BTL Shockwave 5000 User manual

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BTL-5000 Shockwave Series

USER‘S MANUAL

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101IE30/07/2008EN

BEFORE YOU START

Thank you for showing your interest and buying our device the BTL- 5000 SWT Series. We hope you will be satisfied and thanks to you, this device will help many patients.

All of us at BTL wish you every success with your BTL- 5000 SWT Series. 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. Please call or email us your suggestions.

While we would like you to start using your equipment right away, we encourage you to thoroughly read this manual in order to fully understand the operational features of the BTL-5000 SWT system.

Again, thank you for being a BTL customer. In the event of any problem, or if you require service, please make an initial call to your local distributor, who will decide whether to refer the problem to our office.

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CONTENTS

1 GENERAL CHARACTERISTICS OF THE DEVICE....................................................................................... 5

1.1 BTL – 5000 SWT System Series .................................................................................................................. 6

1.2 Shockwave and Its Character....................................................................................................................... 6

1.3 Shockwave Generation................................................................................................................................. 7

1.3.1 Ballistic Principle of the Shockwave Generation ......................................................................................7

1.4 Biological Effects of the Shockwave ............................................................................................................. 7

1.5 Advantages of the Shockwave Treatment .................................................................................................... 8

1.6 Possible Side Effects After the Shockwave Treatment................................................................................. 8

1.7 Indications for the Shockwave Treatment..................................................................................................... 8

1.8 Contraindications to the Shockwave Treatment ........................................................................................... 9

2 INSTRUCTIONS FOR USE .......................................................................................................................... 10

2.1 Front Panel of the BTL- 5000 SWT............................................................................................................. 10

2.2 Rear Panel of the BTL- 5000 SWT ............................................................................................................. 11

2.3 Assembly and Putting into Operation.......................................................................................................... 12

2.4 OPERATING THE DEVICE ........................................................................................................................ 14

2.4.1 Touch Screen.........................................................................................................................................14

2.4.2 Numeric Keypad.....................................................................................................................................15

2.5 Therapy (Setting Principle) ......................................................................................................................... 16

2.5.1 Diagram of the Therapy Setting Process................................................................................................16

2.5.2 Welcome Screen and Selection of Channels, Tabs and Accessories ....................................................17

2.5.3 Setting Therapy Parameters Via the ‘diag’ Button..................................................................................18

2.5.4 Setting Therapy Parameters Via the 'prog' Button .................................................................................18

2.5.5 Setting Therapy Parameters Manually (User Setup) Via the ‘man' Button.............................................19

2.5.6 Therapy Parameters Screen – Ergonomic, Standard and Expert Mode.................................................20

2.5.7 Setting Number of Shocks......................................................................................................................20

2.5.8 Setting Therapy Intensity........................................................................................................................20

2.6 Course of Therapy...................................................................................................................................... 20

2.6.1 Start - Interruption - End of Therapy.......................................................................................................20

2.6.2 Running Therapy Screen .......................................................................................................................22

2.7 Therapy Parameters................................................................................................................................... 22

2.8 Encyclopaedia ............................................................................................................................................ 22

2.9 Therapy Saving .......................................................................................................................................... 23

2.9.1 Save Therapy and Add It to the Client Data ...........................................................................................24

2.9.2 End of Therapy / Shock Generation .......................................................................................................25

3 DEVICE MENU............................................................................................................................................. 26

3.1 Accessories ................................................................................................................................................ 26

3.1.1 Installation of Accessories......................................................................................................................26

3.1.2 Information about Accessories ...............................................................................................................26

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3.1.3 Information about Connectors ................................................................................................................26

3.2 Unit Settings ............................................................................................................................................... 27

3.2.1 Password Setting ...................................................................................................................................27

3.2.2 Sound Setting.........................................................................................................................................27

3.2.3 Screen Saver and Auto Switch-Off.........................................................................................................28

3.2.4 Colour Setting ........................................................................................................................................28

3.2.5 Setting of Display Contrast.....................................................................................................................28

3.2.6 Date and Time Setting............................................................................................................................28

3.2.7 Language Setting ...................................................................................................................................28

3.2.8 Operation Mode......................................................................................................................................28

