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Mitsar EEG Operational Manual - Bio

1. Press Browse button if you like to change location of the WinEEG program Press Next button to continue installation Setup Type x Click the type of Setup you prefer then click Next Program will be installed with the most common options Recommended for most users Compact Program will be installed with minimum required options Custom You may choose the options you want to install Recommended for advanced users lt Back Cancel Select type of Setup you prefer Press Next button to continue installation ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Select Components xi Select the components you want to install clear the components you do not want to install Components y Program Executables 1244 K 3K 277037 K Child database 63267 K Description Space Required 390256 K Space Available 2096832 K lt Back Next gt Cancel Select components you want to install Don t install Sounds component if you don t plan to use auditory biofeedback Don t install Child Database component if you will not use Normative Database including spectra and ERP Press Next button to continue installation Select Program Folder x Setup will add program icons to the Program Folder listed below You may type a new folder name or select one from the existing Folders list Click Next to continue
2. MITSAR CO LTD WARRANTY COUPON 1 for repair replacement within the warranty period Medical equipment electroencephalographic system Mitsar EEG serial manufacturing date Purshased date signature and the seller s seal Commissioned date signature and the seller s seal Assigned for warranty service by Head of the enterprise signature and stamp The customer s signature ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG MITSAR CO LTD WARRANTY COUPON 2 for repair replacement within the warranty period Medical equipment electroencephalographic system Mitsar EEG serial manufacturing date Purshased date signature and the seller s seal Commissioned date signature and the seller s seal Assigned for warranty service by Head of the enterprise signature and stamp The customer s signature ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG DECLARATION OF CONFORMITY We Mitsar Co Ltd Novorossiyskaya str 21 2 194021 St Petersburg RUSSIA Hereby declare under our sole responsibility that the product Electroencephalographic PC controlled system MITSAR EEG 201 serial to which this declaration relates is in conformity with the provisions of Finnish Law 1505 94 and Act 1506 94 transposing Council Directive 93 42 EEC concerning medical devices pensler St PetersDUG irrikia place
3. Computer P SY TASK Patient warming button 1 Figure 14 The connection diagram of Mitsar EEG 201 amplifiers or Mitsar EEG 202 amplifiers with computer and Mitsar EEG system accessories for ERP studies ATTENTION The PCs must not be situated closer than 1 5 m from a patient ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 4 6 Video EEG with Mitsar EEG amplifiers Computer Amplifier Mitsar EEG 201 or Mitsar EEG 202 me Mitsar MITSAR EEG 202 POWER WinEEG USB KEY Video capture card Sound card Microphone In Video In Power sockets Power cable USB cable Power adapter for medical devices Power cable Patient warning Microphone button IR light source Video out Power cable Video camera Camera remote control Power adapter Figure 15 The connection diagram of Mitsar EEG 201 amplifiers or Mitsar EEG 202 amplifiers with computer and Mitsar EEG system accessories for Video EEG ATTENTION The PC must not be situated closer than 1 5 m from a patient ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG AN ATTENTION Different configuration of EEG system for Video EEG can be designed based on Mitsar EEG amplifiers and accessories The connection of multimedia d
4. IM17 Mitsar Co Ltd ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG OPERATION MANUAL MIRN 943119 001 RE Saint Petersburg 2007 ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Attention The information in this document is subject to change without notice Mitsar Co Ltd makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose Mitsar assumes no responsibility for any errors that may appear in this document Mitsar makes no commitment to update or to keep current the information contained in this document No part of this document may be copied or reproduced in any form or by any means without prior written consent of Mitsar Co Ltd Mitsar Co Ltd is an ISO 9001 certified corporation In case of any troubles problems or requests please do not hesitate to contact us in Writing Mitsar Co Ltd Polytekhnicheskaya str 6D Saint Petersburg 194021 RUSSIA via E mail info amitsar spb ru by phone or FAX 7 812 331 09 32 297 90 13 CE For more information please visit www mitsar medical com ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Mitsar Product Warranty Mitsar warrants that each product we sell you is free from defects in labor and materials and shall conform to its product specifications as defined in the
5. Program Folders wine EG Existing Folders AC Administrative Tools Broderbund Software Games_Gosha vi lt Back Cancel Type a new folder name if you want Press Next button to continue installation ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Setup Complete Setup has finished installing WinEEG on your computer Setup can launch the Read Me file and WinEEG Choose the options you want below Click Finish to complete Setup Press Finish button to complete Setup 6 2 WinEEG program initial setup and testing The following steps should be done to complete installation of the WinEEG program 1 Run WinEEG EXE program 2 WinEEG program will automatically ask the location of calibration file EEG CAL distributed by Mitsar Co Ltd together with Mitsar EEG amplifiers Load channel calbration file x r Source of channel calibration file Select the location of EEG CAL file and press OK 4 WinEEG will automatically copy EEG CAL file to working folder of WinEEG program 5 Run the Setup Equipment parameters command The next dialog window will displayed at the screen 10 11 12 13 14 ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG x Monitor size v Amplifiers type Not connected DEMO mode 1 0 port fuss sj Find Sampling rate Hz soo m Parameters of Synchronizatio
6. 6 Connecting the Amplifiers to the computer The Amplifiers is connected to the computer via serial port type USB In order to connect them insert one connector of the cable into the PC s port and the other plug into the appropriate Amplifier connector The connector at the Amplifier s case is not used for another purpose Direct the cable s connector properly it should come into the socket without excessive force For correct choice of the PC s connector see the computer user s manual 7 Methods of installation and use of the software are given in Chapter 6 of this manual After installation of the software carry out trial operation of the system in accordance to the instructions presented in Chapter 6 of this manual 8 Recommendations on adjustment of computer The present section describes elimination of possible faults during the first starting up or reinstallation of the software to a new computer When similar fault appears during normal operation the reason will likely be another All the activities described hereinafter should be executed by a qualified computer expert only The actions of an inexperienced user may cause not repairable damage to the computer After switching the device on the signal comes to input for 1 to 10 seconds after that the input disconnects and the device switches off In this case you have to carry out the following procedures for PCs equipped with processors Celeron Pentium III or
7. Mitsar EEG 201 is provided from internal power supply four dry cells or storage batteries type AA R6 supply voltage 3 0 to 6 5 V 48 mA 5 The Amplifier consumption current not more than 0 048 A 6 The Amplifier total operation time with one set of alkaline batteries not less than 50 hours 7 PC interface USB 8 Digital sampling rate per channel 250 or 500 Hz 9 Calibration signals square wave 0 5 Hz 200 pV 10 Number of channels Model EEG channels Poly channels TTL inputs 104xxxx 19 1 0 105xxxx 21 l 0 106xxxx 19 l 2 107xxxx 21 l 2 10 EEG channel characteristics 10 1 Input voltage range 10 to 1000 uV 10 2 Permissible error for voltage measurements within the range of 10 uV to 50 uV 10 within the range of 50 uV to 1000 uV 5 10 3 Input resistance not less than 200 MQ 10 4 Irregularity of the frequency amplitude response not more than 10 within the designated frequency range Model 104xxxx 1 to 17 5 Hz 105xxxx 0 65 to 35 Hz 106xxxx 1 to 17 5 Hz 107xxxx 0 65 to 35 Hz 10 5 Lower threshold frequency of the Low Cut filter High Pass filters at level 0 7 Model Hz Hz digital Hz digital 104xxxx 0 32 0 06 1 6 0 32 5 01 0 105xxxx 0 5 0 1 1 6 0 32 5 01 0 106xxxx 0 32 0 06 1 6 0 32 5 0 1 0 107xxxx 0 5 0 1 1 6 0 32 50 1 0 10 6 Upper threshold frequency of the High Cut filter Low Pas
8. 60601 1 1 1992 IEC 60601 1 2 1993 IEC 60601 1 4 1996 CISPR 14 1 Ed 3 0 Add 1 2 1993 98 The standard IEC 60601 1 1988 defines the permissible leakage current The connection several systems to the patient the leakage current will sum that can result to not permissible value of total leakage current and running the risk of patient injury Check the total value of leakage current of several systems before connection them to the patient 2 8 Transportation Turn off the system before transportation 2 9 Utilization The utilization of the system and the batteries should be done in correspondence to the domestic regulation ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 3 Mitsar EEG Amplifiers technical data 3 1 Mitsar EEG 201 amplifier The EEG system complies in accordance with the requirements of technical specifications TU 9441 001 25890578 99 The EEG system includes the multi channel bio signal amplifier the personal computer in a desktop or portable notebook type case and additional accessories The Amplifier is controlled by means of the specially developed computer software The Amplifier is designed in four modifications Model 104xxxx Model 105xxxx Model 106xxxx Model 107xxxx where xxxx serial number The Amplifiers connector layout is presented on Figures I and 2 19 channels EEG cap connector DB 25 female connector Power indicator Green LED Compatinble with Flect
9. PC CONTROLLED MONITORING SYSTEM MITSAR EEG The minimal configuration of Mitsar EEG system includes One of amplifiers Item 1 8 Software with user manuals Item 9 ECG electrodes connection cable Item 13 Operation manual Item 14 SAE DK PC connection cable Item 15 6 USB KEY Item 16 1 3 USB KEY configurations A number of WinEEG functions are protected by special electronic device USB KEY connected to USB To open their functionality it is necessary to connect USB KEY to USB and install driver for this device The possible configurations of USB KEY are enumerated in the following table USB KEY label EEG ERP Video EEG Normative recording recording recording database comparison EEG Base EEG EEG Video EEG DB EEG DB Video ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 2 Mitsar EEG Additional information 2 1 Software components Most important component of system is the software It controls the hardware components acquires the data processes the data displays and prints out them stores the data to hard disk and provides user interface The software includes the next modules 1 WinEEG base version This is a program for recording and processing EEG 2 WinEEG advanced version for ERP studies This program includes also options intended for ERP and event related EEG cha
