Zimmer Gentle Pro Instructions For Use Manual
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Zimmer Gentle Pro Instructions For Use Manual

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Instructions for use
Gentle
Pro
EN

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Summary of Contents for Zimmer Gentle Pro

  • Page 1 Instructions for use Gentle...
  • Page 3 Illustrations Front of the device Encoder Handpiece Figure 1: Front of the device...
  • Page 4 Illustrations Rear of the Device Figure 2: Rear of the device Switches / 1 Socket for power cord Connector 2 Main fuse sockets 3 Identification plate 4 Socket for footswitch Figure 3: Rear of the column Switches / 1 Socket for handpiece Connector 2 Socket for water filling / emptying sockets...
  • Page 5 Illustrations Screens and Displays Figure 4: Start-up Screen Settings 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...
  • Page 6 Illustrations 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...
  • 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 Explanation of Symbols In the instructions for use this symbol indicates “Caution”. In the instructions for use this symbol indicates "Attention" with regard to possible Attention damage of the device. Application Part Typ BF Instructions for use Follow instructions for use. Serial number Article number Manufacturer...
  • Page 9 Explanation of Symbols This is an electrical appliance. The appliance must not be disposed of with household waste. The device must 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.

  • Page 10: Table Of Contents

    Contents Illustrations Front of the Device Rear of the Device Screens / Displays Accessories Explanation of Symbols Page Intended Use 1.1 Intended Purpose 1.2 Indications 1.3 Contraindications 1.4 Side Effects 1.1.1. Application Information 1.1.2. Safety Instructions / Warnings 1.1.1. Device Set Up 1.1.1.
  • Page 11 Contents Scope of Delivery and Accessories 1.1.3. Device Combinations 1.1.4. Safety and Maintenance 12.1 Safety 12.2 Maintenance 1.1.5. Functional Test 1.1.6. Legal Information 1.1.7. Error Messages / Troubleshooting / Disposal 1.1.8. Manufacturer’s EMC declaration 1.1.9. Valid for Gentle 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.

  • Page 12: Intended Use

    Intended Use 1.1 Intended Purpose 1.2 Indications 1.1 Intended Purpose Gentle is a device for the external application of radial shockwaves to the uninjured skin in the field of aesthetic medicine, physical therapy and orthopaedics of the musculoskeletal system. By applying radial shockwaves to uninjured skin, pain and conditions with the musculoskeletal system, the skin and muscles can be treated.

  • Page 13: Contraindications

    Intended Use 1.3 Contraindications 1.4 Side Effects Treatment  Cellulitis in Stage I to III recommendations  Weakness of muscle and connective tissue in the upper arm and lower abdomen  Stretch marks on the hip  Stretch marks on the thigh ...

  • Page 14: Application Information

    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 for the mains at any Attention time. Only accessories provided by Zimmer MedizinSysteme GmbH must be used. Attention The silicone protective cap is single use only. Attention...

  • Page 15: Safety Instructions / Warnings

    Safety Instructions / Warnings User Group a) Training: doctors, therapists, members of medical circles who understand the instructions for use and warnings as well as the contraindications and indications of the accompanying documents. b) Knowledge: knowledge of the working principle of shockwave therapy devices. Users of the device must be instructed in the correct use of the system and have appropriate knowledge.

  • Page 16: Device Set Up

    Device Set Up Note: Make sure that the power switch on the device is set to "0". Mains cable Connect the power cable to the appropriate socket (figure 2: 1) on the device and connection connect the cable to the mains. Note: The device may only be connected to power outlets with grounding contact.

  • Page 17: Settings

    Settings 5.1 Initialisation Once the device is turned on, the start-up display appears. As long as the blue bar runs out, a device initialization/ self-test is performed and no therapy can be started. screen After this phase, the device switches automatically in the start-up screen. Note Changes in the basic settings are only possible from the start-up screen (see Figure Settings menu...

  • Page 18: Maintenance Screen

    Settings (8) Load Default Activation of the “Load default” button restores the default factory settings. (9) Colour Scheme Activation of the “Colour scheme” button changes the display colour from dark to bright and vice versa. (10) Handpiece In this display panel, the counter status for the connected handpiece is illustrated. By touching the button with the green arrow in the right bottom of the display the settings are saved and the configuration menu is closed.

  • Page 19: Operation Instructions

    The pulse generator in the handpiece is a wear part and needs to be replaced after a certain period as its ability to function decreases with time. Zimmer MedizinSysteme GmbH guarantees unrestricted use of at least two million pulses per one pulse generator. Depending on the power and frequency, more than two million pulses can be generated.

  • Page 20: Notes On Operation

    Operation Instructions 6.2 Notes on Operation Therapy Please hold the handpiece as shown below. The Gentle operates with mechanical energy; it is transferred to the patient through a handpiece. For this purpose, the handpiece with the applicator is placed vertically on the application area.

  • Page 21: Display And Buttons

    Operation Instructions 6.3 Display and Buttons Description of the display elements and buttons (1) Energy Displays the set pulse energy. When the application is active, the bar graph is filled in. The pulse energy can be set before and during the delivery of pulses via the left controller.

  • Page 22: Performing The Treatment

    Operation Instructions 6.4 Performing the treatment Programme start Activating the right button in the start screen opens the screen selected in the settings menu. In this 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.

