Zimmer ZLipo Med Скачать руководство пользователя страница 37 | Manualshive

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Legal notice

17

Page 29

The ZLipo

Med

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.

Note:

This information applies to the operation of the unit in Germany. Please consider

divergent national regulations in your country, if applicable.

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Содержание ZLipo Med

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

Страница 2: ......

Страница 3: ...Figure Front of the device Fig 1 1 Display 2 Applicators 1 2 ...

Страница 4: ...Figure Rear of the device 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 ...

Страница 5: ...Figure Rear of the device Fig 3 7 Applicator head 8 Applicator tube 9 Applicator connection Fig 4 Applicators available in 4 sizes 7 9 8 ...

Страница 6: ... indicates Caution with regard to possible damage of the device 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 This symbol points out hazardous areas on the device Fuse specification ...

Страница 7: ...s Explanation of symbols Page 1 Indication areas of application 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 ...

Страница 8: ...3 15 Functional test 25 16 Fault messages troubleshooting disposal 26 17 Legal notice 29 18 Manufacturer s EMC declaration 30 Applicable to the ZLipoMed device 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 2018 ...

Страница 9: ...er conditions liver failure Kidney conditions kidney failure Patients with pacemakers Severe cardiac dysrhythmias Mental disorders Unstable motivations Large fat deposits Obesity Malignant tumours Diabetes Infection eczema or acute inflammation in the treatment area Hypertrophic scars in the treatment area Regular consumption of anti inflammatories or blood thinning medication Skin conditions in t...

Страница 10: ...ts may occasionally occur erythema swelling bruising local sensation of numbness tenseness hypercooling with skin burns allergy to cold vasoconstriction hypothermia In very rare cases paradoxical adipocyte hyperplasia has occurred after cryolipolysis treatment ...

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

Страница 12: ...ieces before each treatment session The user can adapt the program settings to the patient s fat and skin condition Auto mode is preset with proven parameters However the user can adjust the settings to the patient s condition Treatment results may vary The cooling fleece is essential and must be used at every treatment Always use a cooling fleece supplied by Zimmer MedizinSysteme GmbH not only to...

Страница 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...

Страница 14: ... 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 touch operation ensure convenience during...

Страница 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...

Страница 16: ...ove the applicator press the buttons on either side of the plug simultaneously Switch off the device and disconnect the power cable from the mains before changing handpieces Caution Failure to connect the applicators with the device correctly can lead to water spillage Fill with distilled water Caution Caution Press the black slider to the right to open the doors on the rear of the device Open the...

Страница 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...

Страница 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...

Страница 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...

Страница 20: ...icator 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 parameters selected a...

Страница 21: ... 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 colou...

Страница 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 ...

Страница 23: ...atient is lying 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 id...

Страница 24: ...29 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 Dimensions Medium sized handpiece W 108 mm D 188 mm H 138 mm Large handpiece optional W 118 mm D 220 mm H 142 mm Small handpiece op...

Страница 25: ...inal 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 ...

Страница 26: ...ot 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 Note If 70 isopropyl alcohol is used for cleaning the devic...

Страница 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...

Страница 28: ...he ZLipoMed 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 Tel 49 731 9761 0 Fax 49 731 9761 118 info zimmer de www zimmer de ...

Страница 29: ...rs medium size 58000500 20 cooling fleeces 117 1 power cable 10102665 1 instructions for use Accessories Item no 58000400 1 applicator small size 58000410 1 applicator medium size 58000420 1 applicator large size 58000559 1 applicator mini size 58000510 1 pack of 25 cooling fleeces 58000560 1 pack of 50 cooling fleeces mini ...

Страница 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 ...

Страница 31: ...e the device in the presence of flammable or combustible materials Water and electricity are a hazardous combination Do not use ZLipoMed in a wet environment Do not immerse any components directly in liquid 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 As t...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 36: ...lm Tel 49 731 9761 0 Fax 49 731 9761 118 info zimmer de www zimmer de Disposal The device may only be returned to the factory in its original packaging It must be disposed of by the factory in Neu Ulm In foreign European countries please refer to national regulations for disposal Contact your distributor if necessary ...

Страница 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 ...

Страница 38: ...h an environment Interference emission measurements Compliance Electromagnetic environment Guideline HF emissions according to CISPR 11 Group 1 The ZLipoMed device uses HF energy only for its internal functioning This means that its HF emissions are very low and it is very unlikely that adjacent electronic devices would suffer interference HF emissions according to CISPR 11 Class A The ZLipoMed de...

Страница 39: ... 1 kV differential mode 2 kV common mode The quality of the supply voltage should correspond to that of a typical business or hospital environment Voltage dips brief interruptions and fluctuations in the supply voltage according to IEC 61000 4 11 5 UT 95 dip in the UT for cycle 40 UT 60 dip in the UT for 5 cycles 70 UT 30 dip in the UT for 25 cycles 5 UT 95 dip in the UT for 5 seconds 5 UT 95 dip ...

Страница 40: ...Med including the cables that is less than the recommended safety distance which is calculated according to the equation applicable to the transmission frequency Recommended safety distance d 1 2 P d 0 35 P for 80 MHz to 800 MHz d 0 7 P for 800 MHz to 2 5 GHz with P as the rated output of the transmitter in watts w according to the information of the manufacturer of the transmitter and d as the re...

Страница 41: ...magnetic environment in which the HF disturbances are controlled The customer or user of the ZLipoMed device can help avoid electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunication devices transmitters and the ZLipoMed device depending on the output power of the communication device as indicated below Rated output of the transmitter W Safety d...

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Страница 44: ...Systeme 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 BäZi 0918 I Version 4 I Subject to changes ...

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