G-Tec g.HIamp Instructions For Use Manual
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G-Tec g.HIamp Instructions For Use Manual

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The product with the above serial number is a prescription device for use in the USA
g.tec medical engineering GmbH
office@gtec.at,
GlobTek power supply
SN:
64 channel electrode
SN:
connector box
Instruction for use
Copyright 2017 g.tec medical engineering GmbH
Sierningstrasse 14
A-4521 Schiedlberg
Austria
Tel.: (43)-7251-22240-0
Fax: (43)-7251-22240-39
http://www.gtec.at
UDI
label
RoHS
6P-
V2.16.01
printed July 2017

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Summary of Contents for G-Tec g.HIamp

  • Page 1 g.tec medical engineering GmbH Sierningstrasse 14 A-4521 Schiedlberg Austria Tel.: (43)-7251-22240-0 Fax: (43)-7251-22240-39 office@gtec.at, http://www.gtec.at label GlobTek power supply RoHS 64 channel electrode connector box Instruction for use V2.16.01 Copyright 2017 g.tec medical engineering GmbH printed July 2017 The product with the above serial number is a prescription device for use in the USA...
  • Page 2 GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 How to contact g.tec:  ++43-7251-22240-0 Phone  ++43-7251-22240-39  g.tec medical engineering GmbH Mail Sierningstrasse 14, 4521 Schiedlberg, Austria  http://www.gtec.at office@gtec.at E-mail Page 2...

  • Page 3: Table Of Contents

    Declaration of conformity ................... 24 Technical specifications ..................25 g.HIamp ..............................25 Medical power supply ..........................26 Pin assignment of g.HIamp rear side connectors (coding not shown) ..28 USB ................................28 HOLD ............................... 28 DIGITAL IN 1............................29 DIGTAL IN 2............................. 29 POWER SUPPLY ............................
  • Page 4 GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 Channels 193-256 (D) ..........................32 +5V DC - 30 mA ............................33 GND ................................. 33 List of abbreviations ..........................33 Electromagnetic compatibility ................28 Page 4...

  • Page 5: Important Notes

    Warning and safety notice If g.HIamp is connected to other devices (except the power supply supplied with g.HIamp) like a PC the following leakage currents have to be checked.
  • Page 6 (minimum). Interference g.HIamp and its components have been tested and comply with the electromagnetic compliance limits (IEC 60601-1-2:2007 Class A). See Chapter Electromagnetic compatibility. The equipment, if not installed and used in accordance with the instructions, may cause interference to other devices in the vicinity.
  • Page 7 V2.16.01 The intended use of the equipment The g.HIamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example the electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG).

  • Page 8: Introduction To G.hiamp

    Furthermore, the device has an internal impedance check unit. Standard electrodes with safety connectors can be connected to g.HIamp via optionally available electrode connector boxes. The device is controlled with a C language Application Programming Interface (C API).
  • Page 9 38400 the number of available channels depends on the purchased type of amplifier  digital filtering of all biosignal data via g.HIamp for sampling frequencies up to 4800 Hz  over-sampling to achieve a high signal to noise ratio ...

  • Page 10: G.hiamp Basic Components

    144 analog input channels for the 144-Channel Amplifier or 80 analog input channels for the 80-Channel Amplifier 64 channel electrode connector box connection cable from 64 channel electrode connector box to g.HIamp GlobTek GTM21097-3005 – medical power supply unit Power line cord...

  • Page 11: Explanation Of Switches, Connectors And Leds

    Sockets, connectors and LEDs on the front side Example: g.HIamp 256-Channel Amplifier front side g.HIamp has up to 4 mono-polar amplification groups with one ground socket each. The analog input channels for EEG are connected via push-pull connectors. g.HIamp Amplifier Type...
  • Page 12 The electrostatic discharge warning symbol: electrostatic discharge impulses must be avoided when connecting electrodes to any of the safety sockets or push pull connectors. Follow the steps in chapter “Save operation of g.HIamp” to avoid electrostatic discharge impulses. Page 12...

  • Page 13: Sockets, Connectors And Switch On The Rear Side

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 Sockets, connectors and switch on the rear side g.HIamp rear view POWER POWER switch for switching ON/OFF the device POWER SUPPLY socket for the connection of the external power supply unit...

  • Page 14: Marking On The Top Side

    5 Marking on the top side g.HIamp 256-Channel Amplifier g.HIamp 144-Channel Amplifier g.HIamp 80-Channel Amplifier do not dispose g.HIamp with domestic waste. Dispose it via the separate collection system for electrical and electronic equipment applied part of type CF follow instruction for use...
  • Page 15 GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 safety class II manufacturer address Type/Typ: 256-Channel Amplifier device type for 256-Channel Amplifier Type/Typ: 144-Channel Amplifier device type for 144-Channel Amplifier Type/Typ: 80-Channel Amplifier device type for 80-Channel Amplifier IP 41: Protected against particulate matter of degree 4 (wire with diameter of 1 mm).
  • Page 16 GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 The figures below show the packaging of the device and the labelling of the box. UDI label: g.HIamp 256-Channel Amplifier REF 7002US HA-2017.02.02 *+EBCI7002US0/$$+7HA-2017.92.027* Page 16...

  • Page 17: Medical Power Supply Globtek Gtm21097-3005

    Medical power supply Part of the medical equipment g.HIamp is the GlobTek GTM21097-3005. It is a 5 V DC medical power supply unit. If the medical power supply is connected to power line the green LED shows the correct operation of the device.

