CoolSculpting® Elite
System User Manual
System Specifications
CS-UM-CM3-02-EN-D
69
Table 27: Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions CISPR 11
Group 1
The system uses RF energy only for its internal function;
therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF Emissions CISPR 11
Class A
(A) The system is suitable for use in all establishments other
than domestic, and may be used in domestic establishments
and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes, provided the following warning statement is
heeded:
CAUTION:
The system is intended for use by healthcare
professionals only. The system may cause radio interference
or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as reorienting or
relocating the system or shielding the location.
The EMISSIONS characteristics of this equipment make it
suitable for use in industrial areas and hospitals (CISPR 11
class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might
not offer adequate protection to radio-frequency
communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the
equipment.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Class A
Table 28: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic
Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±2,4,6, 8kV contact
±2,4,8, 15kV air
Floors 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
IEC 61000-4-4
±2kV for power supply
lines
±1kV for input/output
lines
±2kV for line to ground
±1kV for line to line
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±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.
