Electromagnetic Immunity - Immunity Test - BCI WW1020 Operation Manual

Appendix A: Guidance and Manufacturer's Declaration

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
Electrostatic ±6 kV contact
discharge (ESD)
±8 kV air
IEC 61000-4-2
Electrical fast ±2 kV for power supply
transient/burst lines.
IEC 61000-4-4 ±1 kV for input/output
lines
Surge ±1 kV differential mode
IEC 61000-4-5
±2 kV common mode
Voltage dips, short
<5% U
interruptions, and
(>95% dip in U
voltage variations
for 0.5 cycle
on power supply
input lines
<40% U
(>60% dip in U
IEC 61000-4-11
for 5 cycles
<70% U
(>30% dip in U
for 25 cycles
<5% U
(>95% dip in U
for 5 sec
Power frequency 3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
Note: U is the a.c. mains voltage prior to application of the test level.
T
A-2
COMPLIANCE
LEVEL
±6 kV contact
±8 kV air
±2 kV for power
supply lines.
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common
mode
<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
3 A/m
ELECTROMAGNETIC
ENVIRONMENT –
GUIDANCE
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 typical commercial
or hospital environment.
Mains power quality should
be that of typical commercial
or hospital environment.
Mains power quality
T
should be that of typical
)
T
commercial or hospital
environment. If the user
of the WW1020/WW1000
T
pulse oximeter requires
)
T
continued operation during
power mains interruptions,
it is recommended that the
T
WW1020/WW1000 pulse
)
T
oximeter be powered from
an uninterruptible power
supply or a battery.
T
)
T
Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial or hospital
environment.
Clinician's Operation Manual