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Summary of Contents for Neurosoft Neuron-Spectrum-AM
- Page 1 Technical Manual Neuron-Spectrum-AM Ambulatory EEG and PSG system TM053.01.002.000 (20.09.2014)
- 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...
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Page 3: Table Of Contents
Contents Contents ........................3 Introduction......................... 5 Description and Principle of Operation............. 6 1.1. Function......................6 1.2. Main Specifications ..................7 1.3. Delivery Set ....................10 1.4. Technology and Operation ................13 1.5. Connectors and Indicators ................17 1.6. Display......................19 Mounting and Installation................. - Page 4 Neuron-Spectrum-AM (Technical Manual) Packing and Transportation................40 Utilization ......................41 Delivery Set and Package Data ................ 41 Acceptance Certificate..................41 10. Delivery Certificate.................... 41 11. Storage Data ...................... 42 12. Warranty......................43 13. Reclamation Data ....................44 14. Repair Data ......................46 Annex 1.
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Page 5: Introduction
Introduction This technical manual (hereinafter referred to as “manual”) is the document describing operation and servicing of Neuron-Spectrum-AM ambulatory EEG and PSG system (hereinafter referred to as “system”). This manual is the document which certifies the system specifications guaranteed by the manufacturer. -
Page 6: Description And Principle Of Operation
Neuron-Spectrum-AM (Technical Manual) Description and Principle of Operation 1.1. Function Ambulatory EEG and PSG system Neuron-Spectrum-AM is meant for long-term elec- troencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), electro- cardiogram (ECG), blood supply indexes, respiratory and motion activity recording in any unshielded room. -
Page 7: Main Specifications
Description and Principle of Operation detection of generalized, inflammatory and vascular brain processes and local- ization of pathological activity sources; polysomnographic studies. It is possible to work in the long-term EEG monitoring mode or EEG videomonitoring mode. During EEG acquisition the system provides: ... - Page 8 Neuron-Spectrum-AM (Technical Manual) Table 1. Continued Parameters Values Ratio error of time interval measurement in the range within ±2% from 10 µs up to 10 s High pass filter 0.05, 0.5, 0.7, 1.5, 2, 5, 10 Hz Low pass filter...
- Page 9 Description and Principle of Operation Table 1. Continued Parameters Values Electronic unit weight (without batteries) not more than 0.5 kg Delivery set weight (without computer and printer) not more than 12.2 kg Working parts BF type Safety and Electromagnetic Compatibility Electromagnetic compatibility (EMC) is ensured by fulfilment IEC 60601-1-2:2007 re- quirements.
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Page 10: Delivery Set
Neuron-Spectrum-AM (Technical Manual) 1.3. Delivery Set The delivery set of Neuron-Spectrum-AM ambulatory EEG and PSG system includes electronic unit with different electrode sets for EEG, polygraphic channels and soft- ware which can be delivered to a customer both jointly and separately, and also com- ponents and bought articles (Table 2 and Table 3). - Page 11 Description and Principle of Operation Neoprene belts NSFT 053211.003 and NSFT 053211.003-01 are supplied for NSFT 053201.001 elec- tronic unit, and neoprene belts NSFT 053211.005 and NSFT 053211.005-01 - for NSFT 053201.002 electronic unit. Pouch for electronic unit NSFT 053213.002 is supplied for NSFT 053201.001 electronic unit, and NSFT 053213.003 –...
- Page 12 Neuron-Spectrum-AM (Technical Manual) Table 4. Continued Name Document code or main Number, specification pcs. Video capture card Omix 20 m (Uniqueics Ltd, Russia) USB extension cable NSFT 007998.003 Extension cable NSFT 015103.035 Table 5. Neuron-Spectrum-PSG Equipment Name Document code or main...
