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BTL 6000 SWT TOPLINE User Manual

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BTL-6000 SWT

TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 1 OF 38

loading

Related Manuals for BTL 6000 SWT TOPLINE

Summary of Contents for BTL 6000 SWT TOPLINE

  • Page 1
    BTL-6000 SWT TOPLINE USER’S MANUAL v100AS08/01/2010EN GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 1 OF 38…
  • Page 2
    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.
  • Page 3: Table Of Contents

    Possible side Effects of Shockwave Treatment……………………7 Indications for Shockwave Treatment ……………………..8 Contra-indications for Shockwave Treatment……………………8 INSTRUCTIONS FOR OPERATION……………………….9 The Front Panel of the BTL-6000 SWT Topline ……………………9 Applicator for BTL-6000 SWT Topline ……………………..9 The Rear Panel of the BTL-6000 SWT Topline…………………….10 Assembly and Set-Up………………………….11 Basic Displays and Operating of the Device ……………………12…

  • Page 4
    2.11.3.8 Operation Mode …………………………23 2.11.3.9 Touch Panel Calibration……………………….23 2.11.3.10 User Options…………………………..23 2.11.3.11 Setting of HW Key …………………………23 2.11.3.12 Unit Information …………………………23 2.11.3.13 Unlock Code …………………………..23 2.11.3.14 Service Functions …………………………24 2.11.4 Specific Settings …………………………..24 2.11.4.1 Applicator Button Mode……………………….24 2.11.4.2 Applicator Kit Replacement Wizard …………………….24 LIST OF STANDARD AND OPTIONAL ACCESSORIES ………………..25 MAINTENANCE AND SAFETY INSTRUCTIONS……………………26 4.1.1…
  • Page 5: General Characteristics Of The Device

    A time-saving feature of the BTL-6000 SWT Topline is the predefined programs stored in the memory of the main unit. Based on detailed research and practical use of the device, the well-organized predefined programs will provide recommendations for the treatment of various conditions.

  • Page 6: Shockwave And Its Character

    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-6000 SWT Topline uses the ballistic principle of shockwave generation. 1.3.1 BALLISTIC PRINCIPLE OF SHOCKWAVE GENERATION A pressure wave is formed via a projectile by using accelerated compressed air.

  • Page 7: Biological Effects Of Shockwave Treatment

    1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface. There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects: •…

  • Page 8: Indications For Shockwave Treatment

    1.7 INDICATIONS FOR SHOCKWAVE TREATMENT • Plantar Fasciitis • Achillodynia/Achillobursitis • Inflammations and calcification of shoulder joint tendons. • Pain in the groin area. • Epicondylitis (Tennis and Golf Elbow) • Apex Patellae Syndrome and Tibial Stress Syndrome. • Pain in the hip area and/or the iliotibial tract. •…

  • Page 9: Instructions For Operation

    2 INSTRUCTIONS FOR OPERATION THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE 10 3 10 4 10 5 10 2 touch screen select knob (to select individual parameters) enter key esc key start / stop key (to start and stop therapy) ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’…

  • Page 10: The Rear Panel Of The Btl-6000 Swt Topline

    THE REAR PANEL OF THE BTL-6000 SWT TOPLINE connector for shockwave applicator control unit mains fuse connector for power cable power on/off switch vessel for collecting condensed water type label – contains type of the device, manufacturer and safety and warning signs…

  • Page 11: Assembly And Set-Up

    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 service of BTL devices. Procedure: First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket.

  • Page 12: Basic Displays And Operating Of The Device

    BASIC DISPLAYS AND OPERATING OF THE DEVICE 2.5.1 INITIAL SCREEN AND TYPES OF TABS The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories. Examples of information shown on the tabs: Indicates that no accessories are connected Indicates that the applicator is connected and shockwave therapy can be applied.

  • Page 13: Numeric Keypad

    2.5.3 NUMERIC KEYPAD In addition to setting the numerical values with the select knob on all the screens, the ”numeric keypad» can be use for the faster setting of values. This is the icon for the opening of the numeric keyboard window: Press the numeric keypad button to display the window with the numeric keypad for the parameter with the “pressed”…

  • Page 14: Setting Therapy Parameters Manually (User Setup) Via The ‘Man’ Button

    2.6.3 SETTING THERAPY PARAMETERS MANUALLY (USER SETUP) VIA THE ‘MAN’ BUTTON The therapy parameters screen for the 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.

  • Page 15: Setting Therapy Intensity

    The endless therapy option allows for an infinite number of shocks, that can be applied from the start of the therapy. The end of therapy is not limited to the number of shocks. 2.6.5 SETTING THERAPY INTENSITY The intensity (power) of the shockwave therapy can be set on the therapy parameters screen, even during the course of therapy.

  • Page 16: Therapy Parameters Screen — Ergonomic, Standard And Expert Mode

    2.6.6 THERAPY PARAMETERS SCREEN – ERGONOMIC, STANDARD AND EXPERT MODE This screen always appears before the start of therapy when the diag or prog buttons are pressed (see Diagram of the therapy setting process). If only the most important therapy parameters are shown, then the ergonomic operation mode was selected.

  • Page 17: Running Therapy Screen

    2.7.2 RUNNING THERAPY SCREEN Name of selected therapy / program and the set parameters Set frequency Number of applied shocks Set number of shocks Set intensity Number of remaining shocks Icon and name of connected accessories Time of applied therapy Symbolic description of generated output 2.7.3…

  • Page 18
    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. Painful shoulder Trigger-points Tibial Edge Syndrome Calcar Calcanei (Plantar Fasciitis) Epicondylitis Achillodynia Patellar Tendinopathy (Jumper’s Knee) Trigger points INSTRUCTIONS FOR OPERATION | PAGE 18 OF 38…
  • Page 19: Saving Therapy

    SAVING THERAPY A particular operation can selected after pressing the “save” button. Depending on which operation is selected, a chart with the appropriate data will be shown. An example of the procedure is displayed on the following screens. It is always possible to save the therapy after setting its parameters, for example from the screen of therapy parameters – see the chapter Therapy parameters screen.

  • Page 20: Clients

    2.10.1 CLIENTS This feature allows the entering, editing and deleting of information about clients. A particular therapy can be assigned to each client. 2.10.2 USER DIAGNOSES/PROGRAMS This feature makes it possible to start the user therapies, to adjust their parameters, names and descriptions, to delete them and to sort them by using the buttons and choices shown on the screen.

  • Page 21: Information

    The memory-chip contains a lot of information and reading it takes from 30 seconds to 2 minutes. The “installation of accessories” function serves for faster functioning of the unit. After the installation, under normal operation of the device only the serial number of the accessory is read from the accessory’s memory and the other information is read from the device’s memory.

  • Page 22: Unit Settings

    2.11.3 UNIT SETTINGS This submenu offers the options of setting and displaying these parameters: • Password setting • Sound setting • Screen saver and auto switch-off • Colour setting • Setting of display contrast • Date and time setting • Language setting •…

  • Page 23: Setting Of Display Contrast

    2.11.3.5 Setting of Display Contrast Allows the setting of the optimum contrast (readability) 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.

  • Page 24: Service Functions

    2.11.3.14 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.

  • Page 25: List Of Standard And Optional Accessories

    1x spare fuse T6.3A,L,250V • 1x User’s Manual on CD Optional accessories: • transport case for the BTL-6000 SWT Topline • additional shockwave applicator with focusing shock transmitter • gel 300 ml LIST OF STANDARD AND OPTIONAL ACCESSORIES | PAGE 25 OF 38…

  • Page 26: Maintenance And Safety Instructions

    Exterior cleaning of the device: Use a soft cloth slightly moistened with water or with a 2% detergent solution to clean the exterior of the BTL-6000 SWT Topline 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.

  • Page 27: Shock Transmitter Replacement Procedure

    4.1.1 SHOCK TRANSMITTER REPLACEMENT PROCEDURE The shock transmitter can be replaced as necessary. Three shock transmitters are included as part of the BTL-6000 SWT Topline standard accessories: • 1x replaceable multi-focus shock transmitter (Ø 15mm) • 1x replaceable multi-focus shock transmitter (Ø 9mm) •…

  • Page 28: Procedure Of Worn-Out Tube And Projectile Replacement

    If the applicator stops working correctly after some amount of time, then it is possible to change the worn-out parts of the tube and projectile by using the spare parts kit included in the BTL-6000 SWT Topline package. Do not use damaged applicators! There is a risk of injury to the operating staff or the client.

  • Page 29
    Use the key to unscrew the screw cap of the cartridge. See the pictures below. Remove the worn-out part from the cartridge from the applicator Remove the plastic cover from a new replacement part. MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 29 OF 38…
  • Page 30
    Insert the shock transmitter back into the applicator, including both of its O-rings. 10. Put the shock transmitter screw cap back in place and screw it on tightly by hand. 11. Reconnect the applicator to the BTL-6000 SWT Topline device. MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 30 OF 38…
  • Page 31: General Safety Precautions

    If the source of the concern can be determine after a thorough study of the user’s manual, then contact an authorized BTL service department 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.

  • Page 32: Used Symbols

    BTL’s sole obligations under this warranty are as set forth herein. In no event shall BTL be liable for any lost revenue or profits, direct, indirect, special, incidental or consequential damages of any kind.

  • Page 33: Technical Parameters

    5 TECHNICAL PARAMETERS Identification of the device B T L — 6 0 0 0 S W T T o p l i n e Operating conditions Ambient temperature + 10 ° C to + 40 ° C Relative humidity 30 % to 75 % Atmospheric pressure 700 hPa to 1060 hPa…

  • Page 34
    Technical parameters of the Switching Power Supply Adapter BTL-4000 SWT 150W Design Weight – device only 780 g approx. Dimensions (w x h x d) 142 x 76 x 43,7 mm Covering grade according to EN 60 529 IP20 Class according to IEC 60601-1…
  • Page 35: Emc Information

    Directive and declaration of manufacturer – Electromagnetic Emission BTL-6000 SWT Topline is suitable for use in the specified electromagnetic environment. The purchaser or user of BTL-6000 SWT Topline should assure that it is used in an electromagnetic environment as described below…

  • Page 36
    Directive and declaration of manufacturer – Electromagnetic immunity BTL-6000 SWT Topline is suitable for use in the specified electromagnetic environment. The purchaser or user of BTL-6000 SWT Topline should assure that it is used in an electromagnetic environment as described below.
  • Page 37: Applicable Standards

    5.2 APPLICABLE STANDARDS Name IEC, MDD EN, ISO, Medical electrical equipment – IEC 60601-1:2005 EN ISO 60601-1:2007 Part 1: General requirements for basic safety and essential performance Medical electrical equipment Part 1: General requirements for safety 1.Collateral standard: Safety IEC 60601-1-1:2000 EN ISO 60601-1-1:2001 requirements for medical electrical systems Medical electrical equipment –…

  • Page 38: Manufacturer

    Except as required by applicable law, no warranties of any kind, either expressed or implied, are made for the accuracy, reliability or contents of this document. BTL Industries Limited reserves the right to revise or withdraw this document at any time without prior notice.

BTL 6000 SWT TOPLINE User Manual

  1. Manuals
  2. Brands
  3. BTL Manuals
  4. Medical Equipment
  5. 6000 SWT TOPLINE
  6. User manual
  • Contents

  • Table of Contents

  • Bookmarks

Quick Links

BTL-6000 SWT

TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 1 OF 38

Related Manuals for BTL 6000 SWT TOPLINE

Summary of Contents for BTL 6000 SWT TOPLINE

  • Page 1
    BTL-6000 SWT TOPLINE USER’S MANUAL v100AS08/01/2010EN GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 1 OF 38…
  • Page 2
    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.
  • Page 3: Table Of Contents

    Possible side Effects of Shockwave Treatment……………………7 Indications for Shockwave Treatment ……………………..8 Contra-indications for Shockwave Treatment……………………8 INSTRUCTIONS FOR OPERATION……………………….9 The Front Panel of the BTL-6000 SWT Topline ……………………9 Applicator for BTL-6000 SWT Topline ……………………..9 The Rear Panel of the BTL-6000 SWT Topline…………………….10 Assembly and Set-Up………………………….11 Basic Displays and Operating of the Device ……………………12…

  • Page 4
    2.11.3.8 Operation Mode …………………………23 2.11.3.9 Touch Panel Calibration……………………….23 2.11.3.10 User Options…………………………..23 2.11.3.11 Setting of HW Key …………………………23 2.11.3.12 Unit Information …………………………23 2.11.3.13 Unlock Code …………………………..23 2.11.3.14 Service Functions …………………………24 2.11.4 Specific Settings …………………………..24 2.11.4.1 Applicator Button Mode……………………….24 2.11.4.2 Applicator Kit Replacement Wizard …………………….24 LIST OF STANDARD AND OPTIONAL ACCESSORIES ………………..25 MAINTENANCE AND SAFETY INSTRUCTIONS……………………26 4.1.1…
  • Page 5: General Characteristics Of The Device

    A time-saving feature of the BTL-6000 SWT Topline is the predefined programs stored in the memory of the main unit. Based on detailed research and practical use of the device, the well-organized predefined programs will provide recommendations for the treatment of various conditions.

  • Page 6: Shockwave And Its Character

    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-6000 SWT Topline uses the ballistic principle of shockwave generation. 1.3.1 BALLISTIC PRINCIPLE OF SHOCKWAVE GENERATION A pressure wave is formed via a projectile by using accelerated compressed air.

  • Page 7: Biological Effects Of Shockwave Treatment

    1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface. There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects: •…

  • Page 8: Indications For Shockwave Treatment

    1.7 INDICATIONS FOR SHOCKWAVE TREATMENT • Plantar Fasciitis • Achillodynia/Achillobursitis • Inflammations and calcification of shoulder joint tendons. • Pain in the groin area. • Epicondylitis (Tennis and Golf Elbow) • Apex Patellae Syndrome and Tibial Stress Syndrome. • Pain in the hip area and/or the iliotibial tract. •…

  • Page 9: Instructions For Operation

    2 INSTRUCTIONS FOR OPERATION THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE 10 3 10 4 10 5 10 2 touch screen select knob (to select individual parameters) enter key esc key start / stop key (to start and stop therapy) ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’…

  • Page 10: The Rear Panel Of The Btl-6000 Swt Topline

    THE REAR PANEL OF THE BTL-6000 SWT TOPLINE connector for shockwave applicator control unit mains fuse connector for power cable power on/off switch vessel for collecting condensed water type label – contains type of the device, manufacturer and safety and warning signs…

  • Page 11: Assembly And Set-Up

    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 service of BTL devices. Procedure: First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket.

  • Page 12: Basic Displays And Operating Of The Device

    BASIC DISPLAYS AND OPERATING OF THE DEVICE 2.5.1 INITIAL SCREEN AND TYPES OF TABS The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories. Examples of information shown on the tabs: Indicates that no accessories are connected Indicates that the applicator is connected and shockwave therapy can be applied.

  • Page 13: Numeric Keypad

    2.5.3 NUMERIC KEYPAD In addition to setting the numerical values with the select knob on all the screens, the ”numeric keypad» can be use for the faster setting of values. This is the icon for the opening of the numeric keyboard window: Press the numeric keypad button to display the window with the numeric keypad for the parameter with the “pressed”…

  • Page 14: Setting Therapy Parameters Manually (User Setup) Via The ‘Man’ Button

    2.6.3 SETTING THERAPY PARAMETERS MANUALLY (USER SETUP) VIA THE ‘MAN’ BUTTON The therapy parameters screen for the 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.

  • Page 15: Setting Therapy Intensity

    The endless therapy option allows for an infinite number of shocks, that can be applied from the start of the therapy. The end of therapy is not limited to the number of shocks. 2.6.5 SETTING THERAPY INTENSITY The intensity (power) of the shockwave therapy can be set on the therapy parameters screen, even during the course of therapy.

  • Page 16: Therapy Parameters Screen — Ergonomic, Standard And Expert Mode

    2.6.6 THERAPY PARAMETERS SCREEN – ERGONOMIC, STANDARD AND EXPERT MODE This screen always appears before the start of therapy when the diag or prog buttons are pressed (see Diagram of the therapy setting process). If only the most important therapy parameters are shown, then the ergonomic operation mode was selected.

  • Page 17: Running Therapy Screen

    2.7.2 RUNNING THERAPY SCREEN Name of selected therapy / program and the set parameters Set frequency Number of applied shocks Set number of shocks Set intensity Number of remaining shocks Icon and name of connected accessories Time of applied therapy Symbolic description of generated output 2.7.3…

  • Page 18
    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. Painful shoulder Trigger-points Tibial Edge Syndrome Calcar Calcanei (Plantar Fasciitis) Epicondylitis Achillodynia Patellar Tendinopathy (Jumper’s Knee) Trigger points INSTRUCTIONS FOR OPERATION | PAGE 18 OF 38…
  • Page 19: Saving Therapy

    SAVING THERAPY A particular operation can selected after pressing the “save” button. Depending on which operation is selected, a chart with the appropriate data will be shown. An example of the procedure is displayed on the following screens. It is always possible to save the therapy after setting its parameters, for example from the screen of therapy parameters – see the chapter Therapy parameters screen.

  • Page 20: Clients

    2.10.1 CLIENTS This feature allows the entering, editing and deleting of information about clients. A particular therapy can be assigned to each client. 2.10.2 USER DIAGNOSES/PROGRAMS This feature makes it possible to start the user therapies, to adjust their parameters, names and descriptions, to delete them and to sort them by using the buttons and choices shown on the screen.

  • Page 21: Information

    The memory-chip contains a lot of information and reading it takes from 30 seconds to 2 minutes. The “installation of accessories” function serves for faster functioning of the unit. After the installation, under normal operation of the device only the serial number of the accessory is read from the accessory’s memory and the other information is read from the device’s memory.

  • Page 22: Unit Settings

    2.11.3 UNIT SETTINGS This submenu offers the options of setting and displaying these parameters: • Password setting • Sound setting • Screen saver and auto switch-off • Colour setting • Setting of display contrast • Date and time setting • Language setting •…

  • Page 23: Setting Of Display Contrast

    2.11.3.5 Setting of Display Contrast Allows the setting of the optimum contrast (readability) 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.

  • Page 24: Service Functions

    2.11.3.14 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.

  • Page 25: List Of Standard And Optional Accessories

    1x spare fuse T6.3A,L,250V • 1x User’s Manual on CD Optional accessories: • transport case for the BTL-6000 SWT Topline • additional shockwave applicator with focusing shock transmitter • gel 300 ml LIST OF STANDARD AND OPTIONAL ACCESSORIES | PAGE 25 OF 38…

  • Page 26: Maintenance And Safety Instructions

    Exterior cleaning of the device: Use a soft cloth slightly moistened with water or with a 2% detergent solution to clean the exterior of the BTL-6000 SWT Topline 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.

