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)

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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

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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

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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

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Table 4: Rare Adverse Events
Rare Event
Description
Paradoxical hyperplasia Visibly enlarged tissue volume within the treatment area, which may develop two
to five months after treatment. Surgical intervention may be required.
Late-onset pain Late-onset pain may begin several days after a treatment and usually resolves
within several weeks.
Severe pain Patients may experience pain of varying severity, which more commonly can be
described as mild to moderate, and in rare instances, can be severe.
Freeze burn First and second-degree freeze burn may occur during treatment. It typically
resolves without sequelae with proper care.
Vasovagal symptoms Dizziness, lightheadedness, nausea, flushing, sweating, or fainting might occur
during or immediately after the treatment.
Subcutaneous induration Generalized hardness and/or discrete nodules within the treatment area can
develop after the treatment and might present with pain and/or discomfort.
Hyperpigmentation Hyperpigmentation can occur after treatment and usually resolves spontaneously.
Hernia Treatment might cause new hernia formation or exacerbate a pre-existing hernia,
which can require surgical repair.
Treatment area
demarcation
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.

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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.

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System Overview
This chapter describes the control unit, the applicators, and supplies such as Card, Gelpad, Gel Trap,
Pretreatment Skin Wipe (Skin Wipe), and Comfort Strap.
Control Unit
The control unit (Figure 1) is a portable device that is used to start, stop, and monitor treatments.
Figure 1: Control Unit
A: Touchscreen display
B: Card slot
C: Casters and locks
D: Bucket
E: Top cap lip
F: Access panel
G: Power receptacle and power switch
H: Connector Ports for umbilical cords for Applicators A and B
I: Vents
J: Soft power button

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Touchscreen Display
The touchscreen displays system controls, information about the status of the system, information
about the treatment, and messages for the operator. You can rotate or tilt the display to accommodate
better access.
Card Slot
The card slot accepts treatment cards. You must insert an appropriate Solo or Dual treatment card with
active credits to begin a treatment.
Casters and Locks
The control unit has four casters that swivel. Each caster has a lock. Always engage all four caster
locks when the unit is stationary. Disengage the caster locks to move the unit.
►To engage the caster locks: Press down on the locking lever with the toe of your shoe.
►To release the caster locks: Pull up on the locking lever with the toe of your shoe.
►To move the control unit:
1. Power off the control unit.
2. Unplug the power cord from the wall outlet and place it in the bucket of the control unit.
3. Release the lock on each caster.
4. Push or pull the lip of the top cap to move the control unit to the new location.
Note: Do not push or pull on the touchscreen display or the display post to move the unit.
5. When you have placed the control unit in its new location, engage the lock on each of the four
casters.
While moving the system within the office, place the applicator in the bucket provided on top
of the control unit. In addition, grasp the top cap lip of the system to guide the unit from one
location to another.
Bucket
The bucket is a storage area for applicators and/or consumables. You can remove the bucket from the
control unit for cleaning.
Figure 2: Image of the top the system that shows the bucket

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Top Cap Lip
When the applicator is resting on top of the control unit, the top cap lip helps keep the applicator in
place.
Access Panel
The access panel covers vents, a USB port, and the chiller tank cap (Figure 3):
•Vents: Vents provide airflow that reduces heat build-up inside the control unit. Ensure that all
vents are free from obstructions when the control unit is in operation
•USB port:The USB port (rectangular) is intended for use with approved software and hardware
provided by ZELTIQ.
Chiller tank cap: The cap is for covering the coolant tank. A service technician is required
to add coolant to the system. Please contact customer service.
Figure 3: Rear of control unit with access panel removed
A: Vents
B: USB port (rectangular)
C: Chiller tank cap;
D: Product code and Serial Number
►To remove the access panel: Gently pull the tab at the top of the door toward you to disengage
the magnetic seal; then lift off the entire panel.
►To replace the access panel: Align the access panel with the recess and hold it close to the
control unit until the magnets snap it into place.
Power Receptacle and Power Switch
Do not use the Control Unit if the Power Switch, Power Cord and/or Power Receptacle become
damaged.
If the Power Switch, Power Cord and/or Power Receptacle appears to be damaged, contact
Customer Service as listed in the User Manual.

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Power Cord Clamp
The power cord clamp attaches the power cord to the rear of the control unit, and it acts as a strain
relief to protect the Power Receptacle if the cord is pulled. Install the power cord clamp before using
the system. If the power cord is dislodged during a treatment, the treatment will be ended abruptly.
►To install the power cord clamp:
1. On the back of the control unit, insert the thumbscrew into the hole in the base.
2. Using your fingers, turn the thumbscrew until it is snug. See illustration below.
Example: Power cord clamp installed in base
►To power on the control unit:
1. Insert one end of the power cord into the power receptacle.
2. Insert the other end of the power cord into a grounded wall outlet.
To minimize the risk of electric shock, connect this
equipment to a grounded electrical outlet.
3. Press the power switch on the back of the control unit to the “On” position (Figure 4).
The control unit powers on and illuminates the soft power button (Figure 5).
Figure 4: Close-up of power receptacle and power switch
A; Power receptacle
B: Power switch (current position is “Off”, which is the “0”. The “On” has a “1”)
►To power off the control unit:
1. Press the power switch on the back of the control unit to the Off position.
2. Unplug the power cord from the wall outlet.
3. Unplug the power cord from the power receptacle on the rear of the control unit.

