Air
Life
®
nCPAP Driver Service Manual
2008, Cardinal Health
Page 79 of 81
Table 4: Guidance and Manufacturer's Declaration—Electromagnetic Immunity
The Air
Life
®
nCPAP System Driver is intended for use in the electromagnetic environment
specified below. The customer or user of the Air
Life
®
nCPAP System Driver should assure
that it is used in such an environment.
Immunity Test
IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment—
Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of
the Air
Life
®
nCPAP System Driver,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended Separation
Distance
IEC 61000-4-6
Conducted RF
3 V rms
150 kHz to 80 MHz
3 V rms
d
1.2
P
=
IEC 61000-4-3
Radiated RF
3 V/m
80 MHz to 2.5 GHz
3 V/m
d
1.2
P
=
80 MHz to 800 MHz
E
1
d
2.3
P
=
800 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).
a
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
should be less than the
compliance level in each
frequency range.
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.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz
are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended
separation distance for transmitters in these frequency ranges.
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 theoretically predicted 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 where the Air
Life
®
nCPAP System Driver is used exceeds the applicable RF compliance
level above, the Air
Life
®
nCPAP System Driver should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Air
Life
®
nCPAP System Driver.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
