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Neurosoft Neuro-MEP Technical Manual

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Technical Manual
Neuro-MEP
Neuro-ERG
Digital Neurophysiological Systems
TM006.01.005.003
(27.08.2013)

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Summary of Contents for Neurosoft Neuro-MEP

  • Page 1 Technical Manual Neuro-MEP Neuro-ERG Digital Neurophysiological Systems TM006.01.005.003 (27.08.2013)
  • Page 2 Neurosoft Ltd. © 2014 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...

  • Page 3: Table Of Contents

    1.4. Arrangement and Operation ............... 16 1.5. Connectors and Indicators Function............19 1.6. Synchronization with Stimulators of Third-party Manufacturers ....22 1.7. Synchronization Use with Neuro-MEP.NET Software ......... 23 Mounting and Setting ..................24 2.1. Personnel Requirements Conducting Mounting and Setting ....... 24 2.2.

  • Page 4: Introduction

    +7 (4932) 24-04-37 (Service Department) +7 (4932) 24-04-34 You can also contact SAS Neuromed Company, Authorized European Representa- tive of Neurosoft Company (to Mr. Pierre Scholl) by the following address: Chemin du tomple 84330 Le Barroux, France Phone: +490-650-470, +622-748-384 Fax: +490-650-470 E-mail: bscholl@orange.fr...

  • Page 5: Description And Operation

    (EP), magnetic EP, electroretinogram (ERG), otoacoustic emission (OAE) by 1-4 channels and Neuro-MEP-8 is by 1-8 channels. It is done by biopotentials acquision and input into PC, and measurement, calculation and analysis of its parameters.

  • Page 6: Specifications

    1.2. Specifications Table 1. Main Specifications. Parameters Values Biopotentials Acquisition Channels Number of channels Sampling rate − if you use Neuro-MEP software 200 Hz−40 kHz − 200 Hz−40 (160) kHz if you use Neuro-MEP.NET software A/D converter 16 bit Voltage range 20 µ−50 mV...
  • Page 7 Stimulus amplitude 0.1−100 mA Absolute deviation of stimulus amplitude ±0.1 mA Stimulus duration 50 − 5000 µs − if you use Neuro-MEP software 100 − 50000 µs − if you use Neuro-MEP.NET software Absolute deviation of stimulus duration ±5 µs Stimulus frequency at repetitive stimulation 0.05−50 Hz...
  • Page 8 (0.15 ± 0.0375) cd − (0.2 ± 0.05) cd green penlight Brightness control range -3…0 log units Stimulus duration − if you use Neuro-MEP software 0.1−50 ms − 0.05−1500 ms if you use Neuro-MEP.NET software Relative deviation of stimulus duration within ±10% Stimulus frequency 0.05−100 Hz...
  • Page 9 0.5 kg Safety BF type * if two 4-channel amplifier units are used (Neuro-MEP-8 digital system). ** if amplifier unit with NSFT 006201.012 and higher is used. Safety and Electromagnetic Compatibility Electromagnetic compatibility (EMC) is provided by IEC 60601-1-2:2007 requirements fulfillment.

