ZELTIQ CoolSculpting Elite User manual

CS-UM-CM3-02-EN-D 1
User Manual
CoolSculpting® Elite System
ZELTIQ Aesthetics, Inc.
4410 Rosewood Drive
Pleasanton, CA 94588 USA
www.coolsculpting.com
ZELTIQ Customer Service
Worldwide: ([phone]
USA: ([phone]
(1-888-ZELTIQ1)

2 CS-UM-CM3-02-EN-D
Intellectual Property
Copyright© 2020 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, visit
www.coolsculpting.com/patents .

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Table of Contents
Customer Service.......................................................................................................... 5
Foreword ....................................................................................................................... 6
Indications for Use.................................................................................................................................6
Contraindications...................................................................................................................................7
Warnings ...............................................................................................................................................7
Precautions .........................................................................................................................................10
Adverse Events ...................................................................................................................................10
Freeze Detect System.........................................................................................................................12
User Documentation............................................................................................................................12
.............................................................................................................................................................................. 13
System Overview ........................................................................................................ 13
Control Unit .........................................................................................................................................13
Applicators ..........................................................................................................................................18
Supplies ..............................................................................................................................................20
.............................................................................................................................................................................. 23
Treatment.................................................................................................................... 23
Profiles, Treatments, and Cards..........................................................................................................23
Treatment Procedure ..........................................................................................................................23
1. Set up the control unit...............................................................................................................23
2. Set up the system.....................................................................................................................24
3. Allē Loyalty Program ................................................................................................................25
4. Select Treatment Area..............................................................................................................26
5. Prepare the applicator ..............................................................................................................26
6. Prepare the patient...................................................................................................................27
7. Turn on vacuum using single applicator (i.e. Vacuum or Surface Applicator) ..........................28
8. Start Treatment.........................................................................................................................30
9. End the treatment.....................................................................................................................31
10. Clean the applicator..................................................................................................................33
After a Treatment ................................................................................................................................33
Canceling a Treatment ........................................................................................................................34
Treatment Stopped by System............................................................................................................36

Table of Contents CoolSculpting® Elite System User Manual
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.............................................................................................................................................................................. 37
System Tools............................................................................................................... 37
Controls for System Tools ...................................................................................................................37
System and Card Log Screens ...........................................................................................................38
Service Screens ..................................................................................................................................39
Settings Menu .....................................................................................................................................40
About...................................................................................................................................................42
.............................................................................................................................................................................. 43
System Messages ....................................................................................................... 43
.............................................................................................................................................................................. 46
Cleaning and Maintenance ......................................................................................... 46
Cleaning ..............................................................................................................................................46
Maintenance........................................................................................................................................47
APPENDIX A............................................................................................................................................................................ 48
ZELTIQ Clinical Studies .............................................................................................. 48
APPENDIX B............................................................................................................................................................................ 61
System Symbols.......................................................................................................... 61
APPENDIX C............................................................................................................................................................................ 66
System Specifications ................................................................................................ 66
Data Module Specifications (Modem and Wi-Fi) .................................................................................72
APPENDIX D ........................................................................................................................................................................... 74
Disposal of Hazardous Materials................................................................................ 74

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Customer Service
To report issues with the performance or use of your System, contact ZELTIQ Customer Service:
•Worldwide: ([phone]
•U.S.A.: 1-888-935-8471 (1-888-ZELTIQ1)
•Email: [email protected]
Routine Issues
For questions regarding device performance or to report issues that do not interfere with current patient
treatments:
•Call during regular business hours: Monday through Friday, 6 AM to 6 PM Pacific Time
•Calls are answered in the order received.
Urgent Issues
To report safety concerns or issues that interfere with current patient treatments:
•Call at any time.
•If you call outside of regular business hours, leave a voicemail. A technician will be paged and
will return your call promptly.
Note: The software version within your system is located within the lower left-hand corner of the
screen.
Example: Location of Software version information

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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.

