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GUIDANCE AND MANUFACTURER’S DECLARATION :
ELECTROMAGNETIC IMMUNITY
The device is intended for use in the electromagnetic environment specied 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)
lEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile. If
oors are covered with synthetic material, the relative
humidity should be at least 30%. If ESD interfere with
the operation of equipment, counter measurements
such as wrist strap, grounding shall be considered.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
Not applicable
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1kV dierential
mode
±2kV common
mode
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 sec
Not applicable
Mains power quality should be that of typical commercial
or hospital environment. If the user of the device requires
continued operation during power mains interruptions,
it is recommended that the devices be powered
from an uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3A/m 3A/m
Power frequency magnetic elds should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
E-IM-MediStim-001.indd 18 19/12/2017 14:45:35
18


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