3.2.9 Touch Panel Calibration .........................................................................................................................28

3.2.10 User Options ..........................................................................................................................................28

3.2.11 Style of Operation...................................................................................................................................29

3.2.12 Setting of HW Key..................................................................................................................................29

3.2.13 Unit Information......................................................................................................................................29

3.2.14 Unlock Code...........................................................................................................................................29

3.2.15 Service Functions...................................................................................................................................29

3.3 Specific Settings ......................................................................................................................................... 30

3.3.1 Shockwave Setting.................................................................................................................................30

3.3.2 Applicator Kit Replacement Wizard........................................................................................................31

4 USER OPTIONS........................................................................................................................................... 32

4.1 Clients......................................................................................................................................................... 32

4.2 User Sequences ......................................................................................................................................... 32

4.3 User Diagnoses/Programs.......................................................................................................................... 33

4.4 List of Recent Therapies............................................................................................................................. 33

5 APPLICATION OF SHOCKWAVES............................................................................................................. 34

6 ACCESSORIES............................................................................................................................................ 36

7 MAINTENANCE AND SAFETY INSTRUCTIONS........................................................................................ 37

7.1.1 Shock Transmitter Replacement Procedure...........................................................................................38

7.1.2 Procedure of Worn-out Tube and Projectile Replacement .....................................................................39

7.2 Safety of the Device.................................................................................................................................... 42

7.3 Warranty Conditions ................................................................................................................................... 43

8 TECHNICAL PARAMETERS ....................................................................................................................... 44

8.1 Applicable Standards.................................................................................................................................. 45

8.2 Manufacturer .............................................................................................................................................. 46

9 DEVICE CONFIGURATION ......................................................................................................................... 47

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1 GENERAL CHARACTERISTICS OF THE DEVICE

The BTL -5000 SWT Series is a modern device enabling the application of therapies by using no invasive shockwaves. Shockwaves are one of the most effective ways of treatment of pain connected to the musculoskeletal system. Today, this is the second most frequent reason of absence from work.

The devices are equipped with a colour touch screen on the main unit, and considerably simplifies the use of the device. The touch screen is equipped with a touch pen for easy operation of the device. A vertically positioned device enables you to see the information on the screen clearly from different servicing positions. In addition, the brightness of the display can be adjusted to suit the light conditions in the office or the health centre. The information displayed on the screen will guide you throughout the whole therapy, simply adjust the parameters by pressing the touch screen buttons and turning the knobs on the device.

Selecting a diagnosis from a list of alphabetically organized treatment protocols, or selecting a program, will make an easy and efficient start to the therapy. You can adjust any treatment parameter manually by the simple use of the touch screen buttons. Throughout the whole therapy, the device informs you about the therapeutical method used, type of treatment, number of applied shocks, total and remaining shocks, frequency used, intensity and other necessary data.

Save your time by using the predefined programs of the main unit. Based on detailed research and practical use of the device, the well-organized predefined protocols will present recommendations for treatment of various conditions.

The BTL- 5000 SWT allows you to insert the names of your clients and other relevant information into the internal memory of the device and connect the client data with predefined or your own protocols. When your clients call again, simply recall their name and apply the pre-set therapy.

With every BTL-5000 SWT you can purchase a trolley specially designed for the BTL products. Its design offers maximum comfort of storage and use of the device. Four steady wheels provide simple movement of the device in the office or the health care centre.

The trolley includes a range of accessory containers and baskets.

Please visit our corporate website at http://www.btlnet.com services.

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 5 OF 47

for the latest information on BTL products and

1.1 BTL – 5000 SWT SYSTEM SERIES

The device consists of three units: the main unit, the compressor unit and the applicator.

Main system – BTL- 5000 unit, which includes the main microcomputer and software for control of the whole

equipment, including user encyclopaedia and the therapy guide.

Compressor – apart from the compressor there is also the complete electronics attached for the regulation of

the ballistic pressure.

Applicator – ergonomical applicator simplifies the „course of" the therapy, following the instructions of the

main unit.

The system enables the connection of two applicators. Each applicator can contain a different transmission element, differing in its size and characteristic. Thereby the system features an advantage of service abilities for two different therapies, with no need to change the transmission elements. However, only one applicator can be active at a time. It is not possible to use two applicators together, at the same time.

