ResMed Elisee 350 Clinical Manual page 106

Note 1: U
Note 2: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 3: It is possible that these guidelines do not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a The ISM (Industrial, Scientific, and Medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567
MHz; 26.957 MHz to 27 .283 MHz; and 40.66 MHz to 40.70 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range from 80 MHz to 2.5 GHz
are intended to reduce the probability of interference that the portable and mobile communications equipment may produce if it is
introduced inadvertently into patient environment. For this reason, an additional factor of 10/3 was introduced into the formulae used to
calculate the recommended separation distance for these transmitters in these frequency ranges.
c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and 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 Elisée 350 is used exceeds the applicable RF compliance level above, the Elisée 350 should be observed in this environment to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Elisée 350.
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
WARNING
The Elisée 350 must not be used in the vicinity of other equipment or placed on or beneath
other equipment (see the following table). If this is the case, ensure that it works correctly
when placed in the location where it will be used.
Recommended separation distances between portable and mobile
RF communications equipment and the Elisée 350
The Elisée 350 is intended for use in an environment in which radiated RF disturbances are
controlled. The customer or the user of the Elisée 350 can help prevent electromagnetic
interference by maintaining the minimum separation distances between portable and mobile RF
communications equipment (transmitters) and the Elisée 350 as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed in the table 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: The ISM (Industrial, Scientific, and Medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27 .283 MHz; and 40.66 MHz to 40.70 MHz.
Note 3: An additional factor of 10/3 was introduced into the formulae used to calculate the recommended separation distance for the
transmitters in the ISM frequency bands, between 150 kHz and 80 MHz and in the frequency range from 80 MHz to 2.5 GHz; it is intended
to reduce the probability of interference that the portable and mobile communications equipment may produce if it is introduced
inadvertently into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
100/102
is the voltage of the AC network, prior to application of the test level, included between 100 and 240 VAC.
T
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
outside of ISM band
P
d=1.1
0.12
0.37
1.17
3.7
11.7
150 kHz to 80 MHz 80 MHz to 800 MHz
inside the ISM band
d=1.2
P
d=1.2
0.12 0.12
0.38 0.38
1.2 1.2
3.80 3.80
12 12
800 MHz to 2.5 GHz
P
P
d=2.3
0.23
0.73
2.3
7 .27
23
NOT013281-8