g.tec medical engineering GmbH g.USBamp, USB Biosignal Amplifier: Instruction for use
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V2.16.09
Page 6
The intended function of the equipment
Measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the
attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely
found in clinical settings for the EEG.
The device must not be used for patient monitoring. 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.USBamp can result in burnings under the electrodes and could damage the biosignal amplifier.
Recommended electrodes
The manufacturer recommends EEG electrodes and gel from Grass Instruments, Co (E5GH
electrodes, EC-2 electrode cream, in the USA the electrodes must be FDA cleared).
The electrode diameter should be between 2 and 10 mm. The electrode impedance should be below 5
kOhm.
The device must not be used directly on the heart.
Properties of PC or notebook
g.USBamp requires a PC compatible desktop, notebook workstation or embedded computer running a
Microsoft Windows operating system (Microsoft Windows 10 Pro (Threshold 2), English, 64-Bit).
The table below lists optimal settings:
2 GHz or faster processor
USB 2.0 port
(EHCI – enhanced
Host controller interface)
one free USB port for each g.USBamp
Prescription device
Caution: US federal law restricts the herein described devices to sale by or on the order of a
physician.
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