1.2 SHOCKWAVE AND ITS CHARACTER

The shockwave is defined as a wave with a rapid increase of pressure in a very short time and gradual decline with a phase of small negative pressure.

Shockwaves are aimed at the affected areas that are the cause of chronic pain. The influence of shockwaves leads to for example dissolution of calcic deposits and better vascularisation, and in its final effect it causes relief of pain.

Outside the client's body (extracorporeally), a pressure pulse with a high amplitude is generated, and its energy is concentrated into the target area in the body . The pressure pulse without major losses travels through a water medium to the client and penetrates soft tissue.

The pressure course of the shockwave in time expressively differs from the pressure course of the harmonic sound wave. The shockwave is compared to the ultrasonic waves particularly characterized by a pressure jump change, higher amplitude and non-periodicity.

In the shockwave, the positive amplitude is generally much bigger than the negative amplitude. The frequency rate of the shockwaves is usually low (Hz units) and eventual cavitation (disturbance of material consistency – rise of cavities) will relax. Consequently there is no threat of energy exhaustion on cavitations as in the case of continuous ultrasound.

A substantial part of the shockwave energy penetrates into 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 inhomogeneities.

The 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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 6 OF 47

For therapeutical application, these values are lower, especially the maximum pressure amplitude, which is about 15 MPa, pulse length is 10 to 20 µs, and frequency of the applied shockwave is 1 to 25Hz. The treatment is generally carried out without local anaesthetic and lasts about 15 to 30 minutes. During the first week after the treatment, the client should avoid all activities that could excessively strain the treated area.

1.3 SHOCKWAVE GENERATION

Several types of generators were developed for the shockwave therapy, providing shockwaves with varied characteristics. Shockwaves in their time span and spatial arrangement carry the imprint of the generation method.

The BTL 5000 SWT uses the ballistic principle of the shockwave generation.

1.3.1 BALLISTIC PRINCIPLE OF THE SHOCKWAVE GENERATION

A pressure wave is formed via a projectile by accelerated compressed air, which is generated by an electronically controlled ballistic-pressure compressor. Using elastic impact, the kinetic energy of the projectile is transferred into a probe of the applicator and into the client's body via this probe. Consequently, during the treatment, the end of the applicator must be in immediate contact with the skin and subcutaneous tissue.

1.4 BIOLOGICAL EFFECTS OF THE SHOCKWAVE

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

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

• cellular effect – increase in transmittance of a cell membrane (improvement of 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 calcic fibroblasts,

• support of collagen production,

• reduction of tissue tension,

• analgetic effect:

− destruction of afferent nerves and nerve receptors,

− CNS stimulants, sensed as pain; are also inflammation transmitter substances,

− regression of pain caused by local ischemia,

− gate control theory of pain.

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 7 OF 47

1.5 ADVANTAGES OF THE SHOCKWAVE TREATMENT

• by targeted operation of the shockwave, strain of surrounding tissues is quite insignificant

• the body is not strained by pharmaceuticals (except a short term effect of local anaesthesia)

• possibility to prevent from necessity of surgical intervention and relevant hazard

• thanks to ambulatory treatment the absence from work reduces to a minimum, as well as the absence from

training routine of sportsmen

• for some indications (e.g. tennis elbow) there is basically no other effective treatment

1.6 POSSIBLE SIDE EFFECTS AFTER THE SHOCKWAVE TREATMENT

• erythema or swelling can temporarily occur in the treated area

• loss of bodily sensation or itching can temporarily occur in the treated area

• momentary increase of pain can appear immediately after the treatment

• haematoma

• petechia

• skin damage after previous corticoid therapy

• shockwave application can cause undesirable heart activity

1.7 INDICATIONS FOR THE SHOCKWAVE TREATMENT

• plantar fasciitis

• achillodynia – achillobursitis

• inflammations and calcification of shoulder joint tendons

• pain in the groin area

• epicondylitis (tennis and golf elbow)

• the apex patellae syndrome and tibial stress syndrome

• pain in the area of the hip and 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 in case of grade 1 arthrosis

