DUOLITH SD1»ultra«ESWT APPLICATION BROCHURE

Transcription

1 DUOLITH SD1»ultra«ESWT APPLICATION BROCHURE

2 Non-invasive therapy in the service of people Our objective Better therapies through new technologies. Established in 1987, STORZ MEDICAL AG is a Swiss member company of the KARL STORZ Group. The objective pursued by our physicists and engineers is to conduct ongoing research into shock wave technology and to develop new system concepts. Our products have proved their efficacy all over the world in the fields of urology, orthopaedics, physiotherapy, rehabilitation, gastroenterology, cardiology, dermatology, and aesthetic medicine. New compact systems have recently been developed so that other medical disciplines can also gain access to the benefits of non-invasive shock wave technology. With its pioneering technological innovations, STORZ MEDICAL sets new standards in the treatment of pain in close-to-bone soft tissue of the musculoskeletal system and in on-board ultrasound imaging. As a reliable partner of doctors, we are committed to making a vital contribution to medical progress in the service of new therapy methods. 02

3 Contents Non-invasive therapy in the service of people...02 Contents...03 System key features...04 Intuitive user guidance...05 Physics of shock wave technology...06 F-SW handpiece ( mj/mm²)...07 R-SW handpiece and shock transmitters...08 C-ACTOR handpiece ( mj/mm²)...09 V-ACTOR handpiece...10 DUOLITH SD1»ultra«Indications/Contraindications...11 Shock wave therapy...12 Achillodynia...13 Plantar fasciitis...14 Metatarsalgia...15 Trigger points: plantar foot muscles...16 Tibial stress syndrome...17 Trigger points: calf muscle shortening...18 Patellar tendinitis...19 Trigger points: thigh adductors...20 Trigger points: shortened thigh muscles...21 Trochanteric tendinopathy...22 Trigger points: lumbago...23 Trigger points: dorsalgia...24 Trigger points: cervical syndrome...25 Calcific tendinitis...26 Trigger points: periarticular shoulder pain...27 Radial/ulnar epicondylitis...28 Trigger points: forearm muscles...29 Ultrasound diagnosis...30 This application brochure does not replace the original instruction manual. Read the manual carefully before starting to use the system! 03

4 System key features DUOLITH SD1»ultra«Innovative modularity Configuration R-SW + control module (+ US) Configuration F-SW + control module (+ US) Configuration R-SW + F-SW + control module (+ US) R-SW module Radial shock waves Ergonomic handpiece with built-in display Direct pressure and frequency selection Vibration therapy with V-ACTOR handpiece (optional) F-SW module Focused shock waves Treatment of superficial and deep target areas Constantly high energy dynamics Use of stand-offs for ideal focal zone F-SW module Focused shock waves Treatment of superficial and deep target areas Constantly high energy dynamics Use of stand-offs for ideal focal zone Control module STORZ MEDICAL»Top View«display with touch screen Intuitive user guidance with on-board patient management system Pre-configured indications with treatment parameters Ultrasound diagnosis B&W or colour Doppler (optional) Control module STORZ MEDICAL»Top View«display with touch screen Intuitive user guidance with on-board patient management system Pre-configured indications with treatment parameters Ultrasound diagnosis B&W or colour Doppler (optional) R-SW module Radial shock waves Ergonomic handpiece with built-in display Direct pressure and frequency selection Vibration therapy with V-ACTOR handpiece (optional) Control module STORZ MEDICAL»Top View«display with touch screen Intuitive user guidance with on-board patient management system Pre-configured indications with treatment parameters Ultrasound diagnosis B&W or colour Doppler (optional) 04

5 Intuitive user guidance Buttons on the touch screen Buttons on the R-SW handpiece Mode selector button (only enabled when handpieces are connected), active mode is highlighted in white 2 selector button 3 Shock number selector button 4 selector button 5 Applied shock number reset button/ display 6 Contact pressure display 7 SkinTouch ON/OFF button 8 Pre-configured indications list access button 9 Patient reports list access button 10 Visual Analogue Scale (VAS) access button 11 Language selector button (direct selection/display) 12 Settings menu button: software update, selecting options, service 13 Info menu button: display of serial numbers and indices/versions 14 Indications selector button (indications of various treatment areas) 15 Return to start screen button 1 Start button 2/3 + and buttons for pressure and frequency settings 2 Applied shock number reset: press both + buttons simultaneously 3 Info menu (total shock number, serial number, software): press both buttons simultaneously 4 Applied shock number display Treatment guide for pre-configured indications Pain regions overview Treatment videos 05

