OPERATION MANUAL - Bio-Medical Instruments, Inc.
Contents
1. SYS I set Code number Component name Q ty pcs E1 M Electrode cap medium 54 58 cm 1 E2 Electrode board adapter 1 E3 M Body harness medium 1 E4 Repair electrode 1 E5 9 Aural electrodes 1 pair 1 E6 Disposable sponge disks 100 pcs in pack 1 E7 Needle Syringe Kit 1 E9 Electro Gel can 16 ounces 473 ml 1 E12 Measuring tape 1 E16 Liquid for washing of caps 1 INS 1 User s manual 1 VID 1 Training video film 1 SYS Il set Code number Component name Q ty pcs E1 L Electrode cap large 58 62 cm 1 E1 M Electrode cap medium 54 58 cm 1 E2 Electrode board adapter 1 E3 M Body harness medium 1 E4 Repair electrode 2 OPERATION MANUAL 9 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG E5 9 Aural electrodes 1 pair 2 E6 Disposable sponge disks 100 pcs in pack 1 E7 Needle Syringe Kit 2 E9 Electro Gel can 16 ounces 473 ml 2 E12 Measuring tape 1 E16 Ivory Liquid for washing of caps 1 INS 1 User s manual 1 VID 1 Training video film 1 SYS Ill set Code number Component name Q ty pcs E1 L Electrode cap large 58 62 cm 1 E1 M Electrode cap medium 54 58 cm 1 E1 SM Electrode cap small 50 54 cm 1 E1 XS Electrode cap ultra small 46 50 cm 1 E2 Electrode board adapter 1 E3 M Body harness medium 1 E4 Repair electrode 4 E5 9 A2. OPERATION MANUAL 8 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 4 Electrodes and sensors Electrodes and fixing devices are important components of the EEG system delivered separately All electrodes and fixing devices should comply with the normative requirements Mitsar Co Ltd recommends to use standard electrodes with touch proof connectors and or ElectroCap electrodes cap positioning system Electro Cap International Inc USA or any compatible electrode fixing system CombyCap ActiCap The electrodes may be delivered by Mitsar Co Ltd or user may purchase it separately The recommended standard EEG electrodes with Touch Proof connectors DIN 42 802 are produced in various structural versions e g disk bridge needle adhesive Disk and bridge electrodes are fitted with fixing devices so called mesh caps caps Adhesive electrodes are fixed on patient head with special adhesive paste e g 20 Recommendations for maintenance and disinfection of electrodes should be strictly followed Needle electrodes require special attention For continuous EEG monitoring e g in video EEG monitoring rooms Mitsar Co Ltd recommends to use ElectroCap electrodes cap positioning system Electro Cap International Inc USA or any compatible electrode fixing system CombyCap ActiCap There are different popular versions of Electro Cap systems delivery set
3. 32 2 ADUVITDIS Oia ccs coe ocio eoe c pO be utet poe 32 TUMON _____ _____________ 32 4 Wi ep HEP 32 3 5 Leakage po Ee nec Satan td ines 33 2 Ere 33 3 e tian dash ecu ela Un adnan 34 OC LS cease Ra PM 35 9 9 TEA rt teste 35 A System Operator adt eie Dr pe rte 36 4 1 Application of 36 4 2 Measuring electrode 37 4 3 Software ODOFdliOLDs Hot et pit npe auc cL ses 38 4 4 EEG recording operation 38 4 5 Troubleshooting errare 39 5 Manufacturer s declaration regarding electromagnetic compatibility 41 6 COMMISSION Gt Ute PEE 45 7 DATA ON INSTALLATION AND ASSIGNMENT TO OPERATION 46 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 Description of Mitsar EEG System The electroencephalographic PC controlled system Mitsar EEG hereinafter referred to as the EEG system is intended for acquisition storage at personal computer s HDD processing displaying at PC d
4. 01 Mitsar Co Ltd ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG OPERATION MANUAL Rey 1 03 25 03 2010 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG OPERATION MANUAL T ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Attention 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 The information in this document is subject to change without notice Mitsar Co Ltd quality management system is certified to be in compliance with the European standard EN ISO 13485 2003 In case of any troubles problems or requests please do not hesitate to contact us in writing Mitsar Co Ltd Novorossiyskaya str 21 2 Saint Petersburg 194021 RUSSIA via E mail support mitsar spb ru by phone or FAX 7 812 331 09 32 297 90 13 0537 For more information please visit www mitsar medical com European Union representative MEDISAT Company Bulgaria Rousse 7000 Han Asparuh 31 Tel fax 359 82 839193 E mail office medisat org Web site www medisat org OPERATION MANUAL ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Manufacturer warranty Mitsar Co Ltd warrants that each product we sell is free of manufacturing defects and conforms to its product specifications as defined in this manual If the product goes out of order during the warranty period Mitsar
5. uoneoipu eouepeduul 1591 yndyno Figure8 Functional diagram of Mitsar EEG Amplifier 26 OPERATION MANUAL ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 2 4 Safety requirements The Amplifier complies with the usage safety requirements as per 60601 1 as a device with internal power supply unit of BF type The EEG system conjointly with a line supplied PC complies with the electrical safety requirements class 1 type BF standards EN 60601 1 EN 60601 2 26 EN 60601 1 1 EN 60601 1 2 EN 60601 1 4 The Amplifier as regards protection level against harmful water intrusion refers to common devices devices with housing without water intrusion protection IP 40 as per EN 60529 2 General safety of the EEG system is provided by fulfillment of the requirements of standard 60601 1 1 3 The Amplifier operates within the patient environment see Figure 9 OPERATION MANUAL 27 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 2 5M Figure 9 Example of patient environment 4 The personal computer represents a subsystem of non medical equipment and should be located outside the patient environment 5 The decoupling device built in the ampli
6. Figure 5 Connection of EEG system via isolation transformer Figure 5 shows the following position numbers N fF ND Printer Monitor CPU unit Signal cables PC Amplifier and Amplifier photic stimulator Mitsar EEG Amplifier box Photic stimulator Patient armchair Power cables 9 Mains isolation transformer 10 Photic stimulator power supply unit 11 Photic stimulator power cable The connection diagram shown in Figure 6 is approximate and may differ depending on computer and other equipment involved The mains isolation transformer may be not included in the EEG system delivery set OPERATION MANUAL 19 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG You can purchase transformer yourself or request the system supplier For correct choice of transformer it is necessary to know the power and type of devices which it should be connected to Consult Mitsar Co Ltd for advice if necessary equipment to it should be performed by qualified specialist to follow all safety 1 ATTENTION The choice of mains isolation transformer and connection of requirements The power of the mains isolation transformer should be sufficient to provide normal operation of all devices connected to it OPERATION MANUAL 20 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 7 6 Mitsar EEG portable workstation Mitsar EEG system comb
7. or Zinc Carbon or Zinc Chloride or ZnCl OPERATION MANUAL 30 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG It is recommended to use batteries only of well known manufacturers e g Duracell Energizer Toshiba Philips GP 13 Only persons trained and instructed on safety precautions are admitted to operate the EEG system A personnel training is a part of handing over procedure to the customer 14 Prior to use the electrodes thoroughly read this operation manual provided by the manufacturer 15 The requirements on computer equipment operation system its setting and other programs on the same PC are given in section 1 2 and user s manuals on corresponding software supplied with device AN ATTENTION The following residual risks occur when operating the EEG system 1 Electric shock of patient or personnel due to mechanical damage of the Amplifier casing or casings of computer equipment Safety measures to avoid the risk The EEG system operation is prohibited in case of mechanical damage of the Amplifier casing or casings of computer equipment The components with mechanical damage of casing should be immediately removed from operation and send for repair The Amplifier is to be sent to manufacturer and computer equipment to service center recommended by supplier of this equipment or to servicing organization 2 Possibility to use materials contacting the patient body wit
