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Medela Thopaz+ Gebrauchsanweisung Seite 393

Cardiothoracic drainage
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Electromagnetic compatibility (EMC, IEC 60601-1-2:2007, Table 4)
Electromagnetic immunity
Thopaz + is intended for use in the electromagnetic environment specified below. The
customer or the user of Thopaz + should assure that Thopaz + is used in such an environment.
Immunity
IEC 60601
Tests
test level
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to
80 MHz
Radiated RF
3 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.
Field strengths from fixed RF transmitters, such as base stations for radio (cellular / cordless)
a
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 Thopaz + are used exceeds the applicable RF compliance level
above, Thopaz + should be observed to verify normal operation. If abnormal operation is observed,
additional measures may be necessary, such as reorienting or relocating Thopaz + .
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
b
Compliance
Electromagnetic environment – guidance
level
Portable and mobile RF communications equip-
ment should be used no closer to any part of
Thopaz + , including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
10 Vrms
d = 0.35 √ P
d = 0.35 √ P
80 MHz to 800 MHz
d = 0.7 √ P
10 V/m
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.
Interference may occur in the vicinity of
equipment marked with the following symbol:
a
b
Technical documentation
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