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• Page 1
  BTL-5000 Series U S E R ’ S M A N U A L v 1 1 2 R K 2 1 / 0 4 / 2 0 0 5 E N…
• Page 2
  All of us at BTL wish you every success with your BTL-5000 system. We pride ourselves on being as responsive as possible to our customer’s needs. Your suggestions and comments are always welcome since we believe an ongoing relationship with our customers is critically important to our future product line.

• Page 3: Table Of Contents

  Save Therapy and Add It to the Patient Data ………………23 2.10 Interconnection of Units ……………………..26 2.10.1 Interconnection of BTL-5000 Puls (Combi) and Vacuum Unit BTL vac ……….26 2.10.2 Interconnection of BTL-5000 Puls and BTL-5000 Sono ……………..26 2.10.3 Interconnection of BTL-5000 Puls, BTL-5000 Sono and BTL vac …………27 2.10.4…

• Page 4
  Interconnection of Devices………………………48 Manufacturer …………………………49 UNITS CONFIGURATIONS ……………………..50 Table of Configurations of the Combined Devices BTL 5000 Combi …………50 Table of Configurations of the Electrotherapy Devices BTL-5000 Puls…………54 Table of Configurations of the Ultrasound Therapy Devices BTL-5000 Sono ……….55 Table of Configurations of the Laser Therapy Devices BTL-5000 Laser…………55…

• Page 5: General Characteristics

  With every BTL unit, you can purchase a cart specially designed for BTL products. Its versatile design allows you to conveniently store and use 1 or 2 physiotherapy units and a vacuum unit. The cart includes a range of accessory trays and baskets.

• Page 6: Instructions For Use

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L I N S T R U C T I O N S F O R U S E 2 .

• Page 7: Rear View

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L R E A R V I E W 1 — 6 patient outputs – for exact configuration see Tab. 2.1 mains switch to switch the power supply on/off socket for connection of the mains cable label showing equipment type and manufacturer and safety precautions and warnings…

• Page 8
  * can be supplied or upgraded with HVT module Notes: connector for connection of electrotherapy accessories (BTL-236-1, BTL vac) to E1 generator connector for connection of electrotherapy accessories (BTL-236-1, BTL vac) to E2 generator connector for connection of electrotherapy accessories (BTL-236-1, BTL vac) to E2 generator…

• Page 9: Unpacking And Assembly

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 3 U N P A C K I N G A N D A S S E M B L Y Inspect the box for damage and report any damage to carrier and your distributor.

• Page 10: Operating The Unit

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L Connection of accessories: Connect the accessories to the output connectors (1) — (6) on the rear panel according to the Tab. 2.1. The unit will automatically detect their type and display them on the screen.

• Page 11: Numerical Keyboard

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 4 . 2 N u m e r i c a l K e y b o a r d In addition to setting numerical value with the select (14) button, you can also use “numerical keyboard”.

• Page 12: Therapy Setting

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 5 T H E R A P Y S E T T I N G 2 .

• Page 13: Welcome Screen And Selection Of Channels, Tabs And Accessories

  BTL-236-1 with two electrodes Tab of channel E1 with electrotherapy accessory BTL-236-1 and possibility to apply combined therapy Tab of channel E2 with electrotherapy accessory BTL-236-1 and possibility to apply combined and HVT therapies Tab of selected channel E2 with electrotherapy accessory BTL-236-2.

• Page 14: Setting Therapy Parameters Via The ‘Diag’ Button

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 5 . 3 S e t t i n g T h e r a p y P a r a m e t e r s v i a t h e ‘ d i a g ’ B u t t o n Press the diag (8) button to display a list of therapy protocols / diagnoses.

• Page 15: Setting Therapy Parameters Via The ‘Prog’ Button

  Press the prog (9) button to set the required program number. The program numbers generally correspond to the program numbers used in the traditional BTL physiotherapy line. A letter in front of each number corresponds to the type of therapy selected: E – electrotherapy; U – ultrasound; L – laser.