8. Conducted RF 3 Vrms from 150 3 Vrms from 150 Portable and mobile RF communications EN 61000 4 6 kHz to 80 MHz kHz to 80 MHz equipment should be used no closer to any part of the unit including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P Radiated RF 3 Vrms from 80 3 Vrms from 80 4 1 2 EN 61000 4 3 MHzto 2 5 GHz MHz to 2 5 GH 61000 4 3 210 2 5 GHz 29 5 from 80 MHz to 800 MHz d 2 2 P from 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and is the recommended separation distance in meters Field strengths from fixed RF transmitters as determined by electromagnetic site 1 survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol D Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the System is used exceeds th
9. V Equipment marking ee GRE EIE en es ems ix 1 Description of Mitsar EEG System 2 Tel EE 3 1 2 Personal eee cene nie gehe ke d secius 5 WB ose mei AMA ssa Rt 8 1 4 Electrodes and Sensors io e o ipee ET 9 System WAS tell AVON 12 1 6 System software 0 13 TuconnecHotkdlagi alis esti esteem ELM ELA teen catia 13 UNES tare ello eao teena ea UE 14 1 EP investigatio TEC 15 1 7 3 Video EEG recording voix A t dc elas 16 1 7 4 Investigation with 18 1 7 5 Locating personal computer within the patient environment 19 1 7 6 Mitsar EEG portable 4 44 10000 21 Techhical dald sse penetrate po ett eto tese bo ate epe 22 2 1 Biosignal at a eke nite data ia os 22 2 2 Amplifier technical data tee 23 2 3 Description of operation 25 2 4 Safety requirements ote tee Rh ea ane iu amend 27 3 yxddiliopalintormialiObr ae 32
10. 1 set Operation documents 16 Operation manual 1 pcs 17 User s manual for software package for corresponding software package Delivery version is stipulated in order Possible replacement for electrodes with registration card Possible delivery without electrodes The electrodes should be CE marked for delivery to EC countries PY Possible delivery without PC and or printer as agreed with the customer Configuration and PC resources are discussed with customer PC being exported should comply with the requirements of destination country Possible delivery without this item as agreed with the customer Only for operation with WinEEG software kkkkk OPERATION MANUAL 3 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Additional delivery set for video EEG Component name Q ty Accessories 18 Video capture card 1 2 pcs 19 Video camera with rotating device and set of cables 1 set 20 Infrared video camera with built in microphone and set of cables 1 set 21 Video camera remote control with set of cables 1 set 22 IR lamp 1 pcs 23 Power supply for video cameras microphone and IR light 1 set 24 Microphone and microphone amplifier if necessary 1 set Software 25 WinEEG Video software 1 set Operation documents 26 WinEEG software package user s manual 1 pcs Del
11. 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer Remarks At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 2 These guidelines may not apply in all cases Electromagnetic propagation is affected by absorption and reflection from structures objects and people OPERATION MANUAL 44 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 6 DEED OF COMMISSION The Amplifier Mitsar EEG serial found to be ready for operation Manufactured on Mitsar Co Ltd date signature seal OPERATION MANUAL 45 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 7 DATA ON INSTALLATION AND ASSIGNMENT TO OPERATION The electroencephalographic system Mitsar EEG serial been installed and commissioned Date of installaton Signature Position Name Commissioned by Assigned by OPERATION MANUAL have 46 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG MITSAR CO LTD WARRANTY COUPON 1 for repair replacement within the warranty period Medical equipment electroencephalographic system Mitsar E
12. Co Ltd will correct all detected malfunctions by repair or partial replacement free of 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 This warranty is valid under proper usage and maintenance of the EEG system and doesn t cover damage caused by the following improper usage negligence incompetence or intentional damage unskilled maintenance violation of operating conditions abrupt deviations of temperature and humidity power failures etc violation of storage and transportation conditions improper implementation of technical instructions Some components of the system may have separate warranty period specified in their documents This warranty doesn t cover consumables We do not warrant uninterrupted or error free operation of some parts of the EEG system We provide non Mitsar products as is Non Mitsar manufacturers may provide their own warranties to these products Separate software warranty is provided with software user documentation Customer responsibility The EEG system will be reliable only when operated and maintained in accordance with the instructions contained in this manual accompanying labels and inserts A defective system should not be used Parts which may be broken or missing or those that are clearly worn or contaminated should be replaced immediately with new original replacement parts that have been manu
13. connectors indicators Operation indicator Neutral electrode connectors for polygraph sensors Digital input connector for patient response button Photic stimulator connector USB connector Figure 7 Mitsar EEG 201 Amplifier box layout of connectors and indicators layout for Version 10 70 For Version 03 35 no Fpz and Oz electrode connectors fitted Versions 03 35 and 05 70 have only one pair of connectors for polygraph channels and one connector of neutral electrode for polygraph sensors OPERATION MANUAL 22 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG No connector for ElectroCap electrode is fitted for Version 03 35 2 2 Amplifier technical data Version 03 35 05 70 10 70 EEG channels Number of EEG channels 19 21 21 Bandwidth 0 53 35 Hz 0 16 70 Hz 0 16 70 Hz Additional HF filters 1 6 5 3 Hz 0 53 1 6 5 3 Hz 0 53 1 6 5 3 Hz Additional LF filters 15 30 Hz 15 30 Hz 15 30 Hz Impedance check of electrodes yes yes yes Input voltage range from 10 to 5000 pV Relative error at most within the range of 10 uV to 50 uV 10 96 within the range over 50 uV 5 Notch filter 30 dB at 50 60 Hz Sampling frequency 500 Hz per channel Input resistance over 200 MO Internal noise voltage at most 0 25 uV RMS Channel interaction ratio at most 1 Common
14. reference electrodes as the signals from these electrodes will influence the record quality of all channels If the impedance level is high at all leads then at first instance the quality of neutral electrodes application should be checked Unusable not recording electrodes should be disconnected from the switching box OPERATION MANUAL 37 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG To improve recording quality and to decrease the transient resistance it is recommended to draw apart patient hair and to wipe the skin with alcohol in the place of electrode application 4 3 Software operation In the process of recording the signals from EEG and polygragh channels in digital form enter PC from the Amplifier unit and are displayed on the monitor screen as specific curves graphs Recording of EEG signals on PC hard disk can be initiated and stopped repeatedly for their storage archiving and the following analysis The total record time is limited only by free space available on hard disk In parallel to EEG recording it is possible to record patient video image so called video EEG After finishing recording of EEG signals the saved data are available for visual analysis Similar to recording in visual analysis the EEG signals are displayed on the monitor screen in the form of oscillogram in the mode emulating the paper tape in the recorder Additionally the following is provided in the mode of visual analysis pos
