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Safety and maintenance

14.1 Safety

14

Page 25

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
electrical installation complies with DIN VDE 0100 part 710 or a comparable

standard,



the equipment is operated in accordance with the instructions for use,



extensions, readjustments or modifications are carried out only by persons

authorised by Zimmer MedizinSysteme GmbH,



the user has ascertained the functional safety, the proper operating condition
and mechanical integrity before using the device and handpiece, including

electrode,



the device is operated only by properly trained personnel,



the device is not operated in hazardous areas and/or a combustive

atmosphere,



the device is immediately disconnected from the mains when penetrated by
liquid.

The device does not contain any parts that can be repaired by the operator.

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Содержание ThermoTK

Страница 1: ...Instructions for Use ThermoTK EN ...

Страница 2: ...Figures Front of the device Fig 1 1 Control unit 2 Intensity adjuster 3 Display 4 Therapy time adjuster 5 Slot for SD card 6 Handpiece with electrode 7 Common electrode 2 3 4 5 1 6 7 ...

Страница 3: ...11 NE connection port for 11 1 Cable for common electrode with grey connection 4 pin 11 2 Handpiece with grey connection 4 pin 12 Active connection port for 12 1 Cable for common electrode with white connection 8 pin 12 2 Handpiece with white connection 8 pin 13 Connection for power cable 10 9 8 13 11 11 1 11 2 12 12 1 12 2 9 ...

Страница 4: ... menu 17 Buttons in the status bar Fig 4 Navigation bar Description of functions A Back Switches one page back or to the start up screen B Therapy Switches to the therapy screen C Favourites Switches to the Favourites area D Protocols Switches to Protocols E Save Switches to the Memory area 16 15 E D C B A 14 17 ...

Страница 5: ... mm L 70 mm L 70 mm Common electrodes Common electrode Common electrode 140 mm x 240 mm self adhesive 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 ...

Страница 6: ...on In the instructions for use this symbol indicates Caution with regard to possible damage of the device Products which are marked with the adjacent symbol may not be discarded with household waste Note instructions for use Follow instructions for use Switch on switch off symbol Serial number LOT number Article number GTIN number identification number Manufacturer ...

Страница 7: ...terile 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 Air humidity limit Air pressure limit ...

Страница 8: ...Explanation of symbols This side up Fragile handle with care Protect from moisture Maximum stacking height Recyclable Active Active connection port NE NE connection port ...

Страница 9: ...urpose Mode of action 2 3 Application information 3 4 Warnings 5 5 ThermoTK in brief 8 6 System set up 6 1 Mounting the cables 6 2 Self adhesive electrode 9 10 7 Configuration 12 8 Operation instructions 8 1 Application recommendations 8 2 Performing the treatment 8 3 Displays and buttons 8 4 Protocols 8 5 Favourites 13 14 15 17 18 9 Technical information 19 10 Cleaning Disinfection 20 ...

Страница 10: ...27 16 Safety check Metrological check 28 17 Error messages Troubleshooting Disposal 26 18 EMC declaration 32 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 The instructions for use are valid as of November 2020 ...

Страница 11: ...ch as copper IUDs Use in the region of malignant benign tumours Pregnancy Thromboses Active osteoarthritis and inflammation Open wounds Treatment on mucous membranes Reduced skin or body temperature Treatment in the head region Treatment over the heart Epilepsy Angina pectoris Cardiovascular diseases Nervous disorders Neoplasms Blood clotting disorders Thrombophlebitis Abnormal temperature percept...

Страница 12: ...l paraprofessionals There are no further limitations for the users Target patient group ThermoTK should not be used on infants and young children ThermoTK should not be used on patients who have the contraindications listed There are no further limitations with regard to the target patient group Mode of action The device uses electromagnetic fields of 460 to 540 kHz to bring about an increase in t...

Страница 13: ... according to the EMC information in the accompanying documentation For more information see chapter 18 Manufacturer s EMC declaration Operation of this device in the vicinity of strong electromagnetic fields e g tomographs 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 ...

Страница 14: ...Application information 3 Page 4 Caution If no SD card is inserted in the device no images will be displayed in the Protocols menu ...

Страница 15: ...se the handpiece without an electrode or with a damaged electrode Failure to follow this information can lead to hazards to the patient The common electrode must always have extensive contact with the patient It may otherwise lead to undesired compression of the field lines and thus injury to the patient Attention should thus always be paid to contact of this electrode during treatment The functio...

