BTL Shockwave 5000 User manual

BTL-5000
Shockwave Series

USER‘S MANUAL

PAGE 1 OF 47

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.

PAGE 2 OF 47

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

PAGE 3 OF 47

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

PAGE 4 OF 47

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

g

r

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

2.5 THERAPY (SETTING PRINCIPLE)

2.5.1 DIAGRAM OF THE THERAPY SETTING PROCESS

ENTRY
SCREEN

THERAPY
INTERRUPTION

DIAGNOSIS
SELECTION

PROGRAM SELECTION

MANUÁL
SETTING

RUNNING
THERAPY

THERAPY START

THERAPY
INTERRUPTION

INSTRUCTIONS FOR USE | PAGE 16 OF 47

2.5.2 WELCOME SCREEN AND SELECTION OF CHANNELS, TABS AND ACCESSORIES

After switching the device ON, the entry screen includes information on the channel tabs with icons of connected
accessories. The number of channels - tabs dependents on the required configuration of the device. By pressing
the tab, information of the actual channel displays. Information adjusted on the „invisible channels" will definitely
remain saved. Almost the full screen is available for the "selected channel" - see the picture.

Switching the channels:

Tab of accessories connected to
the input out A (39)

Tab of accessories connected to
the input out B (39)

To switch between the connected accessories, press the W1 tab, see the picture. If both shockwave accessories
are connected, then the channel W1 displays the tab of accessories connected to the input out A (39), and by
pressing it, information on accessories connected to the input out B (39) will display.

Examples of information on the tabs:

Tab of channel W1 with no connected accessories

Tab of a selected channel W1, where the shockwave therapy can be applied with the connected
accessories BTL- 214-1 (SWT A)

Tab of a selected channel W1, where the shockwave therapy can be applied with the connected
accessories BTL- 214-1 (SWT B)

INSTRUCTIONS FOR USE | PAGE 17 OF 47

2.5.3 SETTING THERAPY PARAMETERS VIA THE ‘DIAG’ BUTTON

A list of diagnosis will display after pressing the diag (1) button. Each tab – channel – has its own assigned list of
diagnosis.

A fast search for diagnosis can be done by pressing the buttons with initial letters. For example, press the MNOP
button once and all diagnosis beginning with the letter M will display. According to of the number of presses, other
letters will display e.g. 2 presses of MNOP = N, 3 presses = O and 4 presses = P. The actual selected letter is
displayed in the box on the right, next to the buttons.

After finding the required diagnosis, select it by pressing the enter (8) button.

Information on therapy – encyclopaedia

2.5.4 SETTING THERAPY PARAMETERS VIA THE 'PROG' BUTTON

After pressing the prog (2) button, a screen will display, where a number of the required therapy program can be
entered. Numbers of the particular programs include prefix – a letter matching the selected therapy:

W – Shockwave therapy.

Switching between the two parts of the program number

For faster entry of the program number, you can also use the numeric keypad – for more details see the chapter
Numeric keypad.

INSTRUCTIONS FOR USE | PAGE 18 OF 47

2.5.5 SETTING THERAPY PARAMETERS MANUALLY (USER SETUP) VIA THE ‘MAN' BUTTON

The screen of the therapy parameters for the user (manual) setting will display by pressing the man (3) button. All
specifications of the therapy can be adjusted and possibly saved as the user program or the diagnosis.

By pressing the particular soft buttons, the actual menus and setup dialogs will appear. The majority of dialogs
include illustrations and symbols. See the option diagram of individual settings in this mode:

THERAPY START

INSTRUCTIONS FOR USE | PAGE 19 OF 47

2.5.6 THERAPY PARAMETERS SCREEN – ERGONOMIC, STANDARD AND EXPERT MODE

This screen always opens before the start of therapy, by pressing the diag (1) or prog (2) buttons (see Diagram
of the therapy setting process). The screen either shows the most important parameters of the therapy – you

have selected the ergonomic operation mode, or is shows all information on the therapy – you have selected the
expert or standard operation mode. In addition, the expert mode can modify all the parameters.

The differences between the modes are apparent from the following pictures:

Ergonomic mode Standard mode Expert mode

The operation mode can be set in the menu of the device by pressing menu (4) – for more details see the chapter

Operation mode. The expert operation mode can be entered from any mode by the quick selection – press the
man (3) button.

2.5.7 SETTING NUMBER OF SHOCKS

The total number of shocks for the therapy can be adjusted on screen of the therapy parameters, even during the
therapy course. The number is set either by pressing the button - number of shocks, or quick selection – by
turning the select (9) knob.

With the button number of shocks you can select "endless therapy" - see the picture

The endless therapy includes an infinite number of shocks, that can be applied at the start of the therapy
(end of therapy is not limited by marginal number of shocks).

2.5.8 SETTING THERAPY INTENSITY

The intensity (power) of the shockwave therapy can be only adjusted on the screen of the therapy parameters,
even during the therapy course. The intensity is adjusted either by pressing the intensity button or quick selection
– by turning the intensity (12) knob.

To enter the quick mode of intensity setting, press the intensity knob and turn it at the same time – the adjusted
intensity changes much faster.

