Arcomed Volumed mVP7000 Manuel Utilisateur page 32

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Guidance and manufacturer's declaration - electromagnetic immunity
The Volumed µVP7000 Series is intended for use in the electromagnetic environment specified below. The customer or the user of
the Volumed µVP7000 Series should assure that it is used in such an environment.
IEC 60601 test
Immunity test
level
Conducted RF
3 V
IEC 61000-4-6
rms
150 kHz to 80 MHz
outside ISM bands
10 V
rms
150 kHz to 80 MHz
in ISM bands
Radiated RF
10 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
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
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 40.7 MHz.
b
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.
c
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 Volumed µVP7000 Series is used exceeds the applicable RF compliance
level above, the Volumed µVP7000 Series should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Volumed µVP7000 Series.
d
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 10 V/m.
GA-7000-F 0707.doc
Compliance
level
Portable and mobile RF communications equipment should not be used no
closer to any part of the Volumed µVP7000 Series, including cables, than
the recommended separation distance caculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
10 V
d = 0.35√P
a
10 V
d = 1.2√P
b
10 V/m
d = 1.2√P 80 MHz to 800 MHz
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).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,
each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
Electromagnetic environment - guidance
b
c
should be less than the compliance level in
d
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