10. Power spectra coherence event related potentials event related de synchronization wavelet bandpower and wavelet coherence for selected group of subjects for advanced statistical estimation by using ASCII format Importing Raw EEG from other EEG systems by using EDF ASCII LEXICOR NeuroScan data formats Additional features Build in database or Mitsar database MDB High quality printing of EEG signals Batch processing of EEG for selected set of EEG records Composing and color printing summary reports to include raw wave forms time frequency presentations maps LORETA images and text User defined list of final report templates EEG biofeedback Nonlinear analysis of EEG D2 estimation available by additional order For 7 2 more information please see the WinEEG User manual PSYTASK program introduction The PSYTASK is intended for preparation and carry out both psychophysics and psychophysiology investigations PSYTASK main features are l Visual on the monitor screen and auditory using sound card and speakers stimuli presentation Reaction time measurement To measure the reaction time keyboard and mouse can be used PSYTASK is working together with Mitsar digital EEG recorder WinEEG software and provides a synchronous stimuli presentation with EEG acquisition In this case two computers connected via COM ports are used PSYTASK program works on the first
11. Update button If synchronization COM ports are defined correctly the progress bar will display a process of transferring of task protocols from the PSYTASK program to the WinEEG program Otherwise the WinEEG program will report that the slave computer doesn t respond 18 Change synchronization parameters if necessary and repeat steps 15 17 In some cases it is necessary to find correct combination of COM ports step by step Attention It is necessary to perform steps 15 17 every time when the list of tasks or their parameters is changed in PSYTASK program Attention PSYTASK program is able to send correct task protocols only Please be attentive and check new task protocols before updating list of protocols for the WinEEG program if they were added Attention The procedure of recording and analysis ERP is described in the WinEEG user manual ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 7 Mitsar EEG software quick review This chapter includes quick review of Mitsar EEG software WinEEG and PSYTASK programs The WinEEG program is intended for the clinical observation of electroencephalogram EEG video EEG and evoked event related potentials recording for the diagnostic of brain diseases The software is written for MS Windows XP is designed for recording and assessing EEG synchronously with video signals as well as for recording and analyzing responses of the human brain induced by externa
12. Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed I Search removable media floppy CD ROM eee Browse C Don t search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware cack eo _ Conca 5 Select Search the best driver in these locations uncheck Search removable media floppy CD ROM check Include this location in the search and then click the Browse button ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Select the folder that contains drivers for your hardware Fig GOODIES O Guarview O Library QuickCap Ref2004 ReoRep B Tova F O web site WinEEGCpp vi Find USBDRV folder on your installation CD and then click the OK button Found New Hardware Wizard Please choose your search and installation options GE FJ Search for the best driver in these locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed I Search removable media floppy CD ROM IV Include this location in the search FAUSBDRV v Don t search I will choose the driver to inst
13. and date of issue Peredreeva 1 P r rnnnnnnnnnnnnrr Head of quality control department name position and signature of authorized person of the manufacturer ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG DECLARATION OF CONFORMITY We Mitsar Co Ltd Novorossiyskaya str 21 2 194021 St Petersburg RUSSIA Hereby declare under our sole responsibility that the product Electroencephalographic PC controlled system MITSAR EEG 202 serial to which this declaration relates is in conformity with the provisions of Finnish Law 1505 94 and Act 1506 94 transposing Council Directive 93 42 EEC concerning medical devices apynys SL Perersburgsaausumsenemeans n place and date of issue Peredreeva 1 P annnnnnnnnnnnnnr Head of quality control department name position and signature of authorized person of the manufacturer
14. computer and WinEEG program works on the second computer WinEEG program send synchronization codes to PSYTASK program to control its work and provides a synchronous stimuli presentation with EEG acquisition The recoded data can be used to calculate and analyze event related potentials ERP and or event related desynchronization ERD PSYTASK program can send synchronization codes to another program via COM port This feature provides a possibility to carry out ERP studies using another amplifiers and another program that is able to detect synchronization codes PSYTASK program have a users friendly interface that provide a possibility to design psychological tasks PSYTASK program measures the reaction time and task performance parameters omission and commission errors and save them to build in database for the future analysis and final report preparation ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG For more information how please see the PSYTASK User Manual 7 3 Quick EEG recording The following steps describe briefly how to acquire an EEG and to create a final report 1 Place the electrodes on the patient s head For a normal investigation 19 electrodes are placed using the International 10 20 system Also a common point electrode a N electrode and reference electrodes must be placed Common point and reference electrodes are to be placed in any case whether bipolar or monopolar monta
15. for selected subjects group and estimation of variance of computed parameters Mapping The above mentioned parameters into 2 D topograms using the Hot Metal White Grey RGD Blue Red Sokolow and some others mapping styles EEG spectra ERPs into 3D Talarach atlas by means of LORETA time sequence displaying Dipole source localization for EEG and ERPs Automatic spike detection Automatic spike detection procedure based on amplitude temporal parameters of waveforms Estimation and analysis of dipole sources parameters increase performance of procedure PCI of ICA decomposition of multi channel EEG before spike detection Manual editing of list of spikes Individual spikes averaging Calculation of synchronously to spikes averaged wavelet bandpower and wavelet coherence Manual copying spike waveforms and its parameters to clipbouard Statistical comparison of power spectra coherence ERP event related de synchronization between different states eyes opened eyes closed for one subject group by using t score between subject groups for one state by using t score between single subject and subjects group by using z score between single subject and normative data base by using z score Exporting Raw EEG to other applications by using European data format ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG EDF ASCII format or binary format LEXICOR
16. higher a Replace the batteries for new ones and start the device up again if the situation repeats then b Enter program CMOS Setup while starting up the computer c Enter the following settings names may vary depending on a motherboard s type Virus Warning Disabled Power Management disable Energy Saving function ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 3 1 6 Operation procedures 1 Operating the software Usage of the software is described in the user s manual included in the set of delivery of the system 2 Reference input connectors Reference input connectors Al and A2 may be connected by the Amplifier s internal switch at the software command In case if input connectors Al and A2 are connected it is possible to use as ear average referent A1 A2 2 or as independent referent used instead of ear parietal frontal etc position in this case you may apply one or two reference electrodes In case if input connectors Al and A2 are disconnected it is possible to use as referents Al A2 or A1 A2 2 in this case you should apply two reference electrodes 3 Neutral ground input connectors For successful EEG recording you must use one or two neutral electrodes Connectors for these electrodes are marked N If the neutral electrode is disconnected or defective instead of EEG you can observe as usual a distorted low frequency signal 50 60 Hz
17. interference or saturated amplifiers with pencil beam pattern A special neutral ECG electrode is not provided For ECG recording the potential of appropriate EEG electrode is used 4 EEG exploration features The main reason of unsatisfactory operation of the EEG system may lie in sporadic line 50 60 Hz interferences or high frequency interferences These interferences may be caused by various reasons The electrodes are contaminated Follow electrode maintenance instructions enclosed to electrodes Unsatisfactory applying of signal electrodes additional indication for that is 50 60 Hz picked up in one or more channels Unsatisfactory applying of neutral or reference electrodes additional indication for that is strong 50 60 Hz pickup in one or more channels The electrodes wires or connectors are damaged Powerful electric equipment presents in the neighborhood of the EEG room which generates strong noise X ray installations physiotherapy equipment etc Computer grounding is poor or absent The Amplifiers to computer connecting cable runs right against the computer s monitor There are some individual properties of the patient s skin or his her mental state In this case it is necessary to apply the electrodes more thoroughly to set the patient at rest to ask him her to relax A list of reasons causing noises or disturbances during EEG taking is given hereunder ELECTROENCEPHALOGRAPHIC PC CONTROLLED MO
18. means of connection to the Amplifiers regular or optical cable The permanent disturbance means a disturbance noise which is always present at an EEG record The temporary disturbance means a disturbance noise which appears at the record from time to time It is recommended to start search for unsatisfactory record quality reason from electrode applying quality and operating condition and from grounding connection and its quality ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Use a possibility to check electrode operating impedance The instrument provides high quality EEG recording if the resistance is less than 20 kQ it is recommended to achieve resistance less than 10 kQ and in a case of strong radio interference less than 5 kQ Elimination of reasons 5 and 9 may require installation of the equipment in another room elimination of reasons 5 6 and 9 may require a screened room 5 Switching off The Amplifiers switches off automatically after discontinuance of signals input disconnection of connecting cable or switching the computer off There are no other measures required for switch the Amplifiers off It is recommended to take the batteries out the compartment if service interruption exceeds one month presumably 6 Power cells The Amplifiers is energized from four batteries or accumulators type AA R6 Non hermetic batteries should not be used for power supply of the Amplifier