• acupuncture

• pain trigger points - painful points in muscles

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 8 OF 47

1.8 CONTRAINDICATIONS TO THE SHOCKWAVE TREATMENT

• application to certain tissues (eyes and their surroundings, myocardium, spinal cord, gonad, kidneys, liver)

• coagulation of blood disorders

• polypus in the area of treatment

• pregnancy

• coagulation of blood disorders and the use of anticoagulants

• thrombosis

• tumour disease

• polyneuropathy

• acute inflammation

• growing cartilage in children

• therapy using corticoids

• inapplicable in areas and organs with possible gas content

• inapplicable on areas in proximity to large nerves, vessels, spinal cord and head

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 9 OF 47

2 INSTRUCTIONS FOR USE

2.1 FRONT PANEL OF THE BTL- 5000 SWT

1. diag button to select diagnosis

2. prog button to select therapy program

3. man button to set therapy parameters manually

4. menu button (to set date, time, language, display contrast, sounds, user options, etc.)

5. user button (lists of clients, user diagnoses, programs and sequences, recent therapies, etc.)

6. touch screen

7. ON/OFF power switch (“ON” status indicated by the blue backlight)

8. enter key (to confirm selection or setting)

9. select knob (to select and set individual parameters)

10. esc key (to cancel selection or setting and return to the previous status)

11. time / stop knob (to set therapy time, and to start and stop therapy)

12. intensity knob (to set intensity)

13. hand rest of the applicator

14. shock transmitter of the applicator

15. shock transmitter screw cap of the applicator

16. connector of the applicator

17. guide mark of the connector

18. applicator button for therapy start

19. power activation indicator of the compressor

20. indicator signalling - ready to generate shockwaves ready

21. active tab indicator for the applicator output out A

22. active tab indicator for the applicator output out B

23. handles for easy transport of the compressor unit

BTL-5000 SWT USER’S MANUAL | PAGE 10 OF 47

2.2 REAR PANEL OF THE BTL- 5000 SWT

24. dummy plugs of the connectors

25. mains switch to switch the main unit on/off

26. socket for connection of the mains cable 230 V (or115 V) to the main unit

27. line fuse of the main unit

28. power switch 230V / 115V (bottom part of the main unit)

29. label with serial number and production date

30. com in - communication link input for the main unit (for servicing purposes only)

31. com in / out - communication link connector between the main unit and the compressor

32. type plate - showing device type, manufacturer and safety precautions and warning signs

33. ventilation louver

34. communication link input / output for the compressor unit

35. ON / OFF power switch for the compressor unit

36. socket to connect the mains cable 230 V (or 115 V) to the compressor unit

37. line fuses of the compressor unit

38. power switch 230V / 115V of the compressor unit

39. connectors for the shockwave applicators

40. input for connection of foot pedal

41. communication connectors (for servicing only)

42. catchment container

INSTRUCTIONS FOR USE | PAGE 11 OF 47

2.3 ASSEMBLY AND PUTTING INTO OPERATION

Inspect the package and in case of any damage report it to the delivery service or your distributor. Do not proceed with installation or assembly if the package is damaged.

Unpack the device and place it on a stable horizontal surface suitable for the weight of the device. Always position the unit out of direct sunlight. The device heats up therefore it must be placed away from a direct heat sources such as radiators or room heaters. Cooling of the equipment is provided for by forced air circulation. Cooling vents are located on the rear panel and at the bottom of the BTL-5000 SWT and must not be covered. Do not position the device on a soft surface as it may obstruct the air flow to the bottom cooling vents. Do not put any objects producing heat or containing water or other liquid on the top of the device. Do not place the device close to equipment producing strong electromagnetic, electric or magnetic field (diathermy, X-rays, etc.), as the electronic systems of the device could be undesirably influenced. In case of any questions please call your authorised BTL distributor.

Retain the original packaging to ensure the eventual safe transportation of the device.

Attaching the accessory holder:

Remove the protective caps from the holes on a side of the device. Use a screwdriver to gently slide the blade under the cap and take it out. Align the accessory holder and secure it with two screws from below.

Installation of supports on the compressor unit:

The supports are only installed if the compressor unit will not sit on the cart (different legs are supplied with the cart).

