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TRUSCULPT OPERATOR MANUAL
D1395, REV. K, 02/18
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The truSculpt system is intended for use in the electromagnetic environment specified below. The customer or
the user of the truSculpt system should ensure that it is used in such environment.
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic Environment:
Guidance
Electrostatic
Discharge (ESD)
IEC61000-4-2
±6kV contact
±8kV air
±2, 4, 6kV contact
±2, 4, 8kV air
Floor should 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
IEC61000-4-4
±2kV for power supply
lines
±1kV for input/output
lines
±2kV line to ground
±1kV line to line
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC61000-4-5
±1kV differential mode
±2kV common mode
±0.5, 1kV
differential mode
±0.5, 1, 2kV
common mode
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
IEC61000-4-11
<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 sec.
<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 sec.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the truSculpt
system requires continued operation
during power mains interruptions, it is
recommended that the truSculpt system
be powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m N/A Power-frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
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