2.6 COURSE OF THERAPY

2.6.1 START - INTERRUPTION - END OF THERAPY

Start the therapy by pressing time / stop (11). The therapy can start only, if the channel screen displays the
therapy parameters and all the parameters are adjusted correctly. The device will signalize possible
discrepancies.

INSTRUCTIONS FOR USE | PAGE 20 OF 47

End of interrupted

therapy

Start of interrupted

Therapy parameters
screen

Therapy START

Running therapy
screen

therapy

Paused therapy
screen

Setting frequency,

number of shocks and

therapy intensity

Therapy interrupt. Adjusting number of

shocks and intensity
during interruption

Interrupted therapy – paused therapy – can be restarted by pressing the time / stop key and can be finished by
pressing esc (10).

In pause – interrupted therapy – the parameters of intensity and total number of applied shocks can be modified
by turning the time / stop (11) knob.

The intensity can be also changed during the therapy by turning the intensity (12) knob to the right – to increase
the intensity, or to the left – to decrease the intensity. For a quicker intensity setting, press the intensity (12) knob
while turning. The intensity setting will be much faster when pressing the knob.

Direction of intensity increase

intensity

The shockwaves therapy can also be started / interrupted by the button, located on the shockwave applicator
(18), or by the foot pedal (40). The initial setup of the button or the pedal is adjusted to AUTO. The device
automatically recognizes the holdoff time of the button on the applicator, or the foot pedal and the selected
method of control. If you hold the button or the foot pedal for more than 1sec, then after its subsequent release
the therapy will stop (as in the continual mode, see the chapter APPLICATOR BUTTON MODE / FOOT PEDAL
MODE). During the time of pressing the button or the foot pedal, generation of shockwaves will be in progress.
If the button of the applicator or the foot pedal is pressed for less than 1sec, then after its release the device will
be set to the option ON/OFF (see the chapter APPLICATOR BUTTON MODE / FOOT PEDAL MODE).

INSTRUCTIONS FOR USE | PAGE 21 OF 47

pp

pp

py

2.6.2 RUNNING THERAPY SCREEN

Name of selected therapy /

program and set parameters

No. of a

lied shocks

No. of remaining shocks

Time of a

lied thera

Pressing the time / stop (11) key can also start and interrupt the therapy – see the chapter
Start - interruption - end of therapy.

*the maximum frequency value according to the relevant configuration of the device is 15 Hz or 22 Hz
(see more in the table in the chapter Device configuration).

2.7 THERAPY PARAMETERS

Each therapy can have different parameters. For each therapy, only the parameters that describe that therapy will
be displayed and these parameters can be adjusted in the manual mode, after pressing the man button. An exact
description of the parameters for individual therapies can be found in the relevant User's manual.

Adjusted frequency*

Adjusted no. of shocks

Adjusted intensity

Icon and name of connected
accessories

Symbolic description of
generated output

2.8 ENCYCLOPAEDIA

The encyclopaedia includes information on possible therapies and examples of areas for the shockwave
application. The device is always supplied with a hard copy of encyclopaedia. Its electronic format is included in
the device, and is available from most screens and menus.

Icon to open the encyclopaedia:

If you open the encyclopaedia after a selection of a particular diagnosis, the existent information to the selected
diagnosis will be displayed. Otherwise you will enter the contents of the encyclopaedia – the list of particular
diagnosis. You can browse through the encyclopaedia by turning select (9). After the selection of the required
diagnosis, you will enter the particular information about the diagnosis by pressing enter (8):

INSTRUCTIONS FOR USE | PAGE 22 OF 47

y

py

Information on diagnosis

Moving between
diagnosis

Loading parameters of selected
diagnosis to the parameter screen

- the device is read

Display of graphic information about
diagnosis (e.g. therapy area)

Display of other graphic information about
diagnosis (optional - skin, muscle, skeleton)

Moving between
information, if not displayed
on one screen

for thera

2.9 THERAPY SAVING

The user can select a particular operation after pressing the save button. Depending on a selected operation,
a form with the appropriate data will be revealed. An example of the procedure is displayed on the following
screens.

You can save the therapy always after setting the therapy parameters – i. e. from the screen of therapy
parameters – see the chapter Therapy parameters screen - ergonomic, standard and expert mode.
The following information is saved for each shockwave therapy:

• Frequency

• Number of shocks

• Intensity

When saving the therapy, enter:

• Name of the diagnosis (therapy) – will be displayed in list of diagnosis under the diag (1) button

• Program number – will be displayed between programs under the prog (2) button

• Description, additional information – it is displayed in both lists „below the line"

INSTRUCTIONS FOR USE | PAGE 23 OF 47

A

You can choose the number of the saved program from the numbers 8000 to 8999. The device offers you the
lowest available number. And during saving it adds a letter of the corresponding compressor belonging to the
program. So the resulting number can be e.g.: W- 8001 for the shockwave therapy.

2.9.1 SAVE THERAPY AND ADD IT TO THE CLIENT DATA

All therapy parameters that are saved in this item of the menu are the same as the previous item included in the
therapy saving menu. The saved therapy will also appear in both lists – the list of diagnosis and the list of
programs.

In addition it will also display in the list of therapies assigned to the entered client.

See the following diagram displaying the whole dialog of the therapy saving.