15. total leakage current do not exceed the allowable value measures A ground wire should be connected as the third wire of eurosocket It is inadmissible to connect PCs via adapters isolating the third wire Probable breakage of multisocket extension cord safety grounding will lead to summation of leakage currents up to dangerous values It is inadmissible to use multisocket extension cords without additional safety When connecting other electric equipment follow safety measures to avoid the system damage 3 6 Relocation Turn off the system before relocation When disconnecting cables pull on connector not cable OPERATION MANUAL 33 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 3 7 Maintenance Violation of storage and transportation conditions may cause its damage and malfunction Under suspicion of equipment damage or malfunction it should be turned off and protected against further operation It is recommended to examine daily cables for wear e g breaks If these symptoms present disconnect cable for repair and replacement If the estimated service interruption of the Amplifier is over one month it is recommended to take the batteries out of the battery compartment Exhausted batteries should be replaced by new ones when required The symptom is a special warning message to replace battery which appears when program running When using accumulators follow the c
16. 3 9 Utilization Utilization of the equipment and batteries should be done in correspondence to the requirements of local organizations engaged in utilization of waste OPERATION MANUAL 35 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 4 System operation 4 1 Application of electrodes As rule the lead electrodes are applied on the patient in accordance with diagram 10 20 see Figure 11 that allows with the help of different montages containing of 16 to 24 leads to record a sufficiently informative electroencephalogram Nasion Vertex S 2096 1 Nasion 10 d GX Figure 11 EEG electrodes application diagram in compliance with the International standard lead system 10 20 as per H Jasper 1958 High quality of EEG recording can be obtained only when using an electrolyte layer between the electrode surface and patient skin The following are used as such electrolyte with bridge electrodes cloth liner or cotton pellet moistened in saline with disk electrodes special contact high conductivity gel e g Unimaks manufactured by Geltek Medika Co Ltd with electrode caps manufactured by Electro Cap we recommend to use only ECI Electro Gel with adhesive electrodes we recommend to use adhesive conductive paste e g Ten20 manufactured by Weaver and Company For high quality EEG recording the application of neutral and reference electro
17. 625555680 St 5 place and date of issue Peredreeva Head of quality control department name position and signature of authorized person of the manufacturer OPERATION MANUAL 51
18. EG 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 OPERATION MANUAL 47 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG OPERATION MANUAL 48 ELECTROENCEPHALOGRAPHIC PC CONTROLLED 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 OPERATION MANUAL 49 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG OPERATION MANUAL 50 ELECTROENCEPHALOGRAPHIC PC CONTROLLED 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 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 5666
19. G system is fully turned on Turn off the system power before connecting or disconnecting any system component s or accessories Otherwise you may damage the system Turn on the system by pressing the power button on the CPU unit 3 4 Turn off To provide patient safety disconnect all recording and stimulating electrodes from the patient before you turn off the system The amplifier automatically turns off at signal input stop disconnection of interface cable and PC turn off No additional measures on the Amplifier turn off are required OPERATION MANUAL 32 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Prior to the system turn off be certain to close an application program and exit Windows Otherwise it may cause data loss or problems may occur at the next system starting Turn on the system by pressing the power button on the CPU unit 3 5 Leakage current The EEG system conjointly with PC complies with the electrical safety requirements class type BF standards EN 60601 1 EN 60601 2 26 EN 60601 1 1 The standard EN 60601 1 defines the permissible leakage currents for separate components In case of connecting several systems to the patient their leakage currents will sum As a result the total leakage current can exceed the allowable value and create a dangerous situation If you want to connect equipment to the patient simultaneously with EEG recording insure that the
20. components The following sensors manufactured by S L P Inc were tested for poly signals recording Piezo Crystal Effort Sensor Item 1387 Piezo Crystal Effort Sensor Item 1388 Adult Nasal Oral Pressure Monitoring Cannula Kit Item 14802 FT Kit Body Position Sensor AC Item 1561 Piezo Limb Movement Sensor Item 1770 Piezo Snore Sensor Item 1250 OPERATION MANUAL 11 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 5 System installation Before the beginning of installation thoroughly read this manual N ATTENTION Read section 2 4 Safety requirements First turn on and testing of EEG system is recommended to be performed by the manufacturer representative or by specialists specially trained at the manufacturer s The EEG system does not require special screened compartment if no sources of strong interference are present in the vicinity of the object radio or TV transmitter power transformer radar station X ray unit physiotherapy devices etc Check the presence of components and cables Ensure that all components are not damaged Locate the system components on the working place observing safety requirements specified in this manual Open the battery section cover of the Amplifier box and insert the batteries into the cartridge Pay attention to polarity of battery connection Thus the Amplifier is ready for operation Connect the Amplifier unit to the tripod if an
21. d or other computer equipment video camera etc warranties for such equipment shall be stipulated 3 Warranty for electrodes and electrode fixing devices is 12 months if not stipulated otherwise by the electrode manufacturer 4 During the warranty period Mitsar Co Ltd will provide for the customer necessary consultation regarding operation of the system 5 During the warranty period Mitsar Co Ltd 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 Mitsar Co Ltd shall inform the customer during the 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 software upgrade 7 Post guarantee service for the system shall be carried out by Mitsar Co Ltd or organization authorized by Mitsar under separate contract with the customer 8 The warranty will be considered void In a case of absence of guarantee coupon with date of commissioning manufacturer signature and stamp In a case of broken seals a case of mechanical damages caused during operation If a liquid was poured over into the bioelectric signal amplifier including leakage of batteries of a type not recommended by Mitsar Co Ltd batteries of not recommended type or voltage were used case of atte
22. deo cable Power supply unit Mains socket with grounding and isolation transformer Mitsar EEG Amplifier box CPU init USB key USB A cable mini USB Different configurations of video EEG recording systems may be on the basis of electroencephalographic PC controlled system Mitsar EEG Connections of multimedia accessories may differ from those in the diagram OPERATION MANUAL 17 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 7 4 Investigation with phonostimulator Figure 4 Phonostimulator connection diagram ATTENTION Personal computer should be located outside the patient environment see section 2 4 Safety requirements Figure 4 shows the following position numbers Phonostimulator Phonostimulator synchronization cable Mitsar EEG Amplifier box CPU unit Cable USB A USB B USB A cable mini USB B Cable Stereo Jack 3 5 mm Audio columns N O O A OON OPERATION MANUAL 18 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 7 5 Locating personal computer within the patient environment Sometimes it is necessary to locate computers and other nonmedical parts of the system within the patient environment This problem can be solved using mains isolation transformer corresponding the requirements of EN 60601 1 IEC 60601 1 E T
