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Table 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 a professional healthcare facility electromagnetic
environment with the immunity compliance levels specified below� The customer or the user of the Visual-ICE
Cryoablation System should assure that it is used in such an environment�
Immunity Test IEC 60601 Test Level Compliance Level
Conducted RF
3 Vrms, 6 Vrms in
IEC 61000-4-6
ISM bands over
150 kHz to 80 MHz
80 % AM at 1 kHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2�7 GHz
80 % AM at 1 kHz
Radiated RF
9 V/m – 28 V/m per
Proximity fields
IEC 60601-1-2 Ed� 4,
IEC 61000-4-3
Table 9
(per IEC 60601-
1-2 Ed� 4)
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�
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
a
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 Cryoablation System is used exceeds the applicable RF compliance level above, the Visual-ICE
Cryoablation 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 Cryoablation System�
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m�
b
Electromagnetic environment - guidance
3 Vrms, 6 Vrms in
Portable and mobile RF communications
ISM bands over
equipment should be used no closer to any part
150 kHz to 80 MHz
of the Visual-ICE Cryoablation System, including
80 % AM at 1 kHz
cables, than the recommended separation
distance calculated from the equation applicable
3 V/m
to the frequency of the transmitter�
80 MHz to 2�7 GHz
Recommended separation distance:
80 % AM at 1 kHz
9 V/m – 28 V/m per
IEC 60601-1-2 Ed� 4,
Table 9
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 meters (m)�
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
should be less than the compliance level in each
frequency range
Interference may occur in the vicinity of
equipment marked with the following symbol:
21
80 MHz to 8200 MHz
800 MHz to 2�5 GHz
�
b
,
a
Black (K) ∆E ≤5.0
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