  • Page 10: Delivery Set

    (WEEE)” directive. 1.3. Delivery Set The delivery sets of Neuro-MEP-4, Neuro-MEP-8, Neuro-ERG digital systems in- clude the electronic units of an amplifier, electrical stimulator and auditory-visual stim- ulator, patient button, footswitch, dedicated keyboard and software, which can be de- livered to the customer both jointly and separately, and also components and bought articles.
  • Page 11 Description and Operation Table 2. Continued. Name Document code or main Number, specifications pcs. 1/2 3/4 Holder for dedicated keyboard NSFT 035221.001 Electrode holder NSFT 016221.023 Patient button NSFT 028201.006 Footswitch NSFT 028353.004 NSFT 028353.003 USB cable (A→B) reinforced NSFT 007103.005-01 USB cable (A→B) standard 1.8 m SVGA extension cable...
  • Page 12 Neuro-MEP, Neuro-ERG (Technical Manual) Table 2.Continued. Number, Document code or main pcs. Name specifications 1/2 3/4 TC 9442-990-13218158-2008 Ring electrode (wide) with cable (NSFT 990998.004 (RE-2)) Ground electrode with cable (pediatric) TC 9442-990-13218158-2008 (250 mm) (NSFT 990998.007 (GE-1)) Ground electrode with cable (adult) TC 9442-990-13218158-2008 (NSFT 990998.006 (GE-2))
  • Page 13 TC 3413-004-13218158-2010 Isolation transformer TM-630 (NSFT 036999.001) TM-630M Operational Documentation Neuro-MEP and Neuro-ERG TM006.01.005.003 technical manual Neuro-MEP.NET (version 3) user UM006.03.003.000 manual Workbook “EMG Studies Performing on Digital EMG and EP Systems WB006.03.001.000 Manufactured by Neurosoft Ltd.” DK-01 technical manual TM035.01.001.001...
  • Page 14 Neuro-MEP, Neuro-ERG (Technical Manual) Table 3. Continued. Name Document code or main Number, specifications pcs. Temperature sensor NSFT 039351.003 Tendon hammer NSFT 040356.001 Set of Accessories for High Resolution Pattern-Stimulator Adapter for high resolution pattern- NSFT 033201.003 stimulator connection Video card...
  • Page 15 Set of ear tips (universal) NSFT 007998.002 Dental floss for probe tip cleaning Oral-B (Ireland) (50 pcs.) Probe tip extractor NSFT 006206.016 Software on CD Neuro-MEP.NET software module with Neuro-MEP.NET/ERG and Neuro-MEP.NET/HRV modules Neuro-Audio.NET software with Neuro-Audio.NET/OAE module with Poly-Spectrum.NET software Poly-Spectrum.NET/Rhythm...

  • Page 16: Arrangement And Operation

    Neuro-MEP, Neuro-ERG (Technical Manual) Table 3. Continued. Name Document code or main Number, specifications pcs. Operational Documentation Neuro-Audio.NET user manual UM032.01.005.000 “DK-01” technical manual TM035.01.001.001 Notes: The accessories and consumables of the analogous types can be used if their application is permitted in the country.
  • Page 17 Description and Operation The functional scheme of the digital system is represented on Fig. 1. Amplifier unit Galvanically isolated amplifier module To electrodes of biopotentials Galvanic Amplifiers isolation 4000 V Control Power +5 V from USB supply Electrical stimulator unit Galvanically isolated module of electrical stimulator To stimulating...
  • Page 18 Neuro-MEP, Neuro-ERG (Technical Manual) The function of the electrical stimulation is performed by the electrical stimulator unit. The microcontroller of the unit provides the connection with the computer via USB and generates the signal in the discrete form and supplies it to the digital-analog converter (DAC) via 4000 V galvanic isolation.

  • Page 19: Connectors And Indicators Function

    Description and Operation 1.5. Connectors and Indicators Function The external views of the front and side panels of the amplifier unit are represented on the Fig. 2 and Fig. 3. The front panel of the amplifier unit contains touchproof and DIN connectors to attach the electrodes and LED operation indicator (Fig.
  • Page 20 Neuro-MEP, Neuro-ERG (Technical Manual) The external views of the front and rear panels of the electrical stimulator are repre- sented on the Fig. 4 and Fig. 5. The front panel of the electrical stimulator unit contains the connector for the stimulat- ing electrode attachment and LED operation indicator (Fig.
  • Page 21 Description and Operation The external views of the front and rear panels of auditory-visual stimulator unit are represented on the Fig. 6 and Fig. 7. The front panel of the auditory-visual stimulator unit contains the connectors for the at- tachment of auditory stimulator (headphones) , visual stimulator (LED goggles or mini-ganzfeld) , multy-colored penlights and LED operation indicator (Fig.

  • Page 22: Synchronization With Stimulators Of Third-Party Manufacturers

    Neuro-MEP, Neuro-ERG (Technical Manual) The digital system delivery set can include the USB hub KM-7. Read the information about the connectors and USB hub function and also operation with it in the corre- sponding technical manual. 1.6. Synchronization with Stimulators of Third-party Manufacturers The trigger input socket is used for amplifier synchronization with other devices.

