Appendix A: Guidance and Manufacturer’s Declaration
Clinician’s Operation Manual
A-3
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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5 GHz
2 Hz Modulation
20 V/m
80 MHz to 2.5 GHz
1kHz Modulation
3 Vrms
3 V/m
20 V/m
Portable and mobile RF
communication equipment should
be used no closer to any part
of the WW1020/WW1000 pulse
oximeter, including cable, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
d = 1.2√P
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
d = 0.18√P 80 MHz to 800 MHz
d = 0.35√P 800 MHz to 2.5 GHz
where
P
is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and
d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,
a
should be less than the compliance
level in each frequency range.
b
Interference may occur in the
vicinity of equipment marked with
the following symbol:
4
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed RF transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the WW1020/WW1000 pulse oximeter is used exceeds the applicable RF transmitter compliance level
above, the WW1020/WW1000 pulse oximeter should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the
WW1020/WW1000 pulse oximeter.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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