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Page 13: Technology And Operation
Description and Principle of Operation 1.4. Technology and Operation Ambulatory EEG and PSG system operation is based on the acquisition, saving on built-in memory card and input of brain biopotentials and other physiological signals into PC for the analysis. The system consists of PC and electronic unit. Electronic unit performs acquisition, saving on removable memory card and transfer of brain biopotentials and additional information recorded with the use of electrodes and sensors connected to the elec- tronic unit. - Page 14 Neuron-Spectrum-AM (Technical Manual) The block diagram of the ambulatory EEG and PSG system is shown in Fig. 1. Fig. 1. The block diagram of the ambulatory EEG and PSG system. Electronic unit consists of control unit, amplifier unit, electrode and sensor connectors and batteries.
- Page 15 Description and Principle of Operation Screw pneumatic connector PS is meant for pneumatic breath sensor connection. Amplifier unit is meant for electrode and sensor signal amplification, AD conversion and encryption. А1..А24 differential AC amplifiers are meant for biopotential amplification. The referent commutator consists of the set of electronic switches and is meant for signal selection.
- Page 16 Neuron-Spectrum-AM (Technical Manual) referent buses or LML- electrode signal could be these reference signals. The signal from the amplifier output is transferred to the 3 ADC4 input. S8 electronic switch choose the reference signal for A24 amplifier. This amplifier is meant for gaining signals from Cz/LMR+ connector.
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Page 17: Connectors And Indicators
Description and Principle of Operation Information on current work mode, diagnostic and informational messages are dis- played on the built-in liquid crystal display. Electronic unit control is operated with the help of menu, using keyboard. All the data transmitted to the MC2 from the data receive unit are saved as files on memory card. - Page 18 Neuron-Spectrum-AM (Technical Manual) The front panel of the electronic unit contains monochrome liquid crystal display (1), power button (2), three menu navigation buttons (3), light sensor (9) (only for NSFT 053201.002 electronic units and above) and battery compartment cover. SD/MMC memory card slot (4) is located on the battery compartment upper wall.
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Page 19: Display
Description and Principle of Operation 1.6. Display Electronic unit display space (Fig. 3) is divided into status bar and working area. Status bar Working area Fig. 3. Electronic unit display. The status bar is located at the top of the display and contains the following elements (from left to right): - battery indicator (1);... -
Page 20: Mounting And Installation
Neuron-Spectrum-AM (Technical Manual) Mounting and Installation 2.1. Requirements to the Personnel Conducting Mounting and Installation System installation should be carried out by a person who is empowered by the manufacturer or the technical personnel of the medical institution which is going to use it. - Page 21 Mounting and Installation 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 amperes compensating current leakage through the system connecting cables that leads to the equipment break-down.
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Page 22: Unpacking And Check Of Delivery Set
Neuron-Spectrum-AM (Technical Manual) The following abbreviations are used in the figures: EU – electronic unit; PSU – computer power supply unit (in according to IEC 601-1-88) C – patient chair; HS - hotspot; Kb – keyboard;... -
Page 23: Assembly And Connection To Computer
3.5.7 of the present manual. 5. Neuron-Spectrum.NET software has Wi-Fi connection wizard, which facilitates con- nection of Neuron-Spectrum-AM to the PC. To find more information read user man- ual for the software. The general scheme of connection is shown in Fig. 6. - Page 24 Neuron-Spectrum-AM (Technical Manual) Fig. 6. The connection scheme. To check the electronic unit operability, set the current time on built-in clock (it is per- formed automatically after the program run), set the required exam template parame- ters (electrode montage). The detailed description of these actions you can find in the...
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Page 25: Proper Use
Proper Use Proper Use 3.1. Safety Measures when Using System To provide safety measures and exclude the possibility of medical staff’ or pa- tient’ electric trauma, the medical staff is PROHIBITED to: use system that was mounted and set incorrectly, without following this manual in- structions;... -
Page 26: Setting-Up Procedures
Neuron-Spectrum-AM (Technical Manual) o weak pulse; o limited blood flow or congestion; SpO sensor is not intended for long-term use at one segment. If the measurement lasted more than 30 minutes, it is required to perform next measurements on other fingers (the change of application area is also required in high temperature condi- tions or blood flow insufficiency;... -
Page 27: Memory Card Installation
Proper Use tem displays the message informing that the system works under Neuron- Spectrum.NET software control. Position electrodes on the patient’s body and connect them to the unit. Fasten the electronic unit on the patient’s body using the set of belts. Electrode placement and connection is described in the user manual. - Page 28 Neuron-Spectrum-AM (Technical Manual) [Memory card] [Control module] [Amplifier module] [Date and time] [Language] the item is unavailable if memory card is not inserted the item is available only during exam recording the item is unavailable during exam recording Use [Up] and [Down] buttons to navigate through menu items. The current menu item has a selection.
