Zimmer Gentle Pro Instructions For Use Manual Download Page 1 | Manualshive

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Instructions for use

Gentle

Pro

EN

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Summary of Contents for Gentle Pro

Page 1: ...Instructions for use GentlePro EN ...

Page 2: ......

Page 3: ...Illustrations Front of the device Figure 1 Front of the device Handpiece Encoder ...

Page 4: ...ear of the device Switches Connector sockets 1 Socket for power cord 2 Main fuse 3 Identification plate 4 Socket for footswitch Figure 3 Rear of the column Switches Connector sockets 1 Socket for handpiece 2 Socket for water filling emptying 1 2 ...

Page 5: ... 2 Protocols direct activation of application screen Figure 5 Therapy Screen 1 Pulse Energy Set with the encoder 2 Frequency Set with the encoder 3 Footswitch Sign Press the footswitch to start a therapy 4 Treatment Menu 5 Pulse Mode 6 Handpiece detection 1 2 5 4 6 1 2 3 ...

Page 6: ...ations Screens and Displays Figure 6 Maintenance Screen 1 Handpiece detection information 2 Footswitch 3 Fill Empty the water cooling circuit 4 Handpiece test 5 General Settings 6 Maintenance Sign 1 2 3 4 5 6 ...

Page 7: ...Illustrations Accessories Figure 7 Handpiece Figure 8 Applicator Figure 9 Silicone cap Figure 10 Water evacuation pump Figure 11 Filling funnel with hose ...

Page 8: ...ith regard to possible damage of the device Application Part Typ BF Instructions for use Follow instructions for use Serial number Article number Manufacturer Date of manufacture This symbol indicates danger points on the device Connection socket handpiece Connection socket footswitch Connection for filling the cooling unit with water max 1 5L Max 1 5L ...

Page 9: ...st not be tilted Pump symbol indicating the location of the pump for water evacuation Do not reuse If used more than once cross infection may occur The transport package shall not be exposed to sunlight Symbol to indicate the maximum and minimum temperature limits at which the item shall be stored transported and used Quantity ...

Page 10: ... 1 2 2 1 1 1 2 Application Information 3 1 1 2 3 Safety Instructions Warnings 4 1 1 1 4 Device Set Up 5 1 1 1 5 Settings 5 1 Initialisation Screen 5 2 General Screen 5 3 Maintenance Screen 6 6 7 1 1 2 6 Operation Instructions 6 1 Device Description 6 2 Notes on Operation 6 3 Display and Buttons 6 4 Performing the treatment 8 9 10 11 1 1 1 7 Technical Information 12 1 1 2 8 Cleaning Disinfection 13...

Page 11: ...4 Legal Information 23 1 1 7 15 Error Messages Troubleshooting Disposal 24 1 1 8 16 Manufacturer s EMC declaration 27 1 1 9 Valid for GentlePro devices This instruction for use is an integral part of the device It must be stored with the device and kept accessible at all times for anyone authorized to operate this device The instruction for use is valid in version 1 as of March 2019 ...

Page 12: ...e in case of pain Application Principle Application duration Shockwave therapy lasts a maximum of 15 minutes in therapy Application frequency The device is used for approx 15 applications of 15 minutes each with a maximum of 240 working days per year Between applications at least 10 minutes break should be planned for the preparation of the device Application Restriction Application restrictions a...

Page 13: ...ectly over implanted electronic devices e g pacemaker or pain pump In the area where mechanical energy in the form of vibration results in the damage of the tissue e g in the case of metal supply After fracture in the case of torn muscle fibres or muscle tears In general treatments are not recommended In case of blood clotting disorders or treatments that result in a change in blood coagulation Du...

Page 14: ...veral meters Attention GentlePro is not suitable for use in areas with an explosive flammable or combustive atmosphere Attention Do not place the device adjacent to heat sources heating hot mud products sauna etc and leave a gap of at least 50 cm between the device and a wall to allow for the supply of treatment products and cold air Attention During use the device is to be located in a position a...

