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Zimmer OptonPro Instructions For Use Manual

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Instructions for Use
OptonPro
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Summary of Contents for Zimmer OptonPro

  • Page 1 Instructions for Use OptonPro...
  • Page 2 Illustrations Front of the device Fig. 1 Selection and control elements 1 Controller 2 Display 3 Emergency stop button 4 Slot for SD card 5 On/off switch Applicator with optical fibre 6 Applicator 7 Fibre-optic cable Test sensor 8 Test sensor and bracket for applicator...
  • Page 3 Illustrations Rear of the device Fig. 2 14/15 Connection sockets Connection socket for foot switch Connection socket for interlock socket Connection for power cord Holder for power fuse Identification plate 14/15 Socket without function for OptonPro Fibre-optic output...
  • Page 4 Illustrations Display / Navigation bar Fig. 3 Display Status bar Button on the screen Title bar Navigation bar Fig. 4 Navigation bar (A) Start Moves back to the start page Description of the (B) Back Takes you back one step functions (C) Key Activates key input...
  • Page 5 Illustrations Accessories 22 Small spacer 23 Large spacer 24 Foot switch 25 Laser warning sign with 26 Interlock plug 27 Protective sleeve laser warning lamp 28 Laser protection glasses 29 Laser warning sign...
  • Page 6 Explanation of symbols Caution laser outlet Note: Laser radiation is emitted from applicator tip Turn the emergency stop button clockwise (following the arrows) to unlock Application part type BF Foot switch socket Interlock socket Value of accessible fuses Protection class II Instructions for use Follow instructions for Use Serial number...

  • Page 7: Table Of Contents

    Accessories Explanation of symbols Page Indications Contraindications Side effects Safety instructions/warnings Application information OptonPro – in brief Device set-up 7.1 Safety precautions 7.2 Assembly and commissioning Settings Operating instructions 9.1 Performing the treatment 9.2 Key code 9.3 Thermal threshold test 9.4 Two-phase programs...
  • Page 8 Error messages/troubleshooting/disposal Manufacturer´s EMC declaration Valide for OptonPro devices. This instructions 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 9: Indications

    Indications OptonPro is used to initiate and support the healing of human tissues. The device is suitable for treating the following indications: Myopathy, tendinopathy Lower back pain (e.g. ischialgia) Arthropathy, arthrosis Rheumatoid arthritis Trauma disorders (e.g. distortion, strain) Impingement syndroms (e.g. carpal tunnel syndrome) Skin diseases (e.g.

  • Page 10: Contraindications

    Contraindications - Fresh haematomas - Malignant, semi-malignant, and benign tumours - Treatments around the eye - Pregnancy - During menstruation in the abdomen or lower back Particular caution is advised when applying treatment near the ear, nose, mucous membranes, and blood vessels. Avoid direct irradiation of these areas. In the presence of skin diseases, metabolic diseases, and inflammatory diseases, a physician should be consulted prior to treatment.

  • Page 11: Side Effects

    Side effects When used correctly, no side effects are known. Page 3...

  • Page 12: Safety Instructions/Warnings

    Safety instructions/warnings The OptonPro is a class 4 laser. The laser radiation is extremely hazardous to the eyes and skin. Even diffusely scattered radiation can be dangerous. Laser radiation can cause fires or explosions. The laser radiation emitted by the device is invisible.
  • Page 13 Safety instructions/warnings General 1. The device is not intended for use in potentially explosive and/or combustive environments. 2. The use of flammable anaesthetic gases or oxidising gases such as nitrous oxide (N O) or oxygen should be avoided. Some materials such as cotton, which are saturated with oxygen, can be ignited by the high temperatures that arise when the laser device is used.

  • Page 14: Application Information

    Please keep a safe distance of several meters. OptonPro should not be used in an explosive, flammable or combustive environment. When in use, the device must be located in a position that allows direct access to the central power supply so that it can be disconnected at any time.
  • Page 15 Application information Applicator The applicator is located at the end of the fibre-optic cable. Laser beam is emitted from the tip of the applicator. A lens protects the opening of the outlet against dirt and damage. Only aim the applicator at the area to be treated. Never place it down outside of the test sensor.
  • Page 16 Application information SD card Custom settings and treatment recommendations are saved on the SD card. Treatment If no SD card is inserted, the “Treatment recommendations” button is not shown in recommendations the navigation bar. Favourites If no SD card is inserted and the favourites area is activated, the following message will appear: “SD card was not found”.