  • Page 23: Synchronization Use With Neuro-Mep.net Software

    Connect the external stimulator to the trigger input using a cable. Switch on the external stimulator power supply. Run Neuro-MEP.NET software, execute Setup|Tests templates|Setup menu command, select the required test template, press “Change” button and check the “Third-party firm stimulator” check box on “Hardware|Stimulator” page (see Fig.

  • Page 24: Mounting And Setting

    In other aspects the signal acquisition does not differ from the one described in the corresponding chapters of the user manual. The trigger input of external stimulators connected to the trigger output of Neuro-MEP stimulators must be used in the following order: Connect the external stimulator to the trigger output using a cable.

  • Page 25: Room Selection And Placement

    Mounting and Setting 2.2. Room Selection and Placement Before mounting and setting of digital 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: •...
  • Page 26 Neuro-MEP, Neuro-ERG (Technical Manual) The typical schematics of the equipment location when connecting to the desktop PC and notebook PC are given below (Fig. 11, Fig. 12). Fig. 11. Digital system placement sample when connecting to desktop PC (see explanation below).

  • Page 27: Unpacking And Check Of Delivery Set

    Mounting and Setting • C – patient couch; • D. Kb. – dedicated keyboard; • ES – electrical stimulator; • Fs – footswitch; • Hub – KM-7 external USB hub or the analogous one according to GOST R 50267.0-92 (IEC601-1-88). The connection of the USB hub to the mains is per- formed according to the Fig.

  • Page 28: Mounting And Connection To Computer

    Neuro-MEP, Neuro-ERG (Technical Manual) 2.4. Mounting and Connection to Computer If you purchase the digital system together with the computer (PC), 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.
  • Page 29 Mounting and Setting The delivery set depends on the delivery set variant. For example, the equipment var- iant, shown on the Fig. 14, consists only of an amplifier and an electrical stimulator and allows to carry out the EMG study and recorder somatosensory EP. Fig.
  • Page 30 Neuro-MEP, Neuro-ERG (Technical Manual) If the temperature sensor is included in the delivery set, connect it to any available USB connector of PC. Depending on the delivery set variant, the device may be supplied with high-resolution reversal pattern (800×600, 16 million of colors) instead of the standard reversal pat- tern (320×240, 2 of 15 colors).
  • Page 31 Mounting and Setting Fig. 17 appeared after the digital system connection, press button, with- out inserting the installation disk. Fig. 17. The window of new equipment wizard. If the message such as “Device has not been tested on the Windows XP compatibility” appears, press the “Anyway continue”...

  • Page 32: Proper Use

    Neuro-MEP, Neuro-ERG (Technical Manual) Proper Use 3.1. Safety Measures When Using Digital System To provide safety measures and exclude the possibility of medical staff’ or pa- tient’ electric trauma, the medical staff is PROHIBITED: • To use digital system, mounting and setting of which was done incorrectly, without following this manual instructions.

  • Page 33: Troubleshooting

    The program message: The other program using the End other programs using the “Connection error: digital system is opened (for digital system. If you can’t find Neuro-MEP-4 is already used example, second copy such a program, reload the by another program”.
  • Page 34 Neuro-MEP, Neuro-ERG (Technical Manual) Continuation of Table 5 Trouble Symptom Cause Way of Removal The program message: Amplifier disconnection error. End the operating program, “Neuro-MEP-4 amplifier disconnect the amplifier from disconnection error”. End the the computer (USB-hub) and program, disconnect the...
  • Page 35 Cause Way of Removal The program message: Auditory-visual stimulator Check whether the stimulator “The connection error: Neuro-MEP is not connected is connected. If there are no auditory-visual stimulator to the computer. connection errors, disconnect Neuro-MEP is not connected stimulator from or in disrepair”.
  • Page 36 Neuro-MEP, Neuro-ERG (Technical Manual) Continuation of Table 5 Trouble Symptom Cause Way of Removal The program message: The coil position is wrong: for Set free the “Start’ button of “The button “Start” of the example, the “Start’ button is the stimulator.
  • Page 37 Neuro-MEP.NET or because of the system the next data block from the Neuro-MEP program (if they congestion. Repeat the start”. digital system. If this message are started) and start the appears seldom, it is not the signal registration again.
  • Page 38 Neuro-MEP, Neuro-ERG (Technical Manual) Continuation of Table 5 Trouble Symptom Cause Way of Removal High supply-line noise is in Unusable moment Disconnect the unusable at registered signal (frequency – electrodes are connected to the moment electrodes from 50 Hz or divisible to it – 100 the amplifier, the electrodes the amplifier.