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Soft Power Button
The display includes a soft power button at the lower right corner, which is used to power on the
system, after turning the power switch on the rear of the system to the “On” position. The soft power
button may also be used to power off the system.
When the system is in standby or sleep mode, the power button is illuminated and will pulse. This
indicates that the system is asleep. Pressing the button will awaken the system.
►To power on the control unit:
1. While the power switch is On, and the system is off, press the soft power button on the display.
►To power off the control unit:
1. While the power switch is On, and the system is on, press the soft power button on the display
2. A pop-up message will be displayed asking “Are you sure you want to power off the device?”
3. Select “Yes”
Figure 5: Soft Power Button
Applicator Connectors
The control unit has two connector ports where two umbilical cords attach to perform a simultaneous
treatment. Simultaneous treatment is an option, but not necessary.
Vents
Vents provide airflow that reduces heat build-up inside the control unit. Ensure that all vents are free
from obstructions when the control unit is in operation.

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Applicators
The applicator delivers controlled cooling and heating to the treatment site.
The applicator consists of the applicator connector, the applicator umbilical, and the applicator head.
The applicator is used with supplies provided by ZELTIQ.
The handpiece of the applicators can be disconnected from the umbilical, except for the C80 and S150,
which are used with standalone umbilical.
Always use gelpads with the applicator as instructed in this document.
The applicators are designed to treat most body areas. There are 7 applicators supplied with the
system (Table 6). Clinicians should consider all physical aspects of the area to be treated and use the
applicator that will fit best for each patient.
ZELTIQ defines a specific combination of treatment temperature and duration for each profile.
Typically, a colder treatment temperature is paired with a shorter treatment duration.
Table 6: Applicators supplied with CoolSculpting® Elite System.
Applicator
Total
Cooling
Area
(cm
2
)
Recommended
Treatment
Sites
Profile
Temp.
Range
Profile
Duration
Range
Pre-
Treatment
Skin Care
Post-
Treatment
Care
Option
CoolSculpting Curve 80
(C80™)
35 Small areas
with pinchable
fat, such as
the submental
and
submandibular
areas
Down
to
-15°C
Up to
60
minutes
Skin wipe Manual
massage
CoolSculpting Curve 120
(C120™)
84 Areas with
pinchable fat,
such as the
flanks,
abdomen,
banana roll,
back fat, and
bra fat
Down
to
-15°C
Up to
60
minutes
Skin wipe Manual
massage
CoolSculpting Curve 150
(C150™)
133 Areas with
pinchable fat,
such as the
flanks and
abdomen
Down
to
-15°C
Up to
60
minutes
Skin wipe Manual
massage

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CoolSculpting Curve 240
(C240™)
225 Large areas
with pinchable
fat, such as
the flanks and
abdomen
Down
to
-15°C
Up to
60
minutes
Skin wipe Manual
massage
CoolSculpting Flat 125
(F125™)
83 Vertical bulges
of pinchable
fat, such as
the inner thigh
and upper
arm*
Down
to
-15°C
Up to
60
minutes
Skin wipe Manual
massage
CoolSculpting Flat 165
(F165™)
96 Vertical bulges
of pinchable
fat, such as
the inner thigh
and upper
arm*
Down
to
-15°C
Up to
60
minutes
Skin wipe Manual
massage
CoolSculpting Surface 150
(S150™)
134 Areas with
non-pinchable
fat, such as
the lateral
thigh and
upper
abdomen
Down
to
-15°C
Up to
120
minutes
Skin
wipes
Manual
massage
*The cleared treatment profile for the upper arm is -11oC for 35 minutes.
User Interface
A treatment involves a mix of physical setup at the control unit, interactions with the patient, and
interactions with the system software via the touchscreen. The system guides you through these
transitions with a series of prompts, cues, and feedback as you progress through the treatment
procedure.
Screen Elements
When interacting with the touchscreen, tap a button or other element to select it.
Treatment Status
During a treatment, the screen displays status information to help you monitor progress (
Figure 6).

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20 CS-UM-CM3-02-EN-D
As soon as a treatment begins, the status changes to “Treating” and the system begins counting down
from the total scheduled time. The remaining time is displayed in large numbers within a “clock”
graphic. A blue indicator bar recedes clockwise from the 12:00 position as the treatment progresses.
The treatment temperature, total scheduled treatment time, and the vacuum status are displayed above
the remaining time.
Figure 6: Example of status information displayed prior to starting a treatment
A: Treatment time remaining
B: System status
C: Visual indicator of remaining time
D: Treatment temperature
E: Duration of treatment
F: Vacuum status (on or off)
G: Applicators A and B
Audible Tones
The system provides audible feedback. The control unit beeps:
•When the operator presses a button on the screen
•When a treatment begins
•When the system detects an error
•When a treatment ends
•When a remote notification is sent
Supplies
To order supplies for your CoolSculpting® Elite System, visit [email protected] or
contact Customer Service (see page 5).