19. signals square wave 0 5 Hz 200 uV ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 9 Number of channels Model EEG channels Poly channels TTL inputs 401xxxx 24 8 2 403xxxx 24 8 2 404xxxx 31 l 2 406xxxx 31 l 2 10 EEG and Poly channels characteristics 10 1 Input voltage range Model uV 401xxxx 10 300000 403xxxx 10 100000 404xxxx 10 300000 406xxxx 10 100000 10 2 Permissible error for voltage measurements within the range of 10 uV to 50 uV 10 within the range of 50 uV to 100000 300000 uV 5 10 3 Input resistance not less than 200 MQ 10 4 Irregularity of the frequency amplitude response not more than 10 within the designated frequency range Model Hz 401xxxx 0 35 75 403xxxx 0 35 75 404xxxx 0 35 75 406xxxx 0 35 75 10 5 Lower threshold frequency of the Low Cut filter High Pass filters at level 0 7 401xxxx 403xxxx 404xxxx 406xxxx DC DC 0 16 0 016 Hz 0 16 0 016 Hz 0 16 0 016Hz 0 16 0 016 Hz digital digital digital digital 0 5 0 05 Hz 0 5 0 05 Hz 0 5 0 05 Hz 0 5 0 05 Hz digital digital digital digital 1 6 0 16 Hz 1 6 0 16 Hz 1 6 0 16 Hz 1 6 0 16 Hz digital digital digital digital 5 0 0 5 Hz 5 0 0 5 Hz 5 0 0 5 Hz 5 0 0 5 Hz digital digital digital digital 10 6 Upper thre
20. window will displayed at the screen Parameters of synchronisation xj Parameters of Synchronization Port Synchronization port to which a master computer is connected COM 1 v Baudrate 57600 v Number of bits a v Parity None v Stop bits fi v Synchronisation mode Dont send synchro codes WinEEG control v Cancel 9 Check the all parameters of Synchronization ports The parameters Baudrate Number of bits Parity and Stop bits should be identically defined in both programs 10 Check parameter Presentation device of the WinEEG program It should be specified as PSYTASK ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 11 Check parameter Synchronization mode of the PSYTASK program it should be specified as Don t send synchro code WinEKG control 12 Select COM ports to that the null modem cable connected to each computer 13 Press OK button to close the Equipment configuration dialog window of the WinEEG program 14 Press OK button to close the Parameters of synchronization dialog window of the PSYTASK program 15 Run the Switch to Slave Mode command of the PSYTASK program 16 Run the Setup Stimuli presentation programs command of WinEEG program The following dialog window will displayed at the screen Stimuli presentation program list x Cancel Reread B Tum on EEG recordin di 17 Click the
21. 1 Insert the installation CD into your CD ROM DVD ROM 2 Connect your amplifiers USB cable to an available USB port on your computer Windows automatically detects the device Found New Hardware Wizard dialog box appears Found New Hardware Wizard Welcome to the Found New Pale fl Hardware Wizard FJ Windows will search for current and updated software by looking on your computer on the hardware installation CD or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software C Yes this time only C Yes now and every time connect a device Click Next to continue lt Back Cancel 3 Select No not this time and then click the Next button ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Found New Hardware Wizard This wizard helps you install software for Electro Encephalograph with USB If your hardware came with an installation CD I or floppy disk insert it now What do you want the wizard to do Install the software automatically Recommended Click Next to continue cae Te _ cove 4 Select Install from a list or specific location Advanced and then click the Next button Found New Hardware Wizard Please choose your search and installation options Sata Y Search for the best driver in these locations
22. A 000S OZ0 9ELN9 uut ZHO9 SUWI IVA OOES LL AND Jo1epnbay om Y3ATIONLNOD TWNOIS LS3L Y3aTIONLNOD JONVOIdMI Y3ATIONLNOD asn 49018 TOYXLNOD SHILTIHY ANY SY3HOLIMS SH3HNMdNY 1NdNI Y343N8 SINN t 1NdLNO TYLIDIG LOZ 033 YVSLIN Weibelg 430jg EUONDUNJ Figure 3 Functional diagram of Mitsar EEG 201 amplifier for models 104xxxx and 105xxxx ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG JoyeynBay om Y3ATIONLNOD asn 49018 1081NO2 L0Z 033 YVSLIN Weibelg 430jg PUONDUNJ ui ZHO9 SL DY A 000S OZ0 9ELN9 uut ZHO9 SUU OVA OOES LL AND Y3ATIONLNOD TWNOIS LS3L Y3aTIONLNOD 3JONVOIdMI s431 ANY SY3HOLIMS SHIaHNMdNY 1NdNI Y3433N8 SINN p 1NdNI TYLIDIE Y3433N8 SINN t 1NdLNO TYLIDIG Functional diagram of Mitsar EEG 201 amplifier for models 106xxxx and Figure 4 107xxxx ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 3 1 3 Principle of operation EEG system is intended only for medical purposes and it used to measure and to record the electrical activity of the patient brain EEG and ECG signals are obtained by placing electrodes on the patient and enter the multichannel voltage amplifier The voltage amplifier amplifies the signals up to the level coordinated to the ADC s range and the signals come through analog filters HF and LF first order filters are used The amplified signals are reduced to common s
23. Automatic search for the corresponding driver and allow Windows to install it press button Next Sometimes you will need to reboot computer If you haven t Security Key you can open protected functions by Access Codes The Access Codes are distributed by Mitsar Ltd Mitsar will give you these codes by requirement if you have purchased the corresponding hardware software configuration The Access Codes are unique for each amplifier box and are active if this amplifier box is connected to computer only To generate Access Codes it is necessary to know the information about amplifier box such as its version and its serial number This information can be found using Setup Equipment parameters command For more information see WinEEG User manual The following or similar string will be displayed in Amplifiers type field if the amplifier box is connected to the computer ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Mitsar 202 serial number 4010001 37 Equipment configuration The access codes should be entered to corresponding fields Main to open EEG recording function Video to open video signal capture function Database to open comparison functions with normative database AN ATTENTION The access code is 8 characters string with digits or capital English letters and without additional symbols such as space point comma and others ELECTROENCEPHAL
24. D MONITORING SYSTEM MITSAR EEG 3 2 2 The Amplifiers functional diagram JEL UONEJOS i SlddW OMIY3 Y3ldvav 30 3 Y3ATIONLNOD asn f S E 3 L L0909931 IEP SL dIN urut ZHO9 SWU OWA OOES LL AND w un abe yes su ynz gt aBeyor pares IG000E gt ebeyor 1531 395 OL ZHO9 A0NB gt UONE OS LINS NYOEH ZL LOOZ S08030A OS6O9NANIG L0 002 sued p880 IQA Z S LrLOININIA L 10909231 ZorzaV Y3aTIONLNOD TWNOIS 1531 Y3aTIONLNOD JONVOIdNI ASL AEET X90184 108LNOI anv YOSSII0OHd TWNOIS qvid SY31 ONY YIHILIMS SHIIIMdNY 1NANI Y333n8 INN FLAN WLIO 34ina INN t 1NdLNO TYLIDIG layda W90 luvd90TNY 20Z 933 YVSLIW weeg 4d0 g 2UoNdUN4 Figure 8 Functional diagram of Mitsar EEG 202 amplifier for models 401xxxx 403xxxx 404xxxx and 406xxxx ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 3 2 3 Principle of operation EEG and ECG signals are received by the electrodes and enter the multichannel voltage amplifier The voltage amplifier amplifies the signals up to the level coordinated to the ADC s range and the signals come through analog filters HF and LF first order filters are used The amplified signals are reduced to common signal by means of the voltage switching unit The resulting signal enters the ADC input and the ADC converts it into digital signal consequently for each channel The ADC converts the signals into 16 bit digi
25. If illegal copies of Mitsar software were used 9 The present warranty does not include replacement of electrode sockets and battery cartridge and replacement of batteries Such defects may be eliminated at the customer s request against separate charge 10 The present warranty does not concern equipment not included into the delivery set see section 3 1 hereinabove if not stipulated otherwise by the delivery contract 11 Guarantee coupons are enclosed ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Safety Summary Read and follow all WARNINGS CAUTIONS and NOTES provided in this guide To avoid the possibility of injury damage to your system or data loss always observe these safety precautions during system operation Only trained personnel familiar with safety regulations is allowed to operate the EEG system Only personnel properly trained to operate the Mitsar EEG system should use it for patient testing The personal computer as a part of Mitsar EEG system must not be situated closer than 1 5 m from a patient PC monitor and printer as a part of Mitsar EEG system must be connected to power supply line only via socket equipped with ground contact Do not turn on any system power until all cables have been properly connected and verified To reduce the risk of patient injury turn on any system power before beginning of connection any patient electrodes To reduce the
26. MONITORING SYSTEM MITSAR EEG 4 2 EEG recording with model 106xxxx and 107xxxx amplifiers Computer Amplifier Mitsar EEG 201 model 106 or 107 Photostimulator EEE MITSAR EEG 201 Mitsar A fr x co 3 gt ah Aa Tle Photostimulator cable Power sockets Power cable A USB cable Patient warning button Power adapter for medical devices Power cable Figure 11 The connection diagram of Mitsar EEG 201 amplifiers Model 106xxxx and 106xxxx with computer and Mitsar EEG system accessories ATTENTION The PC must not be situated closer than 1 5 m from a patient ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 4 3 EEG recording with model 401xxxx and 403xxxx amplifiers Computer t USB KEY Power sockets Power cable Power cable gt Power adapter for medical devices Amplifier Mitsar EEG 202 model 401 or 403 EEE Pz Mitsar MITSAR EEG 202 POWER Pg1O ONz OPg2 Fp1 Fpz Fp2 Oo o O F7 F Fz F4 F8 o O O O Oo T3 c3 Cz c4 T4 O o ko o O USB cable Power adapter for medical devices Power cable Photostimulator cable Patient
27. NITORING SYSTEM MITSAR EEG Reason Permanent Temporary disturbance ve Computer is not grounded or it has a poor ground Yes connection Pulsing photostimulator is not grounded or it has a poor ground connection The Amplifiers is installed too close to computer s monitor The Amplifiers connecting cable runs right against the computer s monitor There is powerful electric equipment in the neighborhood of the EEG room which generates strong noise X ray installations physiotherapy equipment etc There is radio or TV transmitter radar station or cellular communication unit in the vicinity of the building the distance depends on the unit s capacity 7 The Amplifiers is placed right against the wall under which electric lines or cables are run The Amplifiers is placed too close to a wide metal surface metal closet box safe etc or to a wall behind which such object is placed There is a cable line with defective or ungrounded screen Yes Yes TV computer network etc in the wall 10 There is a sparkling electric switch defective fluorescent lamp s or such lamp s with a defective starter There is a working engine source closely outside the building 12 Domestic electric appliances microwave oven coffee grinder etc are on at the time of examination Cellular or radio telephone is used at the time of exploration Necessity of photostimulator grounding depends on the device type and
28. OGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 6 Mitsar EEG software installation 6 1 WinEEG program installation WinEEG is a program for EEG recording and processing WinEEG program should be installed on computer to which Mitsar EEG amplifier is connected To install WinEEG program 1 Insert the CD to the corresponding drive 2 Open folder with name WinEEG 3 Run SETUP EXE program 4 Follow the instruction on the screen xi Welcome to the WinEEG Setup program This program will install WinEEG on your computer It is strongly recommended that you exit all Windows programs before running this Setup program Click Cancel to quit Setup and then close any programs you have running Click Next to continue with the Setup program WARNING This program is protected by copyright law and international treaties Unauthorized reproduction or distribution of this program or any portion of it may result in severe civil and criminal penalties and will be prosecuted to the maximum extent possible under law Press Next button to continue installation ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Setup will install WinE EG in the following folder To install to this folder click Next To install to a different folder click Browse and select another folder You can choose not to install WinEEG by clicking Cancel to exit Setup
29. The Amplifier Mitsar EEG 202 Model 406xxxx with power adapter for medical device I piece 9 Software with user manuals for EEG recording and processing 1 set 10 Advanced software with user manuals for EEG and ERP recording and processing 1 set 11 Advanced software with user manuals for video EEG 1 set 12 EEG electrodes and caps 1 set 13 ECG electrodes connection cable 1 piece 14 Operation manual 1 piece 15 PC connection cable 5 7 meter 1 piece 16 USB KEY 1 piece 17 Tripod I piece 18 Photostimulator with cables and power adapter I piece 19 Patient warning button 1 piece 20 Null modem cable I piece 21 Desktop computer for data acquisition gt 1 piece 22 Laptop computer for data acquisition 1 piece 23 Desktop computer for stimuli presentation gt 1 piece 24 Printer gt I piece 25 Video capture card I piece 26 Video camera with set of cables I piece 27 Video camera remote control with set of cables I piece 28 IR light source 1 piece 29 Power supply for video camera camera remote control and IR light source 1 piece 30 Microphone and microphone amplifier if necessary 1 piece The description of this model is places below Here xxxx is a serial number The type of amplifiers depends of the customer s order gt To be delivered at customer order The configuration or model should be discussed with customer ELECTROENCEPHALOGRAPHIC
30. adio or TV transmitter radar station or cellular distance depends on the unit s capacity The Amplifiers is placed right against the wall under which electric lines or cables are run The Amplifiers is placed too close to a wide metal surface metal closet box safe etc or to a wall behind which such object is placed There is a cable line with defective or ungrounded screen Yes Yes TV computer network etc in the wall 10 There is a sparkling electric switch defective fluorescent lamp s or such lamp s with a defective starter There is a working engine source closely outside the building 12 Domestic electric appliances microwave oven coffee grinder etc are on at the time of examination Cellular or radio telephone is used at the time of exploration Necessity of photostimulator grounding depends on the device type and means of connection to the Amplifiers regular or optical cable The permanent disturbance means a disturbance noise which is always present at an EEG record The temporary disturbance means a disturbance noise which appears at the record from time to time It is recommended to start search for unsatisfactory record quality reason from electrode applying quality and operating condition and from grounding connection and its quality Use a possibility to check electrode operating impedance The instrument provides high quality EEG recording if the resistance is less than 20 kQ it is rec
31. all Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware lt Back Next gt Cancel Click the Next button Windows will automatically install driver Windows can ask you to specify corresponding inf and sys file In this case select usbisoch inf and usbisoch sys for Mitsar EEG 201 models 104xxxx and 105xxxx or ftd2xx inf and ftd2xx sys for Mitsar EEG 201 models 106xxxx and 107xxxx and Mitsar EEG 202 models 401xxxx 403xxxx 404xxxx and 406xxxx placed into USBDRV folder 8 ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for Electroencephalograph Mitsar EEG Click Finish to close the wizard H Cancel Click the Finish button to complete installation 5 2 USB KEY driver installation A number of WinEEG functions are protected by special electronic device USB KEY connected to USB To open their functionality it is necessary to connect USB KEY to USB and install driver for this device 1 2 3 4 5 6 7 Insert the CD to the corresponding drive Open the ProtectionKey folder Open Drivers subfolder Run INSTDRV EXE Insert the USB KEY into the USB connector Windows will detect a new hardware Select
32. alog boxes are unique for each video capture and audio capture devices Please look for information about them in corresponding operation manuals 6 4 Initial equipment preparation for carrying out ERP studies Turn off the computers Connect computers together by null modem cable Turn on the computers Install the PSYTASK program on computer that will be used for presentation of stimuli The installation procedure is described in PSY TASK user manual Run the WinEEG program on computer to that the Amplifier is connected Run the PSYTASK program on computer that will be used for presentation of stimuli Run the Setup Equipment parameters command of WinEEG program The following dialog window will displayed at the screen ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Equipment configuration xi Monitor size bg v Amplifiers type Not connected DEMO mode 1 0 port fu SB zj Find Sampling rate Hz 500 7 Parameters of Synchronization Port Synchronization port to which a slave computer is connected COM 1 v Baudrate 57600 v Number of bits fr x Parity None v Stop bits fi v Presentation device PSYTASK v Graphics acceleration Method Tum off v I Synchronization with Vertical Retrace Access codes Main Video Database Cancel 8 Run the Modify synchronization parameters command of PSYTASK program The following dialog
33. d The next dialog window will displayed at the screen Video recoder parameters ixi Main Camera Video Input Device Pinnacle DY AY Capture v Video Input Video Composite v Video compressor Microsoft MPEG 4 Video Codec V1 bs Frames per 25 per second v Resolution 352 x 288 pixels Video format Video Source Audio Input Device SoundMAX Digital Audio Sy Audio Source Audio compressor MPEG Layer 3 v I Would you like to capture audio Additional camera I Would you laike to capture video from additional camera Video Input Device averDvD EZMaker WDM Video Capture v Video Input Video Composite Video compressor Microsoft MPEG 4 Video Codec V1 X Frames per 25 per second v Resolution 320 x 240 pixels Video format Video Source Video block length 300 2 Select Video Input Device for Main camera from the corresponding list 3 Select Video Input from the corresponding list to which the camera is connected sd a Nn 10 11 12 ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Select appropriate Video compressor for Main Camera that will be used for on line compression of video information The compressors Microsoft MPEG 4 Video Codec V1 or Microsoft MPEG 4 Video Codec V3 will be the best for many system configurations We don t recommend you to use this option with rather slow computers Use S
34. e dashaderawaniiacnkadackccaaksey shed unen dude bean 16 TEN SENG NG 17 3 1 6 Operation procedures L uvarsatdeusmsseju nds 19 31 72 Maintenant a sa AAN 21 3 1 8 Troubleshooting qud u suarsrerSesdensekievdamntoe dus aa 21 3 2 Mitsar EEG 202 amplifier vaausssusemsoersemenlgagudjsdndemsnudviuiee 23 3 2 1 Basic t ch nical datai sisese EAE inh 24 3 2 2 The Amplifiers functional diagram rerornnnnnnnnnnnnnnrvnnnnnnnnnrnnrnnnrnnnnnnnenrrrnnnnn 27 3 2 3 Principle of operation user herskende aid 28 3 2 4 Safety measures La EG 28 CRAS E ETAO S o EEE T E E E ET 29 3 2 6 Operation protsdures Lmaacduusedererun seneste 30 27 Maintenant E ait cess lecctcndsiesddiot ote seineiinn iad RAA cedar 33 3 2 8 Troubleshooting guide 5 5 3 sorties AG Soe dat taeeas id caueeesonielns Romana 33 Mitsar EEG Connection diograms arennnnnnrnnnnnnvnrrnnnnnrnnrrnnnnnnnnennnnnnnnennernnannnnnven 34 4 1 EEG recording with model 104xxxx and 105xxxx amplifiers 0 eee 34 4 2 EEG recording with model 106xxxx and 107xxxx amplifiers ssorrrrrrnnonnnnnre 35 4 3 EEG recording with model 401xxxx and 403xxxx amplifiers 0 eee 36 4 4 EEG recording with model 404xxxx and 406xxxx amplifiers sxorrrrrrnnonnrrnre 37 4 5 ERP recording with Mitsar EEG amplifiers errnnnnrnnnrnnnvnnnnnrnrrrnnnnrnrrrnnnnrnnnne 38 4 6 Video EEG with Mitsar EEG amplifiers nrrrrnnnnnnrvnnnnnnnvnnnnrnnrnnnnnvrnrrnnnnnnnnnn 39 4 7 Two cameras
35. e requirements of standard IEC 60601 1 92 as a device with internal BF type power source The EEG system conjointly with a line supplied PC complies with the electrical safety requirements class I type BF standards IEC 60601 1 1988 IEC 60601 2 26 1994 IEC 60601 1 1 1992 2 General safety of the EEG system is provided by fulfillment of the requirements of standard IEC 60601 1 1 1992 3 The Amplifiers operates in a patient s environment 4 The personal computer represents a subsystem of non medical equipment and must be situated at distance from a patient providing impossibility of intended or accidental contact between a patient and the PC 5 The integrated insulating decoupling device in the amplification module supports appropriate safety levels for the amplification module and for personal computer after interconnection 6 Electric strength of the isolation between the operating parts and the PC connection cable reinforced isolation withstands AC voltage of 4 kV at operating temperature ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 7 The connection cable has the length of 4 m at least for removing the PC from a patient s environment AN 8 ATTENTION The PC must not be situated closer than 1 5 m from a patient l I i 3 gt I l ee IEC 2513 2000 Figure 5 An example of patient environment AN 9 ATTENTION PC monitor and printer must be connected to powe
36. ed enough in technique of clinical EEG observation The user should be familiar with operation system Windows XP also 1 1 Available additional manuals There are additional manuals in which the detailed information about software of system is included 1 User manual for WinEEG program The WinEEG program is intended for recording and processing EEG Video EEG and event related potentials observation 2 User manual for PSYTASK program The PSYTASK program is intended for synchronous stimuli presentation during EEG recording for event related studies ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 1 2 Delivery set The delivery set can include the next components in dependence on customer order No Component Quantity l The Amplifier Mitsar EEG 201 Model 104xxxx with 4 batteries I piece 2 The Amplifier Mitsar EEG 201 Model 105xxxx with 4 batteries I piece 3 The Amplifier Mitsar EEG 201 Model 106xxxx with 4 batteries I piece 4 The Amplifier Mitsar EEG 201 Model 107xxxx with 4 batteries I piece 5 The Amplifier Mitsar EEG 202 Model 401xxxx with power adapter for medical device I piece 6 The Amplifier Mitsar EEG 202 Model 403xxxx with power adapter for medical device I piece 7 The Amplifier Mitsar EEG 202 Model 404xxxx with power adapter for medical device I piece 8
