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TECHNICAL PARAMETERS | PAGE 45 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

0.25 mJ/mm

Steps of adjustable values

Intensity 0.1

Bar

Frequency 1

Total number of pulses per therapy

dynamically - according to size from 1 to 50 shocks

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

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

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

IEC 60601-2-10

Clinical investigation of medical devices for human subjects

ISO 14155

Содержание 5000 Shockwave Series

Страница 1: ...PAGE 1 OF 47 BTL 5000 Shockwave Series USER S MANUAL 101IE30 07 2008EN...

Страница 2: ...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 st...

Страница 3: ...c 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...

Страница 4: ...formation 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...

Страница 5: ...gram 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...

Страница 6: ...f 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 ene...

Страница 7: ...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...

Страница 8: ...ng 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 haemato...

Страница 9: ...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 inflammatio...

Страница 10: ...lect 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 int...

Страница 11: ...urposes 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...

Страница 12: ...ts 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 e...

Страница 13: ...orrect 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 lo...

Страница 14: ...e 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 disp...

Страница 15: ...e 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...

Страница 16: ...E 16 OF 47 2 5 THERAPY SETTING PRINCIPLE 2 5 1 DIAGRAM OF THE THERAPY SETTING PROCESS ENTRY SCREEN DIAGNOSIS SELECTION PROGRAM SELECTION MANU L SETTING THERAPY INTERRUPTION RUNNING THERAPY THERAPY INT...

Страница 17: ...g the channels 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...

Страница 18: ...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 2 5 4 SETT...

Страница 19: ...ng 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 actua...

Страница 20: ...ted 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...

Страница 21: ...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...

Страница 22: ...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...

Страница 23: ...ved 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 n...

Страница 24: ...re 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...

Страница 25: ...umber 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...

Страница 26: ...lation 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 fr...

Страница 27: ...tched 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 a...

Страница 28: ...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 Engli...

Страница 29: ...e 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 thi...

Страница 30: ...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 chap...

Страница 31: ...ctions 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 applicat...

Страница 32: ...ng 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 t...

Страница 33: ...he 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 thi...

Страница 34: ...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...

Страница 35: ...APPLICATION OF SHOCKWAVES PAGE 35 OF 47 Patellar tendinopathy jumper s knee Achyllodinia Trigger points Epicondylitis...

Страница 36: ...ocus shock transmitter 15mm 1x replaceable multi focus shock transmitter 9m 1x replaceable focusing shock transmitter 15mm 1x exchangeable kit includes a spare set of O rings 1x applicator holder 1x g...

Страница 37: ...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 sho...

Страница 38: ...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...

Страница 39: ...plicators 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 pla...

Страница 40: ...NS PAGE 40 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 replac...

Страница 41: ...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 ring...

Страница 42: ...ical 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 su...

Страница 43: ...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...

Страница 44: ...y 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 main unit 2xT6 3A 250V tube safety fuse 5...

Страница 45: ...ric 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...

Страница 46: ...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...

Страница 47: ...omical pictures x 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 Magnet...

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