• Page 16: Setting Therapy Parameters Manually Via The ‘Man’ Button

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 5 . 5 S e t t i n g T h e r a p y P a r a m e t e r s M a n u a l l y v i a t h e ‘ m a n ‘ B u t t o n Press the man (11) button to select manual setting for therapy.

• Page 17: Therapy Parameters Screen — Ergonomic, Standard And Expert Mode

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 5 . 6 T h e r a p y P a r a m e t e r s S c r e e n – E r g o n o m i c , S t a n d a r d a n d E x p e r t M o d e This screen opens after pressing the diag (8) or prog (9) button (see 2.5.1 Therapy Flow Chart) before the start of therapy.

• Page 18: Course Of Therapy

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 6 C O U R S E O F T H E R A P Y 2 .

• Page 19: Running Therapy Screen

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 6 . 2 R u n n i n g T h e r a p y S c r e e n Therapy description Intensity Time till end of…

• Page 20: Accessories — Visual Signaling

  A c c e s s o r i e s – V i s u a l S i g n a l i n g Accessories BTL-236 (for electrotherapy) and BTL-237 (ultrasound heads) feature blue pilot lights that signal their operating conditions.

• Page 21: Ultrasound Therapy

  2 . 6 . 5 . 2 U l t r a s o u n d T h e r a p y Generation of ultrasound energy by ultrasound head BTL-237 is indicated: • on the screen – by value of intensity •…

• Page 22: Encyclopaedia

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 8 E N C Y C L O P A E D I A The encyclopaedia provides information about individual therapies, examples of electrode placement and application areas for ultrasound and laser.

• Page 23: Therapy Printing And Saving

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 9 T H E R A P Y P R I N T I N G A N D S A V I N G Pressing the print, save button allows you to make several choices.

• Page 24
  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L Set therapy parameters Save therapy select enter Enter name of diagnosis Enter program number Select patient All information is enter…
• Page 25
  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L A saved therapy will be visible in the: List of diagnoses List of programs and in the list of therapies of the selected patient p a g e 2 5 o f 5 6…

• Page 26: Interconnection Of Units

  U n i t B T L v a c Combine any BTL-5000 Puls or Combi unit with the vacuum unit BTL vac to apply electrotherapy currents by means of suction cup electrodes. Adjustable vacuum pressure ensures simple and convenient attachment of patient electrodes, especially on the parts of body hard to reach with classic electrodes.

• Page 27: Interconnection Of Btl-5000 Puls, Btl-5000 Sono And Btl Vac

  ‘negative polarity’ in the therapy parameters screen of the electrotherapy unit. To apply electrotherapy only with interconnected units, cancel the choice ‘interconnection with electrotherapy’ on the BTL-5000 Sono screen. The electrotherapy electrodes are automatically connected to the electrotherapy output. 2 . 1 0 . 3…

• Page 28: Setup And Operation Of Combined Therapy In Single Devices

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 2 . 1 0 . 4 S e t u p a n d O p e r a t i o n o f C o m b i n e d T h e r a p y i n S i n g l e D e v i c e s After checking for correct interconnection of the electrotherapy and ultrasound units, select a diagnosis or program that utilizes combined therapy.

• Page 29: Menu Button

  Make sure the installed accessory is connected directly, not via interface cable and vacuum or BTl-5000 Sono devices. This will help decrease electromagnetic interference that could cause improper reading of memory data.

• Page 30: Unit Settings

  All audio tones can be switched off or modified as required. Units with laser generator — BTL-5000 Laser, BTL-58xx L, BTL-58xx xL — cannot have the audio tone of the running therapy switched off (in compliance with the applicable standards).

• Page 31: Operation Mode

  N e w O p e r a t i o n M o d e Use this option for the first series BTL-5000 units manufactured in 2001 and early in the year 2002. These units have the knobs (17) and (18) marked as time (17) and start / stop (18). For these units, select the option new operation mode = no (after the new version of firmware is loaded).

