g.tec medical engineering GmbH
g.HIamp, USB Biosignal Amplifier: Instruction for use
____________________________________________________________________________________________________________________
V2.16.01
Page 24
12 Declaration of conformity
Product name
Product: g.HIamp 256-Channel Amplifier, g.HIamp 144-Channel Amplifier, g.HIamp 80-Channel
Amplifier
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 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),
EN 60601-2-26: 2004,
EN 60601-1-2: 2007,
EN 60601-2-25+A1: 2001,
EN 60601-2-40: 1998.
IEC 60601-1: 1996 (+A1 +A2 +A12 +A13),
IEC 60601-2-26: 2004,
IEC 60601-1-2: 2007,
IEC 60601-2-25+A1: 2001,
IEC 60601-2-40: 1998.
Dr. Christoph Guger
Chief Executive Officer
Dr. Günter Edlinger
Chief Executive Officer
Schiedlberg, July 2017