Technical Manual

Neuron-Spectrum-1
Neuron-Spectrum-2
Neuron-Spectrum-3
Neuron-Spectrum-4
Neuron-Spectrum-4/P
CloudEEG

Digital Neurophysiological Systems

TM015.03.002.000
(24.03.2020)
Neurosoft© 2020
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

The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-Spectrum-4 and,

Neuron-Spectrum- 4/P, CloudEEG with Neuron-Spectrum.NET software are intended for use as digital
neurophysiological systems intended for recording, processing and display of biopotential signals such as
Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from
Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.
The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16 (Neuron-Spectrum-2), 19 (Neuron-
Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-Spectrum-4/P, CloudEEG) EEG channels, 1 (Neuron-Spectrum-1,
Neuron-Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 polygraphic channels (Neuron-
Spectrum-4/P, CloudEEG: ECG, EOG), 1 respiratory channel and 2 direct current channels (Neuron-Spectrum-4/P).
Neuron-Spectrum.NET includes the Evoked potentials averaging function and Quantitative
electroencephalography (qEEG), including specific parameters such as Rhythmicity, FFT power ratio and
amplitude metrics.
The devices do not provide alarms, do not provide automated event marking and do not provide to the user any
diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions,
diagnostics centers, neurosurgical hospitals, experimental laboratories and sleep laboratories.
The patient group includes all ages and sexes.*

*Safety of use for this age group is confirmed by the results of clinical data.

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner
Contents
Introduction ............................................................................................................... 4
1. Description and Operation ................................................................................ 5
1.1. Function ........................................................................................................ 5
1.2. Safety Measures ........................................................................................... 6
1.3. Specifications ............................................................................................... 6
1.4. Delivery Set ................................................................................................ 11
1.5. Technology and Operation .......................................................................... 17
1.6. Connectors and Indicators .......................................................................... 18
2. Installation ....................................................................................................... 20
2.1. Requirements to the Personnel Conducting Systems Installation ............... 20
2.2. Room Selection and Placement .................................................................. 20
2.3. Unpacking and Check of Delivery Set ......................................................... 23
2.4. Connection to Computer ............................................................................. 23
3. Proper Use ....................................................................................................... 25
3.1. Safety Measures when Using the Systems ................................................. 25
3.2. Setting-up Procedures ................................................................................ 26
3.3. Exams Performing Using the Systems ........................................................ 27
3.4. Actions in Emergency ................................................................................. 28
4. Servicing .......................................................................................................... 28
4.1. General Requirements ................................................................................ 28
4.2. Servicing..................................................................................................... 28
4.3. Conservation .............................................................................................. 28
5. Current Repair ................................................................................................. 29
5.1. General Requirements ................................................................................ 29
5.2. EEG, ECG Cables, Adapters and Linkers Repair........................................ 29
5.3. Computer Interface Cable Repair (USB cable)............................................ 29
5.4. Auditory Stimulator Repair .......................................................................... 29
5.5. Photic Stimulator Repair ............................................................................. 30
5.6. Visual Pattern-Stimulator Adapter Repair.................................................... 31
6. Packing and Transportation ........................................................................... 32
7. Storage Regulations ........................................................................................ 32
8. Utilization ......................................................................................................... 32
9. Delivery Set and Package Data ....................................................................... 33
10. Acceptance Certificate .................................................................................... 33
11. Delivery Certificate .......................................................................................... 33
12. Storage Data .................................................................................................... 34
13. Warranty ........................................................................................................... 35
14. Reclamation Data ............................................................................................ 35
15. Repair Data ...................................................................................................... 38
Appendix 1. Electromagnetic Emissions and Immunity ...................................... 39
Appendix 2. Trigger Input/Output .......................................................................... 43

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Neuron-Spectrum (Technical Manual)

Introduction
This technical manual (hereinafter referred to as “the manual”) is the combined
document describing operation and servicing of digital neurophysiological systems
Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3, Neuron-
Spectrum-4, Neuron-Spectrum-4/P and CloudEEG (hereinafter referred to as
“the systems”).

The document certifies technical parameters of digital EEG systems, which are
guaranteed by the manufacturer.

Do not start working with the systems before you have read this manual!

Because of the continuous improvements of the digital EEG systems, its construction
could be modified. These modifications do not degrade the digital EEG system
performance and could be not described in this manual.

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

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

or by e-mail:

help@neurosoft.com

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

www.neurosoft.com

or ask questions by phone:

+7 (4932) 59-21-12 (Service Center)

+7 (4932) 24-04-34

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 Description and Operation

1. Description and Operation

1.1. Function
The digital EEG systems Neuron-Spectrum-4/P, CloudEEG are intended for EEG,
long-latency EP recording in any unshielded room.

The digital systems Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-Spectrum-3

and Neuron-Spectrum-4, CloudEEG are produced on the basis of Neuron-
Spectrum-4/P and intended for the recording of EEG and long-latency EP in any
unshielded room.

The devices are portable and can register up to 8 (Neuron-Spectrum-1), 16

(Neuron-Spectrum-2), 19 (Neuron-Spectrum-3), 21 (Neuron-Spectrum-4, Neuron-
Spectrum-4/P, CloudEEG) EEG channels, 1 (Neuron-Spectrum-1, Neuron-
Spectrum-2, Neuron-Spectrum-3 and Neuron-Spectrum-4) or up to 4 (Neuron-
Spectrum-4/P, CloudEEG) polygraphic channels (ECG, EOG), 1 breath channel and 2
direct current channels (Neuron-Spectrum-4/P, CloudEEG).

The systems can be used in the patient care institutions, diagnostics centers,
neurosurgical hospitals and experimental laboratories of the research institutions to:

· Record, review and analyze EEG;

· Record, review and analyze long-latency EP;

· Study polysomnography.

The operation of the device in the video EEG monitoring mode is possible for not
more than 30 days.

The general properties, when carrying out EEG or EP study using EEG channels:

· 21-channel EEG/EP recording in any unshielded room;

· Up to 2 direct current channels recording (Neuron-Spectrum-4/P, CloudEEG);

· Photic, auditory stimulation and stimulation carrying out with the use of reversal
checkerboard pattern;

· Synchronous long-term recording of EEG and video from one, two or three video
cameras and recording of audio information from one or two microphones;

· Long-latency EP recording using EEG channels: flash and reversal pattern visual,
auditory and cognitive (P300, MMN, CNV);

· Spectral EEG analysis, exam report generation, export and import of files in the
standard European data format (EDF);

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Neuron-Spectrum (Technical Manual)

· Review, store and print of the recorded traces, results of their analysis and exam
reports.

A patient stimulation can be performed with the use of stimulators built in the device.

