Appendix A: Guidance and Manufacturer’s Declaration
A-2
Clinician’s Operation Manual
Electromagnetic Immunity - Immunity Test
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The WW1020/WW1000 pulse oximeter is intended for use in the electromagnetic environment
specified below. The customer or end user of the WW1020/WW1000 pulse oximeter should
ensure 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 floors 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.
±1 kV for input/output
lines
±2 kV for power
supply lines.
±1 kV for input/
output lines
Mains power quality should
be that of typical commercial
or hospital environment.
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 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 typical
commercial or hospital
environment. If the user
of the WW1020/WW1000
pulse oximeter requires
continued operation during
power mains interruptions,
it is recommended that the
WW1020/WW1000 pulse
oximeter be powered from
an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial or hospital
environment.
Note: U
T
is the a.c. mains voltage prior to application of the test level.
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