ZELTIQ CoolSculpting System User manual

ZELTIQ Aesthetics, Inc.
4410 Rosewood Drive
Pleasanton, CA 94588 USA
[phone]
www.coolsculpting.com
ZELTIQ Customer Service
Worldwide: ([phone]
USA: ([phone]
(1-888-ZELTIQ1)
User Manual
BRZ-101-TUM-EN2-L
CoolSculpting System
(ZELTIQ Breeze System)

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.

System Overview Contraindications
User Manual 3
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.
CoolSculpting System use 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
The effect of performing a CoolSculpting treatment (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 System of areas with a subcutaneous fat layer thickness of less than 1cm.
Do not use the CoolSculpting System on areas of decreased sensation or perfusion.
Do not use the CoolSculpting System on areas with minimal underlying muscle mass or on areas with
superficially located nerve branches, arteries, or veins.
Do not use the CoolSculpting System on the face, head, genitalia, inguinal creases, axillae, popliteal fossae,
antecubital fossae, hands, or feet.

Treatment Sites System Overview
4 BRZ-101-TUM-EN2-L
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.
Treatment Sites
Observe the following warnings when treating the submental and submandibular areas:
Treatment Site
Warning
WARNING: Cold exposure to the
hypoglossal nerve may cause tongue
deviation following treatment of the
submental and submandibular areas.
Hypoglossal Nerve
WARNING: Cold exposure to the marginal
mandibular nerve may cause lower lip
weakness following treatment of the
submental and submandibular areas.
Marginal Mandibular Nerve
WARNING: Cold exposure to the
submandibular gland may cause
xerostomia, or decrease in saliva
production, following treatment of the
submental and submandibular areas.
Submandibular Gland
Table 1: Submental and Submandibular Areas Treatment Warnings

System Overview Precautions
User Manual 5
Observe the following warning when treating the upper arm:
Treatment Site
Warning
WARNING: Avoid compression of the ulnar
nerve during treatment of the upper arm.
Ulnar Nerve
Table 2: Upper Arm Treatment Warning
Precautions
The system is intended for use by a trained physician or a physician-designated medical professional.
If the operator observes a potential safety issue or operational abnormality during use, the treatment should
be terminated and ZELTIQ Customer Service should be contacted promptly.
The use of other equipment and supplies with the system has not been tested and may cause unexpected
results.
Adverse Events
Common Adverse Events
The following effects can occur in the treatment area during and after a treatment. These effects are
temporary and generally resolve within days or weeks.
During a treatment:
•Sensations of pulling, tugging, and mild pinching at the treatment site.
•Intense cold, tingling, stinging, aching, cramping. 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. Numbness can persist up to several weeks after a
treatment.
•Sensation of fullness in the back of the throat after submental area treatment.
Rare Adverse Events
•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 with a typical onset several days after a treatment and resolution within several weeks.

About the System System Overview
6 BRZ-101-TUM-EN2-L
•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.
•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

System Overview ZELTIQ Clinical Studies
User Manual 7
NOTE: When the flank, abdomen, and thigh studies were performed, the degree of cooling or warming during a
treatment was expressed as the Cooling Intensity Factor (CIF). The CIF was an index that represented the rate
of heat flux into or out of tissue relative to 37°C. A positive CIF described the rate of heat flux out of tissue. A
negative CIF referred to the rate of heat flux into tissue. The studies in this section used the CIF as a unit of
measure. Current treatment parameters refer to the temperature at the surface of the applicator.
The ZELTIQ CoolSculpting System has undergone pre-clinical and clinical investigation (data on file at ZELTIQ).
The clinical investigation and results pertaining to skin cooling for fat layer reduction in submental and
submandibular areas, abdomen, flanks, thighs, and alternate treatment parameters are summarized in this
section.
The below table summarizes the efficacy information for each study that has been conducted. Further details
on each study can be found in the individual summaries below.
Treatment Site
Photographic Review
Results (% correct)
Ultrasound Results (mean
reduction in mm)
Subject Satisfaction
(% satisfied)
Flanks
88.6
N/A
82.1
Abdomen
85.3
1.9
62
Inner thigh
90.5
2.8
93.3
Outer thigh
83.9
2.5
86.5
Modified treatment parameters
85
3.92
88.37
Submental Area
91.4
2.0
83.3
Upper Arm
85.2 [72.9%, 93.4%]
3.2
63.3
Flank Study
Assessment Time Line
A clinical study that enrolled 60 healthy adult subjects, aged 23 to 65 years at two clinical centers was
conducted from August 2007 through June 2008. Each individual received one or more applications of the
ZELTIQ CoolSculpting System with a ZELTIQ vacuum applicator. Assessments of treatment efficacy and safety
were performed as follows:
Day 0 Treatment
1 Week
2 Months
6 Months
Consent Screening
Photographs Ultrasound Baseline Demographics Clinical Assessment
Phone Follow-up Clinical Assessment
Photographs Ultrasound Clinical Assessment
Photographs Ultrasound Clinical Assessment
Four groups were treated with the treatment regimens shown in Table 3. A short period (two to five minutes)
of simultaneous tissue cooling and massage was used during each treatment to facilitate lipolysis. For each
subject, the larger of the two flank bulges was treated, leaving the contralateral side as an untreated control.

