2
BRZ-101-TUM-EN2-L
Preface
Contents
•
Intellectual Property ......................................................................... 2
•
Indications for Use ............................................................................ 2
•
Contraindications ............................................................................. 3
•
Warnings ........................................................................................... 3
•
Treatment Sites ................................................................................ 4
•
Precautions ....................................................................................... 5
•
Adverse Events ................................................................................. 5
•
About the System ............................................................................. 6
•
Freeze Detect System ....................................................................... 6
•
ZELTIQ Clinical Studies ...................................................................... 7
•
System Symbols .............................................................................. 18
•
User Documentation ...................................................................... 20
Intellectual Property
Copyright
©
2018 ZELTIQ Aesthetics, Inc. All rights reserved. Unauthorized duplication or use is prohibited.
COOLSCULPTING
®
, ZELTIQ
®
, and FREEZE DETECT
®
are registered trademarks of ZELTIQ Aesthetics, Inc. The
procedures described in this document are covered by U.S. Patent 7,367,341. Additional issued patents and
patent applications pending worldwide relate to the products and procedures described in this document. For
complete information on patents, go to http://www.coolsculpting.com/about-zeltiq/patents/
Your system may be labeled as the CoolSculpting
®
System, ZELTIQ
®
System, ZELTIQ
®
Breeze System, or the
ZELTIQ
®
Lipolysis System.
Indications for Use
The CoolSculpting System is a skin cooling or heating device. The device is 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. In addition, the device is intended for cold-
assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device
is 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.
Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatological
treatments and act as a local anesthetic for procedures that induce minor local discomfort.
The CoolSculpting System is also indicated for use to provide localized thermal therapy (hot or cold) to
minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, and muscle
spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain,
and spasm and for temporary improvement in local circulation and temporary reduction in the appearance of
cellulite.
The ZELTIQ Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device with a patient
’
s
skin by mitigating minor variances in device-to-skin contact.
In the United States of America, Federal law restricts this device to sale by or on the order of a
physician.
