CareFusion AVEA Operating Instructions Manual page 253

AVEA ventilator systems
G
The AVEA Ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the AVEA
Ventilator should assure that it is used in such an environment
Immunity Test
Conducted RF 3 Vrms
150 kHz to 80 MHz
IEC 61000-4-6 outside ISM bands
10 Vrms
150 kHz to 80 MHz
In ISM bands
10 V/m
Radiated RF
80 MHz to 2,5 GHz
IEC 61000-4-3
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 absorbtion and reflection from structures, objects
and people.
The ISM (industrial, scientific, and medicinal) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to
a
13,567 MHz; 26,957 MHz to 27, 283 MHz; and 40,66 MHz to 40,70 MHz.
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
b
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
c
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed FR transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the AVEA Ventilator is used exceeds the applicable RF compliance level above, the AVEA Ventilator should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the AVEA Ventilator.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d
L2786 Rev. M
60601-1-2 IEC:2001 (E) Table 203
uidance and manufacturer's declaration - electromagnetic immunity
IEC 60601 Compliance level
Test level
a
a
Electromagnetic environment - guidance
Portable and mobile RF communications equipment should
be used no closer to any part of the AVEA Ventilator,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
3 V
10 V
10 V/m
Where is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and
distance in metres (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey,
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
80 MHz to 800 MHz
800 MHz to 2.5 GHz
is the recommended separation
b
should be less than the
c
d
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