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Guidance and manufacturer's declaration – electromagnetic immunity (cont.)
IEC 60601
Immunity test
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV
contact discharge
Electrostatic
discharge (ESD)
+/- 2kV, +/- 4kV,
IEC 61000-4-2
+/- 6 kV, +/- 8kV,
+/- 15 kV
air discharge
± 2 kV
Electrical fast
100 kHz
transient/burst
repetition
IEC 61000-4-4
frequency
± 0,5 kV, ± 1 kV
Surge
Line-to-line
IEC 61000-4-5
Voltage
dips, short
0 % UT; 0,5 cycle
interruptions
At 0°, 45°, 90°,
and voltage
135°, 180°, 225°,
variations on
270°, and 315°
power supply
input lines IEC
61000-4-11
Power
frequency
30 A/m, 50 or
(50/60 Hz)
60 Hz
magnetic field
IEC 61000-4-8
NOTE: U
is the a.c. mains voltage prior to application of the test level.
T
Compliance
test level
level
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV
contact discharge
+/- 2kV, +/- 4kV,
+/- 6 kV, +/- 8kV,
+/- 15 kV
air discharge
± 2 kV
100 kHz repetition
frequency
± 0,5 kV, ± 1 kV
Line-to-line
0 % UT; 0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270°, and 315°
30 A/m, 50/60 Hz
Electromagnetic environment
– guidance
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the breast
pump requires continued operation
during power mains interruptions, it is
recommended that the breast pump
be powered from an uninterruptible
power supply or a battery.
It may be necessary to position the
breast pump further from sources
of power frequency magnetic fields
or to install magnetic shielding. The
power frequency magnetic field
should be measured in the intended
installation location to assure that it is
sufficiently low.
33

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