ZELTIQ Clinical Studies System Overview
8 BRZ-101-TUM-EN2-L
Treatment
Group
Number of
Subjects
Cooling
Intensity Factor
(CIF)
Temperature
Cooling
Duration
(minutes)
Energy Extraction
Rate (mW/cm2)
1
28
33
-4ºC
60 min
63.6
2
11
37
-7ºC
30 min
68.3
3
11
37
-7ºC
45 min
68.3
4
10
42
-10°C
30 min
72.9
Table 3: Treatment Regimens
Clinical Efficacy Results
Blinded Photographic Evaluation
Efficacy was determined by photographic evaluation, ultrasound fat-thickness measurements, clinical
assessments, and subject satisfaction. A blinded photographic evaluation was performed of 50 evaluable
subjects in which three blinded reviewers were provided two series of photographs for each subject, one series
taken at baseline, and the other taken post-treatment. Each reviewer was asked to identify the baseline photo
series independently. In the blinded photographic review of all subjects the reviewers correctly identified the
baseline photo series 88.6% of the time.
Treatment
Group
Number of Subjects
All Data
% Correct ± % SE
All Data
p-values
All Groups
50
88.6 ± 4.1
< 0.001*
Group 1
20
90.7 ± 5.1
< 0.001*
Group 2
10
90.0 ± 9.5
< 0.005*
Group 3
11
90.9 ± 8.7
< 0.001*
Group 4
9
66.7 ± 15.7
< 0.4
Table 4: Independent Photo Review Results
Post-treatment ultrasound measurements of fat layer thickness were compared with baseline measurements,
using the untreated control side to normalize for weight changes that may have occurred during the follow-up
period. The fat layer reduction as measured with ultrasound averaged 18.7% from baseline, after being
normalized by the untreated control side. Ultrasound measurements at two months and at six months indicate
that on average, 75% of the total fat layer reduction for a subject was realized within two months of treatment.
Overall, 82.1% of subjects enrolled in the study indicated they were satisfied with the treatment.
Clinical Safety Results
Reported side effects included pain during or post-treatment, minor or significant bruising of the treated area,
temporary hypoesthesia, tingling, erythema, and edema. All side effects during this study resolved
spontaneously, most resolved within hours or days of the treatment.
Resolution of Hypoesthesia
Partial numbness and, to a lesser extent tingling, over the skin of the application site were reported for all
subjects immediately post-treatment and for 68% of subjects by one week post-treatment. Partial numbness or
tingling is a temporary and anticipated effect of the treatment and was found to resolve without intervention
within two to three weeks on average, although in 8.3% of the cases these effects endured for as long as two
months.

System Overview ZELTIQ Clinical Studies
User Manual 9
Adverse Events
There were four relatively minor adverse events; each was anticipated and resolved without intervention.
During treatment, two adverse events were reported involving pain and/or discomfort. Each of these resolved
after treatment was discontinued. Following treatment, two adverse events were reported: severe bruising and
minor cramping or muscle spasm in the treatment area. Both resolved without intervention within four weeks.
None of the adverse events reported during this study was considered serious or unanticipated.
During the clinical investigation, serum lipids and liver enzymes were measured in a subset of 20 subjects at
times from 1 week to 12 weeks post-treatment to determine whether the CoolSculpting treatment had an
effect on clinical chemistry. The following analytes were measured: Cholesterol, Triglycerides, HDL Cholesterol,
LDL Cholesterol, VLDL Cholesterol, Cholesterol/HDL Ratio, Total Protein, Albumin, AST-SGOT, ALT-SGPT, Total
Bilirubin, and Direct Bilirubin. No statistically significant changes were found for serum lipids or liver enzyme
data from baseline over the duration of the study.
BMI Recommendations
For best results, patients should have a BMI of 30 or less and should maintain a healthy lifestyle following a
treatment. The study evaluations for this clinical investigation included subjects with a Body Mass Index up to
38.7; however, patients who are significantly overweight are less likely to appreciate a significant improvement
with a single treatment.
Skin Type
The clinical investigation subject population included Fitzpatrick skin types ranging from I to VI, with the
majority of subjects being types II to IV. No change in skin pigmentation was observed following a treatment.
Based on the clinical data, ZELTIQ recommends that practitioners read this Preface carefully and pay special
attention to warnings and cautions throughout the User Manual and Directions for Use.
Abdominal Study
A separate clinical investigation with the CoolSculpting device on the fat layer of the abdomen resulted in a
clinically measurable reduction of local subcutaneous fat of the abdomen, in the same manner that that was
previously demonstrated for the flank. Treatments were performed at -10°C (CIF 42) for 60 minutes. The
primary endpoint results (Independent Photo Review) revealed that the percent correct identification of the
pre-treatment images exceeded the pre-established 80% criterion and is statistically significant. Fat layer
reduction in the treated area of the abdomen was further documented by ultrasound imaging which also
revealed a statistically significant and clinically relevant reduction. Overall, 62% of subjects enrolled in the
study indicated they were satisfied with the treatment.
Study data also revealed that the treatment is as safe when used in the abdomen as previously tested for the
flank. Data collected during the study demonstrated that the post-treatment lipid profile and liver function
tests showed no statistically significant difference from baseline. This was true for mean values for the entire
population as well as for each individual subject. No serious adverse events were reported during the abdomen
study. The results of this clinical study provide supportive evidence that treatment with the CoolSculpting
device provides consistent and clinically significant reduction of the fat layer of the abdomen.
Summary of Thigh Studies
ZELTIQ conducted two clinical investigations to determine the safety and efficacy of cold-assisted lipolysis in
the thigh region. In the inner thigh study, 90 treatments were completed with the flat cup vacuum applicator at
-10°C (CIF 42); in the outer thigh study, 40 treatments were completed with the belt applicator at -10°C (CIF
23). Follow-up data is available for both studies up to 16 weeks post-treatment. Three blinded evaluators
assessed the photos for visible reduction of fat in the treatment areas at the 16 -week follow-up visit. The
evaluators were presented with the series of photographs and were asked to identify the pre-treatment
photographs for each subject.