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Mode
Indications
Heating or
cooling
•Can be used to minimize pain post-trauma and post-surgery.
•Can be used to provide temporary relief of minor aches, pains, and muscle spasms.
•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.
Massage
(optional
function)
•Can be used to provide temporary relief of minor muscle aches, pain, and spasm.
•Can be used to provide temporary improvement in local circulation.
•Can be used to provide temporary reduction in the appearance of cellulite.
In the United States of America, federal law restricts this device to sale by or on the order
of a physician.
Contraindications
Localized skin cooling is contraindicated in patients who have:
•Cryoglobulinemia
•Cold agglutinin disease
•Paroxysmal cold hemoglobinuria
Warnings
Unauthorized modification or repair of the control unit, its components, or supplies may result
in unsafe conditions and/or impaired performance. No modification of this equipment is allowed
without express authorization from ZELTIQ. Any unauthorized modification or repair will void
the warranty.
The use of the CoolSculpting® Elite System has not been studied in children, those who are
pregnant or lactating, or patients with:
•Known sensitivity to cold such as cold urticaria, Raynaud’s disease, or Chilblains (pernio)
•Known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol
•Impaired peripheral circulation in the area to be treated
•Neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy
•Impaired skin sensation
•Open or infected wounds
•Bleeding disorders or concomitant use of blood thinners
•Recent surgery or scar tissue in the area to be treated
•Hernia in or adjacent to the treatment site
•Skin conditions such as eczema, dermatitis, or rashes in the area to be treated

Foreword CoolSculpting® Elite System User Manual
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The effect of performing a CoolSculpting® Elite treatment with a vacuum applicator on a
patient who has a hernia in or adjacent to the treatment site has not been studied. The
applicator uses vacuum pressure to draw tissue into the applicator cup during the treatment.
The vacuum pressure may therefore apply pressure on a pre-existing hernia or pre-existing
structurally weak area such as a surgical scar, causing further complications. Physicians
should examine that patient for evidence of pre-existing abdominal or femoral hernia prior to
use of the device.
The system operates at temperatures below 0°C, which can freeze tissue; clinical events that
are common to freezing tissue should be considered.
The use of this device on areas with superficially located nerve branches, arteries, or veins has
not been demonstrated to be safe and effective. Such use may result in injury to the patient.
The effect of performing treatments directly over active implanted devices, such as
pacemakers and defibrillators, is not known.
Patients with chronic pain, sensitivity to cold, or an anxiety disorder may be more prone to pain
or discomfort during the treatment.
Do not use the CoolSculpting® Elite on areas with a subcutaneous fat layer thickness of less
than 1cm.
Do not use the CoolSculpting® Elite on areas of decreased sensation or perfusion.
Do not use the CoolSculpting® Elite on areas with minimal underlying muscle mass or on
areas with superficially located nerve branches, arteries, or veins.
Do not use the CoolSculpting® Elite on the face, head, genitalia, inguinal creases, axillae,
popliteal fossae, antecubital fossae, hands, or feet.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
The use of other electronic medical devices on a patient who is undergoing a treatment might
interfere with the correct functioning of the system, possibly resulting in injury to the patient. Do
not use other electronic medical devices on a patient who is undergoing a treatment.
WARNING: Before using the system, read and understand the additional warnings that
are specific to a treatment site within Table 2 on the following page.

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Table 2: Warnings for Specific Treatment Sites
Treatment Site
Warning
Submental and
submandibular areas
Cold exposure to the hypoglossal
nerve may cause tongue deviation
following treatment of the submental
and submandibular areas.
Hypoglossal nerve
Cold exposure to the marginal
mandibular nerve may cause lower
lip weakness following treatment of
the submental and submandibular
areas.
Marginal mandibular nerve
Cold exposure to the submandibular
gland may cause xerostomia, or
decrease in saliva production,
following treatment of the submental
and submandibular areas.
Submandibular gland
Upper arm
Avoid compression of the ulnar nerve
during treatment of the upper arm.
Ulnar nerve

Foreword CoolSculpting® Elite System User Manual
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Precautions
The system is intended for use by a trained physician or by a physician-designated medical
professional.
If the operator observes a potential safety issue or operational abnormality during use, the operator
should stop the treatment immediately and contact ZELTIQ Customer Service (see page 5).
The use of other equipment and supplies with the system has not been tested and may cause
unexpected results.
Adverse Events
Table 3 lists common adverse events that can occur in the treatment area during and after a treatment.
These effects are temporary and generally resolve within days or weeks.
Table 3: Common Adverse Events
When Occurs
Common Side Effects
During a treatment •Sensations of pulling, tugging, and mild pinching at treatment site
•Intense cold, tingling, stinging, aching, cramping
Note: These sensations subside as the area becomes numb.
Immediately after a
treatment
•Redness and firmness
•Transient blanching and/or mild bruising around the edges of the treatment area
•Tingling and stinging
One to two weeks
after a treatment
•Redness, bruising, and swelling
•Tenderness, cramping, and aching
•Itching, skin sensitivity, tingling, and numbness
Note: Numbness can persist up to several weeks after treatment.
•Sensation of fullness in the back of the throat after submental area treatment