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Electrical Specifications

System Specifications

80

BRZ-101-TUM-EN2-L

Dimensions of the Control Unit and Modules

Height

Depth

Width

Weight

Control unit alone

47.5 in
120.7 cm

35 in
88.9 cm

24 in
61 cm

215 lbs
97.5 kg

Control unit with support arm

62 in
157.5 cm

n/a

n/a

216 lbs
98.0 kg

Upper module

17 in
43.2 cm

27.25 in
69.2 cm

21.25 in
54 cm

65 lbs
29.5 kg

Base module

30.5 in
77.5 cm

28.5 in
72.4 cm

24 in
61 cm

150 lbs
68.0 kg

Table 26:

Control Unit - Dimensions

Electrical Specifications

Electrical Safety

Class I Equipment, single phase AC, Continuous Operation

Contains Type BF Patient-applied Parts

Water Ingress Protection: Ordinary Equipment, IPX0

REF

Voltage

Frequency

Current

BRZ-CG1-BAM-100

100VAC

50-60 Hz

12A

BRZ-CG1-BAM-110

110-120VAC

50-60 Hz

12A

BRZ-CG1-BAM-220

220-240VAC

50-60 Hz

7A

Table 27:

Electrical Specifications

Fuses

The system contains two internal fuses: Type 3AB (ceramic cartridge), Rating: 250VAC, 6.25A, Slo-Blo. The fuses
are not serviceable by the customer.

Medical Safety Standards

The system complies with the following medical safety standards:

•

IEC 60601-1: 1998 + A1, A2

•

IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)

•

EN 60601-1: 2006

•

CAN/CSA C22.2 No 60601.1: 08

•

ANSI/AAMI ES 60601-1: 2005 / AS: 2010

•

AS 3200.1.0: 1998 + A1/NZS 6150: 1990 + A1

•

Electromagnetic Compatibility (EMC) EN 60601-1-2: 2007

Electromagnetic Compatibility

The system has been tested and found to comply with Medical Standard Electromagnetic Compatibility (EMC)
EN 60601-1-2: 2007. The system complies with the standards outlined below.

This system requires special precautions to ensure electromagnetic compatibility with other electrical medical
devices. To ensure EMC, the system must be installed and operated according to the information provided in
this manual.

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Summary of Contents for CoolSculpting System

Page 1: ... Rosewood Drive Pleasanton CA 94588 USA 925 474 2500 www coolsculpting com ZELTIQ Customer Service Worldwide 1 925 474 8160 USA 1 888 935 8471 1 888 ZELTIQ1 User Manual BRZ 101 TUM EN2 L CoolSculpting System ZELTIQ Breeze System ...

Page 2: ...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 t...

Page 3: ... 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 a...

Page 4: ...ubmandibular 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 subma...

Page 5: ...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 sting...

Page 6: ...um 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 c...

Page 7: ...ies 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 h...

Page 8: ... 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 si...

Page 9: ...ns 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 ...

Page 10: ...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 bu...

Page 11: ...t 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 reductio...

Page 12: ... 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...

Page 13: ...ne 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 studie...

Page 14: ...xpected 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 mea...

Page 15: ... 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 Lerne...

Page 16: ...ing 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 L...

Page 17: ...C 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...

Page 18: ...g 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 Dire...

Page 19: ... 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 dir...

Page 20: ...20 BRZ 101 TUM EN2 L This page intentionally left blank ...

Page 21: ...rview 37 Perform a Treatment 37 Perform Another Treatment 45 Cancel a Treatment 47 About Restarting a Treatment 48 Complete a Treatment 49 Chapter 3 Cleaning and Maintenance 53 Cleaning 53 Maintenance 54 Disassembling the Control Unit 57 Assembling the Control Unit 60 Connecting Latches Hoses and Cables 61 Customer Service 62 Appendix A System Messages 63 ZELTIQ Customer Service 63 Recoverable Exc...