ZELTIQ Clinical Studies System Overview
10 BRZ-101-TUM-EN2-L
The overall correct identification rate by the three evaluators was 90.5% for the inner thigh study and 83.9%
for the outer thigh study. At least two out of three evaluators correctly identified 90.5% of all photo pairs for
the inner thigh study and 87.1% for the outer thigh study. The results demonstrate that the ZELTIQ
CoolSculpting System affects the appearance of the thighs.
Change in subcutaneous fat layer thickness was also measured by ultrasound at 16-weeks: In the inner thigh
study average fat thickness change was a 2.7 mm decrease. In the outer thigh study average fat thickness
change was a 2.6 mm decrease. Overall for the inner thigh study, 93.3% of subjects enrolled in the study
indicated they were satisfied with the treatment. Overall for the outer thigh study, 86.5% of subjects enrolled
in the study indicated they were satisfied with the treatment.
Adverse events reported during the studies included numbness and mild contour irregularity. All adverse
events but one resolved by the 16 week follow-up. A mild case of hyperpigmentation in the treatment area
persisted beyond the 16 week follow-up. This is an adverse event that typically resolves spontaneously. The
clinical investigations demonstrate that use of the ZELTIQ CoolSculpting System can safely and effectively
induce cold-assisted lipolysis in the thigh in the same manner as in the abdomen and flanks.
Summary of Study with Modified Treatment Parameters
A study of a modified treatment parameter was designed to evaluate the safety and efficacy of the
CoolSculpting System with a colder, shorter treatment. In this study, 63 treatments were completed with the
CoolCurve+ applicator on 45 subjects. Each subject received one or two non-overlapping unilateral vacuum
treatments of the flank at a treatment temperature of -15°C for 45 minutes; immediately after each treatment,
the treated tissue was massaged manually for two minutes. Follow-up data is available for up to 16 weeks post-
treatment.
Subject safety was assessed throughout the study, including immediately post-treatment, one-week post-
treatment telephone follow-up, and at 8- and 16-week post-treatment clinic visits. The primary safety endpoint
was the occurrence of device- or procedure-related adverse events. No serious adverse events were reported
during the study or 16-week follow-up period. Adverse events reported during the study included mild
numbness, post-treatment pain, hyperpigmentation, subcutaneous induration, and first-degree burn in the
treatment area. All but three adverse events resolved by the 16 week follow-up. Three subjects reported mild
numbness at the 16-week follow-up; all three reported resolution within the next 19 calendar days.
The primary efficacy endpoint was the change in fat layer thickness as measured with ultrasound. Fat layer
reduction in the treated area of the flank was documented by ultrasound imaging pre-treatment and at 8 and
16 weeks post-treatment. Subsequent evaluation of the ultrasound images revealed a statistically significant
and clinically relevant reduction.
Secondary efficacy endpoints included correct identification of pre- and post-treatment images by three
blinded independent reviewers, and subject satisfaction assessment by subject questionnaire. Photos taken at
baseline and at the 16-week follow-up visits were reviewed by a blinded independent panel of three physicians
board-certified in dermatology or plastic surgery. The overall correct identification rate by the three evaluators
was 85%, which exceeded the pre-established 80% criterion and is statistically significant.
The secondary efficacy endpoint for subject satisfaction was performed by means of a questionnaire with
questions about the comfort and subjective results of the treatment, and about the subject’s attitudes toward
CoolSculpting after treatment. With the exception of comfort, the majority of responses were positive to very
positive. Overall, 88.37% of subjects enrolled in the study indicated they were satisfied with the treatment.
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively induce cold-
assisted lipolysis with colder temperatures down to -15°C for shorter duration treatments with vacuum and
surface applicators.
Submental Area Study
ZELTIQ conducted a clinical investigation to determine the safety and efficacy of the CoolSculpting System for
affecting the appearance of visibly localized subcutaneous fat localized in the submental area.

