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Table 12.
Guidance and Manufacturer's Declaration —Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the
user of the system should ensure that it is used in such an environment.
IMMUNITY TESTS
Conducted
RF: conducted
immunity on all
ports
IEC 61000-4-6
Conducted
RF: conducted
immunity on
patient coupling
ports
IEC 61000-4-6
Radiated
RF: hospital
environment
IEC 61000-4-3
Radiated RF:
home healthcare
environment
IEC 61000-4-3
Note:
Ut
is the AC mains voltage prior to application of the test level.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
34
0900-5165 REV-00
IEC 60601 TEST LEVEL
3 Vrms at 0.15 MHz–80
MHz AC/DC/Signal lines
6 Vrms for ISM and
Amateur Radio Bands
between 0.15 MHz–80
MHz
3 Vrms at 0.15 MHz–80
MHz and 480.0498 kHz
6 Vrms for ISM and
Amateur Radio Bands
between 0.15 MHz–80
MHz, 3 sec dwell time
3 V/m
80 MHz–2.7 GHz
80% AM at 1 kHz
10 V/m
80 MHz–2.7 GHz
80% AM at 1 kHz
COMPLIANCE
ELECTROMAGNETIC ENVIRONMENT –
LEVEL
Portable and mobile RF
communications equipment should
be used no closer to any part of the
system, including cables, than the
recommended separation distance
In compliance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d (m)
√P
d=1.2
Interference may occur in the vicinity
of equipment marked with the following
symbol:
In compliance
GUIDANCE
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