Neurosoft Poly-Spectrum-8/V User manual

Technical Manual
Poly-Spectrum-8/V
Veterinary Digital ECG System
TM003.04.001.000
(01.07.2019)

Neurosoft © 2020
5, Voronin str., Ivanovo, 153032, Russia
P.O. Box 10, Ivanovo, 153000, Russia
Phone: [phone] Fax: [phone]
E-mail: [email protected] Internet: www.neurosoft.com

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Contents
Introduction.........................................................................................5
Important Safety Instructions............................................................6
Intended Use..................................................................................6
General Description.......................................................................6
Contraindications...........................................................................7
Possible Side Effects.....................................................................7
Safety Measures............................................................................7
1. Description...................................................................................9
1.1. Main Specifications .................................................................9
1.2. Principle of Operation............................................................12
1.3. Connectors and Indicators ....................................................13
1.4. Labeling.................................................................................14
2. Assembly and Installation.........................................................16
2.1. Requirements to Personnel...................................................16
2.2. Room Selection and Placement............................................16
2.3. Unpacking and Check of Delivery Set...................................17
2.4. System Assembly and Connection........................................18
3. Proper Use..................................................................................20
3.1. Getting Ready.......................................................................20
3.2. Getting Started......................................................................20
3.3. Troubleshooting ....................................................................24
3.4. Actions in Emergency............................................................25
4. Maintenance...............................................................................26
4.1. General Requirements..........................................................26
4.2. User Maintenance.................................................................26
4.3. Disinfection............................................................................27
5. Current Repair............................................................................28
5.1. General Requirements..........................................................28
5.2. ECG Cables (NS003103.009, NS003103.010).....................28
5.3. Computer Interface Cable (USB Cable)................................29

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6. Disposal......................................................................................30
7. Delivery Set and Package Data.................................................30
8. Warranty .....................................................................................30
9. Reclamation................................................................................32
Annex 1. Delivery Set .......................................................................33
Annex 2. Electromagnetic Emissions and Immunity.....................35

Introduction
5
Introduction
This technical manual (hereinafter referred to as “the manual”)
is the combined document describing the operation and servic-
ing of the Poly-Spectrum-8/V veterinary digital ECG system
(hereinafter referred to as “the system”).
The document certifies technical parameters of the system,
which are guaranteed by the manufacturer.
Do not start working with the system before you have read
this document!
You can send your responses and recommendations to
the following address:
Post Office Box 10, Ivanovo, 153000, Russia
or by e-mail:
[email protected]
You can find additional information about Neurosoft products on
our website www.neurosoft.com,
or ask questions by phone:
[phone]; [phone] (Service center),
[phone]; [phone]
You can also contact our Authorized European Representative:
SAS Neuromed Company (Mr. Benjamin Scholl), 360 avenue
du Clapier, ZAС du Couquiou, 84320 Entraigues sur-la-Sorgue,
France.
Phone: [phone], e-mail: [e-mail]
In the USA, please, contact Diagnus LLC, 5 Larson Avenue,
Smithtown, NY 11787 USA.
Phone: [phone], https://www.diagnus.us
E-mail: [e-mail]

Poly-Spectrum-8/V (Technical Manual)
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Important Safety Instructions
Intended Use
The Poly-Spectrum-8/Vveterinary digital ECG system is in-
tended for recording of electrocardiogram (ECG) in animals.
The system can be used in in veterinary practices (including
animal ambulatory services, animal hospitals, livestock farming,
etc.) and research field.
General Description
The system is intended for veterinary use only!
The Poly-Spectrum-8/V system is used to:
estimate the electrical activity of the heart muscle and cardi-
ac performance;
detect the hidden pathology and potential cardiac disturb-
ances;
select the appropriate treatment and assess its effectiveness.
Features:
recording of electrocardiogram (ECG);
real-time data transfer to PC and saving of ECG in the PC
memory;
displaying of ECG on the PC screen and/or printing it on the
paper using a compatible device.