23. des is obligatory The aural electrodes sockets A1 and A2 serve as reference electrodes for EEG signals of corresponding hemisphere Depending on the software settings see corresponding software user s manuals the EEG is recorded either relative to A1 A2 or relative to A1 A2 2 In the second case sockets A1 A2 are electrically connected on software command OPERATION MANUAL 36 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Recording relative to independent reference lead Available is recording relative to independent reference lead used instead of aural parietal frontal etc For this recording it is necessary a to set option in software to connect to close A1 and A2 b to connect reference electrode to one of sockets A1 or A2 In case the reference electrodes are not applied or defective a noise shaped signal will be recorded not reflecting the actual brain activity The neutral electrodes sockets N serve to link biosignals to zero potential of patient body These electrodes are usually applied either on cheekbones or forehead Contact resistance of other electrodes in Resistance check mode is measured relative to neutral electrodes In case the neutral electrode is not applied or defective generally instead of EEG there may be observed distorted low frequency signal 50 60 Hz interference or saturation of amplifiers with spicular breakouts The Mitsar EEG Amplifier also includes separate s
24. ditional extension cord It is inadmissible to connect devices not referring to the EEG system to multisocket extension cord connected to the EEG system gt gt gt 2 gt Multisocket extension cords and multiple socket outlets should be connected via mains isolation transformer Otherwise the structure of multisocket extension cords and multiple socket outlets should allow only tool assist connection Figure 10 Requirement of EN 60601 1 1 IEC 60601 1 1 OPERATION MANUAL 29 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Examples of application of MULTIPLE PORTABLE SOCKET OUTLETS Male plug for equipment Plate fixed on MPSO View from A male plug connected MULTIPLE PORTABLE SOCKET OUTLET accessible only with the use of a TOOL Figure 10 Example of multiple socket outlets with tool assist connection 10 PC should have electrical isolation for 1500 V 11 The amplifier incorporates decoupling device for at least 4 kV voltage in circuit connections with PC 12 The amplifier is energized from four R6 AA batteries 1 5 V and accumulators 1 2 V It is recommended to use alkaline batteries LR6 type oxy alkaline Ni Zn ZR6 type batteries or nickel metal hydride accumulators type R6 HR6 It is inadmissible to use batteries of nonhermetic version It is inadmissible to use salt batteries type R6 commonly designated Heavy Duty
25. e applicable RF compliance level above the System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the System Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m NOTE 1 At 80MHz and 800 2 the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflected from structures objects and people OPERATION MANUAL 43 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 Recommended separation distances between and mobile RF communications equipment and the System portable The System model is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the System as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter in meters output power of transmitter in watts d 1 2 P d 1 2 P d 234P From 150 kHz to 80 MHz From 80 MHz to 800 MHz From 800 MHz to 2 5 0 01 0 12 0 12 02 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8
26. es monitors printers etc used with the EEG system should comply with the requirements of standards EN 60950 or EN 60601 1 and should have conformance certificates OPERATION MANUAL 5 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Requirements to PC for routine investigations Clock frequency at least 2 6 GHz Ram at least 1 Gb Hard disk at least 120 Gb Video adapter AGP or PCI E at least 128 Mb DVD RW PC should have 1 free USB port for the amplifier and 1 for WinEEG security dongle Operation system Windows XP SP3 Windows Vista SP2 Requirements to PC for ERP recording Primary PC Slave presentation PC Clock frequency at least 2 6 GHz Ram at least 2 Gb Hard disk at least 160 Gb Video adapter AGP or PCI E at least 128 Mb DVD RW PC should have 1 free USB port for the amplifier and 1 for WinEEG security dongle PC should have 1 free COM port for PC s synchronization with Null modem cable or 1 extra USB port if USB Serial adapter is used Windows XP SP3 Clock frequency at least 2 GHz Ram at least 1 Gb Hard disk at least 40 Gb Video adapter AGP or PCI E at least 128 Mb If the program is supplied on CD a corresponding disk drive is required PC should have 1 free COM port for PC s synchronization with Null modem cable or 1 extra USB port if USB Serial adapter is used Windows XP SP3 CRT or LCD
27. factured by or available from Mitsar Co Ltd The responsibility of Mitsar Co Ltd for a non functioning system is limited by the warranty set forth in this guide If repair or replacement of this product becomes necessary after the expiration of the warranty the customer should seek advice from Mitsar Co Ltd prior to such repair or replacement If this system needs repair it should not be used until all repairs have been made and the system is functioning properly The owner of this system has the sole responsibility for any malfunction resulting from improper use or maintenance or repair done by anyone other than a qualified Mitsar Co Ltd representative and for any malfunctions caused by any parts that have been damaged or modified by anyone other than a qualified Mitsar Co Ltd representative The owner of this system has the sole responsibility for connection this product to other systems not satisfying the electrical safety requirements class type BF standards EN 60601 1 EN 60601 2 26 EN 60601 1 1 EN 60601 1 2 for medical devices OPERATION MANUAL IV ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Warranty and post guarantee obligations 1 The manufacturer guarantees compliance of the system with technical specifications and operating requirements described below 2 Warranty period is 24 months from the date of commissioning date of signing the commissioning deed If the delivery set includes a computer an
28. fier unit supports appropriate safety levels for the amplifier unit and PC after interconnection 6 Electric strength of insulation between the applied parts and the PC connection cable strengthened insulation complies with the requirements of EN 60601 1 7 The connection cable has the length of at least 3 m for removing the PC from the patient environment OPERATION MANUAL 28 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 8 ATTENTION PC and other non medical electrical devices should be installed outside the patient environment If it is necessary to locate a personal computer or other non medical electrical equipment within the patient environment read section 1 75 Locating personal computer within the patient environment 9 ATTENTION PC monitor and printer should be connected to AC power supply line only via socket equipped with ground contact It is inadmissible to use multisocket extension cords without additional safety measures A ground wire should be connected as the third wire of eurosocket It is inadmissible to connect PCs via adapters isolating the third wire Probable breakage of multisocket extension cord safety grounding will lead to summation of leakage currents up to dangerous values It is inadmissible to locate multisocket extension cords on the floor due to risk of liquid intrusion and their mechanical damages It is inadmissible to power PC via ad