Page 15: ...eas is inadmissible and if disregarded may result in significant damage and endanger both the patient and the user Do not push the sides of the device that are marked with the warning symbol Do not lean on the device Do not use the silicone cap twice as it is a wear and tear part and product cannot be assured in case of using the cap twice Simultaneous connection of the patient to a high frequency...

Page 16: ...he mains switch Filling the water circuit See Chapter 12 2 Switch off the device The unit is switched off via the mains switch To disconnect the unit completely all pole from the mains supply the mains cable has to be removed Attention All cables must be protected from disturbance or other mechanical damage Attention After horizontal transport or assembly the device must stand upright for at least...

Page 17: ...e start menu 2 Language Choose language The selection is made directly in the corresponding line 3 Welcome Text Activation of the Welcome text field opens a window with an alphanumeric keyboard for entering a welcome message on the start up screen Activation of the button with the green hook saves the entered text Activation of the button with the red cross takes you back to the configuration menu...

Page 18: ...ion of the handpiece is shown in this display 2 Footswitch The detection of the footswitch is shown in this display 3 Water cooling circuit Gives the user the possibility to empty and fill the water cooling circuit 4 Beat Counter Here the user can activate stop the beat counter 5 Disconnect the handpiece This gives the user the opportunity to disconnect the handpiece The device pumps out the water...

Page 19: ...d One applicator size is available for the application Changing the applicator heads To change the applicator head hold the handpiece with one hand and unscrew the applicator head from the handpiece with the other hand turning in anti clockwise direction Then screw in the desired head by turning clockwise until it stops Note The applicator head is a wear part and needs to be replaced after a certa...

Page 20: ...g down on application area point is usually not necessary The handpiece is placed and held in a relaxed posture using the hand If required additional pressure can be applied in the direction of the tissue and the angle of use can be varied Depending on the application a different position of the handpiece and the formation of a skin fold between applicator and the applicant s hand can be useful Th...

Page 21: ... row 4 Number of shocks Display of the preselected number of shocks and the currently emitted shocks as well as the total number of emitted shocks if the total number of emitted shocks is not preselected Display of the counting direction in ascending or descending order Activation of the preselection field will open the input menu for entering a preselected number of shocks The pre selection can b...

Page 22: ...his menu the protocols for different treatments are displayed In the picture above an example for a treatment recommendation is shown The application recommendation gives the user an overview on how to guide the handpiece in the right direction If the user has chosen a treatment recommendation and starts a therapy an info button is displayed which shows the treatment settings ...

Page 23: ...ort Temperature 10 50 C Humidity 20 80 relative humidity without condensation Air pressure 700 1060 hPa Storage Temperature 10 C 50 C Humidity 20 80 relative humidity without condensation Air pressure 700 1060 hPa Note Storage and transport only in original packaging Subject to technical modifications Application part Applicator head silicone protective cap Frequency range 1 22 Hz adjustable in 1 ...

Page 24: ...ol free disinfectant for metal and plastics which has a bactericidal virucidal and fungicidal effect or so called wipes Please observe the instructions for use of the respective manufacturer We recommend disinfection at least once a week and if there are indications of possible contamination Consult your hygiene specialist for this Always carry out a cleaning before disinfection Housing and footsw...

Page 25: ...CE Mark 9 Page 14 The product bears the CE mark in accordance with the EC Directive on Medical Devices 93 42 EWG ...

Page 26: ...rotective caps 6825451101 Emptying hose 8000226 Funnel 9325450201 Funnel holder see also accessories Accessories Art no 117 Power cords 5556 Handpiece H2O Slim 50500021 Holder for handpiece 50500038 Lotion 65410410 Storage tray Accessories 93133511 Applicator head 15 mm 93410210 Footswitch holder 94130411 Footswitch 95135115 Silicone protective cap 50 pieces in a box Subject to change Note The dev...

Page 27: ... are provided by the manufacturer Anyone who contrary to these specifications combines devices and thus operates a medical system does so at its own risk Whoever combines the devices and thus operates a medical system is responsible for the correctness of the combination ...

