Zimmer ThermoTK Instructions For Use Manual
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Zimmer ThermoTK Instructions For Use Manual

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Instructions for Use
ThermoTK
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Summary of Contents for Zimmer ThermoTK

  • Page 1 Instructions for Use ThermoTK...
  • Page 2 Figures Front of the device Fig. 1 Control unit Intensity adjuster Display Therapy time adjuster Slot for SD card Handpiece with electrode Common electrode...

  • Page 3: Rear Of The Device

    Figures Rear of the device Fig. 2 12 / 12.1 / 12.2 11 / 11.1 / 11.2 Switches and On/off switch connection ports Ventilation opening Identification plate NE connection port for: 11.1 Cable for common electrode with grey connection (4-pin) 11.2 Handpiece with grey connection (4-pin) Active connection port for:...

  • Page 4: Screens / Display

    Figures Screens / Display Fig. 3 Display views 14 Status bar 15 Buttons on the screen 16 Buttons in the navigation menu 17 Buttons in the status bar Fig. 4 Navigation bar (A) Back Switches one page back or to the start-up Description of screen functions...

  • Page 5: Accessories

    105 mm x 200 mm Common Common electrode cable with Common electrode cable with electrode cables with grey connection (4-pin) white connection (8-pin) Conductive cream ThermoTK conductive cream with dosing aid Holder Holder for electrodes and handpiece Silicone sleeve Non-slip sleeve for handpiece...

  • Page 6: Explanation Of Symbols

    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 of the device. Products which are marked with the adjacent symbol may not be discarded with household waste.
  • Page 7 Explanation of symbols Date of manufacture Indication of the quantity contained Use by Non-sterile Device type BF The device emits energy in the form of non-ionising electromagnetic radiation. CE mark with number of the notified body Medical device Do not reuse Do not use if packaging is damaged Protect from heat (sunlight) Storage temperature range...
  • Page 8 Explanation of symbols This side up Fragile, handle with care Protect from moisture Maximum stacking height Recyclable Active Active connection port NE connection port...

  • Page 9: Table Of Contents

    Accessories Explanation of symbols Page Indications / Contraindications Side effects / Intended purpose / Mode of action Application information Warnings ThermoTK – in brief System set-up 6.1 Mounting the cables 6.2 Self-adhesive electrode Configuration Operation instructions 8.1 Application recommendations 8.2 Performing the treatment 8.3 Displays and buttons...
  • Page 10 Error messages / Troubleshooting / Disposal EMC declaration Valid for the device ThermoTK. 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: Indications / Contraindications

    Indications / Contraindications Indications  Pain treatment in cases of acute and chronic pain  Inflammation of the musculoskeletal system  Improvement in blood circulation in the muscle tissue  Muscle relaxation through reduction in tension of the muscles  Tissue regeneration following physical activities ...

  • Page 12: Side Effects / Intended Purpose / Mode Of Action

    Intended purpose ThermoTK is a medical diathermy device for the external heating of tissues on human skin with the purpose of an increase in tissue temperature and the resultant improvement in blood circulation in the treatment area. It is used for the treatment of selected diseases of the musculoskeletal system with the goal of relieving pain or muscle cramps.

  • Page 13: Application Information

    X-ray or diathermy equipment) may interfere with the operation of the device. Please keep a safe distance of 5 meters. ThermoTK 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 allowing direct access to the device´s central mains supply so that it can be disconnected from the mains...
  • Page 14 Application information If no SD card is inserted in the device, no images will be displayed in the Caution “Protocols” menu. Page 4...

