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Related Manuals for Zimmer ThermoTK
Summary of Contents for Zimmer ThermoTK
- Page 1 Instructions for Use ThermoTK...
- Page 2 Illustrations Front of the device Fig. 1 Selection/operating 1 Control unit elements 2 Intensity adjuster 3 Display 4 Handpiece with applicator head 5 Common electrode Fig. 2 6 Port for common electrode 7 Port for handpiece...
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Page 3: Rear Of The Device
Illustrations Rear of the device Fig. 3 Switches / ports 8 Port for power cable 9 Mains fuse 10 On/off switch 11 Ventilation opening 12 Serial no./identification plate... -
Page 4: Screens / Display
Illustrations Screens / display Fig. 4 Display views 13 Heading 14 Buttons on the screen 15 Navigation menu Fig. 5 Navigation menu (A) Home Switches back to start page Description of the (B) Back Moves one step back functions (C) Treatments Switches to the "Treatment recommendations"... -
Page 5: Accessories
20 Common electrode L, 12 x 15 cm 25 Common electrode, L, 21 Connection tab flexible, 12 x 15 cm Electrode cable 22 Electrode cable with plug 26 Electrode cable with crocodile clip for common electrode flexible Conductive cream 23 ThermoTK conductive cream with dosing aid... - Page 6 Illustrations Accessories Sponge pockets for common electrodes flexible 27 Sponge pocket, L, 14 x 16.5 cm for 28 Sponge pocket, XL, 17 x 21.5 cm common electrode 12 x 15 cm for common electrode 15 x 20 cm Velcro straps 30 Velcro strap, 120 cm 29 Velcro strap, 60 cm...
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Page 7: Explanation Of Symbols
Explanation of symbols In the instructions for use this symbol indicates “Danger”. In the instructions for use this symbol indicates "Caution" with regard to Caution possible damage of the device. Patient connections Applicator head connection Common electrode connection Note instructions for use Follow instructions for use. -
Page 8: Table Of Contents
Accessories Explanation of symbols Page Indications / Contraindications Side effects, intended purpose Application information Warnings ThermoTK – in brief System set-up Default settings 7.1 Configuration 7.2 Information Operation instructions 8.1 Application recommendations 8.2 Performing the treatment 8.3 Displays and buttons 8.4 Therapy recommendations... - Page 9 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.
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Page 10: Indications / Contraindications
Indications / Contraindications Indications • Radial and ulnar epicondylitis • Tendinitis • Bursitis • Osteoarthritis • Spondylarthrosis • Cervicobrachial syndrome • Neck pain • Rotator cuff injury • Impingement syndrome • Carpal tunnel syndrome • Low back pain • Lumbosciatica •... -
Page 11: Side Effects
Side effects, intended purpose Side effects No side effects are known if correct dosages are used and attention is paid to contraindications. Intended purpose The device is used for the therapeutic application of diathermy using long waves. Mode of action The device uses electromagnetic fields of 460 to 540 KHz to bring about an increase in temperature through interaction with the tissue. -
Page 12: Application Information
Please keep a safe distance of several 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 13: Warnings
Warnings Users of the ThermoTK system must be trained in proper use and have the appropriate skills. Any treatment instructions regarding location, duration and intensity require medical knowledge and should be given by authorised physicians, therapists and medical paraprofessionals. These instructions must be followed. - Page 14 Warnings fasteners or threads). Patient body parts which contain metal implants (for example, a bone nail) should normally be excluded from the treatment if special techniques are not used. Hearing aids should be removed. 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.
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Page 15: 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 16: System Set-Up
System set-up Mounting the cables Note: Remove the ThermoTK from the transport bag prior to starting up the system. Operation in the bag is not intended. Ensure that the device is placed on a stable surface. Note: Make sure that the main switch of the device is set to “0”. -
Page 17: Default Settings
Default settings 7.1 Configuration Note: Changes to the basic settings and retrieval of information are only possible in the start-up screen. The following descriptions are based on the factory settings. Start-up screen After the device has been switched on and the self-test performed, the start-up screen opens. - Page 18 Default settings 7.1 Configuration (1) Sound The volume of the signal sounds can be adjusted by activating the control panels. The adjustment can be made using the two arrow buttons. (2) Keyboard sound The keyboard sounds can be activated and deactivated. The selection is made directly in the corresponding line.
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Page 19: Information
Activating the "Informations" button (2) opens the "Informations" screen. Information menu Information (user information as well as general information on the therapy principle with ThermoTK) can be retrieved in the information menu. (1) User guide Activating the field opens the screen with user information. -
Page 20: Operation Instructions
ThermoTK cream makes it possible for the therapist to achieve optimal gliding of the applicator on the skin. ThermoTK cream is very skin compatible and can even be used on very sensitive skin. ThermoTK cream has excellent gliding properties. Because of this, the amount of cream normally needed for a therapeutic application can be reduced and this decreases the cost of consumables. - Page 21 Operation instructions 8.1 Application recommendations for the common electrode XL flexible for the common electrode L flexible Treatment time: Depending on the size of the treatment area and the disease state, the recommended treatment time is between 10 and 20 minutes. Dosage: The dosage should create a gentle warming feeling and depends on the patient's subjective perception.
