About the System
System Overview
6
BRZ-101-TUM-EN2-L
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Frostbite: First- and second-degree frostbite may occur during treatment. It typically resolves without
sequelae with proper care.
•
Vasovagal symptoms: Dizziness, lightheadedness, nausea, flushing, sweating, or fainting during or
immediately after the treatment.
•
Subcutaneous induration: Generalized hardness and/or discrete nodules within the treatment area, which
may develop after the treatment, and may present with pain and/or discomfort.
•
Hyperpigmentation: Hyperpigmentation may occur after treatment. Typically, it resolves spontaneously.
•
Hernia: Treatment may cause new hernia formation or exacerbate pre-existing hernia, which may require
surgical repair.
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Treatment Area Demarcation (TAD): An aesthetic outcome of treatment in which the patient experiences
excessive fat removal in the treatment area, resulting in a visible disruption to the continuous contour of
fat, or unwanted indentation in the treated area.
•
Cold panniculitis: Cold panniculitis results from injury to adipose tissue exposed to cold and may result in a
mild to severe inflammatory response. In mild cases, the symptoms are self-resolving and may include
redness, swelling, skin nodules, warmth, tenderness, and possible low-grade fever. These cases typically
resolve without long-term sequelae. In more severe cases, an intense inflammatory response may result in
more extensive tissue damage, including fat necrosis, which may require medical or surgical intervention.
Frostbite, vasovagal symptoms, sensation in the back of the throat during swallowing, and hyperpigmentation
were observed during clinical trials, while the others were reported in post market use.
WARNING: Before using the system, read and understand the User Documentation set (User Documentation
on page 19).
About the System
The system is comprised of a control unit, a surface or vacuum applicator, massage function and supplies such
as cards, foam borders, gelpads, liners, pretreatment skin wipes, and securement systems. The applicators,
foam borders, gel, gelpads, liners, pretreatment skin wipes, and securement systems are patient-applied parts.
During a treatment, the operator applies a gel/gelpad and applicator to the patient
’
s skin. The vacuum
applicator draws tissue into the applicator cup and holds the tissue against the cooling surfaces of the
applicator; the surface applicator does not use vacuum pressure. The operator starts the treatment. Sensors in
the cooling surfaces of the applicator monitor the skin surface, providing feedback that controls the rate of
heat flux. The gel/gelpad protects the skin by providing thermal coupling at the interface between the cooling
surfaces of the applicator and the skin. The card provides cycles and profiles for use with the system.
Freeze Detect System
The system operates at temperatures below 0°C, which can freeze tissue. Therefore, the system monitors
tissue during cooling and employs multiple safety features including the Freeze Detect
®
system, to minimize the
risk of damage to tissue. In spite of these measures, on rare occasions, the Freeze Detect system can detect a
possible freeze condition.
The Freeze Detect system is comprised of several features, including thermal sensors and proprietary
algorithmic software. Freeze Detect is an integral part of the CoolSculpting System and is automatically
employed when a treatment is initiated. When the Freeze Detect system detects a possible freeze condition, it
stops the treatment and displays a Z409 message. If you receive this message, remove the applicator and
gelpad or gel, and assess the tissue before taking further action. If you receive a second Z409 message for one
treatment site, discontinue the treatment. Failure to follow instructions could result in injury to the patient,
including first- or second-degree burns. Second-degree burns or complications of second-degree burns may
result in hypopigmentation.
ZELTIQ Clinical Studies
