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34
0900-5165 REV-00
Table 12. Guidance and Manufacturer’s Declaration —Electromagnetic Immunity
The system is intended for use in the electromagnetic environment specied below. The customer or the
user of the system should ensure that it is used in such an environment.
IMMUNITY TESTS IEC 60601 TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT –
GUIDANCE
Conducted
RF: conducted
immunity on all
ports
IEC 61000-4-6
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
In compliance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
system, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d (m)
d=1.2 √P
Conducted
RF: conducted
immunity on
patient coupling
ports
IEC 61000-4-6
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
Radiated
RF: hospital
environment
IEC 61000-4-3
3 V/m
80 MHz–2.7 GHz
80% AM at 1 kHz
In compliance
Interference may occur in the vicinity
of equipment marked with the following
symbol:
Radiated RF:
home healthcare
environment
IEC 61000-4-3
10 V/m
80 MHz–2.7 GHz
80% AM at 1 kHz
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 aected by absorption and
reection from structures, objects and people.

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