Instructions for Use OptonPro

Transcription

1 Instructions for Use OptonPro USA

2 Figures Front view of device Fig Selection and control elements 1 Control unit 2 Display 3 Emergency Off button 4 SD card slot 5 On/off switch Applicator with fibre-optic cable and power control sensor 6 Applicator 7 Fibre-optic cable 8 Power control sensor and holder for applicator

3 Figures Display Fig Screen readouts 9 Status bar 10 Buttons on the screen 11 Title bar 12 Navigation bar

4 Figures Rear Fig / 19 Connector sockets 13 Footswitch socket 14 Interlock socket 15 Connector for mains cable 16 Holder for mains fuse 17 Name plate 18 / 19 Socket without function for OptonPro 20 Fibre-optic cable outlet

5 Figures Accessories Fig Spacer small (optional) 23 Spacer large (optional) 24 Footswitch 25 Interlock key 26 Interlock switch (optional) 27 Laser protective glasses 28 Laser warning sign and lamp

6 Explanation of symbols Caution laser aperture Turn the Emergency Off button in the direction of the arrows to unlock Device type BF Footswitch socket Interlock socket Value of the accessible fuses The device is protection class II. Follow operating instructions Serial number Article number

7 Explanation of symbols Manufacturer Date of manufacturing In the user manual, this symbol stands for Caution. Please refer to Precautionary Definitions. In the user manual, this symbol stands for Warning. Please refer to Precautionary Definitions. In the user manual, this symbol stands for Danger. Please refer to Precautionary Definitions.

8 Contents OptonPro Front view of device Fig. 1 Selection and control elements Fig. 2 Screen readouts Rear view of device Fig. 3 Connector sockets Fig. 4 Accessories Page Indications, Contraindications, Safety Instructions 1.1 Precautionary Definitions Indications Contraindications Contraindications Additional Precautions Possible adverse side effects Precautionary Instructions Caution Warning Danger Application Information Protective measures and equipment at the workplace Common terms 10 2 OptonPro briefly 11 3 Installation 3.1 Safety measures 3.2 Installation, starting the system Settings 14 5 Navigation bar 17 6 Instructions for use 6.1 General operation 6.2 Thermal threshold test 6.3 Saving programmes 6.4 Retrieving Favourites / Memory list, opening programmes, editing list 7 Performance test 34 8 Key code

9 Contents OptonPro 9 Technical data Scope of delivery, accessories Combinations General instructions, SD card, accessories, service Maintenance 13.1 Cleaning and Disinfection 13.2 Safety and Maintenance 13.3 Functional test CE mark, legal information Errors, troubleshooting, disposal Manufacturer's EMC declaration 47 Valid for the OptonPro. These operating instructions 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. These operating instructions are valid from January U.S.A. Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

10 Indications, Contraindications, Safety Instructions 1.1. Precautionary Definitions 1 The precautionary instructions throughout the manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows: Text with Caution indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment. Text with Warning indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage. Text with Danger indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury. Note: Throughout this manual Note may be found. These notes are helpful information to aid in the particular area or function being described. 1

11 Indications, Contraindications, Safety Instructions 1.2. Indications / 1.3. Contraindications 1 Indications Contraindications The OptonPro is indicated to provide topical heating for the purpose of elevating the tissue temperature for the: temporary relief of minor muscle and joint aches, pains, and stiffness temporary relief of muscle spasm temporary relief of minor pain and stiffness associated with arthritis promoting relaxation of the muscle tissue temporary increase of local blood circulation The OptonPro should not be used: over areas of fresh haematoma and active hemorrhage over a pregnant uterus over malignant, semimalignant and benign tumours and even over areas that are suspicious or contain potentially cancerous tissue for treatment in the vicinity of the eye, over or applied to the eye during menstruations in the abdominal region and the lower back where analgesia may mask progressive pathology, and where the practitioner would normally avoid the use of any other analgesia in order to retain the beneficial aspects of pain. over areas injected with steroids in the past 2-3 weeks over the neck (thyroid or carotid sinus region) or chest (vagus nerve or cardiac region of the thorax) directly over areas with open wounds, unless covered with a clear protective barrier treatment over sympathetic ganglia for sympathetic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed on patients suspected of carrying serious infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers. over or near bone growth centers until bone growth is complete over the thoracic area if the patient is using a cardiac pacemaker on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result. 2

12 Indications, Contraindications, Safety Instructions 1.2. Indications / 1.3. Contraindications 1 Possible adverse side effects To avoid possible adverse side effects pay attention on the Precautionary Instructions in chapter 1.4! In the event of improper use of laser radiation the application of radiation can cause damage to skin and equipment. Additional examples for possible adverse side effects are: Smoke formation Danger of fire and explosion Electrical hazards Fiber breakage and emission of radiation The human eye is particularly sensitive. Damage to the eye usually causes irreparable malfunction. Take great care! 3

