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GES 400 MR Series User Manual | 8100401-55

•

2015-07-22

1.4.10

Component Recycling and Disposal

WARNING:

Hazardous Material Disposal—

Replace internal batteries only with exactly matching batteries,
which are available from EGI. For replacement and disposal
instructions, contact EGI Technical Support (Table P-3).

CAUTION:

Comply with local regulations when recycling or

disposing of GES components, consumables, and accessories.

You may return components to EGI for recycling or disposal, if
desired. Contact EGI Technical Support (Table P-3) to arrange for
this service.

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Summary of Contents for GES 400 MR

Page 1: ...GES 400 MR Series User Manual 09 15 14 Electrical Geodesics Inc 500 E 4th Avenue Suite 200 Eugene OR 97401 USA www egi com GES 400 MR Series MR Conditional Systems User Manual 0297...

Page 2: ...odesics Inc EGI 500 E 4th Avenue Suite 200 Eugene OR 97401 USA 1 541 687 7962 tel 1 541 687 7963 fax www egi com supportteam egi com orderdesk egi com European Union EU Authorized Representative Gerha...

Page 3: ...GES 400 MR Series User Manual 8100401 55 2015 07 22 3 GES 400 MR Series MR Conditional Systems User Manual...

Page 4: ...4 GES 400 MR Series User Manual 8100401 55 2015 07 22...

Page 5: ...Specifications 29 2 2 Physical Connections 31 2 3 Removing Inserting the Amplifier 34 3 Net Amps Amplifiers 37 3 1 Overview and Specifications 37 3 2 Anti aliasing Filter Effects on EEG Timing 38 3 3...

Page 6: ...6 GES 400 MR Series User Manual 8100401 55 2015 07 22 5 System Configurations 53 5 1 EEG fMRI 54 5 2 EEG fMRI with ERP 55 Appendix A EMC Declarations 57...

Page 7: ...nimizing and attenuating contrary signals and artifacts CAUTION Only MR trained personnel should work with this equipment and only equipment labeled MR safe or MR conditional should enter the specifie...

Page 8: ...EGI Refer to the HC GSN manual Net Station NS software includes the MR Artifact Removal waveform tool 1 EGI 3104200 HASP key 1 Safenet YWRGC 6158560 Net Amps Clock Sync 1 EGI 4608295 Ethernet switch...

Page 9: ...es User Manual 8100401 55 2015 07 22 9 Typical GES MR System GES MR systems operate within the MR environment to acquire simultaneous EEG and fMRI data Figure P 1 Core components of a typical EEG fMRI...

Page 10: ...operation At any time you have additional questions or wish retraining contact EGI Technical Support Table P 3 Typographic Conventions Italics are used for definitions or newly introduced terms Boldfa...

Page 11: ...he problem Try to repeat and define the problem Document the problem Carefully record the sequential details of the problem Report the defined problem Contact EGI Table P 3 EGI contact information EGI...

Page 12: ...12 GES 400 MR Series User Manual 8100401 55 2015 07 22...

Page 13: ...EGI support or authorized engineer Deviating from the supported configuration or running the system with non EGI approved components attached can cause hazards or unexpected performance Note that the...

Page 14: ...vironment Nonmagnetic battery operated FICS amplifier subsystem usable inside the MR imaging room Two ECG channels to facilitate ballistocardiogram attenuation Data acquisition synchronized with MRI g...

Page 15: ...Shipping altitude 11 500 m 37 700 ft maximum 1 3 2 Environmental Conditions for Use For EMC declarations see Appendix A Table 1 2 Environmental conditions for the use of GES MR components Operating t...

Page 16: ...30 Mac Pro desktop computer 1 150 Mac 27 inch display 250 Dell computer 500 Dell 17 inch display 200 1 3 5 GES MR Electrical Specifications Table 1 5 Electrical specifications for GES MRs Maximum inp...

Page 17: ...f Medical Electrical Equipment Part I General Requirements for Safety IEC 60601 2 26 2002 Particular Requirements for the Safety of Electroencephalograph The GES 400 MR series systems carry the Europe...

