ZELTIQ COOLTONE User manual

CS-UM-EMS-01-EN2-C
User Manual
COOLTONE™System
Manufactured for:
Zeltiq Aesthetics, Inc.
4410 Rosewood Drive
Pleasanton, CA 94588 USA
ZELTIQ Customer Service
Worldwide: ([phone]
USA: ([phone]
(1-888-ZELTIQ1)

2 CS-UM-EMS-01-EN2-C
© All rights reserved. No part of this manual may be reproduced, saved or transferred by any means,
including electronic, mechanical and photographic without the prior written approval.
CoolTone is a trademark.

COOLTONE User Manual
CS-UM-EMS-01-EN2-C 3
Table of Contents
Customer Service ........................................................................................................5
Supplies .......................................................................................................................6
Contents of the CoolTone™ System............................................................................................... 6
Foreword......................................................................................................................7
Indications for Use ............................................................................................................................. 7
Contraindications ............................................................................................................................... 7
Safety Cautions and Warnings........................................................................................................... 8
Precautions...................................................................................................................................... 10
Adverse Events................................................................................................................................ 10
Application Information..................................................................................................................... 10
........................................................................................................................................ 11
System Overview .......................................................................................................11
Control Unit...................................................................................................................................... 11
Touch Screens and Displays............................................................................................................ 13
Device Set Up.................................................................................................................................. 14
Settings............................................................................................................................................ 16
1. Startup screen.......................................................................................................................... 16
2. Initialization screen................................................................................................................... 16
3. Home screen............................................................................................................................ 17
4. Select Patient Details................................................................................................................ 19
5. Select the Treatment Area........................................................................................................ 19
6. Position Applicator.................................................................................................................... 20
7. Start Treatment......................................................................................................................... 21
8. Running Treatment................................................................................................................... 22
9. Completed or Interrupted treatment.......................................................................................... 23
........................................................................................................................................ 24
Treatment ..................................................................................................................24
Device Description........................................................................................................................... 24
Applicator Placement ....................................................................................................................... 25
Applicator connection ................................................................................................................... 25
Placing the Applicator................................................................................................................... 25

Table of Contents COOLTONE User Manual
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Securement System ..................................................................................................................... 26
General treatment screen................................................................................................................. 28
........................................................................................................................................ 30
Error Messages / Troubleshooting.............................................................................30
Error messages:............................................................................................................................... 30
Service required ........................................................................................................................... 30
Initialization failed......................................................................................................................... 30
System errors............................................................................................................................... 31
Self Trouble-Shooting................................................................................................................... 33
........................................................................................................................................ 34
Cleaning and Maintenance ........................................................................................34
Device.............................................................................................................................................. 34
Cleaning........................................................................................................................................... 34
Housing / Applicator...................................................................................................................... 34
Securement System ..................................................................................................................... 34
Disinfection................................................................................................................................... 35
Caution......................................................................................................................................... 35
Notice........................................................................................................................................... 35
Routine inspection of equipment ...................................................................................................... 36
Safety inspection.............................................................................................................................. 36
A P P E N D I X A ...................................................................................................................................... 38
System Symbols ........................................................................................................38
A P P E N D I X B ...................................................................................................................................... 41
System Specifications ...............................................................................................41
Electrical Safety............................................................................................................................ 42
Fuses ........................................................................................................................................... 42
Data Module Specifications.............................................................................................................. 47
Electromagnetic Compatibility Compliance - Data Modem............................................................ 47
A P P E N D I X C ...................................................................................................................................... 48
Disposal of Hazardous Materials ...............................................................................48

COOLTONE User Manual
Customer Service
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Customer Service
To report issues with the performance or use of your System, contact Zeltiq Customer Service:
ZELTIQ Customer Service
Worldwide: ([phone]
USA: ([phone]
(1-888-ZELTIQ1)

COOLTONE User Manual
Supplies
6 CS-UM-EMS-01-EN2-C
Supplies
Contents of the CoolTone™System
1 CoolTone™System including:
•1 Control Unit
•2 Applicators
•1 Securement system (including 2 applicator covers and 2 straps)
•1 CoolTone™System User Manual
•2 Mains cable –user select plug type based upon outlet type

Foreword COOLTONE User Manual
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Foreword
The CoolTone™System is an electrically powered device intended for medical purposes that
repeatedly contracts muscle tissue by passing electrical currents through applicators not in contact with
the affected body area. The CoolTone System is intended to provide entirely non-invasive
electromagnetic stimulation for:
• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer
abdomen,
• Strengthening, toning and firming of buttocks and thighs.
Indications for Use
The CoolTone is indicated for:
•Improvement of abdominal tone
•Strengthening of the abdominal muscles
•Development of firmer abdomen
•Strengthening, Toning and Firming of buttocks and thighs
In the United States of America, federal law restricts this device to sale by or on the order
of a physician.
Contraindications
•Active applicator should never be placed over implanted electrical devices like cardiac pacemakers,
cochlear implants, intrathecal pumps, hearing aids etc.
•The CoolTone should be used with caution in persons with Graves’disease, active bleeding
disorders or seizure disorders.
•Women who are close to menstruation may find that it comes sooner, or cramping is increased /
intensified with CoolTone treatments. Therefore, it is recommended to not undergo treatment during
this time of the month.
Other Contraindications:
•Fever
•Application over menstruating uterus
•Application over areas of the skin that lack normal sensation
•Metal or electronic implants in the treatment area

