CoolSculpting® Elite
System User Manual
CS-UM-CM3-02-EN-D
6
Foreword
The
CoolSculpting® Elite
System is a skin cooling or heating device. The system comprises of a control
unit, applicators, and supplies such as cards, gelpads, pretreatment skin wipes, liners, foam borders,
and comfort straps. The applicators, gelpads, pretreatment skin wipes, liners, foam borders, and
comfort straps are patient-applied parts.
During a treatment, the operator applies a gelpad and applicator to the patient’s skin. For a treatment
where two applicators are used simultaneously (Dual
CoolSculpting® Elite
treatment), a second
applicator is applied with another gelpad. The applicator(s) draw tissue into the applicator cup(s) and
hold the tissue against the cooling surfaces of the applicator(s). The operator then starts the treatment.
The Surface S150 applicator is a surface applicator and not have a cup. During the cooling cycle,
sensors in the cooling surfaces of the applicator(s) monitor the skin surface and provide feedback that
controls the rate of heat flux. The gelpad(s) protect the skin by providing thermal coupling at the
interface between the cooling surfaces of the applicator(s) and the skin. The Dual and Solo cards
provide treatments and profiles for use with the system.
Note:
Dual
CoolSculpting® Elite
treatment is to use Applicator A and Applicator B at the same time
during treatment.
Indications for Use
The
CoolSculpting® Elite
System is a skin cooling or heating device. It can be used in cooling or
heating mode, or in an optional massage mode. Table 1 lists the indications for use for each mode.
Table 1:
CoolSculpting® Elite
Intended Use
Mode
Indications
Cooling
•
Indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, back fat,
banana roll, thigh, abdomen and flank, or “love handles” in individuals with a Body Mass Index
(BMI) of 30 or less.
•
Intended for cold-assisted lipolysis of the submental and submandibular areas in individuals
with a BMI up to 46.2.
•
Intended to affect the appearance of visible fat bulges in the upper arm, bra fat, back fat,
banana roll, submental and submandibular areas, thigh, abdomen, and flank.
•
When used for cold-assisted lipolysis of the submental area, the device can also affect the
appearance of lax tissue in the submental area.
•
Can be used to minimize pain and thermal injury during laser and dermatological treatments.
•
Can be used as a local anesthetic for procedures that induce minor local discomfort.