  • Page 15: Warnings

    Performing intercranial, transcardiac and cervical-occipital treatments is prohibited. Failure to follow this information can lead to hazards to the patient. Simultaneously connecting a patient to the ThermoTK system and a surgical high-frequency device is prohibited. Failure to follow this information can lead to hazards to the patient, in particular through burns under the electrodes.
  • Page 16 Warnings Ensure that hearing aids and other electronic devices worn by the patient are removed before treatment. Patients should not come into contact with conductive parts which are grounded or which have a high capacity to ground and which may represent undesired paths for the high frequency range.
  • Page 17 Warnings Ensure that the handpiece with electrode is never directed towards the eyes during operation. Ensure that the handpiece with electrode is not directed at metallic surfaces (such as a couch, washbasin, device housing, etc.). Ensure that the device is not opened. Opening the device can generate life- threatening voltage.

  • Page 18: Thermotk - In Brief

    The compact design enables space-saving work in an office and is ideally suited for mobile use. What's special about ThermoTK can be combined as an integrative therapy with nearly all other ThermoTK manual therapy methods or also used as individual therapy.

  • Page 19: System Set-Up

    This is pulled with the wider side onto the electrode connection on the handpiece. Note: ThermoTK offers various methods for performing the treatment. Dynamic1: 1 dynamic electrode (only use “active” port!, otherwise the dynamic electrode will not be detected)

  • Page 20: Self-Adhesive Electrode

    System set-up 6.2 Self-adhesive electrode Dynamic 2 method 2 dynamic electrodes Connect handpiece Connect the handpiece with the white connection to the white ACTIVE connection port. Connect the handpiece with the grey connection to the grey NE connection port. Note: Ensure that an electrode is inserted in the handpiece and that it is positioned correctly and completely on the handpiece.
  • Page 21 System set-up 6.2 Self-adhesive electrode Application When using self-adhesive electrodes, observe the following application information information: 1. After removing the electrode from the packaging, check to ensure it is not damaged. 2. For the application of the electrodes, select muscles which are well perfused.

  • Page 22: Configuration

    Configuration Note: The following descriptions are based on the factory settings. Configuration menu Factory settings can be changed and individually adjusted in the configuration menu. Select configuration Activating the “Configuration” button (1) opens the “Configuration" screen. Welcome text Activation of the “Welcome text” button opens the alphabetical keyboard to enter a welcome text in the start-up screen.

  • Page 23: Operation Instructions

    Optimal energy transfer can only be guaranteed in connection with the special conductive ThermoTK cream. ThermoTK cream makes it possible for the therapist to optimally slide the electrode on the skin; it is very skin-compatible and can also be used on very sensitive skin.

  • Page 24: Performing The Treatment

    Select the common electrode suitable for your desired therapy. electrode Apply ThermoTK Apply the ThermoTK cream to the treatment area and spread the cream cream evenly over the entire surface of the treatment area. For sensitive patients, it is recommended to also apply cream to the common electrode.

  • Page 25: Displays And Buttons

    Operation instructions 8.3 Displays and buttons Description of the display elements and buttons (1) Start/Stop Activating the "Start/Stop” button starts or stops the power output. (2) Power The bar graph displays the currently set power. The adjustment is made using the left-hand adjuster. Option to adjust the power range in resistive mode: 0 –...
  • Page 26 Operation instructions 8.3 Displays and buttons Operating modes:  Continuous  Pulsed The operating mode set is highlighted in blue. To change the operating mode, this is activated directly at the symbol. If the pulsed operating mode is activated, a selection window opens after the pulsed symbol is selected in which the pulse/pause ratio can be set between 1 and 10 seconds.

  • Page 27: Protocols

    Operation instructions 8.4 Protocols Protocols The "Protocols" menu is used for support when selecting the therapy and provides detailed information about the application. Selecting the body The desired body region is selected by activating the white square. region Select clinical picture After selecting the desired body region, the window with clinical pictures of the selected body region opens.

  • Page 28: Favourites

    Operation instructions 8.5 Favourites Favourites The programs changed and saved in the therapy screen are filed in Favourites through the save procedure. Favourites list In the Favourites list, the programs can be 1. accessed for therapy: To do this, the desired program is selected directly in the corresponding line. 2.

