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Appendix
EMC
Guidelines and manufacturer's declaration – electromagnetic immunity –
The flexible video cysto-urethroscope 11272VUE/VUE-R in combination with the compatible CCU is designed for operation in an electromagnetic environment
as defined below. The user of the device should make sure that it is used in such an environment.
Interference immunity
EN/IEC 60601 test
tests
level
Conducted HF
3 V
disturbances acc. to
rms
150 kHz to 80 MHz
IEC 61000-4-6
Radiated RF disturbances
3 V/m
acc. to 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. The propagation of electromagnetic quantities is affected by absorptions and reflections of
buildings, objects and persons.
Field strengths from fixed transmitters, such as base stations for radio [cellular/cordless] telephones and land mobile radios, amateur radio, AM and
a)
FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to stationary
transmitters, an electromagnetic site survey should be considered. If the measured field strength at the location where the device is used exceeds the
above compliance levels, the device should be monitored to ensure proper function. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the device.
b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Annexe
CEM
Table 4
for medical electrical devices that are not life-supporting
Conformity level
3 V
rms
3 V/m
Anexo
CEM
Electromagnetic environment – guidelines
Portable and mobile RF communications equipment should be
used no closer to any part of the flexible video cysto-urethroscope
11272VUE/VUE-R in combination with the compatible CCU including
cables than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance:
A
150 kHZ to 80 MHz
A
80 MHz to 800 MHz
E
800 MHz to 2.5 GHz
Where P is the rated power of the transmitter in watts [W] according
to the information provided by the manufacturer of the transmitter
and d is the recommended 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 equipment marked with the
following symbol:
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