13 Indications, Contraindications, Safety Instructions 1.4. Precautionary Instructions 1 Caution Read, understand and practice the precautionary and operating instructions. Know the limitations and hazards associated with using any laser light device. Observe the precautionary and operational decals placed on the unit. Use of controls, adjustments, performance of procedures other than those specified herein may result in hazardous exposure to laser light energy. Failure to use and maintain the OptonPro and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty. Electrical devices emit electromagnetic fields during operation that may interfere with other devices. If in doubt, keep a sufficient distance from possible sources of interference, shield the device or avoid operating such devices at the same time. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. Minimize this by not using other equipment with the OptonPro. The device may be opened by service technicians authorized by Zimmer MedizinSysteme only. To avoid the risk of electric shock, the device must be disconnected from the mains supply before any maintenance or cleaning activities by pulling the power plug. DO NOT remove the cover, disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire or personal injury. There are no user-serviceable parts inside the unit. If a malfunction occurs, discontinue use immediately and consult the dealer for repair service. DO NOT use sharp objects such as pencil point or ballpoint pen to operate the buttons on the touch screen as damage may result. DO NOT permit any foreign materials or liquids to enter the unit. Take care to prevent any foreign materials including, but not limited to, inflammables, water, and metallic objects from entering the unit. These may cause unit damage, malfunction of internal components of the system, electrical shock, e.g. and therefore create a risk of injury to the patient. During application the device must be placed in a position in which direct access to the central power of the device is possible, so that it can always be disconnected from the mains. Before use, ensure that the device is operated with a properly connected socket with protective earth. The device must be operated with the supplied power cord. The power cord must be protected against mechanical stress. 4

14 Indications, Contraindications, Safety Instructions 1.4. Precautionary Instructions 1 Warning The device must only be operated in compliance with these operating instructions. All other applications take place at the operator s responsibility. Be sure to read all instructions (operating procedures for each treatment mode, indications, contraindications, warnings, precautions etc.) for operation before treating a patient. This device should be used only under the continued supervision of a licensed practitioner. The device is designed for use by medical professionals only (e.g., doctors, therapists and health paraprofessionals). Use of the control elements or setting options in ways other than those described here can lead to hazardous exposure to radiation or to hazardous conditions causing damage to the unit and applicator! Observe all the relevant safety instructions! Use only accessories that are specially designed for this unit. Do not use accessories manufactured by other companies on this (table, unit, device, etc.). Zimmer MedizinSystems is not responsible for any consequences resulting from using products manufactured by other companies. The use of other accessories or cables may result in increased emissions or decreased immunity and safety of this unit. Make certain that the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes. The device must not be operated if there is visible damage to the device, the fibre-optic cable or the applicator. Call customer service. a. Inspect the output lens of the laser head for blemishes, deformation, pitting, scratches, discoloration and cleanliness before each use. Inspect applicator cables and associated connectors before each use. Before each use clean the lens. Failure to clean the lens will cause beam fragmentation. The fibre-optic cable and applicator are very sensitive optical systems. Use and handle them with care. All of the following conditions will damage the applicator and unit. Damage can adversely affect it s characteristic and is not covered under the warranty: a. Do not drop the applicator or unit on hard surfaces. b. Do not submerge the applicator or unit in water. Protect them against soiling. c. Never kink the fibre-optic cable and protect it against tension. The OptonPro must never be operated if the device, the fibre-optical cable or the applicator is damaged visibly. 5

15 Indications, Contraindications, Safety Instructions 1.4. Precautionary Instructions 1 Danger The unit integrates a class 4 laser. The accessible laser radiation is very hazardous for the eye and hazardous for the skin. Diffuse radiation can also be hazardous. Laser radiation can cause fire or explosion hazard. The laser radiation delivered by the device is invisible. All persons (including patients) must wear protective goggles when in the laser range! DO NOT point the laser light beam directly into human or animal eyes. The lens of the eye does not detect the invisible, coherent laser light beams, potentially resulting in permanent retinal damage DO NOT connect the unit to an electrical supply without first verifying that the power supply unit is the correct voltage. Incorrect voltage may cause unit damage, malfunction, electrical shock, fire, or personal injury. Your unit was constructed to operate only on the electrical voltage specified on the Voltage Rating and Serial Number Plate. Application Information To avoid skin damage, please observe the treatment guidelines. Persons not involved in the treatment should leave the room or stay as far away as possible (see: Laser range). All persons with access to the laser must without fail be instructed about behaviour! Inform the patient about the potential hazard of the laser. This device should be kept out of the reach of children. All persons (including patients) must wear protective goggles when in the laser range! When the laser is not in use, switch it off, place the applicator in the holder. During treatment, the patient must be observed closely and the treatment must be adjusted if necessary or discontinued should any problems develop. Do not allow yourself to be distracted during treatment. If you turn your attention away from the treatment, then first place the equipment at a safe distance (release footswitch). Do not treat through clothing. Do not apply laser on an area of skin that has lotion or ointments applied and don t use it over or on a tattoo, as burns may occur. 6