6 Physics of shock wave technology Focused, radial and defocused shock waves Scientific studies confirm the extraordinary effectiveness of focused shock waves in the treatment of calcific tendinitis, radial epicondylitis, plantar fasciitis and pseudarthrosis. Focused shock waves are also increasingly used in the diagnosis and treatment of myofascial trigger point syndrome. Superficial indications should be treated with radial shock waves. Radial shock waves propagate divergently after application and lose energy as the penetration depth increases. They are characterised by long wavelengths and cannot be focused on deep target areas. Their maximum energy flux density is reached in the superficial region. Focused shock waves (F-SW) are characterised by short wavelengths and are focused on a focal zone outside the therapy head. They are most effective in deep target areas. Different stand-offs are available to vary the penetration depth and adjust it to the tissue layer to be treated. Radial shock waves (R-SW) are introduced into the body by means of a mobile handpiece and cover the entire pain region. Radial shock waves are also referred to as radial pressure waves, which physically speaking is the more accurate term. Defocused shock waves (C-ACTOR ) are preferably used in the diagnosis and treatment of myofascial trigger point syndrome and wound healing disorders. Optionally, the C-ACTOR handpiece can be used instead of the F-SW handpiece. Focused shock wave (F-SW) Radial shock wave (R-SW) Defocused shock wave (C-ACTOR ) 06

7 F-SW handpiece ( mj/mm²) Use of the F-SW handpiece with different stand-offs Without stand-off 50 mm Penetration depth Focal zone: mm Therapeutic effectiveness: mm The handpiece can be used with different stand-offs for different penetration depths: without stand-off with stand-off I (short) with stand-off II (long) Stand-off I (short) Penetration depth Focal zone: mm Silicone oil or coupling gel must be applied between the handpiece and stand-off to ensure reliable coupling. 30 mm Therapeutic effectiveness: mm Stand-off II (long) Penetration depth Focal zone: 0 30 mm 15 mm Therapeutic effectiveness: 0 90 mm Application energy setting Shock wave application has an analgesic effect, so treatment is rather comfortable for patients: Begin with an initial energy level of about 0.1 to 0.25 mj/mm². Higher energy levels are only required for specific applications (e.g. pseudarthrosis). Slowly increase the application energy according to the patient s pain tolerance. The system is factory-set to»auto frequency«. This means that the highest possible frequency setting is selected for each energy level. If you prefer to control the frequency manually, you should disable the»auto frequency«option. To do so, select»options«in the»settings«menu. 07

8 R-SW handpiece and shock transmitters Application energy Begin with an initial energy level of about 1.5 to 3 bar. Slowly increase the application energy according to the patient s pain tolerance, using the buttons provided on the touch screen or handpiece. Shock transmitters for R-SW handpiece Besides the and standard shock transmitters, additional transmitters are available for specific applications. A6 T10 C15 Ø 6 mm, AkuSt transmitter Shock wave acupuncture Penetration depth: 0 40 mm Ø 10 mm, trigger point transmitter Myofascial trigger point therapy,»palpation finger«penetration depth: 0 40 mm Ø 15 mm, CERAma-x ESWT transmitter Gel-free shock wave application, any type of enthesopathy Penetration depth: 0 40 mm DI15 F15 Ø 15 mm, ESWT transmitter Radial shock wave therapy, any type of enthesopathy Penetration depth: 0 40 mm Ø 15 mm, Deep Impact transmitter,»energy Beam«Deep target areas, chronic disorders, high-energy applications Penetration depth: 0 60 mm Ø 15 mm,»focus Lens«transmitter,»Point Focus«energy Superficial pain regions, muscles of mastication, neck Penetration depth: 0 20 mm D20-T D35-S Ø 20 mm, D-ACTOR transmitter Myofascial trigger point therapy, muscle and connective tissue Penetration depth: 0 50 mm Ø 20 mm, D-ACTOR transmitter For professional athletes, deep muscular trigger points, high-energy applications Penetration depth: 0 60 mm Ø 35 mm, D-ACTOR transmitter Myofascial trigger point therapy, muscle and connective tissue, large muscles Penetration depth: 0 50 mm 08

