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Guidance and manufacturer's declaration
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electromagnetic immunity
The device is intended 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 (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV
contact ±15 kV air
Floors should be wood, concrete or ceramic tile. lf
floor are covered with synthetic materi- al, the
relative humidity should be at least 30%.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±2kV for power
supply lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5
± 1 kV line(s) to line(s)
±1 kV
differential 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 sec
<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) for25
cycles <5% UT
(>950/odip in UT) for 5
sec
Mains power quality should be that of a typical
commercial
or hospital environment. lf the user of the DEVICE
requires continued operation during power mains
interruptions,
it is recommended that the DEVICE be powered
from an uninterruptible power supply or a
battery.
Power frequency (50Hz/60Hz)
magnetic field IEC 61000-4-8
l0V/m
l0V/m
Power frequency magnetic field should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Note: Ur is the AC mains voltage prior to application of the test level.
40
EN