The main condition for using the digital EEG systems is the good professional skills of
the medical staff.

1.2. Safety Measures

To ensure the safety and exclude the hazard of medical staff’s or patient’s
electric shock, the medical staff is PROHIBITED:

· to use the digital EEG system which was mounted and installed incorrectly, without
following this manual instructions;

· to connect digital EEG system and other high-frequency equipment to patient (it can
lead to burns in places of electrode attachment or system damage);

· to connect another equipment (not included in delivery set) to electrode slots;

· to open the units to make repair;

· to work with the digital EEG system when the electronic unit, computer or other
devices used together with the stimulator are opened;

· to connect electrodes placed on the patient to protective ground or other

conducting surfaces.

1.3. Specifications
Table 1. Main Specifications

Parameters Values
EEG Channels
Number of channels 8/16/19/21*
Sampling rate 100, 200, 500, 1000, 2000,
5000 Hz
Input range 1–12000 µV
Ratio error of voltage measurement:
· in the range from 10 up to 50 µV within ±15%
· in the range from 51 up to 12000 µV within ±5%
Ratio error of time interval measurement in the range from within ±2%
10 µs up to 10 s

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 Description and Operation

Table 1. Continued

Parameters Values
Sensitivity 1–1000 µV/mm
(step 1 µV/mm)
Ratio error of sensitivity within ±5%
Sweep speed at EEG recording 3–960 mm/s (step 1 mm/s)
Sweep speed at EP recording 5, 10, 20, 50, 100, 200,
500 ms/div.
Ratio error of sweep speed within ±2%
High pass filter 0.05–10 Hz (step 0.01 Hz)
Low pass filter 5–200 Hz (step 0.1 Hz)
Bandpass flatness in range from 0.5 up to 60 Hz from –10 up to +5%
Suppression ratio of power frequency by notch filter not less than 40 dB
Common-mode rejection not less than 110 dB
Input noise level within 0.5-200 Hz (rms value) not more than 2 µV
(not more than 0.3 µV)
Input impedance not less than 400 MΩ
Patient leakage current not more than 50 nA
Polygraphic Channels
Number of channels 1/4**
Input range 0.2–100 mV
Ratio error of voltage measurement in the range:
· from 200 up to 500 µV within ±15%
· from 0.5 up to 100 mV within ±7%
Sensitivity 0.001, 0.002, 0.005, 0.007,
0.01, 0.02, 0.05, 0.07, 0.1,
0.2, 0.5 mV/mm
High pass filter 0.05, 0.1, 0.2, 0.5, 0.7, 1.5, 2,
5, 10 Hz
Low pass filter 5, 10, 15, 35, 75, 100, 150,
200 Hz
Bandpass flatness in the range:
· from 0.5 up to 200 Hz from –10 up to +5%
· from 0.05 up to 0.5 Hz and from 200 up to 250 Hz from –30 up to +5%
Suppression ratio of power frequency by notch filter not less than 40 dB
Input noise level within 0.05-200 Hz not more than 3 µV
Input impedance not less than 400 MΩ
Patient leakage current not more than 50 nA
Common mode rejection not less than 100 dB

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Neuron-Spectrum (Technical Manual)

Table 1. Continued

Parameters Values
Direct Current Channels***
Number of channels 2
Input range from –3 V up to +3 V
Ratio error of voltage measurement in the range:
· from 0.3 mV up to 1 mV within ±15%
· from 1 mV up to 3 V within ±7%
Sensitivity 1, 2, 5, 7, 10, 20, 50, 70, 100,
200, 500 mV/mm
Ratio error of sensitivity within ±5%
Input impedance not less than 100 MΩ
Cutoff frequency (–3 ± 0.5 dB) 200 Hz
Photic Stimulator
Number of channels 1
Stimulus duration 0.1–3000 ms
Relative deviation of stimulus duration within ±10%
Maximal brightness of LED stimulator (FS-1) (16000 ± 1600) cd/m2
Stimulation frequency 0.1–100 Hz
Relative deviation of stimulation frequency within ±1%
Left/right/two-sided stimulation yes
Auditory Stimulator
Number of channels 2 (right and left)
Stimulation level: 0–126 dB SPL (TDH-39)
Stimulation frequency 0.1–100 Hz

Relative deviation of stimulation frequency within ±1%

Stimulus duration 100–5000 µs
Relative deviation of stimulus duration within ±15%
Left/right/double-sided stimulation yes
Compression/depression yes
Pattern-stimulator
Stimulation frequency 0.1–10 Hz
Relative deviation of stimulation frequency within ±10%
Pattern size 4´3, 8´6, 16´12, 32´24,
64´48 sqr.

8
 Description and Operation

Table 1. Continued

Parameters Values
Breath Channel
Number of channels 1
Breath frequency range 6–30 inhalations per minute
Breath channel bandpass 0.05–7.5 Hz
General Specifications and Parameters
Interface USB
Supply voltage:
· electronic unit 5 V DC
· desktop PC-based system 220/230 V AC (50 Hz)
· notebook PC-based system 220/230 V AC (50 Hz) / int.
battery
Electronic unit power consumption not more than 2.8 V´A
Electronic unit dimensions 140´200´45 mm
Electronic unit weight not more than 0.9 kg
Delivery set weight (without computer and printer) not more than 12.5 kg
Safety BF type
Notes:
*number of channels for Neuron-Spectrum-1 (8), Neuron-Spectrum-2 (16), Neuron-
Spectrum-3 (19), Neuron-Spectrum-4 and Neuron-Spectrum-4/P, CloudEEG (21)
correspondingly.

** number of polygraphic channels for Neuron-Spectrum-1 (1), Neuron-Spectrum-2 (1),

Neuron-Spectrum-3 (1), Neuron-Spectrum-4 (1) and Neuron-Spectrum-4/P, CloudEEG (4)
correspondingly.

*** for Neuron-Spectrum-4/P, CloudEEG.

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Neuron-Spectrum (Technical Manual)

Safety and Electromagnetic Compatibility

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

fulfillment.

The devices are 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 - 6 of the present technical manual
may result in increased emission and system decreased immunity.

As for safety, each digital EEG system satisfies IEC 60601-

1:1988+A1:1991+A2:1995, IEC 60601-1-1:2000 and IEC 60601-2-26:2002. The
electronic units of digital EEG systems are 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 the electronic EEG unit:

- Attention: consult user and technical manuals.

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

- Mark of conformance to Russian standards requirements.

- Mark of measuring device conformance to Russian standards

requirements.
- 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.

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 Description and Operation

1.4. Delivery Set

Neuron-Spectrum digital EEG systems include a unit with different accessories sets
for channels of EEG, polygraphic and software which can be delivered to the
customer both jointly and separately, and also components and bought articles. The
delivery set depends on the digital EEG system configuration and corresponds to
Table 2 and Table 3.

