Zimmer enPuls Скачать руководство пользователя страница 38 | Manualshive

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General information

9.5. CE Marking / Legal information

9

36

CE Marking

This product bears the marking

0123 in accordance with EU

Medical Products Directive 93/42/EEC and meets the essential
requirements of Annex I to this Directive.

The product was developed, manufactured and tested using the quality
management system according to DIN EN ISO 13485.

The product is rated in Class II

a

according to Annex IX of the Directive.

Legal Information

National laws and regulations must be observed when installing and
operating this treatment device.

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Содержание enPuls

Страница 1: ...Operating Instructions enPuls Version 2 0 GB...

Страница 2: ......

Страница 3: ...n and control elements 1 Control unit 2 Shock energy controller 3 Touch pen in holder 4 Display 5 Frequency controller 6 SD card slot Handpiece 7 Handpiece with applicator head 25 mm 8 Air vents front...

Страница 4: ...Figures Front view of device 2 Display Screen readouts 11 Status bar 12 Buttons on the screen 13 Title bar 14 Navigation bar 14 12 11 13...

Страница 5: ...f device 3 Switch and connector sockets Switch Connector sockets 15 Main switch 16 Mains fuse 17 Port for mains cable 18 Port for footswitch 19 Port for handpiece 20 Serial number manufacturer s plate...

Страница 6: ...Figures Accessories 4 21 Silicone cap 22 25 mm applicator head 23 15 mm applicator head 24 6 mm applicator head 21 22 23 24...

Страница 7: ...enPuls 1 4 Handpiece 1 5 Applicator heads 1 6 Footswitch 7 8 10 11 12 13 2 Installation 2 1 Fitting the cables starting the system 2 2 Settings 14 15 3 SD Card 17 4 Treatment screen 18 5 Favourites a...

Страница 8: ...unction test 41 13 Error messages 42 14 Scope of delivery Accessories 43 15 Manufacturer s declaration of Electromagnetic Compatibility 44 Valid for the enPuls V 2 0 devices These operating instructio...

Страница 9: ...ce and generates shockwaves which spread out radially in the tissue What are the advantages of enPuls The innovative technology allows a compact design with no need for a compressor The clear and mode...

Страница 10: ...Starting the programme Press the Start button to open the treatment screen for programme P 02 Treatment screen Applicator Positioning handpiece applicator Select the appropriate applicator head for th...

Страница 11: ...he treatment The display in the bottom status bar changes from Ready to Active Note Only activate the shockwave via the footswitch once the handpiece has been positioned on the patient Ending treatmen...

Страница 12: ...n The weight of the handpiece means that it is normally not necessary to apply pressure to the treatment area point The handpiece is placed on the treatment area point and held loosely in position wit...

Страница 13: ...than 2 million shocks can be delivered For more information on the need to replace the shockwave generator see chapter 11 To work with the handpiece on a patient it is essential that one of the applic...

Страница 14: ...the handpiece there should no longer be any thread visible Note Applicator heads are expendable parts and must be replaced after a certain period of use Minor slight deformation or shortening of the...

Страница 15: ...rectional so it is not necessary to align the footswitch exactly To avoid damage please note that only slight pressure needs to be exerted on the switch Use the front part of your foot not the heel to...

Страница 16: ...Connect the mains cable to the designated port 17 of the device and then plug into the mains Connecting the handpiece Plug the handpiece into the appropriate socket 19 of the device and place it on th...

Страница 17: ...Start screen Option to choose between 5 start screens Press the button to open the pull down menu to select the start screen The start screen is selected by pressing on the appropriate row Start displ...

Страница 18: ...e window with information about the current software version of the device Default settings Press the default button to reset the factory default settings Touch calibration Press the Touch Calibration...

Страница 19: ...mendation list are saved on the SD card Note If the SD card is not inserted the message SD card not found appears when the Favourites and Memory buttons are pressed The Therapy button is not shown Dea...

Страница 20: ...d Ready and if treatment is running the text Active appears Mode Shows the selected operational mode continuous in this case Press the Mode button to open the Input window and select the operational m...

Страница 21: ...easing or decreasing of the number of shocks set Number of shocks Shows the pre selected shock numbers as well as the current number of shocks delivered to the patient Also the count direction increas...

Страница 22: ...been reached The footswitch is deactivated and shock delivery is no longer possible The treatment can be continued by resetting the current number of shocks or by adjusting the pre selection When the...

Страница 23: ...d automatically save the programme The programme is automatically saved in the first free space in the list Memory Press the Memory button to open the Memory list and automatically save the programme...

Страница 24: ...emory list Individual saved programmes are listed in Favourites or Memory list From here they can be 1 retrieved for treatment or 2 edited sequence changed or deleted Selecting the Memory or Favourite...

