EGi GES 400 MR Series User Manual
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EGi GES 400 MR Series User Manual

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GES 400 MR Series
MR Conditional Systems
User Manual
0297

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Summary of Contents for EGi GES 400 MR Series

  • Page 1 GES 400 MR Series MR Conditional Systems User Manual 0297...
  • Page 2 The GES 400 MR and GES 410 MR products are CE marked in conformity with the European Medical Device Directive. Information on clearance status in other countries is available upon request. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 3 GES 400 MR Series MR Conditional Systems User Manual GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 4 GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 5: Table Of Contents

    Anti-aliasing Filter Effects on EEG Timing Physical Connections 4. Other GES Components HydroCel GSN MR Nets Net Amps Clock Sync Net Station and DAC Ethernet Switch GES External Power Supply Isolation Transformer GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 6 5. System Configurations EEG-fMRI EEG-fMRI with ERP Appendix A: EMC Declarations GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 7: Preface

    HC GSN MRs (NA 410) Sampling rates are software dependent. Net Station allows 1 Ksps and Amp Server Pro SDK facilitates up to the full sampling rate capability of the amplifiers. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 8 EEG/fMRI placard 8402100 Optional application GeoSource 4602001 Note: This parts list assumes a typical system. Your system components may differ, if you have upgraded or expanded your system. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 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 GES MR system GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 10 It assumes a working proficiency with EEG and computer systems. Note: The term patient is used to refer to subjects, participants, or patients. An EGI support or authorized engineer will install and configure your EGI system, including all connections required for its operation. At the time of initial installation, the EGI support or authorized engineer will also train relevant staff in its operation.
  • Page 11 EGI Technical Support web page www.egi.com/support Email Technical Support supportteam@egi.com Email Sales orderdesk@egi.com Telephone +1.541.687.7962 +1.541.687.7963 Address Electrical Geodesics, Inc. (EGI) 500 E 4th Avenue, Suite 200 Eugene, OR 97401 GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 12 GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 13: Safety And Use Conditions

    Do not operate your GES MR system until you are fully trained and understand all warnings, cautions, and conditions for use provided in EGI’s manuals for the components of your GES system. If you have any questions, contact EGI Technical Support (Table P-3).

  • Page 14: Features

    4 kV patient isolation to mains ground and 1.5 kV isolation mains to mains ground Choice of sampling rates (see Table P-1) • • Full range of channel counts (32 to 256) GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 15: Conditions For Use

    Table 1-3. Site requirements for the location and use of GES MR components Location For indoor use only Surface Area 102 x 150 cm (40 x 59 in.) Ventilation Clearance 7.62 cm (3 in.) GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 16 System input bandwidth 0 to 285 Hz (3 dB) System dynamic range ≥ 115 dB 1.3.6 System Contraindictions No contraindictions for the use of GES MR systems are known to exist. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 17 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 European CE mark This medical equipment is classified as follows: Applied part: Type BF • •...
  • Page 18 Increase the separation between the equipment. • Connect the equipment to an outlet on a different circuit than the one used by the other devices. • Consult EGI Technical Support (Table P-3). GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 19 (EGI and third-party mfr) Do not use in gas Keep dry environment Do not dispose with Always adhere to other waste (comply IEC 60601-1-1 and with local 60601-1-2 regulations) Signal input Digital inputs GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 20: Safety Warnings

    Clock sync device Safety Warnings All EGI MR conditional equipment has been tested for MR safety based on the guidelines from ASTM F2503-05 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment), which is one of the international standards of the American Society for Testing and Materials (ASTM).
  • Page 21 • Use only approved equipment. Do not connect the GES to unauthorized equipment, as physical injury or equipment damage may result. The user is responsible for ensuring that a GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 22 Do not use a GES component that has suffered exposure to liquids until EGI or other qualified personnel certifies that the liquid or liquid residue has not affected device operation or patient safety. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 23 Ensure electrode isolation. Prevent contact between the • conductive part of the electrodes and other conductive parts, including the ground. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 24 Ensure grounding reliability. Achieved only when equipment is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade.” • Use a properly grounded outlet. Otherwise, physical injury or equipment damage may result. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 25 GES components. However, because of the large, unpredictable electrical charges involved in a lightning strike, disconnect the patient and discontinue the data acquisition session during a thunderstorm. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 26 Use only accessories, cables, and replacement parts sold by EGI. The use of accessories and cables other than those that ship with the GES, with the exception of those sold by EGI as replacement parts for internal components, may result in increased emissions or decreased immunity of the GES.
  • Page 27 To clean external surfaces (except camera lenses and monitors screens): Use a cloth dampened with mild soapy water or isopropyl alcohol, taking care not to wet any electrical contacts. • Dry with a clean, dry, lint-free cloth. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 28 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.