Page 22: ...ttings Screen 74 Appendix C System Specifications 79 Essential Performance 79 Disposal of Hazardous Materials 79 Environmental Requirements 79 Electrical Specifications 80 Medical Safety Standards 80 Electromagnetic Compatibility 80 Data Modem Specifications 84 ...

Page 23: ...flow that reduces heat build up inside the control unit Ensure all vents are free from obstructions when the control unit is in operation 3 Drawer The drawer provides storage space for supplies and user documentation 4 Casters and Locks The control unit has four casters that swivel Each caster has a lock Always engage the locks on all four casters before you use the control unit 5 Screen The scree...

Page 24: ...ious screen Previous Increase Date and Time settings Increase Decrease Date and Time settings Decrease Start Start Cancel Cancel Interrupt Interrupt Press Yes to confirm the selection YES Button Press No to cancel the selection NO Button Indicates that the system is cooling in preparation for treatment If this cue persists contact Customer Service Cooling Cue Indicates that the system is warming i...

Page 25: ...s right Gelpad Placement Cue Press to indicate that a new gelpad is on the treatment site GELPAD Indicates that the gelpad was confirmed Gelpad Confirmed Place the applicator over the center of the gelpad Vacuum Applicator Placement Cue Place the applicator on the treatment site and wait until the Start button is displayed Tissue Draw Prompts you to activate or deactivate vacuum pressure Activate ...

Page 26: ...kles or tears left Ensure that the gelpad is smooth and without tears right Gelpad Placement Cue Press to indicate that a new gelpad is on the treatment site GELPAD Indicates that the gelpad was confirmed Gelpad Confirmed Prepare the applicator with gel trap gasket and contour Applicator Preparation Cue Press to indicate that the required preparation is complete CONFIRM Indicates that the preparat...

Page 27: ...at new gel is on the treatment site GEL Indicates that the gel was confirmed Gel Confirmed Press to indicate that a gel trap is in the slot in the applicator cup Gel Trap Cue Insert a gel trap into the slot in the applicator cup GEL TRAP Place the applicator over the center of the treatment site Applicator Placement Cue Place the applicator on the treatment site and wait until the Start button is ...

Page 28: ... Site Preparation Indicates that site preparation was confirmed Site Preparation Confirmed Place the applicator between the borders and attach the securement system Surface Applicator Placement Cue Table 11 Controls and Cues Surface Applicator Patient Data Controls Button Description Name The patient is new to the practice New to Practice The patient is returning to the practice Returning to Pract...

Page 29: ...ample the flanks are selected for a female patient Progress Bar The Progress Bar displays information about the current treatment In the examples below a vacuum profile is presented Sample Description 60 00 Duration of the treatment in MM SS or H MM SS H hours MM minutes and SS seconds This treatment will last 60 00 minutes The treatment progress indicator shows the current stage of the treatment ...

Page 30: ...ructions when the control unit is in operation 3 Latches The latches lock the upper and lower modules of the control unit together 4 Antenna The antenna and data modem send data to ZELTIQ Availability and use of the data modem are subject to regional limitations 5 Casters and locks The control unit has four casters that swivel Each caster has a lock Always engage the locks on all four casters befo...

Page 31: ...e power switch controls power to the control unit and system components The power receptacle houses the plug for the power cord Components 1 Power Switch 2 Power Receptacle 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 3 Press the power switch on the back of the control unit to the On p...

Page 32: ...ables The cables connect the upper module to the base module and carry electrical information between the two modules 5 Hoses The hoses connect the upper module to the base module and carry coolant between the two modules 6 Data Modem The antenna and data modem send data to ZELTIQ Availability and use of the data modem are subject to regional limitations Moving the Control Unit To move the control...

Page 33: ...ns for treatment sites However 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 Applicator Total Cooling Area cm2 Treatment Sites Profile ...

Page 34: ...uch as the lateral thigh and upper abdomen Down to 15 C Up to 120 minutes N A N A Skin wipes Manual massage CoolMini 35 Small areas with pinchable fat such as the submental and submandibular areas Down to 15 C Up to 60 minutes N A 40 Skin wipes Manual massage CoolAdvantage 115 Areas with pinchable fat such as the flanks abdomen thigh and upper arm Down to 15 C Up to 60 minutes N A 80 Skin wipes Ma...