• Page 32: File System Formatting

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 3 . 2 . 1 4 . 2 F i l e S y s t e m F o r m a t t i n g Clears all data and programs created by the user.

• Page 33: User Options Via The «User» Button

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L U S E R O P T I O N S V I A T H E “ U S E R ” B U T T O N Pressing the user (13) button opens a screen allowing access to special features of the unit, as well as to data saved by the user.

• Page 34: User Sequences

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 4 . 2 U S E R S E Q U E N C E S Serves to work with the list of self-designed sequences of therapy programs.

• Page 35
  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L Open the therapy parameters screen. In the manual mode select therapy / sequence (or ultrasound sequence or laser sequence).

• Page 36: Parameters Of Sections In Sequence

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 4 . 2 . 1 . 1 P a r a m e t e r s o f S e c t i o n s i n S e q u e n c e A sequence consists of a few currents/programs that are called sections.

• Page 37: User Diagnoses/Programs

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 4 . 3 U S E R D I A G N O S E S / P R O G R A M S Use this feature to run user designed therapies and edit and delete their parameters, names and therapy comments.

• Page 38: Accessories

  A C C E S S O R I E S F O R U L T R A S O U N D T H E R A P Y user’s guide for ultrasound therapy holder for ultrasound head ultrasound head BTL-237-1-13 for 1 and 3MHz, ERA 0.7 cm ultrasound head BTL-237-4-13 for 1 and 3MHz, ERA 3.24 cm ultrasound gel 235ml, 5l, 10l interface cable between BTL-56xx Puls and BTL-57xx Sono, type PVAC.056…

• Page 39: Maintenance And Safety Instructions

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L M A I N T E N A N C E A N D S A F E T Y I N S T R U C T I O N S All maintenance and repairs must be carried out by authorized personnel only.

• Page 40: Safety

  Always follow your local and national electrical, safety and healthy standards when using this equipment. Call your distributor for advice. • The device does not have any user-servicing parts. Do not remove any covers. Always have the unit repaired by BTL Service Department. p a g e 4 0 o f 5 6…

• Page 41
  • For therapy use only the BTL ultrasound gel; the head is not tested for other gels or oils and use of them could damage the head. If you still want to use other gels, we recommend them to be only water-based gels.

• Page 42: Useful Addresses

  6 . 2 U S E F U L A D D R E S S E S The product is manufactured in accordance with the EU Medical Devices Directive by : BTL Industries Ltd. Suite 401 Albany House 324-326 Regents Street…

• Page 43: Contraindications

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 6 . 4 C O N T R A I N D I C A T I O N S The list of contraindications gives the cases when the manufacturer does not recommend to apply the selected therapy.

• Page 44: Technical Parameters

  0 and I Power switch on the front panel, labelled on off Internal chemical sources Type of batteries lithium CR2032 (replacement by BTL Service Department) Design Weight – device only max. 5 kg Weight –…

• Page 45: Basic Parameters Of Ultrasound Generator

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L Output voltage — HVT max. 390 V (maximum instantaneous value) *maximum value for some currents is limited according to IEC 601-2-10 Tolerance of output amplitude ±…

• Page 46: Technical Parameters Of Ultrasound Heads

  U S E R ‘ S M A N U A L Adjustable values Frequency*** 0 – 5000 Hz, (0 – 10000 Hz for C variant) with laser probe BTL-448 0 – 500 Hz with laser cluster BTL-445 accuracy of frequency ±…

• Page 47: Technical Parameters Of Laser Clusters

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L Laser probes with infrared (invisible) radiation: Type: BTL-448-05IC BTL-448-10IC BTL-448-20IC BTL-448-30IC Output power: 50 mW ± 20 % 100 mW ±…

• Page 48: Applicable Standards

  I N T E R C O N N E C T I O N O F D E V I C E S BTL-5000 Puls can be interconnected with: BTL vac, BTL-5000 Sono, BTL-12, BTL-07p, BTL-4000 Sono BTL-5000 Combi can be interconnected with:…

• Page 49: Manufacturer

  The contents of this document is provided «as 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.