Designations in tables 2 and 3:

· 1 – Neuron-Spectrum-1 digital EEG system;

· 2 – Neuron-Spectrum-2 digital EEG system;

· 3 – Neuron-Spectrum-3 digital EEG system;

· 4 – Neuron-Spectrum-4 digital EEG system;

· 5 – Neuron-Spectrum-4/P digital EEG system;

· 6 – CloudEEG digital EEG system

Table 2. Base Delivery Set

Name Document code of main Quantity per configuration, pcs.

specifications
1 2 3 4 5 6
Neuron-Spectrum-1 NS015201.028 1 − − − − -
electronic unit 1) NS015201.028-001
Neuron-Spectrum-2 NS015201.029 − 1 − − − -
1)
electronic unit NS015201.029-001
Neuron-Spectrum-3 NS015201.030 − − 1 − − -
1)
electronic unit NS015201.030-001
Neuron-Spectrum-4 NS015201.031 − − − 1 − -
electronic unit 1) NS015201.031-001
Neuron-Spectrum-4/P NS015201.033 − − − − 1 -
1)
electronic unit NS015201.033-001
CloudEEG electronic unit NS015201.045-028 − − − − − 1
NS015201.045-029
Stand NS016998.007 − 1 1 1 1 1
(SH–3)
Holder for SN-3 stand NS016221.009 − 1 1 1 1 1
Assembled holder NS016201.038 (H-1) 1 − − − − -
Holder fastener NS006200.002 1 − − − − -
LED photic stimulator NS005302.005 − 1 1 1 1 1
(PS-1)
Stand for electronic unit NS016201.042 (SU-9) − 1 1 1 1 1

LED photic stimulator on NS012302.005 1 − − − − -

holder (PS-3)

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Neuron-Spectrum (Technical Manual)

Table 2. Continued

Name Document code of Quantity per configuration, pcs.

main specifications
1 2 3 4 5 6
Accessories for EEG Acquisition:
1)
EEG/EP Cup electrode Ambu Inc. 12 20 23 25 25 25
Pastes:
1)
Electrode adhesive paste Ten20, 114 g (USA) 1 1 1 1 1 1
Operational Documentation:
Neuron-Spectrum technical TM015.03.002.000 1 1 1 1 1 1
manual
Neuron-Spectrum.NET user UM015.04.002.001 1 1 1 1 1 1
manual
Exams Manager appendix to AU999.01.005.000 1 1 1 1 1 1
user manual
Software on CD:
Neuron-Spectrum.NET without additional 1 1 1 1 1 1
software modules
Package:
Cardboard package (set) 002901.001 1 1 1 1 1 1

Notes:
1)
The accessories and consumables of analogous types can be used if their application is
permitted in the country.

Table 3. Optional Equipment, Accessories and Software

Name Document code or Quantity per configuration, pcs.

main specifications

1 2 3 4 5 6

Auditory stimulator NS032305.005 1 1 1 1 1 1

(headphones) (TDH-39)
3)
Ultima Airflow Sensor Braebon Medical 1 1 1 1 1 1
Corporation
USB extension cable Omix 20 m (UniqueICs, 1 1 1 1 1 1
Russia)
1)
USB hub NS042999.002 1 1 1 1 1 1

12
 Description and Operation

Table 3. Continued

Name Document code or Quantity per configuration, pcs.

main specifications
1 2 3 4 5 6
Neuron-Spectrum-PSG see table 4 1 1 1 1 1 1
equipment
Neuron-Spectrum-Video see table 5 1 1 1 1 1 1
equipment
Accessories for EEG Acquisition:
3
Disposable needle electrode ) Technomed Europe 12 20 23 25 25 25
Electrode cap for 19-channel ELECTRO-CAP 1 1 1 1 1 1
EEG recording 3) (Electro-CAP, USA)
46-50 (XSM), 50-54
(SM),
54-58 (M), 58-62 (L),
34-38, 38-42, 42-46
(pediatric)

Strap for electrode cap3) ELECTRO-CAP 1 1 1 1 1 1

(Electro-CAP, USA)
46-50 (XSM), 50-54
(SM),
54-58 (M), 58-62 (L),
(pediatric)
Electrode cap extension cable NS007103.023-30 1 1 1 1 1 1
Special needle for filling ELECTRO-CAP 1 1 1 1 1 1
electrodes with gel3) (Electro-CAP, USA)
Ear electrode (pair) for ELECTRO-CAP 1 1 1 1 1 1
electrode cap 3) (Electro-CAP, USA)
EEG/EP Cup electrode2) Ambu Inc. 12 20 23 25 25 25
Pastes:
Electrode adhesive paste 2) Ten20, 114 g (USA) 1 1 1 1 1 1
Neuron-Spectrum-LEP Equipment:
Auditory stimulator NS032305.005 (TDH- 1 1 1 1 1 1
(headphones) 39)
Adapter for pattern-stimulator NS033201.005 1 1 1 1 1 1
connection
Adapter for high resolution NS033201.003 1 1 1 1 1 1
pattern-stimulator
connection 3)

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Neuron-Spectrum (Technical Manual)

Table 3. Continued

Name Document code or Quantity per configuration, pcs.

main specifications

1 2 3 4 5 6

Accessories for ECG Acquisition:

INTCO Tab Electrode2) Shanghai lntco Electrode 3 3 3 3 3 3
Manufacturing Co., Ltd.
Cable for one ECG channel NS005103.003 1 1 1 1 1 1
(set – 3 pieces) NS007103.016
Software on CD:
Neuron-Spectrum.NET with Neuron- 1 1 1 1 1 1
software Spectrum.NET/LEP
additional module
with Neuron- 1 1 1 1 1 1
Spectrum.NET/PSG
additional module
with Neuron- 1 1 1 1 1 1
Spectrum.NET/Video
additional module
Electronic Equipment
4)
Isolation transformer NS036999.001 1 1 1 1 1 1
(TM-630M)

Notes:
1) Connect USB devices through the KM-7 USB hub if you use several USB devices.
2) Components which are not included into Neuron-Spectrum-LEP base delivery set.
3) The accessories and consumables of analogous types can be used if their application is
permitted in the country.
4) The delivery of another transformer with similar input and output characteristics certified
according to IEC 60601-1 is permitted.

14
 Description and Operation

Table 4. Neuron-Spectrum-PSG Delivery Set

Document code and main Quantity,

Name
specifications pcs.

