Foreword
CoolSculpting® Elite
System User Manual
12
CS-UM-CM3-02-EN-D
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. Despite 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® Elite
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,
assess the tissue, and 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.
User Documentation
Before using the system, read and understand the user documentation. Table 5 lists the types of user
documentation provided with the
CoolSculpting® Elite
System.
Note:
All images in ZELTIQ user documentation are sample images. Your hardware and information
on the system screen may differ from those depicted in the documentation.
Note:
ZELTIQ reserves the right to modify the content of the user documentation at any time. Retain
the most current user documentation and always review it prior to using any component of the
system.
Table 5: Type of User Documentation
Item
Description
User Manual
Provides detailed information on the components of the system, lists contraindications
and side effects, and describes how to perform treatments, troubleshooting, cleaning,
and maintenance.
