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Table 3. Electromagnetic Immunity
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
Electrostatic
± 8 kV contact
discharge (ESD)
± 15 kV air
IEC 61000-4-2
Electrical fast
± 2 kV for power supply
transient/burst
lines
IEC 61000-4-4
± 1 kV for input/output
lines
Surge
± 0�5 kV, ± 1 kV line(s) to
IEC 61000-4-5
line(s)
± 0�5 kV, ± 1 kV, ± 2 kV
line(s) to earth
Voltage
0 % U
dips, short
45°, 90°, 135°, 180°, 225°,
interruptions
270°, and 315°�
and voltage
0 % U
variations on
70 % U
power supply
cycles at 0° and
input lines
50Hz/60Hz�
IEC 61000-4-11
0 % U
cycles at 50Hz/60Hz�
Power frequency
30 A/m
(50 Hz/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: U
is the a�c� mains voltage prior to application of the test level�
T
Black (K) ∆E ≤5.0
Compliance Level
± 8 kV contact
± 15 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 0�5 kV, ± 1 kV line(s) to
line(s)
± 0�5 kV, ± 1 kV, ± 2 kV
line(s) to earth
; 0�5 cycle at 0°,
0 % U
T
T
45°, 90°, 135°, 180°, 225°,
270°, and 315°�
; 1 cycle
0 % U
T
T
; 25 cycles/30
70 % U
T
cycles at 0° and
50Hz/60Hz�
; 250 cycles/300
0 % U
T
T
cycles at 50Hz/60Hz�
30 A/m
Electromagnetic environment -
guidance
Floors should be wood, concrete or
ceramic tile� If floors are covered with
synthetic material, the relative humidity
should be at least 30 %�
Mains power quality should be that
of a typical commercial or hospital
environment�
Mains power quality should be that
of a typical commercial or hospital
environment�
; 0�5 cycle at 0°,
Mains power quality should be that
of a typical commercial or hospital
environment� If the user of the Visual-ICE
; 1 cycle
Cryoablation System requires continued
; 25 cycles/30
operation during power mains
T
interruptions, it is recommended that
the Visual-ICE Cryoablation System be
; 250 cycles/300
powered from an uninterruptible power
supply or a battery�
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment�
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