Zimmer OptonPro Instructions For Use Manual
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Zimmer OptonPro Instructions For Use Manual

25 watt, 15 watt, 10 watt
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Instructions for Use
OptonPro
25 Watt, 15 Watt, 10 Watt
EN

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Summary of Contents for Zimmer OptonPro

  • Page 1 Instructions for Use OptonPro 25 Watt, 15 Watt, 10 Watt...
  • Page 3 Illustrations Front of the device Fig. 1 Selection and operating Control unit elements Display Emergency stop button On/off switch Applicator with light guide Applicator with 5.1 Manual switch and 5.2 Integrated infrared sensor and laser aperture Optical fibre Test sensor Test sensor and holder for applicator...
  • Page 4 Illustrations Rear of the device Fig. 2 Ports Light guide outlet Connection port for foot switch 10 Identification plate 11 Connection for power cable 12 Holder for mains fuse 13 Connection port for interlock plug 14 Connection port for USB...
  • Page 5 Illustrations Screens / display Fig. 3 Display view Status line Buttons on the screen Buttons in the navigation menu Buttons in the status bar Fig. 4 Navigation menu / (A) Therapy Switches to the therapy screen status bar (B) History Switches to the VAS history Description of the (C) Favourites...
  • Page 6 Illustrations Accessories Spacer, small Spacer, large Foot switch (optional) 4 Laser warning sign with laser Interlock plug Protective laser glasses warning light 7 Laser warning sign Laser warning sign OptonPro 10 W OptonPro up to max. 25 W...

  • Page 7: Explanation Of Symbols

    Explanation of symbols Caution: laser aperture Note: The laser beam exits at the end of the applicator Turn the emergency stop button in the direction of the arrow to unlock Applied part type B Connection port for foot switch Connection port for interlock Rating of the accessible fuses Protection class II Instructions for use...

  • Page 8: Table Of Contents

    Accessories Explanation of symbols Page Indications Contraindications / Side effects Safety information / warnings Application information OptonPro – in brief System set-up 6.1 Safety measures 6.2 Assembly and start-up Configuration Operation instructions 8.1 Performing a treatment 8.2 Displays and buttons 8.3 Protocols...
  • Page 9 Error messages / troubleshooting / disposal Manufacturer's EMC declaration Valid for the device OptonPro. 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.

  • Page 10: Indications

    Indications The following indications can be mentioned in particular: Lateral epicondylitis Chronic neck pain Osteoarthritis of the knee Subacromial impingement syndrome Pain in the lower back The following effects are demonstrably achieved: Lateral epicondylitis Healing Chronic neck pain Pain relief, mobility Osteoarthritis of the knee Pain relief, mobility Subacromial impingement syndrome...

  • Page 11: Contraindications / Side Effects

    Contraindications / Side effects Contraindications Fresh haematoma • Malignant, semi-malignant and benign tumours • Treatments in the area surrounding the eye • Pregnancy • In the region of the abdomen and lower back during menstruation • Particular caution is required when administering treatment near the ear, nose, mucous membranes and blood vessels.

  • Page 12: Safety Information / Warnings

    Safety information / Warnings OptonPro is a class 4 laser. The accessible laser beam is very dangerous to the eye and dangerous to the skin. Even diffusely scattered radiation can be hazardous. The laser beam can cause a risk of fire or explosion.
  • Page 13 10. To avoid the risk of electric shock, the plug must be disconnected from the power supply before performing any cleaning or maintenance activities. 11. Inspect the device before use. If there is any damage, it must not be used. 12. Only accessories provided by Zimmer MedizinSysteme GmbH must be used. Page 4...
  • Page 14 General: The person to be treated must have intact thermal perception. Information for the user The users of the OptonPro must have read the user manual prior to the first use of the device, including the treatment methods, indications, contraindications, warnings and application information.
  • Page 15 Safety information / Warnings General Pilot beam takes the same path as the therapy beam Since the pilot beam takes the same path as the therapy beam, this is a good way to check the integrity of the laser transmission system. If the pilot beam does not appear at the distal end of the applicator, if its intensity is low or if it appears to be scattered, this is a possible indication of a damaged or defective laser transmission system.