Страница 16: ...r the high frequency range In particular no beds or chairs with metal frames should be used Cables to the electrode should be directed such that contact with the patient or with conductive or energy absorbing objects is avoided Non ionising radiation is generated in the device Use the self adhesive common electrode only for one treatment on a patient and discard it after treatment If used multiple...

Страница 17: ... is immediately disconnected from the mains if liquid or foreign bodies penetrate the housing Ensure that the device is inspected by an authorised service employee before it is put back into operation To completely disconnect the device from the mains pull the power cable out of the socket If the output power appears to be too low or if no power can be adjusted the cause may be improper applicatio...

Страница 18: ...d the modern touch operation ensure enjoyment and motivation during treatment Individual program start adjustment and clear simple menus offer the user maximum convenience The compact design enables space saving work in an office and is ideally suited for mobile use What s special about ThermoTK ThermoTK can be combined as an integrative therapy with nearly all other manual therapy methods or also...

Страница 19: ...odes Hands free 2 static self adhesive electrodes Ensure that the device is placed on a stable surface Note Make sure that the power switch of the device is set to 0 Connect power cable Connect the power cable to the provided port 13 on the device and connect the cable to the mains Note The device may only be connected to power outlets with a protective contact Dynamic 1 method 1 dynamic electrode...

Страница 20: ...s are recommended S M M L Hands free method 2 static self adhesive electrodes Connect common electrode cable Connect the common electrode cable with the grey connection to the grey NE connection port Connect the electrode cable with the white connection to the white ACTIVE connection port Connect common electrode with cable Attach the plug connectors of the cable in each case to the tab of the sel...

Страница 21: ...s to the connection ports on the device 7 Remove the electrodes from the skin after use by slowly pulling them off starting at one corner Tearing the electrodes off the skin quickly can lead to skin damage Inadequate skin contact over the entire adhesive surface of the electrode can lead to skin burns or a decreased emission of power The emission of very high power can lead to problems Verify that...

Страница 22: ...he start settings Protocols Favourites and Therapy can be selected By activating the Screen saver button the screen saver can be switched on or off Sleep mode is deactivated by directly touching the display or turning the left right adjuster By activating the Sounds button the signal sounds can be switched on or off If Sounds off is activated the function for adjusting the volume is deactivated Op...

Страница 23: ...ive application in different sizes L M for applications over larger areas S for applications over smaller areas If possible the common electrode should be placed below the area to be treated If the therapy is conducted with 2 movable electrodes the common electrode becomes an active treatment electrode in this mode Optimal energy transfer can only be guaranteed in connection with the special condu...

Страница 24: ...sive electrodes are used no ThermoTK cream is needed The contact area of the common electrode on the skin should never be smaller than the area of the treatment electrode Therapy without a common electrode is not possible Placement of the electrode on the selected treatment point area Adjustment of the desired power using the left hand adjuster The power adjusted is shown in the bar graph Start of...

Страница 25: ...ve mode 0 250 VA 3 Coupling Visual coupling display on the handpiece 4 Mode Frequency Percentage display of the coupling limit value Green LED steadily lit Sufficient coupling Green LED flashes Insufficient coupling Activation of the button 4 opens a selection window with 2 buttons in which the mode and frequency can be adjusted The desired mode is set by directly selecting the upper button Resist...

Страница 26: ...stive alternating Continuous Capacitive Continuous pulsed Capacitive alternating Continuous Hands free Continuous pulsed alternating In the hands free operating mode only the frequency can be selected The working mode is resistive 6 Time Displays the therapy time Can be adjusted from 1 60 minutes The adjustment is made using the right hand adjuster 7 Save Activation of the Save button opens an alp...

Страница 27: ...gion opens The clinical picture is selected directly in the corresponding line Select acute chronic Therapy information Select therapy program The differentiated condition of the clinical picture Acute Chronic is selected directly in the corresponding line After selecting the differentiated condition of the clinical picture another window with detailed therapy and treatment information opens A bar...

Страница 28: ...ites 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 deleted To do this the Delete button is activated highlighted in blue The program is deleted by selecting the program directly in the line ...

Страница 29: ...resistive Operating modes Continuous pulsed Dimensions W 322 mm x H 135 mm x D 234 mm Weight 3 5 kg control unit without accessories Operation 10 C to 40 C 10 to 85 relative humidity without condensation at 700 hPa 1060 hPa Transport storage 10 C to 50 C 10 to 90 relative humidity without condensation at 500 hPa 1060 hPa Note Storage and transport only in original packaging Note Power display W VA...