System Overview ZELTIQ Clinical Studies
User Manual 11
In this study, 60 subjects were enrolled at three clinical sites. Sixty initial treatments were performed with the
prototype CoolMini vacuum applicator; 59 subjects were re-treated at the 6-week follow-up visit. Treatments
were performed at -10°C for 60 minutes. Follow-up data is available through 12 weeks post-treatment. Subject
safety was assessed throughout the study.
The primary safety endpoint was the measurement of all device- or procedure-related adverse events. All
adverse events reported during and after the treatment were included in the safety analysis. The primary
safety endpoint was met. No device- or procedure-related serious adverse events (SAE) and no unanticipated
adverse device effects (UADE) occurred during the study. Four device- or procedure-related adverse events
were reported and have resolved. Clinical safety assessment showed anticipated side-effects, all of which
resolved over the course of the study. The safety data recorded during this study supports the safety of the
treatment parameters and device investigated.
The primary efficacy endpoint was correct identification of pre-treatment vs. 12-week post-final treatment
images by 3 blinded independent reviewers. The overall correct identification rate by the 3 reviewers was 91%
for the per-protocol population (n=58), which met the pre-established 80% criterion for success. The primary
efficacy endpoint was met.
Reduction in subcutaneous fat layer thickness as measured by ultrasound at 12-weeks post-final treatment was
a secondary efficacy endpoint for this study. Analysis of the per-protocol data (57 subjects) showed a
statistically significant (p<0.0001) reduction of 0.20 cm. Therefore, the secondary efficacy endpoint for
reduction of fat layer thickness was met.
The secondary efficacy endpoint for subject satisfaction was assessed by a questionnaire administered at 12
weeks post-final treatment. Overall, 83.3% of subjects enrolled in the study indicated they were satisfied with
the treatment and 80% reported that they would recommend the treatment to a friend.
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively affect the
appearance of visible fat bulges in the submental area with treatment at -10°C for 60 minutes.
Summary of Upper Arm Study
ZELTIQ conducted a clinical investigation to evaluate the safety and efficacy of cryolipolysis for non-invasive
reduction of upper-arm fat.
In this study, 30 subjects were enrolled at two clinical sites. Sixty initial treatments were performed with a
prototype of the CoolAdvantage applicator (CoolFit with aluminum Insert). Each subject was treated once on
each upper arm, at -11°C for 35 minutes. Follow-up data is available through 12 weeks post-treatment. Subject
safety was assessed throughout the study.
The primary safety endpoint was the incidence of unanticipated adverse device effects. Clinical safety
assessment showed anticipated side-effects. There were 4 patients with prolonged numbness lasting greater
than 12 weeks. No unanticipated adverse device effects, or serious device- or procedure-related adverse
effects occurred. All device- and/or procedure-related adverse events resolved spontaneously. The primary
safety endpoint was met.
The primary efficacy endpoint involved independent panel review of pre- and 12-week post-treatment
photographs of the treatment area for discernible fat layer reduction. The per protocol population consisted of
all the treated subjects followed for 12 weeks with weight change of no more than 5% of total body weight at
the time the 12 week images were taken. For the per protocol population, the correct baseline photograph
identification rate by the independent panel reviewers was 85.2% [72.9%, 93.4%].
Further evidence of treatment efficacy is found in the data from ultrasound measurements of fat reduction at
the treated areas, with significant reduction in the fat layer (0.32 cm) from baseline to 12 weeks post-
treatment.
The secondary efficacy endpoint for subject satisfaction was assessed by an IRB-approved questionnaire
administered at 12 weeks post-treatment. 72.41% of the subjects found the procedure to be comfortable to
very comfortable, and 63.3% of the subjects reported that they would recommend the procedure to a friend.

ZELTIQ Clinical Studies System Overview
12 BRZ-101-TUM-EN2-L
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively affect the
appearance of visible fat bulges in the upper arm area with treatment at -11°C for 35 minutes.
Summary of Submental Area Study
A prior study (ZA14-002), approved by the Food and Drug Administration (FDA) under IDE G140083, reported
the efficacy of cryolipolysis for non-invasive reduction of submental fat. Subsequently, a retrospective study
was carried out in which standardized, masked, photographic images from the original ZELTIQ-sponsored
clinical study were evaluated quantitatively to determine the efficacy of the CoolSculpting treatment in
affecting the appearance of lax tissue in the submental area.
This retrospective study started with the ZA14-002 per-protocol population (n=58) for analysis, excluded one
subject due to excessive hair in the submental region, and used the remaining fifty-seven (57) subjects for
analysis. Lateral photographic views of the face taken at baseline and at the 12-week post-final treatment visit
were included in the analysis. Each photograph was cropped and masked prior to evaluation. A board-certified
plastic surgeon identified the following anatomical points on each photograph: the lateral canthus, the
anterior-most point where the nostril meets the columella, and the point where the chin meets the neck
(submental crease). AutoCAD software was used to apply lines to each photograph, and areas in the submental
region were measured. A responder analysis was performed with the criteria being ≥ 20 mm2 decrease in area
as measured on both the right lateral and left lateral views of the region.
A second analysis was performed in which reviewers compared the results from the responder analysis against
results from the independent physician review panel of photos, which had been conducted in the previous
study. This second analysis indicated that 77.2% (44/57) of subjects exhibited a ≥ 20 mm2 area reduction in the
submental and neck tissue. Of those 44 subjects, 42 (95.5%) were correctly identified by the physician panel as
having a visible response.

