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CoolSculpting® Elite

System User Manual

System Symbols

CS-UM-CM3-02-EN-D

A P P E N D I X B

System Symbols

The following symbols are used on the components of the system and on its supplies and packaging.

Table 21: System Symbols

SYMBOL

STANDARD

REFERENCE STANDARD TITLE

SYMBOL

TITLE

EXPLANATORY TEXT

ANSI Z535.6

Product Safety Information

in Product Manuals,

Instructions and Other

Collateral Materials

Warning

Indicates a hazardous situation which, if

not avoided, could result in death or

serious injury.

ANSI Z535.6

Product Safety Information

in Product Manuals,

Instructions and Other

Collateral Materials

Caution

Indicates a hazardous situation which, if

not avoided, could result in minor or

moderate injury.

ISO 15223-1,

Clause 5.1.1

Medical devices —

Symbols to be used with

medical device labels,

labelling and information to

be supplied.

Manufacturer

Indicates the medical device

manufacturer.

ISO 7000-3082 Graphical symbols for use

on equipment.

ISO 15223-1,

Clause 5.1.6

Medical devices —

Symbols to be used with

medical device labels,

labelling and information to

be supplied.

Catalogue

or model

number

Indicates the manufacturer's catalogue

number so that the medical device can

be identified.

ISO 7000- 2493 Graphical symbols for use

on equipment.

ISO 15223-1,

Clause 5.1.7

Medical devices —

Symbols to be used with

medical device labels,

labelling and information to

be supplied.

Serial

number

Indicates the manufacturer's serial

number so that a specific medical

device can be identified.

ISO 7000-2498 Graphical symbols for use

on equipment.

93/42/EEC

2014/53/EU

Medical Device Directive

93/42/EEC

Radio Equipment Directive

2014/53/EU

marking of

conformity

Indicates manufacturer declaration that

the product complies with the essential

requirements of the relevant European

safety and performance protection

legislation.

ISO 15223-1,

Clause 5.1.5

Medical devices —

Symbols to be used with

medical device labels,

labelling and information to

be supplied.

Batch

code

Indicates the manufacturer's batch code

so that the batch or lot can be identified.

Summary of Contents for CoolSculpting Elite

Page 1: ...N D 1 User Manual CoolSculpting Elite System ZELTIQ Aesthetics Inc 4410 Rosewood Drive Pleasanton CA 94588 USA www coolsculpting com ZELTIQ Customer Service Worldwide 1 925 474 8160 USA 1 888 935 8471...

Page 2: ...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 applicati...

Page 3: ...plicators 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 All Loyalty Program 25 4 Select Treatment Area 26...

Page 4: ...rvice Screens 39 Settings Menu 40 About 42 43 System Messages 43 46 Cleaning and Maintenance 46 Cleaning 46 Maintenance 47 A P P E N D I X A 48 ZELTIQ Clinical Studies 48 A P P E N D I X B 61 System S...

Page 5: ...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 con...

Page 6: ...he 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...

Page 7: ...tinin 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...

Page 8: ...e 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 treatmen...

Page 9: ...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 n...

Page 10: ...d 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 tuggin...

Page 11: ...odules 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 sponta...

Page 12: ...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 complicati...

Page 13: ...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 s...

Page 14: ...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...

Page 15: ...g 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...

Page 16: ...amp 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 ris...

Page 17: ...n 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 pre...

Page 18: ...e 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 wit...

Page 19: ...ting 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...

Page 20: ...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 temp...

Page 21: ...or filter replacement instructions Gelpad Provides thermal contact between the applicator and the patient s skin mitigates minor variances in device to skin contact Note Single use item use a new gelp...

Page 22: ...ders for each treatment site Do not reuse borders To apply foam borders for S150 Applicator 1 Clean the treatment site with an alcohol wipe 2 Remove the backing from one pair of foam borders 3 Apply o...

Page 23: ...olo card is used for one applicator placement per treatment 1 unit of treatment is deducted Table 8 Elements of a Treatment Profile Element Units Description Temperature C The treatment temperature Ti...

Page 24: ...t a moment while the card authenticates Screen should display Reading Card Example DUAL CARD Screen Example Solo CARD screen Note The system displays the number of treatments remaining on the card in...

Page 25: ...olSculpting treatments used on the patient When this information is entered tap Next and the prompt changes to Select Treatment Area Note The user has the option of using Applicator A B or both For Du...

Page 26: ...t using both Applicators A and B ensure that there is at least 2 minute window at the end of the treatment to allow for the optional massage This applies if duration of treatment for Applicators A and...

Page 27: ...nt Materials required Gelpad Alcohol wipe Pre treatment skin wipe Use gelpads as instructed in this document Failure to follow instructions may result in tissue injury The gelpad is designed for a sin...

Page 28: ...t the visible side of the gelpad to ensure that it appears intact Use of a damaged gelpad may result in tissue injury If a gelpad shows signs of damage such as tearing thin spots or dryness do not use...

Page 29: ...lockwise until the indicator marking s line up with the lock symbol The S150 applicator does not have a gel trap ii Return to the touchscreen and tap Next The next screen instructs to apply gelpad iii...

Page 30: ...or B the next prompt asks for confirmation by tapping Proceed or to go back to set up by tapping Continue Setup Note When using the Dual card there is one start button to start both applicators after...

Page 31: ...r B first There is a 5 minute window between end of treatment for Applicators A and B to allow 2 minute massage of the treatment areas There is delay timer for start of treatment on the second side fo...

Page 32: ...damaged or cause injury Grasp the head of the applicator firmly before turning off the vacuum or releasing the Comfort straps c After you turn off the vacuum the prompt changes to Massage or New Trea...