  • Page 16: Application Information

    To do this, pull the mains plug out of the socket. The device may be opened only by service technicians authorised by Zimmer MedizinSysteme Caution GmbH.
  • Page 17 Application information Applicator The applicator is at the end of the light guide. The laser beam exits from the front end of the applicator. The aperture is protected by a lens from dirt and damage. Direct the applicator only on the area of the patient to be treated. Never lay it down outside of the test sensor.

  • Page 18: Optonpro - In Brief

    OptonPro – in brief Intended use of OptonPro is a medical therapy device for the generation of a laser beam from three OptonPro wavelengths for the thermal initiation and support of tissue healing processes for external application. The application is contact-free.

  • Page 19: System Set-Up

    System set-up 6.1 Safety measures Safety measures Affix a laser warning sign including light to each door to the treatment room. Remove the laser warning sign sticker from the sheet enclosed with the device and affix it visibly to the device. Select a sticker in a language which can be understood by all employees.

  • Page 20: Assembly And Start-Up

    Remove the spacer from the applicator after the therapy and insert the applicator into the test sensor. Note: The foot switch is not included in the standard scope of delivery of OptonPro. Operation using the foot Connect the foot switch to the port provided (9) and put it on the floor.

  • Page 21: Configuration

    Configuration Note: The following descriptions are based on the factory settings. All buttons, menus and sub-menus can be activated directly on the screen with finger pressure. Ensure that all persons present in the treatment room are wearing protective laser glasses. Changes to the default settings can only be made in the configuration menu from the start-up screen.
  • Page 22 Configuration Deactivation of the code Option to adjust the deactivation time period. The adjustment can be made using the -/+ buttons. The access is deactivated after the set time has passed, if no settings have been made on the screen within this time. The code must then be re-entered.
  • Page 23 OptonPro (10 W/15 W/25 W) device. Import VAS / Favourites Via a USB stick, the data from another OptonPro (10 W/15 W/25 W) can be transferred to this device. Performing Procedure: Insert USB stick into the port provided.

  • Page 24: Operation Instructions

    Operation instructions 8.1 Performing a treatment Note: The following descriptions are based on the factory settings. Open therapy screen Activating the “therapy” button in the start-up screen opens the therapy screen. Adjust power The power is adjusted in the “Power” bar graph. Two options are available for adjusting the power: Using the arrow buttons underneath the bar graph, the power can be adjusted in 0.1-W increments.

  • Page 25: Displays And Buttons

    Operation instructions 8.2 Displays and buttons Description of the display elements and buttons Note: The following description relates to the therapy screen which is provided through the selection of “Protocols” and “Assistant”. If the selection is made directly via “Therapy”, the display (6) is not available. Instead of this, a “Thermal threshold”...
  • Page 26 The setting of 25 W is only possible if all 3 wavelengths are activated. Information on VAS OptonPro has a visual analogue scale, also called a pain scale. The pain scale is often used in pain therapy. It measures the patient's subjective pain intensity.
  • Page 27 Operation instructions 8.2 Displays and buttons VAS history Activating the “History” button in the screen leads directly to the history of the patient currently selected. Activating the “History” button in the navigation bar opens the list with the patients created. The patient to be assessed is selected directly in the line.
  • Page 28 Operation instructions 8.2 Displays and buttons (10) Save Activation of the “Save” button opens an alphabetical keyboard to enter an individual name of the program. Activating the “OK” button accepts the saved data. Activating the “X” button interrupts the process. (11) Performance test The performance test is used to check the laser power emitted.

  • Page 29: Protocols

    Operation instructions 8.3 Protocols Protocols There are 2 options available for selecting the desired therapy: - (1) Body regions - (2) List Selection via body The desired body region is selected by activating the white square. regions Select the clinical picture directly in the corresponding line. If offered, select the treatment type directly in the corresponding line.

  • Page 30: Assistant

    Operation instructions 8.4 Assistant Assistant Individual therapy parameters can be determined via the assistant function. By determining the therapy area, the course of the disease and the skin type, the following information is automatically saved: - Program parameters - Amount of energy to be applied - Therapy time Determine therapy 1.
  • Page 31 Operation instructions 8.4 Assistant 3. Trigger points If treatment of trigger points is planned, the number of trigger points to be treated is set by activating the -/+ buttons on the “Therapy points” display. In the window (6), the data determined as well as the mode of treatment are shown. Activation of the “OK”...