Set therapy parameters Save therapy

Enter name of diagnosis

Enter program name Select client

Enter description

All information entered

- must be saved

fter saving - the therapy will be
displayed with the following lists
(See the next page)

INSTRUCTIONS FOR USE | PAGE 24 OF 47

The saved therapy can be found in these lists on the relevant channel:

List of diagnosis

List of programs

List of therapies of the selected client

2.9.2 END OF THERAPY / SHOCK GENERATION

On a regular basis the therapy ends after the application of the adjusted number of shocks. If, for whatever
reason, you want to end or interrupt the therapy before finishing the adjusted number of shocks, it is possible to
interrupt the therapy by pressing the time / stop key or the button on the applicator. To end the therapy press
esc.

The generation of shocks will finish by expiry of the adjusted number of shocks applied, or it is possible to finish
their generation by releasing (in a state of continual mode) / and pressing again the button of the applicator
(in a state of ON /OFF mode) see the chapter Shockwave setting - applicator button mode.

INSTRUCTIONS FOR USE | PAGE 25 OF 47

3 DEVICE MENU

After pressing menu (4) it is possible to browse the following offers by using the select knob:

• Accessories

• Encyclopaedia – see the chapter Encyclopaedia

• Unit settings

• Specific settings

3.1 ACCESSORIES

In this submenu you can select:

• Installation of accessories

• Information about connected accessories

• Information about the number of clients and connection of connectors on the rear panel of the device

3.1.1 INSTALLATION OF ACCESSORIES

Each connected accessory has the memory that includes identification data of the actual accessory. According to
this data, the device recognizes which accessory is connected, if it is compatible or not, and if the device can
work with the connected accessory or not. The memory also contains a serial number of the accessory.

As the memory contains a lot of information and its downloading lasts from 30 seconds to 2 minutes, there is an
installation of accessories provided for faster work of the device. After the installation, only the serial number of
the accessory is downloaded from the accessory memory and the other information is read from the device
memory.

During the installation process, follow the instructions on the screen. In particular:

• During the installation switch off therapies on all the compressors of the device

• Do not have other accessories connected than the one that is being installed (and connect it directly, not via

interface cables)

These guides are necessary for decrease of electromagnetic interference that could cause improper downloading
of the memory data.

3.1.2 INFORMATION ABOUT ACCESSORIES

This item of the menu displays the information about connected
accessories such as Name of the accessory, its serial number etc.
And mainly it displays for which generator – output / input – the
accessory has been intended and the number of already applied
shocks.

3.1.3 INFORMATION ABOUT CONNECTORS

In the BTL - 5000 SWT, this item of the menu only includes the specification of blind / connected connectors on
the rear panel of the main unit.

DEVICE MENU | PAGE 26 OF 47

3.2 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

• Operation mode

• Touch panel calibration

• User options

• Style of operation

• Setting of HW key

• Unit information

• Unlocking code

• Service functions

3.2.1 PASSWORD SETTING

This menu can change the code - password demanded by the device when it is
switched on. There is no further work with the device possible, without entering
this password. As standard, the device is supplied „unlocked" – with the password
switched off.

3.2.2 SOUND SETTING

This includes acoustic signalling of the pressed buttons, touch panel, etc. and accomplishment of certain
operations (therapy start, therapy interruption, end of therapy etc.). The device includes standard sounding as
set from the manufacturer, i.e. signalling the therapy operations. All audio tones can be switched off (without
tones) or modified as required.

This item can edit individual audio
schemes, create new ones and modify
audio tones for each operation
separately.

The sound volume can be sets in the menu item User options.

DEVICE MENU | PAGE 27 OF 47

3.2.3 SCREEN SAVER AND AUTO SWITCH-OFF

This includes the setup of the screen saver type, activation time of the screen
saver, period of time during which the screen should be switched off and idle time
of the whole device.

3.2.4 COLOUR SETTING

The user can set colours of all elements displayed on the screen. There are 50
preset colour schemes available to choose from, or, if not satisfied with any of
them, the user can create and save his/her own colour schemes. In the custom
colour scheme, the user can step by step select individual elements.

3.2.5 SETTING OF DISPLAY CONTRAST

After selecting this offer, the optimum contrast (readability) of the display can be
set by turning the select (9) knob.

As the contrast of the screen depends on various factors, (such as
temperature), there is a fast and direct setting of the screen contrast, by using
the select (9) knob while simultaneously holding the enter (8) and esc (10)
keys.

3.2.6 DATE AND TIME SETTING

This allows the user to set the date and time in the device.

3.2.7 LANGUAGE SETTING

Preferred language of the texts displayed in the device. As standard, English is preset by the manufacturer.

3.2.8 OPERATION MODE

Select one of the three modes, see the chapter Therapy Parameters Screen – Ergonomic, Standard and
Expert Mode. The ergonomic mode is preset by the manufacturer as standard.

3.2.9 TOUCH PANEL CALIBRATION

If the buttons on the touch screen do not react when pressed, the touch screen needs calibration. The calibration
procedure is apparent from the screen of the device. It is advisable to use the touch- pen during calibration and
follow the instructions, displayed on the screen of the device.

Unsuccessful calibration can always be interrupted by pressing the esc button.

To verify the touch screen adjustments, use the "touch panel function test" feature.