9 C-ACTOR handpiece ( mj/mm²) Use of C-ACTOR handpiece with different stand-offs Stand-off I (short) Penetration depth Therapeutic effectiveness: 60 mm The handpiece can be used with different stand-offs for different penetration depths: with stand-off I (short) with stand-off II (long) Stand-off II (long) Penetration depth Therapeutic effectiveness: 50 mm Silicone oil or coupling gel must be applied between the handpiece and stand-off to ensure reliable coupling. Application energy setting Shock wave application has an analgesic effect, so treatment is rather comfortable for patients: Begin with an initial energy level of about 0.09 to 0.25 mj/mm². Slowly increase the application energy according to the patient s pain tolerance. Change between F-SW and C-ACTOR handpiece The system is factory-set to»auto frequency«. This means that the highest possible frequency setting is selected for each energy level. If you prefer to control the frequency manually, you should disable the»auto frequency«option. To do so, select»options«in the»settings«menu. You can change between the F-SW and C-ACTOR handpiece during treatment (while the system is on) without losing time. Check that both handpieces have been set up for use on the treatment day (initial water filling and brief degassing process, required only once a day). 09

10 V-ACTOR handpiece Benefits and effects V-ACTOR mechanism of action of vibration therapy Muscle and connective tissue relaxation, elimination of adhesions Improved microcirculation Stimulation and acceleration of metabolic activity Improved neuromuscular performance Well-being through increased hormone release (serotonin) Stress reduction through lower cortisol level Revitalisation Physiological muscle vibrations at a frequency of up to 35 Hz are the strongest driving force of microcirculatory processes. The fine resonance thus produced ensures that nutrients are supplied and returned through the smallest vascular and lymphatic channels of the extracellular matrix. This function cannot be managed by the cardiovascular system. Reduced physiological muscle vibrations adversely affect the cellular supply. This may produce a convulsive tendency and cause painful muscle hardening in the form of trigger points. The V-ACTOR enables targeted application of vibration pulses to the tissue. Microcirculation is improved and metabolic waste products and toxins are removed via the blood and lymph. Elongation of fascia and muscle fibres by means of the V-ACTOR restores normal muscle tone as muscle shortening and hardening is eliminated. Mode of action of the V-ACTOR handpiece V10 Treatment of specific muscle points Tissue massage and muscle smoothing V40 Treatment of large muscle areas 10

11 DUOLITH SD1»ultra«Indications/Contraindications The DUOLITH SD1»ultra«can be used to treat the following indications, among others: Achillodynia Plantar fasciitis Metatarsalgia Trigger points: plantar foot muscles Tibial stress syndrome Trigger points: calf muscle shortening Patellar tendinitis Trigger points: thigh adductors Trigger points: shortened thigh muscles Trochanteric tendinopathy Trigger points: dorsalgia Trigger points: lumbago Trigger points: cervical syndrome Calcific tendinitis Trigger points: periarticular shoulder pain Radial/ulnar epicondylitis Trigger points: forearm muscles Wound healing disorders Please keep track of the latest medical publications and new information published by the manufacturer for details on additional indications approved after the date of printing of this brochure. Therapists and patients should wear suitable ear protection during treatment. Patients should be offered ear plugs for use. Treatment with the DUOLITH SD1»ultra«is not allowed in the following cases: Coagulation disorders (haemophilia) Use of anticoagulants, especially Marcumar Thrombosis Tumour diseases, carcinoma patients Pregnancy Children in growth (growth plates) Cortisone therapy up to 6 weeks before first ESWT treatment Generally speaking, shock waves must not be applied to target areas located above air-filled tissue (lungs), nor to large nerves, vessels, the spinal column or head. Possible side effects of treatment with the DUOLITH SD1»ultra«: Swelling, reddening, haematomas Petechiae Pain Skin lesions in case of previous cortisone therapy Side effects generally abate after 2 to 5 days. Make sure they have disappeared before starting the next therapy session. 11