Important Safety Instructions
7
The Poly-Spectrum-8/V system is delivered with Poly-
Spectrum.NET software that includes the Poly-
Spectrum.NET/Veterinary additional module intended for ECG
management and interpretation with automatic report genera-
tion.
Contraindications
There are no contraindications for using the Poly-Spectrum-8/V
system.
Possible Side Effects
There are no side effects if the system is used properly.
The local allergic reactions to working surfaces of reusable
ECG electrodes may occur.
Safety Measures
To provide safety measures and exclude the possibility of
electric trauma of medical staff or examined animal, it is
PROHIBITED:
to use the system which mounting and setting was done
incorrectly without following the manual instructions;
to connect the system and surgical HF equipment to the
examined animal (it can lead to the damage of the system or
cause flash-burns in the places of electrode placement);
to connect any devices, not included in the system delivery
set, to the electrode jacks;
to eliminate faults by opening of the system components
included in the delivery set;
to perform tests when the electronic unit, computer or other
devices of the system are opened;

Poly-Spectrum-8/V (Technical Manual)
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to connect electrodes placed on the examined animal to
protective ground or other conducting surfaces;
clean the system by submersing into liquid, autoclaving, or
steam cleaning as this may damage equipment or reduce its
usable life. The disinfection of the system is described in sec-
tion 4.3 “Disinfection”;
drop the system from more than one meter height. If the
system has been dropped or damaged, the use of the device
is permitted only after it is checked and repaired in the au-
thorized service center.

Description
9
1. Description
1.1. Main Specifications
Table 1. Main Specifications
Parameters
Values
ECG Channels
Number of channels
8
Voltage range
0.03–5 mV
Ratio error of voltage measurement in
the amplitude range:
< 500 µV
from 500 µV up to 5 mV
within 25 µV
within 7%
Input noise level
not more than
20 µV
Bandpass flatness:
from 0.5 up to 60 Hz
from 60 up to 75 Hz
from −10% up to +5%
from −30% up to +5%
Relative error of interval measurement
within 7%
Relative error of calibration pulses recording
within 5%
Heart rate measurement range
30–240 beats per
minute
Relative error of heart rate measurement
1 beats per minute
Control of electrode placement quality
available
Control of electrode break during ECG recording
available
Defibrillation protection
available
Common-mode rejection ratio
not less than 100000
Input impedance
not less than 20 MΩ
General Parameters and Characteristics
Interface
USB

Poly-Spectrum-8/V (Technical Manual)
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Table 1. Continued
Parameters
Values
Supply voltage:
electronic unit
desktop PC-based system
notebook PC-based system
5 V DC
220 V AC (50 Hz)
220 V AC
(50 Hz) / int. battery
Dimensions:
Electronic unit
Transportation bag
(1266825) ±5 mm
(240185130) ±10mm
Cable length:
PC connection cable
ECG cable (for limb leads)
ECG cable (for chest leads)
ECG cable NS017103.008
(2.5 ± 0.2) м
(2.0 ± 0.1) м
(1.5 ± 0.1) м
(1.45 ± 0.1) м
Weight:
electronic unit
transportation bag
packed system
(without computer)
0.3 ± 0.05 kg
0.15 ± 0.05 kg
not more than 1.5 kg
Applied parts
CF type with protection
against defibrillator
discharge
Transportation Conditions
Temperature
from -25 to +60°C
Humidity
20 –95%
(non-condensing)
Atmospheric pressure
from 70 kPa
Storage Conditions
Temperature
from +5 to +40°C
Humidity
30-85%
(non-condensing)
Atmospheric pressure
70-106 kPa
Operation Conditions
Temperature
from +10 to +35°C
Humidity
30-85%
(non-condensing)
Atmospheric pressure
70-106 kPa