29. h insufficient sanitary hygienic and toxicological parameters Safety measures to avoid the risk It is allowable to replace electrodes and or their fixing devises not delivered with the system for the other only if the latter have corresponding certificates 3 Bad record and or incorrect interpretation of results is possible due to the following inadequate personnel qualification incorrect application of electrodes interference application of computer equipment operation system and other software not recommended by the manufacturer Safety measures to avoid the risk The personnel operating the EEG system should be adequately qualified for correct application of electrodes EEG recording and its interpretation OPERATION MANUAL 31 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 3 Additional information 3 1 Other manuals There are additional manuals with detailed information on the EEG system software 1 User s manual on EEG Synapse program 2 User s manual on WinEEG program 3 User s manual PSYTASK program 4 User s manual on BrainTuner program 3 2 Antivirus software The EEG system software may conflict with antivirus software installed on PC This may cause data loss when EEG recording Therefore active scanning of PC and virus cure during operation of our software is not recommended 3 3 Turn on To provide patient safety connect the patient electrodes only after the EE
30. h the system powered on Otherwise you can damage its components OPERATION MANUAL VII ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG A power interruption that occurs during EEG recording session may cause nonrecoverable data loss If you experience frequent power interruptions Mitsar Co Ltd recommends usage of an Uninterruptible Power Supply UPS Do not autoclave any parts of Mitsar EEG system Do not use acetone or other solvents for cleaning the components of the system The mode of electrode resistance measurement can affect the function of the other equipment e g causing interference OPERATION MANUAL VIII ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Equipment marking The following signs are used for marking of the Mitsar EEG system Marking of BF type applied parts ee Marking of direct current Manufacturer name and address Tr Mark of conformity for obligatory certification GOST R Mark of conformity to the requirements of Council Directive 93 42 EEC SN Product serial number OPERATION MANUAL IX Contents uia M T iii Manufacturer warranty duque c iv igo Pee NT iv CUSIOMEN TespoHnsibillly eet e Uer iv Warranty and post guarantee
31. harging instructions provided by accumulator manufacturer The Amplifier operation time from one accumulator set and the number of operation charging cycles significantly depends on the type of charger Consult the accumulator supplier or Mitsar Co Ltd for advice to select a charger if necessary It should be mentioned that the Amplifier operation time with one battery set is longer than that with a set of accumulators up to their discharge The Amplifier should be cleaned with standard means Do not autoclave any parts of the EEG system Do not use acetone for cleaning the components of the system The maintenance of the system components being the standard computer equipment should be performed in accordance with their operation manuals The electrodes after usage should be cleaned from electrolyte contact gel saline rinsed and if necessary disinfected in accordance with instruction on corresponding type of electrode More detailed information on special features of electrodes operation can be obtained from their manufacturers Do not apply agents containing ammonia for cleaning electrodes OPERATION MANUAL 34 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 3 8 Service life Mean service life of the Amplifier till discarding is at least 5 years The storage period shouldn t exceed 1 year from the date of manufacture till commissioning The calibration period is 1 year
32. ienced enough in technique of clinical EEG observation The user should be familiar with operation system Microsoft Windows XP Vista N The EEG system does not feature defibrillator protection OPERATION MANUAL 2 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 1 Delivery set Depending on the system purpose for different types of EEG investigation the EEG system may contain different components Standard delivery set Component name Q ty Hardware 1 a Amplifier version Mitsar EEG 03 35 201 1 1 b Amplifier version Mitsar EEG 05 70 201 1 pcs 1 c Amplifier version Mitsar EEG 10 70 201 Accessories 2 Amplifier to PC connection cable MT RSI 01 5 7 meters 1 pcs 3 with power supply and synchronization 4 Phonostimulator with acoustic speakers and PC connection jea cable USB A USB B 5 EEG electrodes and fixing devices 1 set 6 Electro Gel 1 pcs 7 EEG electrode connection cable 1 pcs 8 Set of batteries R6 AA 4 pcs 9 Rack for Amplifier and or Photic stimulator 2 pcs 10 Dongle 1 pcs 11 Portable cart 1 set 12 Isolation transformer 1 pcs 13 Universal arm for the amplifier and or Photic stimulator 2 pcs Software 14 a EEG Synapse software package roe se 14 b or WinEEG software package 15 HBI normative database
33. ined with PC and isolation transformer could be installed on the portable cart together with universal arms for amplifier box and Photic stimulator This solution allows you to be mobile and flexible inside your division and meets safety requirements Figure 6 Figure 6 shows the following position numbers 1 Photic stimulator 2 Monitor 3 Mitsar EEG Amplifier box 4 Keyboard 5 Mouse 6 Printer 7 Mains isolation transformer 8 CPU unit OPERATION MANUAL 21 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 2 Technical data 2 1 Biosignal Amplifier The EEG system complies with the requirements of technical specifications TU 9441 001 521 18320 2009 The EEG system includes the biosignal amplifier Amplifier stationary or portable PC and additional accessories The Amplifier is controlled by special software The amplifier is delivered in the following versions Mitsar EEG 03 35 201 version hereinafter Version 03 35 Mitsar EEG 05 70 201 hereinafter Version 05 70 Mitsar EEG 10 70 201 hereinafter Version10 70 The layout of Amplifier connectors and indicators is shown in Figure 7 by Version 10 70 example ElectroCap connector 201 EEG electrode connectors Referent aural EEG electrode connectors Neutral EEG electrode connectors Electrode resistance threshold indicators Electrode resistance threshold crossing Polygraph channel
34. isplay and printing out of electroencephalographic and electrocardiographic signals The EEG system refers to medical measuring instruments class The EEG system is intended only for medical application and serves for recording and measuring of patient electrical brain activity The EEG system may be used for acquisition of electroencephalogram EEG video EEG and evoked potentials EP recording for diagnostics of brain diseases The software package for Microsoft Windows XP Vista allows performing an advanced computerized analysis of the EEG on a standard personal computer or notebook including digital filtering montage reformatting spectra and coherence analysis topographic mapping etc Capabilities of EEG analysis depend on the type of software supplied The EEG system includes the biosignals converter hereinafter referred to as the Amplifier controlled by means of special software The Amplifier does not directly contact the patients Accessories that contact patients such as electrodes and fixing devices should correspond to normative requirements and be adequately approved The EEG system is not sterile The system is intended for use in functional diagnostics wards and departments at out patient clinics hospitals and health research institutes health centers in medical exercises dispensaries and other medioprophylactic and educational medical institutions The personnel intended to work with the EEG system should be exper
