Medela Invia Ease Clinician Instructions For Use page 55

Guidance and manufacturer's declaration – electromagnetic immunity
This Invia Ease pump is intended for use in the electromagnetic environment specified below.
The customer or the user of the Invia Ease pump should assure that it is used in such an
environment.
IEC 60601
Immunity test
test level
Conducted RF 3 Vrms
IEC 61000- 150 kHz to
4-6 80 MHz
outside ISM band
6 Vrms
150 kHz to
80 MHz
in ISM and
amateur radio
bands
Radiated RF 10 V/m
IEC 61000- 80 MHz to
4-3 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.
Compliance Electromagnetic environment –
level guidance
Except as indicated in the table on the
next page, portable and mobile RF
communications equipment should be
used no closer to any part of the Invia
Ease pump, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommend separation distance
3 Vrms d = 1.2√P
6 Vrms d = 2.0√P
10 V/m d = 0.35√P 80 MHz to 800 MHz
d = 0.7√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 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.
should be less than the
a
International regulations
b
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