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Related Manuals for Cocoon cooltech
Summary of Contents for Cocoon cooltech
- Page 1 U S E R M A N U A L...
- Page 2 • General description: A general description of the various subsystems of the device. ® cooltech • Installation and set-up: Describes the electrical, space and environmental require- ments that are necessary for the installation of the cooltech device. ® • Operation of the device: How to use the cooltech device.
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Page 3: Table Of Contents
User manual CONTENTS: SAFETY AND REGULATORY ..............5 General safety precautions ................5 Electrical safety requirements ................5 Other safety requirements ................6 MDD regulation ....................7 Required markings and labelling ..............8 STORAGE, HANDLING AND TRANSPORT: INITIAL VERIFICATION OF THE DEVICE AND ITS ACCESSORIES ... 12 List of components and accessories ............. - Page 4 User manual DESCRIPTION OF THE cooltech® PROCEDURE ......32 Intended use ....................32 Prior to the cooltech trea ment…………………………………………………32 ® Operation during the cooltech procedure ............ 33 ® After the cooltech treatment ............... 34 ® Precautions, expected adverse effects and contraindications ......35 DEVICE MAINTENANCE ..............
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Page 5: Safety And Regulatory
The power supply lines must be free of transient surges, voltage or current peaks, voltage drops or voltage surges. WARNING: Avoid connecting cooltech® to the same electrical line as sensitive devices. There are potentially dangerous high voltages inside the device; panels and covers should not be removed, unless by personnel who have been authorised by the manu- facturer to do so. -
Page 6: Other Safety Requirements
EMC and must be installed and cooltech ® operated in accordance with the information provided on EMC. Portable and mobile RF communications equipment can affect the cooltech device during normal use. ® Only the cables and accessories supplied by the manufacturer should be used. The... -
Page 7: Mdd Regulation
® ments for compliance with Annex II of Directive 93/42/EEC on Sanitary Products and its versions, as revised in Directive 2007/47/EEC. cooltech is classified as Class IIa ® electronic medical equipment, the definition of which is active therapeutic equipment that exchanges energy with the human body. -
Page 8: Required Markings And Labelling
User manual Required markings and labelling S1 symbol – Information Information based on Art.13 of d.lgs. 151/05 of 25/07/2005. "Action of Directive 2002/96/CEE related to the reduction of dangerous substances in electrical and electronic equipment and the deterioration of waste products." Located on the technical features label, indicating that the product should not be disposed of with urban waste and must be subject to a separate collection. - Page 9 User manual ISO 7010- W001 Symbol – Information. General warning. The appearance of this symbol on the screen during normal use of the device indi- cates that you must consult the user manual before continuing. 5.12 EN280 Symbol – Information. Manufacturer’s symbol.
- Page 10 Label located on the outer packaging of the device in accordance with the appli- cable requirements of harmonised IEC standard 60601-1 regarding operating conditions. Storage -20ºC a 50ºC Temperature Humidity <90% (Non-condensing) The cooltech devices are supplied from the factory with 50% coolant liquid. SAFETY AND REGULATORY...
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Page 11: Storage, Handling And Transport
Maintaining a minimum of 40 cm of free space at the rear of the device and 20 cm at the sides is recommended. Stand the device on its feet (if using desktop mode). To ensure that the cooltech device functions optimally, the working environment must ®... -
Page 12: Initial Verification Of The Device And Its Accessories
User manual INITIAL VERIFICATION OF THE DEVICE AND ITS ACCESSORIES It is very important that the device is checked thoroughly when it is delivered. This should be performed in the presence of the carrier and with the utmost care and attention, as damage from falls or impacts may not initially be apparent. -
Page 13: List Of Components And Accessories
User manual List of components and accessories Antibacterial filter Cool Gel Pad cryoprotective membrane device and ® cooltech support Set of applicator holders External vacuum tank Callipers Straight HP removable applicators Coupler External tank holder Power cable Cool Gel Cannula to fill the... -
Page 14: Documentation List
User manual Documentation list • User manual • Warranty certificate • Declaration of conformity • Installation manual • Protocol • Informed consent • Quality certificate INITIAL VERIFICATION OF THE DEVICE AND ITS ACCESSORIES... -
Page 15: Description Of The Exterior Of The Device
User manual Description of the exterior of the device The cooltech device consists of the central unit along with its support, two remov- ® able applicators which administer the cold to the treatment area, and a range of accessories used during the normal operation of the device and/or for maintenance. -
Page 16: Description Of The Applicators
User manual Description of the applicators The two removable and independent applicators allow two treatment areas to be worked on simultaneously. They have been specially designed and developed to temporarily apply suction to the treatment area, allowing the adipose tissue to be immobilised and isolated from other tissues, thereby achieving a more precise and penetrating cooling effect. -
