Guidance and manufacture’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The YP-970 Infant Incubator is intended for use in the electromagnetic environment specified below. The customer or
the user of YP-970 Infant Incubator should assure 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
3V
rms
150 kHz to 80 MHz
outside ISM bands
a
10 V
rms
150 kHz to 80 MHz
in ISM bands
10 V/m
80 MHz to 2.5 GHz
3 V
rms
10 V
rms
10 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the YP-970
Infant Incubator, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
P
V
d
⎥
⎦
⎤
⎢
⎣
⎡
=
1
5.3
80 MHz to 800 MHz
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 metres (m).
b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
c
should be less than the compliance level in each
frequency range.
d
Interference may occur in the vicinity of equipment
marked with the following symbol:
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
The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to 6.795MHz; 13.553
MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range 80 MHz
to 2.5GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in
calculating the recommended separation distance for transmitters in these frequency ranges.
c
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 YP-970 Infant Incubator is used
exceeds the applicable RF compliance level above, the YP-970 Infant Incubator should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the YP-970 Infant Incubator.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
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