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Page 29: Menu Commands
Proper Use 3.5. Menu Commands 3.5.1. Switch Off the System To switch off the system choose [Switch off the system] item in the [Main menu] menu. Note: You can not switch off the system during the exam performing (the corresponding menu item is unavailable). - Page 30 If none of electrodes are used, the impedance measurement is also impossible. Continuous Impedance Measurement During Acquisition Neuron-Spectrum-AM system allows to measure the impedance both before the ac- quisition start and during the acquisition itself (Fig. 8). At that the recording process is not paused (Fig.
- Page 31 In this case the impedance is shown by color on the corresponding trace button. To measure the impedance during the acquisition, select the required checkbox in current EEG acquisition style settings of Neuron-Spectrum.NET software and set the interval to measure the impedance (Fig. 10). Fig. 10. Neuron-Spectrum-AM settings in EEG acquisition style settings.
- Page 32 Neuron-Spectrum-AM (Technical Manual) Select the “Show measured impedance on trace buttons” checkbox on “Review” page of “Setup” window to see the measured impedance on trace button (Fig. 11). Fig. 11. The exam review settings. Besides the function of continuous impedance measurement during acquisition can be activated using “Ambulatory monitoring”...
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Page 33: Record Start
Proper Use 3.5.6. Record Start To start exam recording choose [Start recording] item in the [Main menu] menu. To start the exam acquisition the “current” exam file should exist on memory card. The exam acquisition is performed with the “current” exam parameters. During the exam acquisition the blinking circle appears in the status bar. - Page 34 Neuron-Spectrum-AM (Technical Manual) How to Perform Network Search To perform network search choose [Network search] item in the [New profile] menu. If at least one network was found by the system, it displays the [Found networks] menu. This menu contains names of all found networks. The name of each profile...
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Page 35: Options
Proper Use How to Connect to and to Disconnect from the Network Choose the network profile in the [Wireless network] menu. The [Network profile] menu will be displayed. In this menu choose [Connect] item. If your device has successfully connected to a wireless network, the “Device is ready to work with program”... -
Page 36: Language
Neuron-Spectrum-AM (Technical Manual) Note: It is impossible to change date and time during the acquisition (the corresponding menu item is unavailable). If date and time are not set, the system asks you to set them when the unit is switching on. -
Page 37: Actions In Emergency
2. Problems with electronic unit. measurement. 2. Replace the electrode. 3. Consult Neurosoft Company. The indicator of SpO2 channel in The SpO2 sensor is faulty or the 1. Check the sensor connection to Neuron-Spectrum.NET software cable is broken. -
Page 38: Maintenance Service
Neuron-Spectrum-AM (Technical Manual) The delivery set check is done by conformity to the device packing report. 4.2. Maintenance Service 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, battery recharging and replacement. -
Page 39: Current Repair
Current Repair Current Repair 5.1. General Requirements The system repair requires special training of technical staff, special equipment and service software which you can receive from the manufacturer or the representative of the company. The repair connected with the electronic unit opening is prohibited. The repair connected with electronic unit opening is prohibited. -
Page 40: Electrode Cap Repair
Neuron-Spectrum-AM (Technical Manual) 5.4. Electrode Cap Repair The electrode cap is examined externally for cables failure detection. The cables are checked for the break between electrodes and connector pins (Fig. 14). The elec- trodes of the cap should be lubricated by the electrode conducting gel. If the cable break is detected, it should be replaced or repaired by shortening the length. -
Page 41: Utilization
Special requirements to device utilization are not pro- vided by the manufacturer. 8. Delivery Set and Package Data Neuron-Spectrum-AM ambulatory EEG and PSG system with serial number _____________________, is collected and packed according to TC 9441-053-13218158-2012. -
Page 42: Storage Data
Neuron-Spectrum-AM (Technical Manual) 11. Storage Data The system should be stored in the manufacturer package in an enclosed room at from +5 up to +40С and 80% maximum relative humidity (measured at 25С tem- perature). The room air should be free from any dust, acid vapors, alkali vapors, cor- rosive gases and other injurious admixtures which can cause the corrosion. -
Page 43: Warranty
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 (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 44: Reclamation Data
13.1 In case of system breakdown or faultiness in the period of warranty and also prod- uct defect detected when primary acceptance, the consumer should send written notifi- cation to Neurosoft Ltd., authorized European representative or nearest distributor. The actual... - Page 45 Reclamation Data Table 9. Reclamation Data The date of Brief description of The date of Taken measures Note failure or the trouble reclamation trouble sending appearance...
