g.tec medical engineering GmbH
g.HIamp, USB Biosignal Amplifier: Instruction for use
V2.16.01
page 34
16 Electromagnetic compatibility
Medical devices have to comply with special safety regulations regarding electromagnetic compatibility
(EMC). Please keep in mind the respective precautions in this instruction for use manual before
installing and operating g.HIamp. Pay attention to the fact that mobile HF-communication devices (e.g.
mobile phones) may interfere with medical electric devices. g.HIamp must not be used nearby or
stockpiled with other devices. Only the original
components for g.HIamp (see Chapter “g.HIamp basic
components”) from g.tec medical engineering GmbH are to be used for this device. Using third party
manufacturer accessories may result in increased emission or decreased functional immunity of
g.HIamp. 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.
Following values are below the values given by IEC 60601-1-2 for electromagnetic immunity testing:
Immunity test
IEC 60601 test level
Compliance level
Conducted RF IEC 61000-4-6
3 V
eff
150 kHz to 80 MHz
1
1
V
in V
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
1
1
E
in V/m
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 500 V for power supply
lines
all other < 3 m
The lower compliance levels are allowed (according to normative IEC60601-1-2, top 36.202.1 A) as
g.HIamp must be able to accurately measure biosignals having very low amplitudes. Using
electromagnetic interference suppression would yield to an inappropriate too low signal to noise ratio
for g.HIamp.