  • Page 32: Thermal Threshold Test

    Operation instructions 8.5 Thermal threshold test Note: A precondition for the thermal threshold test is intact thermal sensitivity. If this is locally disrupted, the test should be performed at a heat-sensitive site. To do this, the laser beam is applied until the patient perceives the heat. If the application time is in the range of 7 to 11 seconds, the correct laser power is determined.
  • Page 33 Operation instructions 8.5 Thermal threshold test If the emission lasts for less than 7 seconds, the following message appears: “The power is set too high. Please repeat the test.” The power is automatically decreased by 0.5 W. If the patient perceives a feeling of warmth between 7 and 11 seconds (2), the recommended power is determined.

  • Page 34: Favourites

    Operation instructions 8.6 Favourites Favourites The programs changed and saved in the therapy screen are filed in Favourites through the save procedure. Edit In the Favourites list, these can be 1. called up for therapy To do this, the desired patient is selected directly in the corresponding line. 2.

  • Page 35: Technical Information

    Wavelengths OptonPro 10 W 810 nm and 980 nm Wavelengths 810 nm, 980 nm and 1064 nm OptonPro 15 W / 25 W Output power OptonPro 10 W max. 10 W, CW mode OptonPro 15 W max. 15 W, CW mode OptonPro 25 W max.
  • Page 36 Technical information Note: The following data apply to all 3 models. Wavelength pilot beam 650 nm Output power Pilot beam Max. 5 mW Power supply 100-240 V~, 50 Hz / 60 Hz Mains fuse 2 x T 2.5 AL, 250 VA Protection class Applied part Type B, possible contact components applicator, spacer...

  • Page 37: Cleaning / Disinfection

    Cleaning / disinfection Before starting any maintenance and cleaning measures the device must always be • switched off at the main switch and the mains cable must be disconnected. Make sure that when cleaning and disinfecting the labelling of the device (such as •...

  • Page 38: Ce Mark / Manufacturer

    CE mark / Manufacturer The device has a CE mark in accordance with the EC directive on medical devices 93/42/EEC. Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 (0)731. 9761-0 Fax +49 (0)731. 9761-118 www.zimmer.de Page 29...

  • Page 39: Scope Of Delivery, Accessories

    Interlock plug 87450250 Protective glasses 95730012 Laser warning sign for door, including warning light for OptonPro 10 W 95730015 Laser warning sign for door, including warning light for OptonPro 15 W/25 W 93070620 Spacer, small 93070630 Spacer, large 6525411201 Spacer, silicone...

  • Page 40: Device Combinations / Safety And Maintenance / Functional Test

    OptonPro is manufactured according to the DIN EN 60601-1 safety regulations. maintenance As the manufacturer, Zimmer MedizinSysteme 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, •...

  • Page 41: Safety Check

    Metrological control In Germany, it is not necessary to perform either a safety check or a metrological control for the OptonPro device. The device cannot be allocated either to annex 1 or annex 2 of the Medical Device Operator Ordinance (MPBetreibV).

  • Page 42: Error Messages / Troubleshooting / Disposal

    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 main office in Neu-Ulm. Main office Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 (0)731. 9761-291 Fax +49 (0)731.

  • Page 43: Manufacturer's Emc Declaration

    WARNING: Portable HF communication devices (including peripheral devices such as antennas) should be used at a distance of at least 30 cm (12 inches) from any part of the OptonPro device; this includes cables indicated by the manufacturer. There may otherwise be a loss of performance of this device.
  • Page 44 Table 1 Guidance and Manufacturing Declaration- Electromagnetic Emissions The device OptonPro is intended for use in the electromagnetic environment specified below. The customer or user of the device OptonPro should ensure that it is used in such environment. Emission Measurement...
  • Page 45 Table 3 Guidance and Manufacturing Declaration- Electromagnetic Immunity The device OptonPro is intended for use in the electromagnetic environment specified below. The customer or user of the device OptonPro should ensure that it is used in such environment. Immunity Test...
  • Page 46 Manufacturer's EMC declaration Table 4 Electromagnetic immunity to HF radio communication equipment Test Maximum Immunity Test Band Distance Frequency Service Modulation Energy Level (MHz) (MHz) (V/m) 380-390 TETRA 400 Pulse Modulation 18 Hz 430-470 GMRS 460, FRS 460 ± 5kHz Derivation 1kHz Sine 704-787 LTE Band 13, 17...
  • Page 48 OptonPro Instructions for Use Zimmer MedizinSysteme 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...

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