Galil Visual-ICE MRI, Руководство пользователя

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11-6 User Manual
Table 11-4. Electromagnetic Immunity for Systems that are Not Life-supporting
Guidance and manufacturer’s declaration – electromagnetic immunity
The Visual-ICE MRI Cryoablation System is intended for use in a professional healthcare facility
electromagnetic environment with the immunity compliance levels specified below. The customer or the user of
the Visual-ICE MRI 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
Radiated RF
Proximity fields
IEC 61000-4-3
(per IEC 60601-
1-2 Ed. 4)
3 Vrms, 6 Vrms in
ISM bands over
150 kHz to 80 MHz
80% AM at 1 kHz
3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
9 V/m – 28 V/m
per IEC 60601-1-2
Ed. 4, Table 9.
3 Vrms, 6 Vrms in
ISM bands
150 kHz to 80 MHz
80% AM at 1 kHz
3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
9 V/m – 28 V/m
per IEC 60601-1-2
Ed. 4, Table 9.
Portable and mobile RF communications
equipment should be used no closer to any part
of the Visual-ICE MRI 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 MRI
System is used exceeds the applicable RF compliance level above, the Visual-ICE MRI 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 MRI System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.