  • Page 39: Exams Performing Using Digital System

    Proper Use 3.4. Exams Performing Using Digital System Before carrying out exams, it is necessary to set up the digital system and other equipment taking into consideration user manual recommendations. Exam includes the following stages: • electrodes and sensors set up; •...

  • Page 40: Servicing

    Neuro-MEP, Neuro-ERG (Technical Manual) 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 “Personnel Requirements Conducting Mounting and Setting”.

  • Page 41: Current Repair

    Current Repair Current Repair 5.1. General Requirements Digital system repair requires special training of the technical staff and special equip- ment and service software which you can receive from the manufacturer or the repre- sentative of the firm. The repair connected with the electronic unit opening is prohibit- ed.

  • Page 42: Auditory Stimulator Repair

    Neuron-Spectrum (Technical Manual) 5.4. Auditory Stimulator Repair Auditory stimulator (headphones) is examined externally, and circuit resistance of dy- namic head and cable are measured. The measured value should be within the range from 90 up to 110 Ω. When detecting the break or short circuit it is necessary to dis- assemble the cable connector case and check it.

  • Page 43: Led Penlights Repair

    Current Repair 5.6. LED Penlights Repair LED penlights are examined externally for the cable failure detection. Circuit control from the connector side is conducted according to Fig. 21 schematic by the device for LED check. It is necessary to open cable connector case and check the montage. If the failure is not detected, open the LED penlight case and measure the resistance of each cable.

  • Page 44: Ganzfeld Stimulator Repair

    Neuron-Spectrum (Technical Manual) 5.7. Ganzfeld Stimulator Repair Ganzfeld stimulator is examined externally for the cable failure detection. Circuit con- trol from the connector side is conducted according to Fig. 22 schematic by the device for LED check. It is necessary to open cable connector case and check the montage. If the cable break is detected, see the instructions on USB cable repair.

  • Page 45: Packing And Transportation

    Special requirements to device utilization are not pro- vided by the manufacturer. Delivery Set and Package Data Neuro-MEP-4 digital EMG and EP system, Neuro-MEP-8 digital EMG and EP system, Neuro-ERG digital EMG and EP system, is collected and packed according to TC 9441-006-13218158-2005 requirements.

  • Page 46: Acceptance Certificate

    Neuron-Spectrum (Technical Manual) Electrical stimulator unit Dedicated keyboard Patient button Footswitch Adapter for high resolution pattern-stimulator Tendon hammer Stimulation electrode with steel stimulation point 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.

  • Page 47: Warranty

    Warranty Information about the system storage before and in the process of operation is regis- tered 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 12.

  • Page 48: Reclamation Data

    Company (5, Voronin str., Ivanovo, 153032, Russia) only if this registration certifi- cate is provided. You can also contact SAS Neuromed Company, Authorized European Representa- tive of Neurosoft Company (to Mr. Pierre Scholl) by the following address: Chemin du tomple 84330 Le Barroux, France...
  • Page 49 Reclamation Data 13.2. 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 transporta- tion;...

  • Page 50: Repair Data

    Neuron-Spectrum (Technical Manual) 14. Repair Data Table 9. Repair Data. Name and Degree of Date Name of Position, code of faulty imperfec- repair works name, signature of comple- arrival unit tion person tion of repair Carried out Accepted the repair the repair...

  • Page 51: Appendix 1. Electromagnetic Emissions And Immunity

    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 —...
  • Page 52 Neuro-MEP (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.
  • Page 53 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. Immunity test IEC 60601 test Compliance level Electromagnetic environment -...
  • Page 54 Neuro-MEP (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...

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