EEG/EP Cup electrode1) Ambu Inc. 9

1)
Ultima Airflow Sensor Braebon Medical Corporation 1
1)
Ultima Respiratory Effort Sensor Braebon Medical Corporation 1
1)
Reusable Airflow/Snore Sensor Dymedix Inc 1
1)
Ultima Body position sensor Braebon Medical Corporation 1
Video camera CNB-ZBN-21Z27F 1
(CNB Technology Inc,Korea)
Power supply unit GS25E-12P1J (Mean Well 2
Enterprises Co., Taiwan)
Splitter cable NS015103.036 1
Video cable NS015103.013 1
Tripod for video camera HAMA 04127 Star27 3D, 1
63-152 sm
Remote control CNB-SC100 1
Control cable for video camera NS015103.032 1
USB extension cable Omix 20 m (UniqueICs Ltd, Russia) 1
Extension cable NS015103.035 1
IR projector NS015302.004 1
Patient microphone NS015355.003 1
Bracket for patient’s microphone NS015221.007 1
Bracket SAB-03 (N) (Orient, Russia) 1
PCI video capture card USB 1
USB hub NS042999.002 1
Medical tape 1) Article 1527-2, Transpore (3M 1
Company, 3M Health Care, USA)
1)
Electrode adhesive paste TEN20, 114 g (USA) 1

Operational Documentation
2)
Neuron-Spectrum technical manual TM015.03.002.000 1
Package:
Transportation bag - 1
Notes:
1)
The accessories and consumables of analogous types can be used if their application is
permitted in the country.
2)
In case you purchase the digital system with the EEG system manufactured by
Neurosoft Ltd. these positions are not included in the delivery set.

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Neuron-Spectrum (Technical Manual)

Table 5. Neuron-Spectrum-Video Delivery Set

Document code and main Quantity,

Name
specifications pcs.
Video camera CNB-ZBN-21Z27F 1
(CNB Technology Inc, Korea)
Power supply unit GS25E-12P1J (Mean Well 2
Enterprises Co., Taiwan)
Adapter for power supply unit NS015103.036 1

Video cable NS015103.013 1

Video camera tripod HAMA 04127 Star27 3D, 1

63-152 cm (Germany)
Bracket SAB-03 (N) 1
(Orient, Russia)
Remote control CNB-SC100 1
(CNB Technology Inc, Korea)
Control cable for video camera NS015103.032 1

Video capture card USB 1

Patient’s microphone NS015355.003 1

IR projector NS015302.004 1
Electrode cap for 19-channel ELECTRO-CAP 1
EEG recording 1) (Electro-CAP, USA)
46-50 (XSM), 50-54 (SM),
54-58 (M), 58-62 (L),
34-38, 38-42, 42-46 (pediatric)
Strap for electrode cap1) ELECTRO-CAP 1
(Electro-CAP, USA)
46-50 (XSM), 50-54 (SM),
54-58 (M), 58-62 (L),
(pediatric)
Special needle for filling electrodes with ELECTRO-CAP 1
1)
gel (Electro-CAP, USA)
1)
Ear electrode (pair) for electrode cap ELECTRO-CAP 1
(Electro-CAP, USA)
USB extension cable Omix 20 m 1
(UniqueICs Ltd, Russia)
Extension cable NS015103.035 1
USB hub TC 4083-042-13218158-2006 1
NS042999.002

Notes:
1)
The accessories and consumables of analogous types can be used if their application is
permitted in the country.

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 Description and Operation

1.5. Technology and Operation

Digital EEG system mode of operation is based on the acquisition and input of brain
biopotentials and other physiological signals into PC for the analysis of brain electrical
activity taking into account the influence of the other physiological signals.

The functional circuit of the digital EEG system is shown in Fig. 1.

To electrodes of biopotentials
recording, breath sensor, DC
channels

Fig. 1. The functional diagram of the digital EEG system.

EEG, ECG, breath and direct current DC1, DC2 biopotentials are amplified, digitized
in turn by means of analog-digital converter (ADC) and multiplexer (MPX) under the
control of the processor PU1, they are transmitted to USB processor through the
optrons of galvanic isolation.
The processor PU1 of amplifier module controls measurement, calibration, impedance
measurement and internal diagnostics modes.
The power supply of the amplifier module is performed through electrically isolated
DC converter (SU1).
The processor PU2 controls audio stimulus level, duration, frequency and polarity. It
controls the stimulus duration of photic stimulator and generates commands to pattern
stimulator via the signal generators G1, G2, G3.
All the processors receive commands and transmit data through USB processor which
forms data packets to transmit them to computer and deciphers data transmitted from
computer to control the modules.
Digital EEG system operates under control of PC (IBM PC type) with the mouse, key-
board, laser or ink jet printer and installed licensed Windows XP/Vista/7/8 operational
system.
Signal processing, displaying and presentation in different modes after mathematical
analysis, storing of the EEG traces on the hard disc, exam report generation and their
printing is done with the use of PC.

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Neuron-Spectrum (Technical Manual)

1.6. Connectors and Indicators

The external view of front and side panels of the amplifier unit is represented on
Fig. 2, Fig. 3 and Fig. 4.

Touch-proof connectors for electrode cables attachment, LED operation indicator and
impedance indicators are located on the front panel (Fig. 2).

Fig. 2. The external view of the front panel.

EEG channels are marked as “FP1…O2”, “A1”, “A2”, polygraphic channels are

marked as “1”, “2”, “3”, “4”. The slot is used to attach the ground electrode.

The operation indicator glows yellow at the electronic unit connection to the computer,
glows green at the signal acquisition during the program operation.

The color of impedance indicator highlighting shows the quality of electrode

placement: the green color indicates the good quality of electrodes placement, the
yellow color is the mean one, the red color is the bad one. The borders of electrode
placement quality differentiation by colors are software-set.

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 Description and Operation

The top side panel of the amplifier unit contains the connectors for two direct current
channels attachment, the connector for breath sensor attachment, USB cable for the
attachment to computer, the trigger socket (trig-in/trig-out) to attach the stimulators of
other manufacturers, the connector for pattern-stimulator adapter attachment, the
connector for visual stimulator attachment, the connector for the auditory stimulator
attachment (Fig. 3).

Connector for breath sensor attachment

USB cable
Connector for auditory
stimulator attachment

Connector for visual stimulator

connection

Connector for pattern-stimulator adaptor

attachment
Trigger socket (trig-in/trig-out)

DC1 direct current channel

DC2 direct current channel

Fig. 3. The external view of the top side panel.

The bottom side panel contains the connector for electrode cap attachment (Fig . 4).

Connector for electrode cap attachment

Fig. 4. The external view of the bottom side panel.

