BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER USER’S MANUAL BEFORE YOU START Dear Customer, Thank you for purchasing BTL technology. All of us at BTL wish you every success with your system. We pride ourselves on being as responsive as possible to our customers’ needs. Your suggestions and comments are always welcome since we believe an ongoing relationship with our customers is critically important to our future product line. While we would like you to start using your new equipment right away, we encourage a thorough reading of this manual in order to fully understand the operational features of the system. Please visit our corporate website at http://www.btlnet.com for the latest information on BTL products and services. Again, thank you for being a BTL customer. BTL Industries, Ltd. CONTENTS 1 GENERAL CHARACTERISTICS OF THE DEVICE ........................................................................................... 5 1.1 Intended Use .................................................................................................................................................... 5 1.2 The BTL-5000 SWT .........................................................................................................................................5 1.3 Shockwave and Its Character .......................................................................................................................... 5 1.4 Shockwave Generation ....................................................................................................................................6 1.4.1 Ballistic Principle of Shockwave Generation .................................................................................................6 1.5 Possible Side Effects of Shockwave Treatment ............................................................................................... 6 1.6 Contra-indications for Shockwave Treatment...................................................................................................6 2 INSTRUCTIONS FOR OPERATION .................................................................................................................. 7 2.1 The Front Panel of the BTL-5000 SWT ............................................................................................................7 2.2 The Rear Panel of the BTL-5000 SWT ............................................................................................................8 2.3 Assembly and Set-up .......................................................................................................................................9 2.4 Basic Displays and Operating of the Device .................................................................................................. 11 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 Welcome Screen and the Selection of Tabs and Accessories .................................................................... 11 Touch Screen .............................................................................................................................................. 11 Numeric Keypad .......................................................................................................................................... 11 Setting Therapy Parameters Via the ‘diag’ Button ....................................................................................... 11 Setting Therapy Parameters Via the 'prog' Button....................................................................................... 12 Setting Therapy Parameters Manually (User Setup) Via the ‘man' Button .................................................. 12 2.4.6.1 2.4.6.2 2.4.6.3 2.4.6.4 Setting the Therapy Mode ........................................................................................................................ 12 Setting Therapy Intensity .......................................................................................................................... 12 Setting Therapy Frequency ...................................................................................................................... 12 Setting the Number of Shocks .................................................................................................................. 12 2.5 Course of Therapy ......................................................................................................................................... 13 2.5.1 Start, Interruption and End of Therapy ........................................................................................................ 13 2.5.2 Screen During Therapy ............................................................................................................................... 13 2.6 Application of shockwaves ............................................................................................................................. 13 2.7 Device Menu .................................................................................................................................................. 15 2.7.1 Accessories ................................................................................................................................................. 15 2.7.2 Encyclopaedia ............................................................................................................................................. 15 2.7.3 Unit Settings ................................................................................................................................................ 15 2.7.3.1 2.7.3.2 2.7.3.3 2.7.3.4 2.7.3.5 2.7.3.6 2.7.3.7 2.7.3.8 2.7.3.9 Password Setting...................................................................................................................................... 16 Sound Setting ........................................................................................................................................... 16 Screen-Saver and Auto Switch-Off ........................................................................................................... 16 Colour Setting ........................................................................................................................................... 16 Setting of the Display Contrast ................................................................................................................. 16 Date and Time Setting .............................................................................................................................. 16 Language Setting (language) ................................................................................................................... 16 Touch Panel Calibration ........................................................................................................................... 16 User Options............................................................................................................................................. 