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Table 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
Power supply
lines: ±2 kV
Mains power quality should be that of a
typical commercial or hospital environ-
ment.
Surge IEC 61000-
4-5
line(s) to line(s):
±1 kV.
line(s) to earth:
±2 kV.
100 kHz repeti-
tion frequency
line(s) to line(s):
±1 kV.
100 kHz repeti-
tion frequency
Mains power quality should be that of a
typical commercial or hospital environ-
ment.