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EMC Declaration (Continued)
Guidance and manufacturer’s declaration – electromagnetic immunity
The “XXX” is intended for use in the electromagnetic environment specified below. The customer or
the user of the “XXX” should ensure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment
–
guidance
Portable and mobile RF communications
equipment
should be used no closer to any part of the
“XXX”, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 V
d=1.2
√
P
d=1.2 √
P 80MHz to 800MHz
d=2.3
√
P 800MHz to 2.5 GHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
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
b
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 “XXX” is
used exceeds the applicable RF compliance level above, the Medical XXX should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the “XXX”.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [
V
1] V/m.