Page 18: ...Class A and JIS T 0601 1 2 2002 See Appendix A These limits are designed to provide reasonable protection against harmful interference in a typical medical installation The equipment generates radio f...

Page 19: ...zard Canadian Standards Association approval Electrical hazard Manufacturer Type BF applied part body protected patient isolation EU authorized representative Interference hazard Temperature limit 10...

Page 20: ...or Safety in the Magnetic Resonance Environment which is one of the international standards of the American Society for Testing and Materials ASTM Based on these tests including displacement force and...

Page 21: ...resence of the HC GSN during anatomical scans 1 4 1 General Safety Warnings WARNING Always connect all GES components except those inside the MR imaging room to the isolation transformer Never connect...

Page 22: ...equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Any person who connects additional equipment to the signal input port or signal output port configures a m...

Page 23: ...y to the power mains cord supplied with the protective ground terminal The presence of ground protection preserves the patient s safety as well as your own Check that your local electrical plant can g...

Page 24: ...y component other than the Net that is being worn inside or outside of the patient area 1 4 3 Ground Warnings WARNING Disconnect power before servicing to prevent physical injury or equipment damage E...

Page 25: ...er repair nondetachable cords Contact EGI Technical Support Table P 3 for cord repair or replacement Do not position any cable such that it is subject to abuse 1 4 5 Disassembly WARNING Do not open or...

Page 26: ...0950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Any person who connects additional equipment...

Page 27: ...nd unplug GES components before cleaning Prevent any liquid or sterilizing agent from entering any GES component Do not use abrasive products Clean the different surfaces as follows To clean cracks an...

Page 28: ...tching batteries which are available from EGI For replacement and disposal instructions contact EGI Technical Support Table P 3 CAUTION Comply with local regulations when recycling or disposing of GES...

Page 29: ...m 12 5 in Weight 13 6 kg 30 lb incl amplifier Table 2 2 System requirements for the FICS s I O ports Front panel Net port Standard Hypertronics 256 or 128 channel connector Rear panel DC power port 15...

Page 30: ...hnical Support Table P 3 Before charging using or shipping inspect LiPo batteries for damage such as swelling punctured protective cover or broken wiring or plug NEVER charge use or ship any damaged L...

Page 31: ...ifier within the FICS use the GES External Power Supply to power the amplifier When using the amplifier outside of the FICS refer to the GES 400 series manual 8100400 2 2 Physical Connections 2 2 1 Fr...

Page 32: ...nnections and indicators Callout Connection Indicator Description Power ON OFF Turns power on and off whether the power is from the FICS s internal battery required inside the MR imaging room or the G...

Page 33: ...is fully powered When flashing battery power is low CHARGE center When illuminated the FICS s internal battery is being charged When extinguished the battery is fully charged BALANCE right When illum...

Page 34: ...lifier reverse the steps Disconnect the GES External Power Supply if connected Remove the eight screws from the FICS s rear panel CAUTION While handling the FICS s rear panel do not damage the RF shie...

Page 35: ...located near the undercarriage Detach all cables power data and clock sync between the FICS and the amplifier To properly disconnect the Hypertronics connector between the FICS and amplifier firmly g...

Page 36: ...all FICS cables power data and clock sync into the undercarriage cable area While ensuring that you do not damage the RF shielding metal strip carefully reattach the FICS s rear panel Reinstall the re...

Page 37: ...in the Field Isolation Containment System FICS and must be powered by the FICS s internal battery For all safety and use conditions for using the Net Amps amplifiers outside of the MR environment refe...

Page 38: ...aliasing Filter Effects on EEG Timing The anti aliasing filters of the Net Amps amplifiers introduce a temporal delay in the EEG Whether EEG is steaming displaying or recording there is a temporal del...

Page 39: ...to the Net Station 5 manual 8100050 or contact EGI Technical Support Table P 3 CAUTION The anti aliasing filters of the Net Amps amplifiers introduce a temporal delay in the EEG To adjust for the del...

Page 40: ...nnections The longer cable of the MR Nets connects directly to the FICS The Net Amps amplifier is housed within the FICS Figure 3 1 Hypertronics connections between the MR Net FICS and amplifier Note...