35. ivery version is stipulated in order WinEEG software with video EEG option OPERATION MANUAL 4 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Additional equipment for EP investigation Ne Component name Q ty Hardware 27 PC for stimuli presentation 1 set Accessories 28 Patient response button 1 pcs 29 PC to PC null modem cable 1 pcs Software 30 PSYTASK software package 1 set Operation documents 31 PSYTASK software package user s manual 1 pcs Possible delivery without PC as agreed with the customer Configuration and PC resources are discussed with the customer PC being exported should comply with the requirements of destination country AT Delivered only with WinEEG Additional equipment for biofeedback Component name Q ty Hardware 32 Adapter for video audio biofeedback presentation Jammer 1 pcs Accessories 33 Jammer to PC connection cable 1 pcs 34 Audio video cable Jack 3 5 3RCA 2 pcs Software 35 BrainTuner software package 1 set Operation documents 36 BrainTuner software package user s manual 1 pcs Typical EEG system connection diagrams depending on the purpose of EEG investigation are shown in section 1 7 of this manual 1 2 Personal computer PC is an important part of the EEG system Personal computers and other peripheral devic
36. l computer should be located outside the patient environment see section 2 4 Safety requirements Figure 2 shows the following position numbers 1 Synchronization null modem cable 2 CPU unit with PSYTASK program 3 Mitsar EEG Amplifier box 4 CPU unit with WinEEG program 5 Dongle 6 USB A cable mini USB B 7 Patient response button 8 PC power cable 9 Mains socket with grounding and isolation transformer OPERATION MANUAL 15 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 7 3 Video EEG recording 9 E Figure 3 EEG system connection diagram for video EEG recording ATTENTION Personal computer and multimedia accessories should be located outside the patient environment see section 2 4 Safety requirements Figure 3 shows the following position numbers Audio cable for microphone connection Camera power cable 5 Video cable Power divider Infrared videocamera with built in microphone and set of cables Video camera with transfocator and rotating device Camera power cable 6 Cable for connection control panel to rotating device AON Oa 2 N Rotating device control panel OPERATION MANUAL 16 10 11 12 13 14 15 16 17 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Video capture cards Vi
37. mode rejection at least 100 dB at 10 Hz Amplifier capacity 16 bit Polygraph channels Number of polygraph channels 1 1 4 Bandwidth 0 16 70 Hz Additional HF filters 0 53 1 6 5 3 Hz Additional LF filters 15 30 Hz Input voltage range of to 10000 uV Relative error at most 10 Input resistance over 200 Other channels Number of digital inputs 2 2 2 OPERATION MANUAL 23 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG External events inputs yes yes yes Photic stimulator LED yes yes yes Phonostimulator download from yes yes yes PC Connector for electrode cap no yes yes Other characteristics Relative error of time intervals 5 within the range of 0 2 to 10 s at most Amplifier electrical safety BF type with internal power supply unit System electrical safety Class type Amplifier power supply of 3 6 to 6 5 V 4 batteries R6 type System power supply 220 22 V 50 Hz Amplifier consumption current at most 0 048 A at power voltage 6 V Total operation time on one battery at least 50 h set Mean continuous time operation at least 8 h per day PC interface via standard serial USB port Amplifier mass at most 1 kg Amplifier dimensions at most 200 x 140 x 55 mm without tripod The polygraph channels may be used for input and displaying EEG signal Due to the fact that these signals do not comply with
38. monitor with response time at most 8 ms Requirements to PC for video EEG recording Clock frequency at least 2 6 GHz Ram at least 2 Gb Hard disk at least 180 Gb Video adapter AGP or PCI E at least 256 Mb If the program is supplied on CD a corresponding disk drive is required PC should have 1 free USB port for the amplifier and 1 for WinEEG security dongle PC should have 1 or 2 free PCI slots for video capture cards connection Operation system Windows XP SP3 DirectX 9 0c Most modern notebooks are suitable for operation with EEG system however we recommend consulting specialists of Mitsar Co Ltd or our dealers when buying a notebook OPERATION MANUAL 6 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG In case PC does not meet the above requirements the system operability may be checked with a test but Mitsar Co Ltd does not guarantee complete operability Antivirus software is an importance element of data protection However its operation may cause failures during recording Switch off active scanning during recording and planned scanning If you experience any problem with antivirus software usage consult Mitsar Co Ltd OPERATION MANUAL 7 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 3 Software Software is an important element of the EEG system Software controls hardware collects and processes data displays and prints it out stores data o
39. mpts of unauthorized repair or changes in internal connections If illegal copies of Mitsar software were used 9 The present warranty does not include replacement of electrode sockets and batteries This may be performed at the customer s request against separate charge 10 The present warranty does not concern equipment not included into the delivery set see section 1 1 below if not otherwise stipulated by the delivery contract 11 Guarantee coupons are enclosed OPERATION MANUAL V ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Safety summary Pay attention to all warnings advices and notes provided in this manual To avoid the possibility of injury to patient or user damage to your system or data loss always observe these safety precautions during the system operation Two signs are used to define potentially harmful or capable to cause damage conditions or procedures IN WARNING WARNING sign indicates situation or procedures which may be dangerous for patient and or user ATTENTION ATTENTION sign indicates situation or procedures which may cause the equipment damage or its improper usage ATTENTION Read section 2 4 Safety requirements Only trained personnel familiar with safety regulations is allowed to operate the system Only personnel properly trained to operate the Mitsar EEG system should use it for patient examination Personal computer should be located
40. n hard disk and provides user s interface The software includes the following modules 1 EEG Synapse The program includes basic function package for EEG recording and processing 2 Basic version of WinEEG The program includes advanced function package for EEG recording and processing 3 The advanced version of WinEEG for investigation of event related potentials This program also includes functions for ERP recording 4 The advanced version of WinEEG for video EEG This program also includes functions for video EEG recording 5 PSYTASK This program is intended for synchronous stimuli presentation during EEG recording for acquisition of brain event related potentials WinEEG program functions are protected with special electronic device USB key inserted into USB connector of PC or notebook To open these functions a USB key should be inserted and drivers for this device should be installed USB key is necessary for WinEEG program operation Without this specially programmed electronic key most of program functions including data recording will be unavailable Available configurations of USB key are listed in the following table Comparison Video a with HBlmed WI compan USB key type recording recording FEG normative Romane recording database database 7 89 years EEG Base z EEG EEG Video EEG DB t EEG DB Video HBI Database
41. nual to the corresponding software 1 7 Connection diagrams The Mitsar EEG Amplifier EEG system accessories computer computer peripheral and computer multimedia accessories can be connected in different way depending on the goals of EEG investigation Typical system connection diagrams are shown below OPERATION MANUAL 13 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 7 1 EEG recording Figure 1 EEG system connection diagram ATTENTION Personal computer should be located outside the patient environment see section 2 4 Safety requirements Figure 1 shows the following position numbers Photic stimulator glasses Mitsar EEG Amplifier box CPU init Stationary photic stimulator 1 2 3 4 5 Photic stimulator synchronization cable 6 Photic stimulator power supply unit 7 Dongle only for WinEEG 8 USB A cable mini USB B 9 Mains socket with grounding and isolation transformer 1 0 PC power cable OPERATION MANUAL 14 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 7 2 EP investigation P ay 40 Figure 2 EEG system connection diagram for EP investigation ATTENTION Persona
