Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Medela Pump In Style Advanced Mode D'emploi

15. EMC / Technical Description (cont.)
Guidance and manufacturer's declaration – electromagnetic immunity
This breast pump is intended for use in the electromagnetic environment specified below. The
customer or the user of the breast pump should assure that it is used in such an environment.
Immunity IEC 60601
test test level
3 V
Conducted RF
0,15 MHz – 80 MHz
IEC 61000-4-6
6 V in ISM and
amateur radio
bands between 0,15
MHz and 80 MHz
80% AM at 1 kHz
10 V/m (minimum)
Radiated RF
80 MHz – 2,7 GHz
IEC 61000-4-3
80 % AM at 1 kHz
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 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 breast pump is used exceeds the applicable RF
compliance level above, the breast pump should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the breast pump.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
42
Compliance Electromagnetic
level environment – guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the breast pump, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommend separation distance
d
= 1,2
6V
d
= 1,2√P 80 MHz - 800 MHz
d
= 2,3√P 800 MHz - 2.7 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
10 V/m
site survey,
(minimum)
compliance level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol.
√
P
a should be less than the