Zimmer ThermoPro Скачать руководство пользователя страница 31 | Manualshive

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CE-mark

11

Page 24

The product bears the CE-mark

According to the EC directive 93/42/EEC on medical devices.

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Содержание ThermoPro

Страница 1: ...User Manual ThermoPro USA ...

Страница 2: ...ting Elements 1 Mounting bracket with caster including locking device 2 Connection for supporting arm 3 Applicator cable connection 4 Supporting arm including applicator cable 4 1 and applicator 4 2 5 Cable clip 6 Display 7 Slot for SD card 5 3 4 1 2 6 1 7 4 4 2 ...

Страница 3: ...Illustrations Rear view of the Device Fig 2 Device and Operating Elements 8 Mains cable socket 9 Power switch 10 Recessed grip 11 Identification plate 12 Ventilation openings 9 12 8 10 11 ...

Страница 4: ...escription of functions A Home Returns to the Start page B Back Takes you one step back C Memory Switches to the Memory area D Body Area Switches to the Body Area screen E Programs Switches to the Program list F Favorites Switches to the Favorites area G Scroll Forward Moves down a page H Scroll Backwards Moves up a page 16 17 15 14 E D C B A H G F ...

Страница 5: ...r Article number Manufacturer Date of manufacture Applied part type BF The unit emits non ionizing electromagnetic radiation CE Mark The device is tested and manufactured in compliance with relevant safety standards Rx only U S A Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner licensed by the law of the State in which he she practices to use or or...

Страница 6: ... 1 2 Side effects 2 3 Application Information Cautions and Precautions 3 4 Warning Notices 4 5 ThermoPro in brief 10 6 Assembling the Device 11 7 Settings 12 8 Operation Instructions 8 1 Performing Treatment 8 2 Display and Buttons 8 3 Body area 8 4 Favorites and Memory Lists Selecting Programs Editing Lists 14 15 18 19 9 Technical Information 22 ...

Страница 7: ...31 Valid for the ThermoPro device This manual is an integral part of the device It should be kept with the device so that the persons assigned to operate the device can access it at any time The instruction manual is valid from software version 1 8 0 U S A Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner licensed by the law of the State in which he...

Страница 8: ...ial risks is not able to co operate with the operator in maintaining the proper position and in reporting the presence of a heating sensation which is the only indication of an adequate or excessive dose is pregnant If the device operator is pregnant she should remain at least 5 meters away from the applicator when the unit is turned on since the effects of high frequency fields on a fetus have no...

Страница 9: ...morrhage ischemic tissue tuberculous joints or acute infections within the treatment area over or in close proximity to active cancer as therapy may increase blood flow to the tumor on patients or within 10 feet of a person with Cardiac Pacemakers or implanted defibrillators on patients or within 10 feet of patients who have ANY implanted systems with RF programming or metallic lead or any implant...

Страница 10: ...Side Effects 2 Page 3 Side effects Treatment with the ThermoPro can occasionally cause temporary local reddening of the skin ...

Страница 11: ...device in the vicinity of strong electromagnetic fields e g MRI X ray or other diathermy equipment can interfere with the operation of the device Please maintain a safe distance of several meters Caution ThermoPro is not suitable for use in areas having an explosive flammable or combustive environment Caution During use the device should be positioned to allow more direct access to the central pow...

Страница 12: ...old packs due to possible activation of chemical packs with diathermy treatment Caution is recommended when treatment follows the application of hot or cold therapy which may alter the patient s sensation Application of thermal agents over areas of impaired circulation should be performed with caution as the circulation may be insufficient to heat or cool the tissue altering the patient s percepti...

Страница 13: ...s body containing metal implants for example a bone pin should generally be excluded from the treatment unless special techniques are used Patients should not normally undergo shortwave therapy if they have reduced heat sensitivity in the body region to be treated unless the attending physician is notified Shortwave treatment should not be performed on patients through items of clothing Conductive...

Страница 14: ...t the applicator and the applicator cable are handled with the necessary care Severe shocks and impacts can change the radiation pattern Ensure that the device is not opened Opening the device can generate life threatening voltage Make sure that the device is not operated with a damaged applicator or applicator cable Make sure that the device is operated only when the applicator cable and supporti...

