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Appendix A

System Symbols

COOLTONE User Manual

CS-UM-EMS-01-EN2

-C

Symbols

Reference No.

Title

Description

ISO 7000-0632

Temperature limit

This symbol indicates the maximum
and minimum temperature limits at
which the device shall be stored and
transported.

ISO 7000-0623

This way up

This symbol indicates the correct
upright position of the device package.

ISO 7000-3124

Do not bleach

In the instruction for use this symbol
indicates not to bleach the securement
system.

ISO 3758

Regulation: 3114

Tumble dry gentle low
heat

Very mild treatment

In the instruction for use this symbol
indicates not to bleach the securement
system.

ISO 7000-3113

Do not iron

In the instruction for use this symbol
indicates not to iron the securement
system.

ISO 7000-3114

Do not dry clean

In the instruction for use this symbol
indicates not to dry clean the
securement system.

ISO 7000-3088

Machine wash cold
gentle cycle

In the instruction for use this symbol
indicates how to wash the securement
system.

Summary of Contents for COOLTONE

Page 1: ...EMS 01 EN2 C User Manual COOLTONE System Manufactured for Zeltiq Aesthetics Inc 4410 Rosewood Drive Pleasanton CA 94588 USA ZELTIQ Customer Service Worldwide 1 925 474 8160 USA 1 888 935 8471 1 888 ZE...

Page 2: ...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...

Page 3: ...formation 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 1...

Page 4: ...e 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...

Page 5: ...omer Service 5 CS UM EMS 01 EN2 C Customer Service To report issues with the performance or use of your System contact Zeltiq Customer Service ZELTIQ Customer Service Worldwide 1 925 474 8160 USA 1 88...

Page 6: ...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...

Page 7: ...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...

Page 8: ...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 fu...

Page 9: ...one 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 applic...

Page 10: ...nformation 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...

Page 11: ...s the control unit the applicator and the user interface Control Unit The control unit Figure 1 is a portable device that is used to start stop and monitor treatments Figure 1 Front of the Control Uni...

Page 12: ...view COOLTONE User Manual 12 CS UM EMS 01 EN2 C 6 B Figure 2 Rear of the Control Unit 6 Connectors for applicators A and B 7 Ventilation grid 8 Mains connector 9 Main switch 10 Serial no Identificatio...

Page 13: ...w CS UM EMS 01 EN2 C 13 Figure 3 Applicators Touch Screens and Displays Figure 4 Start Treatment 11 Total operating time 12 Remaining treatment time 13 Back to Previous Screen 14 Start Treatment 15 Ap...

Page 14: ...aining treatment time 21 Total treatment time Device Set Up After the transport and before switching on the device make sure that the castors are in the locked position Note Make sure that the CoolTon...

Page 15: ...sed while in a tilted position the cooling oil will not reach all sections of the applicator and will damage the applicator due to overheating For this reason it is recommended to place the applicator...

Page 16: ...CS UM EMS 01 EN2 C Settings 1 Startup screen Once the device is switched on a self test is carried out and the start up screen opens 2 Initialization screen After the start up the device continues the...

Page 17: ...apter 1 System Overview CS UM EMS 01 EN2 C 17 3 Home screen After performing the self test the device automatically displays the home screen Pressing New Treatment button starts a new treatment Insert...

Page 18: ...Chapter 1 System Overview COOLTONE User Manual 18 CS UM EMS 01 EN2 C Leave treatment card in the slot The confirmation image should appear...

Page 19: ...emale B Select Yes or No to confirm if patient is new to practice C Press Next to proceed to Treatment Area screen 5 Select the Treatment Area The user can select one of the treatment areas Buttocks A...

Page 20: ...areas by pressing on the area of treatment The selected treatment area is highlighted in yellow 6 Position Applicator Once the applicators are placed on the selected treatment area the user can press...

Page 21: ...01 EN2 C 21 7 Start Treatment Select the applicator s applied for treatment and start the treatment To select Applicator A or B or both A and B Ensure that the Applicator box is checked Default is unc...

Page 22: ...t treatment Refer to Chapter 2 Treatment for detailed description of conducting a treatment A Selection of the Intensity of Applicator A B Selection of the Intensity of Applicator B C Option to sync t...