System Overview ZELTIQ Clinical Studies
User Manual 13
Summary of Clinical Study Publications
A review of clinical publications revealed 4,792 cryolipolysis treatments during clinical studies. From these
studies, we compiled the numbers of treatments in several anatomical areas: 1,695 treatments in the
abdomen, 1,987 treatments in the flanks, 501 treatments in the back, 323 treatments in the inner thigh, 150
treatments in the lateral thigh, 3 treatments in the anterior thigh, 119 treatments in the submental area, and
14 treatments in the banana roll region.
Efficacy was measured by several techniques including ultrasound and caliper measurements, circumferential
measurements, 3D quantification of volume reduction, and blinded, independent review of clinical
photographs. Based on the compilation of data from these studies, the overall mean ultrasound fat layer
reduction ranged from 10.3 to 25.5% and 1.9 to 8.3 mm.
Compiled mean caliper fat layer reduction ranged from 14.7 to 23.0%. Single studies showed mean 0.9 cm
circumferential reduction in the inner thigh, 2.4 cm circumferential reduction in the flanks, 6.8 cm
circumferential reduction in the abdomen, and 39.6 cm3 volumetric reduction in the flanks.
Based on the compilation of these various studies, the overall mean ultrasound fat layer thickness reduction
was 20.6% and 3.9 mm. Compiled mean caliper fat layer reduction was 22.3%. The independent photo review
was 89.7% correct, on average.
As shown by multiple clinical studies submitted for clearance to the agency, the summary of published data
shows a similarly high safety and efficacy profile for the cryolipolysis procedure. Common procedural side
effects include erythema, bruising, and numbness, which typically resolve within one month of treatment.
Based on the literature review, 6 cases would be considered serious adverse events. These serious adverse
events include three cases of paradoxical hyperplasia in the abdomen, one case of paradoxical hyperplasia in
the abdomen, back, and flanks, one case of contour irregularity in the abdomen, and one case of contour
irregularity in the flank. For 4,792 treatments in published studies, the incidence of serious adverse events is
very low (0.13%). Given the fact that 76.8% of treatments were to the abdomen and flanks, this incidence rate
shows no clear indication of treatment site specificity. The clinical publications indicate that cryolipolysis is a
safe and effective non-surgical procedure for subcutaneous fat reduction.
Summary of Clinical Study Publications for the Submental and Submandibular Areas
Six clinical publications reported safety and effectiveness of 228 cryolipolysis treatments in 102 patients to
include 89 patients with a Body Mass Index (BMI) of up to 46.2 and 27 patients treated in the submental and
submandibular areas.
Literature review of cryolipolysis indicates that clinicians are currently treating below the entire mandible,
including both the submental and submandibular areas, in order to achieve best aesthetic outcome. See Table
1 which summarizes the applicator placement methods tabulated from the six publications. Two applicator
placement approaches are identified: single cycle placed in the center submental area, as well as two cycles
covering the bilateral submandibular area, with a 20 –30% overlap in the center submental area. demonstrates
a typical two-cycle placement method treating submental and submandibular areas.
Reference
Treatment Area
Placement of the applicator
Treatment
Cycles (n)
Bernstein & Bloom, 2017
Submental and
Submandibular
areas
Bilateral treatment cycles with 20% overlap
in the center of the submental area.
52
Single cycle placed in the center submental
area
2

ZELTIQ Clinical Studies System Overview
14 BRZ-101-TUM-EN2-L
Reference
Treatment Area
Placement of the applicator
Treatment
Cycles (n)
Kilmer, Burns, &
Zelickson, 2016
Submental area
Single cycle placed in the center submental
area
119
Leal Silva, Hernandez,
Vazquez, Leal Delgado, &
Blanco, 2017
Submental area
Single cycle placed in the center submental
area
30
Lee, Ibrahim, Arndt, &
Dover, 2018
Submental and
Submandibular
areas
Bilateral treatment cycles with 30% overlap
in the center of the submental area.
Applicator is placed 1 to 2 cm from inferior
aspect of mandible, in sequence.
2
Li, DaSilva, Canfield, &
McDaniel, 2018
Submental and
Submandibular
areas
Single cycle placed in the center submental
area
1
Bilateral treatment cycles with overlap in
the center of the submental area.
2
Suh et al., 2018
Submental and
Submandibular
areas
Bilateral treatment cycles with 30% overlap
in the center of the submental area.
20
Reported safety included common procedural side effects such as erythema, bruising, numbness, edema,
blanching, tingling, increased sensitivity, itching, pigmentation changes, tenderness, and hoarseness, typically
resolving within one month of treatment. It is believed that these side effects are not specifically quantified
and reported in all publications because they are expected, self-resolving, and considered minor; thus, reports
of erythema, bruising, pain, and transient numbness are likely under-reported. From the publications that
reported a total of 228 treatment cycles, the most common side effects at 1-Week post-treatment were
numbness (105 reports), tingling (24), edema (9), and erythema (3 reports).
Several techniques measured effectiveness, techniques including ultrasound measurement, caliper
measurement, Magnetic Resonance Imaging (MRI), three-dimensional (3D) quantification of volume reduction,
patient satisfaction, and blinded, independent review of clinical photographs. The mean ultrasound
measurement of fat layer reduction was 2.4 mm with a range from 2.0 to 2.8 mm. The mean caliper
measurement of fat layer reduction was 3.17 mm (around 33%) with a range from 2.3 to 4.0 mm. The single
study using MRI imaging showed mean reduction of 1.78 mm or 17% subcutaneous fat layer reduction. The
3D imaging showed a mean calculated reduction of 8.5 mL fat volume, and calculated reduction in submental
laxity by 2.25 mm. Three-dimensional volumetric measurement showed a fat reduction of 4.82 cm3.
Blinded, independent photo review was conducted in several studies with correct identification of baseline
photographs ranging from 60% to 91%, averaging 77%. Patient satisfaction ranged from 80% to 93%,
averaging 85%.
There were no device or procedure-related serious adverse events related to treatment of the submental and
submandibular areas in the six publications.

