manualshive.com logo in svg

Zimmer Z Lipo Med, Instructions For Use Manual, Page: 10 / 43

Share
Download
Zimmer Z Lipo Med Instructions For Use Manual Download Page 10

 

Side effects

 

2

 

 

 

 

Page 2

 

 

 

 

 

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. 

 

 

Residual Risks

 

If the device is used within its intended purpose, no other residual risks are 
known besides the side effects and the warnings already mentioned.

 

 

 

Summary of Contents for Z Lipo Med

Page 1: ...Instructions for use ZLipoMed EN ...

Page 2: ...Figure Front of the device Fig 1 1 Display 2 Applicators 1 2 ...

Page 3: ...Figure Applicators 3 Applicator connections 4 Door lock release 5 Fuses and test connection earthing cable UL1015 16awg yellow green 6 Power switch and socket for power cable 4 5 6 3 ...

Page 4: ...Figure Applicators Fig 3 7 Applicator head 8 Applicator tube 9 Applicator connection Fig 4 applicators available in 6 sizes 7 9 8 ...

Page 5: ...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 Serial number Item number Manufacturer Date of manufacture Fuse specification The fleece and the liner are disposable items and should not be reused ...

Page 6: ...ators Explanation of symbols Page 1 Intended use Indication Contraindications 1 2 Side effects 2 3 Application information 3 4 Warnings 5 5 A brief introduction to ZLipoMed 6 6 Device set up 7 7 Default settings 10 8 Operation instructions 15 9 Technical information 16 ...

Page 7: ... number 5192 produced after November 2018 These instructions for use are an integral part of the device They must be stored with the device and kept accessible at all times for anyone authorised to operate this device Last updated September 2021 If the instructions for use have become illegible damaged or are not accessible for the user for other reasons a replacement is to be requested from the m...

Page 8: ... 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: ...uffering from pseudogynaecomastia Indication Male pseudogynaecomastia Contraindications Make sure that your patient visits his doctor before treatment The settings on the device for the therapy must be adapted to the patient s condition Treatment is not recommended in the following cases Pregnant breastfeeding women Blood clotting disorders Immune conditions Cardiovascular conditions heart failure...

Page 10: ... 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 Residual Risks If the device is used within its intended purpose no other residual risks are known besides the side effects and the warnings already mentioned ...

Page 11: ...st be restricted to staff who have been instructed in the safety procedures Do not use the device if it has been dropped or exposed to other massive forces Try to minimise shocks and vibrations Make sure that the handpieces do not come into contact with hard materials that could damage them Before use ensure that the device is powered via a properly grounded mains socket e g electrical installatio...

Page 12: ...just the settings to the patient s condition Treatment results may vary 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 Do not alter the temperature during treatment The fleece and the liner are disposable items and shou...

Page 13: ...to the user and or the patient The device must be switched off before inserting and removing the applicators Do not touch the handpiece connections during operation The patient must not be left unattended during treatment Never leave the device switched on open or unattended Use in wet areas is not permitted and may in case of non compliance lead to considerable damage and endanger both the patien...

Page 14: ...th in the cooled fat cells and the cells are gradually broken down within about 90 days by means of normal metabolisation What are the benefits of ZLipoMed Simultaneous use of two applicators cuts treatment times The use of applicators of different sizes allows efficient and effective treatment of parts of the body The modern colour display showing all treatment related parameters and the modern t...

Page 15: ... 5 metres away from the wall or other elements that could block the flow of air The device can affect computers or other electrical or medical devices A distance of at least 2 metres from such devices should be kept The device must be connected to a power outlet with a protective contact The power supply data on the identification plate must be respected The device should not share its power suppl...

Page 16: ...uttons on either side of the plug simultaneously Switch off the device and disconnect the power cable from the mains before changing handpieces Failure to connect the applicators with the device correctly can lead to water spillage Simultaneous operation of silicone applicators and 360 applicators is not possible Fill with distilled water Press the black slider to the right to open the doors on th...

Page 17: ...12 Note You should always perform the following checks before using the device Are the housings and handpieces clean and disinfected Are the device s castors securely placed on the floor Is the power cable connected to an earthed socket Note When starting up the device the handpieces should be connected and in their mountings Switch device off The device is switched off using the power switch 6 To...

Page 18: ...plicator the right applicator or both applicators Note Depending on the area to be treated treatment can be carried out with just one applicator left or right or with both applicators at the same time Note The program settings and changing the settings are the same for each of the 3 possible selections Consequently the section below describes the individual steps only for treatment with the left a...

Page 19: ... The intensity is preset at 5 5 Operating mode Press the corresponding button to select the operating mode auto or manual which is then displayed in orange 6 Program Program sequences are displayed 7 Phase setting Menu selection to change program sequences 8 Start of treatment Press the start button to start treatment 9 Sounds Switches signal sounds on and off by pressing a button 10 Background co...

Page 20: ... by the applicator can be set to between 10 C and 5 C Press the arrows to increase or decrease the temperature 3 Treatment time Press the arrows to set the treatment time Note The maximum treatment time is 60 minutes This takes account of the treatment times of the individual phases 4 Reset Press the button to reject the parameters selected The preset values are then displayed 5 Save The parameter...

Page 21: ...ows to increase or decrease the vacuum Vacuum intensity 1 10 The intensity is preset at 5 5 Operating mode Press the corresponding button to select the operating mode auto or manual which is then displayed in orange 6 Parameters The parameters are displayed 7 Start of treatment 8 Sounds Press the start button to start treatment Switches signal sounds on and off by pressing a button 9 Background co...

Page 22: ...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 13 Pulse mode The vacuum can be selected as unpulsed or at 3 different pulse rates The pulse rate selected is shown in orange 11 12 13 ...

