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APPENDIX II
Guidance and manufacturer's declaration – electromagnetic immunity
The patient care monitors are intended for use in the electromagnetic environment specified below.
The customer or the user of the monitor should assure that they are used in such an environment.
Immunity test
Electrostatic
±6 kV contact
discharge (ESD)
IEC 61000-4-2
±8 kV air
±2 kV for power
Electrical fast
supply lines
transient/burst
±1 kV for input/output
IEC 61000-4-4
lines
±1 kV differential
Surge
mode
IEC 61000-4-5
±2 kV common mode
<5% U
(>95% dip in U
for 0.5 cycle
40% U
Voltage dips, short
(60% dip in U
interruptions and
for 5 cycles
voltage variations
on power supply
70% U
input lines
(30% dip in U
IEC 61000-4-11
for 25 cycles
<5% U
(>95% dip in U
for 5 sec
Power frequency
(50/60 Hz)
3 A/m
magnetic field
IEC 61000-4-8
NOTE
U
is the a.c. mains voltage prior to application of test level.
T
IEC 60601
Compliance
test level
Complies
Complies
Complies
T
)
T
T
)
T
Complies
T
)
T
T
)
T
Complies
Appendix II-2
Electromagnetic environment -
level
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the monitor
requires continued operation, it is
recommended that the monitor be
powered from an uninterruptible power
supply or a battery.
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
User Manual
guidance
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