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Neuron-Spectrum (Technical Manual)

2. Installation
2.1. Requirements to the Personnel Conducting
Systems Installation
Digital EEG system installation should be carried out by the person who is
empowered by the manufacturer or the technical personnel of the medical institution
which is going to use it. It is necessary to remember that digital EEG system mounting
accuracy defines safety and quality of operation. Further mounting and setting
requirements which define the product safety will be marked by bold and italic fonts
in the text.

2.2. Room Selection and Placement

Before mounting and setting of digital EEG system, it is necessary to select a place
for it, taking into consideration power wiring and protective ground in the room.
Please, read and respect the following requirements and recommendations:

Requirements concerning the room selection and equipment placement:

· The recommended distance from the electronic unit to the nearest electric mains is
not less than 3 meters.

· Do not place the electronic unit in the immediate vicinity (less than 5 meters) to
short-wave or microwave therapeutic equipment (it can lead to its unstable
operation).

· Place the electronic unit at the maximum possible distance from power cables,
switchboards, and different powerful electrical devices which can emit
electromagnetic fields of mains frequency.

· The patient environment (within 1.5 meters) should contain only the
electronic units being the medical devices with the required safety level. The
fact is that the safety level of the computer equipment is insufficient for the
use in the patient environment. Hence, a patient must not contact with the
metal parts of computer equipment cases and the personnel must not touch
simultaneously these parts and patient body. The computer equipment used
in the system should correspond to IEC 60601-1 or be connected via the
isolation transformer (specialized power supply unit – for notebook PC)
corresponding to above-mentioned requirements.

Requirements to mains:

· Do not use electric mains where the neutral conductor and protective ground
are combined. It is strongly prohibited.

20
 Installation

· The use of multi-socket electric mains extender without additional protective

actions is prohibited. The fact is that the probable break of the circuit of the
protective ground of the multi-socket electric mains extender can lead to
summation of leakage current in all connected units on their metal parts to
dangerous values.

· To avoid electrical shock, the mains plug must only be inserted in an

appropriate mains socket outlet provided with a protective earth (ground)
contact.

· Before the digital EEG system setting, the electrician must check the quality
of standard tripolar sockets and the integrity of the protective ground circuit.

· In case the system components are connected to several tripolar sockets,

make sure they are grounded to one and the same protective ground circuit.
Otherwise, there is a danger of several tens of mA leveling current leakage
through the system connecting cables that leads to the equipment
breakdown.

The typical schematics of the equipment location when connecting to the desktop PC
and notebook PC are given below (Fig. 5, Fig. 6).

Fig. 5. The sample of digital EEG system placement when connecting to desktop PC.

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Neuron-Spectrum (Technical Manual)

Fig. 6. The sample of digital EEG system placement when connecting to notebook PC.

The following abbreviations are used on the figures:

· EU – EEG electronic unit;

· PU – notebook PC power unit which corresponds to IEC 60601-1;

· C – patient chair;

· Kb – keyboard;

· M – monitor;

· Nb – notebook PC;

· P – printer;

· Ph – photic stimulator

· PS – pattern-stimulator monitor;

· SU – system unit;

· T – isolation transformer which corresponds to IEC 60601-1;

· Ph – photic stimulator;

· – power cables 220/230 V;

· – power cables 220/230 V (alternative connection);

· – signal cables.

22
 Installation

2.3. Unpacking and Check of Delivery Set

In case the box with the digital EEG system was under conditions of the excessive
moisture or low temperature which differs vastly from the working conditions, it is
necessary to place it in the room and leave for 24 hours in normal conditions.

Unpack the box and take out the digital EEG system components. The delivery set
should correspond to the packing report.

The computer equipment packed in the separate boxes should be opened according
to user and technical manuals for these products.

Check the digital EEG system components to make sure that there is no external
damage.

2.4. Connection to Computer

Place the computer and digital EEG system units according to your plan and connect
the computer equipment according to the schematics described in the operational
documentation for these products.

If you purchase the digital system together with the computer, the equipment is
delivered with installed and configured software. If you purchase the digital system
separately, please install the software from the compact disk (included in the delivery
set) to computer.

The software must be installed before the first connection of digital system
to the computer. Study carefully the corresponding paragraph of the user
manual before starting to work.

Assemble the stand. Fix the electronic unit on this stand.

According to its technical manual included in the delivery set.

Place the electronic unit on the stand as it is shown on Fig. 7.

Assemble the photic stimulator on the stand.

Insert the photic stimulator cable into the connector on top side panel of the
electronic EEG unit. The slot on the top side panel of digital EEG system is used for
the auditory stimulator connection. The slot is used for the pattern-stimulator
adapter connection.

Insert EEG cables into the Fp1,…O2, A1, A2, Ref connectors and grounding jacks
located on the digital EEG unit front panel.

Connect some other sensors and electrodes required for the operation to digital EEG
unit.

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Neuron-Spectrum (Technical Manual)

The general scheme of Neuron-Spectrum-1, Neuron-Spectrum-2, Neuron-

Spectrum-3, Neuron-Spectrum-4, Neuron-Spectrum-4/P, CloudEEG connection is
shown on Fig. 7. The digital EEG system must be connected to USB port on the PC
system unit or USB hub supplied from the electric mains. The connection to the USB
connectors on the monitor or keyboard does not provide the correct device operation.
The connection to passive USB splitter (without supply from electrical mains) is
prohibited.

Fig. 7. The connection scheme.

The digital EEG system can be connected to the computer when it is on or off. If the
window shown on Fig. 8 appears after the digital EEG system connection, press the
button without inserting the installation disk.

Fig. 8. New hardware wizard.

24
 Proper Use

When the message shown on Fig. 9 appears, press the “Next” button. When the
installation is completed, press “Finish”.

Fig. 9. Completing the found new hardware wizard

3. Proper Use
3.1. Safety Measures when Using the Systems
To provide safety measures and exclude the possibility of medical staff’ or
patient’ electric trauma, the medical staff is PROHIBITED:

· To use digital EEG system, mounting and setting of which was done incorrectly,
without following this manual instructions.

· To connect digital EEG system and surgical HF equipment to the patient (it can
cause patient’s flash-burn in the places of electrode placement and digital EEG
system damage).

· To connect any products, which are not included in digital EEG system delivery set,
to electrode jacks.

· To eliminate faults by opening of the components included in the delivery set.

· To provide EEG exams when the electronic unit box, computer or other devices
comprising digital EEG system are opened.

· To connect patient electrodes to protective ground or other conducting surfaces.

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Neuron-Spectrum (Technical Manual)

3.2. Setting-up Procedures

Operating Limitations:

· Ambient temperature is from +10 to +35°С.

· Relative humidity is from 30% to 85%.

· Atmospheric pressure is from 70 to 106 kPa.

Before power supply switching make sure that digital EEG electronic unit and
computer equipment cases have no apparent mechanical failures which can represent
a danger.