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•Implanted defibrillators
•Implanted neurostimulators
•Drug pumps
•Malignant tumor
•Hemorrhagic conditions
•Epilepsy
•Recent surgical procedure
•Pulmonary insufficiency
•Pregnancy
Safety Cautions and 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. Any unauthorized modification or
repair will void the warranty.
During treatment, do not place any ferromagnetic or metallic materials (such as metal
buttons, clasps, piercings, zippers, coins, keys, metallic fibers in the fabrics, etc.), data
carriers (creditcards, USB flash drives etc.) or electronic devices (mobile phones,
tablets, watches, PCs etc.) and other medical device applicators or accessories in the
direct vicinity (less than 30 cm / 1 foot) of the applicator(s). Do not place the device
near other devices that produce strong electromagnetic field (diathermy, X-Ray, cell
phones, radiofrequency) in order to prevent mutual functionality influence. If this
happens, move the device further away from the source of interference or contact an
authorized service personnel.
Ensure that persons with pacemakers are not present in vicinity of the device in
operation less than 1.2 meters, or approx. 4 feet.
Application of CoolTone must be in the abdomen, buttocks and thighs areas.
Application in the heart, head area or area of growth plate is not permitted.
To avoid the risk of electric shock, the mains plug of the device must be disconnected
from the mains before maintenance and cleaning work.
The device is intended to be used exclusively by medical professionals only.
Any treatment instructions regarding treatment location, duration and intensity require
medical knowledge and should be given by authorised physicians, therapists and
health paraprofessionals. It is imperative that these instructions are followed.

COOLTONE User Manual Foreword
CS-UM-EMS-01-EN2-C 9
Please refer to the Material Safety Data Sheet of Isovoltine II, in case of leaking oil or
contact your service engineer.
In case of leaking oil, please wear gloves providing adequate chemical resistance,
specifically to aromatic hydrocarbons, while cleaning.
Ventilate the room in case of leaking oil.
Disposal of the gloves and the oil-soaked cloth according to local regulations. Do not
dispose of in domestic waste.
The use in wet areas is not permitted and may lead to considerable damage to the
device. This non-compliance can endanger both the patient and the user.
Packaging materials must be disposed of properly. It is important to ensure that these
are not accessible to children.
The CoolTone is intended as a standalone device. No other electrical device
should be operated on the patient while being treated with the CoolTone.
The device may not be connected to other devices.
Maximum surface temperature of the applicator is 43oC.
Thermal energy may be accumulated in the applicators at the end of the treatment.
Allow device to cool down before next treatment or turning off the device.
Stimulation should not be applied over the carotid sinus nerves, particularly in patients
with a known sensitivity to the carotid sinus reflex.
Stimulation should not be applied over the neck or mouth. Severe spasm of the
laryngeal and pharyngeal muscles may occur and the contractions may be strong
enough to close the airway or cause difficulty in breathing.
Stimulation should not be applied over swollen, infected, or inflamed areas or skin
eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
Caution should be used for patients with suspected or diagnosed heart problems.
For adults use only.

Foreword COOLTONE 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
Common adverse events may include but may not be limited to:
•Muscular pain
•Temporary muscle spasm
•Temporary joint or tendon pain
•Local erythema or skin redness
Application Information
Before using the CoolTone on a patient, the user should become acquainted with the
operating instructions and individual treatment methods as well as the indications /
contraindications, warnings and application information. Additional sources of
information about types of treatment should be consulted.
Before use, ensure that the device is powered via a properly earthed plug with a
grounded mains outlet. The device must only be operated with the supplied power
cord.
During use, the device is to be located in a position allowing direct access to the
central mains supply so that it can be disconnected for the mains at any time.
The CoolTone is not suitable for use in areas with an oxygen rich, explosive,
flammable or combustive environment.
Inspect the device before use. If there is any damage, it must not be used.
Only accessories provided by the manufacturer must be used.
The maximum treatment time is 30 minutes per treatment cycle. Allow a cool down
period after each treatment.
Maximum surface temperature of the applicator is 43°C. If the maximum temperature
is reached allow the system to cool down. Place the applicators as defined in the
chapter about applicator placement.
During treatment the applicator will warm up, this is normal, If the patient experiences
any discomfort due to excessive heat from the applicator (>43°C) then discontinue
treatment.