  • Page 27: Shock Transmitter Replacement Procedure

    4.1.1 SHOCK TRANSMITTER REPLACEMENT PROCEDURE The shock transmitter can be replaced as necessary. Three shock transmitters are included as part of the BTL-6000 SWT Topline standard accessories: • 1x replaceable multi-focus shock transmitter (Ø 15mm) • 1x replaceable multi-focus shock transmitter (Ø 9mm) •…

  • Page 28: Procedure Of Worn-Out Tube And Projectile Replacement

    If the applicator stops working correctly after some amount of time, then it is possible to change the worn-out parts of the tube and projectile by using the spare parts kit included in the BTL-6000 SWT Topline package. Do not use damaged applicators! There is a risk of injury to the operating staff or the client.

  • Page 29
    Use the key to unscrew the screw cap of the cartridge. See the pictures below. Remove the worn-out part from the cartridge from the applicator Remove the plastic cover from a new replacement part. MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 29 OF 38…
  • Page 30
    Insert the shock transmitter back into the applicator, including both of its O-rings. 10. Put the shock transmitter screw cap back in place and screw it on tightly by hand. 11. Reconnect the applicator to the BTL-6000 SWT Topline device. MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 30 OF 38…
  • Page 31: General Safety Precautions

    If the source of the concern can be determine after a thorough study of the user’s manual, then contact an authorized BTL service department 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.

  • Page 32: Used Symbols

    BTL’s sole obligations under this warranty are as set forth herein. In no event shall BTL be liable for any lost revenue or profits, direct, indirect, special, incidental or consequential damages of any kind.

  • Page 33: Technical Parameters

    5 TECHNICAL PARAMETERS Identification of the device B T L — 6 0 0 0 S W T T o p l i n e Operating conditions Ambient temperature + 10 ° C to + 40 ° C Relative humidity 30 % to 75 % Atmospheric pressure 700 hPa to 1060 hPa…

  • Page 34
    Technical parameters of the Switching Power Supply Adapter BTL-4000 SWT 150W Design Weight – device only 780 g approx. Dimensions (w x h x d) 142 x 76 x 43,7 mm Covering grade according to EN 60 529 IP20 Class according to IEC 60601-1…
  • Page 35: Emc Information

    Directive and declaration of manufacturer – Electromagnetic Emission BTL-6000 SWT Topline is suitable for use in the specified electromagnetic environment. The purchaser or user of BTL-6000 SWT Topline should assure that it is used in an electromagnetic environment as described below…

  • Page 36
    Directive and declaration of manufacturer – Electromagnetic immunity BTL-6000 SWT Topline is suitable for use in the specified electromagnetic environment. The purchaser or user of BTL-6000 SWT Topline should assure that it is used in an electromagnetic environment as described below.
  • Page 37: Applicable Standards

    5.2 APPLICABLE STANDARDS Name IEC, MDD EN, ISO, Medical electrical equipment – IEC 60601-1:2005 EN ISO 60601-1:2007 Part 1: General requirements for basic safety and essential performance Medical electrical equipment Part 1: General requirements for safety 1.Collateral standard: Safety IEC 60601-1-1:2000 EN ISO 60601-1-1:2001 requirements for medical electrical systems Medical electrical equipment –…

  • Page 38: Manufacturer

    Except as required by applicable law, no warranties of any kind, either expressed or implied, are made for the accuracy, reliability or contents of this document. BTL Industries Limited reserves the right to revise or withdraw this document at any time without prior notice.

Loading…

BTL BTL-6000 User manual

BTL-6000 SWT TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

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.

PAGE 2 OF 38

CONTENTS

1 GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………

5

1.1

BTL–6000 SWT Topline System Series………………………………………………………………………………………………………………

5

1.2

Shockwave and Its Character……………………………………………………………………………………………………………………………

6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….

6

1.3.1

Ballistic Principle of Shockwave Generation ………………………………………………………………………………………………………

6

1.4

Biological Effects of Shockwave Treatment …………………………………………………………………………………………………………

7

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..

7

1.6

Possible side Effects of Shockwave Treatment…………………………………………………………………………………………………….

7

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………

8

1.8

Contra-indications for Shockwave Treatment……………………………………………………………………………………………………….

8

2 INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..

9

2.1

The Front Panel of the BTL-6000 SWT Topline ……………………………………………………………………………………………………

9

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..

9

2.3

The Rear Panel of the BTL-6000 SWT Topline…………………………………………………………………………………………………..

10

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….

11

2.5

Basic Displays and Operating of the Device ………………………………………………………………………………………………………

12

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………

12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..

12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………

13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………

13

2.6.1

Setting Therapy Parameters Via the ‘diag’ Button …………………………………………………………………………………………….

13

2.6.2

Setting Therapy Parameters Via the ‘prog’ Button …………………………………………………………………………………………….

13

2.6.3

Setting Therapy Parameters Manually (User Setup) Via the ‘man’ Button ……………………………………………………………

14

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….

14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………

15

2.6.6

Therapy Parameters Screen – Ergonomic, Standard and Expert Mode………………………………………………………………..

16

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………

16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….

16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..

17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..

17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..

17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….

19

2.10

User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………

19

2.10.1

Clients……………………………………………………………………………………………………………………………………………………….

20

2.10.2

User Diagnoses/Programs ……………………………………………………………………………………………………………………………

20

2.10.3

Recent Therapies………………………………………………………………………………………………………………………………………..

20

2.11

Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..

20

2.11.1

Accessories………………………………………………………………………………………………………………………………………………..

20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..

20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..

21

2.11.2

Encyclopaedia…………………………………………………………………………………………………………………………………………….

21

2.11.3

Unit Settings……………………………………………………………………………………………………………………………………………….

22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….

22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………

22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..

22

2.11.3.4

Colour Setting………………………………………………………………………………………………………………………………………

22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..

23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..

23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….

23

PAGE 3 OF 38

2.11.3.8

Operation Mode ……………………………………………………………………………………………………………………………………

23

2.11.3.9

Touch Panel Calibration…………………………………………………………………………………………………………………………

23

2.11.3.10

User Options………………………………………………………………………………………………………………………………………..

23

2.11.3.11

Setting of HW Key ………………………………………………………………………………………………………………………………..

23

2.11.3.12

Unit Information ……………………………………………………………………………………………………………………………………

23

2.11.3.13

Unlock Code ………………………………………………………………………………………………………………………………………..

23

2.11.3.14

Service Functions …………………………………………………………………………………………………………………………………

24

2.11.4 Specific Settings …………………………………………………………………………………………………………………………………………

24

2.11.4.1

Applicator Button Mode………………………………………………………………………………………………………………………….

24

2.11.4.2

Applicator Kit Replacement Wizard ………………………………………………………………………………………………………….

24

3 LIST OF STANDARD AND OPTIONAL ACCESSORIES ……………………………………………………………………………………….

25

4 MAINTENANCE AND SAFETY INSTRUCTIONS………………………………………………………………………………………………….

26

4.1.1 Shock Transmitter Replacement Procedure …………………………………………………………………………………………………….

27

4.1.2 Procedure of Worn-out Tube and Projectile Replacement ………………………………………………………………………………….

28

4.2

General Safety Precautions…………………………………………………………………………………………………………………………….

31

4.3

Used Symbols ………………………………………………………………………………………………………………………………………………

32

4.4

Warranty………………………………………………………………………………………………………………………………………………………

32

5

TECHNICAL PARAMETERS …………………………………………………………………………………………………………………………….

33

5.1

EMC Information …………………………………………………………………………………………………………………………………………..

35

5.2

Applicable Standards……………………………………………………………………………………………………………………………………..

37

5.3

Manufacturer ………………………………………………………………………………………………………………………………………………..

38

PAGE 4 OF 38

1 GENERAL CHARACTERISTICS OF THE DEVICE

The BTL-6000 SWT Topline 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.

The device is equipped with a color touch screen on the main unit which considerably simplifies its use. The touch screen is equipped with a stylus (touch-pen) for easy operation of the device. The horizontally orientation of the device allows the information on the screen to be seen clearly from different servicing positions. Additionally, the brightness of the screen can be set to match the lighting in the room of the office or the health-care center. The on-screen information will guide the user step- by-step through the entire therapy process. The therapeutic parameters are easily set using the touch screen buttons and knobs/keys on the device.

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-6000 SWT Topline is the predefined programs stored in the memory of the main unit. 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-6000 SWT Topline 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.

We also carry a specially-designed cart for the BTL-6000 SWT Topline 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.

For the latest information on BTL products and services, please visit our corporate website at http://www.btlnet.com.

1.1BTL–6000 SWT TOPLINE SYSTEM SERIES

The device consists of two parts: the main unit and the applicator

Main Unit: BTL-6000 SWT Topline which contains the main microcomputer and software for controlling the entire system,in also includes the user encyclopaedia and the therapy guide.

Applicator – ergonomical applicator simplifies the „course of» the therapy, following the instructionsof the main unit.

The BTL-6000 SWT Topline 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.

The device consists of two parts:

Main Unit – contains the main microcomputer and software for controlling the entire system

Applicator – this ergonomically designed applicator will simplify the course of therapy

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 5 OF 38

1.2 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 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 cavitation (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.

A shockwave is defined as a pressure pulse with these characteristics:

High positive pressure amplitude: 10 to 1000 MPa = 100 to 1000 Bar (100x atmospheric pressure)

Low negative pressure amplitude: 1 to 10 MPa

Short time duration: 1 µs to 20 µs

Rapid pressure increase: < 100 ns

Broad frequency spectrum: 1 Hz to 1 MHz

For therapeutic applications, these values are lower, especially the maximum pressure amplitude. The maximum pressure amplitude is about 15 MPa, the pulse length is 10 to 20 µs, and the frequency of the applied shockwave is 1 to 15Hz. The treatment is generally carried out without local anaesthesia and lasts about 15 to 30 minutes. During the first week after treatment, the client should avoid all physical activities that could excessively strain the treated area.

1.3 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-6000 SWT Topline uses the ballistic principle of shockwave generation.

1.3.1BALLISTIC 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.

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 6 OF 38

1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT

The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface.

There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects:

Cellular: Increase in cell membrane transmittance by improving ionic channels activity, stimulation of cell division, stimulation of cellular cytokines production.

Reproduction of vessels in the area of tendons and muscles: Improvement of blood circulation and MTB, increase in concentration of growth factor beta 1, chemotactic and mitogenic effect on osteoblasts.

Effect on nitrogen oxide system: Bone healing and re-modelling.

Improvement of micro-circulation and metabolism

Dissolution of calcified fibroblasts

Supports the production of collagen

Reduction in tissue tension

Analgesic effect:

o Destruction of afferent nerves and nerve receptors.

o CNS stimulants, sensed as pain, are also inflammation transmitter substances. o Regression of pain caused by local ischemia.

oGate control theory of pain.

1.5ADVANTAGES OF SHOCKWAVE TREATMENT

By the targeted application of the shockwaves, stress to the surrounding tissues is quite insignificant.

The body is not burdened by pharmaceuticals, except the short-term effect of local anaesthesia, if used.

The possibility of preventing the necessity of surgical intervention and its relevant hazards.

Thanks to ambulatory treatment, work absences are reduced to a minimum. Additionally, training routine absences for sport athletes is likewise reduced.

For some indications, such as Tennis Elbow, there is really no other effective treatment.

1.6POSSIBLE 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

Hematoma

Petechiae

Skin damage after previous corticoid therapy

Shockwave application can cause undesirable heart activity

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 7 OF 38

1.7INDICATIONS FOR SHOCKWAVE TREATMENT

Plantar Fasciitis

Achillodynia/Achillobursitis

Inflammations and calcification of shoulder joint tendons.

Pain in the groin area.

Epicondylitis (Tennis and Golf Elbow)

Apex Patellae Syndrome and Tibial Stress Syndrome.

Pain in the hip area and/or the iliotibial tract.

Jumper’s Knee (Patellar Tendinitis)

Pain in the hamstring insertions.

Pain on the palmar side of the wrist.

Exostoses of small hand joints from Grade 1 Arthrosis.

Acupuncture

Pain trigger-points or painful points in muscles.

1.8CONTRA-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)

Polypus in the area of treatment

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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 8 OF 38

2INSTRUCTIONS FOR OPERATION

2.1THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE

1

7

103

104

1.touch screen

2.select knob (to select individual parameters)

3.enter key

4.esc key

5.start / stop key (to start and stop therapy)

6.ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’ )

7.USB port in the space of the device’s grip for use only in compliance with IEC 60950-1

The USB port serves only for service purposes such as upload of firmware; it is not designed for therapy use!

2.2APPLICATOR FOR BTL-6000 SWT TOPLINE

8.hand rest of the applicator

9.shock transmitter of the applicator

10.shock transmitter screw cap of the applicator

11.connector of the applicator

12.guide mark of the connector

13.applicator button: to start therapy

INSTRUCTIONS FOR OPERATION | PAGE 9 OF 38

2.3THE REAR PANEL OF THE BTL-6000 SWT TOPLINE

14.connector for shockwave applicator

15.control unit mains fuse

16.connector for power cable

17.power on/off switch

18.vessel for collecting condensed water

19.type label – contains type of the device, manufacturer and safety and warning signs

20.venting grid

INSTRUCTIONS FOR OPERATION | PAGE 10 OF 38

2.4ASSEMBLY 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 source until the device has had to equilibrate to room temperature (Minimum 2 hours).

Unpack the device and place it on a stable horizontal surface which is suitable for its weight. Always position the device out of direct sunlight. During operation, the control unit 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. Do not cover or block these vents. Allow a minimum of 4 inches (10cm) 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 put any heat-producing devices or objects containing water or other liquid 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 service of BTL devices.

Procedure:

1.First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket. The device detects the voltage automatically.

Plug the device directly into the mains socket. Do not use any multi-connection extension cables or two-socket adaptors.

2.Connect the applicator to the connector on the rear panel as follows:

Turn the applicator so that the red dot on its end is in straight line with the red dot on the output connector and only then plug the connector in.

When disconnecting the connector take the indented part of the applicator connector’s end in your fingers and pull slowly towards you to disconnect the connector carefully.

CAUTION! DO NOT TURN THE ENTIRE CONNECTED CONNECTOR BY FORCE, OTHERWISE THERE IS A RISK OF DAMAGE TO THE DEVICE!

The device detects the accessory, specifies its type and displays it on the screen in the appropriate tab. If you connect an improper accessory by mistake, the display shows a message with a help where to connect the given accessory.

3.Then switch on the power on/off switch on the rear panel of the device.

4.Press the on/off switch located on the front panel of the device.

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 your authorized BTL distributor.

INSTRUCTIONS FOR OPERATION | PAGE 11 OF 38

2.5BASIC DISPLAYS AND OPERATING OF THE DEVICE

2.5.1INITIAL SCREEN AND TYPES OF TABS

The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories.

Examples of information shown on the tabs:

Indicates that no accessories are connected

Indicates that the applicator is connected and shockwave therapy can be applied.

2.5.2TOUCH 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

Channels tabs to switch between the channels and selection

The items on the touch screen can be pressed by a finger or by using a special pointer with a soft tip, so — called touchpen, which is included in the accessories of the device. The touch screen must not come in contact with any sharp objects, ball pens etc.

3D buttons of the menu

Information

3D buttons

Channel marking: W = shockwave

1 = No. of generator

Information about connected accessories

Buttons with the same function as

esc and enter on the control panel

INSTRUCTIONS FOR OPERATION | PAGE 12 OF 38

Comment [andy1]: Neni dostupné této verzi

CONTENTS

1

GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………5

1.1

BTL-6000 SWT Topline System Series………………………………………………………………………………………………………………5

1.2

Shockwave and Its Character ……………………………………………………………………………………………………………………………6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….6

1.3.1

1.4

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..7

1.6

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………8

1.8

2

INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..9

2.1

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..9

2.3

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….11

2.5

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………13

2.6.1

2.6.2

2.6.3

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………15

2.6.6

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….19

2.10 User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………19

2.10.1 Clients……………………………………………………………………………………………………………………………………………………….20

2.10.2 User Diagnoses/Programs ……………………………………………………………………………………………………………………………20

2.10.3 Recent Therapies………………………………………………………………………………………………………………………………………..20

2.11 Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..20

2.11.1 Accessories………………………………………………………………………………………………………………………………………………..20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..21

2.11.2 Encyclopaedia…………………………………………………………………………………………………………………………………………….21

2.11.3 Unit Settings……………………………………………………………………………………………………………………………………………….22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..22

2.11.3.4

Colour Setting ………………………………………………………………………………………………………………………………………22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….23

PAGE 3 OF 38

BTL BTL-6000 User manual

BTL-6000 SWT TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

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.

PAGE 2 OF 38

CONTENTS

1 GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………

5

1.1

BTL–6000 SWT Topline System Series………………………………………………………………………………………………………………

5

1.2

Shockwave and Its Character……………………………………………………………………………………………………………………………

6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….

6

1.3.1

Ballistic Principle of Shockwave Generation ………………………………………………………………………………………………………

6

1.4

Biological Effects of Shockwave Treatment …………………………………………………………………………………………………………

7

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..

7

1.6

Possible side Effects of Shockwave Treatment…………………………………………………………………………………………………….

7

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………

8

1.8

Contra-indications for Shockwave Treatment……………………………………………………………………………………………………….

8

2 INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..

9

2.1

The Front Panel of the BTL-6000 SWT Topline ……………………………………………………………………………………………………

9

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..

9

2.3

The Rear Panel of the BTL-6000 SWT Topline…………………………………………………………………………………………………..

10

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….

11

2.5

Basic Displays and Operating of the Device ………………………………………………………………………………………………………

12

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………

12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..

12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………

13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………

13

2.6.1

Setting Therapy Parameters Via the ‘diag’ Button …………………………………………………………………………………………….

13

2.6.2

Setting Therapy Parameters Via the ‘prog’ Button …………………………………………………………………………………………….

13

2.6.3

Setting Therapy Parameters Manually (User Setup) Via the ‘man’ Button ……………………………………………………………

14

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….

14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………

15

2.6.6

Therapy Parameters Screen – Ergonomic, Standard and Expert Mode………………………………………………………………..

16

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………

16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….

16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..

17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..

17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..

17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….

19

2.10

User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………

19

2.10.1

Clients……………………………………………………………………………………………………………………………………………………….

20

2.10.2

User Diagnoses/Programs ……………………………………………………………………………………………………………………………

20

2.10.3

Recent Therapies………………………………………………………………………………………………………………………………………..

20

2.11

Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..

20

2.11.1

Accessories………………………………………………………………………………………………………………………………………………..

20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..

20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..

21

2.11.2

Encyclopaedia…………………………………………………………………………………………………………………………………………….