• Page 50: Units Configurations

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L U N I T S C O N F I G U R A T I O N S 8 .

• Page 51
  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L Type: 5820SL 5825SL 5820L 5825L 5830L 5835L 5840S 5840SL 5840L 5860L Number of therapies Electrotherapy Ultrasound therapy Laser therapy…
• Page 52
  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L Type: 5800SLC 5810SC 5810S2C 5810SLC 5810LC 5810L2C 5820SC 5825SC Number of therapies Electrotherapy Ultrasound therapy Laser therapy Patient cardfile (positions) min.
• Page 53
  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L Type: 5820SLC 5825SLC 5820LC 5825LC 5830LC 5835LC 5840SC 5840SLC 5840LC 5860LC Number of therapies Electrotherapy Ultrasound therapy Laser therapy…

• Page 54: Table Of Configurations Of The Electrotherapy Devices Btl-5000 Puls

  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L 8 . 2 T A B L E O F C O N F I G U R A T I O N S O F T H E E L E C T R O T H E R A P Y D E V I C E S B T L — 5 0 0 0 P U L S Type: 5610…

• Page 55: Table Of Configurations Of The Ultrasound Therapy Devices Btl-5000 Sono

  50 min. 150 min. 150 Step of setting of values standard standard fine fine Encyclopaedia Preset diagnoses Preset programs Interconnection with BTL-5000 Puls Interconnection with PC optional optional optional optional Print optional optional optional optional Language versions Sound schemes…

• Page 56
  B T L — 5 0 0 0 S E R I E S U S E R ‘ S M A N U A L p a g e 5 6 o f 5 6…

BTL-4000

Magnetotherapy

U S E R ’ S G U I D E

2.2 FMF TECHNOLOGY

FMF = Focused Magnetic Field

In dependence on their spatial distribution, magnetic fields are divided into uniform and non-uniform. The uniform field has the same intensity and the same direction in all points of space.

The applicators were designed using state-of the-art ferromagnetic and magnetic materials which enable highly effective magnetic concentration systems to be assembled. These elements focus the electromagnetic field onto the desired space towards the treated body part. Therefore, the magnetic field of the BTL applicator is intentionally non-uniform and focused.

The sides of the applicator are identified as the patient side, from which the magnetic field is emitted to a higher extent, and the operator side, where the field intensities are several times lower.

blue indicator light

The side is marked with a pictograph of a “patient in the magnetic field”. The intensities on this side of the applicator are much higher than those on the operator’s side. During operation of the device, the operator should not touch this side of the applicator.

The side marked with the BTL logo. It is also equipped with a blue indicator lamp which indicates operation of the applicator (continuous light, fast blinking) and its readiness for operation (slow blinking).

BTL-6000 SWT TOPLINE

USER’S MANUAL

v100AS08/01/2010EN

BEFORE YOU START

Dear Customer,

Thank you for purchasing BTL technology. All of us at BTL wish you every success with your system. We pride ourselves on being as responsive as possible to our customers’ needs. Your suggestions and comments are always welcome since we believe an ongoing relationship with our customers is critically important to our future product line.

While we would like you to start using your new equipment right away, we encourage a thorough reading of this manual in order to fully understand the operational features of the system.

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

Again, thank you for being a BTL customer.

BTL Industries, Ltd.

PAGE 2 OF 38

CONTENTS

PAGE 3 OF 38

PAGE 4 OF 38

1 GENERAL CHARACTERISTICS OF THE DEVICE

The BTL-6000 SWT Topline is a state-of-the-art device allowing the application of therapy using non-invasive shockwaves. Shockwaves are one of the most effective ways to treat pain associated with the musculoskeletal system. Musculoskeletal pain is currently the second-leading cause of absences in the workplace.