System Overview ZELTIQ Clinical Studies
User Manual 15
References
Published Papers
1. Bernstein EF, Bloom JD. Safety and Efficacy of Bilateral Submental Cryolipolysis With Quantified 3-
Dimensional Imaging of Fat Reduction and Skin Tightening. JAMA Facial Plast Surg. 2017; 19(5), 350-
357.
2. Leal Silva H, Hernandez EC, Vazquez MG, Leal Delgado S, Blanco AP. Noninvasive submental fat
reduction using colder cryolipolysis. J Cosmet Dermatol. 2017; 1-6.
3. Lee NY, Ibrahim O, Arndt KA, Dover JS. Marginal Mandibular Injury After Treatment With Cryolipolysis.
Dermatol Surg. 2018; 1-3.
4. Li MK, DaSilva D, Canfield D, McDaniel DH. Use of 3-Dimensional Imaging in Submental Fat Reduction
After Cryolipolysis. Dermatol Surg. 2018; 889-892.
5. Suh DH, Park JH, Jung HK, Lee SJ, Kim JH, Ryu JH. Cryolipolysis for submental fat reduction in Asians.
Journal of Cosmetic and Laser Therapy. 2018; 24-27.
6. Kilmer SL, Burns AJ, Zelickson BD. Safety and efficacy of cryolipolysis for non-invasive reduction of
submental fat. Lasers Surg Med. 2015 Nov 26.
7. Seaman SA, Tannan SC, Cao Y, Peirce SM, Gampper TJ. Paradoxical Adipose Hyperplasia and Cellular
Effects after Cryolipolysis: A Case Report. Aesthet Surg J. 2016 Jan; 36(1):NP6-NP13.
8. Keaney TC, Gudas AT, Alster TS. Delayed Onset Pain Associated With Cryolipolysis Treatment: A
Retrospective Study With Treatment Recommendations. Dermatol Surg. 2015 Nov; 41(11):1296-9.
9. Stefani WA. Adipose Hypertrophy Following Cryolipolysis. Aesthet Surg J. 2015 Sep; 35(7):NP218-20.
10. Mahmoud ELdesoky MT, Mohamed Abutaleb EE, Mohamed Mousa GS. Ultrasound cavitation versus
cryolipolysis for non-invasive body contouring. Australas J Dermatol. 2015 Aug 24.
11. Wanitphakdeedecha R, Sathaworawong A, Manuskiatti W. The efficacy of cryolipolysis treatment on
arms and inner thighs. Lasers Med Sci. 2015 Nov; 30(8):2165-9.
12. Garibyan L, Cornelissen L, Sipprell W, Pruessner J, Elmariah S, Luo T, Lerner EA, Jung Y, Evans C,
Zurakowski D, Berde CB, Anderson RR. Transient Alterations of Cutaneous Sensory Nerve Function by
Noninvasive Cryolipolysis. J Invest Dermatol. 2015 Nov; 135(11):2623-31.
13. Singh SM, Geddes ER, Boutrous SG, Galiano RD, Friedman PM. Paradoxical adipose hyperplasia
secondary to cryolipolysis: An underreported entity? Lasers Surg Med. 2015 Aug; 47(6):476-8.
14. Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers
Surg Med. 2015 Feb; 47(2):120-7.
15. Stevens WG, Bachelor EP. Cryolipolysis conformable surface applicator for non-surgical fat reduction in
lateral thighs. Aesthet Surg J. 2015 Jan; 35(1):66-71.
16. Carruthers J, Stevens WG, Carruthers A, Humphrey S. Cryolipolysis and skin tightening. Derm Surg.
2014 Dec; 40 Suppl 12:S184-9.
17. Bernstein EF, Bloom JD, Basilavecchio LD, Plugis JM. Non-invasive fat reduction of the flanks using a
new cryolipolysis applicator and overlapping, two-cycle treatments. Lasers Surg Med. 2014 Dec;
46(10):731-5.
18. Boey GE, Wasilenchuk JL. Fat Reduction in the Inner Thigh Using a Prototype Cryolipolysis Applicator.
Dermatol Surg. 2014; 40(9):1004-9.
19. Stevens WG. Does Cryolipolysis Lead to Skin Tightening? A First Report of Cryodermadstringo.
Aesthet Surg J. 2014; 34(6): NP32-NP34.