16 2.7.3.10 2.7.3.11 2.7.3.12 2.7.3.13 2.7.3.14 2.7.3.15 Setting the HW Key .................................................................................................................................. 16 Unit Information ........................................................................................................................................ 17 Unlock Code ............................................................................................................................................. 17 User Accounts .......................................................................................................................................... 17 Firmware Upgrade .................................................................................................................................... 17 Service Functions ..................................................................................................................................... 17 BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 3 OF 28 2.7.4 Specific Settings .......................................................................................................................................... 17 2.7.4.1 Shockwave setting.................................................................................................................................... 17 2.7.4.2 Applicator Kit Replacement Wizard .......................................................................................................... 18 3 LIST OF STANDARD AND OPTIONAL ACCESSORIES ................................................................................ 19 4 MAINTENANCE AND SAFETY INSTRUCTIONS ............................................................................................ 20 4.1 Shock Transmitter Replacement Procedure................................................................................................... 21 4.2 Procedure of Worn-out Tube and Projectile Replacement ............................................................................. 22 4.3 General Safety Precautions ........................................................................................................................... 24 4.4 Labels ............................................................................................................................................................ 25 4.5 Used Symbols ................................................................................................................................................ 25 5 TECHNICAL PARAMETERS ........................................................................................................................... 26 5.1 Manufacturer .................................................................................................................................................. 27 BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 4 OF 28 1 GENERAL CHARACTERISTICS OF THE DEVICE The BTL-5000 SWT is a state-of-the-art device allowing the application of therapy using non-invasive shockwaves. Shockwaves are one of the most effective ways to treat pain associated with the musculoskeletal system. Musculoskeletal pain is currently the second-leading cause of absences in the workplace. Therapy is easily and efficiently started by simply selecting a diagnosis from an alphabetized list of treatment protocols or by selecting a therapy program. The treatment parameters can be manually set by the simple use of the touch screen buttons. Throughout the course of a therapy session, the device will keep the user informed about the therapeutic method in use, the type of treatment, the total number of shocks to be applied, the number of shocks applied and remaining, the frequency being used, the intensity and other necessary data. A time-saving feature of the BTL-5000 SWT is the predefined programs. Based on detailed research and practical use of the device, the well-organized predefined programs will provide recommendations for the treatment of various conditions. The BTL-5000 SWT allows the entering of client names and other relevant information into the internal memory of the device and to link their data with the predefined programs or with the user’s own. When a client has a return visit, simply call up their name and begin the pre-set therapy. BTL also offers a specially-designed trolley for the BTL-5000 SWT which is sold separately. The design allows convenient movement and use of the device. Four stable castors ensure smooth and easy movement of the device in the office or the health-care center. The trolley has a range of accessory bins and baskets. 1.1 INTENDED USE BTL-5000 SWT is non-invasive therapeutic device intended to be used in case of musculoskeletal system disorders. Application of shockwave energy into the tissue decreases pain sensations and supports local microcirculation what results in local metabolism enhancement. The BTL-5000 SWT uses the ballistic principle of the shockwave generation. The shock wave is formed via a projectile by accelerated compressed air, which is generated by an electronically controlled air- compressor. The kinetic energy of the projectile is transferred into a probe of the applicator and subsequently into the client's body. During the treatment the ending part of the applicator must be in immediate contact with the skin and subcutaneous tissue. 1.2 THE BTL-5000 SWT The device consists of two parts: compressor unit and applicator. The compressor unit: In addition to the compressor itself, it also contains all of the electronics regarding the regulation of the ballistic pressure. The applicator: By following the instructions shown on the main unit’s display, this ergonomically designed applicator will simplify the course of therapy. The BTL-5000 SWT is operated from a separately sold main unit BTL-6000 High Intensity Laser. The main unit contains the main microcomputer and software for controlling the entire system. It also includes the user encyclopedia and the therapy guide. 1.3 SHOCKWAVE AND ITS CHARACTER A shockwave is defined as a wave with a rapid increase of pressure within a very short time and then having a gradual decrease of pressure with a small negative pressure phase. Shockwaves are aimed at the affected areas that are the source of chronic pain. The influence of the shockwaves causes to the dissolution of calcium deposits and leads to better vascularization. The after-effect is relief from the pain. Outside of the client's body (extra-corporeally), a pressure pulse of high amplitude is generated and its energy is BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 5 OF 28 concentrated on the target area. The pressure pulse travels through a liquid medium gel into the client’s body and penetrates soft tissue without major energy loss. The pressure course of the shockwave in real-time in expressively different from the pressure course of the harmonic sound wave. Shockwaves can be compared to ultrasonic waves which are particularly characterized by a pressure jump change, a higher amplitude and non-periodicity. In the shockwave, the positive amplitude is generally much larger than the negative amplitude. The frequency rate of the shockwaves is usually low (in Hz units) and the eventual cavitations (the disturbance of material consistency and the development of cavities) will relax. Consequently, there is no threat of energy absorption in the cavitations as is the case with continuous ultrasound. A substantial part of the shockwave energy penetrates into the liquid (of the organism) with a great positive pressure pulse. Its diffusion is only limited by the actual tissue absorption and eventual reflections on acoustic non-homogeneities. 