37. ee Chapter 4 3 Connect system to power source The power supply requirement is present at next table Power supply voltage 100 240 B Power supply frequency 50 60 Hz Power consumption not 20 W including the computers Turn on the system Nn Install the system specific drivers and software and test the EEG system in correspondents to instructions presented in this manual below see Chapter 5 and 6 AN ATTENTION There are no parts inside the EEG system components which should be maintained by user except the batteries inside Mitsar EEG 201 amplifiers ATTENTION Do not open EEG system cases if the system is connected to power source 2 5 Switching On patient AN ATTENTION Switch on the system before connection the electrodes to WARNING Turn off the system before connection additional components and peripheral devices To switch on the system press Power button on PC ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 2 6 Switching Off DE Disconnect the electrodes from the patient before switching off the system Close all application and turn off Windows before switching of the system Switch off the system before disconnecting it from power supply 2 7 Leakage current The EEG system conjointly with a line supplied PC complies with the electrical safety requirements class I type BF standards IEC 60601 1 1988 IEC 60601 2 26 1994 IEC
38. evices can differ from this connection diagram ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 4 7 Two cameras with Video EEG with Mitsar EEG amplifiers Computer Amplifier Mitsar EEG 201 or Mitsar EEG 202 me Mitsar MITSAR EEG 202 POWER WinEEG mr Video capture card Sound card fh Video Iny I Microphone In USB KEY Power cable Power sockets USB cable Power adapter for medical devices Power cable fie Patient warning Microphone button qj TR light source Sa Video out Power cable Video camera Camera remote Power adapter control ee f en Second video camera Power adapter Video out cx Figure 16 The connection diagram of Mitsar EEG 201 amplifiers or Mitsar EEG 202 amplifiers with computer and Mitsar EEG system accessories for Video EEG ATTTENTION The PC must not be situated closer than 1 5 m from a patient ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 5 Mitsar EEG driver installation 5 1 Amplifier driver installation Corresponding driver should be installed for any device plugged in to USB input Driver installation is standard procedure performed by Windows XP To install driver user should perform a number of standard steps listed below
39. ge is used If EEG is assumed to be recorded in reference to ears two reference electrodes are placed on the ears A reference electrode can be placed on the forehead and connected to Al or A2 input the appropriate electrode is provided in the set and a corresponding montage is set in the program EEG signal quality depends on paying special attention to the placement of common point and reference electrodes 2 Connect the electrodes to their respective inputs on the front panel of the amplifier block 3 Set the electrode impedance checking mode using Recording Impedance command If the impedance value is satisfactory less than 5 KOhm close the Control of Electrode Impedance dialog Otherwise re install those electrode s showing excessive impedance 4 Run the File New command Fill in the patient card choose a montage and check it When these actions are completed successfully a new EEG window will be displayed on the screen 5 Run the Recording EEG Monitoring command Visually check the quality of the live EEG displayed in the new window If any channel is acquiring EEG poorly re install the corresponding electrode s Check EEG acquisition quality using a monopolar montage without averaging 6 Run the Recording EEG Recording command to start recording signals to a file To stop recording run the Recording EEG Recording command once more One fragment of the EEG will be recorded Record another fragment if necessary If ph
40. he WinEEG User manual and the PSYTASK User Manual ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 8 DEED OF COMMISSION The Amplifier Mitsar EEG serial found to be ready for operation Modification underline as required e Mitsar EEG 104xxxx complied with technical specifications TU 9441 001 25890578 99 e Mitsar EEG 105xxxx complies with technical specifications TU 9441 001 25890578 99 e Mitsar EEG 106xxxx complies with technical specifications TU 9441 001 25890578 99 e Mitsar EEG 107xxxx complies with technical specifications TU 9441 001 25890578 99 e Mitsar EEG 401xxxx complies with technical specifications TU 9441 004 52118320 2005 e Mitsar EEG 403xxxx complies with technical specifications TU 9441 004 52118320 2005 e Mitsar EEG 404xxxx complies with technical specifications TU 9441 004 52118320 2005 e Mitsar EEG 406xxxx complies with technical specifications TU 9441 004 52118320 2005 ODDODDODODOD g Manufactured on Mitsar Co Ltd date signature seal ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 9 DATA ON INSTALLATION AND ASSIGNMENT TO OPERATION The electroencephalographic system Mitsar EEG serial have been installed and commissioned Date of installaton Signature Position Name Commissioned by Assigned by ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG
41. ignal by means of the voltage switching unit The resulting signal enters the ADC input and the ADC converts it into digital signal consequently for each channel The ADC converts the signals into 16 bit digital code 65536 quantization levels Synchronization of operation for the voltage switching unit and the ADC control for photostimulator and data communication with the PC are provided by the microcontroller The data are sent to the PC through a standard serial interface type USB via the decoupling device and the level converter The decoupling device acts as a reinforced isolation and may withstand AC voltage of 4 kV for 1 minute The power supply of the Amplifiers is the batteries Necessary internal voltages are generated by the internal power source DC DC converter which is turned on by software command and is kept in ON state by special commands The power source switch off automatically in 2 5 seconds after the program stops transmitting commands for keeping ON or after interruption of PC connection The system software provides creation of data files for input signal digital filtration of the data displaying of those as curves at a PC s monitor memory oscilloscope mode storing of the data on the PC s hard disk and further processing and analysis of signals EEG analysis features are described in the user s manual for the software 3 1 4 Safety measures 1 Regarding operation safety the Amplifiers complies with th
42. in this guide Should repair or replacement of this product become necessary after the expiration of the warranty the customer should seek advice from Mitsar prior to such repair or replacement If this product is in need of repair it should not be used until all repairs have been made and the unit is functioning properly and is ready for use The owner of this product has the sole responsibility for any malfunction resulting from improper use or maintenance or repair done by anyone other than a qualified Mitsar representative and from any malfunction caused by any parts that have been damaged or modified by anyone other than a qualified Mitsar representative The owner of this product has the sole responsibility for connection devices to the system not corresponded to the electrical safety requirements class I type BF standards IEC 60601 1 1988 IEC 60601 2 26 1994 IEC 60601 1 1 1992 IEC 60601 1 2 1993 IEC 60601 1 4 1996 CISPR 14 1 Ed 3 0 Add 1 2 1993 1998 for medical devices ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Mitsar Warranty and Post Guarantee Obligations 1 The manufacturer guarantees compliance of the system with technical specifications subject to the customer s fulfillment of operating requirements described below 2 Warranty period is 24 months beginning with the date of installation and commission date of signing of the commission deed If the BSC delivery set includes a compu
43. is described in the user manual included in the set of delivery of the system 2 Reference input connectors Reference input connectors Al and A2 may be connected by the Amplifier s internal switch at the software command In case if input connectors Al and A2 are connected it is possible to use as ear average referent Al A2 2 or as independent referent used instead of ear parietal frontal etc position in this case you may apply one or two reference electrodes In case if input connectors Al and A2 are disconnected it is possible to use as referents Al A2 or A1 A2 2 in this case you should apply two reference electrodes 3 Neutral ground input connectors For successful EEG recording you must use one or two neutral electrodes Connectors for these electrodes are marked N If the neutral electrode is disconnected or defective instead of EEG one can observe as usual a distorted low frequency signal 50 60 Hz interference or saturated amplifiers with pencil beam pattern 4 EEG exploration features The main reason of unsatisfactory operation of the EEG system may lie in sporadic line 50 60 Hz interferences or high frequency interferences These interferences may be caused by various reasons The electrodes are contaminated Follow electrode maintenance instructions enclosed to electrodes Unsatisfactory applying of signal electrodes additional indication for that is 50 60 Hz picked up in one o
44. l stimuli or internal movements The PSYTASK program is intend for visual and auditory stimuli presentation synchronously with EEG recording The stimuli are presented on the monitor of additional computer connected to the main computer to witch Mitsar EEG amplifier is connected Two computers should be connected via COM ports 7 1 WinEEG program main functions The main functions of WinEEG program is presented at following table Recording Continious unlimited Moving paper emulation Synchronous with stimuli presentation for ERP and event related desynchronization ERD Video EEG Synchronous on line recording of EEG video and audio signals from one or two cameras and microphone On line MPEG 4 compression of video signals and MPEG 3 compression of audio signal Off line compression recompression of video and audio signals Night video recording using video camera with infrared illuminant Manual marking of events during EEG and video recording Off line synchronous playback of EEG video and audio signals Automatic positioning to video pictures corresponding to manually selected EEG sample or marker Editing of EEG and video signals to save meaningful fragments only Advanced service for preparation of CD copy of video EEG record Compact but powerful free video EEG viewer for displaying of CD copy of video EEG record provides next possibilities off line synchronous playback of EEG vide
45. n Port Synchronization port to which a slave computer is connected COM 1 v Baudrate 57600 v Number of bits pr xl Parity None v Stop bits 1 v Presentation device Graphics acceleration Method Tum off v I Synchronization with Vertical Retrace Access codes Main O Video m Database j Cancel Press button Find WinEEG program will automatically search for connected to computer amplifier and displays it identification in Amplifier type field If WinEEG program is not able to find connected to computer amplifier it will display Not connected DEMO mode string in Amplifier type field In this case check the USB cable using to connect amplifiers to computer or reinstall amplifier driver If WinEEG program displays amplifier identification correctly perform the next steps is to check amplifier works properly Run the File New command and press OK button Run the Recording Turn On Off Calibration command Visually check the calibration signal on the screen The calibration signal should be square waveforms with frequency 0 5 Hz and amplitude 200 uV The calibration signal should be the same for all displayed channels Run the Recording Stop command Close EEG window ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 6 3 WinEEG program initial setup of video EEG option 1 Run the Setup Video recordings comman
