Neurosoft Poly-Spectrum-8/V Technical Manual

Veterinary digital ecg system

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

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Summary of Contents for Neurosoft Poly-Spectrum-8/V

  • Page 1 Technical Manual Poly-Spectrum-8/V Veterinary Digital ECG System TM003.04.001.000 (01.07.2019)
  • Page 2 Neurosoft © 2020 5, Voronin str., Ivanovo, 153032, Russia P.O. Box 10, Ivanovo, 153000, Russia Phone: +7 (4932) 95-99-99; +7 (4932) 24-04-34 Fax: +7 (4932) 24-04-35 E-mail: info@neurosoft.com Internet: www.neurosoft.com...
  • Page 3: Table Of Contents

    Contents Introduction ..................5 Important Safety Instructions ............6 Intended Use .................. 6 General Description ............... 6 Contraindications ................7 Possible Side Effects ..............7 Safety Measures ................7 Description ................... 9 1.1. Main Specifications ..............9 1.2. Principle of Operation ............12 1.3.
  • Page 4 Disposal ..................30 Delivery Set and Package Data ..........30 Warranty ..................30 Reclamation ................32 Annex 1. Delivery Set ............... 33 Annex 2. Electromagnetic Emissions and Immunity ..... 35...
  • Page 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.
  • Page 6: Important Safety Instructions

    Poly-Spectrum-8/V (Technical Manual) Important Safety Instructions Intended Use The Poly-Spectrum-8/V veterinary 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.
  • Page 7: Contraindications

    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.
  • Page 8 Poly-Spectrum-8/V (Technical Manual)  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”;...
  • Page 9: Description

    Description 1. Description 1.1. Main Specifications Table 1. Main Specifications Parameters Values ECG Channels Number of channels Voltage range 0.03–5 mV Ratio error of voltage measurement in the amplitude range: within 25 µV  < 500 µV within 7%  from 500 µV up to 5 mV Input noise level not more than 20 µV...
  • Page 10 Poly-Spectrum-8/V (Technical Manual) Table 1. Continued Parameters Values Supply voltage:  5 V DC electronic unit  220 V AC (50 Hz) desktop PC-based system  220 V AC notebook PC-based system (50 Hz) / int. battery Dimensions:  (1266825) ± 5 mm Electronic unit ...
  • Page 11 Description 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.
  • Page 12: Principle Of Operation

    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).
  • Page 13: Connectors And Indicators

    Description 1.3. Connectors and Indicators The panels of the Poly-Spectrum-8/V system 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.
  • Page 14: Labeling

    Poly-Spectrum-8/V (Technical Manual) 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-...
  • Page 15 Description – 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.
  • Page 16: Assembly And Installation

    Poly-Spectrum-8/V (Technical Manual) 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.
  • Page 17: Unpacking And Check Of Delivery Set

    Assembly and Installation  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.
  • Page 18: System Assembly And Connection

    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.
  • Page 19 Assembly and Installation Fig. 6. Configuration 1. Fig. 7. Configuration 2.
  • Page 20: Proper Use

    Poly-Spectrum-8/V (Technical Manual) 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.
  • Page 21 Proper Use The detailed information of how to perform the examination is described in the user manual for the Poly-Spectrum.NET soft- ware with the Poly-Spectrum.NET/Veterinary additional module. Depending on the examined animal, the position of its body during ECG recording is different. The placement of electrodes also differs significantly.
  • Page 22 Poly-Spectrum-8/V (Technical Manual) The placement of electrodes for X-Y lead is shown in Fig. 9. Fig. 9. Placement of electrodes for X-Y lead. The placement of electrodes for apex lead is shown in Fig. 10. Fig. 10. Placement of electrodes for apex lead.
  • Page 23 Proper Use The ECG recording in dogs and cats is performed when the examined animal is in a forced lying position, on the right side, the forelimbs are extended perpendicular to the body and the back ones are at the angle of 45. In dogs, 3 standard and 3 augmented leads are recorded, and also four chest leads (at the fifth or sixth intercostal space).
  • Page 24: Troubleshooting