  • Page 23: Technical Information

    Technical Information Power supply 110-240 Vac, 50-60 Hz Mains fuse 2 x T3,15AL, 250V Power consumption 250 VA Protection class Applied part class IP protection class Device IPX0, Footswitch IPX5, Handpiece IPX0 Operating Mode Continuous operation Dimensions 53 x 54 x 139 cm (L*W*H) Weight 25,4 kg (incl.

  • Page 24: Cleaning Disinfection

    Cleaning Disinfection Before starting maintenance and cleaning measures, the unit must always be Attention switched off with the main switch and the mains plug disconnected. a) During cleaning or disinfection, make sure that no liquid enters the device, the footswitch or the handpiece. Do not use sprays. b) If liquid penetrates into the device or handpiece during cleaning or disinfection, please put the device out of operation, protect it against recommissioning and contact the service department.

  • Page 25: Ce-Mark

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

  • Page 26: Scope Of Delivery And Accessories

    Silicone protective cap 50 pieces in a box Subject to change! Note: The device may only be operated with original accessories from Zimmer MedizinSysteme GmbH. Otherwise, the function and safety of patients, users and other persons cannot be guaranteed. Page 15...

  • Page 27: Device Combinations

    Device Combinations For the Gentle no combination units 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: Safety And Maintenance

    EN 60601-1. a) Zimmer MedizinSysteme GmbH, as the manufacturer, can only be held responsible for safety and reliability if the device is operated at a socket with grounding contact in accordance with the...

  • Page 29: Maintenance

    Safety and Maintenance 12.2 Maintenance Fill the water cooling If the user presses the button to fill the water cooling circuit the following steps have circuit 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.
  • Page 30 Safety and Maintenance 12.2 Maintenance Empty the water To empty the water cooling circuit the user has to press the button in the configuration menu. After that a message occurs that shows the user to plug in the cooling circuit tube and set up a collection container to empty the cooling circuit.
  • Page 31 Safety and Maintenance 12.2 Maintenance If the process was stopped a message occurs to show the user that there could be still some water left in the system. Disconnect the To separate the handpiece, the user has to press the right button in the configuration menu.
  • Page 32 Safety and Maintenance 12.2 Maintenance If process failed 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. The handpiece must not be unscrewed from the device during active therapy.

  • Page 33: Functional Test

    Functional Test Functional test After being switched on, the Gentle automatically performs a self-test and checks the function of the technical components. Page 22...

  • Page 34: Legal Information

    Legal Information a) The Gentle device is not listed in Annex 1 of the MPBetreibV (Medical Devices Operator Ordinance). Please observe the necessary measures. b) The device is not listed in Appendix 2 of the MPBetreibV (Medical Device Operator Ordinance). c) In Germany, the current version of DGUV Regulation 3 (Electrical Installations and Equipment) must also be observed.

  • Page 35: Error Messages Troubleshooting Disposal

    Error Messages Troubleshooting Disposal Loss of function of Despite activating the foot switch, no pulse is triggered. handpiece Possible cause 1 Handpiece / foot switch is not properly connected, or defective. Fix for cause 1 Make sure that the foot switch and handpiece are connected correctly. The plug must be properly snapped in.
  • Page 36 Error Messages Troubleshooting Disposal Fix for cause 1 Check whether the power cord is properly plugged into the electrical outlet and whether the plug is firmly inserted into the socket of the device. Check the power cord for damage. Check the power supply and mains socket. Possible cause 2 Fuse Fix for cause 2...
  • Page 37 The error message below shows the user that the filling process was stopped and process has to be repeated. Please restart to fill the tank according to chapter 12.2., else please contact the customer service department. Head office Zimmer MedizinSysteme GmbH Manufacturer Junkersstraße 9 89231 Neu-Ulm Germany Tel. +49 731 / 9761-291 Fax +49 731 / 9761-299 export@zimmer.de...

  • Page 38: Manufacturer's Emc Declaration

    Manufacturer’s EMC declaration The Gentle is developed according to the recognized standards of technology; the information on the intended use of the components is taken into account. The Gentle must not be operated near active HF surgery devices or magnetic resonance tomography that can cause high levels of electromagnetic interference.
  • Page 39 Manufacturer’s EMC declaration Table 2 Guidance and Manufacturing Declaration- Electromagnetic Immunity The device Gentle is intended for use in the electromagnetic environment specified below. The customer or user of the device Gentle should ensure that it is used in such environment. Immunity IEC 60601- Test Level Compliance Level...
  • Page 40 Manufacturer’s EMC declaration Guidance and Manufacturing Declaration- Electromagnetic Immunity The device Gentle is intended for use in the electromagnetic environment specified below. The customer or user of the device Gentle should ensure that it is used in such environment. Immunity IEC 60601- Test Level Compliance Level Electromagentic Environment -...
  • Page 41 Manufacturer’s EMC declaration Electromagnetic immunity to HF radio communication equipment Test Maximum Immunity Test Band Distance Frequency Service Modulation Energy Level (MHz) (MHz) (V/m) 217Hz 800-960 GSM 800/900, Pulse TETRA 800, iDEN 820, CDMA Modulation 850, LTE Band 5 18Hz 1720 1700- GSM 1800;...
  • Page 44 Gentle 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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