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Zimmer Z Wave Med Instructions For Use Manual

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Instructions for Use
Med
ZWave
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Summary of Contents for Zimmer Z Wave Med

  • Page 1 Instructions for Use ZWave...
  • Page 2 Illustrations Front of the Device Fig. 1 Selection and control 1 Control unit 2 Pulse energy controller elements 3 Display 4 Frequency controller 5 Slot for SD card 6 Power switch Handpiece 7 Handpiece 8 Air vents, front 9 Air vents with fan, rear 10 Holder for handpiece 11 Footswitch Footswitch...

  • Page 3: Illustrations

    Illustrations Rear of the Device Fig. 2 13 Socket for power cord Switches / Connector 14 Mains fuse sockets 15 Socket for handpiece channel I 16 Socket for handpiece channel II 17 Socket for footswitch 18 Identification plate...

  • Page 4: Screens / Displays

    Illustrations Screens / Displays Fig. 3 Display / Application 19 Status bar screen 20 Buttons on the screen 21 Navigation bar Fig. 4 (A) Back Move back one step Navigation bar Description of the (B) Menu Move to the selected menu functions (C) Scrollbar Scroll forward or backward in the list...

  • Page 5: Applicator Head And Accessories

    Illustrations Applicator Head and Accessories Fig. 5 22 39 mm applicator head Applicator head Accessories 23 Silicone cap...

  • Page 6: Explanation Of The Symbols

    Explanation of the Symbols In this instructions for use, this symbol stands for “Danger”. In this instruction for use, this symbol indicates “Caution” with regard to possible Caution damage of the device. Connection socket handpiece Connection socket footswitch Instructions for use Follow instructions for use Products marked with the adjacent symbol must not be disposed of with household waste.

  • Page 7: Table Of Contents

    Table of Contents Illustrations Front of the Device Rear of the Device Screens / Displays Applicator Head and Accessories Explanation of the Symbols Page Indications / Contraindications Side Effects Application Information Warnings – in brief ZWave Set-up Device Settings Operation Instructions 8.1 Device Description 8.2 Notes on Operation 8.3 Performing the Treatment...
  • Page 8 Table of Contents Page CE-mark Scope of Delivery / Accessories Device Combination Safety and Maintenance 14.1 Safety 14.2 Maintenance Function Test Safety Check / Metrological Control Error Messages / Troubleshooting / Disposal Manufacturer’s EMC Declaration Valid for the device ZWave This instructions for use is an integral part of the device.

  • Page 9: Indications / Contraindications

    Indications / Contraindications ● hamstring tendinopathy Indications • Vascular disorders at or in the vicinity of the treatment area Contraindications / • Open wounds at or in the vicinity of the treatment area restrictions of use • Local infections in the treatment area •...

  • Page 10: Side Effects

    Side Effects Side Effects Treatments with ZWave may occasionally cause irritation, petechiae, bruising, swelling or pain. Page 2...

  • Page 11: Application Information

    Inspect the device before use. If there is any damage, do not use the device. Only use accessories from Zimmer MedizinSysteme GmbH. Caution The handpiece of the device is not designed for continuous operation. After a max.

  • Page 12: Warnings

    Warnings Users of ZWave must have the appropriate skills. Any treatment instructions regarding treatment location, duration and intensity of application requires medical knowledge and may only be provided by persons with the appropriate expertise. These instructions must be followed. People who are undergoing simultaneous treatment to reduce and/or alter blood clotting or to prolong blood-clotting time (e.g.

  • Page 13: Zwave Med - In Brief

    – in brief The ZWave A modern and innovative shock wave device. What is the ZWave Radial, ballistic shock wave therapy is a versatile method for the improvement of Shock wave therapy hamstring tendinopathy. It generates shock waves by means of an ergonomic handpiece and emits them What does the through a special applicator.

  • Page 14: Set-Up Device

    Set-up Device Installation of Cables Note: If the ZWave is not mounted on the designated system trolley, please make sure that it is standing on a stable surface. We recommend using the optional swivelling base (see Accessories, chapter 12). Make sure that the power switch of the device is set to “0”. Note: Connect the power Connect the power cable to the appropriate socket (13) in the device, and connect...

  • Page 15: Settings

    Settings Note: Changes in the basic settings are only possible from the start-up screen. Start- After switching on the device and performing the self-test, the start-up screen opens. up screen Settings In the settings menu, the factory settings can be individually changed and adjusted. menu Activating the “Settings”...
  • Page 16 Settings Start menu: (1) Start settings Individual options of the start menu. If you select the “Favourites” setting, the start menu will consist of the favourites list. If you select “Individual program”, the start menu will consist of the application menu. (2) Language Choose language.

