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Tab. 2) Guidance and manufacturer’s declaration - electromagnetic immunity
The Device is intended for use in the electromagnetic environment specified below. The customer or the user of the
Device should assure that it is used in such an environment
Immunity test
IEC 60601 Test level
Compliance level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %
Electrical fast
transient/burst
IEC 61000-4-4
Power supply
lines :±2 kV
input/output lines:±1 kV
Not applicable
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV
100 kHz repetition frequency
Not applicable
Mains power quality
should be that of a typical
commercial or hospital
environment.
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