Page 41: ...onnection Indicator Description Power Power cable connects to the isolation transformer through the GES External Power Supply Ethernet Fiber optic cable connects to an Ethernet switch which then conne...

Page 42: ...LEDs Status indicators Power When illuminated the amplifier is powered turned on and ready to collect data blanks For manufacturer s use only Digital For research only When used provides digital inpu...

Page 43: ...AR mitigation two ECG channels to facilitate ballistocardiogram attenuation longer cables to allow the Nets to go into a magnet easy application with saline solution usability outside of the MR enviro...

Page 44: ...ses to synchronize the data acquisition CAUTION The Net Amps clock sync is MR UNSAFE and not to be positioned or used within the MR environment To use the Net Amps clock sync position it outside the M...

Page 45: ...he external MR clock input is detected and active TR middle left When illuminated the clock sync detects the MR system s TR pulse Detection occurs about two seconds after the MRI scanner begins scanni...

Page 46: ...for synchronized TR pulse inputs and outputs between the MR control rack and other devices in the system In left One of two connections on the clock sync device that accepts a TR pulse input from the...

Page 47: ...d timing facilitates the attenuation of predictable MR artifacts External Clock Input Connects to the clock source of another manufacturer s equipment to synchronize the timing of the EEG amplifier to...

Page 48: ...GES system CAUTION Before upgrading your EGI system computer operating system or EGI software confirm compatibility with EGI Technical Support Table P 3 For computer specifications and operation inst...

Page 49: ...SIDE THE MR ENVIRONMENT Used only outside of the MR environment to recharge the FICS s internal battery power the amplifier for EEG only acquisition 4 6 Isolation Transformer All EGI systems include o...

Page 50: ...EN60742 IEC601 1 CE Mark Power Selectable 115 or 230 V 50 60 Hz input output Leakage current 100 A Outlets Appliance type IEC 60320 Miscellaneous Low weight low magnetic strayfield low mechanical nois...

Page 51: ...55 2015 07 22 51 Table 4 5 ISB 060M specifications and peak power values within desktop GES MRs Fuse rating 6 0 AT 120 V in or 3 15 AT 240 V in Capacity 600 VA max Amplifier power dissipation 15 VA D...

Page 52: ...52 GES 400 MR Series User Manual 8100401 55 2015 07 22...

Page 53: ...the Net Station software it is ready to use with minimum preparation This chapter illustrates the typical GES MR system configurations for EEG fMRI data see 5 1 EEG fMRI data with ERP see 5 2 For the...

Page 54: ...54 GES 400 MR Series User Manual 8100401 55 2015 07 22 5 1 EEG fMRI Figure 5 1 Typical EEG fMRI configuration...

Page 55: ...GES 400 MR Series User Manual 8100401 55 2015 07 22 55 5 2 EEG fMRI with ERP Figure 5 2 Typical EEG fMRI with ERP configuration...

Page 56: ...56 GES 400 MR Series User Manual 8100401 55 2015 07 22...

Page 57: ...GES components see Table A 3 Recommended separation distances between radio frequency RF communications equipment and the GES see Table A 4 Note Portable and mobile RF communications equipment can af...

Page 58: ...romagnetic Environment Guidance RF emissions CISPR 11 Group 1 The GES uses RF energy only for its internal functions Therefore its RF emissions are very low and are not likely to cause any interferenc...

Page 59: ...discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at...

Page 60: ...in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the GES requires cont...

Page 61: ...Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 V rms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 V rms 3 V m Portable and mobile RF commun...

Page 62: ...reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radi...

Page 63: ...pment Rated Maximum Output Power of Transmitter in watts Separation Distance According to Frequency of Transmitter in meters 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2...

Page 64: ...64 GES 400 MR Series User Manual 8100401 55 2015 07 22...

Page 65: ...GES 400 MR Series User Manual 8100401 55 2015 07 22 65...

Page 66: ...GES 400 MR Series User Manual 09 15 14 Electrical Geodesics Inc 500 E 4th Avenue Suite 200 Eugene OR 97401 USA www egi com GES 400 MR Series MR Conditional Systems User Manual 0297...

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