  • Page 17: Optonpro - In Brief

    OptonPro – in brief What is OptonPro? A high-power medical laser treatment device for treatment with laser radiation. What does OptonPro It emits laser beams to provide photochemical and thermal stimulation of those parts of the musculoskeletal system requiring physical treatment.

  • Page 18: Device Set-Up

    Device set-up 7.1 Safety precautions Safety measures Place a laser warning sign and a warning light on each door to the treatment room. The laser safety officer must ensure that all safety measures have been correctly followed. When not in use, the device should be protected against activation of the key button by unauthorised users.

  • Page 19: Assembly And Commissioning

    Device set-up 7.2 Assembly and commissioning Assembling the Connect the power cable to the corresponding socket (11) on the device, and power cable connect the cable to the mains. Interlock connector Connect the interlock plug (27) to the corresponding socket on the device (10). Connect the foot Connect the foot switch (27) to the corresponding socket on the device (10) switch...

  • Page 20: Settings

    Ensure that all individuals in the treatment room are wearing safety goggles. To prevent unauthorised persons from using the laser, the OptonPro must be activated by entering a key code each time it is switched on and off.
  • Page 21 Settings The setting options are shown below. In the factory, the default settings are pre-programmed as shown on the screen. (1) Language Press the “Language” button to open the window for selecting the language. The selection is made directly on the corresponding line. (2) Laser settings Press the “Reminder for performance test”...
  • Page 22 Settings (3) Start-up settings 1. Start menu: Individual options for start settings. 2. Start-up image: Choice between two starting images. The selection is made directly on the corresponding line. 3. Welcome: Activation of the field "Welcome" opens a window with an alphabetic keyboard for entering a custom welcome message on the start-up screen.
  • Page 23 The adjustment is made using two arrow keys. Setting "deactivate” invalidates the default or custom-fitted activation time. Note: Each time the OptonPro is switched on, the key code must be entered. This also applies to the “Deactivated” setting. (10) Standard Pressing the “Standard”...

  • Page 24: Operating Instructions

    Operating instructions 9.1 Performing the treatment Starting the Pressing the “Start” button in the start-up screen opens the programmes programme screen. Programme screen The selection of the desired program is made directly on the line. Operating modes The following operating modes can be selected: - Unpulsed - Single pulse - Serial pulse...
  • Page 25 Operating instructions 9.1 Performing the treatment Setting the operating Pressing the “Parameter” button (1) opens the “Parameter” window. modes Here you can select the settings for the different operating modes. Use the button (2) to select the parameter to be changed. Use the button (3) to set the respective values.
  • Page 26 Operating instructions 9.1 Performing the treatment Reminder In the input field (1) it is possible to enter a certain number of joules. After the set number of joules is given, an acoustic signal sounds. Depending on the number of Joules entered, the signal is repeated at equal intervals until the target total energy is achieved.
  • Page 27 Operating instructions 9.1 Performing the treatment Use the arrow keys There are several options available for setting the power: to adjust the power Using the arrow keys (1) on the underside of the bar graph, the power can be adjusted in 0.1 W increments. Setting power via the Activating the bar graph (1) opens the “Input power”...
  • Page 28 Operating instructions 9.1 Performing the treatment Setting the power The numeric keypad (1) is found in the "Input power" window. via the numeric keypad Activating the number field (1) opens another “Input” window (2). The desired power is entered via the numeric keypad (3). The black shaded digit is changed when you select a number key.
  • Page 29 Operating instructions 9.1 Performing the treatment Activate laser Pressing the “Start” button prepares the laser for operation. This is indicated by the message “Ready” in the footer. The “Start” button is inactivated, and the “Stop” button is activated. Start of treatment By pressing the foot switch, the laser beam is emitted, and the “Ready”...
  • Page 30 Operating instructions 9.1 Performing the treatment End of treatment The power of power is terminated when the foot switch is deactivated or the total energy has been reached. The message in the footer switches from "Active" to "Ready". The power must be manually set to 0.0 W. You can set the value via the two arrows at the bottom of the bar graph.

