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Content

10.

Technical information

11.

Cleaning / Disinfection

12.

CE mark / manufacturer

13.

Scope of delivery and accessories

14.

Device combinations

15.

Safety and maintenance

15.1 Safety
15.2 Maintenance

31
32

16.

Functional test

17.

Safety check / metrological check

18.

Error messages / troubleshooting / disposal

19.

EMC declaration

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.

The instructions for use are valid as of November 2016.

Содержание Cryo 6

Страница 1: ...Instructions for Use Cryo 6 EN ...

Страница 2: ...Front of the device Fig 1 Device and operating elements 1 Castors 2 Castor guards 3 Control panel 4 Shelf plate 5 Treatment tube connection 6 Treatment tube 7 Defrost water container 8 Defrost opening 1 2 4 5 6 8 3 7 ...

Страница 3: ...Illustrations Rear of the device Fig 2 Device and operating elements 9 Air filter 10 Mains switch 11 Mains connection 12 Identification plate 9 10 11 12 ...

Страница 4: ...on changing parameters 16 Arrow for navigation changing parameters 17 Arrow for navigation changing parameters 18 Start stop key Fig 4 OK Start Stop 10 00 P2 7 P P Display views 19 Program view 20 Airflow level display graphical 21 Airflow level display numerical 22 Treatment time display graphical 23 Treatment time display numerical 14 15 13 16 17 18 19 20 21 22 19 1 23 ...

Страница 5: ...structions for use this symbol indicates Caution with regard to possible damage of the device Applied part type B do not push sideways max permitted load on glass plate 35 kg Follow instructions for use Instructions for use Serial number Item number Manufacturer Date of manufacture Max 35kg 77 16lb ...

Страница 6: ...ral 3 2 Cryotherapy 4 5 4 Warnings 6 5 Cryo 6 in brief 7 6 Intended use 8 7 Device set up 7 1 Fitting 7 2 Fitting the supporting arm 9 11 8 Default settings 8 1 Configuration menu 8 2 Device type and device configuration 8 3 Default settings and service 8 4 Defrosting 8 5 Own programs and favourites 8 6 Information and maintenance programs 15 16 17 18 19 20 9 Operating instructions 9 1 Device desc...

Страница 7: ... Safety 15 2 Maintenance 31 32 16 Functional test 33 17 Safety check metrological check 34 18 Error messages troubleshooting disposal 35 19 EMC declaration 37 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 The instructions for use are valid as of November 2016 ...

Страница 8: ...presses in acute injuries x to prevent oedema and haematoma x in sports as preventive early stage treatment before the development of pain immediately after major exertion such as after a competitive event x to treat muscular trigger points in combination with stretching Other indications must be discussed with the patient s doctor or derived from relevant specialist literature Absolute contraindi...

Страница 9: ...mal skin damage Absolute contraindications x Cryoglobulinaemia x Cold agglutinin disease and cold haemolysis x Cold urticaria x Parts of the body with impaired circulation x Raynaud s disease x Parts of the body with impaired sensitivity x Trophic disorders x Hypersensitivity to cold Relative contraindications x When treating children parts of the body that are not being treated must be covered an...

Страница 10: ...Side effects 2 Page 3 Side effects Cold related skin damage such as skin reddening and even mild frostbite and chilblains can occur especially in sensitive patients ...

Страница 11: ...tic and electrical fields can affect the function of the device For this reason do not operate Cryo 6 in the vicinity of devices which generate strong electromagnetic fields X ray or diathermy equipment MRI machines Please keep a safe distance of several meters Caution Cryo 6 is not suitable for use in areas with an explosive flammable or combustive atmosphere Caution Do not place the device adjac...

Страница 12: ...nozzle are suitable for dynamic cooling of larger areas of skin and static cooling of smaller areas x 10 15 cm distance for treatment times of approximately 15 30 minutes Long distances between the skin and the nozzle are suitable for dynamic cooling of large areas of skin x 15 20 cm distance for treatment times of over 30 minutes Longer treatment times are needed for joints and muscles as otherwi...

Страница 13: ...cold to the face it is essential to protect the eyes The air stream should be directed evenly over the area to be treated Avoid static or excessively intensive cooling as this can lead to cold burns and hypothermia The use of the device out of the settings or applications specified in the instructions for use may lead to hazard by the uncontrolled effects of cold Children can become too cold Parts...

Страница 14: ... What are the other benefits of Cryo 6 Its clear LCD display and ergonomic keyboard reflect the state of the art Therapy can be customised through six user focused pre set programs as well as three programs with free choice of settings and an individual start up program How is the necessary concentration of cold achieved Air volume can be set to one of nine levels depending on the size of the area...

Страница 15: ...ser treatment to prevent thermal skin damage Device types 1 Cryo 6 Physio to treat diseases of the support and musculoskeletal systems 2 Cryo 6 Derma to cool the skin of patients undergoing dermatological laser treatment to relieve pain and thermal skin damage The device types are preconfigured in the factory and differ in respect of the pre set fan settings and treatment periods as well as the st...

