11. Electromagnetic Compatibility (EMC)
Guidance and manufacturer's declaration – electromagnetic immunity
This breast pump is intended for use in the electromagnetic environment
specified below. The customer or the user of the breast pump should assure
that it is used in such an environment.
Immunity test
Electrostatic
discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC
61000-4-1 1
32
IEC 60601
test level
± 8 kV contact
discharge
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
air discharge
± 2 kV, 100 kHz
repetition
frequency
± 0.5 kV, ± 1 kV
Line-to-lin e
0 % UT ; 0.5
cycle
At 0°, 45°, 90°,
.
135°,
180°, 225°, 270°,
and
315°
0% UT;1 cycle
At 0°
70% UT; 25
cycles
At 0°
0% UT; 250
cycles
Compliance
Electromagnetic
environment – guidance
level
Floors should be wood,
± 8 kV contact
concrete or ceramic tile.
discharge
If floors are covered with
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
synthetic material,
air discharge
the relative humidity
should be at least 30%.
± 2 kV, 100 kHz
repetition
frequency
± 0.5 kV, ± 1 kV
Line-to-lin e
0 % UT ; 0.5
cycle
At 0°, 45°, 90°,
135°,
180°, 225°, 270°,
and
315°
0% UT;1 cycle
At 0°
70% UT; 25
cycles
At 0°
0% UT; 250
cycles
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.