g.tec medical engineering GmbH
g.HIamp, USB Biosignal Amplifier: Instruction for use
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V2.16.01
Page 7
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).
The device
must not
be used for the determination of brain death. Additional examinations are
needed for diagnosis and no diagnosis may be done only based on using this device.
The intended environment of use
The device
must not
be used in dangerous conditions such as wet rooms or explosive environments.
The relative humidity must be between 25 % and 95 %. The device
must not
be used in combination
with any other medical high-frequency device. The usage of a high frequency device together with
g.HIamp can result in burnings under the electrodes and could damage the biosignal amplifier.
Recommended electrodes
The manufacturer recommends golden re-useable cup EEG electrodes (model C32-634) from
Technomed, Co (K072016) with 1.5 m cable and electrode gel (model: E9) from Electro-cap Intl., Inc.
(K111717).
The electrode diameter should be between 2 and 10 mm. The electrode impedance should be below 5
kOhm. The electrodes must have a 1.5 mm safety connector.
The device
must not
be used directly on the heart.
Properties of PC or notebook
g.HIamp requires a PC compatible desktop, notebook workstation or embedded computer running a
Microsoft Windows operating system (Windows 7 or Windows 10 (Threshold 2), 64bit, Professional
English).
The table below lists optimal settings:
Hardware
Properties
CPU
Processor working at 2000 MHz
Harddisk
20-30 gigabyte
RAM
2 - 4 gigabyte
USB 2.0 port
(EHCI
– enhanced
Host controller interface)
one free USB port for each g.HIamp
Prescription device
Caution: US federal law restricts the herein described devices to sale by or on the order of a
physician.