g.tec medical engineering GmbH
g.USBamp, USB Biosignal Amplifier: Instruction for use
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V2.16.09
Page 20
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Declaration of conformity
Product name
Product: g.USBamp
Manufacturer
g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria
Classification
Safety class
II
Type of applied part
CF
Protection against mechanical distortion and liquids
IP41
Operation mode
S1 (permanent operation)
The manufacturer declares in sole responsibility that the electroencephalograph g.USBamp is in
conformity the following standards:
IEC 60601-1: 1996 (+A1 +A2 +A12 +A13),
IEC 60601-2-26: 2004,
IEC 60601-1-2: 2003,
IEC 60601-2-25+A1: 2001,
IEC 60601-2-40: 1998.
Dr. Christoph Guger
Chief Executive Officer
Dr. Günter Edlinger
Chief Executive Officer
Schiedlberg, Sept. 2017