3.2.10 USER OPTIONS

Here, you can set:

• Direction of movement in the menu when turning the select (9) knob

• Alphabetical order of diagnosis and certain menus (from A to Z / from Z to A)

• Position of the tab bar (up / down)

• Sound volume

DEVICE MENU | PAGE 28 OF 47

3.2.11 STYLE OF OPERATION

• NEW STYLE OF OPERATION

Use this option for main units of the first series (manufactured in 2001 and start of 2002). These devices have the
knobs (11) and (12) marked as time (11) and start / stop (12). It is necessary for these devices to select the
option new style of operation = no after download of the new version of firmware.

New units are preset by the manufacturer to a new operation mode (new style of operation = yes).

• END OF THERAPY – SETTING ZERO INTENSITY / TIME

After the end of the therapy you can choose, if you want to leave the adjusted data of time and intensity on the
screen in zero values, or display the values of the last performed therapy.

• REPEAT SOUND FOR END

This item can switch on / off the function of repeated warning tone of the therapy end.

3.2.12 SETTING OF HW KEY

The device can be remotely configured. For example, if you later decide to purchase the upgrade, the
manufacturer (distributor) will send you 64 -digit code (so - called HW key) that you will enter and the device will
reconfigure its hardware according to the entered key. For the actual HW configuration see the chapter Unit

information.

3.2.13 UNIT INFORMATION

This item shows certain information about the device – serial number, device type, firmware version, etc. It also
contains the information up to when the device will operate – so called "device validity". If the operation of the
device is time limited, this item indicates until which date the device stays fully functional.

3.2.14 UNLOCK CODE

If the operation of the device is time limited, then in this item you can enter the so-called "unlocking code" for
cancellation of the operational time limitation of the device.

3.2.15 SERVICE FUNCTIONS

• REPAIR OF FILES

This checks the file system in the device - system of saved information and repairs possible errors - deletes
empty files, etc. We recommend using this feature in the case of lack of memory, if the device rejects to save any
data, or if you are in doubt that some data may have been lost, etc.

• FILE SYSTEM FORMATTING

If the feature repair of damaged files did not help you, select this function. Unfortunately, together with this
formatting you will loose all the user data and user setup of the device.

• DELETE ACCESSORIES

This item will delete all the installed accessories – use it, when you install the accessories incorrectly – e.g. bad
„scattered" picture on the tab, the connected accessories cannot be detected (permanently displayed question
mark) etc.

• DEFAULT SETTING WITHOUT LOSS OF USER DATA

Restoration of all functions of the device the way they were preset by the manufacturer. User data – clients,
therapies etc. will stay saved.

DEVICE MENU | PAGE 29 OF 47

3.3 SPECIFIC SETTINGS

3.3.1 SHOCKWAVE SETTING

• COMPRESSOR MODE

It adjusts two different types of the mode of pressure control in the
system: - quick start

- silent mode

When using quick start, the pressure control in the system is activated during switching the device on, therefore
the therapy start is instantaneous. We recommend using this setting especially during frequent operations. The
disadvantage of this mode is a higher noise level of the device.

In silent mode the pressure control in the system is activated only immediately before the start of therapy - during
entry to the manual screen of the main unit and after leaving, the pressure stops being kept in the system. That
eliminates the noise of the device, if not in use. The disadvantage can be the prolonged start of the therapy –
according to pressure in the system the start can be extended for about 10 to 15 seconds. We recommend using
this setting for quieter operations.

• THERAPY CONTROL

Here, you can set whether you want the therapy to be controlled by the button on the applicator (18) or using the
foot pedal connected to the unit of the compressor (40). After selecting the type of therapy control, you can
continue by setting the options of the applicator button mode, or the foot pedal mode (see the following chapter).

• APPLICATOR BUTON MODE / FOOT PEDAL MODE

This enables setting of the three different types of modes for the applicator button, or the foot pedal (according to
setting in the previous chapter). You can choose from:

- AUTO mode

- Continual mode

- ON/OFF mode

When setting the AUTO mode the device automatically recognizes
the holdoff time of the button on the applicator (18), or pressing the
foot pedal (40) and the selected way of control. If you hold the
button or the foot pedal for more than 1sec, then after its
subsequent release the therapy will stop (as in the continual
mode, see below). During the time of pressing the button, or the
foot pedal, generation of shockwaves will be in progress.

If the button of the applicator, or the foot pedal is pressed for less than 1sec, then after its release the device will
be set to the option ON/OFF (see below).

By selecting the continual mode you will set the generation of the adjusted shockwaves by only one press of the
button on the shockwave applicator (18), or the foot pedal (40), to end the generation of shockwaves, another
touch of the button on the applicator is necessary, or pressing the pedal.

During activated option of the ON/OFF mode it is necessary to hold the button of the applicator (18), or the foot
pedal (40) pressed throughout the time of the application of shockwaves. Releasing the button or the pedal stops
the generation of the shockwaves.

The setting is saved separately for the button of the applicator and for the foot pedal.

DEVICE MENU | PAGE 30 OF 47

3.3.2 APPLICATOR KIT REPLACEMENT WIZARD

If, after a certain time, the applicator stops generating shockwaves correctly, it is possible to change the applicator
kit, following the chapter Procedure of worn-out tube and roller replacement. Install this replaced kit according
to the displayed instructions.