Страница 16: ...r cable must be disconnected Caution All cables must be protected from pinching or other mechanical damage Fitting the treatment tube Insert the treatment tube into the connector 5 on the front of the device and lock it into place The treatment tube can be stored in the curved groove above the control panel 3 when not in use Fitting the castor guards Attach the castor guards 2 to the wheel holders...

Страница 17: ...the steps described above in reverse order to dismantle the glass plate Never lift the device by the glass plate Note The treatment nozzle and the nozzle attachments can be kept in the storage box Glass plate Clamp bearing Silicon disc Spacing bolt ...

Страница 18: ... hold the tube The supporting arm accessory kit consists of 1 supporting arm mounting bracket 2 M6x16 screws and allen key for mounting 1 anti rotation element 1 supporting arm pole 1 rotating supporting arm 1 tube clip 1 tube holder Also required Glass plate Guide sleeve Picture of the supporting arm after fitting supporting arm Guide through glass plate and anti rotation element Supporting arm p...

Страница 19: ... in such a way that the hole for positioning the supporting arm is on the correct side of the device Step 1 fitting the guide sleeve Assemble the guide sleeve supplied with the glass plate in the hole made for this purpose Step 2 fitting the supporting arm securing element Use the Allen key and the M6x16 screws to screw the mounting bracket to the base of the device Threaded holes are already in p...

Страница 20: ...tion element and pole Place the anti rotation element on the glass plate spacer as shown in the picture Then pass the supporting arm pole through the guide sleeve and the anti rotation element from above and lock it into place in the supporting arm securing element Anti rotation element ...

Страница 21: ...m can move freely up and down They must lie along an axis and allow the pole to bend Step 5 attaching the tube clip tube holder Screw the tube clip b onto the rotating supporting arm and hang the tube holder c onto the fixing screw of the supporting arm The treatment tube can now be passed through the tube securing element and the handpiece can be engaged in the tube clip Recesses below Same bend ...

Страница 22: ...ory settings select a favourite program or define your own programs You can choose from eleven menu items Service Back to treatment Defrost Own programs Favourite Info Automatic maintenance program S01 Automatic maintenance program S02 Cryo device type Device configuration Basic settings Use the arrows 14 and 15 to navigate among the individual menu items Selecting menu items Press the Select key ...

Страница 23: ...of the start up process Use the arrows 14 and 15 to navigate through the sub menu Press the Select key 17 to select an item Languages The following languages are available German English French Italian and Polish Note The External control input External control output and External start input sub menus are inactive Start up process Cryo 6 offers two different options here 1 Direct start 2 Programs...

Страница 24: ...all the parameters that have been changed back to the factory settings Own programs and the favourite program that you have saved will not be lost Press the NO key to retain changed parameters Service This area is password protected and is only accessible to people who have been trained by Zimmer MedizinSysteme GmbH Press the OK key to quit the menu ...

Страница 25: ... water container if it has not been used for a prolonged period for instance during holidays Performing defrosting Press the Select key to immediately begin the defrosting process The defrosting process is carried out in standby mode The treatment fan starts up and runs until the cooling unit s defrosting temperature has been reached The blower then switches off The message Defrost complete appear...

Страница 26: ... save the fan level The fan symbol now stays lit and the time symbol 22 flashes Use the arrows 14 and 15 to select the desired time Press the Save key to save the time Activate the Back key to stop programming the 1 phase program Press the Back key to quit the menu Programming a 2 phase program Here you can arrange for two programs with different fan levels and times to run consecutively in a sing...

Страница 27: ...logs the correct condition of the device Any faults are diagnosed and recorded SO1 This program simulates two 15 minute treatment sessions and one defrosting process The program records key parameters such as temperature and duration The current temperatures of the compressor and evaporator can be checked during the test SO2 The device cools down to 43 C 38 C and starts a 15 minute treatment sessi...

Страница 28: ...reatment the treatment fan blows cold air through the treatment tube At the same time the compressor condenser starts up automatically during treatment in order to ensure constant cooling Standby mode Cryo 6 is in standby mode when no treatment is being carried out The compressor automatically starts up as soon as a certain temperature is exceeded in order to ensure that sufficient cold air is ava...

Страница 29: ...s OK Start Stop 10 00 P2 7 P P Use the program selection keys 14 and 15 to set the desired treatment program and the timer keys 16 and 17 to set the desired treatment time Note The fan level cannot be altered before the start of treatment Start of treatment Press the start stop 18 key to start the program running The fan level 14 and 15 and treatment time 16 and 17 can be altered by pressing the c...

Страница 30: ...erma start up screen direct start 7 05 30 OK Start Stop Direct start Fan level and time can be selected directly Physio start up screen programs OK Start Stop 10 00 P2 7 P P Programs direct selection option among various pre set programs and the use of interval programs Note The device configuration menu item offers a free choice of the desired start up process See chapter 8 for instructions ...

Страница 31: ...yo 6 Derma is factory set for direct start operation Use the Device configuration menu to switch to program operation Changing the pre set values Cryo 6 offers options to adjust the fan level and treatment time to individual requirements and to save these changes see chapter 8 5 The treatment fan can be set to nine levels using the keys 14 and 15 Treatment time can be set to any duration between 0...