Power Supply Switch on and Digital EEG System Test

Digital EEG system power supply switch on is done by pressing the “Power” key of
your PC. The electronic unit has no power supply switch and is constantly connected
to PC. Power supply switch on occurs after PC operational system loading and
Neuron-Spectrum program start.

Troubleshooting

The list of some possible troubles and the ways of their removal is given in Table 6.

Table 6. Possible Troubleshooting

Trouble symptom Cause Way of Removal

When PC switching on, the
indicators on the PC front panel do
not glow.
PC operational system load is not
carried out properly.
Neuron-Spectrum.NET software
doesn’t start.
When switching on the monitoring
mode, the EEG signal can not be
registered.
When starting the program, the
message “Database connection
error” can appear on the screen.
Incorrect PC connection to the
mains.
Faultiness of PC hardware or
software.
Digital EEG system software is not
installed or is installed incorrectly.
Digital EEG system is connected
incorrectly.
1. The directory with patient exam
files was renamed or replaced.
2. The directory with patient exam
files is inaccessible.
Check the PC connection accuracy
to the mains.
Make PC reload. In case the
trouble was not removed, address
to PC firm-supplier.
Check whether the digital EEG
system software is set up. Reinstall
digital EEG system software using
distribution disc.
1. Check whether digital EEG
system is connected.
2.e Consult the manufacturer.
1. Check the connection to local
network. Make sure that the
computer with patient files directory
is connected to local network and
switched on.
2. Restore the name and the
directory placement.

26
 Proper Use

Table 6. Continued.

Trouble symptom Cause Way of Removal

The exam report can’t be created
or printed.
After proper setting of EEG
electrode, the impedance value is
1000 kΩ.
EEG traces recorded in one
hemisphere channel are not
displayed adequately.
EEG traces recorded in one of the
channels are not displayed
adequately.
1. The printer is not set up.
2. The printer is not connected to
PC or out of order.
Derivation cable breaks.
1. Problems with referent electrode
(ear electrode during monopolar
recording with ear electrode
referent).
2. Problems with electronic unit.
1. The derivation cable is out of
order.
2. Problems with electronic unit.
1. Set up the printer using Windows
control panel.
2. Check the printer connection and
its working order.
Replace the derivation cable.
1. Check the quality of electrode
set-ting by impedance measuring.
2. Change places of the referent
electrodes cables (A1 and A2). If
the problem is repeated in the other
hemi-sphere that means the
electrode is out of operation.
Replace it.
3. If the problem was not removed,
the electronic unit is out of
operation. Consult Neurosoft Ltd.
1. Check the quality of electrode
set-ting by impedance
measurement.
2. Replace the electrode.
3. Consult Neurosoft Ltd.

3.3. Exams Performing Using the Systems

Before EEG exams carrying out, it is necessary to set up the digital EEG system and
other equipment taking into consideration user manual recommendations.

Exam carrying out includes the following stages:

· The electrodes and sensors set up.

· The signal recording and functional tests carrying out.

· The recorded EEG review, analysis and printing.

The recording from electrodes and sensors and their placement on the patient is done
according to user manual recommendations.

The order of signal registration and records analysis is given in details in the user
manual.

After finishing the work it is necessary to clean the electrodes in according to the
requirements of the operational documentation of the manufacturer.

If the next patient is not planned till the end of the working day, the digital EEG
system should be switched off. For that switch off the digital EEG system software
and then do the same with the computer and printer. If the long-term dwell in
operation is planned (several days or more), power supply plug of the isolation
transformer is recommended to be disconnected to the power circuit.

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Neuron-Spectrum (Technical Manual)

3.4. Actions in Emergency

In the cases of electrical insulation disturbance of any digital EEG system component
which causes the emergency (fire, mechanical failure, flood, medical staff evacuation)
and threat of patient or staff electrical shock, it is necessary to de-energize the digital
EEG system completely.

4. Servicing
4.1. General Requirements
Safety measures when servicing conforms to the ones described in the chapter 3
“Proper Use”.

Qualification requirements to the medical staff are listed in chapter 2.1 “Requirements
to the Personnel Conducting Systems Installation”.

Servicing of the bought articles included in the digital EEG system is conducted
according to user and technical manuals or typical rules.

When detecting the troubles it is recommended to use the information given in

“Troubleshooting” section. If the troubles can’t be eliminated using digital EEG system
control units or by restart, it should be switched off and checked by the specialist.

Type, volume and periodicity of the servicing except specified in this chapter, are not
determined.

The delivery set check is done by conformity to the device packing report.

4.2. Servicing
Digital EEG system servicing in the process of operation includes the external
examination, check of connectors and cables, removal of contaminations from the
units’ surface using wet fabric.

4.3. Conservation
The digital EEG system components including accessories and operational
documentation should be packed in separate plastic sachets and then placed in a
firm-manufacturer package.

28
 Current Repair

5. Current Repair
5.1. General Requirements
Digital EEG system repair requires special training of the technical staff and special
equipment and service software which you can receive from the manufacturer or the
representative of the firm. The repair connected with the EEG electronic unit opening
is prohibited. The repair of computer equipment and pattern-stimulator monitor can be
conducted by dedicated establishments for computer equipment service.

The digital EEG system current repair includes the component parts and cables
repair. The component parts repair when connecting to digital EEG system is
prohibited.

When conducting current repair, all the EEG units must be switched off.

5.2. EEG, ECG Cables, Adapters and Linkers Repair

Cables are examined externally. The circuit break control is conducted. Shielded
cables are also checked for short circuit between screen and cable, and between
cables. In case of cable break or ground, it is necessary to replace or cut it if the cable
length is sufficient.

5.3. Computer Interface Cable Repair (USB cable)

Computer interface cable (Fig. 10) is examined externally, and the circuit is checked
for short circuit or break. In case of cable failure, it should be replaced or repaired by
shortening the length. When replacing it is necessary to pay attention to the cable
marking. The use of the cable with other marking is prohibited.

Fig. 10. Computer interface cable electrical schematic

5.4. Auditory Stimulator Repair

Auditory stimulator (headphones) (Fig. 11) is examined externally, and circuit
resistance of dynamic head and cable are measured. The measured value should be
between 90 and 110 Ω. When detecting the break or short circuit it is necessary to
open cable jack unit and check it. If the failure is not discovered, open the auditory
stimulator unit and measure each cable and coil of dynamic head. If the cable break is
detected, see the instruction on the USB cable repair (see chapter 5.3 “Computer
Interface Cable Repair (USB cable)”). If the dynamic head failure is detected, address
to firm-manufacturer for the further repair.

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Neuron-Spectrum (Technical Manual)

Fig. 11. Auditory stimulator electrical schematic.