Procedure of the applicator kit replacement on the device:

1. Connect the original applicator to the compressor.

2. Start the applicator kit replacement guide.

3. Now, disconnect the original applicator from the compressor and complete the replacement of the kit (see the
chapter Procedure of worn-out tube and roller replacement)

4. After completion of the kit replacement connect the applicator back to the same channel of the compressor
unit.

5. Finish the guide.

6. The device has successfully installed the replaced kit.

DEVICE MENU | PAGE 31 OF 47

4 USER OPTIONS

Pressing the user (5) button will display the menu with items referring to the data saved by the user or referring to
certain „special" functions of the shockwave generator:

• Clients

• User sequences

• User diagnoses / programs

• Recent therapies

4.1 CLIENTS

This item allows you to enter, edit and delete information about the clients. A particular therapy can be assigned
to each client.

4.2 USER SEQUENCES

This feature - user sequences - is not active for the BTL- 5000 SWT Series.

USER OPTIONS | PAGE 32 OF 47

4.3 USER DIAGNOSES/PROGRAMS

It is possible to start the user therapies, adjust their parameters, names and descriptions, delete them and sort
them by using the buttons and offers on the screen. It is very similar to the creation of a new diagnosis / program
– see the chapter Therapy saving. On the tab of the compressor you can only see those therapies that were
created and belong to this tab.

4.4 LIST OF RECENT THERAPIES

This feature allows you to choose one of the recent accomplished therapies on the selected tab and after
pressing the load button you can restart it and view its parameters.

USER OPTIONS | PAGE 33 OF 47

5 APPLICATION OF SHOCKWAVES

Application of shockwaves is provided by a spring-loaded applicator, which:

• Provides proper and exactly specified contact of the applicator with the treated tissue during the therapy

• Minimizes transmission of reverse shocks to the hand of the therapist thanks to an inbuilt air damper

The component part of the applicator is an ergonomic hand rest (13) used for a comfortable grip of the applicator
and prevents unwanted slipping of the hand from the holder of the applicator during the therapy. The ergonomic
hand rest spins and can be any time adjusted into the desired position.

The anatomical shape of the handle allows the therapist to grip the holder of the applicator comfortably in different
positions, exactly according to the type of the applied therapy and personal preferences of the therapist
(left-handed person, right-handed person, man, woman).

The ergonomic shape of the handle offers the therapist sufficient support during the application, thereby
preventing from the development of tiredness of the hand during the therapy.

Examples of holding the shockwave applicator

Examples illustrate the application of shockwaves in different places and various of ways of holding the applicator.

Painful shoulder

Trigger points

Tibial edge syndrome Calcar calcanei (plantar fasciitis )

APPLICATION OF SHOCKWAVES | PAGE 34 OF 47

Epicondylitis

Achyllodinia

Patellar tendinopathy (jumper's knee)

Trigger points

APPLICATION OF SHOCKWAVES | PAGE 35 OF 47

6 ACCESSORIES

The device is not designed for use in connection with different accessories and other medical equipment except
those stated in this manual.

The following list includes a summary of all accessories that can be supplied with the device.

For detailed information on individual accessories see the enclosed leaflet.

Standard BTL accessories:

• 1x trolley for the BTL- 5000 SWT

• 1x shockwave applicator with multi-focus shock transmitter Ø 15mm

• 1x replaceable multi-focus shock transmitter Ø 9m

• 1x replaceable focusing shock transmitter Ø 15mm

• 1x exchangeable kit (includes a spare set of O-rings)

• 1x applicator holder

• 1x gel 1000 ml

• 1x power cord

• 1x communication cable

• 4x silent blocks for compressor unit

• 1x spare fuse T1.6A/250V for the main unit

• 2x spare fuse T6.3A/250V for the compressor unit

• 1x pen for the for touch screen

• 1x CD with the user's manual

• 2x dust cover of the main unit

• markers for output cables

Optional BTL accessories:

• transport case for the BTL- 5000 SWT

• additional shockwave applicator with focusing shock transmitter

• foot pedal

• gel 300 ml

ACCESSORIES | PAGE 36 OF 47

7 MAINTENANCE AND SAFETY INSTRUCTIONS

Service inspection and measuring of all parameters of the device and relevant recalibration must be executed at
intervals shorter than 30 calendar months. The inspection is carried out by authorised BTL customer service on
the basis user's order. The manufacturer does not guarantee for the technical parameters and safe operation of
the product, if the inspection is not executed on the defined schedule.

Keep the device clean, do not store or use it for a long time in extremely dusty environments and do not spill any
liquid onto the surface. Before using check the device and its accessories (especially cables) for mechanical or
other damages. Do not use the device if damaged!

Cleaning the surface of the device and its parts:

Clean the BTL - 5000 SWT and its parts only with a lightly damp soft cloth. Use water or a 2 % detergent solution.
Never use agents containing alcohol, ammonia, petrol, thinners, etc. To clean the device, do not use abrasive
materials as they could damage the surface of the device and e.g. deteriorate metal parts of the applicator. There
are no aseptic parts of the device and there is no need to sterilize them.

