Zimmer Z Lipo Med Instructions For Use Manual
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Zimmer Z Lipo Med Instructions For Use Manual

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Instructions for use
Med
ZLipo
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Summary of Contents for Zimmer Z Lipo Med

  • Page 1 Instructions for use ZLipo...
  • Page 2 Figure Front of the device Fig. 1 Display Applicators...
  • Page 3 Figure Applicators Applicator connections Door lock release Fuses and test connection (earthing cable UL1015 16awg yellow green) Power switch and socket for power cable...
  • Page 4 Figure Applicators Fig. 3 Applicator head Applicator tube Applicator connection Fig. 4 applicators available in 6 sizes...
  • Page 5 Explanation of symbols This symbol indicates “Danger” with regard to possible risks to people. This symbol indicates “Caution” with regard to possible material damage. Applied part type BF Follow instructions for use. Products marked with the adjacent symbol must not be disposed of with household waste.

  • Page 6: Table Of Contents

    Content Illustrations Front of the device Rear of the device Applicators Explanation of symbols Page Intended use / Indication / Contraindications Side effects Application information Warnings A brief introduction to ZLipo Device set-up Default settings Operation instructions Technical information...
  • Page 7 Content Page Cleaning/Disinfection CE mark / manufacturer Scope of delivery and accessories Device combinations Safety and maintenance Functional test Fault messages / troubleshooting / disposal Legal notice Manufacturer´s EMC declaration Valid for the ZLipo devices with article number 5192, produced after November 2018 These instructions for use are an integral part of the device.
  • Page 8 Content We reserve the right to revise this document at any time or change product specifications described. There is no obligation to provide information about the changes to the customer. All serious incidents associated with the product are to be reported to the manufacturer and the competent authority of the state in which the user and/or the patient is located.

  • Page 9: Intended Use / Indication / Contraindications

    Intended Use / Indication / Contraindications Intended Use Device used to reduce subcutaneous fat non-invasively by maintaining the affected area at a low temperature level. ZLipo was developed for the treatment of male pseudogynaecomastia using cryolipolysis technology. Cryolipolysis is a medical treatment for the destruction of fat cells. Its principle is based on controlled cooling in the range of -10°C to 5°C for the non-invasive, localised reduction of fat deposits.

  • Page 10: Side Effects

    Side effects Side effects The following side effects may occasionally occur: ● erythema ● swelling ● bruising ● local sensation of numbness ● tenseness ● hypercooling with skin burns ● allergy to cold ● vasoconstriction ● hypothermia ● pain in the treatment area In rare cases, paradoxical adipocyte hyperplasia has occurred after cryolipolysis treatment.

  • Page 11: Application Information

    Do not touch the plug with wet hands. Only accessories provided by Zimmer MedizinSysteme GmbH may be used. In order to ensure adequate ventilation, the device must be kept at least 0.5 metres away from other devices or walls.
  • Page 12 The cooling fleece and the liner are essential and must be used at every treatment. Always use a cooling fleece and a liner supplied by Zimmer MedizinSysteme GmbH, not only to improve efficacy but also to protect the treated area.

  • Page 13: Warnings

    Warnings ZLipo is a cryolipolysis device for medical and aesthetic treatments. The device emits high levels of cooling energy than can damage the skin if used excessively. All cooling devices can cause skin damage if incorrectly used. Be aware of the potential danger at all times and comply with the safety guidelines described in these instructions for use.

  • Page 14: A Brief Introduction To Zlipo

    A brief introduction to ZLipo What is ZLipo A safe cryolipolysis device to reduce fat cells in the male torso. As triglycerides in fat become solid at low temperatures, ZLipo uses advanced cryotechnology to selectively treat pockets of fat and so start to eliminate fat cells without damaging surrounding tissue.

