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11-6
ClosureRFG Radiofrequency Generator
Electromagnetic Compliance (EMC)
Electromagnetic Immunity
Guidance and manufacturer’s declaration - electromagnetic immunity
The ClosureRFG radiofrequency generator is intended for use in the electromagnetic
environment specified below. The customer or the user of the ClosureRFG generator should
assure that it is used in such an environment.
IMMUNITY test
IEC 60601 test
level
Compliance
level
Electromagnetic environment
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors shall be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/ burst
IEC 61000-4-4
± 2 kV for
power supply
lines
± 1 kV for
input / output
lines
± 2 kV for
power supply
lines
Not applicable
Mains power quality should be that of
a typical commercial or hospital
environment. If disruption in power
occurs, it may be necessary to reset the
unit by disconnecting and reconnecting
the catheter.
Surge IEC
61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
<5% UT
(>95% dip in
UT) for 0.5
cycle
40% UT (60%
dip in UT) for 5
cycles
70% UT (30%
dip in UT) for
25 cycles
<5% UT
(>95% dip in
UT) for 5 s
<5% UT
(>95% dip in
UT) for 0.5
cycle
40% UT (60%
dip in UT) for 5
cycles
70% UT (30%
dip in UT) for
25 cycles
<5% UT
(>95% dip in
UT) for 5 s
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
ClosureRFG generator requires
continued operation during power
interruptions, it is recommended that
the ClosureRFG generator be powered
from an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be a levels characteristic of a
typical location in a typical commercial
or hospital environment.