1.4 SHOCKWAVE GENERATION Several types of generators have been developed for shockwave therapy, each producing shockwaves with varied characteristics. Each type of generation method induces shockwaves with different time progressions and spatial arrangements. The BTL-5000 SWT uses the ballistic principle of shockwave generation. 1.4.1 BALLISTIC PRINCIPLE OF SHOCKWAVE GENERATION A pressure wave is formed via a projectile by using accelerated compressed air. The compressed air is generated by an electronically-controlled ballistic-pressure compressor. Using elastic impact, the kinetic energy of the projectile is transferred into the probe of the applicator and then into the client's body. Consequently, during the treatment, the end of the applicator must be in direct contact with the skin and subcutaneous tissue. 1.5 POSSIBLE SIDE EFFECTS OF SHOCKWAVE TREATMENT Erythema or swelling can temporarily occur in the treated area. Loss of bodily sensation or itching can temporarily occur in the treated area. Momentary increase of pain appearing immediately after treatment. Hematoma Petechiae Skin damage after previous corticoid therapy. 1.6 CONTRA-INDICATIONS FOR SHOCKWAVE TREATMENT Application to certain tissues: The eyes and the surrounding area, the myocardium, the spinal cord, the gonads, the kidneys and the liver Blood disorders, coagulation problems or the use of anticoagulants Blood thinning medications (Warfarinization) Pregnancy Thrombosis Tumor diseases Polyneuropathy Acute inflammation Growing cartilage in children Therapy using corticoids Inapplicable on areas of the body and organs with possible gas content Inapplicable on areas in proximity to large nerve bundles, blood vessels, the spinal cord and the head BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 6 OF 28 2 INSTRUCTIONS FOR OPERATION 2.1 THE FRONT PANEL OF THE BTL-5000 SWT 11 10 10 10 8 10 9 10 7 10 6 10 1 10 2 10 4 10 5 10 3 1. hand rest of the applicator 2. shock transmitter of the applicator 3. shock transmitter screw cap of the applicator 4. connector of the applicator 5. guide mark of the connector 6. applicator button: to start therapy 7. power activation indicator of the compressor unit 8. indicator; signals that the device is ready to generate shockwaves: “ready” 9. active tab indicator for the applicator output: “out A“ 10. active tab indicator for the applicator output: “out B“(this function is only available for the older types of device) 11. handles for easy transport of the compressor unit BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 7 OF 28 2.2 THE REAR PANEL OF THE BTL-5000 SWT 12 10 13 10 14 10 15 10 16 10 17 10 18 10 19 10 20 10 21 10 12. ventilation cover 13. communication link: input / output for the compressor unit. 14. on/off power switch for the compressor unit. 15. socket to connect the main power cable 230 V (or 115 V) to the compressor unit 16. line fuses of the compressor unit 17. power switch 230 V / 115 V of the compressor unit 18. connector for the shockwave applicator 19. input for connection of foot pedal 20. communication connectors (for servicing purposes only) 21. condensed water container BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 8 OF 28 2.3 ASSEMBLY AND SET-UP Inspect the box for damage and report any damage to the transport carrier and the distributor. Do not proceed with assembly and set-up if the box is damaged. Keep the original box and packaging to ensure safe future transport of the device. When bringing the device from a cold environment into a warm one, do not plug it into the power immediately; allow it to adjust to the new temperature for approximately 2 hours before use. Unpack the device and place it on a stable horizontal surface which is suitable for its weight. We recommend using the BTL trolley, which can be purchased separately. Always position the device out of direct sunlight. During operation, the device gets warm, so it must not be positioned near direct heat sources. The device is self-cooled by forced air circulation. The cooling vents are located on the rear panel and on the bottom of the BTL-5000 SWT. Do not cover or block these vents. Allow a minimum of 4 inches (10 cm) clearance behind the rear panel. Do not place the device on a soft surface (such as a towel) which may obstruct air flow to the bottom cooling vents. Do not put any heat-producing devices or any objects containing water or other liquids on the device. Do not place the device close to appliances producing strong electromagnetic, electric or magnetic field (diathermy, X-rays, etc.), otherwise it could be undesirably influenced. In the event of any questions, please contact an authorized BTL distributor. Keep the original box and packaging to ensure safe future transport of the device. Installation of supports on the compressor unit: These supports are only to be installed if the compressor unit will not be used with the BTL trolley. Different legs are supplied with our trolley. The BTL-5000 SWT package includes legs for the compressor unit which will prevent it from moving around during therapy. Screw in the supports according to the picture. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 9 OF 28 13 33 14 3 17 18 1. Connect the BTL-5000 SWT compressor unit to the main unit by connecting the communication cable to the input / output of the communication link of the relevant unit. On the BTL-5000 SWT compressor unit, plug the communication cable into the link connector (13). 2. First connect the shockwave compressor unit to the electrical outlet and then to the main unit. Plug the device directly into the main power outlet. Do not use a multi-connection extension cord or an outlet adapter. Verify the correct main power voltage of 230 V (or 115 V). Before the first connection of the device to the main power, it is necessary to check the voltage switch (17) is in the position corresponding to local voltage standards, either 230 V or 115 V. For further details, see the note “Switching the device to different mains voltage” in the Chapter Maintenance and safety instructions. In the event of any questions, please call your BTL distributor. 