Scientific Literature - ShockWave Dual Power

Scientific Literature

ShockWave Dual Power Physiotherapy/Beauty

Shockwaves are acoustic waves, i.e. sound pulses, that carry high energy, characterized by a particular waveform (rapid peak of positive pressure followed by a rapid phase of negative pressure), able to produce direct mechanical stimulation. Generated in an aqueous medium and conveyed on a defined point referred to as “focus” (or target), they transmit a measurable amount of energy, able to provide precise therapeutic effects.

How they work When the shockwave travels through living tissues (through appropriate energy levels for the treatment site and desired therapeutic effect), said tissues undergo a beneficial “micro hydro massage”, able to promote a series of biochemical and cellular reactions, which are ultimately responsible for the therapeutic effect.

With calcific formations, which often occur in inflamed tendons and ligaments, what leads to their disappearance after treatment with shockwaves (not in all treated cases though), is not linked to a direct mechanical action (of “breaking”) but to their dissolution, through the activation of local biochemical processes.

Physical principle

Summary of the sound wave phenomenon

Physical principle

What is ShockWave Dual Power SHOCKWAVE DUAL POWER is the evolution

of "monomodal" shockwave devices based on the concept that it is necessary to generate sound waves to be applied to tissues to obtain appreciable results in therapeutic or aesthetic terms.

The “multi-mode” approach of SHOCKWAVE DUAL POWER is the first great innovation in the field of shock waves after decades of technological immobility, so much so that it is covered by an international patent.

The concept underlying SHOCKWAVE DUAL POWER can be explained with a simple,

if you have the key of a door it is perfectly useless to break it down with your shoulder. yet effective example:

The R&D Department and the Scientific Division of Winform have worked for a long time looking for this “key”, and found it in the possibility of generating tissue

modifications that allow the sound wave to propagate effectively, without the need to use extremely high pressure as in traditional systems.

This effect was achieved thanks to the synergy of devices capable of preparing the “road” for a uniform wave, propagated by a high reaction piezoelectric system with fast rise ramp pulses.

The shock pressure generated by this system is calibrated to be able to effectively penetrate tissues bio-stimulated by SHOCKWAVE DUAL POWER, reaching the therapeutic target in a quick and controlled manner.

All that is summed up as being able to keep the effectiveness of traditional shockwave systems but in a more comfortable and safer manner for the patient, who does not perceive any pain or discomfort during treatment.

SHOCKWAVE DUAL POWER, the modern concept of shockwave.

Physical principle TRADITIONAL SHOCKWAVE All traditional shockwave systems use very high pressure, always painful for the patient.

SHOCKWAVE DUAL POWER

ShockWave Dual Power use the synergy for a revolutionary shockwave concept

1. TECAR: GEL-SOL transition of the extracellular matrix O3

2. SHOCKWAVE: implosion of water molecules and release of energy (cavitation effect)

O3 O3 O3 O3

3. TRANSDERMAL VEHICULATION: oxygenation of the tissue with LifeGel

O3

SYNERGIC WAVE SHOCKWAVE DUAL POWER OF WINFORM Winform has developed and patented a complex and effective system that, thanks to the synergy of TECAR and Transdermal Delivery, opens the door to and allows the shockwave to penetrate with no more need for very high pressure and above all, without causing any pain to the patient.

Physical principle

What is the Tecar method The physical principle of its functioning involves the application to the human body of a medium frequency system, which produces a field between the two electrodes (positive and negative) at the level of the body area interposed, which becomes an active part of a capacitor. The biological tissue, in this case, makes the ionic charges available becoming a second species armor for the condenser. Second type conductors are those in which the transport of current occurs by physical movement of ions through a liquid. When a system of this type interacts with the organism, if equipped with the appropriate characteristics, it determines changes in the activity of the biological system.

The physical principle of the capacitor applied to the human body does not use the emission of radiant energies or electromagnetic fields in the body but, in a very natural way, uses what the body makes available as its own electrolytic charges, attracting and rejecting them, by speeding up in this way mechanisms which, in any case, take place physiologically but considerably slowed down in the presence of a pathology. This technology considers both voltage and frequency of the acting field both the impedance of the tissues of the human body, or the measure of their ease of conducting electric current. The overall impedance value of a tissue is the result of the impedance of the different tissues that compose it. An accurate calculation of these parameters allows: • •

Greater efficacy, provided by the optimal energy dose Lesser contraindications and certainties of the result, eliminating energy overdose.

In conclusion, this technology creates an epochal change by placing different parameters on the use and application of the physical principles of radiofrequency applied to the organism for a therapeutic process.

With Winform Tecar devices it is possible to obtain all the biological effects listed below, customizing the therapy based on the specific needs of each pathology and each patient treated: • acceleration of the natural systemic reparative reaction; • reactivation of the superficial lymphatic and blood microcirculation by the

capillary vasodilation; • facilitates the reabsorption of oedemas; • reduction of contractures and muscle spasms; • increase in nerve conduction; • increase in the extensibility of collagen due to viscosity reduction; • acceleration of enzymatic activity; • increase in the nociceptive threshold.

The SCE and SIVSEA systems allow a control of the energy emission and consequently of the thermal effects that occur in depth. Thanks to these control systems, the maximum degree of safety is guaranteed for the respect of biological tissues, optimizing the effectiveness of the treatment and avoiding incurring secondary effects (due to a return of energy to the handpiece or an energy overdose on the treated tissues). All this is possible thanks to a constant control of the impedance of the substrates and automatic regulation of the emission intensity.