Page 28: ... cables and connectors must be checked for damage that could impair the safety of the device e g cracks the device is only operated by appropriately trained personnel the device is not operated in potentially explosive atmospheres and or combustion promoting atmospheres the device is immediately disconnected from the mains if liquids penetrate b The device does not contain any parts that can be se...

Page 29: ...he button to fill the water cooling circuit the following steps have to be done The message gives the user the instruction to plug in the filling tube Then the user has to fill in the distilled water and monitor the fill level in the images shown below The fill level should be between maximum and minimum ...

Page 30: ...button in the configuration menu After that a message occurs that shows the user to plug in the tube and set up a collection container to empty the cooling circuit See figure below After that Step a message occurs that shows that the pumping process If the process is finished a message appears that shows the user that the whole system is empty ...

Page 31: ... the system Disconnect the handpiece To separate the handpiece the user has to press the right button in the configuration menu After that a message occurs that shows the user how to put the handpiece while the device empties the handpiece If the user presses the green hook the process is started After that a message occurs that the handpiece is separated ...

Page 32: ...an error message occurs and gives the user the instruction to repeat the process If the process was successful a message occurs to show the user that the handpiece can now be disconnected Attention The handpiece must not be unscrewed from the device during active therapy ...

Page 33: ...Functional Test 13 Page 22 Functional test After being switched on the GentlePro automatically performs a self test and checks the function of the technical components ...

Page 34: ...the MPBetreibV Medical Device Operator Ordinance c In Germany the current version of DGUV Regulation 3 Electrical Installations and Equipment must also be observed d These instructions apply to the operation of the equipment in Germany Observe any deviating national regulations in your country Note These requirements apply to the operation of the device in Germany Divergent regulations may apply i...

Page 35: ...d thoroughly clean the rear dome Then hold the handpiece without applicator head with the opening facing downwards and produce some shocks maximum 10 with 2 or 5 Hz frequency at the lowest energy level Then re insert the applicator head If the error persists the applicator head must be changed Possible cause 2 Wear of shockwave generator Fix for cause 2 The shockwave generator is a wear part and i...

Page 36: ...irst check the power supply completely for possible errors If the fault persists contact the service representative customer service immediately Error message SD card On the SD card the user defined settings as well as the application list are stored If the SD card is not inserted the display application recommendation will not open upon activation of the start button on the home screen The follow...

Page 37: ...as shown in Figure 3 After connecting the pump empty the tank manually by using the pump Troubles during filling process The error message below shows the user that the filling process was stopped and has to be repeated Fix Please restart to fill the tank according to chapter 12 2 else please contact the customer service department Head office Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße ...

Page 38: ...ise degradation of the performance of this equipment could result The device was tested for RF immunity only at selected frequencies Nearby transients at other frequencies may result in degraded operation The frequencies tested are listed in Table 4 The GentlePro is developed according to the recognized standards of technology the information on the intended use of the components is taken into acc...

Page 39: ... must correspond to that of a typical commercial or hospital environment Surges in accordance with IEC 6100 4 5 Line to Line 0 5 kV 1 kV 0 5 kV 1 kV Surges in accordance with IEC 6100 4 5 Line to Earth 0 5 kV 1 kV 2 kV 0 5 kV 1 kV 2 kV Voltage dips in accordance with IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 The supply voltag...

Page 40: ...ould ensure that it is used in such environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guideline Conducted Disturbances induced by RF fields according IEC 61000 4 6 3 V 0 15 MHz to 80 MHz 6 V in ISM Band between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz to 80 MHz 6 V in ISM Band between 0 15 MHz and 80 MHz 80 AM at 1 kHz In the vicinity of devices bea...

Page 41: ... m 780 217Hz 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse Modulation 18Hz 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 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse Modulation 217 Hz 0 2 0 3 9 5500 5785...

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Page 44: ...MW 0319 I Version 1 I Modifications reserved 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 GentlePro Instructions for use ...

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