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Guidance and manufacture’s declaration – electromagnetic immunity – for EQuIPMEnT and sYsTEMs that are not lIFE-suPPORTInG
Guidance and manufacture’s declaration – electromagnetic immunity
The SBM 38 blood pressure monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the SBM 38
blood pressure monitor 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
3 V
rms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 V
rms
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the SBM 38
blood pressure monitor, including cables, than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance:
d
=
d
=
80 MHz to 800 MHz
d
=
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).
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:
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 SBM 38
blood pressure monitor is used exceeds the applicable RF compliance level above, the SBM 38 blood pressure monitor should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
SBM 38 blood pressure monitor.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.