21

2.11.3

Unit Settings……………………………………………………………………………………………………………………………………………….

22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….

22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………

22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..

22

2.11.3.4

Colour Setting………………………………………………………………………………………………………………………………………

22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..

23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..

23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….

23

PAGE 3 OF 38

2.11.3.8

Operation Mode ……………………………………………………………………………………………………………………………………

23

2.11.3.9

Touch Panel Calibration…………………………………………………………………………………………………………………………

23

2.11.3.10

User Options………………………………………………………………………………………………………………………………………..

23

2.11.3.11

Setting of HW Key ………………………………………………………………………………………………………………………………..

23

2.11.3.12

Unit Information ……………………………………………………………………………………………………………………………………

23

2.11.3.13

Unlock Code ………………………………………………………………………………………………………………………………………..

23

2.11.3.14

Service Functions …………………………………………………………………………………………………………………………………

24

2.11.4 Specific Settings …………………………………………………………………………………………………………………………………………

24

2.11.4.1

Applicator Button Mode………………………………………………………………………………………………………………………….

24

2.11.4.2

Applicator Kit Replacement Wizard ………………………………………………………………………………………………………….

24

3 LIST OF STANDARD AND OPTIONAL ACCESSORIES ……………………………………………………………………………………….

25

4 MAINTENANCE AND SAFETY INSTRUCTIONS………………………………………………………………………………………………….

26

4.1.1 Shock Transmitter Replacement Procedure …………………………………………………………………………………………………….

27

4.1.2 Procedure of Worn-out Tube and Projectile Replacement ………………………………………………………………………………….

28

4.2

General Safety Precautions…………………………………………………………………………………………………………………………….

31

4.3

Used Symbols ………………………………………………………………………………………………………………………………………………

32

4.4

Warranty………………………………………………………………………………………………………………………………………………………

32

5

TECHNICAL PARAMETERS …………………………………………………………………………………………………………………………….

33

5.1

EMC Information …………………………………………………………………………………………………………………………………………..

35

5.2

Applicable Standards……………………………………………………………………………………………………………………………………..

37

5.3

Manufacturer ………………………………………………………………………………………………………………………………………………..

38

PAGE 4 OF 38

1 GENERAL CHARACTERISTICS OF THE DEVICE

The BTL-6000 SWT Topline 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.

The device is equipped with a color touch screen on the main unit which considerably simplifies its use. The touch screen is equipped with a stylus (touch-pen) for easy operation of the device. The horizontally orientation of the device allows the information on the screen to be seen clearly from different servicing positions. Additionally, the brightness of the screen can be set to match the lighting in the room of the office or the health-care center. The on-screen information will guide the user step- by-step through the entire therapy process. The therapeutic parameters are easily set using the touch screen buttons and knobs/keys on the device.

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-6000 SWT Topline is the predefined programs stored in the memory of the main unit. 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-6000 SWT Topline 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.

We also carry a specially-designed cart for the BTL-6000 SWT Topline 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.

For the latest information on BTL products and services, please visit our corporate website at http://www.btlnet.com.

1.1BTL–6000 SWT TOPLINE SYSTEM SERIES

The device consists of two parts: the main unit and the applicator

Main Unit: BTL-6000 SWT Topline which contains the main microcomputer and software for controlling the entire system,in also includes the user encyclopaedia and the therapy guide.

Applicator – ergonomical applicator simplifies the „course of» the therapy, following the instructionsof the main unit.

The BTL-6000 SWT Topline 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.

The device consists of two parts:

Main Unit – contains the main microcomputer and software for controlling the entire system

Applicator – this ergonomically designed applicator will simplify the course of therapy

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 5 OF 38

1.2 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 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 cavitation (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.

A shockwave is defined as a pressure pulse with these characteristics:

High positive pressure amplitude: 10 to 1000 MPa = 100 to 1000 Bar (100x atmospheric pressure)

Low negative pressure amplitude: 1 to 10 MPa

Short time duration: 1 µs to 20 µs

Rapid pressure increase: < 100 ns

Broad frequency spectrum: 1 Hz to 1 MHz

For therapeutic applications, these values are lower, especially the maximum pressure amplitude. The maximum pressure amplitude is about 15 MPa, the pulse length is 10 to 20 µs, and the frequency of the applied shockwave is 1 to 15Hz. The treatment is generally carried out without local anaesthesia and lasts about 15 to 30 minutes. During the first week after treatment, the client should avoid all physical activities that could excessively strain the treated area.

1.3 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-6000 SWT Topline uses the ballistic principle of shockwave generation.

1.3.1BALLISTIC 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.

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 6 OF 38

1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT

The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface.

There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects:

Cellular: Increase in cell membrane transmittance by improving ionic channels activity, stimulation of cell division, stimulation of cellular cytokines production.

Reproduction of vessels in the area of tendons and muscles: Improvement of blood circulation and MTB, increase in concentration of growth factor beta 1, chemotactic and mitogenic effect on osteoblasts.

Effect on nitrogen oxide system: Bone healing and re-modelling.

Improvement of micro-circulation and metabolism

Dissolution of calcified fibroblasts

Supports the production of collagen

Reduction in tissue tension

Analgesic effect:

o Destruction of afferent nerves and nerve receptors.

o CNS stimulants, sensed as pain, are also inflammation transmitter substances. o Regression of pain caused by local ischemia.

oGate control theory of pain.

1.5ADVANTAGES OF SHOCKWAVE TREATMENT

By the targeted application of the shockwaves, stress to the surrounding tissues is quite insignificant.

The body is not burdened by pharmaceuticals, except the short-term effect of local anaesthesia, if used.

The possibility of preventing the necessity of surgical intervention and its relevant hazards.

Thanks to ambulatory treatment, work absences are reduced to a minimum. Additionally, training routine absences for sport athletes is likewise reduced.

For some indications, such as Tennis Elbow, there is really no other effective treatment.

1.6POSSIBLE 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

Hematoma

Petechiae

Skin damage after previous corticoid therapy

Shockwave application can cause undesirable heart activity

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 7 OF 38

1.7INDICATIONS FOR SHOCKWAVE TREATMENT

Plantar Fasciitis

Achillodynia/Achillobursitis

Inflammations and calcification of shoulder joint tendons.

Pain in the groin area.

Epicondylitis (Tennis and Golf Elbow)

Apex Patellae Syndrome and Tibial Stress Syndrome.

Pain in the hip area and/or the iliotibial tract.

Jumper’s Knee (Patellar Tendinitis)

Pain in the hamstring insertions.

Pain on the palmar side of the wrist.

Exostoses of small hand joints from Grade 1 Arthrosis.

Acupuncture

Pain trigger-points or painful points in muscles.

1.8CONTRA-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)

Polypus in the area of treatment

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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 8 OF 38

2INSTRUCTIONS FOR OPERATION

2.1THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE

1

7

103

104

1.touch screen

2.select knob (to select individual parameters)

3.enter key

4.esc key

5.start / stop key (to start and stop therapy)

6.ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’ )

7.USB port in the space of the device’s grip for use only in compliance with IEC 60950-1

The USB port serves only for service purposes such as upload of firmware; it is not designed for therapy use!

2.2APPLICATOR FOR BTL-6000 SWT TOPLINE

8.hand rest of the applicator

9.shock transmitter of the applicator

10.shock transmitter screw cap of the applicator

11.connector of the applicator

12.guide mark of the connector

13.applicator button: to start therapy

INSTRUCTIONS FOR OPERATION | PAGE 9 OF 38

2.3THE REAR PANEL OF THE BTL-6000 SWT TOPLINE

14.connector for shockwave applicator

15.control unit mains fuse

16.connector for power cable

17.power on/off switch

18.vessel for collecting condensed water

19.type label – contains type of the device, manufacturer and safety and warning signs

20.venting grid

INSTRUCTIONS FOR OPERATION | PAGE 10 OF 38

2.4ASSEMBLY 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 source until the device has had to equilibrate to room temperature (Minimum 2 hours).

Unpack the device and place it on a stable horizontal surface which is suitable for its weight. Always position the device out of direct sunlight. During operation, the control unit 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. Do not cover or block these vents. Allow a minimum of 4 inches (10cm) 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 put any heat-producing devices or objects containing water or other liquid 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 service of BTL devices.

Procedure:

1.First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket. The device detects the voltage automatically.

Plug the device directly into the mains socket. Do not use any multi-connection extension cables or two-socket adaptors.

2.Connect the applicator to the connector on the rear panel as follows:

Turn the applicator so that the red dot on its end is in straight line with the red dot on the output connector and only then plug the connector in.

When disconnecting the connector take the indented part of the applicator connector’s end in your fingers and pull slowly towards you to disconnect the connector carefully.

CAUTION! DO NOT TURN THE ENTIRE CONNECTED CONNECTOR BY FORCE, OTHERWISE THERE IS A RISK OF DAMAGE TO THE DEVICE!

The device detects the accessory, specifies its type and displays it on the screen in the appropriate tab. If you connect an improper accessory by mistake, the display shows a message with a help where to connect the given accessory.

3.Then switch on the power on/off switch on the rear panel of the device.

4.Press the on/off switch located on the front panel of the device.

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 your authorized BTL distributor.

INSTRUCTIONS FOR OPERATION | PAGE 11 OF 38

2.5BASIC DISPLAYS AND OPERATING OF THE DEVICE

2.5.1INITIAL SCREEN AND TYPES OF TABS

The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories.

Examples of information shown on the tabs:

Indicates that no accessories are connected

Indicates that the applicator is connected and shockwave therapy can be applied.

2.5.2TOUCH 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

Channels tabs to switch between the channels and selection

The items on the touch screen can be pressed by a finger or by using a special pointer with a soft tip, so — called touchpen, which is included in the accessories of the device. The touch screen must not come in contact with any sharp objects, ball pens etc.

3D buttons of the menu

Information

3D buttons

Channel marking: W = shockwave

1 = No. of generator

Information about connected accessories

Buttons with the same function as

esc and enter on the control panel

INSTRUCTIONS FOR OPERATION | PAGE 12 OF 38

Comment [andy1]: Neni dostupné této verzi

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BTL BTL-6000 User manual

BTL-6000 SWT TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

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.

PAGE 2 OF 38

CONTENTS

1 GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………

5

1.1

BTL–6000 SWT Topline System Series………………………………………………………………………………………………………………

5

1.2

Shockwave and Its Character……………………………………………………………………………………………………………………………

6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….

6

1.3.1

Ballistic Principle of Shockwave Generation ………………………………………………………………………………………………………

6

1.4

Biological Effects of Shockwave Treatment …………………………………………………………………………………………………………

7

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..

7

1.6

Possible side Effects of Shockwave Treatment…………………………………………………………………………………………………….

7

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………

8

1.8

Contra-indications for Shockwave Treatment……………………………………………………………………………………………………….

8

2 INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..

9

2.1

The Front Panel of the BTL-6000 SWT Topline ……………………………………………………………………………………………………

9

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..

9

2.3

The Rear Panel of the BTL-6000 SWT Topline…………………………………………………………………………………………………..

10

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….

11

2.5

Basic Displays and Operating of the Device ………………………………………………………………………………………………………

12

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………

12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..

12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………

13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………

13

2.6.1

Setting Therapy Parameters Via the ‘diag’ Button …………………………………………………………………………………………….

13

2.6.2

Setting Therapy Parameters Via the ‘prog’ Button …………………………………………………………………………………………….

13

2.6.3

Setting Therapy Parameters Manually (User Setup) Via the ‘man’ Button ……………………………………………………………

14

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….

14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………

15

2.6.6

Therapy Parameters Screen – Ergonomic, Standard and Expert Mode………………………………………………………………..

16

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………

16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….

16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..

17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..

17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..

17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….

19

2.10

User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………

19

2.10.1

Clients……………………………………………………………………………………………………………………………………………………….

20

2.10.2

User Diagnoses/Programs ……………………………………………………………………………………………………………………………

20

2.10.3

Recent Therapies………………………………………………………………………………………………………………………………………..

20

2.11

Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..

20

2.11.1

Accessories………………………………………………………………………………………………………………………………………………..

20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..

20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..

21

2.11.2

Encyclopaedia…………………………………………………………………………………………………………………………………………….

21

2.11.3

Unit Settings……………………………………………………………………………………………………………………………………………….

22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….

22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………

22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..

22

2.11.3.4

Colour Setting………………………………………………………………………………………………………………………………………

22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..

23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..

23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….

23

PAGE 3 OF 38

2.11.3.8

Operation Mode ……………………………………………………………………………………………………………………………………

23

2.11.3.9

Touch Panel Calibration…………………………………………………………………………………………………………………………

23

2.11.3.10

User Options………………………………………………………………………………………………………………………………………..

23

2.11.3.11

Setting of HW Key ………………………………………………………………………………………………………………………………..

23

2.11.3.12

Unit Information ……………………………………………………………………………………………………………………………………

23

2.11.3.13

Unlock Code ………………………………………………………………………………………………………………………………………..

23

2.11.3.14

Service Functions …………………………………………………………………………………………………………………………………

24

2.11.4 Specific Settings …………………………………………………………………………………………………………………………………………

24

2.11.4.1

Applicator Button Mode………………………………………………………………………………………………………………………….

24

2.11.4.2

Applicator Kit Replacement Wizard ………………………………………………………………………………………………………….

24

3 LIST OF STANDARD AND OPTIONAL ACCESSORIES ……………………………………………………………………………………….

25

4 MAINTENANCE AND SAFETY INSTRUCTIONS………………………………………………………………………………………………….

26

4.1.1 Shock Transmitter Replacement Procedure …………………………………………………………………………………………………….

27

4.1.2 Procedure of Worn-out Tube and Projectile Replacement ………………………………………………………………………………….

28

4.2

General Safety Precautions…………………………………………………………………………………………………………………………….

31

4.3

Used Symbols ………………………………………………………………………………………………………………………………………………

32

4.4

Warranty………………………………………………………………………………………………………………………………………………………

32

5

TECHNICAL PARAMETERS …………………………………………………………………………………………………………………………….

33

5.1

EMC Information …………………………………………………………………………………………………………………………………………..

35

5.2

Applicable Standards……………………………………………………………………………………………………………………………………..

37

5.3

Manufacturer ………………………………………………………………………………………………………………………………………………..

38

PAGE 4 OF 38

1 GENERAL CHARACTERISTICS OF THE DEVICE

The BTL-6000 SWT Topline 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.

The device is equipped with a color touch screen on the main unit which considerably simplifies its use. The touch screen is equipped with a stylus (touch-pen) for easy operation of the device. The horizontally orientation of the device allows the information on the screen to be seen clearly from different servicing positions. Additionally, the brightness of the screen can be set to match the lighting in the room of the office or the health-care center. The on-screen information will guide the user step- by-step through the entire therapy process. The therapeutic parameters are easily set using the touch screen buttons and knobs/keys on the device.

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-6000 SWT Topline is the predefined programs stored in the memory of the main unit. 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-6000 SWT Topline 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.

We also carry a specially-designed cart for the BTL-6000 SWT Topline 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.

For the latest information on BTL products and services, please visit our corporate website at http://www.btlnet.com.

1.1BTL–6000 SWT TOPLINE SYSTEM SERIES

The device consists of two parts: the main unit and the applicator

Main Unit: BTL-6000 SWT Topline which contains the main microcomputer and software for controlling the entire system,in also includes the user encyclopaedia and the therapy guide.

Applicator – ergonomical applicator simplifies the „course of» the therapy, following the instructionsof the main unit.

The BTL-6000 SWT Topline 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.

The device consists of two parts:

Main Unit – contains the main microcomputer and software for controlling the entire system

Applicator – this ergonomically designed applicator will simplify the course of therapy

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 5 OF 38

1.2 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 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 cavitation (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.

A shockwave is defined as a pressure pulse with these characteristics:

High positive pressure amplitude: 10 to 1000 MPa = 100 to 1000 Bar (100x atmospheric pressure)

Low negative pressure amplitude: 1 to 10 MPa

Short time duration: 1 µs to 20 µs

Rapid pressure increase: < 100 ns

Broad frequency spectrum: 1 Hz to 1 MHz

For therapeutic applications, these values are lower, especially the maximum pressure amplitude. The maximum pressure amplitude is about 15 MPa, the pulse length is 10 to 20 µs, and the frequency of the applied shockwave is 1 to 15Hz. The treatment is generally carried out without local anaesthesia and lasts about 15 to 30 minutes. During the first week after treatment, the client should avoid all physical activities that could excessively strain the treated area.

1.3 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-6000 SWT Topline uses the ballistic principle of shockwave generation.

1.3.1BALLISTIC 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.

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 6 OF 38

1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT

The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface.

There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects:

Cellular: Increase in cell membrane transmittance by improving ionic channels activity, stimulation of cell division, stimulation of cellular cytokines production.

Reproduction of vessels in the area of tendons and muscles: Improvement of blood circulation and MTB, increase in concentration of growth factor beta 1, chemotactic and mitogenic effect on osteoblasts.

Effect on nitrogen oxide system: Bone healing and re-modelling.

Improvement of micro-circulation and metabolism

Dissolution of calcified fibroblasts

Supports the production of collagen

Reduction in tissue tension

Analgesic effect:

o Destruction of afferent nerves and nerve receptors.

o CNS stimulants, sensed as pain, are also inflammation transmitter substances. o Regression of pain caused by local ischemia.

oGate control theory of pain.

1.5ADVANTAGES OF SHOCKWAVE TREATMENT

By the targeted application of the shockwaves, stress to the surrounding tissues is quite insignificant.

The body is not burdened by pharmaceuticals, except the short-term effect of local anaesthesia, if used.

The possibility of preventing the necessity of surgical intervention and its relevant hazards.

Thanks to ambulatory treatment, work absences are reduced to a minimum. Additionally, training routine absences for sport athletes is likewise reduced.

For some indications, such as Tennis Elbow, there is really no other effective treatment.

1.6POSSIBLE 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

Hematoma

Petechiae

Skin damage after previous corticoid therapy

Shockwave application can cause undesirable heart activity

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 7 OF 38

1.7INDICATIONS FOR SHOCKWAVE TREATMENT

Plantar Fasciitis

Achillodynia/Achillobursitis

Inflammations and calcification of shoulder joint tendons.

Pain in the groin area.

Epicondylitis (Tennis and Golf Elbow)

Apex Patellae Syndrome and Tibial Stress Syndrome.

Pain in the hip area and/or the iliotibial tract.

Jumper’s Knee (Patellar Tendinitis)

Pain in the hamstring insertions.

Pain on the palmar side of the wrist.

Exostoses of small hand joints from Grade 1 Arthrosis.

Acupuncture

Pain trigger-points or painful points in muscles.

