Zimmer enShock Instructions For Use Manual
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Zimmer enShock Instructions For Use Manual

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Instructions for Use
enShock
EN

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Summary of Contents for Zimmer enShock

  • Page 1 Instructions for Use enShock...
  • Page 2 Figures Front of the device Fig. 1 Handpiece connector Display Central control knob...
  • Page 3 Figures Rear of the device Fig. 2 Switches and Foot switch connector connection ports Earth connector Speaker Air vent Fuse holder Connection for power cable On/off switch...
  • Page 4 Figures Screens/display Fig. 3 11 Indicator for the adjusted energy 12 Start/stop button 13 Store button 14 Switches to Protocols 15 Switches to Favourites 16 Switches to Therapy 17 Switches to Settings...
  • Page 5 Figures Accessories Fig. 4 Handpiece 18 Gel pad fixation ring 19 Therapy activation button Gel pads 5 / 10 / 15 / 20 / 25 / 30 / 35 / 40 mm Foot switch (optional) Conductive gel Power cable...
  • Page 6 Explanation of symbols General warning sign: this symbol points out hazards on the device. In the instructions for use, this symbol indicates “Dangers and warnings”. In the instructions for use, this symbol indicates "Caution" with regard to Caution possible damage to the device. Products which are marked with the adjacent symbol may not be disposed of in household waste.
  • Page 7 Explanation of symbols Indication of the quantity contained in the packaging. Non-sterile. Device type BF. CE marking with the number of the notified body. Medical device. Protect from heat (sunlight). Storage and transport temperature range. Storage and transport air humidity range. Storage and transport air pressure range.
  • Page 8 Explanation of symbols Unique Device Identification Maximum stacking height...

  • Page 9: Table Of Contents

    Screens/display Accessories Explanation of symbols Page Intended purpose, indications, contraindications and side effects Application information Warnings enShock – in brief System set-up Settings Operation instructions 7.1 Application recommendations 7.2 Performing the treatment 7.3 Displays and buttons 7.4 Protocols 7.5 Favourites...
  • Page 10 Safety checks/metrological checks Error messages/troubleshooting/disposal EMC declaration Valid for the device enShock. 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.

  • Page 11: Intended Purpose, Indications, Contraindications And Side Effects

    Intended purpose, indications, contraindications and side effects Intended purpose The enShock is intended to deliver focused shock waves for the treatment of various indications of the musculoskeletal system. Indications The enShock provides focused shock wave therapy for people with musculoskeletal disorders and other conditions as considered appropriate by the health care professionals providing treatment.
  • Page 12 Target patient enShock should not be used on infants and young children. population enShock should not be used on patients who have any of the contraindications listed. Patients must be physically and mentally able to consciously perceive and express the perception of pain stimuli.

  • Page 13: Application Information

    X-ray or diathermy equipment) may interfere with its operation. Please keep a safe distance of 5 metres. enShock is not suitable for use in areas with an explosive, flammable or combustive environment. During use, the device is to be located in a position that allows direct access to the device’s central mains supply, so that it can be disconnected from the...
  • Page 14 Otherwise, no focused shock wave will be able to be applied to the patient. The conductive gel is absolutely necessary for uniform energy transfer. If the enShock is placed on a foreign equipment trolley or other storage surface, care must be taken to ensure that it is designed for the maximum device weight, with accessories, and that the device is positioned stably so that it does not fall down, including during transport.

  • Page 15: Warnings

    Warnings Treatment instructions regarding the location, duration and intensity of the treatment require medical knowledge and should only be given by medical professionals. These instructions must be followed. The patient must not be left unattended during therapy. Performing intracranial, transcardiac and cervical-occipital treatments is prohibited.

  • Page 16: Enshock - In Brief

    An ultramodern, innovative therapy system for applying focused extracorporeal shock waves. What does enShock enShock is used to apply electrically activated pressure waves. The individual pressure waves meet in a focal point. The penetration depth is determined by the chosen gel pad.

  • Page 17: System Set-Up

    System set-up Ensure that the device is placed on a stable surface. No special training or instruction is required in order to use the device. However, the device may only be used by medical professionals who have previously familiarised themselves with the device and the instructions for use and understand the intended use, application and warning notes outlined therein.

  • Page 18: Settings

    Settings Note: The following descriptions are based on the factory settings. Settings menu Factory settings can be changed and individually adjusted in the “Settings” menu. Select settings Activating the “Settings” button (A) opens the “Configuration" screen. Welcome text Activating the “Welcome” button opens the alphabetical keyboard, with which you can enter a welcome text for the start-up screen.

  • Page 19: Operation Instructions

    Gel pads enShock comes with 8 gel pads to ensure an optimal penetration depth. The penetration depth in human tissue depends on the gel pad used. The diameter of the gel pads reflects the penetration depth. Example: a gel pad with a diameter of 20 mm leads to a maximum energy level at a depth of 20 mm.

  • Page 20: Performing The Treatment

    Operation instructions 7.2 Performing the treatment Note: The following descriptions are based on the factory settings. Note: All buttons, menus and sub-menus can be activated directly on the screen by pressing with the finger. Open therapy screen Activating the “Therapy” button opens the therapy screen. Select gel pad Select the appropriate gel pad and place this correctly into the handpiece.

  • Page 21: Displays And Buttons

    Operation instructions 7.3 Displays and buttons Description of the display elements and buttons (1) Energy Displays the energy level and allows it to be adjusted from 0.005 to 0.500 mJ/mm in increments of 0.005 mJ. (2) Gel pad Displays the recommended gel pad. (3) Treatment time Displays the treatment time remaining.
  • Page 22 Operation instructions 7.3 Displays and buttons (11) Protocols Switches to Protocols (12) Favourites Switches to Favourites (13) Therapy Switches to Therapy (14) Settings Switches to Settings Page 12...

