Vitrolife EmbryoScope - Electromagnetic Immunity

EmbryoScope time-lapse incubator
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12.2 Electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The EmbryoScope time-lapse incubator is intended for use in the home healthcare environment
specified below. The customer or the user of the EmbryoScope time-lapse incubator 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
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 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-
4:2012
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 2 kV for power
supply lines
± 1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surges
IEC 61000-4-
5:2005
± 0.5 kV, ± 1 kV line-
to-line
± 0.5 kV, ± 1 kV,
± 2 kV line-to-ground
± 0.5 kV, ± 1 kV line-
to-line
± 0.5 kV, ± 1 kV,
± 2 kV line-to-ground
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-
11:2004
EUT:
Reduction of input
voltage to 0% for 0.5
cycles @ 0°, 45°, 90°,
135°, 180°, 225°, 270°
and 315°
Result:
PASS: No change in
operation. The system
remained safe.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the EmbryoScope time-lapse
incubator requires continued operation
during mains power interruptions, it is
recommended that the incubator be
powered from an uninterruptible power
supply or battery.
EUT remained safe during the test.
Reduction of input
voltage to 0% for 1
cycle @ 0°
PASS: No change in
operation. The system
remained safe.
Reduction of input
voltage to 70% for 30
cycles @ 0°
PASS: No change in
operation. The system
remained safe.
Reduction of input
voltage to 0% for 300
cycles
PASS: The system is
allowed to turn off as
long as it establishes
normal operation after
the test.
Power frequency
(50/60 Hz)
magnetic fields
IEC 61000-4-
8:2009
30 A/m
30 A/m
PASS: No change in
operation. The system
remained safe.
Power frequency magnetic fields should be
at levels characteristic of a typical
commercial or hospital environment.