Page 35: ...pplicator directions for use for safety information on using gel Gelpad The gelpad provides thermal contact between the applicator and the patient s skin The gelpad is intended for a single use only Refer to the gelpad directions for use or the CoolAdvantage instructions for use for safety information on selecting and using gelpads Gel Trap CoolAdvantage and CoolMini Applicators The gel trap fits ...

Page 36: ...Supplies System Overview 36 BRZ 101 TUM EN2 L This page intentionally left blank ...

Page 37: ...from two sides therefore the rate of heat extraction and the intensity of cooling achieved during a given period of time are greater with a vacuum applicator than with a surface applicator However the total heat extraction for a given treatment is a function of temperature and time regardless of the applicator type Elements of a Profile A profile contains the following elements Element Description...

Page 38: ...isk of electric shock connect this equipment to a grounded electrical outlet 5 Engage the locks on all four casters 6 Power on the control unit The Applicator and Card cues are displayed on the Startup screen Attach the Applicator to the Control Unit These examples show a vacuum applicator To attach the applicator to the control unit 1 Ensure that the support arm is installed on the side of the co...

Page 39: ...e and locked in place 7 Slip the applicator cable into the loop at the top of the support arm 8 Apply Velcro straps to connect the applicator cable to the support arm The applicator is authenticated When the process is complete the authentication confirmation and the Card cue are displayed in the middle of the screen The name of the applicator is displayed in the lower left corner In this example ...

Page 40: ...reen The name of the card and the number of cycles remaining are displayed in the lower right corner The Next button is displayed In this example the name of the card is CoolCard 3 Press the Next button The New to Practice and Returning to Practice buttons are displayed If the patient data controls are not displayed contact Customer Service Enter Patient Data If the Usage Metrics function has been...

Page 41: ...or the current patient and treatment site 6 The Profile panel is displayed In this example a vacuum applicator profile is displayed Select a Profile To select a profile 1 On the profile panel press the Display Profiles button The drop down list of available profiles is displayed The default profile is selected This example shows vacuum applicator profiles 2 Press the desired profile The drop down ...

Page 42: ...ton If the liner is not detected disconnect the tabs from the hooks Grasp the frames of the liner and remove the liner from the applicator cup Repeat the installation process To apply a gelpad Inspect the treatment site to ensure that the skin is intact Treat over intact skin only 1 Remove jewelry that is in or directly adjacent to the application site 2 Wipe the treatment site with an alcohol wip...

Page 43: ...licator touch pad The vacuum is activated The Vacuum On button and the Tissue Draw indicator are displayed The Vacuum Status light on the applicator touch pad shines blue 2 Place the applicator over the center of the gelpad on the treatment site 3 Ensure that the gelpad extends beyond the edges of the applicator cup 4 For best results ensure that tissue is drawn into the applicator cup 5 Optional ...

Page 44: ... applicator 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 If the gelpad slips and the cooling surfaces of the applicator come into direct contact with the patient s skin tissue injury may result Inspect the gelpad and liner to ensure that they extend beyond ...

Page 45: ...nt Place the applicator head on top of the control unit with the cooling surfaces facing downward Place the applicator head on top of the control unit with the cooling surfaces facing upward Allow gel to drain onto a towel or other absorbent material n a Remove the gelpad or gel from the treatment site Remove the liner gelpad and foam borders from the treatment site Discard the used gelpad or gel ...

Page 46: ...e cooling surfaces facing downward Place the applicator head on top of the control unit with the cooling surfaces facing upward Allow gel to drain onto a towel or other absorbent material n a Remove the gelpad or gel from the treatment site Remove the liner gelpad and foam borders from the treatment site Remove the liner from the applicator cup n a Discard the used gelpad or gel and liner accordin...

