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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
±6 kV cont act
±8 kV air
±6 kV cont act
±8 kV air
Floors should be wood, con-
crete 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
IEC61000-4-5
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.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT (>95%
dip in UT ) for 0.5
cycle
40% UT (60% dip in
UT ) for 5 cycles
70% UT (30% dip in
UT ) for 25 cycles
<5% UT (>95% dip
in UT ) for 5 s
not applicable Mains power quality should
be that of a typical commercial
or hospital environment. If
the user of the device requires
continued operation during
power mains interruptions,
it is recommended that the
device be powered from an
uninterruptible power supply
or a battery.
Power
frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels cha-
racteristic of a typical location
in a typical commercial or
hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
EMC GUIDANCE
147


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