Cleaning accessories getting in contact with the client (e.g. shock transmitters):

Cleanse after each client using agents approved by the competent health officer. You can use e.g. Sekusept,
Bacilol and other. For the cables of the accessories you can use e.g. Incidur spray etc. Surface of the shock
transmitter with the cap can be washed with warm water, however for the complete removal of gel from the shock
transmitter it is necessary to unscrew the shock transmitter and clean it.

Fuse replacement

The fuse of the main unit is set on the rear panel in a round black box (27). Fuses of the shockwave compressor
are placed on the rear panel of the unit in a round black box (37). Check the accuracy of the inserted fuses during
their replacement. The main unit (25) and the shockwave compressor (35) both use different types of fuses!

Before replacement, first make sure that the mains switches of the main unit (25) and the shockwave compressor
(35) are in „0" position and disconnect the power cords from both units. Use a suitable screwdriver or a coin to
turn the segment of the fuse case to the left and remove the fuse. Insert a new fuse and finish the replacement
similar way, but turn it to the right. It is prohibited to insert a fuse with different indication, than mentioned
on the sign above the fuse box.

This operation can be accomplished only by a person familiarized with this procedure!

Switching the device to different mains voltage

The witch of the main unit (28) is placed under the device in a round black box. The switch of the shockwave
compressor (38) is placed on the rear panel of the unit. Before switching over, firstly make sure that the power
switches (25, 35) are in the „0" position and disconnect the power cords from the device. Use a suitable
screwdriver or a coin to turn the segment of the switches so sign on the switch with the arrow pointing to,
correspond to the voltage of the local mains distribution system.

MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 37 OF 47

This operation can be accomplished only by person familiarized with this procedure!

If in doubt contact the authorised BTL customer service. The manufacturer is not responsible for any damage
incurred by incorrect switchover.

Transport and storage

We recommend retaining the original packaging of the device to ensure its maximum protection during
transportation. Disconnect the mains cables and the accessories cables. Avoid heavy shocks. The device must
be stored or transported under the conditions defined in the chapter Technical parameters.

7.1.1 SHOCK TRANSMITTER REPLACEMENT PROCEDURE

The shock transmitter (14) can be replaced by another one as necessary; three shock transmitters are the part of
the BTL - 5000 SWT standard accessories:

• 1x replaceable multi-focus shock transmitter Ø 15mm

• 1x replaceable multi-focus shock transmitter Ø 9mm

• 1x replaceable focusing shock transmitter Ø 15mm

Replacement procedure:

1. Unscrew the screw cap of the shock transmitter by hand (15).

2. Remove the shock transmitter from the applicator (14) (including both O - rings).

O-rings

3. Insert the selected shock transmitter „as it is" to the applicator (including the mounted O - rings).

4. Put the shock transmitter's screw cap of the applicator back on and screw it tightly by hand (15).

MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 38 OF 47

7.1.2 PROCEDURE OF WORN-OUT TUBE AND PROJECTILE REPLACEMENT

If the applicator stops working correctly after a certain time, it is possible to change the worn-out system of tube
and projectile by using the exchangeable kit that is part of the BTL - 5000 SWT package.

Do not use damaged applicators; otherwise you may cause risk of injury to the operating staff or the client.

The packaging of the spare kit includes:

• 1x exchangeable kit

• 1x key to unscrew / screw the cartridge screw cap

• 1x plastic covering of the exchangeable kit

• 1x set of spare O-rings

Replacement procedure:

1. Firstly, according to the chapter Applicator kit replacement wizard start
guide of the kit replacement.

2. Unscrew the screw cap of the shock transmitter by hand (15).

3. Remove the shock transmitter from the applicator (14) (including both O - rings).

O-rings

MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 39 OF 47

4. Using the key (part of the packaging) unscrew the screw cap of the cartridge, follow the pictures.

5. Remove the worn-out kit from the cartridge of the applicator.

6. Take out a new replaceable kit from the plastic cover.

MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 40 OF 47

7. Carefully insert the kit "as it is" into the cartridge of the applicator in the direction shown in the picture (do not
touch the rear cover behind the spring, as it is coated with a thin layer of lubricant from production!).

The front cover of the kit must be adjusted in position shown in the picture and inserted in one level with the
edge of the outer case of the applicator (push the kit a tiny bit inside the case of the applicator). The replaced

kit must move freely!

8. After the insertion of the kit, firmly screw the screw cap of the cartridge back using the key.

9. When replacing the applicator kit we recommend replacing the O-rings on the applicator

attachment too. Spare O-rings are included in the accessories. Then put the applicator attachment
(14) with both O-rings replaced back in.

10. Insert the shock transmitter back to the applicator (14) (including both O - rings).

11. Put the screw cap of the shock transmitter back on and screw it tightly by hand (15).

12. Connect the applicator back to the BTL - 5000 SWT device and finish the installation of the new kit according
to the chapter Applicator kit replacement wizard.

MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 41 OF 47

7.2 SAFETY OF THE DEVICE

ATTENTION!

Only accessories connected to the connectors marked as follows can be applied to the client. The client's part is
of BF type. Attention, the values of power, electric current or voltage can exceed the safe values of the power,
current and voltage.

The device is equipped with a protective system against the connection of different equipment other than supplied
by the manufacturer; consequently it does not allow for operation with equipment from other manufacturers.

