Appendix C: Guidance and Manufacturer’s Declaration
Pulse Oximeter for Sleep Screening Operation Manual
C-3
IMMUNITY
ELECTROMAGNETIC ENVIRONMENT
GUIDANCE
Power frequency (50/60 Hz)
IEC 61000-4-8
IEC 60601 TEST LEVEL Power frequency magnetic fields should be the
typical levels of a:
Commercial environment
Hospital environment
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3 A/m
COMPLIANCE LEVEL
3 A/m
Conducted RF
IEC 61000-4-6
IEC 60601 TEST LEVEL Recommended separation distance:
d = 1.2
3 V rms
150 kHz to 80MHz
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COMPLIANCE LEVEL
3 Vrms 80% AM
modulation @ 1kHz
150 kHz to 80 MHz.
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Radiated RF
IEC 61000-4-3
IEC 60601 TEST LEVEL Recommended separation distance:
d = 0.35 √P 80 MHz to 800 Mhz
d = 0.70 √P 800 MHz to 2.5 GHz
3 V/m
80 MHz to 2.5 GHz
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COMPLIANCE LEVEL
10 V/m 80% AM
80 MHz to 2.5 GHz
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P
= Manufacturer’s output power in watts (W).
d
= Recommended distance in meters (m).
Field strengths from fixed RF transmitter watts (as determined by an electromagnetic site survey
a
, should
be less than the compliance level in each frequency range.
b
CAUTION! Interference may occur in the vicinity of equipment marked with the following symbol:
4
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: 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 3403 pulse oximeter is used exceeds the applicable RF transmitter compliance level above, the 3403
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 3403 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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