16 Indications, Contraindications, Safety Instructions 1.4. Precautionary Instructions 1 The following factors may have an influence when applying laser light: colour of skin, age of lesion, depth of lesion, sensitivity of the patient, tissue type and medications that increase sensitivity to light. Some patients are more sensitive to laser output (e.g., patients taking medications that increase sensitivity to light) and may experience a reaction similar to a heat rash. As a general rule the treatment should always be stopped / interrupted as soon as the warmth threshold is reached. A warmth perception within the tolerance level is acceptable. Stop / interrupt the treatment and lower the dosage if patient reports increasing warmth or feeling hot. Recommendation for therapeutic treatments: The OptonPro has not been tested for the skin types V and VI. The applicator always has to be in skin contact. The recommended therapeutic skin temperature range is 40 C - 45 C. The OptonPro warms the skin within this range at the following settings: duty cycle output power [W] 1:10 1: :5 1: :1 1-7 CW 1-7 Please note that no output power besides this range can be chosen. Recommended treatment time: 10 min Maximal transition time to reach the target temperature of 40 C: 5 min Recommended total time: 15 min. After a total time of 15 min the OptonPro warns the user that the recommended treatment time is reached. (chapter 6.1 page 23) Recommended transition time for representative settings: output mode output power [W] recommended transition time [min] 1 Hz, 1: Hz, 1: Hz, 1: ,5 CW

17 Indications, Contraindications, Safety Instructions 1.4. Precautionary Instructions 1 Protective measures and equipment at the workplace Power control sensor The power control sensor enables measurement and balance of the output laser radiation. The power control sensor also serves as the storage place for the applicator after treatment and when the device is not in use. The applicator is thus protected against soiling and damage. Applicator The applicator is on the end of the fibre-optic cable. The laser beam exits through the front end of the applicator. The opening is protected against soiling and damage by a lens. Point the applicator only in the direction of the area to be treated. Never set it down outside the power control sensor. Aiming Beam A red aiming beam targets the treatment location. Please be aware that the laser light will be applied into this direction. Footswitch The footswitch is used to trigger the laser beam. Only press the footswitch if you have previously directed the applicator to the part of the patient s body to be treated. An acoustic signal sounds while the laser radiation is being delivered. Position the footswitch such that it cannot be pressed inadvertently or actuated by unauthorized persons. Emergency Off button The Emergency Off button can be used to stop the operation of the device immediately by disconnecting the power supply. To stop operation, press the Emergency Off button until it locks and the device switches off. To resume operation, return the button to its original position by turning the red button in the direction of the arrows. Warning sign The warning sign must be affixed at the entrance to the laser area. The laser area is marked in sign. The entry to the laser area is usually the door of the treatment room. If there are several doors, all doors have to be marked with this sign, or non-used doors are to be closed before starting up the laser. If the laser area comprises an area separated off from the treatment room with curtains or a screen, the sign has to be affixed on the access side of the area. 8

18 Indications, Contraindications, Safety Instructions 1.4. Precautionary Instructions 1 Warning lamp The warning lamp has to be affixed in such a way that it can be seen from outside the laser area and warns people of entering this area. This is usually the access door to the treatment room or the access side of the screen. The lamp has to be switched on before starting up the laser. Interlock Upon opening of the secured door (or if applicable several doors) the interlock switch interrupts the laser beam. When the door is closed the beam is activated again. When the door has opened, the footswitch has to be released immediately. Protective glasses All persons present in the treatment room (patient, therapist, assistants) must wear suitable protective glasses. Use only protective glasses with an optical density of OD > 3 at 810nm and 980nm and a light penetration of at least 20% in the visible range. The glasses must be heat and UV resistant and comply with EN 207 requirements. Treatment room In the surroundings of the laser workplace there should be no reflective surfaces (equipment, windows, walls, ceilings, fittings, pictures, mirrors, e.g.). Ensure that any reflecting objects in the treatment area cannot deflect the laser radiation. Matt-surfaced or diffusely scattering instruments should be used if necessary. Ensure that the laser is not aimed uncontrolled at the surroundings (instruments, stretcher, and furniture e.g.). Note that the laser radiation can escape through windows, glass doors or other openings in the treatment room. Take the relevant protective measures. The device is not intended for the use in explosive areas and /or combustion-enhancing atmospheres. Avoid using combustible anaesthetic gases or oxidising gases such as nitrogen oxide (N2O) and oxygen. When saturated with oxygen, some materials, such as cotton, can ignite at high temperatures which arise in normal operation of the laser equipment. The solvents in adhesives and flammable solutions used for cleaning and disinfection should be given time to evaporate before the laser equipment is used. Caution is advised as well regarding the body s own gases, which can be flammable. Ensure that the working area of the laser is free of flammable substances. Pay special attention to the patient s clothing. 9

19 Indications, Contraindications, Safety Instructions 1.5. Common terms 1 Continuous Wave (CW) The output of the laser light is not interrupted during the treatment. Serial Pulse In this operating mode, the continuous wave is interrupted automatically briefly at regular intervals. Duty Cycle This is the ratio of the on time to the total time of the cycle. Dosage measured in Joules [J ] or Joules / cm 2 [J/cm 2 ] intensity of the laser light over the treatment area Energy measured in Joules [J] treatment time multiplied by the power Frequency measured in [Hz] Power measured in Watts [W] directly proportional to the treatment time Power density measured in Watts / cm 2 [W/cm 2 ] ratio of the power divided by the treatment area Treatment area measured in [cm 2 ] equal to area output spot size area of tissue affected by the laser Recommended treatment time measured in seconds [s] recommended time to have a therapeutic effect Transition time measured in seconds [s] time it takes until the temperature has reached 40 C to achieve a therapeutic effect Recommended total time measured in seconds [s] transition time + treatment time = total time 10