  • Page 15: Device Set-Up

    Device set-up 6.1 Site preparation Note: Do not expose the device to direct sunlight. Operate the device at room temperatures of between 10 and 26°C and air humidity of between 30 and 75%. Do not set the device up close to fan heaters or air conditioners. Make sure that the power switch of the device is set to “0”.
  • Page 16 Device set-up 6.2 Starting up the device Connect power cable Connect the power cable to the provided port (6) on the device and connect the cable to the mains. The device may only be connected to power outlets with a protective contact Note: Note: All cables must be protected from pinching or other mechanical damage.
  • Page 17 Device set-up 6.2 Starting up the device Distilled water must run through the whole system when installing the device for the first time. Do this by starting up the device for 30 seconds (without selecting a treatment) and then fill up again to the red mark. This procedure must be repeated for each handpiece when it is connected for the first time.

  • Page 18: Default Settings

    Default settings Start-up screen ZLipo carries out a self-test after it has been switched on. The current status of Self-test pre-cooling can be read off during the test. Applicator selection Once precooling has been completed, the user can select the left applicator, the right applicator or both applicators.
  • Page 19 Default settings Program screen (in auto mode) (1) Selected applicator The selected applicator (left, right or both) is shown in orange. Press the corresponding button to switch applicator. (2) Treatment time The remaining treatment time is displayed. (3) Temperature The temperature in the applicator is displayed. (4) Vacuum intensity The vacuum intensity is displayed.
  • Page 20 Default settings Phase setting Pressing the phase setting button opens the selection window in which phases can (in auto mode) be defined. The settings defined during the previous session are displayed. The process of constructing and setting the first phase is explained below. The other two phases are constructed in a similar way.
  • Page 21 Default settings Program screen (in manual mode) (1) Selected applicator The selected applicator (left, right or both) is shown in orange. Press the corresponding button to switch applicator. (2) Treatment time The remaining treatment time is displayed (3) Temperature The temperature in the applicator is displayed (4) Vacuum intensity The vacuum intensity is displayed.
  • Page 22 Default settings Setting parameters (in manual mode) (11) Temperature The temperature emitted by the applicator can be set to between -10°C and 5°C. Press the arrows to increase or decrease the temperature. (12) Treatment time Press the arrows to set the treatment time. Note: The maximum treatment time is 60 minutes.

  • Page 23: Operation Instructions

    Operation instructions Note: The following recommendations are only guidelines and must of course be adapted to the patient's individual situation. Restrict access to the treatment room to staff who have been instructed. Note: Note: Always use the cooling fleece during treatment to protect the area being treated and to increase efficacy.

  • Page 24: Technical Information

    Technical information Basic device power supply 220 - 240 Vac, 50 Hz Fuse 2xT10AH, 250 V and 16 A automatic fuse in power switch Sound power level 61.5 dB during normal operation (with operation of the cooling unit) Power consumption 1200 VA Protection class IP class...
  • Page 25 Technical information Applied part BF type, applicator with cooling fleece and liner Filling medium Distilled water max. 1.8 litres Storage and transport only in original packaging. Store the device in an Note: environment free from corrosive substances such as salts or acids. Protect the device from dust when in store.

  • Page 26: Cleaning/Disinfection

    Cleaning Disinfection Note: Always keep the device and handpieces clean in order to achieve optimum results. Before starting any maintenance and cleaning measures the device must always be switched off at the main switch and the mains cable must be disconnected. Cleaning the device while it is in operation can be dangerous for the user and/or the device.
  • Page 27 Cleaning Disinfection Housing/cables In the event of visible contamination, the housing and all cables can be cleaned using commercially available alcohol-free plastic cleaners. Wipe the surface until the dirt is removed, using a soft cloth soaked according to the specifications of the manufacturer of the cleaning agent but not dripping wet.

  • Page 28: Ce Mark / Manufacturer

    CE mark and manufacturer The ZLipo device bears the CE mark in accordance with the EC directive on medical devices 93/42/EEC. Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm Germany Tel. +49 731 / 9761-0 Fax +49 731 / 9761-118 info@zimmer.de...

  • Page 29: Scope Of Delivery And Accessories

    Scope of delivery and accessories Scope of delivery Item no. 5192 ZLipo incl. filler tube 58000500 20 cooling fleeces 58000573 pack of 10 liners for cooling fleeces 67300124 power cable 10102665 instructions for use Accessories Item no. 58000400 applicator, small size 58000410 applicator, medium size 58000420...