Страница 15: ...ntraction or during menstruation as therapy may temporarily increase menstrual flow over exposed spinal cord i e following laminectomy spinal fusion etc directly over the cranial region as little is known about the electromagnetic effects on the cerebrum to determine if it represents a serious hazard when shortwave diathermy is applied to the head in the vicinity of the heart directly over the epi...

Страница 16: ...ith caution Establishment of acceptable intensity levels for desensitized areas may be related to the intensity levels tolerated on normal skin in opposite or related body parts The device generates lethal high voltage Ensure that there is no power output during the positioning of the applicator and thus no accidental irradiation of patient and user Ensure that the user doesn t stay in the applica...

Страница 17: ... maximum user comfort User information on indications will support you during therapy What else does ThermoPro offer The option of either pulsed or continuous application opens up a wide range of indications to the operator Intended Use ThermoPro is a shortwave diathermy device for use in applying therapeutic deep heat for selected medical conditions by applying electromagnetic energy in the radio...

Страница 18: ...ly be connected to power outlets with a properly grounded contact Note After completion of the assembly check again to see whether the supporting arm connection is properly inserted into the connector Check that the applicator cable is properly connected to the connector The device may only be operated when the applicator cable has been properly connected Otherwise a risk to people and environment...

Страница 19: ...screen opens Note Activating the Start 2 button will immediately switch to the application screen Settings menu In the settings menu the factory settings can be individually changed and adjusted Selecting settings Pressing the Settings 1 button opens the Settings screen The settings are described below The default settings are pre programmed as shown on the screen 1 2 3 4 5 6 1 2 7 ...

Страница 20: ... sound when the control panels are activated Adjustment is done by using the two arrow keys 4 OK Touch the OK button to switch to the start screen 5 Version Touching the Version button opens a window with information about the current software version 6 Default settings Touching the default button restores the default factory settings 7 Welcome Clicking in the Welcome field opens a window with an ...

Страница 21: ...e coupling indication A maximum coupling should always be achieved The better the coupling the more energy is transferred A distance of max 1 cm is recommended Output settings Set the output by using the arrow keys or bar graph Starting therapy Pressing the Start button begins the therapy The function of the Start button changes to Stop The display in the status bar changes from Ready to Active En...

Страница 22: ...r 0 10 W in increments of 5 10 200 W in increments of 10 3 Bar graph Function 1 Displays the set power During active therapy the bar graph is filled in Function 2 Activating the bar graph 3 opens the window to select the power Selection options 20 50 70 100 120 150 and 200 W Selecting the desired output is performed in the corresponding field Pressing the Cancel button cancels the operation 1 3 4 ...

Страница 23: ...10 Hz increments 200 Hz 800 Hz in 100 Hz increments 1000 Hz Duty cycle 10 400 Hz 10 90 in 10 increments 500 1000 Hz 25 50 75 5 Coupling Graphic display of the coupling 1 Percentage display of the coupling 2 Symbol of acoustic coupling signal 3 The acoustic coupling signal can be switched on and off by pressing the symbol The symbol changes accordingly Coupling signal activated Coupling signal disa...

Страница 24: ...ncrements 9 Save Touching the button opens the box to input the name of a particular program to be stored in the memory or favourites list 10 Start Stop Touching the Start button after entering the output starts the therapy The function of the Start button changes to Stop Touching the Stop button during therapy sets the output to zero and the therapy time is suspended The function of the Stop butt...

Страница 25: ... After selecting a body area the therapy screen opens The output power is always set to 0 All parameters can be individually adjusted Do NOT apply shortwave diathermy in areas where treatment may impact patient safety See Warnings Section 4 of this Manual for more information Note Each patient should be individually assessed to determine the appropriateness of the chosen parameter settings prior t...

Страница 26: ...list Memory list Touching the button 1 opens the list of favourites and automatically stores the program in the Favorites list Touching the button 2 opens the memory list and stores the program in the Memory list Touching OK closes the Save screen and transfers the program to the corresponding list The program is always stored in the first available space on the list Touching the button 3 interrup...

Страница 27: ...al so only the steps for retrieving and editing the favourites list are described Select Favorites List Pressing the Favorites button opens the favourites list Retrieving Program The desired program is directly selected in the corresponding row Editing Favorites List Activating the buttons 1 and 2 allows individual favorite pages to be viewed Button 1 scrolls forward button 2 backwards Activating ...