Page 23: ...the user can start a new treatment for the same patient or for a new patient after cooldown is completed Do not turn system off when it is cooling down If the treatment is interrupted before completio...

Page 24: ...eld generating section equipment operation technicians assistants and patients must not wear or hold any items which can be affected by the magnetic field Use of this device in the presence of strong...

Page 25: ...the device is turned off To disconnect the applicators turn the knob to the left To connect the applicators hold the applicator end to the connecting pins and slowly turn the knob to the right side If...

Page 26: ...ap via the connection piece The system is designed to maintain applicator position throughout the treatment Ensure that the CoolTone logo on the applicator is visible through the white securement cove...

Page 27: ...over the desired treatment area s 3 Place one end of the strap over the applicator s Place the connection piece on the strap 4 Secure the other end of the strap over the connection piece At the end of...

Page 28: ...atment 4 Intensity of Applicator A To adjust the intensity of applicator A only check that the button Synced is not activated If the button is not activated it shows Sync instead of Synced Otherwise p...

Page 29: ...button the intensity of the applicators can be synced together or can be operated independently If the button shows Sync the applicators can be adjusted individually If the button shows Synced the adj...

Page 30: ...ing problems apply or if the following remedies do not help turn off the power to the equipment and contact Zeltiq Customer Service Error messages Service required If a service must be performed a mes...

Page 31: ...shooting CS UM EMS 01 EN2 C 31 System errors If an error in the system occurs the information about the error and a corresponding error number as well as a short description how to proceed is shown in...

Page 32: ...ower the control unit off and on If the problem persists contact Customer Service T502 YYY Control Unit Error Power the control unit off and on If the problem persists contact Customer Service T530 YY...

Page 33: ...t Confirm if the LCD displays an ERROR message Check if the output strength is set by checking the intensity values after pressing the Start button Over Temperature message is displayed If applicator...

Page 34: ...labels of the device such as warnings labels of control devices identification plate are not damaged when cleaning and disinfecting Cleaning Housing Applicator In the event of visible contamination th...

Page 35: ...and at the end of every day as well as in the event of evidence of possible contamination Consult with your health professional when doing so Always perform cleaning prior to disinfection Monitor hou...

Page 36: ...the applicator before storing 3 After storing the device for a long period of time be sure to check the device before using it 4 Please note the following regarding storage conditions Keep out of wate...

Page 37: ...e mains in the event of the penetration of liquids The device does not contain any parts that can be repaired or serviced by the operator Modifications of this device are not permitted Service and rep...

Page 38: ...ructions and Other Collateral Materials WARNING Indicates a use of misuse of the device that is associated with a risk of serious and or permanent injury and death IEC 60417 5333 Type BF applied part...

Page 39: ...ries 21 CFR 801 109 Prescription Only Caution In the United States of America federal law restricts this device to sale by or on the order of a physician IEC 60417 Regulation W005 Potential for Electr...

Page 40: ...instruction for use this symbol indicates not to bleach the securement system ISO 3758 Regulation 3114 Tumble dry gentle low heat Very mild treatment In the instruction for use this symbol indicates n...

Page 41: ...are designed to operate normally when stored shipped and operated under the conditions specified in Table Use of the system in an oxygen rich environment may cause fire Do not use the system in an oxy...

Page 42: ...atient applied Parts Water Ingress Protection Ordinary Equipment IPX0 Table 7 Electrical Specifications REF Voltage Frequency Current Input power 220 240 VAC 10 50 60 Hz Maximum 3 kVA Fuses The main f...

Page 43: ...ecause it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Use of accessories applicator...

Page 44: ...ference Harmonic emissions IEC 61000 3 2 Not performed because the device will not be connected to public grid Voltage fluctuations Flicker emissions IEC 61000 3 3 Not performed because the device wil...

Page 45: ...gle phase at 0 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 Voltage interruptions accordance with IEC 61000 4 11 0 UT 250 300 cycle 0 UT 250 300 cycle Magnetic field of supply frequency 50 60...

Page 46: ...0 GMRS 460 FRS 460 FM 18Hz Derivation 1kHz Sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse Modulation 217Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse Modula...

Page 47: ...nd can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications There is no guarantee that interfer...

Page 48: ...PENDIX C Disposal of Hazardous Materials Various components of the system may contain materials whose disposal is subject to regulation The upper module of the system contains a lithium battery which...

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