42. ockets marked PN for connection of neutral conductors of polygraph sensors e g EEG The EEG system during recording initially applies monopolar montage however monopolar montage during and after recording may be converted to any other type suitable for user 4 2 Measuring electrode resistance The quality of electrode application contact with skin can be checked with mode Resistance check in program running with the EEG system Herewith the quality of electrodes application can be checked both in the program itself and on the device front panel In the program the chart with electrodes is displayed similarly to location of those in the device The electrode color corresponds to resistance value designated on the scale Resistance can be checked from the front panel with the help of special resistance threshold crossing indicators of electrodes see Figure 5 The current resistance threshold is also indicated on the front panel and may be changed with the help of program in the mode Resistance check When applying electrodes it is necessary to obtain that for the threshold set value all threshold crossing indicators go off The device provides high quality EEG recording with the resistance value less 20 kO it is recommended to obtain the resistance less 10 kQ and in the presence of strong radio interference 5 kQ In order to decrease the impedance maximum attention should be paid to the quality of application of neutral and
43. outside the patient environment see section 2 4 Safety requirements If it is necessary to locate a personal computer or other non medical electrical equipment within the patient environment read section 1 75 Locating personal computer within the patient environment gt gt OPERATION MANUAL VI ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Do not turn on the system power until all cables have been properly connected and verified To provide patient safety connect the patient electrodes only after the system is fully turned on To provide the patient safety disconnect all recording and stimulating electrodes from patient before you turn off the system Connect patient electrodes only to corresponding inputs of bioelectric signal amplifier Connection to any other devices or sockets may cause injuries 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 EN 60601 1 1 for medical electrical systems Proper usage of this system depends on careful reading of all instructions and labels Turn off the system power before connecting or disconnecting any system component s or accessories Otherwise you can damage the system P P DE Do not disconnect or reconnect any system components or accessories wit
44. ps short lt 5 UT 596 UT The quality of the line power interruptions and voltage variations supply input lines EN 61000 4 1 1 power 95 96 dip of UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT 95 96 dip of UT for 5 seconds 95 96 dip of UT for 0 5 cycles 40 UT 60 96 dip in UT for 5 cycles 70 UT 30 96 dip in UT for 25 cycles 5 9 UT gt 95 dip of UT for 5 seconds that of a or hospital supply should be typical commercial environment If the user of the System requires continued operation during power mains interruptions it is recommended that the System be powered by an uninterruptible power supply or a battery Power magnetic field EN 61000 4 8 frequency 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level OPERATION MANUAL 42 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG RF immunity The System is intended for use in the electromagnetic environment specified below The customer or the user of the System should assure that it is used in such an environment Immunity test EN 60601 1 2 Compliance Electromagnetic environment guidance test level level
45. sed control device The data are transferred to computer via standard USB type serial interface through the decoupling device and the level converter providing conditioning levels of the decoupling device and serial interface The decoupling device provides insulation strengthening The Amplifier is energized from electrochemical cells internal power supply unit Voltages necessary for device operation are generated by power supply unit which is initiated by program command and then maintained in turn on condition by sending special commands If program terminates command transmission to maintain device in turn on condition or communication with computer is interrupted the power supply unit automatically will be turned off in 2 5 seconds Device turn on condition is displayed with special operation indicator on the device front panel The system software provides creation of data files for input biosignal primary digital filtration of the data displaying of those as curves at a PC monitor storing of the data on PC hard disk and their further processing EEG analysis features are described in the user s manual for the software OPERATION MANUAL 25 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 5 JOjJlUOJA sn soveyeg D lt 5 2 5 D gt JeuJjeg uonejos
46. sibility of manual measurement of signal parameters intervals and amplitudes measurement of horizontal and vertical scale paper travel speed and sensitivity marking of interesting parts of records deleting artifact record parts etc A detailed description of software operation is given in corresponding description enclosed with the system delivery set 4 4 EEG recording operation features The main reason of unsatisfactory operation of the EEG system may be periodic line 50 60 Hz or high frequency interference Although the EEG system complies with the requirements of standard EN 60601 1 2 due to small amplitude of EEG signals there may occur signal distortions owing to external interference This interference may be caused by various reasons 1 Computer grounding is poor or absent 2 The electrodes are contaminated Follow maintenance instructions enclosed to electrodes 3 Unsatisfactory application of EEG electrodes indication for that is 50 60 Hz pickup in one or more channels 4 Unsatisfactory application of neutral or reference electrodes indication for that is 50 60 Hz pickup in one or more channels Damage of conductors or connectors for connection of electrodes Powerful electric equipment is present in the neighborhood of the EEG room which generates strong interference e g X ray installations physiotherapy equipment etc 7 or radio transmitter radar or cellular station located wi
47. stem is intended for use in all facilities CISPR 11 including residential areas and in any facilities Harmonic emissions Class A connected directly to a public power supply IEC 61000 3 2 providing electricity to Harmonic emissions Voltage fluctuations flicker Complies buildings used for residential purposes emissions IEC 61000 3 3 OPERATION MANUAL 41 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG Interference immunity The System is intended for use in the electromagnetic environment specified below The customer or the user of the System should assure that it is used in such an environment Immunity test EN 60601 1 2 Compliance level Electromagnetic test level environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood discharge ESD discharge discharge concrete or ceramic tile If EN 61000 4 2 8 kV air discharge 8 kV air discharge floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for poweri 2 kV for power The quality of the line power Transient Burst supply lines supply lines supply should be that of a EN 61000 4 4 typical commercial or hospital environment Surge 1 kV differential t 1 differential The quality of the line power EN 61000 4 5 mode mode supply should be that of a typical commercial or hospital 2 kV common 2 kV environment mode mode Voltage di
