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B-3
Guidance and Declaration - Electromagnetic Immunity
The device is suitable 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
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 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
(EFT)
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
(>3m)
±2 kV for power
supply lines
±1 kV for
input/output lines
(>3 m)
Surge
IEC 61000-4-5
±1 kV
differential mode
±2 kV common
mode
±1 kV
differential mode
±2 kV common
mode
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
<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
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the product requires
continued operation
during power mains
interruptions, it is
recommended that the
product be powered from
an uninterruptible power
supply or a battery.
87


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