Medela Invia Motion Mode D'emploi page 39

IEC 60601-1-2, Table 4
Electromagnetic Immunity
The Invia Motion NPWT System is intended for use in the electromagnetic environment
specified below. Users of the Invia Motion NPWT System should assure that they are
used in such environment.
Immunity
Tests
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-3
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 absorption and reflection from structures, objects and people.
a Field strengths from fixed RF 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 Invia Motion NPWT System are used exceeds the applicable RF compliance level above, Invia
Motion NPWT System should be observed to verify normal operation. If abnormal operation is observed,
additional measures may be necessary, such as reorienting or relocating Invia Motion NPWT System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
200_4169_ifu_invia_motion_patient_EN_ES_FR.indd 39
IEC 60601 Compliance
test level level
3 Vrms 10 Vrms
150 kHz to 80
MHz
With power
supply:
3 V/m
3 V/m
80 MHz to 2.5
80 MHz to 800
GHz
MHz
3 V/m
800 MHz to 2.5
GHz
Without
power supply
(battery):
10 V/m
80 MHz to 800
MHz
10V/m
800 MHz to 2.5
GHz
Electromagnetic
environment-guidance
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
Invia Motion NPWT System, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
√
d = 0.4 P
√
P
d = 1.2
80 MHz to 800 MHz
√
P
d = 2.3
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 recom-
mended separation distance in meters (m)
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of equip-
ment marked with the following symbol:
a
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