20 OptonPro - briefly 2 What is the OptonPro? What does the OptonPro do? What is the advantage of the OptonPro? The OptonPro is a topical heat lamp. It emits energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. The simultaneous application of laser light of two wavelengths (810 and 980nm) opens up a wide range of therapy options for the user. Modern microprocessor control and the precise mechanism of power measurement make it simple and safe to use. The clear and modern color display showing all parameters relevant for treatment and the modern touchscreen control makes treatment motivating and enjoyable. Customized programs, start configurations and a clear, simple menu navigation make operation of the device easy and convenient for users. Note: The device is designed for use by medical professionals only (e.g., doctors, therapists and health paraprofessionals). 11

21 Installation 3.1. Safety measures 3 Safety measures Attach a laser warning sign and a warning light to every door to the treatment room. When it is not in use, the device must be protected from unauthorized use by actuating the code key. If an entrance door is within the range of dangerous laser radiation (NOHD), the door has to be secured by installing an interlock switch. If not, the interlock key can be used instead. Commissioning 1. Ensure that the protective goggles are accessible for the operators of the device at all times. 2. Plug the interlock switch (26) or key (25) into the socket (14) on the rear of the device. 3. Connect the footswitch to the socket (13) on the rear of the device and place it in an easily accessible position for treatment. 4. Connect the power cable to the power socket (15) and the mains supply. 12

22 Installation 3.2. Installation, starting the system 3 Note: Installing the mains cable Make sure that the main switch of the device is set to '0'. Ensure that all persons present in the treatment room are wearing protective goggles. Ensure that the applicator (6) is inserted completely into the power control sensor (8). Connect the mains cable to the designated port (15) on the device and then plug into the mains. Interlock switch Connect the interlock switch (26) to the appropriate socket on the device (14). The laser interlock switch must be installed by a professional or qualified electrician. Serious eye injury can result if the device is not properly installed. Also, when installing the device for multiple doors, the total resistance may not exceed 4800 ohm. Connecting the footswitch Switching on Selecting a program Plug the footswitch (24) into the appropriate socket (13) and then place it on the floor. Switch on the device using the main switch. Activate the Start key and select a program. Activating key code Activate the code key and enter the key code Set treatment parameters Setting intensity Setting operating mode parameters Activating the laser Applicator Starting treatment Ending treatment Adjust treatment parameters. Set / adjust the appropriate output power. Output power will affect energy density. Set operation mode parameters. Operating mode will affect energy density. Activate the laser by pressing the Start key. Place the applicator in the correct position on the treatment area. Depress the footswitch to start the treatment. The treatment is interrupted or terminated by deactivating the footswitch. After treatment, insert it into the power control sensor. 13

23 Settings 4 In the configuration menu, the factory settings can be changed and customized. Note: Selecting the Configuration menu Changes to the default settings can only be made from the start screen. Press the Configuration button to open the Configuration menu. (13) (2) (11) (12) (1) (3) (4) (5) (7) (10) (8) (9) (6) The following configuration options are available: (1) Selection of language (2) Laser settings (3) Selection of the start menu (4) Selection of the start screen (5) Editing the welcome message (6) Setting the screen brightness (7) Setting the volume for acoustic signals (8) Editing the key (digital code to activate the laser) (9) Setting the code activation time (10) Version, for viewing the software version (11) Standard, for restoring the default settings (12) Touch calibration (13) Service Note: Saving settings The "Service" menu is accessible to service technicians only. Press the OK button to save the changed settings and return to the start screen. 14

24 Settings 4 Language Laser settings Press the "Language" button to open the window for selection of the language. Select directly in the appropriate row. Activating the button memory for performance test opens a window with various options that reminds on conducting the performance test. The selection is made directly on the row. 1. Activated: If 10 hours of therapy are exceeded without conducting a performance test, the message No performance test was conducted for more than 10 hours. It is recommended to conduct a performance test will be displayed with every startup of the device. 2. Once: If 10 hours of therapy are exceeded without conducting a performance test, the message mentioned above will be displayed on the next devices startup. 3. Deactivated: There no information about conducting a performance test in general. Start menu Note: Start display Welcome Configuration options for the program start settings: Press the "Start menu" button to open the window for selecting the program start configurations. Select directly in the appropriate row. In the US Version Treatment recommendation can not be activated. Selection option between two start screens: press the "Start screen" button to open the window for selecting the start display. Select directly in the appropriate row. Option to enter an individual welcome message which is displayed in the status bar after switching on the device. Press the Welcome button to open the screen keyboard to enter a welcome message. Press "OK" to accept the new settings. Press "Cancel" to cancel the process. Volume Option to adjust the volume of the signals when activating control fields. Adjust the volume using the two arrow keys. Brightness Setting option for the screen brightness. Adjust the brightness using the two arrow keys. 15