1.8CONTRA-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)

Polypus in the area of treatment

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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 8 OF 38

2INSTRUCTIONS FOR OPERATION

2.1THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE

1

7

103

104

1.touch screen

2.select knob (to select individual parameters)

3.enter key

4.esc key

5.start / stop key (to start and stop therapy)

6.ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’ )

7.USB port in the space of the device’s grip for use only in compliance with IEC 60950-1

The USB port serves only for service purposes such as upload of firmware; it is not designed for therapy use!

2.2APPLICATOR FOR BTL-6000 SWT TOPLINE

8.hand rest of the applicator

9.shock transmitter of the applicator

10.shock transmitter screw cap of the applicator

11.connector of the applicator

12.guide mark of the connector

13.applicator button: to start therapy

INSTRUCTIONS FOR OPERATION | PAGE 9 OF 38

2.3THE REAR PANEL OF THE BTL-6000 SWT TOPLINE

14.connector for shockwave applicator

15.control unit mains fuse

16.connector for power cable

17.power on/off switch

18.vessel for collecting condensed water

19.type label – contains type of the device, manufacturer and safety and warning signs

20.venting grid

INSTRUCTIONS FOR OPERATION | PAGE 10 OF 38

2.4ASSEMBLY 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 source until the device has had to equilibrate to room temperature (Minimum 2 hours).

Unpack the device and place it on a stable horizontal surface which is suitable for its weight. Always position the device out of direct sunlight. During operation, the control unit 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. Do not cover or block these vents. Allow a minimum of 4 inches (10cm) 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 put any heat-producing devices or objects containing water or other liquid 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 service of BTL devices.

Procedure:

1.First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket. The device detects the voltage automatically.

Plug the device directly into the mains socket. Do not use any multi-connection extension cables or two-socket adaptors.

2.Connect the applicator to the connector on the rear panel as follows:

Turn the applicator so that the red dot on its end is in straight line with the red dot on the output connector and only then plug the connector in.

When disconnecting the connector take the indented part of the applicator connector’s end in your fingers and pull slowly towards you to disconnect the connector carefully.

CAUTION! DO NOT TURN THE ENTIRE CONNECTED CONNECTOR BY FORCE, OTHERWISE THERE IS A RISK OF DAMAGE TO THE DEVICE!

The device detects the accessory, specifies its type and displays it on the screen in the appropriate tab. If you connect an improper accessory by mistake, the display shows a message with a help where to connect the given accessory.

3.Then switch on the power on/off switch on the rear panel of the device.

4.Press the on/off switch located on the front panel of the device.

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 your authorized BTL distributor.

INSTRUCTIONS FOR OPERATION | PAGE 11 OF 38

2.5BASIC DISPLAYS AND OPERATING OF THE DEVICE

2.5.1INITIAL SCREEN AND TYPES OF TABS

The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories.

Examples of information shown on the tabs:

Indicates that no accessories are connected

Indicates that the applicator is connected and shockwave therapy can be applied.

2.5.2TOUCH 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

Channels tabs to switch between the channels and selection

The items on the touch screen can be pressed by a finger or by using a special pointer with a soft tip, so — called touchpen, which is included in the accessories of the device. The touch screen must not come in contact with any sharp objects, ball pens etc.

3D buttons of the menu

Information

3D buttons

Channel marking: W = shockwave

1 = No. of generator

Information about connected accessories

Buttons with the same function as

esc and enter on the control panel

INSTRUCTIONS FOR OPERATION | PAGE 12 OF 38

Comment [andy1]: Neni dostupné této verzi

CONTENTS

1

GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………5

1.1

BTL-6000 SWT Topline System Series………………………………………………………………………………………………………………5

1.2

Shockwave and Its Character ……………………………………………………………………………………………………………………………6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….6

1.3.1

1.4

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..7

1.6

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………8

1.8

2

INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..9

2.1

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..9

2.3

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….11

2.5

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………13

2.6.1

2.6.2

2.6.3

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………15

2.6.6

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….19

2.10 User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………19

2.10.1 Clients……………………………………………………………………………………………………………………………………………………….20

2.10.2 User Diagnoses/Programs ……………………………………………………………………………………………………………………………20

2.10.3 Recent Therapies………………………………………………………………………………………………………………………………………..20

2.11 Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..20

2.11.1 Accessories………………………………………………………………………………………………………………………………………………..20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..21

2.11.2 Encyclopaedia…………………………………………………………………………………………………………………………………………….21

2.11.3 Unit Settings……………………………………………………………………………………………………………………………………………….22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..22

2.11.3.4

Colour Setting ………………………………………………………………………………………………………………………………………22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….23

PAGE 3 OF 38

BTL BTL-6000 User manual

BTL-6000 SWT TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

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.

PAGE 2 OF 38

CONTENTS

1 GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………

5

1.1

BTL–6000 SWT Topline System Series………………………………………………………………………………………………………………

5

1.2

Shockwave and Its Character……………………………………………………………………………………………………………………………

6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….

6

1.3.1

Ballistic Principle of Shockwave Generation ………………………………………………………………………………………………………

6

1.4

Biological Effects of Shockwave Treatment …………………………………………………………………………………………………………

7

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..

7

1.6

Possible side Effects of Shockwave Treatment…………………………………………………………………………………………………….

7

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………

8

1.8

Contra-indications for Shockwave Treatment……………………………………………………………………………………………………….

8

2 INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..

9

2.1

The Front Panel of the BTL-6000 SWT Topline ……………………………………………………………………………………………………

9

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..

9

2.3

The Rear Panel of the BTL-6000 SWT Topline…………………………………………………………………………………………………..

10

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….

11

2.5

Basic Displays and Operating of the Device ………………………………………………………………………………………………………

12

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………

12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..

12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………

13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………

13

2.6.1

Setting Therapy Parameters Via the ‘diag’ Button …………………………………………………………………………………………….

13

2.6.2

Setting Therapy Parameters Via the ‘prog’ Button …………………………………………………………………………………………….

13

2.6.3

Setting Therapy Parameters Manually (User Setup) Via the ‘man’ Button ……………………………………………………………

14

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….

14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………

15

2.6.6

Therapy Parameters Screen – Ergonomic, Standard and Expert Mode………………………………………………………………..

16

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………

16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….

16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..

17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..

17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..

17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….

19

2.10

User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………

19

2.10.1

Clients……………………………………………………………………………………………………………………………………………………….

20

2.10.2

User Diagnoses/Programs ……………………………………………………………………………………………………………………………

20

2.10.3

Recent Therapies………………………………………………………………………………………………………………………………………..

20

2.11

Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..

20

2.11.1

Accessories………………………………………………………………………………………………………………………………………………..

20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..

20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..

21

2.11.2

Encyclopaedia…………………………………………………………………………………………………………………………………………….

21

2.11.3

Unit Settings……………………………………………………………………………………………………………………………………………….

22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….

22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………

22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..

22

2.11.3.4

Colour Setting………………………………………………………………………………………………………………………………………

22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..

23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..

23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….

23

PAGE 3 OF 38

2.11.3.8

Operation Mode ……………………………………………………………………………………………………………………………………

23

2.11.3.9

Touch Panel Calibration…………………………………………………………………………………………………………………………

23

2.11.3.10

User Options………………………………………………………………………………………………………………………………………..

23

2.11.3.11

Setting of HW Key ………………………………………………………………………………………………………………………………..

23

2.11.3.12

Unit Information ……………………………………………………………………………………………………………………………………

23

2.11.3.13

Unlock Code ………………………………………………………………………………………………………………………………………..

23

2.11.3.14

Service Functions …………………………………………………………………………………………………………………………………

24

2.11.4 Specific Settings …………………………………………………………………………………………………………………………………………

24

2.11.4.1

Applicator Button Mode………………………………………………………………………………………………………………………….

24

2.11.4.2

Applicator Kit Replacement Wizard ………………………………………………………………………………………………………….

24

3 LIST OF STANDARD AND OPTIONAL ACCESSORIES ……………………………………………………………………………………….

25

4 MAINTENANCE AND SAFETY INSTRUCTIONS………………………………………………………………………………………………….

26

4.1.1 Shock Transmitter Replacement Procedure …………………………………………………………………………………………………….

27

4.1.2 Procedure of Worn-out Tube and Projectile Replacement ………………………………………………………………………………….

28

4.2

General Safety Precautions…………………………………………………………………………………………………………………………….

31

4.3

Used Symbols ………………………………………………………………………………………………………………………………………………

32

4.4

Warranty………………………………………………………………………………………………………………………………………………………

32

5

TECHNICAL PARAMETERS …………………………………………………………………………………………………………………………….

33

5.1

EMC Information …………………………………………………………………………………………………………………………………………..

35

5.2

Applicable Standards……………………………………………………………………………………………………………………………………..

37

5.3

Manufacturer ………………………………………………………………………………………………………………………………………………..

38

PAGE 4 OF 38

1 GENERAL CHARACTERISTICS OF THE DEVICE

The BTL-6000 SWT Topline 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.

The device is equipped with a color touch screen on the main unit which considerably simplifies its use. The touch screen is equipped with a stylus (touch-pen) for easy operation of the device. The horizontally orientation of the device allows the information on the screen to be seen clearly from different servicing positions. Additionally, the brightness of the screen can be set to match the lighting in the room of the office or the health-care center. The on-screen information will guide the user step- by-step through the entire therapy process. The therapeutic parameters are easily set using the touch screen buttons and knobs/keys on the device.

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-6000 SWT Topline is the predefined programs stored in the memory of the main unit. 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-6000 SWT Topline 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.

We also carry a specially-designed cart for the BTL-6000 SWT Topline 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.

For the latest information on BTL products and services, please visit our corporate website at http://www.btlnet.com.

1.1BTL–6000 SWT TOPLINE SYSTEM SERIES

The device consists of two parts: the main unit and the applicator

Main Unit: BTL-6000 SWT Topline which contains the main microcomputer and software for controlling the entire system,in also includes the user encyclopaedia and the therapy guide.

Applicator – ergonomical applicator simplifies the „course of» the therapy, following the instructionsof the main unit.

The BTL-6000 SWT Topline 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.

The device consists of two parts:

Main Unit – contains the main microcomputer and software for controlling the entire system

Applicator – this ergonomically designed applicator will simplify the course of therapy

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 5 OF 38

1.2 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 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 cavitation (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.

A shockwave is defined as a pressure pulse with these characteristics:

High positive pressure amplitude: 10 to 1000 MPa = 100 to 1000 Bar (100x atmospheric pressure)

Low negative pressure amplitude: 1 to 10 MPa

Short time duration: 1 µs to 20 µs

Rapid pressure increase: < 100 ns

Broad frequency spectrum: 1 Hz to 1 MHz

For therapeutic applications, these values are lower, especially the maximum pressure amplitude. The maximum pressure amplitude is about 15 MPa, the pulse length is 10 to 20 µs, and the frequency of the applied shockwave is 1 to 15Hz. The treatment is generally carried out without local anaesthesia and lasts about 15 to 30 minutes. During the first week after treatment, the client should avoid all physical activities that could excessively strain the treated area.

1.3 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-6000 SWT Topline uses the ballistic principle of shockwave generation.

1.3.1BALLISTIC 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.

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 6 OF 38

1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT

The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface.

There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects:

Cellular: Increase in cell membrane transmittance by improving ionic channels activity, stimulation of cell division, stimulation of cellular cytokines production.

Reproduction of vessels in the area of tendons and muscles: Improvement of blood circulation and MTB, increase in concentration of growth factor beta 1, chemotactic and mitogenic effect on osteoblasts.

Effect on nitrogen oxide system: Bone healing and re-modelling.

Improvement of micro-circulation and metabolism

Dissolution of calcified fibroblasts

Supports the production of collagen

Reduction in tissue tension

Analgesic effect:

o Destruction of afferent nerves and nerve receptors.

o CNS stimulants, sensed as pain, are also inflammation transmitter substances. o Regression of pain caused by local ischemia.

oGate control theory of pain.

1.5ADVANTAGES OF SHOCKWAVE TREATMENT

By the targeted application of the shockwaves, stress to the surrounding tissues is quite insignificant.

The body is not burdened by pharmaceuticals, except the short-term effect of local anaesthesia, if used.

The possibility of preventing the necessity of surgical intervention and its relevant hazards.

Thanks to ambulatory treatment, work absences are reduced to a minimum. Additionally, training routine absences for sport athletes is likewise reduced.

For some indications, such as Tennis Elbow, there is really no other effective treatment.

1.6POSSIBLE 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

Hematoma

Petechiae

Skin damage after previous corticoid therapy

Shockwave application can cause undesirable heart activity

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 7 OF 38

1.7INDICATIONS FOR SHOCKWAVE TREATMENT

Plantar Fasciitis

Achillodynia/Achillobursitis

Inflammations and calcification of shoulder joint tendons.

Pain in the groin area.

Epicondylitis (Tennis and Golf Elbow)

Apex Patellae Syndrome and Tibial Stress Syndrome.

Pain in the hip area and/or the iliotibial tract.

Jumper’s Knee (Patellar Tendinitis)

Pain in the hamstring insertions.

Pain on the palmar side of the wrist.

Exostoses of small hand joints from Grade 1 Arthrosis.

Acupuncture

Pain trigger-points or painful points in muscles.

1.8CONTRA-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)

Polypus in the area of treatment

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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 8 OF 38

2INSTRUCTIONS FOR OPERATION

2.1THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE

1

7

103

104

1.touch screen

2.select knob (to select individual parameters)

3.enter key

4.esc key

5.start / stop key (to start and stop therapy)

6.ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’ )

7.USB port in the space of the device’s grip for use only in compliance with IEC 60950-1

The USB port serves only for service purposes such as upload of firmware; it is not designed for therapy use!

2.2APPLICATOR FOR BTL-6000 SWT TOPLINE

8.hand rest of the applicator

9.shock transmitter of the applicator

10.shock transmitter screw cap of the applicator

11.connector of the applicator

12.guide mark of the connector

13.applicator button: to start therapy

INSTRUCTIONS FOR OPERATION | PAGE 9 OF 38

2.3THE REAR PANEL OF THE BTL-6000 SWT TOPLINE

14.connector for shockwave applicator

15.control unit mains fuse

16.connector for power cable

17.power on/off switch

18.vessel for collecting condensed water

19.type label – contains type of the device, manufacturer and safety and warning signs

20.venting grid

INSTRUCTIONS FOR OPERATION | PAGE 10 OF 38

2.4ASSEMBLY 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 source until the device has had to equilibrate to room temperature (Minimum 2 hours).

Unpack the device and place it on a stable horizontal surface which is suitable for its weight. Always position the device out of direct sunlight. During operation, the control unit 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. Do not cover or block these vents. Allow a minimum of 4 inches (10cm) 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 put any heat-producing devices or objects containing water or other liquid 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 service of BTL devices.

Procedure:

1.First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket. The device detects the voltage automatically.

Plug the device directly into the mains socket. Do not use any multi-connection extension cables or two-socket adaptors.

2.Connect the applicator to the connector on the rear panel as follows:

Turn the applicator so that the red dot on its end is in straight line with the red dot on the output connector and only then plug the connector in.

When disconnecting the connector take the indented part of the applicator connector’s end in your fingers and pull slowly towards you to disconnect the connector carefully.

CAUTION! DO NOT TURN THE ENTIRE CONNECTED CONNECTOR BY FORCE, OTHERWISE THERE IS A RISK OF DAMAGE TO THE DEVICE!

The device detects the accessory, specifies its type and displays it on the screen in the appropriate tab. If you connect an improper accessory by mistake, the display shows a message with a help where to connect the given accessory.

3.Then switch on the power on/off switch on the rear panel of the device.

4.Press the on/off switch located on the front panel of the device.

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 your authorized BTL distributor.

INSTRUCTIONS FOR OPERATION | PAGE 11 OF 38

2.5BASIC DISPLAYS AND OPERATING OF THE DEVICE

2.5.1INITIAL SCREEN AND TYPES OF TABS

The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories.

Examples of information shown on the tabs:

Indicates that no accessories are connected

Indicates that the applicator is connected and shockwave therapy can be applied.

2.5.2TOUCH 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

Channels tabs to switch between the channels and selection

The items on the touch screen can be pressed by a finger or by using a special pointer with a soft tip, so — called touchpen, which is included in the accessories of the device. The touch screen must not come in contact with any sharp objects, ball pens etc.

3D buttons of the menu

Information

3D buttons

Channel marking: W = shockwave

1 = No. of generator

Information about connected accessories

Buttons with the same function as

esc and enter on the control panel

INSTRUCTIONS FOR OPERATION | PAGE 12 OF 38

Comment [andy1]: Neni dostupné této verzi

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2015-08-06 | Просмотров [1888]

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Отрицательные стороны

Перед походом в салон Deaura я попыталась найти отзывы, но не нашла. Мне не сказали, какая будет косметика, а просто, что меня приглашают на процедуру по волосам. Сегодня я уже нашла правильные отзывы об этой косметике, но есть и целый сайт, где ее нахваливают. Думаю, это сами работники этой фирмы пишут. Практически целое здание у них на Невском, рядом с Невским Паласом, без вывески. Сколько ж туда надо денег вбухать в ремонт и платить аренду… Все подробно описывать не буду, очень похоже на бесплатную процедуру косметики Дишели. Обстановка пошикарней — различие. Но прессует консультант очень. Очень навязчиво. Даже грубо — «сколько лет-то вам уже, не девочка, пора за ум взяться» — вот в таком духе. По телефону «зазывала» пообещала 1/1, 5часа, меня прессовали 2, 5, зная, что далеко живу и дома двое детей — после работы!
Консультант (сослалась на большую личную дружбу с менеджером) притащила мня к менеджеру, просто силком, та предложила мне самое супер предложение: акцию на сегодня (стоимость курса 107000руб) за 69 с 2-х годовой рассрочкой и платежом в 3тыс рублей ежемесячно. Отказавшись, я «опозорила» своего консультанта, которая меня все время парила, и оставшееся время все сокрушалась, как я ее опозорила. Причем показуху они стараются везде устроить. Напр., когда я на минуту зашла к менеджеру (который делает предложение по цене), тут же нас «случайно поймал» другой консультант, который слезно упрашивал менеджера, о скидке, что сидит у него дама, которая готова по 10 тыс в мес платить, я ему тут же предложила мой листочек — на тебе по 3 тыс, дорогуша. Потому что менеджер ему отказала — сказала: последняя скидка сегодня предлагается лично этой даме (мне).
Молодые девушки как-то быстрее уходили, а таких девушек, как я, за 40, они особенно окучивают.
Я не верю в чудодейственность этой косметики, но волосы действительно выглядят ухоженными. Я понимаю, что этого можно добиться и другими средствами. Напр., я пользуюсь чистым кератином и коллагеном, добавляю их в средства для волос. После мытья сбрызгиваю спреем с маслом (Шварцкопф) по 300руб/флакон и у меня волосы выглядят не хуже. Уверена на 100%, что если купить их набор (а там +12 процедур=69 тыс- кредит на 2 года) такого результата не будет, только в салоне у них для разводилова средства получше стоят. Года 4 назад в компании Золотой дождь тоже была такая «спа-процедура» на лицо, я купила пробник (в принципе, недорого), но результата не было такого, как на процедуре.
Просто жаль своего времени и обманутых женщин. Я вообще как в прошлое попала года 90, когда все такими наивными были. Неужели в 2014 году такое возможно — так откровенно вымогают деньги, прикрываясь косметикой, которой 3-5 тыс красная цена? 2 аппарата их, которые входят в набор, не больше 500 руб стоят. Просто надо же как-то оплачивать это здание на Невском и зарплату куче народа, даже если у них не белее 25000, но их там толпы.