  • Page 31: Key Code

    Operating instructions 9.2 Key code Note: It is recommended to activate the key code in the program screen. If the key code is first activated in the treatment screen, the treatment screen will be disabled, and it will not be possible to enter the intensity. Activating the key code Pressing the “Code”...

  • Page 32: Thermal Threshold Test

    Operating instructions 9.3 Thermal threshold test Note: The thermal threshold test is recommended to prevent overdose for darker skin types (skin type IV, V, VI), especially in CW mode. The thermal threshold test requires an intact thermal sensitivity. If it is locally disturbed, the test should be carried out on a heat-sensitive spot. For this purpose, the laser beam is applied until the patient detects the heat.
  • Page 33 Operating instructions 9.3 Thermal threshold test Performance The laser power is now set at the discretion of the user and is emitted by pressing the foot switch. During the emission of the laser power, the elapsed time in the bar graph (3) is displayed in the thermal threshold test window.

  • Page 34: Two-Phase Programs

    Operating instructions 9.4 Two-phase programme Two-phase The laser power can be applied statically and dynamically. programme It is recommended to use both methods in succession during a session. Note: The trigger and main pain points are thus treated statically, and the remaining pain areas are treated dynamically.

  • Page 35: Storing Programs

    Operating instructions 9.5 Storing programmes Note: To store programmes, the SD card must be properly inserted into the SD card slot. If this is not the case, it will not be possible to save programmes. The programmes can also be saved unchanged. In the treatment screen, the programme parameters can be modified and saved.
  • Page 36 Operating instructions 9.5 Storing programmes The parameters of the pre-defined programmes can be individually modified and saved. Save and name a Pressing the “Save” button opens a window to enter the programme name. programme The programme name is entered via the keyboard. Note: The programmes can be saved in the favourites list or in the memory list.

  • Page 37: Favourites/Memory List Retrieving Programs, Editing Lists

    Operating instructions 9.6 Favourites/memory list Retrieving programs, editing lists The individually saved programmes are listed in the favourites list. These can be: retrieved for treatment edited (shifted in the sequence and deleted). Note: The steps for retrieving and editing the favourites/memory list are identical; therefore, only the retrieval and editing of the favourites list is described.
  • Page 38 Operating instructions 9.6 Favourites/memory list Retrieving programs, editing lists Editing favourites Pressing the button (1) returns you to the programme. Pressing the button (2) moves the programme to the top. Pressing the button (3) moves the programme to the bottom. Pressing the button (4) deletes the programme.

  • Page 39: Treatment Recommendations

    Operating instructions 9.7 Treatment recommendations The “Treatment Recommendations” menu helps users to select the appropriate treatment options. Treatment Pressing the “Treatment” button opens the “Treatment recommendations” menue. Note: In the “Therapy” menu, there are two ways of selecting the desired treatment: - via the body region - via the list Therapy selection...
  • Page 40 Operating instructions 9.7 Treatment recommendations Therapy selection Pressing the “List” button opens the list of indications. via list Note: Regardless of whether the application is selected via body region or list, the program steps up to the treatment screen are identical and are therefore only described once below.

  • Page 41: Performance Test

    Performance test The performance test is used to control the emitted laser power. It should be performed once daily before the first use of the laser. Procedure 1. Activation of the button “performance test”. 2. If necessary, enable the laser by entering the key code. 3.

  • Page 42: Key Code

    Key code The laser is protected by a key code, which must be entered each time the device is switched on. Note: If access is disabled, only the parameters can be set. Activating the laser via the “Start” button, setting the power, and calibration are not possible.