25 Settings 4 Code Option to set an individual key code. Pressing the "Code" button opens the number window to enter the code. To set an individual key code, the old code must first be input into the "Old code" field in the number window. Press "OK" to trigger the message for input of a new 4-digit key code, and the cursor automatically jumps to the "New code" field. The new key code is input in the number window. Press "OK" to accept the input and close the number field. Press "Cancel" to cancel the process. Deactivating access Option for setting the deactivation period. Adjust the period using the two arrow keys. The "deactivated" setting disables the factory-set or user-set activation time. Version Note: Touch calibration Default Press the Version button to open a window with information about the current software version. Touch calibration is not used for capacitive touch. Press the Default button to restore the factory settings. Aiming beam Activating the button Aiming beam opens a window with various options for the use of the Aiming beam. 1. Deactivated: Aiming beam is not activated. 2. At laser active : An aiming beam is activated when laser power is emitted. 3. At laser ready : An aiming beam is activated, as soon as the laser is in an optional status by pressing start. Note: Note: If the option at laser ready is activated, the aiming beam will become deactivated as soon as the laser is no longer in an operational status due to further activities such as storing or opening the parameter window. The aiming beam only gives information on the direction of the laser beam. It is not equivalent with the diameter of the laser beam and is no indicator for the size of the treatment area. 16

26 Navigation bar 5 The navigation bar makes operation quick and easy. It is on the right side of every screen. Description of functions (1) (2) (3) (4) (5) (6) (7) (1) Favorites: Switches to Favorites area (2) Programes: Switches to the Program list (3) Memory: Switches to the Memory area (4) Performance test level: Switches to the Performance Test screen (5) Code: Opens the input field for input of the code or deactivates the code (6) Back: Goes one step back (7) Home: Switches to the Start screen 17

27 Navigation bar 5 Description of the selection buttons Configuration Press the button to open the settings menu. Start Press the button to open the start screen from the Programe window or to confirm an action. Cancel Press the button to reject the changes made. Saving Press the button to open the screen to save a program. Editing Deleting Press the button to open the Memory screen to edit the memory list to open the Favorite screen to edit the favourite list Press the button when in the Edit screen to delete the highlighted program from the list. Scrolling forwards Press the button to scroll one page down the list. Scrolling backwards Press the button to scroll one page up the list. 18

28 Navigation bar 5 OK Press the button to confirm the changes in the selected list. Moving forwards Press the button to move forward by one position. Moving backwards Press the button to move backwards by one position. Set values Press the button to increase or decrease values Thermal threshold test Press the button to start a thermal threshold test 19

29 Instructions for use 6.1. General operation 6 Note: The following descriptions are all based on the factory settings. All buttons, menus and submenus are activated directly on the screen by touching it. Ensure that all persons present in the treatment room are wearing protective goggles. To prevent use of the laser by unauthorized persons The OptonPro must be activated by input of a key code every time the device is switched off and on again. The activating code is required for the setting and emission of laser power. Starting the program (2) (1) Press the "Start" button (1) to open the program screen. Press the "Settings" button (2) to open the configuration screen. Program screen Select the desired program directly in the list. 20

30 Instructions for use 6.1. General operation 6 Note: We recommend activating the key code in the program screen. If the key code is not activated in the treatment screen, the treatment screen is deactivated, and intensity entries cannot be made. (1) Activating the key code Press the "Code (1)" button to open a numerical keypad to enter the code. Enter the factory-programmed code 1234 or your own code as programmed in the configuration menu (Section 4) and confirm with the "OK" button. After activating the code, the symbol on the code button (2) changes and the message Please activate the laser using Start" is shown in the status bar. (2) 21

31 Instructions for use 6.1. General operation 6 Setting parameters Press the "Parameters" button to open the "Parameters" window. The parameters for the various operating modes can be selected here. (1) (2) The parameters to be changed are selected with the buttons (1). The values are set with the buttons (2). Press "OK" to accept the changed settings. Press "Cancel" to cancel the process. Operating modes: Setting options in the serial pulse mode The following operating modes can be selected: Continuous Serial pulse Frequency Duty factor Serial pulse 1, 2, 4, 5, 10 Hz 1:1 1:10 Serial pulse 25 Hz 1:1 1:3 Serial pulse 50 Hz 1:1 Adjustable Power range Duty factor output power [W] 1:6-1: :2-1: :1 1-7 CW 1-7 The adjustable output power is limited to the range above. Note: Please be aware that all operation modes other than CW will reduce the average energy output. 22