  • Page 29: Technical Information

    Technical information Mains voltage 100 V – 240 V / 50/60 Hz Power consumption Max. 300 VA Output power 150 W effective at 500 Ω in resistive mode 250 VA effective at 500 Ω in capacitive mode 60 W effective at 500 Ω in hands-free mode Interval: 1 W/VA increments up to 10 W/VA 5 W/VA increments up to 10 W/VA...

  • Page 30: Cleaning, Disinfection

    Cleaning, disinfection Before starting any cleaning and maintenance measures the device must always be switched off at the main switch and the mains plug must be disconnected. It is extremely important to ensure that no moisture enters the system/handpiece during cleaning. Do not use sprays. If, during cleaning/disinfection, moisture penetrates the system, take the device out of service, protect it from being used again and contact your service representative.
  • Page 31 Cleaning, disinfection Note: Use the device only in a hygienic environment. Page 21...

  • Page 32: Ce Mark

    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 22...

  • Page 33: Scope Of Delivery And Accessories

    Common electrode (140 x 240 mm) 50601070 Self-adhesive electrodes (105 x 200 mm) 50601065 Silicone sleeves 50601075 Holder for electrodes and handpiece 50600110 ThermoTK conductive cream with dosing aid Power cable 10105043 Instructions for use Item no. Accessories 50601000 Handpiece with white connection (8-pin)

  • Page 34: Device Combination

    Device combinations No combination devices or connections to other medical or nonmedical devices are intended for ThermoTK by the manufacturer. Anyone who combines devices against these guidelines and thus creates a medical system does so under his/her own responsibility. Page 24...

  • Page 35: Safety And Maintenance

    Safety and maintenance 14.1 Safety ThermoTK is manufactured and tested according to the currently valid medical device standards. Zimmer MedizinSysteme GmbH can only consider itself to be responsible for safety and reliability if  the device is operated using a proper power outlet with earth contact and the...

  • Page 36: Maintenance

    Safety and maintenance 14.2 Maintenance Before starting any cleaning and maintenance measures the device must always be switched off at the main switch and the mains plug must be disconnected. Electrodes/common Inspect the surface of the electrodes and the common electrodes regularly for electrode cracks and other damage.

  • Page 37: Functional Test

    Functional test Functional test Regularly check the functionality of the handpiece and the electrode. Regularly check the handpiece and electrodes for any damage. Perform the test as described below:  Connect the handpiece with the white connection to the device. ...

  • Page 38: Safety Check / Metrological Check

    Metrological control In Germany, it is not necessary to perform either a safety check or a metrological control for the ThermoTK device. In Germany, the MPBetreibV (Medical Device Operator Ordinance) as well as the DGUV V3 (Accident prevention regulation – electrical systems and equipment), among others, apply in their respective current versions.

  • Page 39: Error Messages / Troubleshooting / Disposal

    Malfunction, error message, 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 40 No power transfer Possible cause 1: No conductive cream was used as a lubricant. Remedy for cause 1: Ensure that only ThermoTK cream is used. Possible cause 2: Internal cable defect Remedy for cause 2: Check this by performing the "Cable control" test.
  • Page 41 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 42: Emc Declaration

    WARNING: Portable HF communication devices (including peripheral devices such as antennas) should be used at a distance of at least 30 cm (12 inches) from any part of the ThermoTK device; this includes cables indicated by the manufacturer. There may otherwise be a loss of performance of this device.
  • Page 43 Table 1 Guidelines and manufacturer's declaration – Electromagnetic emissions The ThermoTK device is intended to be used in the electromagnetic environment indicated below. The customer or user of the ThermoTK device must ensure that it is used in such an environment.
  • Page 44 Table 3 Guidelines and manufacturer's declaration – Electromagnetic immunity The ThermoTK device is intended to be used in the electromagnetic environment indicated below. The customer or user of the ThermoTK device must ensure that it is used in such an environment.
  • Page 45 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 46 ThermoTK 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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