46. nges studies 3 WinEEG advanced version for video EEG This program includes also option intended for video EEG 4 PSYTASK This is a program for synchronous presentation of visual and acoustic stimuli with EEG recording during ERP studies 2 2 Electrodes Electrodes and electrodes caps are important component of EEG system but they are delivered separately Mistar Co Ltd recommends use the standard electrodes with touch proof connectors ElectroCap electrode positioning system Electro Cap International Inc USA or any compatible electrodes cap All electrodes used together with Mitsar EEG system should be certified Mitsar Co Ltd does not provide the warranties of appropriate quality of EEG recording if not certified or damaged electrodes are used AN ATTENTION The usage not certified electrodes can damage the system ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 2 3 Antivirus software The Mitsar EEG system software can interfere with antivirus software This can result in data loss during EEG recording The active scanning is not recommended Do not use the scanning during EEG recording 2 4 System installation Before the beginning of installation read attentively this manual 1 Start with installation from checking the components and cables Be sure that these components have no damage 2 Connect the components in accordance with connection diagrams presented in this manual below s
47. o and audio signals digital filtering of EEG data montage reformatting EEG mapping Artifacting OCG subtraction using regression method Spatial filtration on the basis of estimation of filter parameters using Principle Component Analysis PCA or Independent component analysis ICA EEG epoch elimination on the basis of low and high frequency power values Manual EEG epoch elimination ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Remontaging Any monopolar Any bipolar Common average reference Weighted average references Hjorth n Lemos Laplacian and some others Digital filtering A set of IIR bandpass filters Notch filters at 50 or 60 Hz 12 th order more then 40 dB attenuation High order bandpass FIR filters Calculating Absolute and relative spectra spectral ratios spectral asymmetries coherence phase Cross correlations of EEG Spectral density arrays Event related potentials ERPs Event related de synchronization ERD ERS Event related wavelet transforms time frequency decomposition of EEG responses and estimation event related bandpower Event related wavelet coherence Estimation a reaction time omission and commission errors in behavioral paradigms Grand averaging of power spectra coherence event related potentials event related de synchronization event related wavelet bandpower event related wavelet coherence
48. ommended to achieve resistance less than 10 kQ and in a case of strong radio interference less than 5 kQ Elimination of reasons 5 and 9 may require installation of the equipment in another room elimination of reasons 5 6 and 9 may require a screened room 5 Switching off ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG The Amplifiers switches off automatically after discontinuance of signals input disconnection of connecting cable or switching the computer off There are no other measures required for switch the Amplifiers off 3 2 7 Maintenance 1 There is no special measure for maintenance of system 2 The device should be cleaned by standard means TAN scx Do not autoclave any parts of Mitsar EEG system TAN six ION Do not use acetone for cleaning the components of system 3 The electrodes should be cleaned and sterilized by as described into their accompanying documentation 3 2 8 Troubleshooting guide Possible problems and methods of their elimination are given in the table hereunder Problem symptoms Method of elimination After signal input attempt the Poor connection of the Check the connection power indicator remains dim __ interface cable connector After signal input attempt the Poor connection of the Check the connection of the power indicator remains dim __ power adapter power adapter After signal input attempt the Serial computer port Check the computer po
49. omputer s HDD processing displaying at PC s display and printing out of electroencephallographic signals The devices are intended for the clinical observation of electroencephalogram EEG video EEG and evoked event related potentials ERP recording for the diagnostics of brain diseases The software package for MS Windows XP allow to perform an advanced computerized analysis of the EEG on the standard personal computer or Notebook including digital filtering montage reformatting spectra and coherence analysis topographic mapping and etc The EEG system includes the biosignals converter hereinafter the Amplifiers The Amplifiers is controlled by means of the specially developed computer software Mitsar EEG device is not sterile Device does not directly contact the patients Accessories that contact patients such as electrodes and caps are the same as used with the legally marketed devices or are comprised of the same components materials as legally marketed accessories The system is intended for use in functional diagnostics wards and departments at out patient s clinics hospitals health research institutes health centers and other medical institutions Patient population includes adults children and infants This document if intended for administrative personal of medical institute or clinic medical doctors and medical nurses and other medical staff The personal intended to work with the EEG system should be experienc
50. otostimulation is necessary turn the photostimulator on using the Recording Photostimulation on off command wait for the time needed change the photostimulation frequency or turn the photostimulator off and so on After finishing the photostimulation procedure stop EEG recording 7 Stop EEG acquisition using the Recording Stop command 8 Save the newly created EEG file into the database using the File Save command 9 Remove the electrodes and let the patient go AN ATTENTION To avoid data loss do not carry out Step 9 before Step 8 10 Analyze the newly recorded EEG See EEG window chapter of the WinEEG user manual ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 11 Open the Final Report window using the Analysis Final Report command 12 Compose the final report and save it to the database using the File Save command 13 Print the final report and illustrative fragments of the EEG using the File Print command 14 Close the WinEEG window using the File Exit command The EEG recorded to the hard disk is the raw one acquired using monopolar montage in relation to reference electrodes with the widest bandwidth But the EEG displayed on the screen is reformatted and filtered according to the montage parameters that have been set see Setup Montage List command The raw EEG data may be reformatted into any montage without limitation For more information how to do this please see t
51. ource button to specify compression parameters if corresponding video capture card support on line compression Select frame rate if it is possible We recommend use the sampling rate equals to 25 or 30 frames per second Press button Video format to specify parameters of video format Usually these parameters include the resolution of video data Specific for video capturing device Press button Video Source to specify parameters of video capturing Specific for video camera Select Audio input device from the corresponding list Select appropriate Audio compressor that will be used for on line compression of audio information The compressors MPEG Layer 3 will be the best for many system configurations Turn of audio capturing checking the button Would you like to capture audio Specify minimal length of block of video data placed into one file using Video block length field By another words the old video file will be closed and new file will be created every specified seconds Specify parameters for additional camera if it is connected and will be used The parameters are specified at the same way as described above see 2 7 Attention The video and audio compressors will be available if corresponding codecs have installed Attention Please specify all parameters of Video format Video source and Audio source carefully The quality of recorded signal will depend on these parameters Unfortunately corresponding di
52. provided by fulfillment of the requirements of standard IEC 60601 1 1 1992 3 The Amplifiers operates in a patient s environment 4 The personal computer represents a subsystem of non medical equipment and must be situated at distance from a patient providing impossibility of intended or accidental contact between a patient and the PC 5 The integrated insulating decoupling device in the amplification module supports appropriate safety levels for the amplification module and for personal computer after interconnection 6 Electric strength of the isolation between the operating parts and the PC connection cable reinforced isolation withstands AC voltage of 4 kV at operating temperature 7 The connection cable has the length of 4 m at least for removing the PC from a patient s environment ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG ZN 8 ATTENTION The PC must not be situated closer than 1 5 m from a patient f ee ee a7 IEC 2513 2000 Figure 9 An example of patient environment AN 9 ATTENTION PC monitor and printer must be connected to power supply line only via socket equipped with ground contact 10 Electric strength of the PC s insulation against power line must be not less than 1500 V 11 The Amplifiers has the decoupling device providing electric strength not less than 4 kV AC for computer connection circuits 12 Only trained personnel familiar with safety reg
53. r s manual 6 Connect power adapter to appropriate connector of Amplifier s case and to power source 7 Methods of installation and use of the software are given in Chapter 6 of this manual After installation of the software carry out trial operation of the system in accordance to the instructions presented in Chapter 6 of this manual 8 Recommendations on adjustment of computer The present section describes elimination of possible faults during the first starting up or reinstallation of the software to a new computer When similar fault appears during normal operation the reason will likely be another All the activities described hereinafter should be executed by a qualified computer expert only The actions of an inexperienced user may cause not repairable damage to the computer After switching the device on the signal comes to input for 1 to 10 seconds after that the input disconnects and the device switches off In this case you have to carry out the following procedures for PCs equipped with processors Celeron Pentium III or higher a Enter program CMOS Setup while starting up the computer b Enter the following settings names may vary depending on a motherboard s type Virus Warning Disabled Power Management disable Energy Saving function 3 2 6 Operation procedures 1 Operating the software ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Usage of the software
54. r supply line only via socket equipped with ground contact 10 Electric strength of the PC s insulation against power line must be not less than 1500 V 11 The Amplifiers has the decoupling device providing electric strength not less than 4 kV AC for computer connection circuits 12 Only trained personnel familiar with safety regulations is allowed to operate the EEG system 3 1 5 Starting up 1 First engaging and testing of the equipment should be carried out by the manufacturer s representative s or by personnel specially trained by the manufacturer ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 2 The system s operation site The EEG system Mitsar EEG does not require a special screened camera subject to absence of closely situated interference source radio or TV transmitter power transformer radar station X ray unit physiotherapy equipment etc 3 Place the EEG system s components at the site in accordance to safety measures described herein 4 Open the battery compartment and insert batteries into the cartridge Strictly observe the batteries polarity Now the unit is ready for operation 5 Install the Amplifiers unit onto the tripod and install the Amplifiers in a proper place adjusting the tripod height It is not recommended to place the Amplifiers close to concrete or metal structures or close to power lines that may cause additional 50 60 Hz stray pick up
