9-4 User Manual
Table 9-3. Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The ICEfx Cryoablation System is intended for use in a professional healthcare facility electromagnetic
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
Floors should be wood, concrete or
Electrical fast
transient/burst
± 2 kV for power supply
lines
±1 kV for input/output
lines
± 2 kV for power
supply lines
±1 kV for input/output
lines
Mains power quality should be that
of a typical commercial or hospital
Surge
to line(s)
± 2 kV line(s) to earth
line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that
of a typical commercial or hospital
Voltage dips, short
interruptions and
on power supply
input lines
U
T
U
T
; 1 cycle
U
T
U
T
U
T
U
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; 1 cycle
U
U
T
cycles
Mains power quality should be that
of a typical commercial or hospital
ICEfx System requires continued
operation during power mains
interruptions, it is recommended that
the ICEfx System be powered from
an uninterruptible power supply or a
battery.
Power frequency
magnetic field
typical location in a typical commercial
NOTE: U
T