48. t for monitor hard disk USB port etc also it is desirable to disable screensaver Enable graphic acceleration in program settings In program use only oscilligraphy mode If your video card is slow use 16 bit video modes install DirectX check correspondence of video card drivers and the operation system in use download and update video card drivers from the site of manufacturer or replace your video card with later versions 8 If your PC is fitted only with integrated video card except notebooks try to install external video card 9 Try to install the EEG system on another PC If none of recommendations listed above gives positive result consult Mitsar Co Ltd customer support or your dealer OPERATION MANUAL 40 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 5 Manufacturer s declaration regarding electromagnetic compatibility ELECTROMAGNETIC EMISSION The Electroencephalographic PC controlled System Mitsar EEG is intended for use in the electromagnetic environment specified below The customer or the user of the System should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The System uses HF energy only for its internal CISPR 11 function The HF emission is therefore very low and it is improbable that nearby electronic devices might be disturbed RF emissions Class B The Sy
49. the standard on EEG measuring channel namely due to small value of time constant there occurs distortion of QRS complex the EEG input signal can t be used for calculation of EEG parameters and making out a diagnosis by waveform The input EEG signal may be used for position visual estimation and calculation of time delays between the R wave position and some other signals OPERATION MANUAL 24 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 2 3 Description of operation principle EEG system is intended only for medical purposes The system is used to measure and record the electrical activity of the patient s brain Electroencephalographic and polygraph signals are obtained by placing electrodes sensors and enter the multichannel voltage amplifier Amplifier The voltage amplifier which functional diagram is shown in Figure 8 amplifies the electrical signals up to the level coordinated to the analog digital convertor ADC 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 This signal is applied to ADC input which converts it to digital form sequentially for each channel The ADC converts the signal to 16 bit digital code Synchronization of the voltage switching unit and the ADC control of photic stimulator and data exchange with computer are effected by microcontroller ba
50. thin small distance from the building distance depends on device capacity OPERATION MANUAL 38 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 8 The Amplifier is located close to a wall with flush electric or cable wiring which screen is faulty or ungrounded 9 The amplifier is located near a large metallic surface metal cabinet box safe etc or close to a wall behind which such object is located 10 The cable connecting the Amplifier and PC is laid close to powerful device or interference source CRT monitor isolation transformer laser printer UPS etc 11 During investigation there is a sparkling electric switch defective fluorescent lamp 12 Domestic electric appliances microwave oven coffee grinder etc are on at the time of investigation 13 Cellular or radio telephone is used during investigation It is recommended to start search for unsatisfactory record quality reason from grounding connection and its quality electrode applying quality and their operability and so on as per list Eliminate the reason found Some reasons may require relocation of the EEG system to another room or application of screened compartment Also pay attention to the fact that although the EEG system complies with the requirements of electromagnetic compatibility it may cause interference for operation of more sensitive equipment 4 5 Troubleshooting This section presents recommendations on troubleshooting d
51. ural electrodes 1 pair 2 E6 Disposable sponge disks 100 pcs in pack 2 E7 Needle Syringe Kit 4 9 Electro Gel can 16 ounces 473 ml 3 E12 Measuring tape 1 E16 Ivory Liquid for washing of caps 1 INS 1 User s manual 1 VID 1 Training video film 1 Recommended set for perinatal wards Code number Component name Q ty pcs 11 1 Perinatal electrode cap 42 46 11 2 Perinatal electrode cap 38 42 cm 1 11 3 Perinatal electrode cap III 34 38 cm 1 E2 Electrode board adapter 1 12 Perinatal body harness 1 E4 Repair electrode 5 5 6 Aural electrodes 6 1 pair 2 E6 Disposable sponge disks 100 pcs in pack 1 EZ Needle Syringe Kit 1 E8B Special blunt needle 100 pcs 1 E11 Electro Gel can 128 ounces 3 8 1 I3 Perinatal measuring tape 1 All electrodes used in EEG recording session should feature current collecting surface of homogeneous material Preferably to have electrodes of one manufacturer Non observance of these rules may cause high polarization voltage of electrodes and suppression of amplifies OPERATION MANUAL 10 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG All electrodes used with the EEG system should be certified Mitsar Co Ltd does not guarantee the adequate quality of EEG recording when using noncertified and defective electrodes Usage of noncertified electrodes may cause damage of the EEG system
52. uring device operation All procedures listed below should be performed only by IT specialists as an inexperienced user may cause complete computer failure If at an attempt to signal input the operation indicator on the front panel does not go on and no input is initiated the following checks should be performed 1 Check the USB cable connection Connect the USB cable from the Amplifier to another USB socket of PC 2 Batteries are incorrectly inserted or cartridge contact is faulty Check the batteries polarity and cartridge contacts 3 Batteries may be exhausted Check batteries and replace them if necessary If after turning on the device the input signal continues for 1 10 seconds herewith the operation indicator on the front panel is lighted then it stops and the device turns off try to do the following 1 Check batteries and their polarity in the Mitsar EEG Amplifier Replace batteries if necessary OPERATION MANUAL 39 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 2 May be hard disk of PC is full Clear space on hard disk for the program operation Check disk defragmentation 3 Close all programs running in parallel terminate antivirus automatic scanning security programs Ensure that nobody works with the data on your PC via local network The processes running background may use much processor time 4 Turn off all power saving options Power Management at least for the time of inpu
53. y and adjust the tripod height locate the Amplifier in the place suitable for you It is not recommended to install the Amplifier close to concrete walls metal structures near circuit voltage wires this may cause additional interference induction 50 60 Hz Connect the system components in accordance with connection diagrams given in this manual below see section 1 7 Prior to system operation start ensure that all cables are carefully laid and fixed with special means and can t be incidentally disconnected or trod on Connect the system with power supply unit 220 22 V 50 Hz Ensure that the system is connected to corresponding mains socket with reliable protective grounding Turn on the system by pressing the power button on the CPU unit There are no parts inside the EEG system which should be maintained by user except the batteries inside Mitsar EEG Amplifier Do not open the EEG system cases if they are connected to power supply unit Risk of electric shock OPERATION MANUAL 12 ELECTROENCEPHALOGRAPHIC PC CONTROLLED SYSTEM MITSAR EEG 1 6 System software installation The corresponding drivers should be installed for any device plugged in to USB input including those for the Amplifier Driver installation for new devices being connected is a standard procedure performed by the operation system Detailed instruction on drivers and software installation can be found in the user s ma
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