    Poly-Spectrum-8/V (Technical Manual) During ECG recording, the owner must be in sight, because the examined animal feels safe when the owner is nearby. The owner can gently stroke the animal or scratch it behind the ear. It is not allowed to use any sedatives or neuroleptics to calm the examined animal, because the unreliable results will be dis- played on the ECG.
  • Page 25: Actions In Emergency

    1. Check the connection of the acquisition in the connection of the system to the PC. monitoring mode system. 2. Contact Neurosoft service center. 1. Set up the printer using the The exam report 1. The printer is not can’t be generated Windows control panel.
  • Page 26: Maintenance

    Poly-Spectrum-8/V (Technical Manual) 4. Maintenance 4.1. General Requirements The safety measures when servicing conforms to the ones described in sections “Important Safety Instructions. Safety Measures”. The qualification requirements to the staff are listed in section 2.1 “Requirements to Personnel”. The maintenance of the bought articles included in the system is conducted according to user and technical manuals or typical rules.
  • Page 27: Disinfection

    Before cleaning the electronic unit, switch it off. As you clean, visually inspect the unit and its components for damage or wear. Contact Neurosoft if you notice damage to the exterior of the component. For routine cleaning of the electronic unit, use a cloth gently wrung in phenoles (Bacillotex®...
  • Page 28: Current Repair

    Poly-Spectrum-8/V (Technical Manual) 5. Current Repair 5.1. General Requirements The repair of the system requires special training of technical staff, special equipment and service software. The manufactur- er and its representatives have everything necessary for this. The repair connected with the opening of electronic units is prohibited.
  • Page 29: Computer Interface Cable (Usb Cable)

    Current Repair Fig. 12. Electrical schematic of ECG cable. 5.3. Computer Interface Cable (USB Cable) The computer interface cable (Fig. 13) is examined externally, and the circuit is checked for short circuit or break. In case the cable is broken, replace it or cut it if the cable length is suffi- cient.
  • Page 30: Disposal

    The system disposal should be performed ac- cording to your local regulations. 7. Delivery Set and Package Data The Poly-Spectrum-8/V veterinary digital ECG system is col- lected and packed. The system is ready for operation. Package report number ________________...
  • Page 31 8.4. The manufacturer is obliged to repair the system in case of its breakdown during the warranty period free of charge. The repair is carried out in Neurosoft service center (5, Voronin str., Ivanovo, 153032, Russia) in compliance with the procedure stated in chapter 9 “Reclamation”.
  • Page 32: Reclamation

    9.1. In case of system breakdown or faultiness in the period of warranty and also product defect detected when primary ac- ceptance, the consumer should send written notification to Neurosoft. This notification should contain the following infor- mation:  customer’s name and address;...
  • Page 33: Annex 1. Delivery Set

    Annex 1. Delivery Set Annex 1. Delivery Set The base delivery set for the veterinary digital ECG system Poly-Spectrum-8/V is given in Table 3. Table 3. Base delivery set Name Order code or main Quanti- specifications Poly-Spectrum-8/V electronic NS003201.003-021 unit...
  • Page 34 Poly-Spectrum-8/V (Technical Manual) Table 3. Continued Name Order code or main Quanti- specifications ECG cable (for limb leads and NS017103.008 chest leads) Software: Poly-Spectrum.NET software with Poly- Spectrum.NET/Veterinary additional module Operational Documentation: Poly-Spectrum-8/V technical TM003.04.001.000 manual Poly-Spectrum.NET user manual with Poly- UM004.03.001.000...
  • Page 35: Annex 2. Electromagnetic Emissions And Immunity

    Annex 2. Electromagnetic Emissions and Immunity Annex 2. Electromagnetic Emissions and Immunity Guidance and manufacturer’s declaration – electromagnetic emissions The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
  • Page 36 Poly-Spectrum-8/V (Technical Manual) Guidance and manufacturer’s declaration – electromagnetic immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
  • Page 37 Annex 2. Electromagnetic Emissions and Immunity Guidance and manufacturer’s declaration – noise immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
  • Page 38 Poly-Spectrum-8/V (Technical Manual) Guidance and manufacturer’s declaration – noise immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
  • Page 39 Annex 2. Electromagnetic Emissions and Immunity Recommended separation distances between portable and mobile RF communications equipment and the system The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to...

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