Description
11
Safety and Electromagnetic Compatibility
Electromagnetic compatibility (EMC) is provided by conform-
ance to IEC 60601-1-2-2014 (EN 60601-1-2:2015) require-
ments.
The system is intended for operation in electromagnetic envi-
ronment, which special features are specified in Annex 2.
Portable and mobile RF communication equipment can affect
the system operation.
The use of equipment not listed in Table 3 of this technical
manual may result in increased emission and system de-
creased immunity.
As for safety, the system satisfies IEC 60601-1:2012
(AAMI/ANSI ES 60601-1:2005/(R2012) and A1:2012 and
A2:2010/(R)2012, EN 60601-1:2006/A1:2013) and IEC 60601-
1-2-2014 (EN 60601-1-2:2015) and IEC 60601-2-25:2011 (EN
60601-2-25:2015).
The electronic unit is supplied by regulated power supply
through USB interface, it has double isolation and CF type ap-
plied parts with protection against defibrillator discharge accord-
ing to IEC 60601-1:2012 (AAMI/ANSI ES 60601-
1:2005/(R2012) and A1:2012 and A2:2010/(R)2012, EN 60601-
1:2006/A1:2013).

Poly-Spectrum-8/V (Technical Manual)
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1.2. Principle of Operation
The operation of the system is based on the recording and input
of electrical signals in the heart to computer to perform the
analysis of cardiac function in animals.
The block diagram of the system is shown in Fig. 1.
Fig. 1. The Poly-Spectrum-8/V system.
ECG signal is transferred to 8 channels of the amplifier via the
electrodes. The amplified signal is delivered to the multi-
channel analog-to-digital converter (ADC).
The central processor refers to the ADC from time-to-time, pro-
cesses the received information and transfers it to the USB
processor. The USB processor transfers data to the computer
and controls the power supply unit.
The power supply unit provides all electronic components of the
system with the required power supply from the USB bus in the
mode of data reading to PC.
The PC is used to process the recorded physiological signals,
display them on the monitor in various forms after the mathe-
matical analysis, store the original signals on the hard disk,
generate the examination reports and print them.

Description
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1.3. Connectors and Indicators
The panels of the Poly-Spectrum-8/Vsystem are shown in
Fig. 2 and Fig. 3.
Fig. 2. Front panel of Poly-Spectrum-8/V.
If the LED indicator is orange, the device is connected to the
computer and +5 V voltage is supplied to USB. The green color
of the LED indicator means the device is in the operation mode.
Fig. 3. Panel with the connector for ECG cable.

Poly-Spectrum-8/V (Technical Manual)
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1.4. Labeling
The example of labeling of electronic unit is shown in Fig. 4.
Fig. 4. Labeling of electronic unit.
Interpretation of symbols on electronic units:
–CF type applied parts with protection against
defibrillator discharge according to IEC 60601-
1:2012 (AAMI/ANSI ES 60601-1:2005/(R2012) and
A1:2012 and A2:2010/(R)2012, EN 60601-
1:2006/A1:2013) and IEC 60601-1-2-2014 (EN
60601-1-2:2015) and IEC 60601-2-25:2011 (EN
60601-2-25:2015).
–attention: consult operational documentation.
–number according to catalogue by ISO 15223-1.
–serial number by ISO 15223-1.
manufacturer’s name and address by ISO 15223-1.
manufacturing date by ISO 15223-1.

Description
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–mark of conformance to 2014/30/EU of the
European Parliament and of the Council of 26
February 2014 on the harmonization of the laws of
the Member States relating to electromagnetic
compatibility.
- mark of compliance in the voluntary certification
system in the Russian Federation.
–mark of conformance to 2012/19/EC “On waste
electrical and electronic equipment (WEEE)” directive.
–sign of the Member State of the Eurasian Economic
Community and the Customs Union.
–ingress protection according to IEC (EN) 60529.
The equipment is identified with the GS1-128 barcode integrat-
ed to the barcode in DataMatrix format (Fig. 5).
Fig. 5. DataMatrix barcode.
DataMatrix code is a two-dimensional barcode, consisting of
black and white "cells" or modules arranged in either a square
or rectangular pattern. The DataMatrix code is described in
ISO/IEC 16022:2006 standard.
To decode the information about the item DataMatrix code can
be read by a scanner or a smartphone camera as a two-
dimensional image.