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

Therapy is easily and efficiently started by simply selecting a diagnosis from an alphabetized list of treatment protocols or by selecting a therapy program. The treatment parameters can be manually set by the simple use of the touch screen buttons. Throughout the course of a therapy session, the device will keep the user informed about the therapeutic method in use, the type of treatment, the total number of shocks to be applied, the number of shocks applied and remaining, the frequency being used, the intensity and other necessary data.

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

The BTL-6000 SWT Topline allows the entering of client names and other relevant information into the internal memory of the device and to link their data with the predefined programs or with the user’s own. When a client has a return visit, simply call up their name and begin the pre-set therapy.

We also carry a specially-designed cart for the BTL-6000 SWT Topline which is sold separately. The design allows convenient movement and use of the device. Four stable castors ensure smooth and easy movement of the device in the office or the health-care center.

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

1.1BTL–6000 SWT TOPLINE SYSTEM SERIES

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

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

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

The BTL-6000 SWT Topline is a state-of-the-art device allowing the application of therapy using non-invasive shockwaves. Shockwaves are one of the most effective ways to treat pain associated with the musculoskeletal system. Musculoskeletal pain is currently the second-leading cause of absences in the workplace.

The device consists of two parts:

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

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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 5 OF 38

1.2 SHOCKWAVE AND ITS CHARACTER

A shockwave is defined as a wave with a rapid increase of pressure within a very short time and then having a gradual decrease of pressure with a small negative pressure phase.

Shockwaves are aimed at the affected areas that are the source of chronic pain. The influence of the shockwaves causes to the dissolution of calcium deposits and leads to better vascularization. The after-effect is relief from the pain.

Outside of the client’s body (extra-corporeally), a pressure pulse of high amplitude is generated and its energy is concentrated on the target area. The pressure pulse travels through a liquid medium gel into the client’s body and penetrates soft tissue without major energy loss.

The pressure course of the shockwave in real-time in expressively different from the pressure course of the harmonic sound wave. Shockwaves can be compared to ultrasonic waves which are particularly characterized by a pressure jump change, a higher amplitude and non-periodicity.

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

A substantial part of the shockwave energy penetrates into the liquid (of the organism) with a great positive pressure pulse. Its diffusion is only limited by the actual tissue absorption and eventual reflections on acoustic non-homogeneities.

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

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

∙Low negative pressure amplitude: 1 to 10 MPa

∙Short time duration: 1 µs to 20 µs

∙Rapid pressure increase: < 100 ns

∙Broad frequency spectrum: 1 Hz to 1 MHz

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

1.3 SHOCKWAVE GENERATION

Several types of generators have been developed for shockwave therapy, each producing shockwaves with varied characteristics. Each type of generation method induces shockwaves with different time progressions and spatial arrangements.

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

1.3.1BALLISTIC PRINCIPLE OF SHOCKWAVE GENERATION

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

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 6 OF 38

1.4 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT

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

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

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

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

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

∙Improvement of micro-circulation and metabolism

∙Dissolution of calcified fibroblasts

∙Supports the production of collagen

∙Reduction in tissue tension

∙Analgesic effect:

o Destruction of afferent nerves and nerve receptors.

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

oGate control theory of pain.

1.5ADVANTAGES OF SHOCKWAVE TREATMENT

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

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

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

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

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

1.6POSSIBLE SIDE EFFECTS OF SHOCKWAVE TREATMENT

∙Erythema or swelling can temporarily occur in the treated area.

∙Loss of bodily sensation or itching can temporarily occur in the treated area

∙Hematoma

∙Petechiae

∙Skin damage after previous corticoid therapy

∙Shockwave application can cause undesirable heart activity

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 7 OF 38

1.7INDICATIONS FOR SHOCKWAVE TREATMENT

∙Plantar Fasciitis

∙Achillodynia/Achillobursitis

∙Inflammations and calcification of shoulder joint tendons.