  • Page 18: Usb Cable

    7 USB cable Part of the medical equipment g.HIamp is the USB cable. It is a 4 pin cable used for the connection of g.HIamp with a PC. One side has a standard USB connector (PC USB) the other side a Mini-Snap 8- pin connector (USB).

  • Page 19: 64 Channel Electrode Connector Box And Multi Lead Connection Cable

    Part of the medical equipment is the g.tec 64 channel electrode connector box and the corresponding connection cable. One 64 channel electrode connector box enables the connection of 64 electrodes and 1 ground electrode with 1.5mm standard safety plugs to g.HIamp via the multi lead connection cable.

  • Page 20: Push-Pull Connectors

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 9 Push-Pull Connectors g.HIamp connections on the rear side rely on highly reliable self-latching connectors based on the push-pull principle. Connecting a plug to the corresponding socket plug socket cable For connecting the self latching plug to the socket push the plug axially into the socket.

  • Page 21: Safe Operation Of G.hiamp

    The correct operation of g.HIamp is indicated by a green LED on the front side. If the LED is not on please control the power supply connection and the fuse of g.HIamp.

  • Page 22: Measuring Biosignal Data

    Switching off and storage of g.HIamp To switch off g.HIamp and to store the device correctly, please perform the following steps: Step 1: Switch off the device with the switch on the rear side (switch position OFF). The green LED is off.

  • Page 23: General Notes

    +40 Celsius and below +5 Celsius. Waste disposal details Bring the device to a recycling center or sent it back to the manufacturer. Cleaning You can clean the device carefully with medical rubbing alcohol. Liquid must not enter the g.HIamp. Page 23...

  • Page 24: Declaration Of Conformity

    Protection against mechanical distortion and liquids IP41 Operation mode S1 (permanent operation) The manufacturer declares in sole responsibility that the physiological signal amplifier g.HIamp 256- /144-/80-Channel Amplifier is in conformity with the following standards: EN standards: and IEC standards: EN 60601-1: 1996 (+A1 +A2 +A12 +A13),...

  • Page 25: Technical Specifications

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 13 Technical specifications g.HIamp Model g.HIamp Type 256-Channel Amplifier or 144-Channel Amplifier or 80-Channel Amplifier Rated power consumption 20 VA Rated DC voltage Rated current of fuse 4A, quick acting fuse, type 20 mm 250 V≈...

  • Page 26: Medical Power Supply

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 Analog signal processing time and digital inputs sampling frequency AI/DI* AI/DI* [Hz] for amplifier for amplifier Version < 1.0.9 Version >=1.0.9 [samples] [samples]** 1200 2400 4800 9600...
  • Page 27 GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use ____________________________________________________________________________________________________________________ V2.16.01 Reseller GlobTek, Inc. Germany Hafenweg 26a, 48155 Münster, Germany Model number GTM21097-3005 Page 27...

  • Page 28: Pin Assignment Of G.hiamp Rear Side Connectors (Coding Not Shown)

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use V2.16.01 14 Pin assignment of g.HIamp rear side connectors (coding not shown) Direction Function USB Vbus USB Data - USB Data + USB ID Digital GND Shield No internal connection...

  • Page 29: Digital In 1

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use V2.16.01 DIGITAL IN 1 Direction Function Digital In 1 Digital In 2 Digital In 3 Digital In 4 Digital In 5 Digital In 6 Digital In 7 Digital In 8 Digital GND Vcc (3.3V)

  • Page 30: Power Supply

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use V2.16.01 POWER SUPPLY Direction Function Supply V+ (5V) Supply V- (0V) page 30...

  • Page 31: Pin Assignment Of G.hiamp Front Side Connectors

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use V2.16.01 15 Pin assignment of g.HIamp front side connectors Channels 001-064 (A) Direction Function Channel 1 Channel 2 Channel 3 Channel 63 Channel 64 Signal GND Channels 065-128 (B)

  • Page 32: Channels 129-192 (C)

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use V2.16.01 Channels 129-192 (C) Direction Function Channel 129 Channel 130 Channel 131 Channel 191 Channel 192 Signal GND Channels 193-256 (D) Direction Function Channel 193 Channel 194 Channel 195...

  • Page 33: Dc - 30 Ma

    GmbH g.HIamp, USB Biosignal Amplifier: Instruction for use V2.16.01 +5V DC - 30 mA Direction Function Supply Analog GND (0V AP) Internal use – do not connect Supply Auxiliary supply (+5V AP) Direction Function Signal GND List of abbreviations...

  • Page 34: Electromagnetic Compatibility

    As electric and magnetic fields may interfere with the functional reliability of the device, avoid using g.HIamp close to devices emitting powerful magnetic fields, e.g. magnetic resonance machines, x-ray equipment.
  • Page 35 V2.16.01 Guidance and manufacturer´s declaration – electromagnetic emission g.HIamp is intended for use in the electromagnetic environment specified below. The customer or the user of the g.HIamp should assure that it is used in such an environment. Emission test Compliance...
  • Page 36 USB Biosignal Amplifier: Instruction for use V2.16.01 The g.HIamp is intended for use in the electromagnetic environment specified below. The customer or the user of the g.HIamp should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
  • Page 37 USB Biosignal Amplifier: Instruction for use V2.16.01 The g.HIamp is intended for use in the electromagnetic environment specified below. The customer or the user of the g.HIamp should assure that it is used in such an environment. Immunity test IEC 60601 test level...
  • Page 38 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the g.HIamp is used exceeds the applicable RF compliance level above, the g.HIamp should be observed to verify normal operation.
  • Page 39 Recommended separation distances between portable and mobile RF communications equipment and the g.HIamp The g.HIamp is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the g.HIamp can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the g.HIamp as recommended below, according to the maximum output power of...

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