12 Shock wave therapy Treatment Make sure the patient is in a comfortable position. Always use gel for coupling to ensure perfect shock wave transmission. Position the handpiece at right angles to the skin surface. Make sure the entire transmitter surface is in contact with the skin. Start treatment at a moderate energy level. Slowly increase the energy level during the therapy session. Depending on the indication treated, up to 8000 shocks can be applied per session. Apply 300 to 500 shocks per painful spot or trigger point. In general, 3 to 6 treatment sessions are necessary at intervals of 5 to 10 days. The individual treatment steps must be performed in the correct order. Treatment steps of combined therapy Step 1: F-SW ( shocks) Select the stand-off according to the required penetration depth (none or stand-off I or II)! Remember to apply silicone oil! Apply shock waves locally to the painful spots until the nature of the pain changes (patient s biofeedback). ( shocks) Use the transmitter for large-area dynamic muscle smoothing and mobilisation of fascia and muscle fibres. Step 1: F-SW Stand-off: 0, I or II Parameters: 1 8 Hz; mj/mm² Number of shocks: ( shocks) To round off a successful therapy, use the V- ACTOR handpiece to relax muscles and connective tissue and improve metabolic activity. Perform dynamic treatment of large target areas along the muscle, applying up to extra shocks per therapy session. : Parameters: Hz; bar Number of shocks: Parameters: ; bar Number of shocks: Good to know... Treatment steps of radial shock wave therapy Shock wave treatment is experienced differently by each patient. Painful spots are localised by taking a detailed medical history and by palpation of the painful regions, following the patient s indication of pain. The analgesic effect of shock waves is produced by the gate control mechanism and by the release of tissue hormones. Once the primary point of pain has been eliminated by the analgesic effect of the shock waves, other painful spots may appear that were previously covered up by the primary pain. In general, local anaesthesia should not be used. Reduce the energy level, if necessary. No strain or pressure should be exerted on the treated body regions throughout the entire therapy. Step 1: R-SW ( shocks) Select one of the following shock transmitters according to the depth of the target area and the patient s pain tolerance: F15, or DI15. Apply shock waves locally to the painful spots until the nature of the pain changes (patient s biofeedback). ( shocks) Use the transmitter for large-area dynamic muscle smoothing and mobilisation of fascia and muscle fibres. Step 1: R-SW : F15,, DI15 Parameters: 8 ; bar Number of shocks: ( shocks) To round off a successful therapy, use the V-AC- TOR handpiece to relax muscles and connective tissue and improve metabolic activity. Perform dynamic treatment of large target areas along the muscle, applying up to extra shocks per therapy session. : Parameters: Hz; bar Number of shocks: Parameters: ; bar Number of shocks:

13 Achillodynia Pre-treatment preparations: ultrasound Diagnosis and localisation of the treatment area Example see image: thickened Achilles tendon with hypoechogenic zone Shocks/session 500 Shocks/session mj/mm bar 4 Hz 12 Hz Stand-off II C15 Shocks/session bar D20-T The shock transmitter for R-SW treatment should be selected according to the required penetration depth. 13

14 Plantar fasciitis Pre-treatment preparations: ultrasound Diagnosis and localisation of the treatment area Example see image: thickened plantar fascia Shocks/session 2000 Shocks/session mj/mm bar 4 Hz 12 Hz Stand-off I/II DI15 Shocks/session bar The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 14

15 Metatarsalgia Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 12 Hz Stand-off I/II DI15 Shocks/session bar The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 15

16 Trigger points: plantar foot muscles Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 12 Hz Stand-off I/II C15 Shocks/session bar The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 16

17 Tibial stress syndrome Shocks/session 1200 Shocks/session mj/mm bar 4 Hz Stand-off I/II F15 Shocks/session bar The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 17

18 Trigger points: calf muscle shortening Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off 0/I/II DI15 Shocks/session bar D20-T The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 18

19 Patellar tendinitis Shocks/session 1500 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off II C15 Shocks/session bar The shock transmitter for R-SW treatment should be selected according to the required penetration depth. 19

20 Trigger points: thigh adductors Shocks/session 1500 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off 0/I/II DI15 Shocks/session bar D35-S The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 20

21 Trigger points: shortened thigh muscles Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off 0/I/II T10 Shocks/session bar D35-S The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 21

22 Trochanteric tendinopathy Shocks/session 1500 Shocks/session mj/mm bar 4 Hz Stand-off 0 DI15 Shocks/session bar D20-T The shock transmitter for R-SW treatment should be selected according to the required penetration depth. 22