55. r more channels Unsatisfactory applying of neutral or reference electrodes additional indication for that is strong 50 60 Hz pickup in one or more channels The electrodes wires or connectors are damaged Powerful electric equipment presents in the neighborhood of the EEG room which generates strong noise X ray installations physiotherapy equipment etc Computer grounding is poor or absent The Amplifiers to computer connecting cable runs right against the computer s monitor There are some individual properties of the patient s skin or his her mental state In this case it is necessary to apply the electrodes more thoroughly to set the patient at rest to ask him her to relax A list of reasons causing noises or disturbances during EEG taking is given hereunder Reason Permanent Temporary disturbance disturbance Computer is not grounded or it has a poor ground connection ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 2 Pulsing photostimulator is not grounded or it has a poor ground connection 3 The Amplifiers is installed too close to computer s monitor 4 The Amplifiers connecting cable runs right against the computer s monitor of the EEG room which generates strong noise X ray 5 There is powerful electric equipment in the neighborhood installations physiotherapy equipment etc communication unit in the vicinity of the building the There is r
56. rding 11 1 Input voltage range 0 03 to 5 mV 11 2 Voltage relative deviation from prescribed value within the range of 0 1 to 5 mV not more than 15 11 3 Irregularity of the frequency amplitude response within the range of 1 to 17 5 Hz not more than 15 11 4 Common mode rejection ratio not less than 80 dB 11 5 Internal noise voltage reduced to input within the range of 0 5 to 15 Hz not more than 10 uV p p 11 6 Permissible ratio error limits for time domain within the range of 0 2 to 10 s 5 11 7 Input impedance not less than 100 MQ 12 Average operating time not less than 8 hours per day 13 14 15 16 ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Electrical safety of the Amplifiers complies with the requirements for instruments with internal power supply type BF standards IEC 60601 1 1988 IEC 60601 2 26 1994 The EEG system complete with line powered PC complies with the electrical safety requirements class I type BF standards IEC 60601 1 1988 IEC 60601 2 26 1994 and IEC 60601 1 1 1992 Electromagnetic compatibility of the EEG system complies with requirements of standard IEC 60601 1 2 1993 Working condition temperature range 10 to 35 C moisture range 25 to 95 without condensation ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 3 1 2 The Amplifiers functional diagrams ul ZHO9 SW DV
57. rect electrodes Input connectors Neutral electrode connectors Photostimulator output connector Patient warning button mput connector Power supply input USB output Figure 6 Mitsar EEG 202 amplifier connectors layout for models 401xxxx and 403xxxx ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 31 channels EEG cap connector DB 37 female connector Compatinble with Flectrocap Ltd EEG cap Power indicator Green LED Mitsar EEG electrode mput connectors POLY channel Input connectors Referect electrodes input connectors Neutral electrode connectors Photostimulator output connector Patient warning button mput connector Power supply input USB output Figure 7 Mitsar EEG 202 amplifier connectors layout for models 404xxxx and 406xxxx 3 2 1 Basic technical data 1 Weight of the Amplifier not more than 2 kg Weight of the package without a computer and a printer not more than 10 kg 2 Dimensions of the Amplifier without tripod 200 x 140 x 48 mm and power supply 3 The Amplifier operates by computer system Power supply 100 240 V 50 60 Hz via 12V DC power adapter for medical devices Ja The Amplifier consumption current not more than 0 20 A 12V PC interface USB Digital sampling rate per channel internal 2000 Hz Digital sampling rate per channel to computer 500 Hz oOo I A Ua A Calibration
58. risk of patient injury disconnect all recording and stimulating electrodes from the system before you turn off system power Connect patient electrodes to fully electrically isolated physiological devices only Connection to any other devices or external electrical oulets may result in personal injury Any devices connected to Mitsar EEG system should be certified by Mitsar Co LTD to provide the conformity of system to requirements for leakage current in accordance with the standard IEC 60601 1 1 1992 for medical electrical systems A CAUTIONS Proper use of this system depends on careful reading of all instructions and labels Turn OFF system power before connecting or disconnecting any system component s or accessories You may damage the device s Do not disconnect or reconnect any system components or accessories with the system powered on You may damage the components A power interruption that occurs during a recording session may cause loss of data in that recording If you experience frequent power interruptions Mitsar recommends the usage of an Uninterruptible Power Supply UPS to help prevent power interruptions Do not autoclave any parts of Mitsar EEG system Do not use acetone for cleaning the components of system ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Continuous impedance checking may need to be disabled if the impedance check signal interferes with other equipment Conten
59. rocap Ltd EEG cap Mitsar amp ON EEG electrode input connectors A Referect electrodes input connectors Neutral electrode connectors POLY channel input connector Photostimulator output connector MITSAR EEG 201 i USB output Figure 1 Mitsar EEG 201 amplifier connectors layout for models 104xxxx and 105xxxx ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 19 channels EEG cap connector DB 25 female connector Compatinble with Electrocap Ltd EEG cap Power indicator Green LED Mitsar MITSAR EEG 201 M tsar EEG electrode input connectors Referect electrodes input connectors Neutral electrode connectors POLY channel mput connector Photostimulator output connector Patient warning button input connector i USB output Figure 2 Mitsar EEG 201 amplifier connectors layout for models 106xxxx and 107xxxx A ATTENTION The Fpz and Oz EEG input connectors absent in Model 104xxxx and Model106xxx JN ATTENTION The 19 channels EEG cap connector is absent in Model 104xxxx and Model106xxx 3 1 1 Basic technical data 1 Weight of the Amplifier not more than 1 kg Weight of the package without a computer and a printer not more than 10 kg 2 Dimensions of the Amplifier without tripod 185 x 135 x 45 mm 3 The Amplifier operates by computer system ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 4
60. rt power indicator remains dim __ faulty Power indicator glows No Poor connection in the Check the connecting cable signal from the instrument interface cable connector Power indicator glows No Serial computer port Check the computer serial port signal from the instrument faulty ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 4 Mitsar EEG connection diograms The Mitsar EEG amplifiers Mitsar EEG system accessories computers computer peripheral and computer multimedia accessories can be connected at the different ways depending on the goals of EEG research There are the connection diagrams for the typical Mitsar EEG system configuration only 4 1 EEG recording with model 104xxxx and 105xxxx amplifiers Computer Amplifier Mitsar EEG 201 model 104 or 105 Photostimulator l Mitsar 6 ON FaN pa z g NO ON Poly a pl ler Stim Photostimulator cable PC MITSAR EEG 201 Power a sockets Power cable G USB cable Patient waring button Power adapter for medical devices Power cable Figure 10 The connection diagram of Mitsar EEG 201 amplifiers Model 104xxxx and 105xxxx with computer and Mitsar EEG system accessories ATTENTION The PC must not be situated closer than 1 5 m from a patient ELECTROENCEPHALOGRAPHIC PC CONTROLLED
61. s It is recommended to use alkaline cells or Ni Mn accumulators from well known manufacturers 3 1 7 Maintenance 1 It is recommended to take the batteries out the compartment if service interruption exceeds one month presumably 2 Exhausted batteries should be replaced by new ones when required The signs of batteries exhaust are e Special warning message about necessity of battery change e More and more frequent warning No response from ADC or No reply from the device or Channel faulty 3 The device should be cleaned by standard means JN ATTENTION Do not autoclave any parts of Mitsar EEG system ATTENTION Do not use acetone for cleaning the components of system 4 The electrodes should be cleaned and sterilized by as described into their accompanying documentation 3 1 8 Troubleshooting guide Possible problems and methods of their elimination are given in the table below Problem symptoms Method of elimination After signal input attempt the Poor connection of the Check the connection power indicator remains dim __ interface cable connector ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG After signal input attempt the Batteries low Check the batteries Replace if power indicator remains dim necessary After signal input attempt the Serial computer port Check the computer port power indicator remains dim __ faulty After attempt of signal input Ba
62. s filter at level 0 7 Model Hz Hz digital Hz digital 104xxxx 35 25 3043 151 5 ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 105xxxx 70 7 3043 15415 106xxxx 3543 5 30 3 15 1 5 107xxxx 70 7 3043 151 5 10 7 Notch filter 50 60 Hz frequency not less than 40 dB 10 8 Internal noise voltage reduced to input within the range of 0 5 to30 Hz not more than 2 uV p p 10 9 Common mode rejection ratio Typically 100dB at 50 or 60 Hz 10 10 Channels interference factor within 2 10 11 Permissible ratio error limits for time domain within the range of 0 2 to 10 s 5 10 11 Input impedance not less than 200 MQ 11 POLY channel characteristics A ATTENTION The POLY channel is intended for ECG signal input and representation As the POLY channel does not comply the requirements of standard for measuring ECG channel especially due to low time constant that will result to distortion of the QRS complex the incoming ECG signal may not be used for calculation of the ECG parameters and for diagnosing based on the curve shape The incoming ECG signal can be used for visual estimation of the position and for calculation of time delays between the R wave position and some other EEG waveforms A ATTENTION The POLY channels can be used for measurement patient response parameters using Patient warning button during Event Related Potentials reco