  • Page 17: Operation Instructions

    The pulse generator in the handpiece is a wear part and needs to be replaced after a certain period as its ability to function decreases with time. Zimmer MedizinSystemeGmbH guarantees unrestricted use of at least two million pulses per one pulse generator. Depending on the power and frequency, more than two million pulses can be generated.
  • Page 18 Operation Instructions 8.1 Device Description The generation of the mechanical pulse energy causes a substantial build-up of Handpiece heat in the handpiece. To avoid reducing the life of the handpiece, a temperature temperature monitoring / switch is integrated. An internal shutdown mechanism forces the handpiece to cool if regulation excessive temperatures are reached.

  • Page 19: Notes On Operation

    Operation Instructions 8.2 Notes on Operation Please hold the handpiece as shown below. Therapy The ZWave operates with mechanical energy; it is transferred to the patient through a handpiece. For this purpose, the handpiece with the applicator is placed vertically on the application area.

  • Page 20: Performing The Treatment

    Operation Instructions 8.3 Performing the Treatment Note: All buttons, menus, and sub-menus can be directly activated on the screen with a touch of your finger. Activation of the “Application” button opens the application screen with the Select application programme appropriate programme. All relevant application recommendations are pre-set, but the pulse energy must be individually stepped up for each application.

  • Page 21: Display And Buttons

    Operation Instructions 8.4 Display and Buttons Descriptio n of the display elements buttons Displays the set pulse energy. When the application is active, the bar graph is filled in. The pulse energy can be set before and during the delivery of pulses. The pulse energy is adjustable between Energy 60–185 mJ in 10 mJ steps.
  • Page 22 Operation Instructions 8.4 Display and Buttons Display of the preselected number of shocks and the currently emitted shocks as well as the total number of emitted shocks if the total number of emitted shocks is not pre-selected. Display of the Number of shocks counting direction in ascending or descending order.

  • Page 23: Treatment Of Hamstring Tendinopathy

    Operation Instructions 8.5 Treatment of Hamstring Tendinopathy Note: The use of the device for orthopaedic and physiotherapeutic purposes is intended for healthcare professionals (e.g. ph assistants) only. Application Press the “Application” button in the Navigation bar to reach the application screen. Setting the Adjust the pulse energy to 90 mJ.

  • Page 24: Sd-Card

    Operation Instructions 8.6 SD-Card On the SD-card, the user-defined settings as well as the body regions and the SD-Card application list are stored. If the SD-card is not inserted, the display application recommendation will not open upon activation of the start button on the home page. The following message appears: “SD card not found.

  • Page 25: Favourites Lists - Retrieving Programs And Editing List

    Operation Instructions 8.7 Favourites Lists – Retrieving Programs and Editing Lists The parameters of the pre-defined programs can be individually modified and saved. Activating the “save” button opens the field for entering the program name. Store and name program The program name is entered via the keyboard. Note: The programs can be saved in the favourites list.
  • Page 26 Operation Instructions 8.7 Favourites Lists – Retrieving Programs and Editing Lists Individually stored programs are listed in the favourites list. These can be retrieved here for application, 2. for editing (moving and deleting). Activation of the “Favourites” button opens the favourites list. Select favourite list The desired program is directly selected in the corresponding row Open program...
  • Page 27 Operation Instructions 8.7 Favourites Lists – Retrieving Programs and Editing Lists Edit favourites Activation of button (1) moves the program to the bottom. Activation of button (2) moves the program to the top. Activation of button (3) deletes the program. Activation of button (4) saves the modifications and returns you to the program.

  • Page 28: Technical Information

    Technical Information Basic device 100 – 240 V / 50/60 Hz; 220 V/60 Hz Power supply Fuse 2 x T3.15AH, 250 V Power consumption 250VA Protection class Application class Applied part Applicator head / silicon protection cap 1 Hz – 22 Hz, adjustable in 1 Hz steps Frequency range 3 burst modes with 4, 8, or 12 pulses 60 –...

  • Page 29: Info-Chart Duration Of Treatment

    Technical Information 9.1 Info-chart Duration of Treatment Max. possible pulses per application frequency Page 21...

  • Page 30: Cleaning Disinfection

    Cleaning Disinfection - Before starting any maintenance and cleaning measures, the device must always be turned off with the main switch, and the mains cable must be disconnected. - Make sure that during the cleaning and disinfection the labelling of the device (such as warnings, label of control devices and identification plate) are not damaged.