5.5. Photic Stimulator Repair

Photic stimulator is examined externally for the cable failure detection. Circuit control
from the jack side is conducted according to the schematic in Fig. 12 by the device for
LED check. It is necessary to open cable jack unit and check the montage. If the
failure is not detected, open the photic stimulator unit and measure the resistance of
each cable. If the cable break is detected, see the instructions on USB cable repair
(see chapter 5.3 “Computer Interface Cable Repair (USB cable)). Detection and
elimination of LED failure can be done only by firm-manufacturer.

Fig. 12. Photic stimulator electrical schematic.

30
 Current Repair

5.6. Visual Pattern-Stimulator Adapter Repair

Pattern-stimulator adapter is examined externally for cable failure detection (Fig. 13).
Circuit control from the jack side is impossible. It is necessary to open cable jack unit
and check the montage. If the failure is not detected, open the jack unit from the
monitor side and measure the resistance of each cable. If the cable break is detected,
see the instructions on USB cable repair (see chapter 5.3 “Computer Interface Cable
Repair (USB cable)).

Fig. 13. Electrical schematic of pattern-stimulator adapter cable.

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Neuron-Spectrum (Technical Manual)

6. Packing and Transportation

The package should conform to the accepted one when manufacturing and delivering.
In case the factory package is damaged, but the long-term EEG system storage and
transportation is expected, respect the following recommendations:

· The digital EEG system with operational documentation should be packed in plastic
sachets and cardboard boxes.

· The cardboard boxes should be covered by the paper tape or pressure sensitive
adhesive.

· The digital EEG systems can be transported by all kinds of covered carries (except
non-heated airplane pods) according to rules of goods transportation for each mode
of transport.

The digital EEG system portage by sea transport should be done according to “Safety
Regulations for Sea Transport of General Cargoes”.

The shipment type is by containers and part-load consignment.

7. Storage Regulations
The digital EEG system should be stored in the firm-manufacturer package in an
enclosed space at 5-40°С and 80% maximal relative humidity (measured at
temperature of 25°С). The air should be free from any admixtures which can cause
the corrosion.

The digital EEG systems should be put on the shelves not more than in four rows.

8. Utilization
The device utilization is performed according to the current legislation of the area
where the equipment is used. Special requirements to device utilization are not
provided by the manufacturer.

32
 Delivery Set and Package Data

9. Delivery Set and Package Data

Digital neurophysiological system Neuron-Spectrum-1,

Digital neurophysiological system Neuron-Spectrum-2,

Digital neurophysiological system Neuron-Spectrum-3,

Digital neurophysiological system Neuron-Spectrum-4,

Digital neurophysiological system Neuron-Spectrum-4/P,

Digital neurophysiological system CloudEEG

serial number _____________________,

is collected and packed according to TC 9441-014-13218158-2006.

Package report number _______________________

Package report date _______________________

The detailed information about the delivery set is described in the package report
which is an integral part of the present document and should be kept along with it.

10. Acceptance Certificate

The system corresponds to TC 9441-014-13218158-2006 and is ready for operation.

DC representative ___________________
Signature

11. Delivery Certificate

The system is delivered to a customer __________________________________
Date

System was handed _______________________

Signature

System was accepted _____________________

Signature

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Neuron-Spectrum (Technical Manual)

12. Storage Data

The systems should be stored in according to the requirement of the present technical
manual.

Information about the system storage before and in the process of operation is
registered in Table 7.

Table 7. Storage Data.

Date of Storage conditions Position, name

and signature of
beginning of end of storage
person
storage
responsible for
storage

34
 Warranty

13. Warranty
13.1 The manufacturer guarantees the system quality conformance to TC 9441-014-
13218158-2006 requirements if the rules of operation, storage, transportation and
mounting prescribed in the operational documentation are observed.

13.2 Warranty period is 24 months from the delivery date to the customer (chapter 11).

The warranty period of components exposed to wear (cables) is 30 days.

There is no warranty for consumables (gels and pastes).

The warranty period can be prolonged for the period from reclamation submission up to
repair completion (chapters 14, 15).

13.3 The operation of guarantee commitment is stopped if:

· the rules of operation, storage, transportation and mounting prescribed in

the operational documentation are not observed;

· the warranty period is expired;

· a user brakes the seal without permission of the manufacturer.

13.4 The manufacturer is obliged to repair the equipment in case of breakdown during
the warranty period free of charge. The repair is carried out in the service center of
Neurosoft Ltd. (5, Voronin str., Ivanovo, 153032, Russia) only if this registration
certificate is provided.

14. Reclamation Data

14.1 In case of system breakdown or faultiness in the period of warranty and also product
defect detected when primary acceptance, the consumer should send written notification
to Neurosoft Ltd., authorized European representative or nearest distributor. The actual
list of Neurosoft Ltd. distributors is represented on the web site:
http://www.neurosoft.ru/eng/useful/links.aspx. This notification should contain the following
information:

· the consumer’s name and the address;

· the serial number of the system (see chapter 9 of the present manual or the system
marking);

· the copy of chapter 11 of this manual or the number and the date of the invoice or
other document confirming the system purchase.

· the detailed description of failures. If it is possible indicate the reasons and

circumstances preceding the fault detection (in addition it is recommended to add the
test report, the exam data, photos and other materials allowing to solve the problem
as soon as possible).

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Neuron-Spectrum (Technical Manual)

14.2 In case of system return to the service center for the repair or the replacement,
the following rules should be observed:

· it should be packed so to exclude the possibility of its damage during the

transportation;

· the notice (see item 14.1) and the present manual must be added to the device being
returned.

14.3 All the reclamations, its description and taken measures should be registered in
Table Table 8.

36
 Reclamation Data

Table 8. Reclamation Data.

The date of Brief description of The date of Taken measures Note

failure or trouble the trouble reclamation
appearance sending

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Neuron-Spectrum (Technical Manual)

15. Repair Data

Table 9. Repair Data.

Name and Degree of Date Name of Position,

code of imperfection repair name, signature of
completion arrival
faulty unit works person
of repair
Carried Accepted
out the after the
repair repair

38
 Appendix 1. Electromagnetic Emissions and Immunity

Appendix 1. Electromagnetic Emissions and

Immunity
Guidance and manufacturer’s declaration – electromagnetic emissions
The digital system is intended for use in the electromagnetic environment specified below. The customer or the
user of the digital system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment — guidance
RF emissions Group 1 The digital system uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions are
very low and not likely to cause any interference in
nearby electronic equipment.
RF emissions Class B The digital system is suitable for use in all
CISPR 11 establishments, including domestic establishments
and those directly connected to the public low-
Harmonic emissions Not applicable voltage power supply network that supplies
IEC 61000-3-2 buildings used for domestic purposes.
Voltage fluctuations' flicker Not applicable
emissions
IEC 61000-3-3

The digitale EEG systems are 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.