Страница 25: ...g and editing Favourites list and the Memory list 5 23 Editing Press the Edit button to open the Edit Favourites screen Activate the desired programme by pressing the appropriate row You are now able...

Страница 26: ...easing counting direction to the preset value by decreasing counting direction Press the button to move an item of the list upwards by one position Press the button to move an item of the list downwar...

Страница 27: ...rate in 1000 increments activation of the button reduces the number of the pulses in 1000 steps Activation of the button increase the pulse rate in 100 increments activation of the button reduces the...

Страница 28: ...s you to select the treatment The treatment can be selected using the body region menu or the treatment recommendation list Therapy Press the Therapy button to open the Selecting by body region window...

Страница 29: ...Further steps will only be described once as the selection though Body Parts or List opens a similar list Selecting detailed symptoms The selection of a treatment recommendation opens another window s...

Страница 30: ...ment information After selecting the detailed symptoms another window opens showing detailed treatment and treatment information Selecting the treatment programme Press the Therapy button to open the...

Страница 31: ...Treatment recommendation 7 29 Retrieving treatment information Press the Info button to open the window with the treatment information...

Страница 32: ...shoulder problems Status post muscular injuries Chronic patellar tendonitis Jumper s knee Achillodynia Plantar fasciitis Heel spurs Myofascial trigger point treatment e g neck Myofascial trigger poin...

Страница 33: ...after a fracture In general we advise against treatments if blood clotting disorders are present or the patient is receiving treatment that results in a change in the blood clotting behaviour during p...

Страница 34: ...ing Caution In the Operating Instructions this symbol stands for Caution with regard to possible damage to property Port for handpiece Port for footswitch Follow Operating Instructions Instrument type...

Страница 35: ...ho are concurrently receiving treatment involving a reduction and or modification of blood clotting or prolongation of the blood clotting time e g with acetylsalicylic acid should consult their therap...

Страница 36: ...120 mJ Mode of operation Intermittent use max 6000shocks 15min break Accuracy 20 Shockwave handpiece Ergonomic model with anodized aluminium case and fan cooling Dimensions 230 mm in length 50 mm diam...

Страница 37: ...cordance with the Operating Instructions if extensions reconfigurations or modifications are implemented only by persons authorised by Zimmer MedizinSysteme users must ensure that the device and the h...

Страница 38: ...meets the essential requirements of Annex I to this Directive The product was developed manufactured and tested using the quality management system according to DIN EN ISO 13485 The product is rated i...

Страница 39: ...ull the silicone cap over the applicator head If you do not use the protective cap the lubricant can get inside the applicator head and handpiece which can lead to permanent soiling and malfunctioning...

Страница 40: ...rature becomes too high forcing the handpiece to cool If the temperature switch is activated this is indicated by a message on the display and shocks can no longer be emitted After acknowledging the m...

Страница 41: ...d clean the rear dome thoroughly Then hold the handpiece without the applicator head with the opening downward and at 2 or 5 Hz frequency release a few shocks maximum 10 at the lowest energy level The...

Страница 42: ...nd the power plug Above the mains input socket of the device there are fine wire fuses which isolate the mains voltage in the event of any electrical problem Open the flap and check the fuses Replace...

Страница 43: ...he handpiece and the footswitch are connected correctly to the device Check for proper mains connection Function test Testing Switch on the device Depress the footswitch briefly the fan and shockwave...

Страница 44: ...has reached the operating temperature the message Over temperature is replaced by the message Ready in the status bar and the treatment can be continued In the status bar the message Ready appears an...

Страница 45: ...itch 1 Mains cable 1 Operating instructions 1 Test template 1 Transport case 2 Touch pen 1 Holder for handpiece Accessories Item No 50500016 Holder for handpiece 93133520 6 mm applicator head 93133510...

Страница 46: ...he enPuls Version 2 0 should ensure that it is operated in such an environment Interference tests Conformity Electromagnetic environment guideline RF emissions according to CISPR 11 Group 1 The device...

Страница 47: ...EC 6100 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interr...

Страница 48: ...MHz to 2 5 GHz 3 Veffektive value 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Portable and mobile radio equipment should not be used any closer to the enPuls Version 2 0 including cables than the recomm...

Страница 49: ...s Version 2 0 device is intended for operation in an electromagnetic environment where RF disturbances are monitored The customer or user of the enPuls Version 2 0 device can help prevent electromagne...

Страница 50: ...I Version 4 I Right of modifications reserved enPuls Version 2 0 Zimmer MedizinSysteme GmbH Junkersstra e 9 D 89231 Neu Ulm Tel 49 731 97 61 291 Fax 49 731 97 61 299 export zimmer de www zimmer de Op...

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