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Guidance and manufacture’s declaration – electromagnetic immunity
The DEVICE is intended for use in the electromagnetic environment specified below. The
customer or the user of DEVICE should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance level Electromagnetic environment
test level - guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete
discharge ±8 kV air ±8 kV air or ceramic tile. If floor are covered
(ESD) with synthetic material, the
IEC 61000-4-2 relative humidity should be at
least 30%.
Electrical fast ±2 kV for power ±2kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial
IEC 61000-4-4 or hospital environment.
Surge ± 1 kV line(s) to ±1 kV differential Mains power quality should be
IEC 61000-4-5 line(s) mode that of a typical commercial
or hospital environment.
Voltage dips,
<
5% UT
<
5% UT Mains power quality should be
short (
>
95% dip in UT) (
>
95% dip in UT) that of a typical commercial or
interruptions for 0.5 cycle for 0.5 cycle hospital environment. If the user
and voltage of the DEVICE requires continued
variations on 40% UT 40% UT operation during power mains
power supply (60% dip in UT) (60% dip in UT) interruptions, it is recommended
input lines for 5 cycles for 5 cycles that theDEVICE be powered from
IEC 61000-4-11 an uninterruptible power supply
70% UT 70% UT or a battery.
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
for 5 sec for 5 sec
<
5% UT
<
5% UT
(
>
95% dip in UT) (
>
95% dip in UT)
for 0.5 cycle for 0.5 cycle
for 5 sec for 5 sec
Power 3A/m 3A/m Power frequency magnetic fields
frequency should be at levels characteristic
(50Hz/60Hz) of a typical location in a typical
magnetic field commercial or hospital IEC
61000-4-8 environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.