Положительные стороны

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Комментарии:

Опубликовано: 02-10-2014
ЕЛЕНА

ПРЕДПОЛАГАЯ НАДУВАТЕЛЬСТВО, ПРИ ПРОВЕРОЧНОМ ЗВОНКЕ, МОЛ ПОМНЮ ЛИ Я О ЗАВТРАШНЕЙ ПРОЦЕДУРЕ, НАИВНО ПОЖАЛОВАЛДАСЬ, ЧТО ПОЕДУ НЕ ИЗ ДОМА, А ПАСПОРТ ДОМА…

-ой, без паспорта у нас нельзя

-ну значит не получится

-а я могу вас переписать на другой день?

— нет, вам нужен мой паспорт, а не моя морда лица.

И ТАК УЖЕ ВО ВТОРОЙ РАЗ. ОЧЕНЬ БЫ ХОТЕЛА ПРИЙТИ НЕ ОДНА, ЧТОБЫ ПОНЯТЬ, НА КАКОМ МОМЕНТЕ ЧЕЛОВЕК РЕШАЕТСЯ НА КРЕДИТ… НО ИДТИ БЫЛО НЕ С КЕМ, А, УЧИТЫВАЯ МЕТОД НЕЙРОЛИНГВИСТИЧЕСКОГО ПРОГРАММИРОВАНИЯ, ПОБОЯЛАСЬ ИДТИ ОДНА.

Опубликовано: 14-10-2014
Эльвира

Здравствуйте! что мне делать я попалась на эту удочку? как расторгнуть договор?

Опубликовано: 17-12-2014
marta06

Генеральному директору ООО»Сервис — Косметики» Рогожному М.В

191025 г.Санкт-петербург Невский пр 55 кор А

от……ФИО, адрес, телефон

ПРЕТЕНЗИЯ

Для приглашения на процедуру демонстрации косметики и тестирования мне звонили неоднократно, уговаривая прийти в клинику.По телефону и СМС мне сообщили адрес клиники г.Санкт-Петербург, Невский пр 55 кор А и настоятельно просили взять паспорт с собой для подтверждения личности, мотивируя это тем, что в клинике пропускной режим, которого как оказалось, нет в помине, и назначили время для моего посещения. (Такого-то числа) при совершении телефонного звонка на мой мобильный телефон (при этом мною не было дано предварительное разрешение на совершение звонков, что является нарушением ч.1. ст.18 Федерального Закона РФ от 13.03.2006 N 38-ФЗ (ред. от 28.07.2012 с изменениями, вступившими в силу с 01.01.2013) «О РЕКЛАМЕ»), сотрудниками компании ООО «Сервис Косметики», я была приглашена на бесплатную процедуру по уходу за волосами . При проведении презентации мне была сделана процедура по мытью волос косметикой « DeAura », с применением аппарата «инфракрасная расческа», а так же предоставлена в устной форме информация о натуральном составе косметики и её исключительных свойствах, производителе, месте производства, необходимых условиях её применения. Уже дома самостоятельно, из приложения к договору я выяснила, что некоторые компоненты являются химическими соединениями и могут вызвать аллергическую реакцию и принести вред моему здоровью.

При завершении процедуры, между мной (ФИО) и ООО»Сервис Косметики» в лице генерального директора Рогожного М.В, был заключен договор купли-продажи №……………. на покупку косметических средств для ухода за волосами «DeAura» (в качестве приложения к курсу лечения, ибо по заявлениям сотрудников фирмы, ООО «Сервис Косметики» НЕ ЗАНИМАЕТСЯ ПРОДАЖЕЙ И РАСПРОСТРАНЕНИЕМ КОСМЕТИКИ!!) и годовое медицинское обслуживание на сумму 49810, 00 руб (сорок девять тысяч восемьсот десять рублей 00 копеек). Данная косметическая продукция была приобретена мною по договору потребительского кредитования с банком (наименование банка)…… сроком на (срок кредита)……. месяца. Прошу обратить особое внимание, что при заключении кредитного договора не был предоставлен документ о сумме годовых процентов за пользование кредитом (хотя сотрудница ООО «Сервис Косметики» ввела меня умышленно в заблуждение, что я ничего не переплачу) .Представитель кредитного отдела ООО «Сервис Косметики» не спросила меня о моих доходах, месте работы, наличии других кредитов в других банках, написав от себя что моя зарплата ………тысяч рублей . Таким образом, банк даже не удосужился проверить мою платежеспособность. Так же, во время подписания документов меня постоянно отвлекали посторонними разговорами сотрудница ООО «Сервис Косметики», в силу чего я не смогла детально ознакомиться с текстом подписываемых документов и осознать негативные последствия совершаемой сделки.

Также мною выяснены следующие обстоятельства:

1. На маркировке потребительской упаковки косметических товаров, входящих в комплектацию Набора « DeAura » отсутствует информация об ограничениях(противопоказаниях) к применению, в нарушение требований п.4.5., п.4.6.ГОСТ Р51391-99″Изделия парфюмерно-косметические.Информация для потребителя.Общие требования», в составе продукции имеются химические компоненты, которые могут вызвать аллергические реакции покупателей(заказчиков), особенно с чувствительной кожей, но в клинике « DeAura » врачи рассказывают, что подходит для всех, что является ложной информацией.Были нарушены ст.10 и ч.2 ст.12 Закона Российской Федерации от 7 февраля 1992 года № 2300-1 «О защите прав потребителей».

2. Перед процедурой мне не проводили должное тестирование косметики на аллергены. В состав косметических средств входят химические вещества опасные для жизни и здоровья. (Сорбитан или РЕG 40-ограничен для использования в косметике-доказана токсичность для кожи-аллергичен. Циклопентасилоксан-вызывает нарушения эндокринной системы-способен влиять на биохимические процессы на клеточном уровне-вызывает раздражение кожи и раковые опухоли.Fragranse-вызывает аллергию-может влиять на нервную систему-токсичен. и др)

Согласно ФЗ «О защите прав потребителей» «Ответственность изготовителя (исполнителя, продавца) за ненадлежащую информацию о товаре» п.2 ст.12 Продавец (исполнитель), НЕ предоставивший Покупателю полной и достоверной информации о товаре (работе, услуге), несёт ответственность, предусмотренную пп 1 — 4 ст. 18 ФЗ ЗПП или п.1 ст.29 ФЗ ЗПП, за недостатки товара (работы, услуги), возникшие после его передачи потребителю вследствие отсутствия у него такой информации.

3, Во время подписания договора консультант ввела меня в заблуждение о конечной сумме договора, уверив, что переплаты не будет. Но сумма кредита отличается от суммы в договоре в большую сторону.

4, В случае возврата товара ненадлежащего качества, проданного в кредит, потребителю возвращается уплаченная за товар денежная сумма в размере погашенного ко дню возврата указанного товара кредита, а также возмещается плата за предоставление кредита.

(п. 5 в ред. Федерального закона от 21.12.2004 N 171-ФЗ)

На основании изложенного, руководствуясь статьями 177, 178, 179 Гражданского кодекса РФ, статьями 10, 12, 14, 18, 19 Закона Российской Федерации от 7 февраля 1992 года № 2300-1 «О защите прав потребителей» ТРЕБУЮ:

1 Перечислить в течении 10дней на мой р/с №………………….. в …..(наименование банка) полную сумму в размере 44 400 руб плюс проценты за пользование кредитом за первый месяц

2.Предоставить копии следующих документов сотрудника ООО «Сервис — Косметики», проводившего мне косметологическую процедуру

— Диплом о базовом медицинском образовании (высшим или среднем) государственного образца РФ;

— Документ, подтверждающий квалификацию, которая соответствует нормативам для работы в клиниках;

— Сертификат и свидетельство о повышении квалификации по соответствующей специальности за последние 5 лет, причем в наличии обязательны оба документа.

Обращаю Ваше внимание, что в соответствии со статьей 22 Закона Российской Федерации указанные требования потребителя подлежат удовлетворению продавцом (изготовителем, уполномоченной организацией или уполномоченным индивидуальным предпринимателем, импортером) в течение десяти дней со дня предъявления соответствующего требования.

В случае принятия решения об отказе в удовлетворении моего требования

прошу Вас предоставить мотивированный и обоснованный ответ в письменной форме в течение 10 дней.

В случае задержки возврата денежных средств, буду требовать неустойку(пени) %от суммы за каждый день задержки. При неполучении ответа в указанные сроки, или получении мотивированного отказа, я буду вынуждена обратиться в суд для защиты своих прав. В исковом заявлении, помимо вышеизложенного, я буду просить суд взыскать с Вашего предприятия неустойку и компенсацию морального вреда. Также будут поданы заявления с копией данной претензии в правоохранительные, налоговые органы и органы прокуратуры, Роспотребнадзор, контролирующие организации и СМИ для правовой оценки деятельности ООО «Сервис Косметики», а также в службу безопасности …….(наименование банка).

Претензия составлена в 2-х экземплярах на 6 листах.

……………..2013г. ____________ ФИО

Получил ______________________/________________________/

Должность _____________________________________________

Дата ___________________ Печать

Опубликовано: 14-10-2014
Ольга

Кто-нибудь знает, где можно познакомиться с реквизитами компании EL Erman Cosmetic Manufacturing. То, что я нахожу-1) это в Тель-Авиве адрес по Yohannan Hasandlar 9 в страшненьком жилом доме — адрес регистрации компании и 2) в Ашдоде -вроде должно быть производство в припортовом районе по Haplada, 3, но по этому адресу, похоже, только склады. Кто-нибудь знает, где найти данные по производству косметики компанией EL Erman Cosmetic Manufacturing, тем более, что в России продается еще множество марок косметики (Angelic Luxury, Egomania Beauty, Elevatione time stops, дешели, деаура и т.д.), которые типа производятся этой компанией.

И еще не могу найти информацию по научным исследованиям компании и патентам.

Кто-нибудь знает где со всем этим можно ознакомиться. Ольга.

Отзывы о компании

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08.09.2016
| отрицательный отзыв

0 0

Deaura — Всем привет, развели меня по полной

Всем привет, развели меня по полной!!! 3 месяца мне звонили с прозьбой придти, я согласилась. Сказали что все займет 1 час, в реальности 3 часа. Девушка очень добро душная спрашивала про все, потом предложила скидку как для друга 40000 даже можно в кредит !!! Я думала как здорово, оформили кредит за 3 мин. Хотя я и работала 2 недели на Подробнее>>

15.09.2015
| положительный отзыв

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DEAURA отзыв сотрудника Тарасова Ольга

Хорошая косметика. И обслуживание понравилось! Чтобы вот так всё и сразу.. и дали попробовать, а потом покупать! Супер решение)) Я опробовала на себе восстанавливающую серию для волос. После окрашиваний волосы стали дико вылезать и сечься. Пробовала сыворотки и бальзамы, но был или временный эффект, или вообще раздражение. Из проф.серий что пробовала, было только привыкание((( Попробовала Дэауру. Сначала заметила, что волосы стали мягче, послушнее. Постепенно увеличилась густота волос, кончики перестали так сильно повреждаться. Отдельное спасибо за спреи защитный и укладочный! С ними причёска как с обложки))) Подробнее>>

22.09.2015
| положительный отзыв

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DEAURA отзыв сотрудника Александра

Добрый день всем! Только вчера была в салоне, где испытала на себе косметику Дэаура! Меня туда притащила подруга. по правде сначала я очень скептически отнеслась к ее рассказам(она уже полгода пользуется этой комсетикой). Но за это время она действительно стала лучше выглядеть. и я рещила — была не была! я выбрала процедуру по уходу за волосами. И вот тут моему удивлению не было предела!уже после !!!первой!!! процедуры мои волосы стали выглядеть живее и как то лучше! помимо нанесения на волосы всяческих препаратов, косметолог еще использовала какой-то аппарат. как оказалось он идет в наборе вместе с косметикой. Вобщем я Подробнее>>

24.09.2015
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DEAURA отзыв сотрудника Nina-88

Доброго дня всем, познакомилась с дэаурой и теперь мучаюсь. у меня та ситуация что называется и хочется и колется. Начну сначала -буквально вчера я сходила на презентацию косметики деаура. Она оказалась дейвствительно находкой! У меня с детсвта были проблемы с волосами, поэтому я постоянно пытаюсь их укреплять, очень за ними слежу — но все безрезультатно. Они так и лезут. а на вид как солома, какими бы средствами я ни пользовалась! поэтому если я узнаю о чем-нибудь новом для волос -обязательно стараюсь попробовать, а вдруг это оно? то что поможет мне справиться с моими проблемами… И вот услышала про деуру Подробнее>>

24.09.2015
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DEAURA отзыв сотрудника Мэри-Энн

Я просто влюбилась в ДЭауру, но у меня не хватало средств, чтоб купить ее. И тогда я пошла на небольшую хитрость… Я взяла свою сестру и отвела ее в салон, куда сама ходила на презентацию косметики. А потом, когда сестренка тоже увидела результаты использования на себе, предложила ей купить набор для лица на пополам. Таким образом мы обе и потратились несильно, и получили то что хотели! Теперь обе пользуемся Деаурой, тем более она расходуется экономно, и все хорошеем и получаем комплименты! Так что если вы не можете позволить себе приобрести что-то очень нужное, найдите напарника — и все Подробнее>>

25.09.2015
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DEAURA отзыв сотрудника Veronika82

Я работаю с косметикой Deaura уже более полугода, и за это время смогла убедиться в ее действенности. Конечно, действие косметики отличается для разных людей, но сказать, что она вообще не действует — это значит соврать. При этом я очень часто сталкиваюсь на просторах всемирной паутины с такими высказываниями, как «в салонах Deaura работают непрофессионалы и т.д.» и мне очень обидно за себя и за девочек — своих коллег. Я сама по образованию медик. И в нашем салоне все имеют медицинское образование. Откуда клиенты берут информацию, что кто-то из нас некомпетентен — мне непонятно. А насчет косметики — я ничео плохого Подробнее>>

30.09.2015
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DEAURA отзыв сотрудника The wall

Столько читала, что deaura лохотрон, развод и проч. что со своим духом авантюризма просто не могла пропустить презентацию косметики, когда меня пригласили. Для начала изучила информацию, которую нашла о косметике деаура, отзывы сотрудников, клиентов. Очень удивило, что отзывы делились либо на восторженные либо на откровенно негативные. В итоге в назначенный день и час отправилась испытаывать свою удачу. Краткие итоги: 1.Первое впечатление – отличное. просторный светлый салон, вокруг специалисты в белых халатах, будто находишься в профессиональном медицинском учреждении.2.Вежливость. Пока ждала процедуру, заполнила анкету, поболтала с девочкой на ресепшене, выпила чашку кофе, заботливо предложенною мне тою же девочкой.3.Профессиональный косметолог, которая преждле чем Подробнее>>

30.09.2015
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DEAURA отзыв сотрудника Stasy

Мою маму пригласили на бесплатную презентацию косметики Deaura. При этом сказали обязательно принести с собой паспорт. Испугавшись слова бесплатно, мама позвонила мне. Я – юрист. Первое что сделала, полезла в интернет искать отзывы. Среди прочих нашла и такие формулировки: deaura лохотрон, деаура отзывы развод. В общем, решила сопроводить маму на процедуру – на всякий случай. Когда мы пришли в салон, и мама отправилась непосредственно на презентацию, я попросила сертификаты, изучила их. С сертификатами оказалось все в порядке. Также и с образованием персонала. Оставалось выяснить последнее: почему процедура проводится бесплатно. И здесь все оказалось предельно просто и понятно: Подробнее>>

30.09.2015
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DEAURA отзыв сотрудника Маргарита Семеновна

Долго собиралась и в итоге решилась – вчера приобрела себе набор косметики Deaura. Цена конечно достаточно высокая, но для целого набора израильской косметики с минералами Мертвого моря и частицами золота вполне оправданная.Познакомилась лично с этой косметикой я неделю назад, но сразу покупать не стала, все размышляла о целесообразности покупки. Когда мне провели презентацию, на себе увидела действие косметики, но придя домой полезла в интернет и ужаснулась! Вбиваю в поисковике: деаура отзывы, вижу: развод, deaura лохотрон. Но как же так? Ведь я сама была в салоне и ничего такого не заметила! В итоге неделю все взвешивала, пыталась понять, в чем развод Подробнее>>

03.10.2015
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DEAURA отзыв сотрудника Nata-Fim

В свое время я решила стать косметологом, чтобы помогать женщинам оставаться красивыми и ухоженными! И это действительно здорово! Я работаю с косметикой Deaura, и за это время смогла помочь многим нашим клиентам) А вот недавно появилась информация, что у Дэауры появились новые средства — по уходу за волосами. Они направлены на борьбу с выпадением волос и на стимулирование восстановления кожи головы и волос. Так что приходите к нам в салон! Думаю, эти новинки придутся по душе многим))) Подробнее>>

07.10.2015
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DEAURA отзыв сотрудника Ева-Ева

Я хочу поделиться своими впечатлениями от посещения процедуры с израильской косметикой Деаура. На днях мне позвонила девушка и пригласила на бесплатную презентацию косметики, сказав, что мой номер им оставила моя подруга. Я согласилась, благо, сейчас у меня много свободного времени. Накануне пошла в салон. Долго думала, какую бы процедуру выбрать, остановилась все же на косметике для волос — потому что с ними у меня зимой беда — сохнут, секутся, теряют блеск. Сначала я прошла диагностику у трихолога, мне мне с огромным увеличением показали кожу голову и структуру самого волоса, потом была сама непосредственная процедура. Мне помыли голову шампунем, потом был Подробнее>>

09.10.2015
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DEAURA отзыв сотрудника Mandarinka