ZELTIQ Clinical Studies System Overview
16 BRZ-101-TUM-EN2-L
20. Sasaki GH, Abelev N, Tevez-Ortiz A. Noninvasive Selective Cryolipolysis and Reperfusion Recovery for
Localized Natural Fat Reduction and Contouring. Aesthet Surg J. 2014 Mar; 34(3):420-31.
21. Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-Dimensional
Volumetric Quantification of Fat Loss Following Cryolipolysis. Lasers Surg Med. 2014 Feb; 46(2):75-80.
22. Jalian HR, Avram MM, Garibyan L, Mihm MC, Anderson RR. Paradoxical Adipose Hyperplasia after
Cryolipolysis. JAMA Dermatol. 2014 Mar; 150(3):317-9.
23. Boey GE, Wasilenchuk JL. Enhanced Clinical Outcome with Manual Massage Following Cryolipolysis
Treatment: A 4-Month Study of Safety and Efficacy. Lasers Surg Med. 2014 Jan; 46(1):20-6.
24. Stevens WG, Pietrzak LK, Spring MA. Broad Overview of a Clinical and Commercial Experience with
CoolSculpting. Aesthet Surg J. 2013 Aug 1; 33(6):835-46.
25. Dierickx CC, Mazer JM, Sand M, Koenig S, Arigon V. Safety, Tolerance, and Patient Satisfaction With
Noninvasive Cryolipolysis. Dermatol Surg. 2013 Aug; 39(8):1209-16.
26. Bernstein EF. Longitudinal Evaluation of Cryolipolysis Efficacy: Two Case Studies. J Cosmet Dermatol.
2013 Jun; 12(2):149-52.
27. Kotlus BS, Mok C. Evaluation of Cryolipolysis for Subcutaneous Fat Reduction. Am J of Cosmet Surg.
2013; 30(2), 89-93.
28. Lee, J. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through Cryolipolysis. Obes
Weight Loss Ther 2013, 3:6.
29. Shek SY, Chan NPY, Chan HL. Non-Invasive Cryolipolysis for Body Contouring in Chinese —a First
Commercial Experience. Lasers Surg Med. 2012 Feb; 44(2):125-30.
30. Brightman L, Geronemus R. Can Second Treatment Enhance Clinical Results in Cryolipolysis? Cosmet
Dermatol. 2011; 24(2):85-88.
31. Klein K, Zelickson B, Riopelle JG, Okamoto E, Bachelor EP, Harry RS, Preciado JA. Non-Invasive
Cryolipolysis for Subcutaneous Fat Reduction Does Not Affect Serum Lipid Levels or Liver Function
Tests. Lasers Surg Med. 2009 Dec; 41(10):785-90.
32. Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical Efficacy of Noninvasive Cryolipolysis
and Its Effects on Peripheral Nerves. Aesthetic Plast Surg. 2009 Jul; 33(4):482-8.
Published Abstracts
1. Loss L. Cryolipolysis Treatment of a Lipoma: A Case Study. Lasers Surg Med. 2014; 45(4):364.
2. Burns AJ, Saltz R, Stevens G, Kilmer S. Cryolipolysis Using the Treatment to Transformation Approach:
One Year Follow Up. Lasers Surg Med. 2014; 46(S25):18.
3. Jalian HR, Tam J, Garibyan L, Anderson RR. Selective Cryolysis of Sebaceous Glands. Lasers Surg Med.
2014; 46(S25):2.
4. Macedo O, Corradini C, Matayoshi L. Cryolipolysis Treatment for Subcutaneous Fat Layer Reduction.
Journal of the American Academy of Dermatology. 2012; 66(4):Suppl. 1: AB25.
5. Mayoral F, Kaminer M, Kilmer S, Weiss R, Zelickson B. Effect of Multiple Cryolipolysis Treatments on
the Abdomen. Lasers Surg Med. 2012; 44(S24):15.
6. Dover J, Kaminer M, Teahan M, Barrett L. Patient Satisfaction at 2 and 6 Months after a Single Non-
Invasive Cryolipolysis Treatment for Subcutaneous Fat Layer Reduction. Lasers Surg Med. 2011;
43(S23):968.
7. Kim H, Suh D, Park J, Rhue J, Lee S, Song K, Shin M, Ok C. Clinical Evaluation of a Non-Invasive
Cryolipolysis for the Treatment of Subcutaneous Fat Removal in Korean Patients. Lasers Surg Med.
2011; 43(S23):973.