Page 47: ...he treatment is canceled and a message is displayed The treatment was canceled by the operator 4 Press the Next button To cancel a treatment after the first 10 minutes 1 Press the Cancel button The treatment is canceled and a message is displayed The treatment was canceled by the operator 2 Press the Next button The Warming cue may be displayed for up to 2 minutes When the applicator cup is ready ...

Page 48: ...e following Recoverable Exceptions The coolant level is low Z403 YYY Applicator control error Z408 YYY Treatment quality error Z412 YYY Potential loss of patient contact Z415 YYY Interference detected Z426 YYY And the Restart timer interval of 60 minutes has not expired Interrupt a Treatment To interrupt a treatment 1 Press the Interrupt button The Treatment Interrupted screen is displayed The Res...

Page 49: ...te Remove the liner and gelpad from the treatment site Discard the used gelpad or gel according to your site s medical waste protocols Discard the used liner and gelpad according to your site s medical waste protocols See Vacuum Applicator Treatment on page 42 See Surface Applicator Treatment on page 43 Complete a Treatment To complete a treatment When the treatment is complete a message is displa...

Page 50: ...faces of the applicator are delicate Use care when cleaning and storing the applicator See Cleaning on page 53 Test Vacuum Pressure for Massage Standard vacuum applicators only Before you start a treatment you can test and modify the vacuum pressure for massage to ensure that the vacuum pressure is high enough to keep the applicator in place during the treatment To test the vacuum pressure for mas...

Page 51: ...d modify the vacuum pressure for massage 7 If you turn off the vacuum and then remove the vacuum applicator from the site a Discard the used gelpad or gel according to your site s medical waste protocols b Clean the treatment site c Apply a new gelpad or new gel Refer to the Directions for Use for your gelpad ...

Page 52: ...Complete a Treatment Treatment 52 BRZ 101 TUM EN2 L This page intentionally left blank ...

Page 53: ...aning Guidelines Unplug the control unit before cleaning Use sterilization wipes or spray the cleaning agent on a soft wipe paper towel or equivalent material CAUTION Do not spray or spill any fluid directly on any part of the control unit applicators or supplies CAUTION Do not submerge the applicator or any other part of the system in any liquid Do not use excessive amounts of fluid Do not apply ...

Page 54: ...y Maintenance External Chiller Filter The CoolSculpting control unit has an external filter installed that is located on the front bottom of the system Picture A and is easily replaceable The purpose of this filter is to extend the service life of your control unit Location of filter Picture A When to replace Every 6 months or Blue Thermometer icon appears for extended period of time Picture B ...

Page 55: ...age is displayed replace the chiller filter promptly To replace the external chiller filter 1 Slide the filter out of the slot 2 Pull the filter downward to slip it out from under the spring 3 Discard the used filter 4 Remove a new filter from the package 5 Slide the bottom of the new filter into the slot 6 Fold the front of the filter up under the spring 7 Ensure that the front of the filter is f...

Page 56: ...re for shipping a module a small amount of coolant may be lost When the level of coolant is low the control unit displays a message It is safe to add coolant while the control unit is powered on CAUTION The use of unauthorized coolant has not been tested Always use coolant authorized by ZELTIQ To add coolant 1 Locate the chiller tank cap 2 Press down on the recessed end of the blue lever on the ch...

Page 57: ...base module Disassemble the control unit to prepare to ship either module to the factory for repair or replacement CAUTION The upper and base modules of the control unit are heavy Do not attempt to lift either module by yourself This procedure requires two people Latches To disassemble the control unit 1 Power off the control unit 2 Engage the locks on all four casters 3 Disconnect the power cord ...

Page 58: ...1 TUM EN2 L 1 Flip the handle of the latch upward and turn it counterclockwise until the top of the clasp disengages 2 Pull the handle back and let it hang downward Cables and Hoses To disconnect cables and hoses 1 Turn the thumbscrew on the cover of the access panel ...