The BTL-5000 e-stim SWT package includes compressor unit legs, which prevent the unit from moving during therapy.

Screw the supports according to the following picture.

INSTRUCTIONS FOR USE | PAGE 12 OF 47

1. Connection of the BTL -5000 SWT main unit with the compressor is accomplished by connecting the communication cable to the input/output of the communication link on the relevant unit. Plug the communication cable into the link connector on the main unit (31) and into the link connector (34) on the unit of the compressor.

2. At first connect the shockwave compressor to the socket and then the main unit of the BTL -5000 SWT device.

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

adapters.

Check the correct mains voltage - 230 V (or 115 V)

Before the first connection of the device to the mains, it is necessary to check if both the mains voltage switches (26 and 28) are in the position corresponding to local voltage standards, (either in the position 230V or 115V). For details, see the note “Switching the device to different mains voltage“

MAINTENANCE AND SAFETY INSTRUCTIONS. In case of any questions please call your BTL distributor.

3. Connect the supplied accessories step by step to the output connectors (39) on the rear panel of the

shockwave compressor as follows (item No. 3 on the picture):

in the chapter

Turn the connector of the applicator so the red spot on its end is in direct line with the red spot on the output connector of the shockwave compressor and then plug the connector in.

INSTRUCTIONS FOR USE | PAGE 13 OF 47

WHEN DISCONNECTING THE CONNECTOR, hold the grooved end part of the applicator of the connector with your fingers, slowly pull the connector towards you and disconnect it carefully.

WARNING!!! DO NOT TURN THE WHOLE CONNECTED CONNECTOR BY

FORCE, AS IT CAN DAMAGE THE DEVICE!!!

The device detects the accessories, specifies the type and displays it on the screen in the appropriate tab. In the case of connecting improper accessories by mistake, a warning and help will display on the screen with instructions where to connect the appropriate accessories.

4. Activate the ON / OFF power switch of the compressor unit (35).

5. Then turn the power supply switch to switch the main unit ON/ OFF (25)

6. Press the ON /OFF switch placed on the front panel of the main unit (7)

Note:

After switching on, the device will test all its internal circuits and functions (about 10 - 15 secs) and in the case of any fault the system will signalize it and 'lock' itself into a secure mode. If this situation occurs, please call your authorised BTL distributor.

2.4 OPERATING THE DEVICE

2.4.1 TOUCH SCREEN

The touch screen can display several graphic items, some of them are only informative, some can be pressed and thereby activated. See the following basic items:

• soft buttons (can be pressed to change the indicated values )

• informative text

• channels tabs (switching 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 touch- pen, which is included in the accessories of the device. The touch screen must not come in contact with any sharp objects, ball pens etc.

Selected channel

The BTL -5000 SWT Series allows the connection of up to two applicators, but only one can be active. Only one so-called "selected channel" can be operated at a time. The selected channel has a light tab. All information on the screen and all control elements relate to this channel. The most important information about therapies on the other channels can be viewed on their tabs.

INSTRUCTIONS FOR USE | PAGE 14 OF 47

The BTL 5000 SWT does not allow the use of two applicators at the same time. Each applicator can contain a different transmission item, differing in its size. This brings the advantage of applicability for two different therapies without the need to change the transmission elements.

Soft buttons of the menu

Information

Channel marking: W = shockwave 1 = No. of

Tab of the selected channel

enerato

2.4.2 NUMERIC KEYPAD

In addition to setting the numerical values with the select knob (9) on all the screens, you can also use the „numeric keypad" for quicker setting.

Icon to open the window with the numeric keypad:

Information about connected accessories

Soft buttons (for therapy on the selected channel)

Buttons with the same function as (8) and (10)

Press the numeric keypad button to display the window with the numeric keypad for the parameter with the light button (on the picture: the button - number of shocks - 2000). Set the required values and return to the previous screen by pressing the enter (8) button. If you do not want to enter any values or change the selected parameter, leave the window with the numeric keypad by pressing the esc (10) button.

If you enter a value out of the allowed range of values (stated above the entering box) or the device cannot set it, then the value is rounded to the nearest lower allowed value.

INSTRUCTIONS FOR USE | PAGE 15 OF 47

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