Page 17: Installation And Set-Up
User manual INSTALLATION AND SET-UP Colocación del equipo en el soporte A support is supplied with the device to assist mobility and functionality. The image shows how the device should be positioned on the support This process must be performed by two people, with one holding each side so that the device can be positioned on the support. -
Page 18: Positioning The External Vacuum Tanks
User manual Positioning the external vacuum tanks The device comes with two connectable external tanks (one per applicator), which are required to correctly apply the suction to the adipose tissue and prevent gel and other substances from getting into the device and damaging it. The external vacuum tanks are supplied with the device and incorporate a protective antibacterial filter To connect the external vacuum tanks correctly:... -
Page 19: Connecting The Applicators
User manual Connecting the applicators Note the position of the applicators on the device. Position the applicator connector so that it is aligned with the lateral inserts and that appear in the image of the device’s connector. centring pins Anchor the mobile fastening element of the applicator’s connector on the mount- ing elements of the connector and metal support tab on the device until it is perfectly interlocked, as shown in the image... -
Page 20: Switching On The Device
Wait a few seconds for the TFT touch screen to light up and the start screen to appear. TFT – Touch screen The operator can interact with the cooltech device through a touch screen. Gently ®... -
Page 21: Switching Off The Device
User manual Refer to the Safety and regulatory section for cleaning requirements and to avoid causing touch screen errors. Remove the plastic screen protector before use. Switching off the device The device is designed for continuous use (refer to the Safety and regulatory section) so it can be kept activated between different treatments. -
Page 22: Operating The Device
User manual OPERATING THE DEVICE The different screens and the software of the device are explained below. For more details, tap the HELP button. HELP button This button appears on all screens. While help is activated, any area or button on the screen can be tapped to display related information. - Page 23 “default” values will appear. To ensure that the prede ned treatment values that appear are appropriate, enter the true value measured in the treatment area using the "callipers". Use the cooltech ®...
- Page 24 User manual Applicator 1 (Straight HP) Applicator 2 (Straight HP) TREATMENT Straight HP Straight HP TEMPERATURE Curved HP Curved HP Ti g ht HP Ti g ht HP TREATMENT TIME SUCTION PRESSURE To modify the parameters that have been established by the software: The prede ned parameters that display for both Applicator 1 and Applicator 2 can be modi ed at will by the operator, within the allowable limits.
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Page 25: Treatment Screen
User manual Prede ned values table The predefined “default” values table for the treatments varies depending on which applicator is being used. For example, for a certain applicator the predefined values table may look like this: Treatment area Treatment Treatment time Suction size (mm) temperature (°C) - Page 26 User manual The Applicator 1 and Applicator 2 icons are marked with an (X) when idle, this indicates that the treatment has not yet begun. The treatments screen allows the user to view and modify the pre-established treat- ment values using the INCREASE/DECREASE buttons, this can be done as follows: Tap the TREATMENT TEMPERATURE button for Applicator 1 or Applicator 2 and alter the established values using the INCREASE/DECREASE buttons.
- Page 27 User manual • Current temperature: Displays the actual temperature that the device is operating at. The working temperature decreases gradually until it reaches the programmed value, it then remains at said value. • Time remaining: Displays the actual time left until the treatment finishes, this is conveyed by means of a countdown from the pre-selected time value.
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Page 28: Configuration Screen
• Table number: Indicates the internal and independent number of each device. Specific information for the manufacturer. • Model: Indicates the model of the device: cooltech® • Hours and minutes in operation: The hours in operation are indicated by the first four digits, and the two remaining digits indicate the minutes. -
Page 29: Codes And Licensing Screen
User manual Codes and licences screen This screen can be accessed from the start screen or the configuration screen by tapping the CODES AND LICENCES button. Internal codes can be entered on this screen. Specific information for the manufacturer. HOME button VIEWER button ENTER NUMBER button Indicates that a valid... -
Page 30: System Alerts
User manual SYSTEM ALERTS The device uses a series of error messages to indicate that it is not functioning correctly. When a warning symbol is displayed on the screen, carefully read the information in the user manual to learn about the corresponding error before continuing to use the device. - Page 31 User manual Insufficient Suction This alert indicates that the applicator is not applying suction correctly. Replace the applicator, tap the screen and restart the applicator. Contact the SAT if this error repeats three times. Incorrect Applicator Temperature If one of the applicators detects a temperature problem, discontinue working with the device and contact the SAT Ambient Temperature Outside of the Range The ambient temperature of the room is too low or too high for continuous use.