3. Connect the supplied accessory to the output connector (18) on the rear panel of the shockwave compressor unit as follows: Turn the connector of the applicator so the red spot on its end is lined up with the red spot on the output connector on the shockwave compressor unit and then plug it in. WHEN DISCONNECTING THE CONNECTOR, grip the grooved end of the applicator cable firmly with your fingers slowly pull the connector towards you and disconnect it carefully. WARNING!!! DO NOT TURN THE ENTIRE CONNECTED CONNECTOR BY FORCE, AS IT CAN DAMAGE THE DEVICE!!! The device detects the accessory connected, determines its type and displays it on the screen in the appropriate tab. In the event of the connection of improper accessories by mistake, a warning and help instructions will be displayed on the screen about where or how to correctly connect the appropriate accessories. 4. Activate the on/off power switch of the compressor unit (14). 5. Turn the power supply switch (0/I) to turn on the main unit on/off. 6. Press the on/off button located on the front panel of the main unit. Note: After switching the device on, the device will run a self-diagnostic of its internal circuits and its functions for about 10 to 15 seconds. If any fault is detected, the screen will display a warning message. If necessary; the control unit will lock itself into a “secure” mode. If this situation occurs, please contact an authorized BTL distributor. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 10 OF 28 2.4 BASIC DISPLAYS AND OPERATING OF THE DEVICE 2.4.1 WELCOME SCREEN AND THE SELECTION OF TABS AND ACCESSORIES After switching the device ON, the welcome screen includes information on the tabs with icons of the currently connected accessories. The number of tabs depends on the configuration of the device. By pressing the tab, information of the actual tab will be displayed. Information entered on the so-called “invisible tabs” will definitely remain saved. Examples of information shown on the tabs Tab indicates that no accessories are connected. Tab indicates that shockwave therapy can be applied using the connected accessory 2.4.2 TOUCH SCREEN The touch screen can display several graphic elements. Some are only for informative purposes but others can be pressed and activated. These basic elements include: 3D buttons which can be pressed to change the indicated values informative text The items on the touch screen can be pressed by a finger or by a touch-pen, which is included in the accessories of the device. The touch screen must not come in contact with any sharp objects, ball pens etc. 2.4.3 NUMERIC KEYPAD In addition to the setting of the numerical values with the select knob on all the screens, the ”numeric keypad" can be used for the faster setting of values. This is the icon for the opening the numeric keyboard window: Press the numeric keypad button to display the window with the numeric keypad for the parameter with the “pressed” light button. Set the required values and return to the previous screen by pressing the enter button. If you do not want to enter any values or change the selected parameter, leave the window with the numeric keypad by pressing the esc button. If you enter a value out of the allowed range of values (stated above the entering box) or the device cannot set it, then the value is rounded to the nearest lower allowed value. 2.4.4 SETTING THERAPY PARAMETERS VIA THE ‘DIAG’ BUTTON A list of diagnosis will display after pressing the diag button. To find a diagnosis quickly, press the button for the first letter of the therapy required. For example, after pressing the MNOP button once, there are listed diagnoses starting with the first letter, in this case "M". Other letters are searched depending on how many times the button is pressed. Thus pressing MNOP twice will equal “N”, pressing the button three times will equal "O", etc.. The currently selected letter will be displayed in the box to the right of the buttons. After finding the required diagnosis, press the enter button to select it. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 11 OF 28 2.4.5 SETTING THERAPY PARAMETERS VIA THE 'PROG' BUTTON After pressing the prog button, a screen will appear where the number of the required therapy program can be entered. The numbers of the particular programs for shockwave will be prefixed with the letter “W”, the numbers of the particular programs for laser therapy will be prefixed with the letter “L”. For faster entry of the program number, use the numeric keypad. For more details see the Chapter Numeric keypad. 2.4.6 SETTING THERAPY PARAMETERS MANUALLY (USER SETUP) VIA THE ‘MAN' BUTTON The therapy parameters screen for user (manual) setting will be displayed by pressing the “man” button. All specifications of the therapy can be set and possibly saved as a user program or a diagnosis. Pressing of individual buttons will open an individual menu and pop-up boxes for the settings. Most of the pop-ups are accompanied with illustrative pictures and/or symbols. 2.4.6.1 Setting the Therapy Mode Following therapy modes can be set: 2.4.6.2 continual frequency single shocks burst Setting Therapy Intensity The intensity (power) of the shockwave therapy can be set on the therapy parameters screen, even during the course of therapy. The intensity is set by pressing button labeled the intensity. 2.4.6.3 Setting Therapy Frequency The frequency of the shockwave therapy can be set on the therapy parameters screen, even during the course of therapy. The frequency is set by pressing the frequency. 2.4.6.4 Setting the Number of Shocks The total number of shocks for a therapy can be set on screen of the therapy parameters, even during the course of therapy. The number can be set by pressing the number of shocks. By pressing is possible to select "endless therapy.” The endless therapy option allows for an infinite number of shocks that can be applied from the start of therapy. The end of therapy is not limited to the number of shocks. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 12 OF 28 2.5 COURSE OF THERAPY 2.5.1 START, INTERRUPTION AND END OF THERAPY Start therapy by pressing “start” button on the screen. The therapy can only start, if the tab screen displays the therapy parameters and all those parameters are correctly set. The device will warn of any possible discrepancies. Normally, the therapy ends after the application of the preset number of shocks. However, it is possible to end or interrupt (pause) the therapy before it has finished running. To interrupt therapy, press the “pause” button on the screen or press the button on the applicator. To end therapy, simply press “esc”. The generation of shocks will stop when the preset number of shocks has been applied. It is also possible to terminate their generation by releasing (in continual mode) and then pressing the button of the applicator again (in ON/OFF mode) Interrupted or paused therapy can be restarted by pressing the “continue” button on the screen and can be terminated by pressing the “esc” button. Shockwave therapy can also be started or interrupted by using the button located on the shockwave applicator, or by using the foot pedal. The factory default setting of the button or the pedal is the AUTO mode. The device automatically recognizes the hold time of the button on the applicator or on the foot pedal as well as the selected method of control. If the button or the foot pedal is held for more than 1 second, then after its subsequent release the therapy will stop (as in the continual mode; see the Chapter Specific settings). During the time while pressing the applicator button or the foot pedal, the generation of shockwaves will continue. If the applicator button or the foot pedal is pressed for less than 1 second, then after its release the device will be set to the ON/OFF option (see the Chapter Specific settings). 