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Aeroge
168 PB
Guidance and manufacturer’s declaration - electromagnetic immunity
This Aerogen Solo nebuliser system is intended for use in the electromagnetic
environment specified below. The customer or the user of the Aerogen Solo nebuliser
system should assure that it is used in such an environment.
Immunity Test IEC/EN 60601
Test Level
Compliance
Level
Electromagnetic
Environment - Guidance
Conducted RF
IEC/EN 61000-4-6
Radiated RF
IEC/EN 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the Aerogen Solo nebuliser
system, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended Separation Distance
d = [1.17] √P
d = [1.17] √P... 80MHz to 800MHz
d = [2.33] √P... 800MHz to 2.5GHz
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 separation distance for 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 Aerogen Solo nebuliser system is used exceeds the applicable RF
compliance level above, the Aerogen Solo nebuliser system should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orientating or relocating the Aerogen Solo nebuliser system.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m
40


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