  • Page 30: Device Combinations

    Device combinations The manufacturer has not specified any combination devices for the ZLipo device. Anyone who combines devices against these guidelines and thus creates a medical system does so under his/her own responsibility. Page 22...

  • Page 31: Safety And Maintenance

    Please check whether ZLipo is authorised in your country. As the manufacturer, Zimmer MedizinSysteme GmbH can only consider itself to be responsible for the safety and reliability of the device if • the device is operated using a proper power outlet with earth contact and the electrical installation complies with DIN VDE 0100 part 710, •...
  • Page 32 Safety and maintenance 14.2 Maintenance Air filters Both air filters should be checked once a month and cleaned if dirty. Press the black slider on the door to the right to open the doors on the rear of the device. To release the air filter, push down the black slider on the filter and turn the air filter to the left in the direction of the opened lock.

  • Page 33: Functional Test

    Functional test A function test should be carried out if you have any doubts about whether the device is functional. Note: Check whether the applicators are correctly connected to the device before carrying out the function test. Check whether the power cable is correctly connected to the device and live. Functional test Switch device on.

  • Page 34: Fault Messages / Troubleshooting / Disposal

    Fault messages / troubleshooting / disposal Error message Water level low first warning If this symbol appears on the left-hand side of the bottom screen bar, the water level in the device is getting low. Please top up with distilled or deionised water as described in chapter 5.
  • Page 35 Fault messages / troubleshooting / disposal Error message Handpiece temperature The temperature in the handpiece is not properly regulated. Please replace the handpiece. If two handpieces are being used to administer treatment, the user can continue to administer treatment using the intact handpiece. Error code (left/right): 0: normal 1: Error...
  • Page 36 Fault messages / troubleshooting / disposal Main office Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm Germany Tel. +49 731 / 9761-0 Fax +49 731 / 9761-118 info@zimmer.de www.zimmer.de Disposal The device and its applicators may only be returned to the factory in the original packaging.

  • Page 37: Legal Notice

    Legal notice The ZLipo device is not listed in annex 1 of the MPBetreibV (German Medical Devices Operation Ordinance). The device is not listed in annex 2 of the MPBetreibV (German Medical Devices Operation Ordinance). In Germany, the German Social Accident Insurance (DGUV) (Regulation 3 – Electrical systems and equipment), as amended, must also be observed.

  • Page 38: Manufacturer's Emc Declaration

    Manufacturer's EMC declaration The ZLipo was developed according to the recognised rules of engineering; the information on use as intended of the components was taken into account. The ZLipo should not be operated near active HF surgical devices or magnetic resonance imaging devices which can cause significant electromagnetic interference.
  • Page 39 Manufacturer's EMC declaration Table 1: Guidelines and manufacturer’s declaration – Electromagnetic emissions The ZLipo device is intended to be used in an electromagnetic environment as indicated below. The customer or user of the ZLipo device must ensure that it is used in such an environment. Electromagnetic environment –...
  • Page 40 Manufacturer's EMC declaration Guidelines and manufacturer’s declaration – Electromagnetic immunity The ZLipo device is intended to be used in an electromagnetic environment as indicated below. The customer or user of the ZLipo device must ensure that it is used in such an environment. IEC 60601 –...
  • Page 41 Manufacturer's EMC declaration Table 3: Guidelines and manufacturer’s declaration – Electromagnetic immunity The ZLipo device is intended to be used in an electromagnetic environment as indicated below. The customer or user of the ZLipo device must ensure that it is used in such an environment. IEC 60601 –...
  • Page 42 Manufacturer's EMC declaration Table 4: Electromagnetic immunity to HF radio equipment Test Maximum Test level Band Distance frequency Service Modulation energy immunity (MHz) (MHz) (V/m) 380 – 390 TETRA 400 Pulse modulation 18 Hz 430 – 470 GMRS 460, FRS 460 ±...
  • Page 43 Instructions for use Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 7 31. 97 61-291 Fax +49 7 31. 97 61-299 export@zimmer.de www.zimmer-aesthetics.com...

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