32 Instructions for use 6.1. General operation 6 Setting target parameters Press the "Rated parameter" button to open the "Rated parameter" window. (1) (2) Reminder Entry field (1) gives the option of entering a specific number of Joules. An acoustic signal sounds once the specified number of Joules has been output. The signal repeats at the same intervals depending on the number of Joules entered until the target total energy has been delivered. If no target total energy is entered, an acoustic signal only sounds once the set number of joules has been delivered. Total energy In the entry field (2) "Total energy", a target total energy can be set. Once the target total energy is delivered, an acoustic signal sounds and the laser application is stopped. The application can be continued by pressing the footswitch again. Input reminder, total energy An "Input" window is opened by pressing the "Reminder" (1) and "Total energy" (2) buttons. Select the desired decimal position with the cursor or activate it. The required values are entered with the numeric keypad. Press "OK" to accept the new settings. Press "Cancel" to cancel the process. Note: Reminder maximal recommended total time Setting a reminder and a target total energy is not necessary to carry out the therapy. After 15 min an acoustic signal sounds and a message appears on the screen which asks the user: The recommended treatment period is finished. Do you wish to continue treatment? Yes / No Yes: The output power is hold and the therapy can be continued by pressing the footswitch. No: The laser is de-activated. The total time and total energy are hold. 23

33 Instructions for use 6.1. General operation 6 Use the arrow keys to set the power Several options are available for setting power. 1. The power can be adjusted in 0.1 W steps with the arrow keys (1) beneath the bar graph. (1) Setting power with the selection field 2. Press the bar graph (1) to open the window Input power (2). The selection is made by pressing the button with the desired power (3). The power is set in 1 W steps. Press "OK" to activate the selected power. Press "Cancel" to cancel the procedure. (2) (3) (1) 24

34 Instructions for use 6.1. General operation 6 Setting power with number block 3. There is a number block (1) in the "Input power" window. (1) Press the number block (1) to open another window Input (2). (2) (3) (4) The required power is entered with the numeric keypad (3). The numbers with the black background are changed when a number button is selected. After setting the 1st digit the black marking automatically jumps to the 2nd digit. The selected digit can be manually changed with the arrow keys (4). 25

35 Instructions for use 6.1. General operation 6 Activating the laser Press the Start button to put the laser into operational status. The operational status of the laser is indicated by the "Ready" message in the status bar. The Start button is inactive, the Stop button active. Aiming Beam Starting treatment The aiming beam is active when the laser is activated with the start button. This setting cannot be changed. Laser power is delivered by pressing the footswitch, and the Ready message changes to Active. The current power delivered in Watts is shown in the bar graph. 26

36 Instructions for use 6.1. General operation 6 Note: Ending treatment During treatment, the patient must be observed closely and the treatment must be adjusted if necessary or discontinued should any problems develop. Please refer to the Application Information. Power delivery is stopped by deactivating the footswitch or when the total energy has been delivered. The display in the bottom status bar changes from "Active" to "Ready". The power must be manually set to 0.0 W. Either set the values with the two arrows beneath the bar graph or activate the bar graph, then the number block and enter the value with the numerical keypad. Insert the applicator into the power control sensor. Note: If power delivery is stopped with the "Stop" button, the message "Please activate the laser with Start" appears. If it is activated, the display in the status bar changes to "Ready" and the laser is again in operational status. We recommend locking the laser after every treatment session to prevent unauthorised use. Lock the device by pressing the "Code" button. The device lock is indicated by the key: If you deactivate the code after a treatment, ensure that the code is reactivated before the next treatment by entering the code. 27

37 Instructions for use 6.2 Thermal threshold test 6 Note: The integrated thermal threshold test is an optional manual feature of the OptonPro which offers a tool to assess the warmth sensitivity, the individual local absorption rate and the feedback options of the patient. The thermal threshold test is recommended to avoid an overdose, particularly in CW mode. The thermal threshold test requires unimpaired thermal sensitivity. If locally impaired, the test should be conducted at a warmth-sensitive location. Execution The laser beam is applied until the patient feels a sensation of warmth. The right laser power is set properly if the application time is between 7 and 11 seconds. Press the "Thermal threshold" button (1) to open the window to perform the thermal threshold test (2). The thermal threshold test is performed in continuous mode, which is automatically set after pressing the "Thermal threshold" button. (3) (2) (1) 28

38 Instructions for use 6.2 Thermal threshold test 6 Execution The laser power is now set according to the user's best judgement and delivered by pressing the footswitch. During delivery of laser power, the elapsed time is displayed in the bar graph (3) in the thermal threshold test window. The laser beam is applied until the patient feels and reports a sensation of warmth. The right laser power is set properly if the application time is between 7 and 11 seconds. If the patient feels a sensation of warmth, the laser delivery is stopped by lifting foot off the footswitch. If the output lasts longer than 11 seconds, a message is displayed and the power is increased by 0.5 W. If the laser output is less than 7 seconds, a message is displayed and the power is reduced by 0.5 W. The thermal threshold test is now repeated with the modified power. If the test is stopped between 7 and 11 seconds, the recommended power has been determined. This is shown by a message. The test mode is ended by selecting the "Warmth threshold" window. The specified laser power remains saved, and the original operating mode is restored. Note: If a higher output power is required for efficient therapy adapt the program parameters for example to serial pulse, increase the pulse ratio and / or use spacers to reduce the average energy output to mitigate the risk of skin burns to the patient. Please refer to page