  • Page 23: Protocols

    Operation instructions 7.4 Protocols Protocols The "Protocols" menu is used for support when selecting the therapy and provides information about the application. Selecting the body The desired body region is selected by activating the white square. region After selecting the desired body region, the window with corresponding indications will open.

  • Page 24: Favourites

    Operation instructions 7.5 Favourites Favourites When changes are made to programmes in the therapy screen, these are automatically listed in Favourites when saved. Favourites list In the Favourites list, the programmes can be: 1. Accessed for therapy: To do this, select the desired programme directly in the corresponding line and then click the “Confirm”...

  • Page 25: Technical Information

    Technical information Mains voltage 220 V AC; 60 Hz 230 V AC; 50 Hz Power consumption Max. 300 VA Fuse T5AL/250 VAC Output energy 0.005–0.500 mJ/mm ± Operating mode Single Pulse or Continuous Pulse Output frequency 1–12 Hz ± Expected lifetime of 5,000,000 shocks handpiece Protection class...

  • Page 26: Reprocessing Cleaning/Disinfection

    Only use the device and accessories in a hygienic, dirt- and dust-free environment. Reprocessing enShock and all its accessories do not need to be sterilised and are not intended for restrictions this purpose. enShock and all its accessories are not suitable for machine cleaning and disinfection.
  • Page 27 Housing and foot switch: Disinfection of the enShock housing is not required insofar as it is outside the patient environment. Nevertheless, we recommend disinfecting the housing at least once a week by means of wipe disinfection using a commercially available non-alcoholic plastic and metal disinfectant that is suitable for medical devices (e.g., Mikrozid...
  • Page 28 Reprocessing cleaning, disinfection Sterilisation enShock and all its accessories are not intended for sterilisation and are not suitable for this process. Storage enShock and all its accessories should be stored in a dry and dust-free environment at room temperature, protected from direct sun light.

  • Page 29: Ce Marking

    Accords with the EC Directive on Medical Devices 93/42/EEC and meets the essential requirements of Appendix I of this directive. The device is classified in class IIa according to Appendix IX of the directive. Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Page 19...

  • Page 30: Scope Of Delivery And Accessories

    Scope of delivery and accessories Item no. Scope of delivery 5440 enShock control unit 5445 Handpiece 54201000 Set of gel pads 54202500 Bottle with conductive gel 54201020 Power cable 10105114 Instructions for use Item no. Accessories 5445 Handpiece 54201000 Set of gel pads...

  • Page 31: Device Combinations

    Device combinations enShock is not intended by the manufacturer to be combined with other devices or connected to other medical or non-medical devices. Anyone who combines devices against these guidelines, thereby creating a medical system, does so on his/her own responsibility.

  • Page 32: Safety And Maintenance

    Fuses and other spare parts may only be replaced by trained service staff. The device may only be serviced by trained staff. All information required for servicing can be found in the enShock service manual or can be requested from the manufacturer. Upon request, Zimmer MedizinSysteme will provide wiring diagrams, lists of components, descriptions, calibration instructions or other documents.

  • Page 33: Maintenance

    Safety and maintenance 13.2 Maintenance Before starting any cleaning and maintenance measures, the device must always be switched off using the main switch, and the mains plug must be disconnected. Handpiece Inspect the connector, cable and surface of the handpiece regularly for cracks and other damage.

  • Page 34: Functional Testing

    Functional testing Functional test Regularly check the functionality of the handpiece and the optional foot switch. Regularly check the handpiece, gel pads and foot switch for any damage. Perform the test as described below:  Connect the handpiece to the device. ...

  • Page 35: Safety Checks/Metrological Checks

    In Germany, it is not necessary to perform either a safety check or a metrological check for the enShock device. In Germany, the MPBetreibV (Medical Device Operator Ordinance) and DGUV V3 (Accident Prevention Regulation – Electrical Systems and Equipment), among others, apply in their respective current versions.

  • Page 36: Error Messages/Troubleshooting/Disposal

    Error messages/troubleshooting/disposal Malfunction of the Possible cause 1: handpiece/ Handpiece is not correctly connected to the device. no power output Remedy for cause 1: Check whether the handpiece is correctly connected to the device. The plug must be fully engaged. Check the cable of the handpiece for damage or kinks.
  • Page 37 You may get in touch with them via your sales representative or via the main office in Neu-Ulm. Main office Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax +49 731.

  • Page 38: Emc Declaration

    The tested frequencies are listed in Table 4. The enShock device does not contain any components which can age during the life of the device or which can lead to worsening of the electromagnetic compatibility. Thus no maintenance is necessary during the service life of the device to ensure basic safety.
  • Page 39 Table 1 Guidelines and manufacturer's declaration – Electromagnetic emissions The enShock device is intended to be used in the electromagnetic environment indicated below. The customer or user of the enShock device must ensure that it is used in such an environment.
  • Page 40 Table 3 Guidelines and manufacturer's declaration – Electromagnetic immunity The enShock device is intended to be used in the electromagnetic environment indicated below. The customer or user of the enShock device must ensure that it is used in such an environment.
  • Page 41 Manufacturer's EMC declaration Table 4 Electromagnetic immunity to HF radio equipment Test Maximum Test level Band Distance frequency Service modulation energy immunity (MHz) (MHz) (V/m) 380 – 390 TETRA 400 Pulse modulation 18 Hz 430 – 470 GMRS 460, FRS 460 ±...
  • Page 42 Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 97 61-291 Fax +49 731. 97 61-299 export@zimmer.de www.zimmer.de...

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