BTG Visual-ICE, Руководство пользователя

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Visual-ICE™ Cryoablation System
8-5
Table 8-4. Electromagnetic Immunity for Systems that are Not Life-supporting
Guidance and manufacturer’s declaration – electromagnetic immunity
The Visual-ICE Cryoablation System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Visual-ICE System should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part of
the Visual-ICE System, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
80 MHz to 800 MHz
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 recommended
separation distance in metres (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:
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 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 the Visual-ICE System is
used exceeds the applicable RF compliance level above, the Visual-ICE System should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the Visual-ICE System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.