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Guidance and manufacturer’s declaration — electromagnetic immunity
The Z2 CPAP System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Z2 CPAP System should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment —
guidance
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 Z2 CPAP
System is used exceeds the applicable RF compliance level above, the Z2 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 Z2 CPAP System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Conducted RF
IEC61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3V
3V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Z2 CPAP System, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d =1.2 √P
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) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (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:
Recommended separation distances between portable and mobile
RF communications equipment and the Z2 CPAP System
The Z2 CPAP System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Z2 CPAP System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Z2 CPAP System as recommended below,
according to the maximum output power of the communications equipment.
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
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.
WARNINGS:
Please note that mobile RF communications equipment can affect medical electrical equipment.
Wireless Quality of Service for Z2 Bluetooth Communication
with Z2 Mobile App
The Z2 and Mobile App utilize only a very small fraction of the available bandwidth and
throughput. Based on this, the Z2 and Mobile App are highly tolerant of reductions in wireless
quality of service and performance will not be affected until service is essentially lost. Wireless
connectivity is not part of the essential performance of the Z2. All functions of the Z2 can be
performed on the Z2 unit itself. The Mobile App and Z2 are tested for coexistence with other in-
band radio frequency sources. The Bluetooth hardware module is FCC listed, and complies with
FCC PART 15 SUBPART C.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Rated maximum
output power of
transmitter W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
d =1.2 √P
80 MHz to 800 MHz
d =1.2 √P
800 MHz to 2,5 GHz
d =2.3 √P
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