Страница 28: ...o the program Activating the button 2 moves the program to the top Activating the button 3 moves the program down Activating the button 4 deletes the program Note Activating the button 4 triggers a safety query Do you really want delete the program Activating the Yes button deletes the program Activating the No button will cancel the deletion 1 2 4 3 ...

Страница 29: ...istance between the applicator and the patient of a maximum of 1 cm Pulse rate 10 1000 Hz CW mode Adjustable 10 200 Hz in 10 Hz increments 200 800 Hz in 100 Hz increments 1000 Hz Duty cycle 10 400 Hz 10 90 in 10 increments equivalent to 1 10 9 10 500 1000 Hz 25 50 75 Pulse width 250 µs 90 ms in 250 µs increments Preset not adjustable Dimensions Width 22 9 in 581 mm x Depth 18 in 459 mm x Height 33...

Страница 30: ...cifications of the manufacturer of the cleaning agent but not dripping Disinfection We recommend that disinfection to be carried out at least once a week as well as in the event of evidence of possible contamination Consult with your health professional when doing so Always perform cleaning prior to disinfection Housing applicator and cables can be disinfected using disinfectant wipes To do so use...

Страница 31: ...CE mark 11 Page 24 The product bears the CE mark According to the EC directive 93 42 EEC on medical devices ...

Страница 32: ...acket with castors incl locking device 2 Cable clip 1 Power cable 1 User manual 1 Assembly instructions Accessories Art Nr 95523110 Applicator including applicator cable 91525010 Supporting arm 93521010 Mounting bracket with castors incl locking device 80000410 Cable clip 2 count 67300126 Power cable 10102233 User manual 10102148 Assembly instruction ...

Страница 33: ...nations 13 Page 26 For ThermoPro no combination devices are provided by the manufacturer Anyone who contrary to these guidelines combines devices and operates a medical system in this way does so at their own risk ...

Страница 34: ...cal installation complies with DIN VDE 0100 part 710 or similar the device is operated in accordance with the instructions for use extensions readjustments or modifications are only carried out by persons authorized by Zimmer MedizinSysteme the operator is satisfied regarding functional safety proper condition and mechanical integrity of the device and applicator prior to use of the device the dev...

Страница 35: ...t occurs An extended function test as described below can also be performed This test should be performed monthly or if there are any doubts about the functionality of the device Function test Select continuous operating mode and set an output power of 5 W Move your forearm into the treatment field and make sure that the coupling indicator displays at least 50 ...

Страница 36: ...ible cause Faulty connection or damaged applicator or applicator cable Troubleshooting Check the correct position of the supporting arm and that the applicator cable is correctly joined to the applicator cable connection Check the applicator for visible damage Error message SD card If the SD card is not inserted the following message appears when you press the Favourites Memory and Therapy buttons...

Страница 37: ...usa com Zimmer MedizinSysteme GmbH Junkersstrasse 9 89231 Neu Ulm Germany Tel 49 731 9761 0 Fax 49 731 9761 118 www zimmer de Disposal The device must be returned to the factory in its original packaging It must be disposed of only by Zimmer MedizinSysteme In foreign European countries please refer to the national regulations for disposal Contact your distributor if necessary ...

Страница 38: ...se in the specified electromagnetic environment The purchaser or user of the ThermoPro device should assure that it is used in an electromagnetic environment as described below Emissions test Compliance Electromagnetic Environment RF emissions CISPR 11 Group 2 The ThermoPro device must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected...

Страница 39: ...vel Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode IEC 60601 1 2 Test level Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 Un for 0 5 cycles 40 Un for 5 cycles 70 Un f...

Страница 40: ...ld be used no closer to any part of the ThermoPro device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Radiated RF EN 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Conducted RF EN 61000 4 6 3 V 150 kHz to 80 MHz 3 V rms d 1 2 P Where...

Страница 41: ...tput power of the transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at the maximum output power not listed above the recommended separation distance d in meters m can be estimated the equation ...

Страница 42: ...0 102 233 TW 1118 I Version 1 1 I Modifications reserved ThermoPro Zimmer MedizinSystems 3 Goodyear Suite B Irvine CA 92618 Tel 800 327 3576 Fax 949 727 2154 www zimmerusa com info zimmerusa com User Manual ...

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