39 Instructions for use 6.3. Saving programmes 6 Note: The SD card must be correctly inserted into the SD card slot for saving programes. If this is not the case, it is not possible to save programes. The programmes may also be saved unchanged. The program parameters can be changed and saved in the treatment screen. Saving and naming a program Press the "Save" (1) button (1) to open the screen to enter the program name. Enter the program name using the keyboard. 30

40 Instructions for use 6.3. Saving programmes 6 Note: Programes can be saved in the Favorites list or in the Memory list. There are 120 memory spaces available in each case. Saving to the Favorites list / Memory list (1) (2) (3) Press the "Favorites" button (1) to open the Favorites list and automatically save the program to the Favorites list. Press the "Memory" button (2) to open the Memory list and automatically save the program to the Memory list. The program is always saved in the first free space in the list. Press the OK button to close the Edit Favorites or Edit Memory screen and return to the treatment screen. The program name is shown in the title bar. Press Cancel (3) to stop the save procedure. Note: If no name is entered for the program, and the "Favorites" or "Memory" button is pressed, the following message is shown. Press OK, enter a name, and repeat the save procedure. 31

41 Instructions for use 6.4. Retrieving Favorites / Memory list opening program, editing list 6 OptonPro has one Favorites list and one Memory list. The saved programmes can be stored in one of the both lists. They can be: 1. opened for treatment or 2. edited (sequence changed or deleted). Note: The steps for opening or editing the Favorites and Memory lists are identical; therefore, only opening and editing the Favorites list are described below. Selecting the Favourites list Press the Favorites button to open the Favorites list. Retrieving a program Select the desired program directly in the list. Editing the Favourites list Press keys (1) and (2) to view the individual Favorites pages. Press key (1) to scroll forward and key (2) to scroll back. (3) (2) (1) Press the "Edit" button (3) to open the "Edit Favorites" screen. 32

42 Instructions for use 6.4. Retrieving Favorites / Memory list opening program, editing list 6 Editing Favourites Select the program to be edited by clicking directly in the row. (1) (4) (2) (3) Press the arrow key (1) to move the program up. Press the arrow key (2) to move the program down. Press the "Delete" button (3) to delete the program. Press "OK" (4) to return to the Favorites list. Note: Pressing the Delete button triggers the security prompt. Do you really want to delete this program? Press the "Yes" button to delete the program. Press the "No" button to cancel the delete action. 33

43 Performance test 7 The performance test serves to control the laser power delivered. It should be run once a day before using the laser. (1) (2) (3) (4) Procedure 1. Activation the button performance test. 2. Enable the laser by entering the key code. 3. If the interlocking device is installed, close door. 4. Ensure that the laser applicator is in the power control unit 5. Activate the laser with Start. 6. Enter the maximum laser power. 7. Press the footswitch for the specified time During the performance test, the elapsed time is displayed in the bar graph in the window (3). Results of performance test The result of the performance test is shown in window (1). 1. Performance test passed: Laser is operating with accepted output parameters as established by the manufacturer. 2. Restricted accuracy: The laser shows a deviation in laser power. This indicates soiling or age-related deviations of the laser system. The device can be used further, but maintenance should still be carried out within the next 4 weeks. 3. Performance test failed: The laser power is outside the permitted range. The device must not be used. Do not operate the device and contact customer service. The performance test can be repeated by pressing the reset button (4). The performance of the last performance test is indicated in the window (2). 34

44 Key code 8 The laser is protected from unauthorized access by a key code, which must be input every time it is switched on. Note: Correct entry of the key code If the code is deactivated, only the parameters can be set. The laser cannot be activated using the Start button, power settings cannot be changed, and performance test cannot be conducted. If an incorrect key code is entered, this is indicated with the following message. After confirming with the OK button, the entry can be repeated. Automatic deactivation of the key code The code deactivates automatically after 10 minutes if nothing is done on the screen in this time. The code must then be re-entered. If something is done within 10 minutes, the deactivation period automatically resets to 10 minutes. Note: The configuration menu (Section 4) includes the option of defining a personal code and customizing the deactivation periods. 35

45 Technical data 9 Power supply Power consumption Mains fuse V~, 50Hz / 60 Hz max. 200 VA 2x T 2A Protection class II Applied part Type BF in accordance with IEC Laser system 4 semiconductor diode lasers, fibre-optic cables Output power laser: max. 7 W, min. 1 W aiming beam: max. 5 mw Precision ± 20% Output Mode Repetition rate CW, serial pulse 1 Hz, 2 Hz, 4 Hz, 5 Hz, 10 Hz, 25 Hz, 50 Hz Duty cycle Frequency Duty factor 1, 2, 4, 5, 10 Hz 1:1 1:10 25 Hz 1:1 1:3 50 Hz 1:1 Adjustable Power range Laser Wavelength Aiming Beam Duty factor output power [W] 1:6-1: :2-1: :1 1-7 CW nm and 980 nm 650 nm Divergence 0.76 rad (43.44 ) Applicator treatment distance 9 mm (0.35 in) *(when the applicator is in skin contact) Ø output spot size 10 mm (0.39 in) area output spot size 0.8 cm 2 (0.12 in 2 ) power density (for output spot size) max. 8.8 W/ cm 2, min. 1.3 W/ cm 2 36