2.5.2 SCREEN DURING THERAPY Name of selected therapy / program and set parameters No. of remaining shocks Preset frequency Preset no. of shocks No. of applied shocks Time of applied therapy Preset intensity Icon of connected accessories 2.6 APPLICATION OF SHOCKWAVES Application of shockwaves is provided via a spring-loaded applicator, which: Provides proper and exactly specified contact of the applicator with the treated tissue during therapy. Minimizes the transmission of reverse shocks to the hand of the therapist due to the built-in air damper. An integral part of the applicator is the ergonomic hand rest which provides a comfortable grip and prevents unwanted slippage of the hand during therapy. The ergonomic hand rest swivels and can be set into the desired position at any time. The ergonomically-shaped handle allows the therapist to grip the applicator comfortably in various different positions. The orientation can be varied according to the type of applied therapy and the personal preferences of the therapist whether they are left-handed / right-handed or male / female. The ergonomic shape of the handle offers the therapist sufficient support during the application. This reduces the tiring of the therapist hands during the course of therapy. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 13 OF 28 Examples of how to hold the shockwave applicator These examples illustrate the application of shockwaves in different areas and several of ways of holding the applicator. Epicondylitis Achillodynia Patellar Tendinopathy (Jumper's Knee) Trigger points Painful shoulder Trigger-points Tibial Edge Syndrome Calcar Calcanei (Plantar Fasciitis) BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 14 OF 28 2.7 DEVICE MENU After pressing the menu button on the touch screen you can browse the following menus of the device function: 2.7.1 accessories encyclopaedia unit settings specific settings ACCESSORIES From this submenu it is possible to select: information This menu item displays the information about connected accessories such as the name of the accessory, its serial number etc. Mainly, it displays which generator (output / input) the accessory should be connected to and the number of already applied shocks. 2.7.2 ENCYCLOPAEDIA The encyclopaedia provides information about the preset clinical protocols, therapeutic possibilities and examples of how to use the device. An electronic version in the device is accessible from most screens and from the device menu. Icon to open the encyclopaedia: After opening the encyclopaedia following the selection of a specific diagnosis, the information on the selected diagnosis will be displayed. Otherwise you will enter the encyclopaedia’s table of contents which lists the individual clinical protocols. Here it is possible to scroll using the select knob. After selecting the required diagnosis, press the enter to get to the specific information on the clinical protocols. 2.7.3 UNIT SETTINGS This submenu offers the options of setting and displaying the following parameters: password setting sound setting screen-saver and auto switch-off colour setting setting the display contrast led brightness setting date and time setting language setting (language) touch panel calibration user options style of operation setting the hw key unit information unlock code user accounts firmware upgrade service functions dialog history BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 15 OF 28 2.7.3.1 Password Setting Allows change of the device’s password which is required by the device after it is switched on. Without entering the password, further work with the device is impossible. 2.7.3.2 Sound Setting Allows the setting of the acoustic signalling for when buttons or the touch screen are pressed as well as for certain operations such as therapy start, therapy interruption, end of therapy etc. The device includes a set of standard sounds from the manufacturer, for example the signalling the therapy operations. All audio tones can be muted (no sound) or modified as required. Allows editing of the individual audio schemes, the creation of new ones and the modification of the audio tones for each operation separately. The user’s own settings will always be displayed at the end of the list of sound schemes. The sound volume can be also set under the User options menu. 2.7.3.3 Screen-Saver and Auto Switch-Off Includes the setup of the screen-saver type, the activation time of the screen-saver, the period of time before which the screen will switch off and idle time for the whole device. To cancel the Screen-saver mode, press the esc key on the device. Do not forget to save the settings by pressing the enter key. 2.7.3.4 Colour Setting Allows setting of the colours of the controls displayed on the screen. There are 5 preset colour schemes available to choose from. 2.7.3.5 Setting of the Display Contrast Allows the setting of the optimum contrast of the display by turning the select knob. Since the contrast of the screen depends on various factors, such as the temperature of the room, there is a faster and direct way of setting the screen contrast. To quickly change the contrast, turn the select knob while simultaneously holding enter and esc keys. 2.7.3.6 Date and Time Setting Allows the setting of the date and time for the device. 2.7.3.7 Language Setting (language) Allows the setting of the preferred language of the texts displayed on the device’s screen. The factory default is English. 2.7.3.8 Touch Panel Calibration If the buttons on the touch screen do not react when pressed, the touch screen needs calibration. The process of the calibration is shown on the screen. During the calibration, use the touch-pen (stylus) and follow the on-screen instructions. Calibration, if not successful, can be interrupted at any time by pressing the esc button. To verify the touch screen adjustments, use the "touch panel function test" function. 2.7.3.9 User Options This menu items allows the setting of: 2.7.3.10 direction of movement of menu (standard / reverse) sorting of diagnoses (in ascending order / in descending order) tabs position (top / bottom) sound volume Setting the HW Key The device can be remotely reconfigured. If it is later decided to purchase the upgrade, the manufacturer (distributor) will send the 64-digit code (the so-called “HW key”) that when entered will reconfigure its hardware according to that key. For the actual HW configuration see the next entry, Unit information. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 16 OF 28 2.7.3.11 Unit Information Shows specific information about the device such as serial number, device type, firmware version etc. It also contains the information of when the device will operate – so called "device validity". If the operation of the device is time limited, this item indicates until which date the device stays fully functional. 2.7.3.12 Unlock Code If the operation of the device is time limited, then in this item you can enter the so-called "unlocking code" for cancellation of the operational time limitation of the device. 2.7.3.13 User Accounts The function allows creating personal account for every person who operates the device. Everyone has their own password to log in. 2.7.3.14 Firmware Upgrade Enables to upgrade the firmware version in the device. 2.7.3.15 Service Functions repair of files Checks the file storage system of the device, the system of saved information. It will repair possible errors, delete empty files, etc. We recommend using this feature in the event of a lack of memory space, if the device rejects saving any data, or if you are in doubt that some data may have been lost. file system formatting Should be used only if the repair of damaged files feature did not help. Unfortunately, when this feature is used the entire memory is re-formatted and all the user-data and the user setup of the device will be lost. default setting without loss of user data Restores all functions of the device to the factory default settings. However, all user–data related to clients, programmed therapies, etc. will stay saved. 2.7.4 2.7.4.1 unit log data export SPECIFIC SETTINGS Shockwave setting compressor mode This allows for the selection of one of the two different types of pressure control modes of the system: quick start or silent mode. When using quick start, the pressure control of the system is activated immediately after switching the device ON, therefore the start of therapy is instantaneous. We recommend using this setting, especially if the device is used frequently. The disadvantage of this mode is that there is a higher noise level from the device. In silent mode, the pressure control in the system is activated only immediately before the start of therapy. When the manual screen is opened and then closed, the pressure stops being held in the system. This eliminates noise from the device when not actively in use. The disadvantage can be a prolonged period before the start of therapy. Depending on the pressure in the system, this period could 10 to 15 seconds longer than in quick start mode. We recommend using this mode for quieter operations. therapy control This allows the user to select whether the therapy will be controlled using the button on the applicator or using the foot pedal which is connected to the compressor unit. After selecting the type of therapy control, continue by setting the options of either the applicator button mode or the foot pedal mode. Read the next chapter for further information. applicator / foot pedal BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 17 OF 28 This allows the selection of one of the three different types of modes for the applicator button function or the foot pedal, depending on which was selected. The choices are: AUTO, continual or ON/OFF. In AUTO mode, the device automatically recognizes the hold time of the button on the applicator or the pressing of the foot pedal as well as the selected way of control it. If the button of the applicator or the foot pedal is pressed for more than 1 second, then after its subsequent release therapy will stop. This will be the same in the continual mode. During the time it takes to press the button or the foot pedal, the generation of shockwaves will be in progress. If the button of the applicator or the foot pedal is pressed for less than 1 second, then after its release the device will be set to the ON/OFF mode option (see below). In continual mode, the generation of the preset shockwaves is accomplished by only one press of the button on the shockwave applicator or the foot pedal. To end the generation of shockwaves, it is necessary to press the button on the applicator or the pedal again. In ON/OFF mode, it is necessary to hold the button of the applicator or the foot pedal pressed throughout the duration of the application of shockwaves. Releasing the button or the pedal stops the generation of shockwaves. This setting will be saved separately for the button of the applicator and for the foot pedal. 2.7.4.2 Applicator Kit Replacement Wizard If, after a certain amount of time, the applicator stops generating shockwaves correctly, it is possible to change the worn-out applicator parts. Follow the instructions detailed in the Chapter Procedure of Worn-out Tube and Projectile Replacement of this manual. Install this replacement part according to the instructions. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 18 OF 28 3 LIST OF STANDARD AND OPTIONAL ACCESSORIES The device is not designed for use with any accessories or medical equipment other than those stated in this manual. The following table contains a list of all standard and optional accessories that can be supplied with the device. Standard accessories: 1x shockwave applicator with multi-focus shock transmitter (Ø 15 mm) 1x replaceable multi-focus shock transmitter (Ø 9 m) 1x replaceable focusing shock transmitter (Ø 15 mm) 1x exchangeable kit (includes a spare set of O-rings) 1x applicator holder 1x gel (1000 ml) 1x power cord 1x communication cable 4x silent blocks for compressor unit 2x spare fuse for the compressor unit (T6.3AL/250 V) 1x user's manual markers for output cables Optional accessories: additional shockwave applicator with focusing shock transmitter foot pedal gel (300 ml) BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 19 OF 28 4 MAINTENANCE AND SAFETY INSTRUCTIONS The recommended intervals for inspection of the device are 24 months after installation, subsequently each 12 months. The intervals may differ according to the local regulations. The inspection shall be performed according to procedure authorized by BTL. To keep the device clean, do not store or use it in extremely dusty environment for a long time. Do not immerse it in any liquid. Before each use, checks that the device and its accessories (especially cables) are not mechanically or otherwise damaged. Do not use the device if it is damaged! Cleaning the surface of the device and its parts: Use a soft cloth slightly moistened with water or with a 2% detergent solution to clean the exterior of the BTL-5000 SWT device and its parts. Never use cleaning agents containing alcohol, ammonia, benzine, thinners, etc. Never use abrasive cleaning materials which will scratch the device's surfaces. No parts of the device require sterilization. Care should be given to prevent water or other liquids from getting inside the device. Cleaning and maintenance of accessories which come into contact with the client (e.g. shock transmitters): Clean and disinfect after each client using approved cleaning agents. For example, Sekusept, Bacilol, and