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Page 46: Repair Data
Neuron-Spectrum-AM (Technical Manual) 14. Repair Data Table 10. 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... -
Page 47: Annex 1. Electromagnetic Emissions And Immunity
Annex 1. Electromagnetic Emissions and Immunity Annex 1. 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. Emissions test Compliance Electromagnetic environment —... - Page 48 Neuron-Spectrum-AM (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 49 Annex 1. Electromagnetic Emissions and Immunity 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...
- Page 50 Neuron-Spectrum-AM (Technical Manual) Recommended separation distances between portable and mobile RF communications equipment and 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...
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Page 51: Annex 2. Description, Configuration And Setup Of Wireless Networks
– special signal identifying the presence of an access point – to make this function work. Work of Neuron-Spectrum-AM in Ad hoc Mode This mode should be used if there are no infrastructure networks or it is impossible to connect to them. - Page 52 Neuron-Spectrum-AM (Technical Manual) Fig. 15 After that click on the option called “Create an ad hoc network” (Fig. 16). Fig. 16...
- Page 53 Annex 2. Description, Configuration and Setup of Wireless Networks The window that appears next requires you to give a network name, security key and the security type (WPA2-Personal is recommended) (Fig. 17). Fig. 17 After network creation open control Network connection manager panel (Fig.
- Page 54 Neuron-Spectrum-AM (Technical Manual) Open dialog with wireless network adapter properties using this panel (Fig. 19). Fig. 19 Open “Internet protocol version 4 (TCP/IPv4)” properties dialog (Fig. 20). Fig. 20 The “General” tab requires you to give the PC IP address and subnet mask. You...
- Page 55 Sometimes it is necessary to find and install new drivers for wireless network adapter because some manufacturers do not support its products. Work of Neuron-Spectrum-AM in Infrastructure Mode Infrastructure mode is much more expensive than ad hoc mode to implement, but it al- lows increasing throughput, and also infrastructure mode management is much easier than ad hoc mode management.
- Page 56 Neuron-Spectrum-AM (Technical Manual) The network consisting of one access point and wired network segment. Physical and logical structure of such network is given in Fig. 21. Fig. 21 Networks which contain cable or DSL router have the same logical structure. In this case access point is integrated with boundary router and Ethernet switch in one case and has the same IP address.
- Page 57 Annex 2. Description, Configuration and Setup of Wireless Networks The network consisting of several access points and boundary router con- nected by wired segment. Physical and logical structure of such network is shown in Fig. 22. Fig. 22 Wireless Network Planning and Installing To ensure the monitoring of the obtained signals in real-time mode, the system uses the built-in wireless adapter that complies with wireless IEEE802.11b/g/n standards.
- Page 58 Channels (for Equipment that Complies with 802.11b/g Standards) Fig. 23. Recommended network configuration. To ensure the correct operation of Neuron-Spectrum-AM system it is recommended to observe the following rules: Arrange not more than four acquisition units in one base station coverage area.
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Page 59: Annex 3. Memory Card File Storage Structure
Neuron-Spectrum-AM acquisition units to ensure the stable operation and disable access to Internet. Annex 3. Memory Card File Storage Structure The work directory has NS\DEV_0001 name. It can contain exam subdirectories and REC_TMLP setting file to create new exams.
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