Страница 32: ... 0 C to 40 C 10 to 90 relative humidity without condensation at 600 hPa to 1060 hPa Note Storage and transport only in original packaging Evaporator temperature generated 115 V device 230 V device minimum standby 38 C 43 C maximum standby 25 C 25 C Air output temperature room temperature up to 25 C average 25 C at the start of treatment 31 C maximum 18 C after 15 minutes of treatment Figures accur...

Страница 33: ...ried out at least once a week as well as if there is any indication of contamination Consult with your hygiene specialist when doing so Always perform cleaning prior to disinfection Housing cables and accessories can be disinfected using disinfectant wipes Use a commercially available alcohol free disinfectant for metal and plastic with bactericidal virucidal and fungicidal properties Observe the ...

Страница 34: ... Page 27 The device has a CE mark in accordance with the EC directive on medical devices 93 42 EEC Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 D 89231 Neu Ulm Tel 49 731 9761 291 Fax 49 731 9761 299 www zimmer de ...

Страница 35: ...s cable 230 V 65853112 1 accessory storage tray 10101665 1 instructions for use Scope of delivery Version Cryo 6 Derma Item no 95853411 1 treatment tube Light Neo 66850122 1 glass plate with handles 94851511 1 screw Set for glass shelf 80400756 4 plastic castors 75 mm 65851610 1 defrosted water container 67300124 1 mains cable 230 V 65853112 1 accessory storage tray 10101665 1 instructions for use...

Страница 36: ...5370216 Adapter for nozzles 65370225 Nozzle 5mm 65370224 Nozzle 10mm 65370223 Nozzle 15mm 66850122 Glass plate with handles 93852620 Supporting arm for Physio tube Version Cryo 6 Derma Item no 95853411 Treatment tube Light Neo 65373510 Nozzle for Derma tube 66850112 Glass plate without handles 94851511 Screw Set for glass shelf 93852630 Supporting arm for Derma tube 95855610 Bracket for laser tube...

Страница 37: ... comply with the laser manufacturer s instructions for use when doing so The party combining the devices and thus operating a medical system is independently responsible for combining the devices correctly When using devices in combination please comply with the safety regulations of DIN EN 60601 1 ...

Страница 38: ...the equipment is operated in accordance with the instructions for use x extensions readjustments or modifications are carried out only by persons authorised by Zimmer MedizinSysteme x the user has confirmed the functional safety and the proper operating condition for him herself before use x the device is operated only by properly trained personnel x the device is not operated in areas at risk of ...

Страница 39: ...recommend cleaning the filter element more frequently in carpeted rooms or in areas where dust formation is likely to be higher for other reasons Note The software message must be confirmed by pressing the OK key after the air filter has been cleaned Emptying the defrost water container When Cryo 6 is switched off after use or when the defrosting program is started the cooling system heats up and ...

Страница 40: ...n check the function of the cooling technology as described below 1 Switch on the device 2 Wait until the device is ready for use This is the case when the device displays the program selection menu direct start menu 3 Press the start stop key 18 to start up Cryo 6 4 Select the various airflow levels one after the other and check the strength of the air stream and the cold air output ...

Страница 41: ...evice is not listed in attachment 1 of the ordinance A metrological control MTK according to section 11 of the MPBetreibV Medical device operator ordinance is also not required for the device Cryo 6 The device is not listed in attachment 2 of the ordinance Note These requirements apply to the operation of the device in Germany Please consider divergent national regulations in your country ...

Страница 42: ...ove the plug from the socket Remove the defrost water container and place a flat container underneath the device to capture the defrost water Slowly pull out the defrost opening using a twisting motion Clean the defrost opening under running water and screw it back into place Error messages Device components that are important to the running of programs are tested when the device is switched on an...

Страница 43: ...er functional problems contact your service representative Main office Zimmer MedizinSysteme GmbH Junkersstraße 9 D 89231 Neu Ulm Tel 49 731 9761 291 Fax 49 731 9761 299 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 Conta...

Страница 44: ...cated below The customer or user of the Cryo 6 should ensure that it is operated in such an environment Interference emission measurements Compliance Electromagnetic environment Guideline HF emissions according to CISPR 11 Group 1 The Cryo 6 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...

Страница 45: ...tal environment Surges according to IEC 6100 4 5 1 kV differential mode 2 kV common mode 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 cycl...

Страница 46: ... radio equipment should not be used at a distance away from the Cryo 6 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 G 3 G 3 IRU 0 WR 0 G 3 IRU 0 WR GHz with P as the rated output of the transmitter in watts w according to the information of the manufacturer o...

Страница 47: ...ctromagnetic environment in which the HF disturbances are controlled The customer or user of the Cryo 6 device can help avoid electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunication devices transmitters and the Cryo 6 device depending on the output power of the communication device as indicated below Rated output of the transmitter W Safety d...

Страница 48: ... MedizinSysteme GmbH Junkersstrasse 9 D 89231 Neu Ulm Tel 49 731 97 61 291 Fax 49 731 97 61 299 export zimmer de www zimmer de Instructions for Use EN 10 101 665 UR 1216 I Version 4 I Right of modification reserved ...

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