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

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GES 400 Series
Geodesic EEG Systems
Clinical User Manual
0297

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Summary of Contents for EGi GES 400 Series

  • Page 1 GES 400 Series Geodesic EEG Systems Clinical User Manual 0297...
  • Page 2 GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 3 GES 400 Series Geodesic EEG Systems Clinical User Manual GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 4 Copyright 2013-2015 by Electrical Geodesics, Inc. All rights reserved. GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 5: Table Of Contents

    Anti-aliasing Filter Effects on EEG Timing Physical Connections Mounting Options 3. Other GES Components HydroCel GSNs Net Station, DAC, and HASP Ethernet Switch GES External Power Supply Isolation Transformer Physio16 (optional) GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 6 4. System Configurations EEG-only ( WITH MOST AMPLIFIERS EEG-only ( WITH THE NA AMPLIFIER EEG/PNS Appendix A: EMC Declarations GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 7: Preface

    HC GSNs, except G Nets (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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 8 Optional components Physio16 1 or 2 4609268 Most Nets have a modular Hypertronics connector. HC GSN G Nets have a D-sub connector and connect only to the Net Amps 405 amplifier. GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 9 Typical GES System Figure P-1. Core components of a typical EEG-only GES system GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 10 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 12 GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 13: Safety And Use Conditions

    Do not operate your GES 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

    European Union (EU) Authorized Representative Contact Phone 011 49 6442 962073 011 49 6442 962074 Gerhard Frömel Email g.froemel@mps-gmbh.eu Mailing Address Medical Product Service GmbH Borngasse 20 35619 Braunfels Germany GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 15: Conditions For Use

    Table 1-3. Site requirements for the location and use of GES 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 16 No contraindications for the use of GES systems are known to exist. 1.4.6 Certifications and Classifications For all current EGI regulatory certifications, including CE declarations, go to www.egi.com or contact EGI Technical Support (Table P-3) This medical equipment is certified to the following: •...
  • Page 17 • IEC 60601-2-26:2002 (Particular Requirements for the Safety of Electroencephalograph) • The GES 400 series systems carry the European CE mark This medical equipment is classified as follows: • Applied part: Type BF • System: MDD Class IIa Equipment, Electrical Class I Equipment •...
  • Page 18 Association approval Electrical hazard Manufacturer Type BF applied part EU authorized (body protected, representative patient isolation) Temperature limit Interference hazard 10˚C to 35˚C (50˚F to 95˚F) Functional earth Humidity limits terminal GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 19: Safety Warnings

    • Never deviate from supported configurations and never connect non-EGI components to the isolation transformer or to other EGI components. All EGI components must be installed and GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 20 Position the patient and operate the GES only as described in • this manual. • Do not use in flammable gas environments. • Do not use in oxygen rich environments. GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 21 • Ensure electrode isolation. Prevent contact between the conductive part of the electrodes and other conductive parts, including the ground. GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 22 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 23 Use only approved power connections and never connect a non-GES power cord or multiple socket outlet (i.e., power strip or extension cord) to the GES. Use only the EGI-approved power cords, connectors, cables, adapters, and multiple socket outlet that came with the GES.
  • Page 24 • 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 25 To clean external surfaces (except camera lenses and monitor 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 26 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 27: Net Amps Amplifiers

    ± 200 mV Precision 0.024 μV/bit Common-mode rejection ≥ 90 dB Isolation-mode rejection ≥ 120 dB Filters 4 KHz antialiasing filter Input impedance ≥ 1.0 GΩ Patient isolation 4 kV GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 28: Anti-Aliasing Filter Effects On Eeg Timing

    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 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 29: Physical Connections

    Net Amps amplifiers directly or indirectly as follows. See Figure 4-2 for the HC GSN G Net’s connection to the Net Amps 405 amplifier. Figure 2-1. Three ways an HC GSN connects to most Net Amps amplifiers GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 30 Not applicable. 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 31: Mounting Options