Page 59: ...1 Grasp the head of the data modem cable 2 Pull the head straight out of the USB port To disconnect a cable 1 Locate the ring that is closest to the back of the access panel 2 Turn the ring counterclockwise until it moves freely 3 Pull the ring off the connector To disconnect a hose 1 Squeeze the metal clasp at the top of the hose connector 2 Pull back until the hose connector disengages from the ...

Page 60: ...pper module down Assembling the Control Unit CAUTION The upper and base modules of the control unit are heavy Do not attempt to lift either module by yourself This procedure requires two people To install the upper module 1 Engage the locks on all four casters 2 Ensure that the power cord is disconnected from the control unit 3 Ensure that the cables and hoses that are attached to the base module ...

Page 61: ...e until the top clasp is snug against the hook 4 Press the handle down To connect the hoses and cables 1 Start with the hose on the right 2 Press the hose into the jack 3 Repeat for the hose on the left 4 Press the cable connector on the right over the post 5 Turn the ring clockwise until it is snug Do not overtighten 6 Repeat for the remaining cables working from right to left 7 Close the cover o...

Page 62: ...ldwide 1 925 474 8160 United States 1 888 935 8471 1 888 ZELTIQ1 Routine Issues For questions regarding device performance or to report issues that do not interfere with current patient treatments Call during regular business hours 6 am to 6 pm Pacific Time Monday through Friday Calls are answered in the order received Urgent Issues To report safety concerns or issues that interfere with current p...

Page 63: ... a new card Remove the card from the applicator and insert a new card The coolant level is low Z403 YYY Add coolant Add coolant The card and applicator are incompatible Z404 YYY Remove the card from the applicator Insert a card that is appropriate for the applicator type Applicator software error Z405 YYY Replace the applicator Use another applicator Card error Z406 YYY Disconnect and reconnect th...

Page 64: ... interrupted treatment or start a new treatment Card compatibility error Z417 YYY Replace the card Insert a card that is compatible with the control unit Card compatibility error Z418 YYY Call Customer Service Call Customer Service Card compatibility error Z420 YYY Call Customer Service Call Customer Service Card error Z421 YYY Disconnect and reconnect the card Disconnect and reconnect the card Di...

Page 65: ...Message Recommended Action The applicator is disconnected Connect the applicator to the control unit The card is disconnected Insert the card into the slot on the applicator Ensure that the card is inserted correctly The treatment was canceled by the operator Restart the treatment or start a new treatment The treatment is complete Turn off vacuum remove the applicator and gelpad or gel and clean t...

Page 66: ... following text and messages may be displayed Software Update Approximate installation time xx minutes Installation must be performed no later than YYYY MM DD to ensure continued use Enter the Software Update Key Installation complete Press the Next button Installation error Z930 Power the control unit off and on If the problem persists contact Customer Service Installation error Z961 YYY Remove t...

Page 67: ... applicator adapter to the control unit Approximate installation time xx minutes Installation must be performed no later than YYYY MM DD to ensure continued use Software updating Installation complete Press the Next button The applicator adapter was not detected If you have an adapter connect it to the control unit To proceed with the update press the Next button To skip the update press the Skip ...

Page 68: ...Software Updates and Messages System Messages 68 BRZ 101 TUM EN2 L This page intentionally left blank ...

Page 69: ...r the current card Card Log Display the Service screen to access the Vacuum Diagnostic and Chiller Diagnostic screens For use during a Customer Service call Service Display the Settings screen to access the Calibration Time Zone and Date and Time screens Settings Table 21 Controls for System Tools System Log Screen The System Log screen displays information about system events and errors Heading D...

Page 70: ...System Tools screen press the Previous button Availability and use of the data modem are subject to regional limitations The Upload Data button is displayed only if the modem is activated The data upload function is for use during a call with customer service To upload data to ZELTIQ 1 On the System Log screen press the Upload Data button The Upload Status screen is displayed When the process is c...

Page 71: ...of the usage as HH MM where H hour and M minute in AM PM Status The status of the usage Canceled Error Unknown Successful Table 23 Card Log Headings To view the Card Log screen 1 Attach the applicator to the control unit 2 Insert the card into the slot on the applicator The control unit authenticates the card 3 When the process is complete press the Next button 4 On the System Tools screen press t...