Page 33: ...pplicator from the umbilical then attach the cap Note Be sure to put on the cap on the applicator handpiece before cleaning the applicator c Use a cotton towel to remove any residual gel from the slot...

Page 34: ...ent Properties page displays b Go to Setup the system step 1 and repeat the procedure from that point If you have finished performing treatments and want to power down the system use the soft power of...

Page 35: ...Tap Next d Tap the OFF button on the touchscreen to toggle the vacuum from ON to OFF the S150 applicator does not have the vacuum feature The screen prompt changes to Massage or New Treatment If ther...

Page 36: ...tment is stopped by the system for Dual treatment A Error text B Error code C STOPPED notice To respond to a stopped treatment a Follow any instructions displayed on the screen Look up the error code...

Page 37: ...Close button The Tools session closes and the system returns you to the treatment session Table 9 Controls for System Tools Button Name Description Tools Enters and exits the Tools session When a tre...

Page 38: ...s button The Logs menu appears under the Tools menu 2 From the Logs menu tap the System or Card button The Log screen appears Note The System and Card Log data is presented in table form Within the ta...

Page 39: ...ck button to return to the Tools menu b Tap the Close button to exit the Tools session and return to the treatment session Chiller To view the Chiller screen Note Call Customer Service page 5 for both...

Page 40: ...t up 1 From the Tools menu tap the Settings button The Settings menu appears under the Tools menu 2 From the Settings menu tap the Notifications button The System Notification screen appears 3 For cha...

Page 41: ...n to exit the Tools session and return to the treatment session Date and Time The Date and Time screen allows you to set the system s date and time To set the date and time 1 From the Tools menu tap t...

Page 42: ...you to turn the snowflake logo on or off To turn the snowflake logo on or off 1 From the Tools menu tap the Settings button The Settings menu appears under the Tools menu 2 From the Settings menu tap...

Page 43: ...exception or an error message occurs carry out the recommended action if any If the problem persists record both codes and contact Customer Service see page 5 The codes help Customer Service identify...

Page 44: ...ent or start a new treatment Z417 Card compatibility error Z417 YYY Replace the card Insert a card that is compatible with the control unit Z426 Interference detected Z426 YYY Start a treatment If the...

Page 45: ...the problem persists contact Customer Service Z980 Z980 YYY Software Installation Error Power the control unit off and on and retry the software installation If the problem persists contact Customer...

Page 46: ...ing Guidelines Unplug the control unit before cleaning Use cleaning wipes or spray the cleaning agent on a soft wipe paper towel or equivalent material After cleaning the system components dry them wi...

Page 47: ...Dry the bucket with a cloth and return to its slot Maintenance Filter Replacement The purpose of this filter is to extend the service life of your control unit It is recommended to replace the filter...

Page 48: ...at layer reduction in submental and submandibular areas abdomen flanks thighs and alternate treatment parameters are summarized in this section Table 16 summarizes the efficacy information for each st...

Page 49: ...oup Number of Subjects Cooling Intensity Factor CIF Temperature Cooling Duration minutes Energy Extraction Rate mW cm2 Group 1 28 33 4 C 60 min 63 6 Group 2 11 37 7 C 30 min 68 3 Group 3 11 37 7 C 45...

Page 50: ...s 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 wer...

Page 51: ...trated 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...

Page 52: ...anner 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 S...

Page 53: ...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 Al...

Page 54: ...nible 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 imag...

Page 55: ...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 Effic...

Page 56: ...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...

Page 57: ...bmandibular 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 Bila...

Page 58: ...M 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 t...

Page 59: ...o 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 Colem...

Page 60: ...m 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 Prosp...

Page 61: ...for use on equipment ISO 15223 1 Clause 5 1 6 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Catalogue or model number Indicates the manufactur...

Page 62: ...on equipment ISO 15223 1 Clause 5 4 4 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Caution Read all warnings and precautions in instructions...

Page 63: ...sed with medical device labels labelling and information to be supplied Fragile handle with care Indicates a medical device that can be broken or damaged if not handled carefully ISO 7000 0621 Graphic...

Page 64: ...use on equipment This Way Up Indicates correct upright position of the transport package ISO 7000 Reference 2402 Graphical Symbols for use on equipment registered symbols Do Not Stack To indicate tha...

Page 65: ...ng symbols Machine wash cold very mild process Machine wash cold Delicate Gentle ISO 3758 Reg No 3124 Textiles Care labelling code using symbols Do Not Bleach Do Not Bleach Per ISO 3758 Reg No 3107 Te...

Page 66: ...e system and its components are designed to operate normally when stored shipped and operated under the conditions specified in Table 23 Environmental Requirements Use of the system in an oxygen rich...

Page 67: ...Electrical Safety Class I Equipment Single Phase AC Continuous Operation Contains Type BF Patient applied Parts Water Ingress Protection Ordinary Equipment IPX0 Table 25 Electrical Specifications REF...

Page 68: ...lled and interconnected Install the system in a room that complies with all applicable IEC CEC and NEC requirements for safety of electrical devices Portable and mobile RF communications equipment may...

Page 69: ...ent make it suitable for use in industrial areas and hospitals CISPR 11 class A If it is used in a residential environment for which CISPR 11 class B is normally required this equipment might not offe...

Page 70: ...agnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Portable and mobile RF communications equipment should be used no closer to any...

Page 71: ...Table 29 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the System The system is intended for use in an electromagnetic environment in which radiated RF d...

Page 72: ...ooth 15 dBm ZigBee 15 dBm Electromagnetic Compatibility Compliance Data Modem The CoolSculpting Elite System with the data modem complies with the following medical safety standards IEC 60601 1 2 2014...

Page 73: ...cifications These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can rad...

Page 74: ...us components of the system may contain materials whose disposal is subject to regulation The system contains a lithium battery which is not serviceable by the customer Dispose of all components of th...

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