CADENCE II Fetal Monitor User Manual
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A5.2 Electromagnetic Immunity – for all EQUIPMENT and
SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The CADENCE II Fetal Monitor is intended for use in the electromagnetic environment specified
below. The customer or the user of CADENCE II Fetal Monitor 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
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood,
concrete or ceramic tile. If floor
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 2 kV 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 to line
± 2 kV line to ground
± 1 kV line to line
± 2 kV line to ground
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency
(50Hz, 60Hz)
magnetic field
IEC61000-4-8
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5% U
T
(> 95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 sec
< 5% U
T
(> 95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip in U
T
)
for 5 cycles
70% U
T
(30% dip in U
T
)
for 25 cycles
< 5% U
T
(> 95% dip in U
T
)
for 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the CADENCE II Fetal
Monitor requires continued
operation during power mains
interruptions, it is recommended
that the CADENCE II Fetal
Monitor be powered from an
uninterruptible power supply or
a battery.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.