потрясающая косметика! у меня набор для ухода за волосами, а у мамы — за лицом) ну мы с ней делимся… эта косметика сделана из натуральных ингредиентов (страна-производитель — Израиль), очень приятно пахнет и потрясающе действует! волосы гладкие, сильные, здоровые, даже выпадать перестали! а в наборе для лица есть маска Клеопатры — с частичками золота — она снимается с лица магнитом. После нее кожа разглаженная, ровный цвет лица и как будто бы золотистый оттенок. Мне очень нравится! Все, кто не пробовал эту косметику, попробуйте! Тем более — презентация как правило бесплатная! Подробнее>>

10.10.2015
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DEAURA отзыв сотрудника MissisCorn

Я могу сказать честно: я люблю свою работу. Причин для этого несколько. Вот я всегда думала, что работа либо должна приносить очень много денег, либо быть лююбимой. Очень здорово, конечно, когда оба этих условия совпадают, но так бывает далеко не всегда… Итак, почему я люблю свою работу…1. Я работаю с израильским брендом Deaura, который представляет на российском косметическом рынке косметику для волос, лица и тела. Это косметика отменного качества и невероятной эффективности. Я пользуюсь ей сама, подарила маме, сестре и подруге.2. Каждый день я общаюсь с людьми, дарю им радость и красоту и получаю в ответ их улыбки и напитываюсь Подробнее>>

11.10.2015
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DEAURA отзыв сотрудника Машка

Никогда не думала, что такое может быть, что косметика, ну кроме декоративной конечно, могла дать результат после первого же применения. А оказывается, такое может быть! Я ходила на презентацию косметики Deaura. Там в составе соли и минералы Мертвого моря, частички золота и какой-то разработанный израильскими учеными комплекс особенный. Короче, косметика действует! С первого раза увидела изменения! Это просто сказка какая-то! Но есть одно Но… Это цена. Она высокая. При этом логичная. Есть достойное обоснование: раз — это то, что косметика продается в наборе, в котором много средств (не помню точно сколько, но как минимум 8, а может и больше). Два Подробнее>>

16.10.2015
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DEAURA отзыв сотрудника kaznetzowa.dascha

Я отработала в этой компании чуть больше года косметологом. Сейчас сижу в декрете. Могу сказать, что нравился коллектив и даже начальство. В начальниках у нас ходила 30-летняя Юля, к которой мы так и обращались. На работе у нас была демократия и сколько я там не работала никто даже не разу не поругался. Клиенты попадались в основном доброжелательные и только иногда приходили скандальные дамочки, которые начинали раздавать претензии уже с порога. Нампример, одна женщина все время мне объясняла как мне делать мою работу. А так вцелом очень даже неплохо. Когда буду выходить из декрета, думаю вернуться в Дэауру. Коллектив наверное поменяется, Подробнее>>

17.10.2015
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DEAURA отзыв сотрудника anneta_zueva

могу рассказать о своих впечатлениях о работе в дэауре. работаю полгода с хвостиком на позиции косметолога. зарплата нормальная, коллектив тоже вполне, ничего необычного и из ряда вон выходящего. но вот косметика меня удивила! реально крутая косметика, я даже себе ее купила)) я думаю, понятно, что я как профессионал сразу могу разобраться, что за чудо в баночках передо мной. так вот, я почитала состав, испробовала на себе и была удивлена. это реальная разработка израильских ученых. в ней есть 24-каратное золото, витамин В3, гексил-пептид и куча растительных экстрактов. золото усиливает действие остальных компонентов и получается реально работающая косметика. я взяла себе серию Подробнее>>

18.10.2015
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DEAURA отзыв сотрудника sveta.krylova.72

работаю сейчас администратором в московском салоне. есть у нас и дэаура в продаже. работаю всего-то несколько недель, а уже так закрутилась! но мне нравится эта движуха! море клиентов, постоянно новые прибывают, я все хочу сама попробовать эту косметику, так ее нахваливают все. но мне пока без надобности – и так вроде все в порядке)) но ажиотаж вокруг этой косметики сумасшедший! думаю может маме прикупить к 8 марта, она наверянка будет рада. работается в этом салоне хорошо, ссориться тут не с кем да и некогда. клиенты в основном все дамы приличные, интеллигентные, разговаривают вежливо. особых минусов нет, а вот в плюсах Подробнее>>

22.10.2015
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DEAURA отзыв сотрудника schablowa.ekaterina

проработала здесь всего три месяца (пришлось уволиться, т.к. мужу предложили работу в другом городе) но хочется отметить, что впечатления от этой компании остались самые хорошие. коллектив нормальный, без чудиков – мы пару раз даже собирались рабочей компанией и гуляли все вместе. зэпэ вовремя выплачивали – стабильно дав раза в месяц на карту приходили деньги. да и других претензий нет, даже к клиентам, хотя кто-кто, а они бывают очень разные. мне попадались не снобы, не хамы, не жалобщики. в целом мне нравилось там работать, жаль, что пришлось уехать. Подробнее>>

23.10.2015
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DEAURA отзыв сотрудника djuliya.morozowa

сейчас вот работаю в этой компании. всегда на всякий случай оставляю отзывы о салонах, где я когда-то работала, здесь напишу пока мысли есть. тружусь я косметологом и на сегодня это мое лучшее место работы. до этого работала в салоне в спальном районе, там приходило два человека в день. и еще в одной шарашкиной конторе, которая мне денег не доплатила. я тогда решила, что пойду теперь только в проверенное место. дэауру мне посоветовала одноклассница, которая тоже здесь работала, но в другой должности. она администратором была, но недолго – ушла в декрет через 4 месяца. я в дэауре уже год и три. Подробнее>>

24.10.2015
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DEAURA отзыв сотрудника titova.ni2016

с дэаурой работала полтора года. успела за этой время не только стать настоящим профи (я косметолог), но и узнать много новых классных людей. я уже там не работаю, но друзья из дэауры у меня остались. созваниваемся, встречаемся, гуляем все вместе. нас 5 человек в нашей дэауровской компании. в самом салоне было здорово – женщины к нам приходили в основном взрослые, приятные в общении, не кто попало. пару раз только попались скандальные дамочки, которые всем недовольны были. но мне показалось, что им ничем не угодить было. администратор наша – сговорчивая женщина, поэтому мы быстро те конфликты разрулили. Подробнее>>

26.10.2015
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DEAURA отзыв сотрудника juliya.tkachenko2016

работаю косметологом в дэауре, причем достаточно долго для этой работы – два года почти, т.е. с самого начала. работа нравится, все-таки я на это училась и еще до этого работала, т.е. неплохо разбираюсь в этой теме. очень удобный график, всегда договариваюсь с начальством, если возникает необходимость. среди клиентов, конечно, иногда попадаются странные или плохо воспитанные люди, не знающие элементарных правил общения. но это случается довольно редко, чаще всего мы общаемся с нормальными людьми, много кто разговаривает приветливо и с хорошим настроением. с таким клиентом пообщаешься – на весь день настроение. мы тоже в свою очередь стараемся создать хорошую атмосферу. слава Подробнее>>

12.12.2015
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DEAURA отзыв сотрудника Малышкина

Осторожно, мошенники. Схема развода та же самая, что у дешели. Звонок, бесплатное приглашение, обязательно возьмите паспорт. По телефону спрашивают точно ли я являюсь Гражданкой РФ или нет, требуют паспорт, с начала разговора идет речь о БЕСПЛАТНЫХ процедурах. Если клиент является иностранным гражданином, его на бесплатные процедуры НЕ ПРИГЛАШАЮТ, КРЕДИТ НА ИНОСТРАНЦЕВ НЕ ОФОРМИТЬ. Заманивают на бесплатно только граждан России, не знают сами кому звонят, списывают все наши номера с авито и с других досок объявлений. Нарушают закон о рекламе, вводят клиента в заблуждение, с самого начала разговора начинается ЛОЖЬ. Спрашиваю откуда мой номер, хотя я заранее знаю ответ, мне отвечают, Подробнее>>

25.09.2015
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DeAura — Некачественная косметика

У меня была сильная аллергия после процедуры косметики на лицо. Пришлось потратиться на крем rozex. / 30 eur / что бы снять аллергию и оттек. Та же реакция была и с кожей головы — покраснения и зуд. Правда это прошло через несколько дней. А вот лицо пришлось спасать rozexom. Я обращалась к косметологу этого салона и к главе компании, но Подробнее>>

10.09.2015
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DeAura — Втюхали товар и не знал что можно его вернуть им обратно

Позвонили, пригласили на бесплатные процедуры и пропихнули таким образом свой товар, плачу им уже 5-6 месяцев. Недавно мои друзья посоветовали вернуть им обратно, я даже ни одного флакона не открыл, хотел подарить своей девушке, но она отказалась принимать такое «г» и тоже сказала мне, верни всё обратно! Дальше я не знал что делать и как дальше быть! Просто посещал их Подробнее>>

06.09.2015
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DeAura — Юридическая помощь по Расторжение договоров

Юридическая компания оказывает услуги по расторжению договоров с Салоном Красоты Deaura:
— консультации по телефону;
— составление претензии;
— сопровождение процедуры расторжения договора;
— получение справки из Банка об отсутствии задолженности по кредитному договору.
_____________________________
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Доброго дня.подскажите как вернуть деньги ,если мужа развели на кредит чтоб он купил у них средства для волос.он опомнился только когда вышел из офиса.мне месяц ничего не говорил.кредит на 94000р.а у нас ребенок.средства не открывали!!просто свиньи уроды!!эти второй кредит на семью.у нас ребенок 7 лет!!!как быть.это было без моего ведома.притензию написали!!пожалуйста помогите… Подробнее>>

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Навязали мне эту косметику, у меня оказалась на нее аллергия, я обратилась к дерматологу и мне назначили курс капельниц, чтобы вымыть эту дрянь из организма. Пришла к их юристу , что бы расторгнуть договор и вернуть косметику. Юрист грубо ответила — ой, мне только не рассказывайте сказки. Я ушла с косметикой ни чего не добившись. Решила позвонить в главный офис Подробнее>>

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Но то что они делают — это ЧИСТЫЙ РАЗВОД НА ДЕНЬГИ.
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Вернулась из салона на Соборной после БЕСПЛАТНОЙ процедуры диагностики волос с коробкой косметики для лица deaura и договорами на оказание косметических услуг на 30 месяцев по уходу за лицом и волосами, а главное неподъемным кредитом. Ну лох да и только. Опомнилась дома. Методики уговоров у них на уровне. Нас воспитывали, что врать не хорошо, а когда дома вчиталась в договора, Подробнее>>

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BTL 6000 SWT TOPLINE User Manual

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BTL-6000 SWT

TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 1 OF 38

Related Manuals for BTL 6000 SWT TOPLINE

Summary of Contents for BTL 6000 SWT TOPLINE

  • Page 1
    BTL-6000 SWT TOPLINE USER’S MANUAL v100AS08/01/2010EN GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 1 OF 38…
  • Page 2
    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.
  • Page 3: Table Of Contents

    Possible side Effects of Shockwave Treatment……………………7 Indications for Shockwave Treatment ……………………..8 Contra-indications for Shockwave Treatment……………………8 INSTRUCTIONS FOR OPERATION……………………….9 The Front Panel of the BTL-6000 SWT Topline ……………………9 Applicator for BTL-6000 SWT Topline ……………………..9 The Rear Panel of the BTL-6000 SWT Topline…………………….10 Assembly and Set-Up………………………….11 Basic Displays and Operating of the Device ……………………12…

  • Page 4
    2.11.3.8 Operation Mode …………………………23 2.11.3.9 Touch Panel Calibration……………………….23 2.11.3.10 User Options…………………………..23 2.11.3.11 Setting of HW Key …………………………23 2.11.3.12 Unit Information …………………………23 2.11.3.13 Unlock Code …………………………..23 2.11.3.14 Service Functions …………………………24 2.11.4 Specific Settings …………………………..24 2.11.4.1 Applicator Button Mode……………………….24 2.11.4.2 Applicator Kit Replacement Wizard …………………….24 LIST OF STANDARD AND OPTIONAL ACCESSORIES ………………..25 MAINTENANCE AND SAFETY INSTRUCTIONS……………………26 4.1.1…
  • Page 5: General Characteristics Of The Device

    A time-saving feature of the BTL-6000 SWT Topline is the predefined programs stored in the memory of the main unit. Based on detailed research and practical use of the device, the well-organized predefined programs will provide recommendations for the treatment of various conditions.

  • Page 6: Shockwave And Its Character

    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-6000 SWT Topline uses the ballistic principle of shockwave generation. 1.3.1 BALLISTIC PRINCIPLE OF SHOCKWAVE GENERATION A pressure wave is formed via a projectile by using accelerated compressed air.

  • Page 7: Biological Effects Of Shockwave Treatment

    1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface. There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects: •…

  • Page 8: Indications For Shockwave Treatment

    1.7 INDICATIONS FOR SHOCKWAVE TREATMENT • Plantar Fasciitis • Achillodynia/Achillobursitis • Inflammations and calcification of shoulder joint tendons. • Pain in the groin area. • Epicondylitis (Tennis and Golf Elbow) • Apex Patellae Syndrome and Tibial Stress Syndrome. • Pain in the hip area and/or the iliotibial tract. •…

  • Page 9: Instructions For Operation

    2 INSTRUCTIONS FOR OPERATION THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE 10 3 10 4 10 5 10 2 touch screen select knob (to select individual parameters) enter key esc key start / stop key (to start and stop therapy) ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’…

  • Page 10: The Rear Panel Of The Btl-6000 Swt Topline

    THE REAR PANEL OF THE BTL-6000 SWT TOPLINE connector for shockwave applicator control unit mains fuse connector for power cable power on/off switch vessel for collecting condensed water type label – contains type of the device, manufacturer and safety and warning signs…

  • Page 11: Assembly And Set-Up

    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 service of BTL devices. Procedure: First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket.

  • Page 12: Basic Displays And Operating Of The Device

    BASIC DISPLAYS AND OPERATING OF THE DEVICE 2.5.1 INITIAL SCREEN AND TYPES OF TABS The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories. Examples of information shown on the tabs: Indicates that no accessories are connected Indicates that the applicator is connected and shockwave therapy can be applied.

  • Page 13: Numeric Keypad

    2.5.3 NUMERIC KEYPAD In addition to setting the numerical values with the select knob on all the screens, the ”numeric keypad» can be use for the faster setting of values. This is the icon for the opening of the numeric keyboard window: Press the numeric keypad button to display the window with the numeric keypad for the parameter with the “pressed”…

  • Page 14: Setting Therapy Parameters Manually (User Setup) Via The ‘Man’ Button

    2.6.3 SETTING THERAPY PARAMETERS MANUALLY (USER SETUP) VIA THE ‘MAN’ BUTTON The therapy parameters screen for the 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.

  • Page 15: Setting Therapy Intensity

    The endless therapy option allows for an infinite number of shocks, that can be applied from the start of the therapy. The end of therapy is not limited to the number of shocks. 2.6.5 SETTING THERAPY INTENSITY The intensity (power) of the shockwave therapy can be set on the therapy parameters screen, even during the course of therapy.

  • Page 16: Therapy Parameters Screen — Ergonomic, Standard And Expert Mode

    2.6.6 THERAPY PARAMETERS SCREEN – ERGONOMIC, STANDARD AND EXPERT MODE This screen always appears before the start of therapy when the diag or prog buttons are pressed (see Diagram of the therapy setting process). If only the most important therapy parameters are shown, then the ergonomic operation mode was selected.

  • Page 17: Running Therapy Screen

    2.7.2 RUNNING THERAPY SCREEN Name of selected therapy / program and the set parameters Set frequency Number of applied shocks Set number of shocks Set intensity Number of remaining shocks Icon and name of connected accessories Time of applied therapy Symbolic description of generated output 2.7.3…

  • Page 18
    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. Painful shoulder Trigger-points Tibial Edge Syndrome Calcar Calcanei (Plantar Fasciitis) Epicondylitis Achillodynia Patellar Tendinopathy (Jumper’s Knee) Trigger points INSTRUCTIONS FOR OPERATION | PAGE 18 OF 38…
  • Page 19: Saving Therapy

    SAVING THERAPY A particular operation can selected after pressing the “save” button. Depending on which operation is selected, a chart with the appropriate data will be shown. An example of the procedure is displayed on the following screens. It is always possible to save the therapy after setting its parameters, for example from the screen of therapy parameters – see the chapter Therapy parameters screen.

  • Page 20: Clients

    2.10.1 CLIENTS This feature allows the entering, editing and deleting of information about clients. A particular therapy can be assigned to each client. 2.10.2 USER DIAGNOSES/PROGRAMS This feature makes it possible to start the user therapies, to adjust their parameters, names and descriptions, to delete them and to sort them by using the buttons and choices shown on the screen.

  • Page 21: Information

    The memory-chip contains a lot of information and reading it takes from 30 seconds to 2 minutes. The “installation of accessories” function serves for faster functioning of the unit. After the installation, under normal operation of the device only the serial number of the accessory is read from the accessory’s memory and the other information is read from the device’s memory.

  • Page 22: Unit Settings

    2.11.3 UNIT SETTINGS This submenu offers the options of setting and displaying these parameters: • Password setting • Sound setting • Screen saver and auto switch-off • Colour setting • Setting of display contrast • Date and time setting • Language setting •…

  • Page 23: Setting Of Display Contrast

    2.11.3.5 Setting of Display Contrast Allows the setting of the optimum contrast (readability) 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.

  • Page 24: Service Functions

    2.11.3.14 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.

  • Page 25: List Of Standard And Optional Accessories

    1x spare fuse T6.3A,L,250V • 1x User’s Manual on CD Optional accessories: • transport case for the BTL-6000 SWT Topline • additional shockwave applicator with focusing shock transmitter • gel 300 ml LIST OF STANDARD AND OPTIONAL ACCESSORIES | PAGE 25 OF 38…

  • Page 26: Maintenance And Safety Instructions

    Exterior cleaning of the device: Use a soft cloth slightly moistened with water or with a 2% detergent solution to clean the exterior of the BTL-6000 SWT Topline 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.

  • Page 27: Shock Transmitter Replacement Procedure

    4.1.1 SHOCK TRANSMITTER REPLACEMENT PROCEDURE The shock transmitter can be replaced as necessary. Three shock transmitters are included as part of the BTL-6000 SWT Topline standard accessories: • 1x replaceable multi-focus shock transmitter (Ø 15mm) • 1x replaceable multi-focus shock transmitter (Ø 9mm) •…

  • Page 28: Procedure Of Worn-Out Tube And Projectile Replacement

    If the applicator stops working correctly after some amount of time, then it is possible to change the worn-out parts of the tube and projectile by using the spare parts kit included in the BTL-6000 SWT Topline package. Do not use damaged applicators! There is a risk of injury to the operating staff or the client.