Poly-Spectrum-8/V (Technical Manual)
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2. Assembly and Installation
2.1. Requirements to Personnel
The assembly and installation of the system should be carried
out by a person who is empowered by the manufacturer or
technical personnel of the medical institution which is going to
use it. Remember, that the accuracy of system mounting de-
fines the safety and quality of its operation. Further mounting
and setting requirements which define the product safety will be
marked by bold font in the text.
2.2. Room Selection and Placement
Before installation of the system, select the place for it taking
into consideration the power wiring and protective ground in the
room. Please, read the following requirements and recommen-
dations:
Requirements concerning the room selection and equip-
ment placement:
The location of electronic unit in the immediate vicinity (less
than 5 meters) with short-wave or microwave therapeutic
equipment is not permitted (it can lead to its unstable opera-
tion).
The animal environment (within 1.5 meters) should con-
tain only the electronic units being the medical device
with the required safety level. As the computer equip-
ment safety level is not sufficient for use in the animal
environment, it is necessary to exclude the possibility of
animal touching the metal parts of the computer equip-
ment cases and the simultaneous contact of these parts
and animal's body by the personnel.

Assembly and Installation
17
It is recommended to place the electronic unit on the maxi-
mum possible distance from power cables, switchboards,
and different powerful electrical devices which can emit elec-
tromagnetic fields of mains frequency.
Requirements to mains:
Do not use electric mains where the neutral conductor and
protective ground are combined. It is strongly prohibited.
Before the system is installed, the quality of standard tripolar
sockets and the integrity of protective ground circuit must be
checked by electrician.
The recommended distance from the electronic unit to the
nearest electric mains is not less than 3 meters.
2.3. Unpacking and Check of Delivery
Set
In case the box with the system was under conditions of the
excessive moisture or low temperature which differs vastly from
the working conditions, place the system in the room with nor-
mal conditions and leave it there for 24 hours.
Unpack the box and take the system components out. 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 system components and make sure that there is no
external damage.

Poly-Spectrum-8/V (Technical Manual)
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2.4. System Assembly and Connection
Place the computer and electronic unit of the Poly-Spectrum-
8/V system according to your plan and connect the computer
equipment according to the operational documentation for them.
If you buy the system with the computer, the equipment is de-
livered with installed and configured software. If you purchase
the system separately, please install the software from the elec-
tronic media included in the delivery set.
The software must be installed before the first connection
of the system to PC. The installation and working with the
program is described in the user manual.
If the distributive is missing or the software update is re-
quired, address to your local dealer. The authorized
Neurosoft dealers are listed on the website:
https://neurosoft.com/en/pages/dealers.
Insert the USB connector into the USB port of the PC system
unit. The device drivers shall be installed automatically.
Plug the ECG cable in the ECG connector.
The system must be connected to the USB port on the sys-
tem unit or to USB hub powered from the mains. If the sys-
tem is connected to the USB connectors on a computer
monitor or keyboard, it may not work correctly. It is strong-
ly prohibited to use passive USB hubs (not connected to
the mains) as a part of the system.
The connection of two configurations of the Poly-Spectrum-8/V
system is shown in Fig. 6 and Fig. 7.

Assembly and Installation
19
Fig. 6. Configuration 1.
Fig. 7. Configuration 2.

Poly-Spectrum-8/V (Technical Manual)
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3. Proper Use
3.1. Getting Ready
Operating Limitations:
Ambient temperature is from +10 to +35С.
Relative humidity is from 30 to 85% (non-condensing).
Atmospheric pressure is from 70 to 106 kPa.
Before the power supply is switched on, make sure that
the electronic unit and computer equipment cases have no
apparent mechanical failures which can represent danger.
Power Supply Switch on and System Test
The power supply of the system is switched on by pressing the
Power button on the PC. The electronic unit has no power sup-
ply and it is connected to the PC all the time. The power supply
is switched on when the operating system is loaded and the
Poly-Spectrum.NET program is started.
3.2. Getting Started
Before starting ECG exams, configure the system taking into
consideration exam type and recommendations of the user
manual for this software.
The examination includes the following stages:
preparation of animal for ECG recording and placement of
electrodes;
recording of ECG signals;
analysis of the obtained results and their printing.