26
Doc. HD40-0007-02 En-Eu L-4
Guidance and manufacturer’s declaration — electromagnetic immunity
The
Z1
CPAP System is intended for use in the electromagnetic environment specified below. The
customer or the user of the
Z1
CPAP System should assure that it is used in such an environment.
Immunity test
IEC
60601 test
level
Compliance
level
Electromagnetic environment,
guidance
Portable and mobile RF communi-
cations equipment should be used
no closer to any part of the
Z1
CPAP
System, 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 Vrms
150 kHz to
80 MHz
d
= 1,2√P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
80 MHz to
2,5 GHz
d
= 1,2√P 80 MHz to 800 MHz
d
= 2,3√P 80 MHz to 2,5 GHz
where
P
is the maximum output power
rating of the transmitter in watts (W) ac-
cording to the transmitter manufacturer
and
d
is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmit-
ters, as deter-mined by an electromag-
netic 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) tele-
phones 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
Z1
CPAP System is used exceeds the applicable RF
compliance level above, the
Z1
CPAP System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the
Z1
CPAP System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