  • Page 31: Ce-Mark

    CE-mark The product bears the CE marking in accordance with EC Directive 93/42/EEC concerning medical devices Page 23...

  • Page 32: Scope Of Delivery Accessories

    Scope of Delivery Accessories Scope of delivery Combination with column Art. no. 5532 1 ZWave control unit 9160 1 Syscart with tray mount 5511 2 Handpieces 93133530 3 Applicator heads 39 mm 65137110 10 Silicone caps 50500038 1 ZWave Lotion 94130411 1 Footswitch 65410410...

  • Page 33: Device Combination

    Device Combination For ZWave no combination devices are provided by the manufacturer. Anyone who, contrary to this specification combines devices and thus operates a medical system does so at its own risk. Page 25...

  • Page 34: Safety And Maintenance

    The ZWave is manufactured according to the DIN EN 60601-1 safety regulations. Zimmer MedizinSysteme GmbH can only be held responsible for 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 35: Maintenance

    Safety and Maintenance 14.2 Maintenance Before cleaning and maintenance, the device must always be switched off with the main switch, and the power cord must be disconnected. Checking the impact During the course of normal use, a deformation/shortening of the rear impact dome dome on the applicator head may occur.

  • Page 36: Function Test

    Function Test After the device is switched on, the ZWave performs a self-test, which checks all internal components. If the event of a fault, an error message appears. In addition, an extended function test can be performed as described below. This test should be performed monthly or if there are any doubts about the viability of the device.

  • Page 37: Safety Check Metrological Control

    Safety Check Metrological Control Neither safety check (STK) nor metrological control (MTK) are required for ZWave in Germany. In Germany, the Medical Devices Operator Ordinance (Medizinprodukte- Betreiberverordnung, MPBetriebV) and the BG Electrical Plant and Equipment regulations (BG-Vorschrift Elektrische Anlagen und Betriebsmittel, BGV A3) apply in their current version, amongst other regulations.

  • Page 38: Error Messages Troubleshooting Disposal

    Error Messages Troubleshooting Disposal Loss of function of Despite activating the foot switch, no pulse is triggered handpiece Possible cause 1 Handpiece / foot switch is not properly connected, or defective. Fix for cause 1 Make sure that the foot switch and handpiece are connected correctly. The plug must be properly snapped in.
  • Page 39 Error Messages Troubleshooting Disposal In the status bar, the message “Handpiece not found” appears. Applicator not found Possible Cause Handpiece not connected or incorrectly connected. Fix for cause Make sure the handpiece is properly connected. The plug must be properly snapped Device Malfunction No response to the main switch / display remains dark Possible cause 1...
  • Page 40 The device may only be returned to the factory in the original packaging. It must be Disposal disposed off by Zimmer MedizinSysteme GmbH. In foreign (European) countries, please observe the national regulations regarding disposal. Contact your distributor if necessary.

  • Page 41: Manufacturer's Emc Declaration

    Manufacturer's EMC Declaration The ZWave is developed according to the recognized standards of technology; the information on the intended use of the components is taken into account. The ZWave must not be operated near active HF surgery devices or magnetic resonance tomography that can cause high levels of electromagnetic interference.
  • Page 42 Manufacturer's EMC Declaration Table 1 Guidance and Manufacturing Declaration- Electromagnetic Emissions ZWave The device is intended for use in the electromagnetic environment specified below. The customer or user ZWave of the device should ensure that it is used in such environment. Emission Measurement Compliance Electromagnetic Environment-Guidelines...
  • Page 43 Manufacturer's EMC Declaration Guidance and Manufacturing Declaration- Electromagnetic Immunity ZWave The device is intended for use in the electromagnetic environment specified below. The customer or user ZWave of the device should ensure that it is used in such environment. Immunity IEC 60601- Test Level Compliance Level Electromagnetic Environment -...
  • Page 44 Manufacturer's EMC Declaration Table 3 Guidance and Manufacturing Declaration- Electromagnetic Immunity ZWave The device is intended for use in the electromagnetic environment specified below. The customer or user ZWave of the device should ensure that it is used in such environment. Immunity Test IEC 60601-Test Compliance Level...
  • Page 45 Manufacturer's EMC Declaration Electromagnetic immunity to HF radio communication equipment Test Maximum Immunity Test Band Distance Frequency Service Modulation Energy Level (MHz) (MHz) (V/m) 5240 5100- WLAN 802.11 a/n Pulse 5800 Modulation 5500 217 Hz 5785 Page 37...
  • Page 46 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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