23 Trigger points: lumbago Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off I T10 Shocks/session bar Generally speaking, shock waves must not be applied to target areas located above air-filled tissue (lungs), nor to large nerves, vessels, the spinal column or head. The shock transmitter for R-SW treatment should be selected according to the required penetration depth. 23

24 Trigger points: dorsalgia Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off II C15 Shocks/session bar Generally speaking, shock waves must not be applied to target areas located above air-filled tissue (lungs), nor to large nerves, vessels, the spinal column or head. The shock transmitter for R-SW treatment should be selected according to the required penetration depth. 24

25 Trigger points: cervical syndrome Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off II T10 Shocks/session bar Generally speaking, shock waves must not be applied to target areas located above air-filled tissue (lungs), nor to large nerves, vessels, the spinal column or head. The shock transmitter for R-SW treatment should be selected according to the required penetration depth. 25

26 Calcific tendinitis Pre-treatment preparations: ultrasound Diagnosis and localisation of the treatment area Example see image: supraspinatus tendon with several small calcific deposits Shocks/session 1500 Shocks/session mj/mm bar 4 Hz 12 Hz Stand-off I/II DI15 Shocks/session bar D20-T The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 26

27 Trigger points: periarticular shoulder pain Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off I/II C15 Shocks/session bar The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 27

28 Radial/ulnar epicondylitis Pre-treatment preparations: ultrasound Diagnosis and localisation of the treatment area Example see image: inhomogeneity in the flexor insertion region, dense calcific deposit Shocks/session 1500 Shocks/session mj/mm bar 4 Hz 12 Hz Stand-off I/II F15 Shocks/session bar The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 28

29 Trigger points: forearm muscles Shocks/session 1000 Shocks/session mj/mm bar 4 Hz 10 Hz Stand-off I/II C15 Shocks/session bar The stand-off for F-SW treatment and the shock transmitter for R-SW treatment should be selected according to the required penetration depth. 29

30 Ultrasound diagnosis Tool and control bars at a glance A Top tool bar A B Bottom tool bar C Left control bar D Right control bar C D B How to save an image The patient at issue must have been created in the patient management software. If a specific indication is selected for the patient, this indication will apply to the ultrasound mode. If not, press 7 to select the desired default setting. Start the scan and press * (Freeze) to freeze it. Texts, labels (using 0 ) and measuring values (using F8 ) can be added to images. Select the desired images and press 8 to save them in the applicable patient record. How to reset an image to start values Press F1 F1-F6 to return to the start-up B-mode. Press to return to the original default setting. User-specific default settings If you wish to save your settings, press 7 to select default settings (will appear in C ) and press»save«at the bottom of the screen. 30

31 A Top tool bar // F1 F6 F7 F8 F9 F10 F // Probe type display F1-F6 F1 F6, mode selector buttons (B, M, PW, CFM, DPI, DPDI) F7 Left control bar enable button for zoom function F8 Right control bar enable button for measurement function F9 Image bar ON/OFF F10 Right control bar enable button for video recording (Cine) F11 Automatic image adjustment/optimisation button (for each mode) 3 Menu (software) button: selecting options, touch screen calibration 4 Display of selected measurement instrument B Bottom tool bar * <> * Freeze/Run button 1 4 Left control bar enable button for basic parameter settings (for each mode) 5 Left control bar enable button for depth compensation (TGC) 6 Left control bar enable button for palette (gamma curve, brightness, contrast, colour) 7 Left control bar enable button for default settings 8 Save button to save images to the patient management system 9 Save button to save cine-loops to the patient management system 0 Right control bar enable button for comments (texts/labels for images). Right control bar enable button for marking the treatment areas on the body <> Cine-loop button (approx. 300 frames) C Left control bar 10 Ultrasound parameter settings 11 Screen selector button for parameter and image quality settings D Right control bar 12 Measurements in different modes 13 Screen selector button for B-mode, M-mode, PW-mode

32 HUMANE TECHNOLOGY TECHNOLOGY FOR PEOPLE STORZ MEDICAL AG Lohstampfestrasse Tägerwilen Switzerland Tel. +41 (0) Fax +41 (0) Subject to change without notice. The information in this brochure is only intended for medical and healthcare professionals. The brochure provides information on products and indications that may not be available in all countries. This brochure contains treatment recommendations provided by experienced users. Not available in the US. SM E 0215/SIH