    For manufacturer’s use only. blanks Digital Not applicable. Mounting Options The Net Amps amplifier can be placed on a table, placed on EGI’s cart, or optional rolling attached to a wall with EGI’s amplifier wall mount bracket. WARNING: To prevent injury and equipment damage when mounting the wall bracket to a wall: use a qualified service technician;...
  • Page 32 Figure 2-3. Amplifier mounting options GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 33: Other Ges Components

    3. Other GES Components HydroCel GSNs The net-like elastomer structure of EGI’s HydroCel GSNs conforms to a patient’s head and gently holds each sensor (containing an electrode) in place without scalp abrasion or glues to collect EEG signals from the scalp. Routine HC GSNs are used with a mild saline solution and LTM HC GSNs are used with water-soluble EEG paste.
  • Page 34 GSNIC, or to hold cables out of the way. For connectivity, see Figure 2-1. It can be mounted to a wall or table with different brackets. GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 35: Net Station, Dac, And Hasp

    HASP key, which is similar to a USB flash drive. All authorized EGI software users have a HASP key that plugs into one of the USB ports of any EGI 5.1 cm x 1.6 cm Mac OS system computer to allow access to the purchased (2 in.

  • Page 36: Ethernet Switch

    GES External Power Supply, which is medical grade. See section 1.4.7, “Ratings,” for input ratings. 18.4 cm x 10.5 cm x 8.3 cm (7.250 in. x 4.125 in. x 3.250 in.) GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...

  • Page 37: Isolation Transformer

    Isolation Transformer All EGI systems include one or more isolation transformers (medical grade Toroid W Series), and all EGI components must plug into an isolation transformer to provide the attached components with isolation from mains power for patient safety. Figure 3-1. Isolation transformer connections for GES systems Table 3-1.

  • Page 38: Physio16 (Optional)

    Selectable gain values within the Net Station software • • Runs on wall power (via a medical-grade AC adapter plugged into the isolation transformer) or on battery power • Maintains PNS isolation from EEG GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 39 Physio16’s internal lithium-ion polymer (LiPo) battery only with an exactly matching battery, which is available from EGI. For replacement batteries and disposal instructions, contact EGI Technical Support (Table P-3). GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 40 Figure 3-2. Physio16 connections and indicators GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 41 3.6.2 Compatible Sensors Table 3-4. Sensors tested compatible with the Physio16 and available from EGI Part Mfr P/N EGI P/N zRIP Kit Pro-Tech 1076329 6156125 (adult) Thermistor-cannula MVAP/Braebon 0510 6156131 PTAF Lite Pressure Pro-Tech P1289 6156141 Transducer Start-up Kit P1664-...
  • Page 42 GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 43 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 set up.
  • Page 44 EEG-only WITH MOST AMPLIFIERS Figure 4-1. Typical EEG-only (with most amplifiers) configuration GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 45 EEG-only WITH THE NA 405 AMPLIFIER Figure 4-2. Typical EEG-only (with the NA 405) configuration GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 46 EEG/PNS Figure 4-3. Typical EEG/PNS configuration GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 47 WARNING: EGI equipment should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, EGI equipment should be observed to verify normal operation in the configuration in which it will be used. GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 48 Harmonic emissions Class A domestic and those directly IEC 61000-3-2 connected to the public low- Voltage Complies voltage power-supply network that fluctuations/flicker supplies buildings used for domestic purposes. emissions IEC 61000-3-3 GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 49 ± 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 50 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 51 = 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 52 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 53 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 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 54 GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 55 GES 400 Series Clinical User Manual | 8100399-53 • 2015-07-22...
  • Page 56 Electrical Geodesics, Inc. 500 E 4th Avenue, Suite 200 Eugene, OR 97401 www.egi.com...

This manual is also suitable for:

Ges 400Ges 405Ges 410

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