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Neuron-Spectrum (Technical Manual)

Guidance and manufacturer’s declaration – electromagnetic immunity

The digital system is intended for use in the electromagnetic environment specified below. The customer
or the user of the digital system should assure that it is used in such an environment.
Electromagnetic environment
Immunity test IEC 60601 test level Compliance level
-guidance
Electrostatic discharge Floors should be wood, concrete
(ESD) ±6 kV − contact ±6 kV or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be at
least 30%.
±8 kV − air ±8 kV

1)
Electrical fast ±2kV Mains power quality should be
transient/burst ±2 kV − for power that of typical commercial or
IEC 61000-4-4 supply lines hospital environment.

±1 kV − for Not applicable

input/output lines

2)
Surge ±1kV Mains power quality should be
IEC 61000-4-5 ±1 kV differential that of typical commercial or
mode hospital environment.

2)
±2 kV common ±2kV
mode

Voltage dips, short Mains power quality should

interruptions and voltage <5% UT
variations on power (>95% dip in UT) for
supply input lines 0,5 and 1 cycle
IEC 61000-4-11
40% UT (60% dip in
UT) for 5 cycles
3)
20 ms be that of a typical
commercial or hospital
environment. If the user of the
digital system requires
continued operation during
power mains interruptions, it
3)
100 ms is recommended that the
digital system be powered
from an uninterruptible power
supply or a battery.

3)
70% UT (30% dip in 500 ms
UT) for 25 cycles

120% UT (20% dip

3)
in UT) for 25 cycles 500 ms

<5% UT
3)
(>95% dip in UT) for 5000 ms
5s
Power frequency Power frequency magnetic
magnetic field 3 A/m 3 A/m fields should be that of a
IEC 61000-4-8 typical commercial or hospital
environment.
1) Ensured by PC compliance with IEC 61000-4-4 requirements.
2) Ensured by PC compliance with IEC 61000-4-5 requirements.
3) Ensured by PC compliance with IEC 61000-4-11 requirements.
Note: UT – is the a.c. mains voltage prior to application of the test level.

40
 Guidance and manufacturer’s declaration – electromagnetic immunity
The digital system is intended for use in the electromagnetic environment specified below. The customer or the
user of the digital system should assure that it is used in such an environment.
IEC 60601 test Electromagnetic environment -
Immunity test Compliance level
level guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the digital system,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.

3)
Conducted RF 3 Vrms 150 kHz to 3V
IEC 61000-4-6 80 MHz outside d = 1 . 17 P
ISM bands1)

Radiated RF
IEC 61000-4-3 3 V/m 3 V/m d = 1 . 17 P
80 MHz to 2.5 GHz (80 MHz to 800 MHz);

d = 2 . 33 P
(800 MHz to 2.5 GHz).

Field strengths from fixed RF

transmitters, as determined by
an electromagnetic site survey
1)
, should be less than the
compliance level in each
frequency range 2). Interference
may occur in the vicinity of
equipment marked with the
following symbol:

1)
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
digital system is used exceeds the applicable RF compliance level above, the digital system should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the digital system.
2)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
3)
Ensured by PC compliance with IEC 61000-4-6 requirements.

Notes:
1. At 80 MHz and 800 MHz, the higher frequency range applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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Neuron-Spectrum (Technical Manual)

Recommended separation distances between portable and mobile RF communications

equipment and digital system
The digital system is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the digital system can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the digital system as recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter, m
Rated maximum output 150 kHz up to 80 MHz
80 MHz to 800 MHz 800 MHz to 2.5 GHz
power of transmitter, W outside ISM bands
d = 1 . 17 P d = 1 . 17 P d = 2 . 23 P

0.01 0.117 0.117 0.233

0.1 0.369 0.369 0.738
1 1.167 1.167 2.333
10 3.689 3.689 7.379
100 11.667 11.667 23.333
Notes:
1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
3. For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where Р
is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

42
 Appendix 2. Trigger Input/Output

Appendix 2. Trigger Input/Output

The side panel of Neuron-Spectrum digital system provides a trigger socket for the
attachment of stimulators produced by the other manufacturers to the digital system.

The devices connected to the trigger socket must have protection class against
electrical shock according to IEC 60601-1.

Cables for connection of devices produced by the other manufacturers are not
included into delivery set and must be produced according to the recommendations
stated in the present Appendix.

The trigger socket is a double-pin plug of 2.5 mm diameter. It is used as a trigger input
to synchronize the program with external stimulus and as trigger output to transfer the
pulse synchronously with the work of internal stimulators.

The socket schematic and triggering pulse parameters are described on Fig. 14.

If the trigger input is used, then negative polarity pulse TTL not less than 5 µs must be
at the input. Pulse droop will be considered as the beginning of synchronization. The
synchronization signal is also generated by short-circuit of input to common wire for
not less than 5 µs.

Permanent short-circuiting of input to common wire makes the signal

transmission from internal stimulators impossible.

When the trigger output is used, with each stimulus, negative polarity pulse of TTL
level appears at the connector which fall corresponds to the beginning of the stimulus.

Pulse duration for photic, auditory and pattern stimulation is from 500 up to 600 µs at
the trigger output (Т on Fig. 14).

+5V

Socket EP253
1
1 2 Trigger input 2.5 mm

Trigger output

5V

Fig. 14. Socket schematic and specifications of triggering pulse.

The external stimulators connected to the trigger input must be used in the following
order:

1. Connect the external stimulator to the trigger input using a cable.

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Neuron-Spectrum (Technical Manual)

2. Switch on the external stimulator power supply.

3. Run the program, and check the “Third-party firm stimulator” check box on “EEG
acquisition” page (in the stimulation parameters settings for the stimulator)
(Fig. 15).

Fig. 15. The recording start window from external stimulator.

4. In the stimulation settings it is recommended to set those stimulus parameters

which the external stimulator has as these particular values are saved together
with the trace and taken into analysis.

In other aspects the signal acquisition does not differ from the one described in the
corresponding chapters of the given manual.

The external stimulators connected to the trigger output must be used in the following
order:

1. Connect the external stimulator to the trigger output using a cable.

2. Switch on the external stimulator power supply.

3. Run the program, uncheck the “Third-party firm stimulator” check box in the
stimulation parameters settings for the stimulator.

4. In the stimulation settings it is recommended to set those stimulus parameters

which the external stimulator has as these particular values are saved together
with the trace and taken into analysis.

In other aspects the signal acquisition does not differ from the one described in the
corresponding chapters of the given manual.

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