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Table 3:
Guidance and manufacturer’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below.
The customer the user of the Pulse Oximeter should assure that it is used in such environment.
Immunity test
IEC 60601 test level
Compliance level
Radiated RF
IEC61000-4-3
10 V/m 80 MHz- 2.7 GHz
10 V/m80 MHz- 2.7 GHz
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 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 Pulse Oximeter is used exceeds the
applicable RF compliance level above, the 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 Pulse Oximeter.
b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m.