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Page 22: Performing The Treatment
Operation instructions 8.2 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 with finger pressure or the stylus. Start-up screen Activating the "Start" button (3) opens the "Capacitive mode" therapy screen. Therapy screen Page 13... - Page 23 Apply the ThermoTK cream to the common electrode and spread the cream evenly over the entire surface of the common electrode. Treatment with Also apply the ThermoTK cream to the treatment area and spread the cream ThermoTK cream evenly over the entire surface of the treatment area.
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Page 24: Displays And Buttons
Operation instructions 8.3 Displays and buttons Description of the display elements and buttons (1) Bar graph Displays the output adjusted. During active therapy, the bar graph is filled in. The colour in the bar graph changes depending on the output adjusted. Blue for low output, green for high output. - Page 25 Operation instructions 8.3 Displays and buttons Coupling level Activating the “Coupling” button opens a window to adjust or deactivate the adjustment desired coupling level. (1) Numeric Numeric keyboard to enter an individual coupling value from 1-100%. keyboard (2) Display field Displays the set value.
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Page 26: Therapy Recommendations
Operation instructions 8.4 Treatment recommendations The "Treatment recommendations" menu is used for support when selecting treatment and provides detailed information about the application. Treatment Activating the "Treatment" button opens the "Treatment recommendations" menu. Body region selection The body region is selected by clicking on the blue circle. Select clinical picture After selecting the desired body region, the window with conditions in the selected body region opens. - Page 27 Operation instructions 8.4 Treatment recommendations Therapy information After selecting the differentiated condition of the clinical picture, another window with detailed therapy and treatment information opens. Select treatment Activating the "Treatment" button opens the treatment screen with the program corresponding program. Programm 2-phase program: combinations...
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Page 28: Technical Information
Technical information Mains voltage 100 – 240 V / 50/60 Hz Fuse 2 x T2A, 250 V Power consumption 160 VA Output power 120 W effective (350 Wpeak) at 100 Ω Frequency 460 kHz ("resistive" operating mode) 540 kHz ("capacitive" operating mode) Accuracy ±... -
Page 29: 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 cable must be disconnected. Housing Clean the housing with conventional alcohol-free plastic cleaner or with a mild soap solution (such as detergent). -
Page 30: Ce Mark
CE mark The device has the CE mark 0068 according to 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 IIb according to appendix IX of the directive. Page 21... -
Page 31: Scope Of Delivery And Accessories
ThermoTK control unit 50600300 ThermoTK handpiece with magnet system 50600400 Electrode cable with plug 98550110 Electrode cable with ThermoTK banana plug 50600335 Applicator head, S, 35 mm, with magnet system, insulated 50600360 Applicator head, M, 60 mm, with magnet system, insulated 50600385... -
Page 32: Device Combination
Device combinations No combination devices or connections to other 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 23... -
Page 33: 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 34: 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 cable must be disconnected. Applicators/common Inspect the surface of the applicators and the common electrodes regularly for electrodes cracks and other damage. -
Page 35: Functional Test
Functional test Functional test Regularly check the functionality of the handpiece and the electrode. To do this, perform the "Cable control" test regularly. Perform the test as described below: • Hold the applicator on the common electrode. • Activate the "Start" button. Wait until the functional test is completed. "Cable control ok"... -
Page 36: 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 BGV A3 (Regulation of the German Employer's Liability Insurance Association on electrical systems and equipment), among others, apply in their respective current versions. -
Page 37: Error Messages / Troubleshooting / Disposal
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 38 Replace the fuse only with one with the exact same name/equal rating. Before doing so, check the power supply thoroughly for possible faults. If the error recurs, immediately inform the service department/customer service. Sales Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax +49 731. 9761-299 www.zimmer.de...
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Page 39: Emc Declaration
Portable and mobile HF communication devices (such as mobile phones, cell phones) can affect medical electrical devices. ThermoTK may only be operated with the original parts indicated in the list of the scope of delivery and accessories. Operation of the device with other parts can lead to increased emissions or reduced interference immunity of the device! Guidelines and manufacturer's declaration –... - Page 40 Guidelines and manufacturer's declaration – Electromagnetic immunity The ThermoTK device is intended to be operated in an electromagnetic environment as indicated below. The customer or user of the ThermoTK device should ensure that it is used in such an environment.
- Page 41 If the measured field strength in the location in which the ThermoTK device is used exceeds the above compliance level, the ThermoTK device must be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ThermoTK device.
- Page 42 Recommended safety distances between portable and mobile HF telecommunication devices and the ThermoTK device The ThermoTK device is intended to be operated in an electromagnetic environment in which the HF disturbances are controlled. The customer or user of the ThermoTK device can help avoid electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunication devices (transmitters) and the ThermoTK device –...
- Page 43 ThermoTK 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.de...
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