Medela Thopaz - Page 48

EMC
Technical documentation | 48
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 environment.
Immunity
Tests
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
test level
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Compliance
level
10 Vrms
10 V/m
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of Thopaz, including cables, than the
re
commended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 0.35 √ P
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 recom-
mended separation distance in meters (m)
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
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:
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 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.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.