  • Page 43: Technical Data

    Technical information Wavelength 810 nm and 980 nm Wavelength of pilot beam 650 nm Power supply 100–240 V~, 50/60 Hz 220 V ~/60 Hz Power consumption max. 200 VA Mains fuse 2 × T 2A Protection class Application part Type BF in accordance with EN 60601-1 Laser system 4 semi-conductor diode lasers, optical fibres Treatment field...
  • Page 44 Technical information Dimensions H 30 × W 35 × L 20 cm Laser class Safety distance NOHD (nominal ocular hazard distance) 1.66 m Beam divergence 35° Interlock device Door contact switch, open when door is opened, load up to 12 V, 10 mA, series circuit in the case of several doors Display Liquid crystal display (LCD)

  • Page 45: Cleaning/Disinfection

    Cleaning/disinfection – Before starting any maintenance or cleaning measures, the device must be switched off with the main switch, and the power cable must be unplugged. – Make sure that when cleaning and disinfecting the labels of the device (such as warnings, labels of control devices, identification plate) are not damaged.
  • Page 46 Cleaning/disinfection Then proceed as indicated under "Housing / Foot switch". Use a cotton swab to clean the applicator lens. Absolutely no cleaning or disinfectant agent must be left on the applicator lens! Any contamination will change the optical properties of the lens. Contact the service department in such a case.

  • Page 47: Ce Mark

    CE mark The product bears the CE mark in accordance with EC directive 93/42/EEC concerning medical devices. Page 39...

  • Page 48: Scope Of Delivery/Accessories

    Scope of delivery and accessories Scope of delivery Article no.* 1 Basic unit 1 Power cable 1 Foot switch 1 Interlock plug 2 Sets of safety glasses 1 Laser warning sign for door incl. warning light 1 Small spacer 1 Large spacer 25 Protective sleeves 1 Instructions for use *see accessories...

  • Page 49: Device Combinations

    Device combinations For OptonPro no combination devices 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. Page 41...

  • Page 50: Safety And Maintenance

    Safety and maintenance The OptonPro is manufactured in accordance with the DIN EN 60601-1 safety regulations. Zimmer MedizinSysteme GmbH shall only be held responsible for the safety and reliability of the device if  the device is operated using a proper power outlet with earth contact, the electrical installation complies with DIN VDE 0100 part 710 ...

  • Page 51: Functional Test

    Functional test Note: Ensure that all individuals in the treatment room are wearing safety glasses. Implementation 1. Conduct a performance test (Chapter 10). 2. Press the emergency stop button. The device must switch off immediately. Return the button to its original position by turning the red knob in the direction of the arrows.

  • Page 52: Safety Checks

    Metrological checks In Germany, neither a safety check nor a metrological check is required for the OptonPro. The device is neither assigned to Appendix 1 nor Appendix 2 of the MPBetreibV (Medical Device Operator Ordinance). In Germany, the MPBetreibV Medical Devices Operator Ordinance and BGV B2 (German Occupational Health and Safety Regulations on Electrical Systems and Equipment) apply in their current versions.

  • Page 53: Error Messages/Troubleshooting/Disposal

    Errors Troubleshooting Disposal Malfunction of the No response to the main switch; the display remains dark. device Possible cause 1: Mains connection Remedy for cause 1: Check whether the power cable is properly plugged into the electrical outlet and the plug is firmly inserted into the socket of the device.
  • Page 54 Disposal The device may only be returned to the factory in the original packaging. It must be disposed of by Zimmer MedizinSysteme GmbH. In foreign (European) countries, please refer to national regulations for disposal. Contact your distributor if necessary.

  • Page 55: Manufacturer´s Emc Declaration

    Portable and mobile RF communications equipment (such as mobile telephones) can affect electrical medical devices. The OptonPro may only be used with the original parts specified in the list of delivery and accessories. The operation of the device with other parts may result in increased emissions or decreased resistance of the device! Guidelines and manufacturer’s declaration –...
  • Page 56 Guidelines and manufacturer’s declaration – electromagnetic interference emissions The OptonPro is intended for use in one of the electromagnetic environments specified below. The customer or user of the OptonPro should ensure that it is only used in such an environment.
  • Page 57 Guidelines and manufacturer’s declaration – electromagnetic interference emissions The OptonPro is intended for use in one of the electromagnetic environments specified below. The customer or user of the OptonPro should ensure that it is only used in such an environment.
  • Page 58 EMC manufacturer’s declaration The OptonPro is intended for use in one of the electromagnetic environments specified below. The customer or the user of the OptonPro can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OptonPro – depending on the power power of the communications equipment as specified below.
  • Page 60 OptonPro Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 9 D-89231 Neu-Ulm Tel. +49 731. 97 61-291 Fax +49 731. 97 61-299 export@zimmer.de www.zimmer.de...

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