  • Page 29
    Use the key to unscrew the screw cap of the cartridge. See the pictures below. Remove the worn-out part from the cartridge from the applicator Remove the plastic cover from a new replacement part. MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 29 OF 38…
  • Page 30
    Insert the shock transmitter back into the applicator, including both of its O-rings. 10. Put the shock transmitter screw cap back in place and screw it on tightly by hand. 11. Reconnect the applicator to the BTL-6000 SWT Topline device. MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 30 OF 38…
  • Page 31: General Safety Precautions

    If the source of the concern can be determine after a thorough study of the user’s manual, then contact an authorized BTL service department 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.

  • Page 32: Used Symbols

    BTL’s sole obligations under this warranty are as set forth herein. In no event shall BTL be liable for any lost revenue or profits, direct, indirect, special, incidental or consequential damages of any kind.

  • Page 33: Technical Parameters

    5 TECHNICAL PARAMETERS Identification of the device B T L — 6 0 0 0 S W T T o p l i n e Operating conditions Ambient temperature + 10 ° C to + 40 ° C Relative humidity 30 % to 75 % Atmospheric pressure 700 hPa to 1060 hPa…

  • Page 34
    Technical parameters of the Switching Power Supply Adapter BTL-4000 SWT 150W Design Weight – device only 780 g approx. Dimensions (w x h x d) 142 x 76 x 43,7 mm Covering grade according to EN 60 529 IP20 Class according to IEC 60601-1…
  • Page 35: Emc Information

    Directive and declaration of manufacturer – Electromagnetic Emission BTL-6000 SWT Topline is suitable for use in the specified electromagnetic environment. The purchaser or user of BTL-6000 SWT Topline should assure that it is used in an electromagnetic environment as described below…

  • Page 36
    Directive and declaration of manufacturer – Electromagnetic immunity BTL-6000 SWT Topline is suitable for use in the specified electromagnetic environment. The purchaser or user of BTL-6000 SWT Topline should assure that it is used in an electromagnetic environment as described below.
  • Page 37: Applicable Standards

    5.2 APPLICABLE STANDARDS Name IEC, MDD EN, ISO, Medical electrical equipment – IEC 60601-1:2005 EN ISO 60601-1:2007 Part 1: General requirements for basic safety and essential performance Medical electrical equipment Part 1: General requirements for safety 1.Collateral standard: Safety IEC 60601-1-1:2000 EN ISO 60601-1-1:2001 requirements for medical electrical systems Medical electrical equipment –…

  • Page 38: Manufacturer

    Except as required by applicable law, no warranties of any kind, either expressed or implied, are made for the accuracy, reliability or contents of this document. BTL Industries Limited reserves the right to revise or withdraw this document at any time without prior notice.

Loading…

BTL BTL-6000 User manual

BTL-6000 SWT TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

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.

PAGE 2 OF 38

CONTENTS

1 GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………

5

1.1

BTL–6000 SWT Topline System Series………………………………………………………………………………………………………………

5

1.2

Shockwave and Its Character……………………………………………………………………………………………………………………………

6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….

6

1.3.1

Ballistic Principle of Shockwave Generation ………………………………………………………………………………………………………

6

1.4

Biological Effects of Shockwave Treatment …………………………………………………………………………………………………………

7

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..

7

1.6

Possible side Effects of Shockwave Treatment…………………………………………………………………………………………………….

7

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………

8

1.8

Contra-indications for Shockwave Treatment……………………………………………………………………………………………………….

8

2 INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..

9

2.1

The Front Panel of the BTL-6000 SWT Topline ……………………………………………………………………………………………………

9

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..

9

2.3

The Rear Panel of the BTL-6000 SWT Topline…………………………………………………………………………………………………..

10

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….

11

2.5

Basic Displays and Operating of the Device ………………………………………………………………………………………………………

12

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………

12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..

12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………

13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………

13

2.6.1

Setting Therapy Parameters Via the ‘diag’ Button …………………………………………………………………………………………….

13

2.6.2

Setting Therapy Parameters Via the ‘prog’ Button …………………………………………………………………………………………….

13

2.6.3

Setting Therapy Parameters Manually (User Setup) Via the ‘man’ Button ……………………………………………………………

14

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….

14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………

15

2.6.6

Therapy Parameters Screen – Ergonomic, Standard and Expert Mode………………………………………………………………..

16

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………

16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….

16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..

17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..

17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..

17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….

19

2.10

User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………

19

2.10.1

Clients……………………………………………………………………………………………………………………………………………………….

20

2.10.2

User Diagnoses/Programs ……………………………………………………………………………………………………………………………

20

2.10.3

Recent Therapies………………………………………………………………………………………………………………………………………..

20

2.11

Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..

20

2.11.1

Accessories………………………………………………………………………………………………………………………………………………..

20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..

20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..

21

2.11.2

Encyclopaedia…………………………………………………………………………………………………………………………………………….

21

2.11.3

Unit Settings……………………………………………………………………………………………………………………………………………….

22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….

22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………

22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..

22

2.11.3.4

Colour Setting………………………………………………………………………………………………………………………………………

22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..

23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..

23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….

23

PAGE 3 OF 38

2.11.3.8

Operation Mode ……………………………………………………………………………………………………………………………………

23

2.11.3.9

Touch Panel Calibration…………………………………………………………………………………………………………………………

23

2.11.3.10

User Options………………………………………………………………………………………………………………………………………..

23

2.11.3.11

Setting of HW Key ………………………………………………………………………………………………………………………………..

23

2.11.3.12

Unit Information ……………………………………………………………………………………………………………………………………

23

2.11.3.13

Unlock Code ………………………………………………………………………………………………………………………………………..

23

2.11.3.14

Service Functions …………………………………………………………………………………………………………………………………

24

2.11.4 Specific Settings …………………………………………………………………………………………………………………………………………

24

2.11.4.1

Applicator Button Mode………………………………………………………………………………………………………………………….

24

2.11.4.2

Applicator Kit Replacement Wizard ………………………………………………………………………………………………………….

24

3 LIST OF STANDARD AND OPTIONAL ACCESSORIES ……………………………………………………………………………………….

25

4 MAINTENANCE AND SAFETY INSTRUCTIONS………………………………………………………………………………………………….

26

4.1.1 Shock Transmitter Replacement Procedure …………………………………………………………………………………………………….

27

4.1.2 Procedure of Worn-out Tube and Projectile Replacement ………………………………………………………………………………….

28

4.2

General Safety Precautions…………………………………………………………………………………………………………………………….

31

4.3

Used Symbols ………………………………………………………………………………………………………………………………………………

32

4.4

Warranty………………………………………………………………………………………………………………………………………………………

32

5

TECHNICAL PARAMETERS …………………………………………………………………………………………………………………………….

33

5.1

EMC Information …………………………………………………………………………………………………………………………………………..

35

5.2

Applicable Standards……………………………………………………………………………………………………………………………………..

37

5.3

Manufacturer ………………………………………………………………………………………………………………………………………………..

38

PAGE 4 OF 38

1 GENERAL CHARACTERISTICS OF THE DEVICE

The BTL-6000 SWT Topline 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.

The device is equipped with a color touch screen on the main unit which considerably simplifies its use. The touch screen is equipped with a stylus (touch-pen) for easy operation of the device. The horizontally orientation of the device allows the information on the screen to be seen clearly from different servicing positions. Additionally, the brightness of the screen can be set to match the lighting in the room of the office or the health-care center. The on-screen information will guide the user step- by-step through the entire therapy process. The therapeutic parameters are easily set using the touch screen buttons and knobs/keys on the device.

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-6000 SWT Topline is the predefined programs stored in the memory of the main unit. 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-6000 SWT Topline 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.

We also carry a specially-designed cart for the BTL-6000 SWT Topline 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.

For the latest information on BTL products and services, please visit our corporate website at http://www.btlnet.com.

1.1BTL–6000 SWT TOPLINE SYSTEM SERIES

The device consists of two parts: the main unit and the applicator

Main Unit: BTL-6000 SWT Topline which contains the main microcomputer and software for controlling the entire system,in also includes the user encyclopaedia and the therapy guide.

Applicator – ergonomical applicator simplifies the „course of» the therapy, following the instructionsof the main unit.

The BTL-6000 SWT Topline 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.

The device consists of two parts:

Main Unit – contains the main microcomputer and software for controlling the entire system

Applicator – this ergonomically designed applicator will simplify the course of therapy

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 5 OF 38

1.2 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 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 cavitation (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.

A shockwave is defined as a pressure pulse with these characteristics:

High positive pressure amplitude: 10 to 1000 MPa = 100 to 1000 Bar (100x atmospheric pressure)

Low negative pressure amplitude: 1 to 10 MPa

Short time duration: 1 µs to 20 µs

Rapid pressure increase: < 100 ns

Broad frequency spectrum: 1 Hz to 1 MHz

For therapeutic applications, these values are lower, especially the maximum pressure amplitude. The maximum pressure amplitude is about 15 MPa, the pulse length is 10 to 20 µs, and the frequency of the applied shockwave is 1 to 15Hz. The treatment is generally carried out without local anaesthesia and lasts about 15 to 30 minutes. During the first week after treatment, the client should avoid all physical activities that could excessively strain the treated area.

1.3 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-6000 SWT Topline uses the ballistic principle of shockwave generation.

1.3.1BALLISTIC 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.

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 6 OF 38

1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT

The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface.

There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects:

Cellular: Increase in cell membrane transmittance by improving ionic channels activity, stimulation of cell division, stimulation of cellular cytokines production.

Reproduction of vessels in the area of tendons and muscles: Improvement of blood circulation and MTB, increase in concentration of growth factor beta 1, chemotactic and mitogenic effect on osteoblasts.

Effect on nitrogen oxide system: Bone healing and re-modelling.

Improvement of micro-circulation and metabolism

Dissolution of calcified fibroblasts

Supports the production of collagen

Reduction in tissue tension

Analgesic effect:

o Destruction of afferent nerves and nerve receptors.

o CNS stimulants, sensed as pain, are also inflammation transmitter substances. o Regression of pain caused by local ischemia.

oGate control theory of pain.

1.5ADVANTAGES OF SHOCKWAVE TREATMENT

By the targeted application of the shockwaves, stress to the surrounding tissues is quite insignificant.

The body is not burdened by pharmaceuticals, except the short-term effect of local anaesthesia, if used.

The possibility of preventing the necessity of surgical intervention and its relevant hazards.

Thanks to ambulatory treatment, work absences are reduced to a minimum. Additionally, training routine absences for sport athletes is likewise reduced.

For some indications, such as Tennis Elbow, there is really no other effective treatment.

1.6POSSIBLE 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

Hematoma

Petechiae

Skin damage after previous corticoid therapy

Shockwave application can cause undesirable heart activity

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 7 OF 38

1.7INDICATIONS FOR SHOCKWAVE TREATMENT

Plantar Fasciitis

Achillodynia/Achillobursitis

Inflammations and calcification of shoulder joint tendons.

Pain in the groin area.

Epicondylitis (Tennis and Golf Elbow)

Apex Patellae Syndrome and Tibial Stress Syndrome.

Pain in the hip area and/or the iliotibial tract.

Jumper’s Knee (Patellar Tendinitis)

Pain in the hamstring insertions.

Pain on the palmar side of the wrist.

Exostoses of small hand joints from Grade 1 Arthrosis.

Acupuncture

Pain trigger-points or painful points in muscles.

1.8CONTRA-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)

Polypus in the area of treatment

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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 8 OF 38

2INSTRUCTIONS FOR OPERATION

2.1THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE

1

7

103

104

1.touch screen

2.select knob (to select individual parameters)

3.enter key

4.esc key

5.start / stop key (to start and stop therapy)

6.ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’ )

7.USB port in the space of the device’s grip for use only in compliance with IEC 60950-1

The USB port serves only for service purposes such as upload of firmware; it is not designed for therapy use!

2.2APPLICATOR FOR BTL-6000 SWT TOPLINE

8.hand rest of the applicator

9.shock transmitter of the applicator

10.shock transmitter screw cap of the applicator

11.connector of the applicator

12.guide mark of the connector

13.applicator button: to start therapy

INSTRUCTIONS FOR OPERATION | PAGE 9 OF 38

2.3THE REAR PANEL OF THE BTL-6000 SWT TOPLINE

14.connector for shockwave applicator

15.control unit mains fuse

16.connector for power cable

17.power on/off switch

18.vessel for collecting condensed water

19.type label – contains type of the device, manufacturer and safety and warning signs

20.venting grid

INSTRUCTIONS FOR OPERATION | PAGE 10 OF 38

2.4ASSEMBLY 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 source until the device has had to equilibrate to room temperature (Minimum 2 hours).

Unpack the device and place it on a stable horizontal surface which is suitable for its weight. Always position the device out of direct sunlight. During operation, the control unit 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. Do not cover or block these vents. Allow a minimum of 4 inches (10cm) 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 put any heat-producing devices or objects containing water or other liquid 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 service of BTL devices.

Procedure:

1.First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket. The device detects the voltage automatically.

Plug the device directly into the mains socket. Do not use any multi-connection extension cables or two-socket adaptors.

2.Connect the applicator to the connector on the rear panel as follows:

Turn the applicator so that the red dot on its end is in straight line with the red dot on the output connector and only then plug the connector in.

When disconnecting the connector take the indented part of the applicator connector’s end in your fingers and pull slowly towards you to disconnect the connector carefully.

CAUTION! DO NOT TURN THE ENTIRE CONNECTED CONNECTOR BY FORCE, OTHERWISE THERE IS A RISK OF DAMAGE TO THE DEVICE!

The device detects the accessory, specifies its type and displays it on the screen in the appropriate tab. If you connect an improper accessory by mistake, the display shows a message with a help where to connect the given accessory.

3.Then switch on the power on/off switch on the rear panel of the device.

4.Press the on/off switch located on the front panel of the device.

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 your authorized BTL distributor.

INSTRUCTIONS FOR OPERATION | PAGE 11 OF 38

2.5BASIC DISPLAYS AND OPERATING OF THE DEVICE

2.5.1INITIAL SCREEN AND TYPES OF TABS

The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories.

Examples of information shown on the tabs:

Indicates that no accessories are connected

Indicates that the applicator is connected and shockwave therapy can be applied.

2.5.2TOUCH 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

Channels tabs to switch between the channels and selection

The items on the touch screen can be pressed by a finger or by using a special pointer with a soft tip, so — called touchpen, which is included in the accessories of the device. The touch screen must not come in contact with any sharp objects, ball pens etc.

3D buttons of the menu

Information

3D buttons

Channel marking: W = shockwave

1 = No. of generator

Information about connected accessories

Buttons with the same function as

esc and enter on the control panel

INSTRUCTIONS FOR OPERATION | PAGE 12 OF 38

Comment [andy1]: Neni dostupné této verzi

CONTENTS

1

GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………5

1.1

BTL-6000 SWT Topline System Series………………………………………………………………………………………………………………5

1.2

Shockwave and Its Character ……………………………………………………………………………………………………………………………6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….6

1.3.1

1.4

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..7

1.6

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………8

1.8

2

INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..9

2.1

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..9

2.3

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….11

2.5

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………13

2.6.1

2.6.2

2.6.3

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………15

2.6.6

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….19

2.10 User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………19

2.10.1 Clients……………………………………………………………………………………………………………………………………………………….20

2.10.2 User Diagnoses/Programs ……………………………………………………………………………………………………………………………20

2.10.3 Recent Therapies………………………………………………………………………………………………………………………………………..20

2.11 Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..20

2.11.1 Accessories………………………………………………………………………………………………………………………………………………..20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..21

2.11.2 Encyclopaedia…………………………………………………………………………………………………………………………………………….21

2.11.3 Unit Settings……………………………………………………………………………………………………………………………………………….22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..22

2.11.3.4

Colour Setting ………………………………………………………………………………………………………………………………………22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….23

PAGE 3 OF 38

Запантентованная технология электроакустического воздействия фокусированной волны

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Эффект после лечения аппаратом BTL 6000 FSWT (Великобритания) Loading…

BTL BTL-6000 User manual

BTL-6000 SWT TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

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.

PAGE 2 OF 38

CONTENTS

1 GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………

5

1.1

BTL–6000 SWT Topline System Series………………………………………………………………………………………………………………

5

1.2

Shockwave and Its Character……………………………………………………………………………………………………………………………

6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….

6

1.3.1

Ballistic Principle of Shockwave Generation ………………………………………………………………………………………………………

6

1.4

Biological Effects of Shockwave Treatment …………………………………………………………………………………………………………

7

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..

7

1.6

Possible side Effects of Shockwave Treatment…………………………………………………………………………………………………….

7

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………

8

1.8

Contra-indications for Shockwave Treatment……………………………………………………………………………………………………….

8

2 INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..

9

2.1

The Front Panel of the BTL-6000 SWT Topline ……………………………………………………………………………………………………

9

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..

9

2.3

The Rear Panel of the BTL-6000 SWT Topline…………………………………………………………………………………………………..

10

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….

11

2.5

Basic Displays and Operating of the Device ………………………………………………………………………………………………………

12

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………

12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..

12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………

13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………

13

2.6.1

Setting Therapy Parameters Via the ‘diag’ Button …………………………………………………………………………………………….

13

2.6.2

Setting Therapy Parameters Via the ‘prog’ Button …………………………………………………………………………………………….

13

2.6.3

Setting Therapy Parameters Manually (User Setup) Via the ‘man’ Button ……………………………………………………………

14

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….

14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………

15

2.6.6

Therapy Parameters Screen – Ergonomic, Standard and Expert Mode………………………………………………………………..

16

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………

16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….

16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..

17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..

17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..

17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….

19

2.10

User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………

19

2.10.1

Clients……………………………………………………………………………………………………………………………………………………….

20

2.10.2

User Diagnoses/Programs ……………………………………………………………………………………………………………………………

20

2.10.3

Recent Therapies………………………………………………………………………………………………………………………………………..

20

2.11

Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..

20

2.11.1

Accessories………………………………………………………………………………………………………………………………………………..

20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..

20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..

21

2.11.2

Encyclopaedia…………………………………………………………………………………………………………………………………………….

21

2.11.3

Unit Settings……………………………………………………………………………………………………………………………………………….

22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….

22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………

22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..

22

2.11.3.4

Colour Setting………………………………………………………………………………………………………………………………………

22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..

23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..

23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….

23

PAGE 3 OF 38

2.11.3.8

Operation Mode ……………………………………………………………………………………………………………………………………

23

2.11.3.9

Touch Panel Calibration…………………………………………………………………………………………………………………………

23

2.11.3.10

User Options………………………………………………………………………………………………………………………………………..

23

2.11.3.11

Setting of HW Key ………………………………………………………………………………………………………………………………..

23

2.11.3.12

Unit Information ……………………………………………………………………………………………………………………………………

23

2.11.3.13

Unlock Code ………………………………………………………………………………………………………………………………………..