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Page 32: Description Of The Cooltech Procedure
However, the area will soon become anaesthetised. Use the coupler for tissue with hard or low adiposity. IMPORTANT: The cooltech® device has many mechanisms to ensure the safety of the treatment, including temperature-sensor control of the cooling plates. -
Page 33: Operation During The Cooltech Procedure
To do this, the applicator must be changed and the entire process repeated (from the application of the gel). For more information on the proper procedure for the suction test, consult the cooltech treatment protocol. -
Page 34: After The Cooltech Treatment
This process can take between 5 and 10 minutes. Please note: If you do not have a quick guide to using the cooltech device, please contact the MANUFACTURER.. DESCRIPTION OF THE COOLTECH® PROCEDURE... -
Page 35: Precautions, Expected Adverse Effects And Contraindications
• Ensure that the position of the applicator will not irritate areas with bony protuberances. • The informed consent provided by the MANUFACTURER must be completed and returned by the patient before the treatment is performed. DESCRIPTION OF THE COOLTECH® PROCEDURE... - Page 36 Nausea, dizziness or vasovagal symptoms (very unusual) In the submental area: disorders of the motor nerves of the perioral area (marginal mandibular and hypoglossal), sub- maxillary salivary gland disorders (dry mouth or decreased production of saliva) (extremely rare) DESCRIPTION OF THE COOLTECH® PROCEDURE...
- Page 37 • Active or recent malignant pathology, within the last 5 years (cancer), use of anti- cancer drugs • Precancerous, malignant or suspicious lesions in the treatment area • History of paradoxical adipose hyperplasia Please note: For more information about the cooltech procedure, consult the treat- ment protocol. DESCRIPTION OF THE COOLTECH® PROCEDURE...
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Page 38: Device Maintenance
User manual DEVICE MAINTENANCE General considerations for cleaning and maintenance • For safety reasons, the power cable must be disconnected from the mains before cleaning the device. • Cleaning and sanitising the device’s applicators after each treatment is recom- mended. Remove the product residue (gel) left in the applicator after each treat- ment, then clean and disinfect the applicator before using it again. -
Page 39: Cleaning The Air Filter (Ventilation)
User manual Cleaning the air filter (ventilation) There is an air filter at the bottom of the device to prevent dust from getting inside. The filter can be removed by pulling it. This filter should be cleaned once a month. Clean the filter with a vacuum cleaner or by shaking it out. - Page 40 User manual Then, with the cannula filled with distilled water, insert the end of the cannula’s tube into the inner hole of the applicator and inject the water into it. Remove the tube from the hole. Repeat this process at least twice. To clean thicker gel residues, after performing the previous step, fill the cannula with air and insert the end of the tube into the inner hole of the applicator and inject the air.
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Page 41: Technical Sheet
User manual TECHNICAL SHEET BASIC OPERATION Type of device Controlled cold device for medical use TECHNICAL SPECIFICATIONS Maximum continuous vacuum pressure 250 mbar Vacuum regulation range -100 mbar up to -250 mbar (± 10%) Maximum cooling power (in each applicator) 210W Cooling power (in each applicator) 100W @ 0°C with an ambient temperature of 25°C... - Page 42 User manual TECHNICAL SHEET...
- Page 43 User manual TECHNICAL SHEET...
- Page 44 Its various applicators cool the treatment area to achieve extraordinary results from the 1st session. Straight HP Curved HP Double HP Tight HP Tiny HP Oval HP www.cocoonmedical.com Customer Service: PASSATGE MASOLIVER, 24-28 T.
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Questions and answers
I can’t find what the issue is with my machine
Common issues with the Cocoon CoolTech machine include:
1. Uneven Cooling – The head may unevenly cool fatty tissue, requiring replacement of the electrical cooling modules and re-sealing the head.
2. Faulty Sensors – Sensors may need replacement if they malfunction.
3. Cooling System Issues – The cooling system may need disassembly, cleaning, and re-sealing to maintain proper function.
Regular maintenance and inspections are recommended to prevent these issues.
This answer is automatically generated