System Specifications
CoolSculpting® Elite
System User Manual
70
CS-UM-CM3-02-EN-D
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment - Guidance
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% U
T
: 0.5 cycle at 0
o
,
45
o
, 90
o
, 135
o
, 180
o
,
225
o
, 270
o
, and 315
o
0% U
T
: 1 cycle and 70%
U
T
: 25/30 cycles
Single phase: at 0
o
0% U
T
: 250/300 cycle
0% U
T
: 0.5 cycle at 0
o
,
45
o
, 90
o
, 135
o
, 180
o
,
225
o
, 270
o
, and 315
o
0% U
T
: 1 cycle and 70%
U
T
: 25/30 cycles
Single phase: at 0
o
0% U
T
: 250/300 cycle
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the system requires continued
operation during power mains
interruptions, it is recommended
that the system be powered from
an uninterruptible power supply
or a battery.
*
U
T
is the AC mains voltage prior to application of the test level.
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
30A/m
30A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
Portable and mobile RF communications equipment should be used no closer to any part of the system,
including its cables, than the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended Separation Distance:
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1.17
√
P
Radiated RF
IEC 61000-4-3
3V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.2
√
P 80 MHz to 800 MHz
d = 2.3
√
P 800 MHz to 2.5 GHz
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 the 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:
RF Wireless
Communications
Equipment
IEC 61000-4-3
See Table 9 of EN
60601-1-2:2015.
See Table 9 of EN
60601-1-2:2015.
See table below for recommended
separation distances.