  • Page 29: Fics

    90 dB attenuation 100 to 450 MHz RF/electromagnetic noise interference coupled onto the at least 90 dB attenuation MR Net and through the Net cable into the amplifier GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 30 FICS’s internal lithium-ion polymer (LiPo) battery pack only with an exactly matching battery pack, which is available from EGI. For replacement battery packs and disposal instructions, contact EGI Technical Support (Table P-3). GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 31: Physical Connections

    The Net Amps amplifier is housed within the FICS. Note: Twist the Net connector’s lever 180° clockwise to lock it and 180° counterclockwise to unlock it. Figure 2-1. Hypertronics connections between the MR Net, FICS, and amplifier GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 32 NOT TO BE USED INSIDE THE MR ENVIRONMENT. Powers the FICS from the GES External Power Supply to recharge the FICS’s internal battery or to power the amplifier for EEG-only acquisition outside of the MR environment. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 33 Clock Sync Brings synchronized timing from the MR control rack into the EEG amplifier via the Net Amps clock sync. This synchronized timing facilitates the attenuation of predictable MR artifacts. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 34: Removing/Inserting The Amplifier

    Do not damage the RF shielding or pull the battery pack cables. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 35 FICS and amplifier, firmly grasp the amplifier and pull it straight out from the FICS. Note: When reinstalling, carefully align the guide pin and hole of the connector. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 36 While ensuring that you do not damage the RF shielding metal strip, carefully reattach the FICS’s rear panel. Reinstall the rear panel’s eight screws. Tighten until snug, but not overtight. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 37: Net Amps Amplifiers

    Table 3-1. Dimensions and weight of the Net Amps amplifier Height 10.77 cm (4.24 in.) Depth 30.18 cm (11.88 in.) Width 28.98 cm (11.41 in.) Weight 6.8 kg (15 lb) GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 38: Anti-Aliasing Filter Effects On Eeg Timing

    EEG acquisition. It also does not affect the alignment of events entered during review or from the operation of tools after data acquisition. Note: Net Station 5.1.1 and later provide options for automatic adjustment of this delay. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 39 36 ms 36 ms 13 ms 500 s/s 18 ms 66 ms 66 ms 34 ms 250 s/s 36 ms 112 ms 112 ms 76 ms 125 s/s 72 ms GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 40: Physical Connections

    Net Amps amplifier is housed within the FICS. Note: Twist the Net connector’s lever 180° clockwise to lock it and 180° counterclockwise to unlock it. Figure 3-1. Hypertronics connections between the MR Net, FICS, and amplifier GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 41 Physio16 (1) Fiber optic cable connects to one optional Physio16 for PNS measures. Physio16 (2) Fiber optic cable connects to a second optional Physio16 for additional PNS measures. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 42 EEG. WARNING: See all warnings in the “Safety and Use Conditions” chapter before connecting accessory equipment. Refer to third-party manufacturer documentation. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 43: Other Ges Components

    See Figure 2-1 for how HC GSN MR Nets connect to the FICS. For the step-by-step instructions for applying your HC GSN MR Nets, refer to the EEG-fMRI preparation instructions (8402100). GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 44: Net Amps Clock Sync

    The Net Amps clock sync connects to other system components with the connections and indicators shown in Figure 4-1 and described in Table 4-1. Figure 4-1. Net Amps clock sync front panel connections and indicators GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 45 ADC Reset process occurs only once per MRI scan. Specifically, if no TR pulse is detected for the first 30 seconds of an MRI scan, then this LED illuminates and the ADC Reset process is GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 46 The Net Amps clock sync connects to other system components with the connections shown in Figure 4-2 and described in Table 4-2. Figure 4-2. Net Amps clock sync rear panel connections GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 47 EEG, within Net Station. WARNING: See all warnings in the “Safety and Use Conditions” chapter before connecting accessory equipment. Refer to third-party manufacturer documentation. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 48: Net Station And Dac

    Net Amps amplifier and the DAC). CAUTION: If needed, replace the Ethernet switch only with an exactly matching replacement, or contact EGI Technical Support (Table P-3) for an equivalent substitute. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...

  • Page 49: Ges External Power Supply

    Isolation Transformer All EGI systems include one or more isolation transformers (medical grade Toroid W Series), and all EGI components, except the FICS, must plug into an isolation transformer to provide the attached components with isolation from mains power for patient safety.
  • Page 50 Table 4-4. ISB-030M specifications and peak power values within laptop GES MRs Fuse rating 3.15 AT (120 V in.) or 1.6 AT (240 V in.) Capacity 300 VA max. Amplifier power dissipation 15 VA DAC and amplifier load 55 VA GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 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 DAC, monitor, and amplifier load 245 VA GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 52 GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 53 EGI support or authorized engineer during installation. After the EGI support or authorized engineer has installed and trained you on the use of your EGI system, including the Net Station software, it is ready to use with minimum preparation.
  • Page 54 EEG-fMRI Figure 5-1. Typical EEG-fMRI configuration GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 55 EEG-fMRI with ERP Figure 5-2. Typical EEG-fMRI with ERP configuration GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 56 GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 57 If adjacent or stacked use is necessary, the EGI equipment should be observed to verify normal operation in the configuration in which it will be used. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 58 Harmonic emissions Class A domestic and those directly IEC 61000-3-2 connected to the public low- Voltage Complies voltage power-supply network fluctuations/flicker that supplies buildings used for domestic purposes. emissions IEC 61000-3-3 GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 59 ± 1 kV differential ± 1 kV differential IEC 61000-4-5 quality should be mode mode that of a typical ± 2 kV common ± 2 kV common commercial or mode mode hospital environment. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 60 IEC 61000-4-8 characteristic of a typical location in a typical commercial or hospital environment. Note: U is the AC mains voltage before application of the test level. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 61 = 2.3 √P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 62 If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocation the GES. Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 63 Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. GES 400 MR Series User Manual | 8100401-55 • 2015-07-22...
  • Page 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...
  • Page 66 Electrical Geodesics, Inc. 500 E 4th Avenue, Suite 200 Eugene, OR 97401 www.egi.com...

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