Page 72: ...of the chiller Chiller Diagnostic The data modem can upload data to ZELTIQ Availability and use of the data modem are subject to regional limitations Data Modem Table 24 Controls for Service Tools To view the Service screen 1 On the System Tools screen press the Service button The Service screen is displayed Vacuum Diagnostic Screen The Vacuum Diagnostic screen provides information about the perfo...

Page 73: ...ller Diagnostic screen provides information about the performance of the chiller Any changes to settings on this screen are temporary and do not influence the functionality of the system during a treatment To view the Chiller Diagnostic screen 1 On the Service screen press the Chiller Diagnostic button The Chiller Diagnostic screen is displayed On the sample screen the applicator is connected the ...

Page 74: ...een is displayed On the sample screen the Network Type is HSDPA_3G and the Connection Quality is Unknown 2 Follow the instructions provided by Customer Service To return to the Service screen press the Previous button Settings Screen The Settings button is available on the System Tools screen Ensure that the Time Zone setting is correct before you update the Date and Time settings Controls for Set...

Page 75: ...ate the screen 1 On the System Tools screen press the Settings button 2 Press the Calibration button The Calibration screen is displayed 3 Use a cotton swab to press the cross hatch The system records your touch and moves the cross hatch to the next position 4 Press the cross hatch in each position After you press the last setting the system displays a message 5 To save your new settings touch the...

Page 76: ...s check the Date and Time settings after you modify the time zone To modify the time zone 1 On the Settings screen press the Time Zone button The Time Zone screen displays a list of regions 2 To select a region press the name of the region and then press the Next button The Time Zone screen displays a list of zones within the region you selected 3 To scroll through the list press and drag the scro...

Page 77: ...Time settings To modify date and time settings 1 On the Settings screen press the Date Time button The Date and Time screen is displayed 2 To modify settings press the Decrease and Increase buttons 3 To save changes press the Next button 4 To discard changes press the Cancel button The Settings screen is displayed The 24 Hour setting controls the hour of the day and is in a 24 hour format ...

Page 78: ...tton The Usage Metrics button controls the display of patient data controls The tools on the Data screen are for use during a call with Customer Service To view the Data screen 1 On the Settings screen press the Data button 2 The Data screen is displayed 3 Follow the instructions provided by Customer Service ...

Page 79: ... module of the system contains a lithium battery which is not serviceable by the customer Dispose of all components of the system in accordance with applicable regulations Contact your local environmental control agency for additional information on recycling or disposing of the system in your area Environmental Requirements The system and its components are designed to operate normally when store...

Page 80: ... BAM 220 220 240VAC 50 60 Hz 7A Table 27 Electrical Specifications Fuses The system contains two internal fuses Type 3AB ceramic cartridge Rating 250VAC 6 25A Slo Blo The fuses are not serviceable by the customer Medical Safety Standards The system complies with the following medical safety standards IEC 60601 1 1998 A1 A2 IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 EN 60601 1 2006 CAN CSA C22 2 No 6...

Page 81: ...3 CAUTION Do not use cables or accessories other than those provided by ZELTIQ The use of other cables or accessories may result in increased electromagnetic emissions or decreased immunity to such emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions The system is intended for use in the electromagnetic environment specified below The customer or user of the system should en...

Page 82: ...1000 4 5 1kV differential mode 2kV common mode 0 5 1kV differential mode 0 5 1 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 se...

Page 83: ...Field strengths from fixed RF transmitters as determined by the electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is aff...

Page 84: ...eters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by abs...

Page 85: ...to an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field service technician for help Data Modem Canada The CoolSculpting System with the data modem complies with RSS 210 of Industry Canada Operation is subject to the following two conditions 1 This device may not cause interference 2 This device must accept any interference including...

Page 86: ...ZELTIQ Aesthetics Inc 4410 Rosewood Drive Pleasanton CA 94588 USA 925 474 2500 www coolsculpting com 10 2018 ...

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