63. shold frequency of the High Cut filter Low Pass filter at level 0 7 ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG Model Hz Hz digital Hz digital Hz digital 401xxxx 150 15 TOT 30 3 15 1 5 403xxxx 150 15 70 7 30 3 151 5 404xxxx 150 15 TET 30 3 151 5 406XXXX 150 15 70 7 30 3 151 5 10 7 Notch filter 50 60 Hz frequency not less than 40 dB 10 8 Internal noise voltage reduced to input within the range of 0 5 to30 Hz not more than 1 5 uV p p 10 9 Common mode rejection ratio not less than 100 dB 10 10 Channels interference factor within 2 10 11 Permissible ratio error limits for time domain within the range of 0 2 to 10 s 5 10 11 Input impedance not less than 200 MQ 11 Average operating time not less than 8 hours per day 12 Electrical safety of the Amplifiers complies with the requirements for instruments with internal power supply type BF standards IEC 60601 1 1988 IEC 60601 2 26 1994 13 The EEG system complete with line powered PC complies with the electrical safety requirements class I type BF standards IEC 60601 1 1988 IEC 60601 2 26 1994 and IEC 60601 1 1 1992 14 Electromagnetic compatibility of the EEG system complies with requirements of standard IEC 60601 1 2 1993 15 Working condition temperature range 10 to 35 C moisture range 25 to 95 without condensation ELECTROENCEPHALOGRAPHIC PC CONTROLLE
64. tal code 65536 quantization levels Synchronization of operation for the voltage switching unit and the ADC control for photostimulator and data communication with the PC are provided by the microcontroller The data are sent to the PC through a standard serial interface type USB via the decoupling device and the level converter The decoupling device acts as a reinforced isolation and may withstand AC voltage of 4 kV for I minute The power supply of the Amplifiers is a special power adapter designed for medical devices Necessary internal voltages are generated by the internal power source DC DC converter which is turned on by software command and is kept in ON state by special commands The power source switch off automatically in 2 5 seconds after the program stops transmitting commands for keeping ON or after interruption of PC connection The system software provides creation of data files for input signal digital filtration of the data displaying of those as curves at a PC s monitor memory oscilloscope mode storing of the data on the PC s hard disk and further processing and analysis of signals EEG analysis features are described in the user s manual for the software 3 2 4 Safety measures 1 The EEG system conjointly with a line supplied PC complies with the electrical safety requirements class I type BF standards IEC 60601 1 1988 IEC 60601 2 26 1994 IEC 60601 1 1 1992 2 General safety of the EEG system is
65. ter and or other computer equipment video camera etc warranties for such equipment shall be stipulated separately 3 Warranty for electrodes and electrode fixing devices is 12 months if not stipulated otherwise by the electrode manufacturer 4 During warranty period the manufacturer will provide for the customer necessary consultation regarding operation of the system 5 During warranty period the manufacturer undertakes against presentation of the filled guarantee coupon to restore serviceability of the system by means of setting up repair or replacement of the entire device or its parts 6 The manufacturer shall inform the customer during warranty period on all new developments and modifications of the system and shall suggest substitution of earlier software versions for upgraded ones free of charge 7 Post guarantee service for the system shall be carried out by the manufacturer under separate contract with the customer 8 The warranty will be considered void e Ina case of absence of guarantee coupon with date of commission manufacturer s signature and stamp e Inacase of broken seals e Inacase of mechanical damages caused during operation e Ifa liquid was poured over into the device including leakage of batteries of a type not recommended by the manufacturer e If batteries of not recommended type and or voltage were used e Inacase of attempts of unauthorized repair or changes in internal connections e
66. ts 1 3 4 5 6 7 Mitsar EEG System overvie W Luse 3 1 1 Available additional manuals s i cs2scgesiecg ciseetedpensagenads ctetecs iandheete aden tienen debate 3 T 2 gt Delivery Setra kaaa aene eE A mete EAEE aipe Eiai 4 1 3 USB ICE We COMMOUNAMON Sc ceutecn seuetee tect Nara wreak cad aes artes anges cad cv vag stare tres teen ahaa tees 5 Mitsar EEG Additional information ccccccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeeesnnaeeeeeea 6 2 1 Software Components sarees sddnedacets leceesseuecteeedad eid aaveeedevendestedsanedes aed btus teeta tates 6 ZIP GEIOCUOUCS siecsins tis a a aa sae EAEE cr cee tele elt iia a aE Cue daha 6 23 AMIS SOW ANS uviss danene Alaunt ja 7 2 4 System installation ren ade ek lone aid none tacts aa een EE TR 7 2 5 SWICMAG OM sasea e aa T a E a a aa E Ea 7 2 6 Switching Off eene ae EE aranea AA E a Ea AEEA RE E E ARDERE AE 8 2 7 Leakage current 2 axed ches see cre exse Seve atten arta aecaanc bade S eegiead eeate ce semcansaeateeerecaseere 8 2 8 Transporalbnsaravdur eee 8 29 VZ 8 Mitsar EEG Amplifiers technical data errnronrrrrnnnnnnvvnnnrnnnnrnnnrnnnrnnnnrrrrrrnnnrrnnnn 9 3 1 Mitsar EEG 201 amplifier vaastedaasusead eee essensen den 9 3 11 BASIC 180N NEA AG Guss ae 10 3 1 2 The Amplifiers functional diagrams rernnnnnnnnnnnnrnrvnnnnnnnnnnrrrnnnnnnnnnnnnrnrrrnnnnn 14 3 1 3 Principle of operation uvv ameaqvkvseueuehkjuidje 16 3 1 4 Safety measures LL w
67. tteries are inserted ina Check the batteries polarity and the power indicator remains wrong way or cartridge cartridge contacts dim even after replacement of contact is faulty batteries Power indicator glows No Poor connection in the Check the connecting cable signal from the instrument interface cable connector Power indicator glows No Serial computer port Check the computer serial port signal from the instrument faulty When the signals discontinue Batteries exhausted Check the batteries Replace if the power indicator still glows necessary ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 3 2 Mitsar EEG 202 amplifier The EEG system complies is accordance with the requirements of technical specifications TU 9441 004 52118320 2005 The EEG system includes the multi channel bio signal amplifier the personal computer in a desktop or portable notebook type case and additional accessories The Amplifier is controlled by means of the specially developed computer software The Amplifier is designed in four modifications Model 401xxxx Model 403xxxx Model 404xxxx Model 406xxxx where xxxx serial number The Amplifiers connector layout is presented on Figures 5 and 6 19 channels EEG cap connector DB 25 female connector Compatinble with Electrocap Ltd EEG cap Power indicator Green LED Mitsar PaO EEG electrode input connectors Refe
68. ulations is allowed to operate the EEG system 3 2 5 Starting up 1 First engaging and testing of the equipment should be carried out by the manufacturer s representative s or by personnel specially trained by the manufacturer 2 The system s operation site ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG The EEG system Mitsar EEG does not require a special screened camera subject to absence of closely situated interference source radio or TV transmitter power transformer radar station X ray unit physiotherapy equipment etc 3 Place the EEG system s components at the site in accordance to safety measures described herein 4 Install the Amplifiers unit onto the tripod and install the Amplifiers in a proper place adjusting the tripod height It is not recommended to place the Amplifiers close to concrete or metal structures or close to power lines that may cause additional 50 60 Hz stray pick up 5 Connecting the Amplifiers to the computer The Amplifiers is connected to the computer via serial port type USB In order to connect them insert one connector of the cable into the PC s port and the other plug into the appropriate Amplifier connector The connector at the Amplifier s case is not used for another purpose Direct the cable s connector properly it should come into the socket without excessive force For correct choice of the PC s connector see the computer use
69. user documentation If the product does not function as warranted during the warranty period we will repair or replace it without charge If in our judgment we are unable to do so you may return it to us and we will refund your money Limit of Warranty Misuse accident modification unsuitable physical or operating environment improper maintenance or damage caused by a product for which we are not responsible may void the warranty Certain components may have separate warranty periods as stated in the product user documentation Consumables are not covered under warranty Items Not Covered by Warranty We do not warrant uninterrupted or error free operation of a product We provide certain non Mitsar products on an as is basis Non Mitsar manufacturers or suppliers may provide their own warranties to you Separate software warranty is provided with software user documentation Customer Responsibility This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this manual accompanying labels and inserts A defective product should not be used Parts which may be broken or missing or those that are clearly worn distorted or contaminated should be replaced immediately with clean genuine replacement parts that have been manufactured by or available from Mitsar The responsibility of Mitsar for a non functioning product is limited by the warranty set forth
70. waring button Figure 12 The connection diagram of Mitsar EEG 202 amplifiers Model 401xxxx and 403xxxx with computer and Mitsar EEG system accessories ATTENTION The PC must not be situated closer than 1 5 m from a patient ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 4 4 EEG recording with model 404xxxx and 406xxxx amplifiers Computer Amplifier Mitsar EEG 202 model 404 or 406 Photostimulator Er Mitsar MITSAR EEG 202 POWER FaN ca E a 5 Photostimulator cable Power sockets Power cable USB cable Patient Power adapter warning for medical devices button Power cable Power adapter for medical devices Power cable Figure 13 The connection diagram of Mitsar EEG 202 amplifiers Model 404xxxx and 406xxxx with computer and Mitsar EEG system accessories ATTENTION The PC must not be situated closer than 1 5 m from a patient ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 4 5 ERP recording with Mitsar EEG amplifiers Computer Amplifier Mitsar EEG 201 or Mitsar EEG 202 me Mitsar MITSAR EEG 202 POWER WinEEG USB KEY Power sockets Power cable USB cable Power adapter for medical devices Power cable i
71. with Video EEG with Mitsar EEG amplifiers 0 cceeeeeee 41 Mitsar EEG driver installation smvumvmemeismunad ueivbkeinm iin i 42 5 1 Amplifier driver installation sum dente deedeebeieansntdncte rasnsenssbensenaddeleenelsaentens 42 52 USB KEY driver installation akse ee 45 Mitsar EEG software installation eerrrnrrrnnrorrrrrnnnonvrrrrnnrnnvrnnnnnnnnnnnnrnnnnrnnernenn 47 6 1 WinEEG progranmstallatibn vu taccetees ace cet erots ce cetin sabe tes cceet dived teteee 47 6 2 WinEEG program initial Setup and testing rrrnrrnnnonnrrrrnnnonvrrrnnnnnnrrennnnnnnrnnnnn 50 6 3 WinEEG program initial setup of video EEG option rrrvnavonvrrrnnnnnvrrnnnnnnnnnnnnnr 52 6 4 Initial equipment preparation for carrying out ERP studies 53 Mitsar EEG software quick review nnrrrnrrnnnnnrnrrrrnnnnnnrennnnnnnnnnnnrnnnnnnnnnrnrnnnnnnnr 56 7 1 WinEEG program main functions uvs4ressomassrGebsnueintvmkui 56 7 2 PSYTASK program introduction ung ka ad Vesar cusssuentevaavacene 58 ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 7 3 Quick EEG recording EN 59 8 DEED OF GOMMIBSION Lue ete 9 DATA ON INSTALLATION AND ASSIGNMENT TO OPERATION ELECTROENCEPHALOGRAPHIC PC CONTROLLED MONITORING SYSTEM MITSAR EEG 1 Mitsar EEG System overview The electroencephalographic PC controlled system Mitsar EEG hereinafter the EEG system is purposed for acquisition storage at personal c

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