System Overview System Symbols
User Manual 17
8. Burns JA, Allison J, Bachelor E, Dover J, Coleman S, Fitzpatrick R, Garden J, Geronemus R, Goldberg D,
Kilmer S, Kramer S, Levinson M, Mayoral F, Okamoto E, Tanzi E, Riopelle J, Weiss R, Zelickson B.
Analysis of Side Effects of Non-Invasive Cryolipolysis for Subcutaneous Fat Layer Reduction –Interim
Report from Controlled Clinical Trials. Lasers Surg Med. 2010; 42(S22):21.
9. Dover J, Burns J, Coleman S, Fitzpatrick R, Garden J, Goldberg D, Geronemus R, Kilmer S, Mayoral F,
Tanzi E, Weiss R, Zelickson B. A Prospective Clinical Study of Noninvasive Cryolipolysis for
Subcutaneous Fat Layer Reduction –Interim Report of Available Subject Data. Lasers Surg Med. 2009;
41(S21):43.
10. Kaminer M, Weiss R, Newman J, Allison J. Visible Cosmetic Improvement with Cryolipolysis:
Photographic Evidence. Presented at the Annual Meeting of the American Society for Dermatologic
Surgery, 2009, Phoenix, AZ.
ZELTIQ Customer Service
•Worldwide: ([phone]
•U.S.A.: 1-888-935-8471 (1-888-ZELTIQ1)
System Symbols
The following symbols are used on the components of the system and on its supplies and packaging.
Manufacturer
Indicates the medical device manufacturer, as
defined in EU Directives 90/385/EEC,
93/42/EEC and 98/79/EC.
Per ISO 15223-1
Reg. No. 3082
Authorized Representative in the European
Community
Indicates the Authorized representative in the
European Community.
Per ISO 15223-1
Refer to instruction manual/booklet
To signify that the instruction manual/booklet
must be read.
Per IEC 60878
Reg. No. M002
Consult instructions for use (user manual,
directions for use)
Indicates the need for the user to consult the
instructions for use.
Per ISO 15223-1
Reg. No. 1641
Conformité Européene or European
Conformity
Indicates manufacturer declaration that the
product complies with the essential
requirements of the relevant European
health, safety and environmental protection
legislation.
Article 17
Caution
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
that cannot, for a variety of reasons, be
presented on the medical device itself.
Per ISO 15223-1
Reg. No. 0434A
Do not reuse
Indicates a medical device that is intended for
one-time use only.
Per ISO 15223-1
Reg. No. 1051
Do not use if package is damaged
Indicates a medical device that should not be
used if the package has been damaged or
opened.
Per ISO 15223-1
Reg. No. 2606
Type BF applied part
To identify a type BF applied part complying
with IEC 60601-1.
Per IEC 60417
Reg. No. 5333
Potential for Electromagnetic Interference
Per IEC 60417
Reg. No. W005

System Symbols System Overview
18 BRZ-101-TUM-EN2-L
Catalog number
Indicates the manufacturer’s catalog number
so that the medical device can be identified.
Per ISO 15223-1
Reg. No. 2493
Serial number
Indicates the manufacturer’s serial number so
that a specific medical device can be identified.
Per ISO 15223-1
Reg. No. 2498
Quantity
Batch code
Indicates the manufacturer’s batch code so
that the batch or lot can be identified.
Per ISO 15223-1
Reg. No. 2492
Protective earth ground
To identify any terminal which is intended for
connection to an external conductor for
protection against electric shock in case of a
fault, or the terminal of a protective earth
(ground) electrode.
Per IEC 60417
Reg. No. 5019
WARNING: High voltage
Per IEC 60417
Reg. No. W012
Equipotential contact
To identify the terminals which, when
connected together, bring the various parts of
an equipment or of a system to the same
potential, not necessarily being the earth
(ground) potential, e.g. for local bonding.
Per IEC 60417
Reg. No. 5021
Alternating current
To indicate on the rating plate that the
equipment is suitable for alternating current
only; to identify relevant terminals.
Per IEC 60417
Reg. No. 5032
Use by date
Indicates the date after which the medical
device is not to be used.
Per ISO 15223-1
Reg. No. 2607
Special disposal methods are required for this
electrical device. Refer to local and national
regulations.
Per Directive 2002/96/EC (WEEE)
Locked position
To identify the location of a lock. To identify
the control that effects a locking function. To
indicate that the component or function is in
its locked state.
Per IEC 60417
Reg. No. 5569
Unlocked position
To identify the control that effects an
unlocking function. To indicate that the
component or function is in its unlocked state.
Per IEC 60417
Reg. No. 5570
On (Power)
To identify the control that starts a function
or operation. To identify the control that
enables a function or operation to be engaged
or activated.
Per IEC 60417
Reg. No. 5007
Off (Power)
To identify the control that stops a function or
operation. To identify the control that disables
a function or operation to be engaged or
activated.
Per IEC 60417
Reg. No. 5008
Peel here
Single patient use

System Overview User Documentation
User Manual 19
Regulatory Compliance Mark (Australia)
cTUVus: Meets minimum electrical safety
standards of Canada and the USA.
CAUTION: Federal Law (USA) restricts this
device to sale by or on the order of a
physician
Machine wash, cold, very mild process
Per ISO 3758
Reg. No. 3088
Do not bleach
Per ISO 3758
Reg. No. 3124
Tumble dry gentle, low heat, very mild process
Per ISO 3758
Reg. No. 3107
Do not iron
Per ISO 3758
Reg. No. 3113
Do not dry clean
Per ISO 3758
Reg. No. 3114
Table 5: System Symbols
For information on symbols and indicators that are displayed on the screen, see System Overview on page 23.
User Documentation
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.
User Manual
The User Manual provides detailed information on the components of the system, contraindications and side
effects, performing treatments, troubleshooting, and cleaning, and maintenance.
Directions for Use
A directions for use document is included with each applicator and with supplies. The document provides up-
to-date information on safety and usage. Refer to the most recent directions for use for each item.
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.
Conventions in User Documentation
Name
Description
Note
Additional information that is not associated with risk.
Caution
Use or misuse of the device is associated with risk of minor temporary injury and
damage to equipment.
Warning
Use or misuse of the device is associated with risk of serious and/or permanent
injury and death.
Table 6: Conventions in User Documentation

20 BRZ-101-TUM-EN2-L
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