Incidur Spray can be used. For the cables of accessories, use Incidur Spray and the alike. The exterior surface of the shock transmitter can be washed with warm water with its cap on. However, to completely remove all of the contact gel from the shock transmitter, it will be necessary to unscrew the shock transmitter and clean it. Fuse replacement: The fuses of the shockwave compressor unit are located in the round black box on its rear panel. During replacement, verify that the correct fuse is being inserted. Before replacement, make sure that the main power switch of the shockwave compressor unit is in the “0" position and the power cords is disconnected from the unit. Turn the segment of the fuse box to the left using a flathead screwdriver or coin in the slot in order to remove the fuse. Insert a new fuse and turn it to the right. Do not use fuses other than those stated above the fuse box! This action should only be done by a person acquainted with this procedure! Switching the device to different main power voltage: The voltage switch for the shockwave compressor unit is located on its rear panel. Before switching over, first make sure that the main power switch is in the “0” position and the power cord is disconnected from the unit. Use a flathead screwdriver or a coin to turn the segment of the switches so that the arrow on the switch points to the voltage of your local electrical rating. This operation should only be done by a person familiar with this procedure! If in doubt, contact an authorized BTL customer service. The manufacturer is not responsible for any damage caused by an incorrect switchover. Transport and storage: Keep the shipping container and all packaging materials. Transport the unit in original box to ensure maximum protection. Unplug the main power cable and all accessory cables. Take care to avoid shocks or jarring movements to the device during transport. This device should only be transported and stored under the conditions defined in the Chapter Technical Parameters. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 20 OF 28 4.1 SHOCK TRANSMITTER REPLACEMENT PROCEDURE The shock transmitter can be replaced as necessary. Three shock transmitters are included as part of the BTL-5000 SWT standard accessories: 1x replaceable multi-focus shock transmitter (Ø 15 mm) 1x replaceable multi-focus shock transmitter (Ø 9 mm) 1x replaceable focusing shock transmitter (Ø 15 mm) Replacement procedure: 1. Use the transmitter nut wrench [1a] (included in the package) to unscrew the screw cap of the shock. 2. Remove the shock transmitter (14) and both O-rings from the applicator. O-rings 3. Insert the selected shock transmitter “as is" to the applicator, including the mounted O-rings. 4. Put the transmitter screw cap back in place and screw it on tightly, using the transmitter nut wrench. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 21 OF 28 4.2 PROCEDURE OF WORN-OUT TUBE AND PROJECTILE REPLACEMENT If after some time the applicator stops working correctly, it is possible to replace the old tube and projectile kit by means of the replacement kit, which is included in the supplied BTL-5000 SWT package. Do not use damaged applicators! There is a risk of injury to the operating staff or the client. Replacement procedure: 1. Start the Applicator kit replacement wizard (menu / specific settings) and follow the instructions on the screen. Use the transmitter nut wrench [1a/1b] (included in the package) to unscrew the screw cap of the transmitter. 2. Remove the transmitter [2/3a/3b] and O-rings [2a/2b/3] from the applicator. 3. Use the body nut wrench [1b] (included in the package) to unscrew the cap of the cartridge [4]. Follow the pictures. 4. Remove the worn/out part [5] from the cartridge of the applicator. 5. Remove the plastic cover from a new replacement part. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 22 OF 28 6. Carefully insert the new kit [6] "as is" into the cartridge of the applicator in the direction as shown in the picture. Do not touch the rear cover behind the spring, as it is coated with a thin layer of lubricant from the factory. 7. The front cover of the replacement kit must be set to the position shown in the picture and pushed inside flush with the outer edge of the applicator case (push the kit slightly into the applicator case). The replaced kit must move freely! 8. After inserting the new kit, firmly screw the screw cap [4] of the cartridge back in place using the body nut wrench [1b]. 9. When replacing the applicator kit, replace O-rings [2a/2b/3] on the applicator attachment at the same time. Spare O-rings are included in the accessories. 10. Insert the transmitter [2/3a/3b] back into the applicator, including its O-rings [2a/2b/3]. 11. Put the transmitter screw cap back in place and screw it on tightly, using the transmitter nut wrench [1a/1b]. WARNING! If the screw cap is not TIGHTENED FIRMLY, the projectile may get jammed! 12. Reconnect the applicator to the device. Finish the installation by following the instructions of the Applicator kit replacement wizard. The new installation will reset the counter of shocks to zero. The warranty does not cover damages caused by improper installation!! BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 23 OF 28 4.3 GENERAL SAFETY PRECAUTIONS Read the User’s Manual carefully and become familiar with all its safety requirements, operating procedures and maintenance instructions before using the device. It is not allowed to use the device and its accessories in any manner other that is in accordance with the User’s Manual. It is prohibited to use the device in the way that is not in accordance with the Intended use (defined in the Chapter 1.1). The device has applied parts of the BF (Body Floating) type – i.e. parts, which come into direct physical contact with the patient during normal device use. The connectors marked with this symbol can be connected to the foot operated switch to start therapy. The foot pedal is located under the bottom part of the shockwave compressor unit. Shockwave therapy is requires direct bodily contact, therefore do not use on damaged skin! Do not apply shockwave therapy to areas of the body with gas-containing organs, close to large nerve bundles or blood vessels, on the spinal cord or on the head! The device does not use any drugs, creams, gels or other substances which are an integral part or which are applied by its use. The device is equipped with a protection system that prevents connecting accessories other than those supplied by the manufacturer. Consequently, it will not operate with equipment from other manufacturers. The electrical wiring to which the device is to be connected must be installed and tested according to the existing valid standards. If the user is not sure that the main power supply is safe, it should be inspected by an inspection engineer. Check whether the parameters of the main power supply correspond to the requirements of the device according to Technical Parameters. Also, verify that the voltage switch on the device is turned