Page 23: ...ng in a comfortable position start the application via the start button on the screen or the start button on the actual applicator The patient must not be left unattended during operation He should be asked how he is feeling at regular intervals at least every 15 minutes Please monitor the temperature on the screen for 2 3 minutes until the ideal temperature has been reached If the ideal temperatu...

Page 24: ...mum cooling temperature on applied component 10 C 5 C Dimensions W 665 mm D 629 mm H 1082 mm Weight approx 84 kg with handpieces Operation 10 to 26 C 30 to 75 relative humidity without condensation at 700 to 1060 hPa Storage transport without filled water 10 to 50 C 10 to 90 relative humidity without condensation at 500 to 1060 hPa Applicators Medium handpiece 108 mm x 188 mm x 138 mm Large handpi...

Page 25: ...max 1 8 litres Note Storage and transport only in original packaging Store the device in an environment free from corrosive substances such as salts or acids Protect the device from dust when in store Minimise shocks and vibrations Do not drop the device Always use suitable equipment when lifting Subject to technical changes ...

Page 26: ...enetrate the device Do not use sprays If during cleaning or disinfecting liquid penetrates the device please put the device out of service protect it from being used again and contact your service representative Make sure that when cleaning and disinfecting the labelling of the device such as warnings labels of control devices identification plate is not damaged The device and its applied part are...

Page 27: ...lcohol free disinfectant for metal and plastic with bactericidal virucidal and fungicidal properties Observe the instructions for use of the respective manufacturer Wipe all surfaces using a soft cloth soaked according to the specifications of the manufacturer of the disinfectant but not dripping or with cloths pre impregnated with disinfectant wipes Also observe requirements for drying or post cl...

Page 28: ...LipoMed 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 www zimmer de ...

Page 29: ...ons for use Accessories Item no 58000400 1 applicator small size 58000410 1 applicator medium size 58000420 1 applicator large size 58000559 1 360 applicator mini size 58000430 1 360 applicator small size 58000440 1 360 applicator medium size 58000510 1 pack of 25 cooling fleeces 58000560 1 pack of 50 cooling fleeces mini 58000573 1 pack of 10 liners for cooling fleeces 58000574 1 pack of 10 liner...

Page 30: ...13 Page 22 The manufacturer has not specified any combination devices for the ZLipoMed device Anyone who combines devices against these guidelines and thus creates a medical system does so under his her own responsibility ...

Page 31: ...uid The use of third party cables and accessories can lead to increased emissions or a reduction in safety Third party accessories must not be connected to the device Do not use damaged cables Do not use ZLipoMed near devices which generate a strong electrical field or equipment which creates electromagnetic waves ZLipoMed may be used only by doctors with appropriate specialist knowledge of fat re...

Page 32: ...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 Then pull the air filter down and away Use a mild soap solution to clean the air filter and dry it afterwards Then replace the air filter and turn it to the right in the direction of the closed lock ...

Page 33: ...y connected to the device and live Functional test Switch device on Select an applicator that is connected to the device Press the start button on the screen The LEDs on the applicator turn blue and cooling starts The animation on the screen starts and the time starts to count down Note Switch off ZLipoMed after the functional test has been completed If the device is to be used immediately afterwa...

Page 34: ...ibed in chapter 5 The device can no longer be used safely if it contains less than 900 ml of water and the error message displayed appears Please top up with distilled or deionised water as described in chapter 5 Error message Handpiece not connected Handpiece not or not correctly connected Check whether the handpiece is correctly connected The plug must be fully inserted this is indicated audibly...

Page 35: ...g properly Please contact customer service Error message Program Reset The device is not working properly and must be switched off If the error message appears again after the device has been switched back on please contact customer service Error message Communication There is a communication error between the CPU and the LCD Please contact customer service Customer service It is essential that yo...

Page 36: ...8 info zimmer de www zimmer de Disposal The device and its applicators may only be returned to the factory in the original packaging It may be disposed of only by the factory in Neu Ulm In foreign European countries please refer to national regulations for disposal Contact your distributor if necessary Used fleeces and liners can be disposed of in household waste ...

Page 37: ...ed 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 Note This information applies to the operation of the unit in Germany Please consider divergent national regulations in your country if applicable ...

Page 38: ...ot specified or provided by the manufacturer of this device can lead to increased electromagnetic interference emissions or decreased electromagnetic immunity of this device resulting in improper operation The ZLipoMed device does not contain any exchangeable components cables or other parts which lead to worsening of the EMC WARNING Portable HF communication devices including peripheral devices s...

Page 39: ...uctuations flickers according to IEC 61000 3 3 Complies Table 2 Guidelines and manufacturer s declaration Electromagnetic immunity The ZLipoMed device is intended to be used in an electromagnetic environment as indicated below The customer or user of the ZLipoMed device must ensure that it is used in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic environme...

Page 40: ...st correspond to that of a typical business or hospital environment When the user of the ZLipoMed device needs further operation even in the case of interruptions in the power supply it is recommended to operate the ZLipoMed device from an uninterruptible power supply or a battery 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 1 cycle and 70 UT 25 cycles Single phase at 0 Voltage inter...

Page 41: ...t IEC 60601 test level Compliance level Electromagnetic environment Guidelines Conducted disturbances by HF fields according to IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM band between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz 80 MHz 6 V in ISM band between 0 15 MHz and 80 MHz 80 AM at 1 kHz In the environment of devices which bear the following symbol interferences are possible Radiated el...

Page 42: ...z deviation 1 kHz sinus 2 0 3 28 710 704 787 LTE band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Pulse modulation ...

Page 43: ...inSysteme 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 Instructions for use EN 10 102 665 I 0921 I Version 8 I Subject to changes ...

Reviews:

No comments