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GES 400 MR Series User Manual | 8100401-55

•

2015-07-22

Electromagnetic Immunity

Table A-2.

Electromagnetic compatibility (EMC) immunity guidelines and declarations for GESs

GESs are intended for use in the electromagnetic environment specified below.
The customer or user of a GES should ensure that it is used in such an
environment.

Immunity Test

IEC 60601 Test

Level

Compliance

Level

Electromagnetic

Environment—

Guidance

Electrostatic
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 least 30%.

Electrical fast
transient/burst
IEC 61000-4-4

2 kV for power-

supply lines

1 kV for

input/output
lines

2 kV for power-

supply lines

1 kV for

input/output
lines

Mains power
quality should be
that of a typical
commercial or
hospital
environment.

Surge
IEC 61000-4-5

1 kV differential

mode

2 kV common

mode

1 kV differential

mode

2 kV common

mode

Mains power
quality should be
that of a typical
commercial or
hospital
environment.

Содержание GES 400 MR

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

Страница 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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