to the correct voltage according to the main power supply parameters. The device requires the environmental conditions that are stated in the Chapter Technical Parameters. It must not be used in an environment where there is a danger of explosion or of water penetrating the device. The device cannot be in connection with flammable anesthetics or oxidizing gasses (O2, N2O, etc.). Do not place the device in direct sunlight or near strong electromagnetic fields to prevent mutual functionality influence. If this happens, move the device further away from the source of interference or contact an authorized BTL service. Inspect the device thoroughly before each use. Look for loose cables, cracked cable insulation, cracks in the shockwave applicator’s housing and functional behavioral differences in the display or the operating elements. If any anomalies or inconsistencies are found, stop using the device and contact an authorized BTL service. If the behavior of the device shows any divergences from the functionality procedures described in this user’s manual, stop using the device and contact an authorized BTL service. If the device shows any defects or if there are any doubts concerning its correct and safe functioning, terminate therapy immediately. If the source of the concern can be determine after a thorough study of the user's manual, then contact an authorized BTL service immediately. If the device is not used in accordance with this manual or if it is used when the device exhibits functional differences from those stated in this manual, then BTL is not responsible for any damage to or caused by the device. Do not try to open, remove protective covers, or dismantle the device for any reason. There is a danger of electrical shock and/or serious injury. Even the replacement of the lithium battery and the air micro-filter must be done an authorized BTL service only! The connectors for accessories, as well as the other connectors, must not be used for connecting anything else other than what they are designed for. There is a danger of electrical shock and/or serious damage to the device. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 24 OF 28 The device does not use or emit any toxic substances during its operation, storage or transport under the stated conditions. Before the start of therapy, verify that all of the input parameters correspond to the user's requirements. To terminate operation, do not use the main power switch! Instead, press the “on/off” button. The time interval between turning off the main power switch and turning it back on must be at least 3 seconds. If it is necessary to discard the device, the lithium battery must be removed. The removed battery must be disposed according to local hazardous waste disposal requirements. Do not place the device in municipal waste containers. The device itself does not contain any toxic materials which could harm the environment when disposed of ecologically. The device and its accessories must be used in compliance with this manual. The device must be placed out of the reach of children. The device does not contain any components, except for the fuses and parts containing in the shockwave transmitter replacement kit, which can be repaired or replaced by the user. Do not remove the cover from the control unit. All repairs must be done by an authorized BTL service. Do not disconnect the applicator during therapy. Do not place the device near running water. Do not spill water (or other liquids) on the device. There is a risk of electric shock! 4.4 LABELS Instrument type label 4.5 USED SYMBOLS Warning: the values of supply voltage exceed safe values. Class II equipment Type BF applied part Read the manual before operating the device Electric and electronic equipment. Do not use municipal waste to dispose of the unit. Its disposal is subject to the 2002/95/EC Directive. Foot operated switch Name and address of the manufacturer Date of manufacture Serial number Batch code Catalogue number BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 25 OF 28 5 TECHNICAL PARAMETERS Name BTL-5000 SWT Model BTL-5000 SWT POWER The device can be connected BTL-6000 High Intensity Laser 7 W / 810 + 980 nm BTL-6000 High Intensity Laser 12 W / 1064 nm Operating conditions Ambient temperature +10 °C to +40 °C / 50 °F to 105 °F Relative humidity 30 % to 75 % Atmospheric pressure 800 hPa to 1060 hPa Position Vertical: On legs Type of operation Permanent Transport and storage conditions Ambient temperature -10 °C to + 55 °C/15 °F to 130 ° F Relative humidity 25 % to 85 % Atmospheric pressure 650 hPa to 1100 hPa Position of the compressor Basic, fixed with transit bolt Additional conditions Transport only in the original container Power supply Compressor unit maximum input 550 VA Mains voltage (switched) ~ 99 V to 126 V (115 V nominal) AC ~ 198 V to 252 V (230 V nominal) AC Mains frequency 50 Hz to 60 Hz Equipment protection class II; In accordance with IEC 61140 External exchangeable fuses Compressor unit: 2x T6.3AL/250 V tube safety fuses (5 x 20 mm) In accordance with IEC 60127 Power switch On the back of device, positions 0 (off) and I (on). In accordance with IEC 60601-1 To disconnect from the mains, unplug the male plug of the power cord from the mains socket outlet. Design Weight: Compressor unit Maximum 20 kg/44 lbs. Weight: Applicator Maximum 900 g/1.9 lbs. (including cable) Compressor unit dimensions 330 x 270 x 320 mm (w x h x d) Applicator dimensions 40 x 280 x 140 mm (w x h x d) IP code IP 20; In accordance with EN 60 529 Indicator lights Compressor unit: 1x green, 1x yellow, 2x blue Classification Applied part type BF Adjustable values Shock intensity Maximum 5 bar (maximum instantaneous value) Shock frequency Maximum 22 Hz Therapy period Increments of adjustable values 0 – 9999 shocks Intensity 0.1 bar Frequency 1 Hz Total number of shocks per therapy From 1 to 50 shocks at a time BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 26 OF 28 5.1 MANUFACTURER BTL Industries Ltd. 161 Cleveland Way Stevenage Hertfordshire SG1 6BU United Kingdom E-mail: sales@btlnet.com http://www.btlnet.com For service, please contact our service department at service@btlnet.com. th Date of last revision: 10 of August 2016 ID: 214-80MANEN200 © No part of this manual may be reproduced, saved in a research centre or transferred by any means incl. electronic, mechanic, photographic or other records without previous approval from BTL Industries Limited BTL Industries Limited operates a policy of continuous development. Therefore, it reserves the right to make changes and improvements to the products without prior notice. The content of this document is provided "as it is ". Except as required by applicable law, no warranties of any kind, either expressed or implied, are made in relation to the accuracy, reliability or contents of this document. BTL Industries Limited reserves the right to revise this document or withdraw it at any time without prior notice. BTL-5000 SWT FOR BTL-6000 HIGH INTENSITY LASER – USER’S MANUAL I PAGE 27 OF 28 214-80MANEN200