46 Technical data 9 Dimensions (H x W x L) Weight 300 mm x 350 mm x 200 mm (11.81 in x in x 7.87 in) Total weight: 3.8 kg (8.38 lb) Laser class 4 Safety distance Interlock NOHD (Nominal Ocular Hazard Distance) 1.66 m (65.35 in) Interlock Key: Key which enables to use the device without an interlock switch when there is no entrance door is within the range of dangerous laser radiation (NOHD). Interlock switch: Door contact switch, which opens upon opening the door, capacity 12V, 10mA, series installation possible for multiple doors. Display Environmentalconditions Liquid crystal display (LCD) Operation: Temperature: 50 F to 104 F (+10 C to + 40 C) Humidity: 30% to 90% rel. humidity without condensation Atmospheric pressure: hpa Storage and transport: Temperature: 14 F to 122 F (-10 C to + 50 C) Humidity: 10% to 90% rel. humidity without condensation Atmospheric pressure: hpa Storage and transport In original packaging only. Packaging Regulatory Compliance Please retain the packaging. The device must only be shipped and stored in the original packaging. IEC / EN IEC / EN IEC / EN IEC / EN Complies with 21 CFR and except for deviations pursuant to Laser Notice No. 50, dated June 24, It has to be paid attention when installing and using the device. 37

47 Scope of delivery, accessories 10 Scope of delivery OptonPro Mains cable Footswitch Interlock key Protective glasses (2 pair) Laser warning sign with lamp User Manual Accessories Item No. 46xx OptonPro 9160 Syscart Mains cable Footswitch Interlock switch Interlock key Protective glasses Laser warning sign with lamp Spacer small Spacer large 38

48 Combinations 11 For OptonPro no combination devices are provided by the manufacturer. If, contrary to these specifications, OptonPro is combined with other devices and thus is operates as a medical system, this is done at own risk. 39

49 General instructions SD card / accessories / service 12 SD card User-defined settings are saved on the SD card. Favorites If no SD card is inserted and the Favorites area is activated, the following message appears: "No SD card has been found". Insert the SD card and press "OK". Memory If no SD card is inserted and the Memory area is activated, the following message appears: "No SD card has been found". Use of the Memory requires an SD card. Insert the SD card and press "OK". Accessories Only the included accessories must be used when operating the system. Service The device may be opened by service technicians authorized by Zimmer MedizinSystems only. 40

50 Maintenance 13.1 Cleaning and Disinfection 13 Cleaning and Disinfection Housing / footswitch Applicator / Spacer - To avoid the risk of electric shock, the device must be disconnected from the mains supply before any maintenance or cleaning activities by pulling the power plug. - Make sure that during cleaning and disinfecting the labelling of the device (such as warnings, labeling of controls, nameplate) is not damaged. - Make sure that no liquids enter the device, foot switch or applicator when cleaning or disinfecting. Do not use sprays. - If during cleaning or disinfecting fluid penetrates the device or applicator, please put the device out of service, protect it from starting up again and contact your service representative. - Because of the use on uninjured and healthy skin the device and its application part are uncritical in terms of hygiene. Output lens Before each use clean the lens. There must be no residues of the cleaners and disinfectants left on the output lens of the applicator. The output lens must be inspected regularly for soiling. Clean and disinfect with standard cleaning agents and disinfectants suitable for optical systems. Attention: If flammable solutions are used for cleaning and disinfection, the laser must not be used for about 10 minutes to allow the solutions to evaporate. Otherwise residues may ignite. Cleaning: The housing, the foot switch and all cables can be cleaned with commercial soft plastic clean of any visible dirt. Wipe clean the surface with a not dripping soft cloth, soaked according to the specifications of the manufacturer of the cleaning agent, until the dirt is removed. Disinfection: We recommend performing disinfection at least once a week and in case of potential contamination. To do this, consult your hygiene specialist. Always perform cleaning prior to disinfection. Housing and foot switch can be disinfected with disinfectant wipes. Use a commercially available alcohol-free disinfectant for metal and plastics with bactericidal, virucidal and fungicidal effects. Observe the application instructions of the manufacturer. Wipe clean all surfaces with a not dripping soft cloth soaked according to the specifications of the manufacturer of the disinfectant or pre-impregnated disinfectant wipes (so-called Wipes). If necessary pay attention to specifications for drying or post-cleaning. Cleaning: Remove spacer from the applicator before cleaning. Then proceed as indicated under "housing/foot switch". To clean the lens use a cotton swab. Disinfection: We recommend performing disinfection at least once a week and in case of potential contamination. To do this, consult your hygiene specialist. Always perform cleaning prior to disinfection. Remove spacer from the applicator before disinfecting. Use a commercially available alcohol-free disinfectant for metal and plastics with bactericidal, virucidal and fungicidal effects. Then proceed as indicated under "housing / foot switch". To disinfect the lens use a cotton swab. 41