Страница 30: ...face until the dirt is removed using a soft cloth soaked according to the specifications of the manufacturer of the cleaning agent but not dripping wet Disinfection We recommend that disinfection is to be carried out at least once a week as well as if there is any indication of contamination Consult with the hygiene specialist regarding this matter Always perform cleaning prior to disinfection Per...

Страница 31: ...Cleaning disinfection 10 Page 21 Note Use the device only in a hygienic environment ...

Страница 32: ...e 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 ...

Страница 33: ...ctions for use Item no Accessories 50601000 1 Handpiece with white connection 8 pin 50601010 1 Handpiece with grey connection 4 pin 50601055 1 Common electrode cable 210 cm with white connection 8 pin 50601060 1 Common electrode cable 210 cm with grey connection 4 pin 50601020 1 Electrode resistive 30 mm 50601025 1 Electrode resistive 50 mm 50601030 1 Electrode resistive 70 mm 50601035 1 Electrode...

Страница 34: ...ation 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 ...

Страница 35: ...s operated in accordance with the instructions for use extensions readjustments or modifications are carried out only by persons authorised by Zimmer MedizinSysteme GmbH the user has ascertained the functional safety the proper operating condition and mechanical integrity before using the device and handpiece including electrode the device is operated only by properly trained personnel the device ...

Страница 36: ...st be replaced Inspect the surface regularly for cracks and other damage If a surface is damaged or if the adhesion is inadequate the electrode must be replaced Observe the application information on the packaging of the electrode Electrode cable Regularly check the electrode cable of the handpiece and the common electrode for integrity If there is any damage the cable must be replaced Electrodes ...

Страница 37: ...ction to the device Attach an electrode to the handpiece Connect the common electrode with the grey connection to the device Attach the plug connector of the cable to the tab of the common electrode No message functionality is guaranteed Message Handpiece not detected check whether you have selected the correct electrode and that it is correctly attached to the handpiece If the error recurs immedi...

Страница 38: ... 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 These are to be followed when operating the device Note These requirements apply to the operation of the device in Germany Please consider divergent national regulations in your country ...

Страница 39: ...kinks Possible cause 2 The electrode cable is not correctly connected to the device or the plug connector of the electrode cable is not correctly connected to the common electrode Remedy for cause 2 Check whether the electrode cable is correctly connected to the device The plug must be fully engaged Check whether the plug connector is correctly connected to the common electrode Possible cause 3 Co...

Страница 40: ...ction Remedy for cause 1 Check whether the mains plug is correctly plugged into the socket and the device plug is firmly inserted in the port of the device Check the power cable for damage Check the mains and socket Possible cause 2 Fuse Remedy for cause 2 The mains input socket of the device contains microfuses which disconnect the device from the mains in the event of an electrical problem Open ...

Страница 41: ...asionally device errors can be corrected by switching the system off waiting 5 seconds and switching the system back on Repairs and services should be performed only by persons authorised by Zimmer It is essential that you notify technical support customer service of any problems that occur frequently or cannot be resolved You may get in touch with them via your sales representative or via the mai...

Страница 42: ...hich are not specified or provided by the manufacturer of this device can lead to increased electromagnetic interference emissions or decreased electromagnetic immunity of this device resulting in improper operation The ThermoTK device does not contain any exchangeable components cables or other parts which lead to worsening of the EMC WARNING Portable HF communication devices including peripheral...

Страница 43: ...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 Immunity tests IEC 60601 test level Compliance level Electromagnetic environment Guidelines Electrostatic discharge ESD according to IEC 61000 4 2 8 kV contact discharge 2 kV 4 kV 8 kV 15 kV air discharge 8 kV contact discharge 2 kV 4 kV 8 kV 15 ...

Страница 44: ...evices which bear the following symbol interferences are possible Radiated electromagnetic HF fields according to IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM to 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Single phase at 0 Single phase at 0 When the user of the ThermoTK device needs further operation even in the case of interruptions in the power supply it is recommended to operate the ThermoTK device ...

Страница 45: ...z deviation 1 kHz sinus 2 0 3 28 710 704 787 LTE band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Pulse modulation ...

Страница 46: ...steme 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 ThermoTK Instructions for Use EN 10 105 043 UR 1120 I Version 1 I Right of modification reserved ...

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