Do not apply the shockwave to the areas with the body organs containing gases, or close to big nerves,

vessels, spinal cord or the head!

The device does not use any pharmaceuticals or matters, which would be applied or were an integral part of the
device.

The connectors marked with these signs can be connected with the foot pedal for initiation of the therapy. The
foot pedal is placed under the bottom part of the shockwave compressor.

General safety precautions:

• Carefully read the service instructions before the first activation of the device.

• The device should only be used under the control of a physician who determined the indication.

• All personnel, using this device must be knowledgeable in the servicing technique, maintenance and

verification of the device and about the principles of safe work with the device.

• Electrical mains connected to the device must be performed according to the existing valid standards

(IEC 364) and must be certificated according to these standards. If you are not sure, that the power mains
supply is in perfect order, carry out a technical revision by an engineering inspector.

• Crosscheck, whether the parameters of the power mains supply correspond with the requirements of the

device according to the chapter Technical parameters and if the mains voltage switch on both units of the
device is switched to the correct voltage according to the parameters of the power mains.

• The device is designed to work in an environment defined in the chapter Technical parameters. It must not

be used in an environment with threats of e.g. explosion hazard, or water penetration. The device must not be
used in connection with flammable anaesthetics, or oxidative gases (O2, N2O etc.).

• Place the device out of direct sunlight and out of reach of strong electromagnetic fields, to avoid undesirable

interactions. In case of undesirable interactions place the device away from source of disturbance, or contact
the authorised BTL service centre.

• Before every use, examine the device properly (loose cables, damaged cable insulation, the surface of

accessories, functions of the display, operating elements etc.) and in case of any discrepancy stop using the
device and contact the authorised BTL service centre. If the behaviour of the device shows any divergences
from the function procedure described in the instruction manual, stop using the device and contact the
authorised BTL service centre.

MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 42 OF 47

• If the device shows any signs of defects, or you are in doubt about its correct operation, stop the therapy

immediately. If you cannot detect the source of doubts even after careful reading through the instruction
manual, appeal to the authorised service department of the BTL device without delay. If the device is used
contrary to this instruction manual, or it is used despite the device showing functional divergences from this
instruction manual, then the user is responsible for any damage caused by the device!

• Do not disassemble the device in any case. Dismantling and unlocking the safety cover can cause danger of

electric shock. Eventual replacement of the lithium battery and the air micro filter must by carried out by
authorised BTL service centre.

• All materials and parts that come into direct contact with the client's body (detergents used for cleaning the

shock transmitter ...), must meet the appropriate standards, relevant to irritation, allergization, toxicity
genotoxicity, carcinogenity according to the standards ISO 10993 - 1, ISO 10993 - 3, ISO 10993 5. The user
himself is responsible for all these materials and parts that were not supplied by the BTL device distributor.

• Do not connect the connectors used for the accessories and the other connectors with anything other than

the equipment intended by the service instructions, as it can cause danger of electric shock and serious
damage of the device!

• The device does not radiate or does not use any toxic materials during its operation, storage and transport

under the given conditions.

• When transferring the device from a cold environment into warm, wait before plugging it into the power mains,

until the temperature levels (2 hours minimum).

• Before starting the therapy, check whether all the adjusted parameters correspond to your requirements.

• The shock wave is used as the contact therapy – Do not in any case apply on damaged skin!

• Do not terminate the application by switching off the mains switch, but by pressing the time / stop (11) key.

When switching the device off and on, there is a time delay necessary of at least 3 seconds.

• When disposing of the device after years of operation, it is necessary to remove the lithium battery. Dispose

of it in a proper way – do not put the battery into the communal waste. The device can then be disposed of in
the usual way. The device does not contain any toxic materials that could damage the environment when
disposed of in the ecological way.

• It is not allowed to use the device and accessories other than according to the instruction manual.

• This device must be kept out of reach of the children.

• The device does not include any components to be reparable by the user, except the replacement kit. Do not

remove any covers from the device. Repairs must always be provided by the authorised BTL service centre.

• Do not unplug the applicator during therapy.

7.3 WARRANTY CONDITIONS

The manufacturer provides a 24 months guarantee for the device from the date of purchase mentioned in the
certificate of warranty, and 6 months for the accessories and the expendable supplies (guarantee does not apply
to common wear of the parts).

Conditions of the guarantee determine, if the device is not used in compliance with this instruction manual, or
unprofessional intervention to the device is carried out by third parties. In case of malfunction of the device always
contact the authorized BTL service centre.

MAINTENANCE AND SAFETY INSTRUCTIONS | PAGE 43 OF 47

8 TECHNICAL PARAMETERS

Identification of the device BTL - 5000 SWT BASIC / BTL - 5000 SWT POWER

Operating conditions

Ambient temperature + 10 °C to+ 40 °C
Relative humidity 30 % to 75 %
Atmospheric pressure 700 hPa to 1060 hPa
Position vertical – on legs
Type of operation permanent

Transport and storage conditions

Ambient temperature - 10 °C to + 55 °C
Relative humidity 25 % to 85 %
Atmospheric pressure 650 hPa to 1100 hPa
Position of the main unit any
Position of the compressor basic
Storage time max. 1 year
Additional conditions transport only in the supplied packing