∙Pain in the groin area.

∙Epicondylitis (Tennis and Golf Elbow)

∙Apex Patellae Syndrome and Tibial Stress Syndrome.

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

∙Jumper’s Knee (Patellar Tendinitis)

∙Pain in the hamstring insertions.

∙Pain on the palmar side of the wrist.

∙Exostoses of small hand joints from Grade 1 Arthrosis.

∙Acupuncture

∙Pain trigger-points or painful points in muscles.

1.8CONTRA-INDICATIONS FOR SHOCKWAVE TREATMENT

∙Application to certain tissues: The eyes and the surrounding area, the myocardium, the spinal cord, the gonads, the kidneys and the liver

∙Blood disorders, coagulation problems or the use of anticoagulants

∙Blood thinning medications (Warfarinization)

∙Polypus in the area of treatment

∙Pregnancy

∙Thrombosis

∙Tumor diseases

∙Polyneuropathy

∙Acute inflammation

∙Growing cartilage in children

∙Therapy using corticoids

∙Inapplicable on areas of the body and organs with possible gas content

∙Inapplicable on areas in proximity to large nerve bundles, blood vessels, the spinal cord and the head

GENERAL CHARACTERISTICS OF THE DEVICE | PAGE 8 OF 38

2INSTRUCTIONS FOR OPERATION

2.1THE FRONT PANEL OF THE BTL-6000 SWT TOPLINE

1

7

103

104

1.touch screen

2.select knob (to select individual parameters)

3.enter key

4.esc key

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

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

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

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

2.2APPLICATOR FOR BTL-6000 SWT TOPLINE

8.hand rest of the applicator

9.shock transmitter of the applicator

10.shock transmitter screw cap of the applicator

11.connector of the applicator

12.guide mark of the connector

13.applicator button: to start therapy

INSTRUCTIONS FOR OPERATION | PAGE 9 OF 38

2.3THE REAR PANEL OF THE BTL-6000 SWT TOPLINE

14.connector for shockwave applicator

15.control unit mains fuse

16.connector for power cable

17.power on/off switch

18.vessel for collecting condensed water

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

20.venting grid

INSTRUCTIONS FOR OPERATION | PAGE 10 OF 38

2.4ASSEMBLY AND SET-UP

Inspect the box for damage and report any damage to the transport carrier and the distributor. Do not proceed with assembly and set-up if the box is damaged. Keep the original box and packaging to ensure safe future transport of the device.

When bringing the device from a cold environment into a warm one, do not plug it into the power source until the device has had to equilibrate to room temperature (Minimum 2 hours).

Unpack the device and place it on a stable horizontal surface which is suitable for its weight. Always position the device out of direct sunlight. During operation, the control unit gets warm, so it must not be positioned near direct heat sources. The device is self-cooled by forced air circulation. The cooling vents are located on the rear panel and on the bottom. Do not cover or block these vents. Allow a minimum of 4 inches (10cm) clearance behind the rear panel. Do not place the device on a soft surface (such as a towel) which may obstruct air flow to the bottom cooling vents. Do not put any heat-producing devices or any objects containing water or other liquids on the device. Do not put any heat-producing devices or objects containing water or other liquid on the device. Do not place the device close to appliances producing strong electromagnetic, electric or magnetic field (diathermy, X-rays, etc.), otherwise it could be undesirably influenced.

In the event of any questions, please contact an authorized service of BTL devices.

Procedure:

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

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

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

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

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

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

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

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

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

Note:

After switching the device on, the device will run a self-diagnostic of its internal circuits and its functions for about 10 to 15 seconds. If any fault is detected, the screen will display a warning message. If necessary; the control unit will lock itself into a “secure” mode. If this situation occurs, please contact your authorized BTL distributor.

INSTRUCTIONS FOR OPERATION | PAGE 11 OF 38