exam report generation;

•Preview, storage and print of the recorded traces, results of their analysis and exam

reports.

1.2. Specifications

Table 1. Main Specifications.

Parameters

Values

Biopotentials Acquisition Channels

Number of channels 4/8

Sampling rate

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

200 Hz−40 kHz

200 Hz−40 (160) kHz

A/D converter 16 bit

Voltage range 20 µ−50 mV

Ratio error of voltage measurement:

−in the range from 20 up to 100 µV

−

in the range from 0.1 up to 50 mV

within ±15%

within ±5%

EP voltage range at averaging 0.1−400 µV

Ratio error of EP voltage measurement at

averaging within ±10%

Common-mode rejection not less than 100 dB

Noise level, rms not more than 0.5 µV

Input impedance not less than 200/1000** MΩ

Amplifiers input capacitance not more than 25/22** pF

Patient leakage current not more than 0.1 µA

Bandpass flatness:

−in the band from 0.02 up to 0.05 Hz and

from 5 up to 10 kHz

−

in the band from 0.05 Hz up to 5 kHz

from –30 up to +5%

from –10 up to +5%

High pass filter 0,02;0,05;0,1; 0,2; 0,3; 0,5; 1; 2; 3; 5; 10; 20;

30; 50; 100; 200; 300; 500; 1000;

2000; 3000 Hz

Low pass filter 10; 20; 35; 50; 75; 100; 150; 200; 300; 500

Hz; 1; 2; 3; 5; 10 kHz

Sensitivity

−if you use Neuro-MEP software

−if you use Neuro-MEP.NET software

0,05; 0,1; 0,2; 0,5; 1; 2; 5; 10; 20; 50; 100;

200; 500 µV/div; 1; 2; 5; 10; 20; 50 mV/div.

0,05; 0,075; 0,1; 0,15; 0,2; 0,25; 0,4; 0,5;

0,75; 1; 1,5; 2; 2,5; 4; 5; 7,5; 10; 15; 20; 25;

40; 50; 75; 100; 150; 200; 250; 400; 500; 750;

µV/div.; 1; 1,5; 2; 2,5; 4; 5; 7,5; 10; 15; 20; 25;

40; 50 mV/div.

Ratio error of sensitivity within ±5%

Description and Operation

Table 1. Continued.

Parameters

Values

Sweep speed 0.1, 0.15, 0.2, 0.25, 0.4, 0.5, 0.75, 1, 1.5, 2,

2.5, 4, 5, 7.5, 10, 15, 20, 25, 40, 50, 75, 100,

150, 200, 250, 400 ms/div.;

0.5, 0.75, 1, 1.5, 2 s/div.

Ratio error of sweep speed within ±1%

Suppression ratio of power frequency by

notch filter not less than 40 dB

Electrical Stimulator

Stimulus amplitude 0.1−100 mA

Absolute deviation of stimulus amplitude ±0.1 mA

Stimulus duration

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

50 −5000 µs

100 −50000 µs

Absolute deviation of stimulus duration ±5 µs

Stimulus frequency at repetitive stimulation

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

0.05−50 Hz

0,01−100 Hz

Relative deviation of stimulus frequency

during repetitive stimulation within ±1%

Interstimuli interval at paired stimulation

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

10−5000 ms

10−100000 ms

Burst stimulation:

−pulse frequency

•if you use Neuro-MEP software

•if you use Neuro-MEP.NET software

−maximal burst duration

•if you use Neuro-MEP software

•if you use Neuro-MEP.NET software

does not support

40−1000 Hz

does not support

50 ms

Auditory Stimulator

Number of channels 2 (right and left)

Stimulation level 0−127 dB SPL (ТА-01)

0−130 dB SPL (TDH-39)

Stimulus frequency

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

0.05−30 Hz

0.01−100 Hz

Relative deviation of stimulus frequency within ±1%

Stimulus duration

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

100−50000 µs

50−90000 µs

Relative deviation of stimulus duration within ±15%

Left/right/double-sided stimulation yes

Neuro-MEP, Neuro-ERG (Technical Manual)

Table 1. Continued.

Parameters

Values

Photic Stimulator

Maximum brightness of:

−LED goggles

−mini-ganzfeld stimulator

(1100 ± 110) cd/m2

(1500 ± 150) cd/m2

Maximum luminescence power of:

−white penlight

−red penlight

−blue penlingt

−

green penlight

(0.2 ± 0.05) cd

(0.3 ± 0.075) cd

(0.15 ± 0.0375) cd

(0.2 ± 0.05) cd

Brightness control range -3…0 log units

Stimulus duration

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

0.1−50 ms

0.05−1500 ms

Relative deviation of stimulus duration within ±10%

Stimulus frequency

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

0.05−100 Hz

0.01−100 Hz

Relative deviation of stimulus frequency within ±1%

Left/right/double-sided stimulation by LED

goggles yes

Pattern Stimulator

Stimulation frequency

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

0.1−5 Hz

Relative deviation of stimulation frequency within ±10%

Pattern resolution:

−standard stimulator

−

high resolution stimulator

320×240 pixels, 15 colors

800×600 pixels, 16 millions of colors

OAE Probe

Stimulus intensity

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

0−80 dB

does not support

Absolute deviation of stimulus intensity within ±3 dB

Stimulus duration

−if you use Neuro-MEP software

−if you use Neuro-MEP.NET software

100−50000 µs

does not support

Relative deviation of stimulus duration within ±15%

Stimulus frequency

−if you use Neuro-MEP software

−

if you use Neuro-MEP.NET software

0.05−50 Hz

does not support

Relative deviation of stimulus frequency

within ±15%

Receiver bandpass flatness:

−from 500 up to 2500 Hz

−

from 2500 up to 4500 Hz

not more than 10 dB

not more than 20 dB

Description and Operation

Table 1. Continued.

Parameters

Values

Microphone bandpass flatness:

−

in the band from 500 up to 4500 Hz

not more than 6 dB

General Parameters and Characteristics

Interface USB

Supply voltage:

−Electronic units

−Desktop PC-based system

−Notebook PC-based system

5 V DC

220/230 V AC (50 Hz)

110 V AC (60 Hz)

220/230 V AC (50 Hz)

110 V AC (60 Hz)/

int. battery

Dimensions:

−Amplifier unit

−Auditory-visual stimulator unit

−Electrical stimulator control unit

190×140×50 mm

155×105×40 mm

Weight:

−Amplifier unit

−Auditory-visual stimulator unit

−Electrical stimulator control unit

not more than 1 kg

not more than 0.5 kg

Safety BF type

* if two 4-channel amplifier units are used (Neuro-MEP-8 digital system).

** if amplifier unit with NSFT 006201.012 and higher is used.

Safety and Electromagnetic Compatibility

Electromagnetic compatibility (EMC) is provided by IEC 60601-1-2:2007 requirements

fulfillment.

The digital system is intended for operation in electromagnetic environment, which

special features are specified in Appendix 1.

Portable and mobile RF communication equipment can affect the system operation.

The use of the equipment not listed in tables 2 and 3 of the present technical manual

may result in increased emission and system decreased immunity.

As for safety, the digital system satisfies IEC 60601-1:1988 + A1:1991 + A2:1995,

IEC 60601-1-1:2000 and IEC 60601-2-40:1998 requirements. The electronic unit is

supplied by regulated power supply through USB interface, it has double isolation and

BF type work parts according to IEC 60601-1.

Interpretation of Symbols on Electronic Units:

−

−−

−

Attention: consult user and technical manuals.

−

Work parts of BF type according to IEC 60601-1.

Neuro-MEP, Neuro-ERG (Technical Manual)

−

Mark of conformance to Russian standards requirements GOST R.

−

Mark of measuring device with approved type.

−

Mark of conformance to 93/42/EEC “Concerning Medical Devices” directive.

−

Mark of conformance to 2002/96/EC “On waste electrical and electronic

equipment (WEEE)” directive.

1.3. Delivery Set

The delivery sets of Neuro-MEP-4,Neuro-MEP-8,Neuro-ERG digital systems in-

clude the electronic units of an amplifier, electrical stimulator and auditory-visual stim-

ulator, patient button, footswitch, dedicated keyboard and software, which can be de-

livered to the customer both jointly and separately, and also components and bought

articles. The delivery sets depending on the functional variant are represented in the

Table 2 and Table 3.

The Table 2 and Table 3 include the following:

1. Neuro-MEP-4 digital EMG and EP system;

2. Neuro-MEP-8 digital EMG and EP system;

3. Neuro-MEP-4 digital EMG and EP system (Neuro-MEP-4/S delivery set)

4. Neuro-MEP-8 digital EMG and EP system (Neuro-MEP-8/S delivery set)

5. Neuro-ERG digital ERG system.

6. Neuro-MEP-4 digital EMG and EP system (Neuro-EMG delivery set)

7. Neuro-MEP-4 digital EMG and EP system (Neuro-EP delivery set)

Table 2. Base Delivery Set

Name

Document code or main

specifications

Number

pcs.

1/2

3/4

Neuro

MEP

amplifier unit NSFT 006201.012

1/2

1 1 1

Neuro

MEP

auditory-visual stimulator

unit NSFT 025201.010 1 1 1 - 1

Neuro

MEP

electrical stimulator control

unit NSFT 024201.017 1 1 - 1 1

Holder NSFT 016201.038

NSFT 016201.038-01 1 1 1 1 1

Cleat for 2 amplifier units fixation on

holder NSFT 006200.003 -/1

-/1

- - -

Holder fastener NSFT 006200.002 -/1

-/1

1 1 1

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