Power supply

Main unit max. Input 80VA
Compressor maximum input 550VA
Mains voltage (switched) ~ 99 V to 126 V (115 V nominal), AC

Frequency 50 Hz to 60 Hz
Equipment protection class II (according to IEC 536)
External exchangeable fuse 1xT1.6A / 250V, tube safety fuse 5 x 20 mm, according to IEC 127-2

2xT6.3A / 250V, tube safety fuse 5 x 20 mm, according to IEC 127-2

Power switch according to IEC 601 - 1 at the back of the device, position 0 and I

Design

Weight – main unit only max. 5.3 kg
Weight – compressor unit max. 20 kg
Weight - applicator max. 900 g including cable
Main unit dimensions (w x h x d) 230 x 390 x 260 mm
Compressor unit dimensions (w x h x d) 330 x 270 x 320 mm
Dimensions - applicator (w x h x d) 40 x 280 x 140 mm
IP code according to EN 60 529

IP 20

Display units

Graphic colour touch screen diag. 5.7" / 14.5 cm, resolution 320x240 pixels (BTL - 5000 SWT Basic)
diag. 8.4" / 21.5 cm, 640x480 pixels (BTL - 5000 SWT Power)
Indicators 1x blue for the main unit
1x green, 1x yellow, 2x blue for the compressor

Classification

Applied part type BF
Class according to MDD 93/42/EEC IIb

~ 198 V to 252 V (230 V nominal), AC

(main unit)

(compressor unit)

TECHNICAL PARAMETERS | PAGE 44 OF 47

Adjustable values

Shock intensity max. 3 / 5* Bar (maximum instantaneous value)
Shock frequency max. 15 Hz / 22 Hz*
Therapy period 0 – 9999 shocks

*only for BTL- 5000 SWT POWER

Shockwave specifications

Maximum positive pressure max. 15.8 MPa
Maximum negative pressure max. 0.9 MPa
Energy density

Steps of adjustable values

Intensity 0.1 Bar
Frequency 1 Hz
Total number of pulses per therapy dynamically - according to size from 1 to 50 shocks

0.25 mJ/mm

2

8.1 APPLICABLE STANDARDS

Name IEC, EN, ISO, MDD

Medical electric device. Part 1: General requirements for safety IEC 601-1
Appendices to EN 601-1 A2, A11 a A12
Medical electric device. Part 1-1: Systems IEC 60601-1-1
Medical electric device. Part 1: EMC - requirements and examinations IEC 60601-1-2
ISM – radio interference characteristics EN 55011
EMC – electrostatic discharge IEC 61000-4-2
EMC – radiated electromagnetic field IEC 61000-4-3
EMC – fast electric transient effects/pulse groups IEC 61000-4-4
EMC – shock pulse IEC 61000-4-5
Medical electric device. Part 4: Programmable electric medical systems IEC 60601-1-4
Medical device - risk analysis ISO 14971
Bio-compatibility of medical device ISO 10 993-1

Statutory rules for determination of technical requirements to sanitary engineering assets
Particular requirements for the safety of equipments for extracorporeally induced lithotripsy IEC 60601-2-36

Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and
muscle stimulators

Clinical investigation of medical devices for human subjects

NV 181/2001 Col.
MDD 93/42/EEC

IEC 60601-2-10

ISO 14155

TECHNICAL PARAMETERS | PAGE 45 OF 47

8.2 MANUFACTURER

This product is manufactured in accordance with the EU Medical Devices Directive by:

BTL Industries Ltd.

161 Cleveland Way

Stevenage

Hertfordshire

SG1 6BU

United Kingdom

E-mail: [e-mail]

http://www.btlnet.com

For service, please contact the service department at [e-mail]

.

No part of this manual may be reproduced, saved in a research centre or transferred by any means incl. electronic, mechanic,

photographic or other records without previous approval from BTL Industries Limited

BTL Industries Limited operates a policy of continuous development. Therefore, it reserves the right to make changes and

improvements to the products without prior notice.

The content of this document is provided "as it is ". Except as required by applicable law, no warranties of any kind, either

expressed or implied, are made in relation to the accuracy, reliability or contents of this document. BTL Industries Limited

reserves the right to revise this document or withdraw it at any time without prior notice.

TECHNICAL PARAMETERS | PAGE 46 OF 47

9 DEVICE CONFIGURATION

Type:

Number of shockwave therapies 1 1

Display, diag.

Client's records x x
Encyclopaedia x x

Encyclopaedia with anatomical
pictures

Predefined diagnosis 13 13
Preset programs 13 13
Language versions x x
Sound schemes x x
Colour schemes x x
Recent therapy x x
Electrotherapy upgrade - x
Laser therapy upgrade - x
Magnetic therapy upgrade - x
Ultrasound therapy upgrade - x
Additional applicator* - optional
Shockwave parameters :
Pressure 1.5 - 3 Bar 1.5 - 5 Bar
Frequency 1 - 15 Hz 1 - 22 Hz
Individual shocks mode x x
Continual mode x x
Burst mode - x

* Possible simultaneous connection of two applicators

BTL-5000 SWT BASIC BTL-5000 SWT POWER

colour touch screen

diag. 5.7"

- x

colour touch screen

diag. 8.4"

DEVICE CONFIGURATION | PAGE 47 OF 47