23

2.11.3.14

Service Functions …………………………………………………………………………………………………………………………………

24

2.11.4 Specific Settings …………………………………………………………………………………………………………………………………………

24

2.11.4.1

Applicator Button Mode………………………………………………………………………………………………………………………….

24

2.11.4.2

Applicator Kit Replacement Wizard ………………………………………………………………………………………………………….

24

3 LIST OF STANDARD AND OPTIONAL ACCESSORIES ……………………………………………………………………………………….

25

4 MAINTENANCE AND SAFETY INSTRUCTIONS………………………………………………………………………………………………….

26

4.1.1 Shock Transmitter Replacement Procedure …………………………………………………………………………………………………….

27

4.1.2 Procedure of Worn-out Tube and Projectile Replacement ………………………………………………………………………………….

28

4.2

General Safety Precautions…………………………………………………………………………………………………………………………….

31

4.3

Used Symbols ………………………………………………………………………………………………………………………………………………

32

4.4

Warranty………………………………………………………………………………………………………………………………………………………

32

5

TECHNICAL PARAMETERS …………………………………………………………………………………………………………………………….

33

5.1

EMC Information …………………………………………………………………………………………………………………………………………..

35

5.2

Applicable Standards……………………………………………………………………………………………………………………………………..

37

5.3

Manufacturer ………………………………………………………………………………………………………………………………………………..

38

PAGE 4 OF 38

1 GENERAL CHARACTERISTICS OF THE DEVICE

The BTL-6000 SWT Topline 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.

The device is equipped with a color touch screen on the main unit which considerably simplifies its use. The touch screen is equipped with a stylus (touch-pen) for easy operation of the device. The horizontally orientation of the device allows the information on the screen to be seen clearly from different servicing positions. Additionally, the brightness of the screen can be set to match the lighting in the room of the office or the health-care center. The on-screen information will guide the user step- by-step through the entire therapy process. The therapeutic parameters are easily set using the touch screen buttons and knobs/keys on the device.

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-6000 SWT Topline is the predefined programs stored in the memory of the main unit. 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-6000 SWT Topline 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.

We also carry a specially-designed cart for the BTL-6000 SWT Topline 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.

For the latest information on BTL products and services, please visit our corporate website at http://www.btlnet.com.

1.1BTL–6000 SWT TOPLINE SYSTEM SERIES

The device consists of two parts: the main unit and the applicator

Main Unit: BTL-6000 SWT Topline which contains the main microcomputer and software for controlling the entire system,in also includes the user encyclopaedia and the therapy guide.

Applicator – ergonomical applicator simplifies the „course of» the therapy, following the instructionsof the main unit.

The BTL-6000 SWT Topline 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.

The device consists of two parts:

Main Unit – contains the main microcomputer and software for controlling the entire system

Applicator – this ergonomically designed applicator will simplify the course of therapy

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 5 OF 38

1.2 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 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 cavitation (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.

A shockwave is defined as a pressure pulse with these characteristics:

High positive pressure amplitude: 10 to 1000 MPa = 100 to 1000 Bar (100x atmospheric pressure)

Low negative pressure amplitude: 1 to 10 MPa

Short time duration: 1 µs to 20 µs

Rapid pressure increase: < 100 ns

Broad frequency spectrum: 1 Hz to 1 MHz

For therapeutic applications, these values are lower, especially the maximum pressure amplitude. The maximum pressure amplitude is about 15 MPa, the pulse length is 10 to 20 µs, and the frequency of the applied shockwave is 1 to 15Hz. The treatment is generally carried out without local anaesthesia and lasts about 15 to 30 minutes. During the first week after treatment, the client should avoid all physical activities that could excessively strain the treated area.

1.3 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-6000 SWT Topline uses the ballistic principle of shockwave generation.

1.3.1BALLISTIC 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.

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 6 OF 38

1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT

The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the bone-soft tissue interface.

There is an improvement in the regeneration and repair of tissues in the following areas and the achievement of the following effects:

Cellular: Increase in cell membrane transmittance by improving ionic channels activity, stimulation of cell division, stimulation of cellular cytokines production.

Reproduction of vessels in the area of tendons and muscles: Improvement of blood circulation and MTB, increase in concentration of growth factor beta 1, chemotactic and mitogenic effect on osteoblasts.

Effect on nitrogen oxide system: Bone healing and re-modelling.

Improvement of micro-circulation and metabolism

Dissolution of calcified fibroblasts

Supports the production of collagen

Reduction in tissue tension

Analgesic effect:

o Destruction of afferent nerves and nerve receptors.

o CNS stimulants, sensed as pain, are also inflammation transmitter substances. o Regression of pain caused by local ischemia.

oGate control theory of pain.

1.5ADVANTAGES OF SHOCKWAVE TREATMENT

By the targeted application of the shockwaves, stress to the surrounding tissues is quite insignificant.

The body is not burdened by pharmaceuticals, except the short-term effect of local anaesthesia, if used.

The possibility of preventing the necessity of surgical intervention and its relevant hazards.

Thanks to ambulatory treatment, work absences are reduced to a minimum. Additionally, training routine absences for sport athletes is likewise reduced.

For some indications, such as Tennis Elbow, there is really no other effective treatment.

1.6POSSIBLE 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

Hematoma

Petechiae

Skin damage after previous corticoid therapy

Shockwave application can cause undesirable heart activity

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 7 OF 38

1.7INDICATIONS FOR SHOCKWAVE TREATMENT

Plantar Fasciitis

Achillodynia/Achillobursitis

Inflammations and calcification of shoulder joint tendons.

Pain in the groin area.

Epicondylitis (Tennis and Golf Elbow)

Apex Patellae Syndrome and Tibial Stress Syndrome.

Pain in the hip area and/or the iliotibial tract.

Jumper’s Knee (Patellar Tendinitis)

Pain in the hamstring insertions.

Pain on the palmar side of the wrist.

Exostoses of small hand joints from Grade 1 Arthrosis.

Acupuncture

Pain trigger-points or painful points in muscles.

1.8CONTRA-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)

Polypus in the area of treatment

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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 8 OF 38

2INSTRUCTIONS FOR OPERATION

2.1THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE

1

7

103

104

1.touch screen

2.select knob (to select individual parameters)

3.enter key

4.esc key

5.start / stop key (to start and stop therapy)

6.ON/OFF switch (back lit, in blue, when the control unit is ‘’on’’ )

7.USB port in the space of the device’s grip for use only in compliance with IEC 60950-1

The USB port serves only for service purposes such as upload of firmware; it is not designed for therapy use!

2.2APPLICATOR FOR BTL-6000 SWT TOPLINE

8.hand rest of the applicator

9.shock transmitter of the applicator

10.shock transmitter screw cap of the applicator

11.connector of the applicator

12.guide mark of the connector

13.applicator button: to start therapy

INSTRUCTIONS FOR OPERATION | PAGE 9 OF 38

2.3THE REAR PANEL OF THE BTL-6000 SWT TOPLINE

14.connector for shockwave applicator

15.control unit mains fuse

16.connector for power cable

17.power on/off switch

18.vessel for collecting condensed water

19.type label – contains type of the device, manufacturer and safety and warning signs

20.venting grid

INSTRUCTIONS FOR OPERATION | PAGE 10 OF 38

2.4ASSEMBLY 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 source until the device has had to equilibrate to room temperature (Minimum 2 hours).

Unpack the device and place it on a stable horizontal surface which is suitable for its weight. Always position the device out of direct sunlight. During operation, the control unit 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. Do not cover or block these vents. Allow a minimum of 4 inches (10cm) 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 put any heat-producing devices or objects containing water or other liquid 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 service of BTL devices.

Procedure:

1.First connect the device in mains by means of the supplied power supply adapter, which you will connect to the connector on the rear panel of the device and to a 100 V or 240 V mains socket. The device detects the voltage automatically.

Plug the device directly into the mains socket. Do not use any multi-connection extension cables or two-socket adaptors.

2.Connect the applicator to the connector on the rear panel as follows:

Turn the applicator so that the red dot on its end is in straight line with the red dot on the output connector and only then plug the connector in.

When disconnecting the connector take the indented part of the applicator connector’s end in your fingers and pull slowly towards you to disconnect the connector carefully.

CAUTION! DO NOT TURN THE ENTIRE CONNECTED CONNECTOR BY FORCE, OTHERWISE THERE IS A RISK OF DAMAGE TO THE DEVICE!

The device detects the accessory, specifies its type and displays it on the screen in the appropriate tab. If you connect an improper accessory by mistake, the display shows a message with a help where to connect the given accessory.

3.Then switch on the power on/off switch on the rear panel of the device.

4.Press the on/off switch located on the front panel of the device.

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 your authorized BTL distributor.

INSTRUCTIONS FOR OPERATION | PAGE 11 OF 38

2.5BASIC DISPLAYS AND OPERATING OF THE DEVICE

2.5.1INITIAL SCREEN AND TYPES OF TABS

The initial screen after the switch-on of the device contains the tab displaying information about the connected accessories.

Examples of information shown on the tabs:

Indicates that no accessories are connected

Indicates that the applicator is connected and shockwave therapy can be applied.

2.5.2TOUCH 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

Channels tabs to switch between the channels and selection

The items on the touch screen can be pressed by a finger or by using a special pointer with a soft tip, so — called touchpen, which is included in the accessories of the device. The touch screen must not come in contact with any sharp objects, ball pens etc.

3D buttons of the menu

Information

3D buttons

Channel marking: W = shockwave

1 = No. of generator

Information about connected accessories

Buttons with the same function as

esc and enter on the control panel

INSTRUCTIONS FOR OPERATION | PAGE 12 OF 38

Comment [andy1]: Neni dostupné této verzi

CONTENTS

1

GENERAL CHARACTERISTICS OF THE DEVICE…………………………………………………………………………………………………5

1.1

BTL-6000 SWT Topline System Series………………………………………………………………………………………………………………5

1.2

Shockwave and Its Character ……………………………………………………………………………………………………………………………6

1.3

Shockwave Generation…………………………………………………………………………………………………………………………………….6

1.3.1

1.4

1.5

Advantages of Shockwave Treatment ………………………………………………………………………………………………………………..7

1.6

1.7

Indications for Shockwave Treatment …………………………………………………………………………………………………………………8

1.8

2

INSTRUCTIONS FOR OPERATION……………………………………………………………………………………………………………………..9

2.1

2.2

Applicator for BTL-6000 SWT Topline ………………………………………………………………………………………………………………..9

2.3

2.4

Assembly and Set-Up…………………………………………………………………………………………………………………………………….11

2.5

2.5.1

Initial Screen and Types of Tabs ……………………………………………………………………………………………………………………12

2.5.2

Touch Screen……………………………………………………………………………………………………………………………………………..12

2.5.3

Numeric Keypad …………………………………………………………………………………………………………………………………………13

2.6

Setting of Therapy …………………………………………………………………………………………………………………………………………13

2.6.1

2.6.2

2.6.3

2.6.4

Setting the Number of Shocks……………………………………………………………………………………………………………………….14

2.6.5

Setting Therapy Intensity………………………………………………………………………………………………………………………………15

2.6.6

2.7

Course of Therapy…………………………………………………………………………………………………………………………………………16

2.7.1

Start, Interruption and End of Therapy…………………………………………………………………………………………………………….16

2.7.2

Running Therapy Screen ……………………………………………………………………………………………………………………………..17

2.7.3

End of Therapy / Generation of Shocks…………………………………………………………………………………………………………..17

2.8

Application of Shockwaves ……………………………………………………………………………………………………………………………..17

2.9

Saving Therapy …………………………………………………………………………………………………………………………………………….19

2.10 User Settings: The ‘user’ Button ………………………………………………………………………………………………………………………19

2.10.1 Clients……………………………………………………………………………………………………………………………………………………….20

2.10.2 User Diagnoses/Programs ……………………………………………………………………………………………………………………………20

2.10.3 Recent Therapies………………………………………………………………………………………………………………………………………..20

2.11 Unit Settings: The ‘menu’ Button ……………………………………………………………………………………………………………………..20

2.11.1 Accessories………………………………………………………………………………………………………………………………………………..20

2.11.1.1

Installation …………………………………………………………………………………………………………………………………………..20

2.11.1.2

Information…………………………………………………………………………………………………………………………………………..21

2.11.2 Encyclopaedia…………………………………………………………………………………………………………………………………………….21

2.11.3 Unit Settings……………………………………………………………………………………………………………………………………………….22

2.11.3.1

Password Setting………………………………………………………………………………………………………………………………….22

2.11.3.2

Sound Setting ………………………………………………………………………………………………………………………………………22

2.11.3.3

Screen Saver and Auto Switch-Off…………………………………………………………………………………………………………..22

2.11.3.4

Colour Setting ………………………………………………………………………………………………………………………………………22

2.11.3.5

Setting of Display Contrast……………………………………………………………………………………………………………………..23

2.11.3.6

Date and Time Setting …………………………………………………………………………………………………………………………..23

2.11.3.7

Language Setting………………………………………………………………………………………………………………………………….23

PAGE 3 OF 38

Источник

Запантентованная технология электроакустического воздействия фокусированной волны

Аппликатор

  • Монокристалл – нет снижения интенсивности ударных импульсов весь срок службы
  • Всего 3 насадки для регулировки фокусного расстояния
  • Простая замена аппликатора
  • Возможность регулировки параметров терапии через экран аппликатора
  • Не требует обслуживания

Медицинские показания

Наиболее общие показания к применению УДАРНО-ВОЛНОВОЙ ТЕРАПИИ — лечение хронических болей в опорно-двигательном аппарате, возникающих из-за тендинопатии, триггерных точек, а также разрушение кальцификатов и стимуляция заживления костей.

Эффект после лечения аппаратом BTL 6000 FSWT (Великобритания)

Научное исследование

Хенч М (Hench M)., Сеппель Г (Seppel G).: Оценка терапевтического эффекта экстракорпоральной ударно-волновой терапии при хроническом подошвенном фасциите

Лечение фокусированной ударно-волновой терапией направленного действия обеспечило превосходные результаты при оценке по визуальной аналоговой шкале, а также по шкале Роулз-Моудсли по сравнению с плацебо-терапией. Уменьшение боли во время первых нескольких шагов утром составило почти 64% за 3-месячный период наблюдения.

Наиболее распространенные области применения

Применение аппарата BTL 6000 FSWT (Великобритания)

Применение аппарата BTL 6000 FSWT

Применение аппарата BTL 6000 FSWT (Великобритания)

Применение аппарата BTL 6000 FSWT

Отзывы об аппарате ударно-волновой терапии BTL 6000

Театр балета Юрия Григоровича и аппарат BTL

Константинос Аидонидис, физиотерапевт, Греция

— Результаты были потрясающими, а восстановление — невероятно быстрым.

Клиника “BodyRehab” благодарит BTL и особенно г-на М.Витсиоса за предложение флагманских аппаратов BTL: лазера высокой интенсивности BTL-6000, ударно-волновой терапии BTL-6000 и BTL-4000 Premium.

«Мы использовали новую серию аппаратов BTL в лечении травм опорно-двигательного аппарата у танцоров балета. Кроме того, они использовались для восстановления артистов российского Театра балета Юрия Григоровича во время их выступлений в Греции.

Результаты были потрясающими, а восстановление — невероятно быстрым. Спасибо вам! Мы верим, что это лишь начало продуктивнейшего сотрудничества!»

Коржакова Марина Викторовна, врач-хирург Медицинский центр Мой доктор, Брянск

Коржакова Марина Викторовна, врач-хирург, медцентр «Мой доктор», Брянск

— Очень удобно, мобильно, при соблюдении правил работы — максимально безопасно. После начала использования повысилась эффективность лечения, особенно у пациентов с заболеваниями опорно-двигательного аппарата.

Пациенты довольны результатами лечения, длительно сохраняющимся эффектом, возможностью при определенной патологии отказаться от обезболивающих препаратов, а режим проведения процедур, не требующий ежедневных посещений, экономит их время. Многие пациенты уже после пары процедур (особенно с гонартрозами) чувствуют значительное уменьшение болевого синдрома.

При работе с избыточными жировыми отложениями эффект после курса лечения виден даже без измерений. Я рекомендую аппарат коллегам, особенно если необходимо добиться стойкой ремиссии заболевания.

Лукьянова Татьяна Владимировна, к. м. н., доцент.
Первый МГМУ им. И. М. Сеченова, кафедра восстановительной медицины, реабилитации и курортологии Института профессионального образования, Россия. Врач-физиотерапевт высшей категории.
Нугманов Чингиз Аскарович, врач-андролог, реконструктивно-пластический хирург Института репродуктивной медицины,
Институт Репродуктивной Медицины, г. Алматы, Республика Казахстан

Клинический случай синдрома хронической тазовой боли

Клинический случай от кандидата медицинских наук, врача-уролога Университетской клиники СПбГУ, нейроуролога Клиники экспертной урогинекологии Ковалева Глеба Валерьевича.

К.м.н., врач-уролог Университетской клиники СПбГУ, нейроуролог Клиники экспертной урогинекологии Ковалёв Г.В.

Мужчина 33 года. Жалобы на постоянные тянущие боли в промежности без четкой локализации, купируемые 2 таблетками НПВС. Лечился свечами, массажем предстательной железы. Ночью спит. Спортсмен, без вредных привычек.

Анамнез: боли появились 2,5 месяца назад. Посещал тренажерный зал, поднимал большие веса, половая жизнь регулярная. Любит баню, а после бани «ледяную купель». Анализы «чистые».

Per rectum: внутренние запиральные мышцы безболезненные, мышца поднимающая задний проход болезненная справа. Отмечает болезненность при пальпации в проекции канала Алькока справа. Предстательная железа умеренно болезненная.

Лечение:

  • Курс FSWT BTL-6000 2 раза в неделю — 6 процедур по стандартному протоколу лечения СХТБ (частота 8 Гц, насадка для минимальной глубины воздействия).
  • Курс переферической магнитной нейромодуляции BTL EMSELLA по протоколу 2,3 раза в неделю, 10 процедур. Совмещали FSWT и EMSELLA.
  • Медикаментозная терапия — баклосан 40 мг – 1,5 мес.

Результат спустя 15 дней: ВАШ — 0, боль прошла полностью.

Характеристики

Глубина проникновения

до 65 мм

Интенсивность (плотность потока энергии — EFD)

0,65 мДж/мм2

Макс. частота при макс. интенсивности (EFD)

10 Гц

Аппликатор с монокристаллом

без снижения интенсивности ударных импульсов весь срок службы

Экран

8.4″ цветной сенсорный

Цветная терапевтическая энциклопедия

с анатомическими изображениями

Количество предустановленных программ

5 программ для урологии

Диагнозы пользователей

Есть

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