Furthermore, depending on the set SIVSEA, and the variation of the same, during the treatment it is possible to obtain specific biological effects and evaluate the treatment efficacy on the basis of the modification of the tissue density obtained.

It is a painless method with no side effects that allows to transdermally deliver active ingredients with high molecular weight to cell interstitial spaces without the intermediation of blood circulation in the first phase (ex. pharmaceutical drugs, homeopathic products, phyto-pharmaceutical products).

The active ingredients applied to the skin meet a barrier to penetration consisting of the stratum corneum. Winform transdermal delivery system allows the substance to travel through intracellular spaces overcoming this obstacle and to cross cell membranes.

Winform technology uses a patented method in which high frequency pulsed currents work in synergy with low frequency modulated currents.

Transdermal delivery is a technique that allows the transport through the skin of medium-low molecular weight active ingredients in the intra and extracellular spaces, limiting interactions with the bloodstream. This route of administration allows a controlled release of the substance, that is, the molecule can be made available for a long period of time, from a few hours to several days, thanks to the reserve role played by the integument.

Any incompatibilities with the active ingredients of the drug are also minimized, the potential toxicological risks associated with the use of more classic routes of administration (such as gastro-intestinal or intravenous for example), the aggression of intestinal flora associated with the orally use and the hepatic first pass effect, in which a large portion of the active ingredient is absorbed, transported to the liver and metabolized by the liver enzymes, inactivating it.

The stratum corneum is the most superficial one of the skin barriers against the intake of external material and constitutes a real obstacle to the transdermal diffusion of active pharmacological and cosmetic principles.

Physiologically, only a small number of molecules with low molecular weight and high lipophilicity is suitable to pass through the stratum corneum (highly hydrophobic), to reach the treatment target and thus perform the relevant therapeutic action, while the majority of hydrophilic molecules cannot “passively� cross the barrier of the integument and they remain thus superficial. Furthermore, if some of these molecules were able to penetrate at the epidermal level, they would risk to be prematurely degraded by the epidermal enzymes, thus further reducing their bioavailability.

Physical principle

What is the method Transdermal Delivery

Biological effects

Interactions shockwave and biological tissues Shockwaves have been used in the medical field for over forty years: initially 1 their use was identified as a therapeutic tool able to intervene on the structure of kidney stones, shattering them and reducing their size so as to facilitate their elimination. The lithotripsy proved to be a method so effective, safe and highly repeatable that it quickly became the gold standard for the treatment of renal and urethral lithiasis 2.

But the real breakthrough in the orthopaedic and rehabilitation field occurred in 1986, when the first experimental studies on the influence of shock waves on bone tissue 3 began, as it was feared that the lysis effect on the renal calculus would also affect the iliac and femur bones, damaging them.

Graff et al. study showed that the bone tissue of the treated animals had not reported macroscopic changes, but through histological investigation we could observe some microcracks which, after 2-3 weeks from exposure, had completely regenerated, with the presence of new bone tissue (osteogenesis).

The slight changes observed by the authors on the bone exposed to treatment were not a contraindication to the lithotripsy, leaving instead room for a wide scientific debate on the new therapeutic horizons of the method.

Haupt picked up the correct intuition of Graff and his collaborators and began a series of experiments (in particular on animal models) to evaluate the biostimulation potential of shock waves, both in the regeneration of soft tissues 4 and of bone tissue 5 6 7 8.

C. Chaussy et al. “First clinical experience with extracorporeally induced destruction of kidney stones by shock waves” - The Journal of Urology (1982), Vol 127; 2 I. Riedler et al. “Outcome and Safety of extracorporeal Shock wave lithotripsy as first-line therapy of lower pole nephrolithiasis” - Urol. Int. (2003); Vol. 7; 350-354; 3 J. Graff, KD Richter, J Pastor “Effect of High Energy Shock Waves on Bony Tissue” (1986)- in Walker V.R., Sutton R.A.L., Cameron E.C.B, Pak C.Y.C, Robertoson W.G. (eds) “Urolithiasis”, Springer (1989); 4 G. Haupt, M. Chvapil “Effect of Shock wave on the healing of partial thickness wounds in piglets” - J Surg Res (1990); Vol. 49; 45; 5 G. Haupt, A. Haupt, M. Chvapil, G W Drack, T H Senge “Wound and fracture healing: new indication for extracorporeal shock waves?” - J Endourol (1990) suppl. 4; s54; abstract A-4; 6 G. Haupt, A. Haupt, B. Gerety & M. Chvapil “Enhancement of fracture healing with extracorporeal shock wave” - J Urol part 2 (1990), 143, 230A, Abstract 109; 7 G. Haupt, G. Ekkernkamp, M.Chvapil, M. Haupt, B.Gerety “Influence of shock waves on fracture healing” Urology (1992) Vol. 39, 529; 8 G. Haupt “Use of extracorporeal shock waves in the treatment of pseudoarthrosis, tendinopathy and other orthopeadics diseases”, The Journal of Urology (1997), Vol. 158, page. 4-11; 1

In 1988, the two Bulgarian researchers Valchanou and Michailow 9, supplied the first clinical results of the treatment, through shock waves, of the delays of bone consolidation and of pseudoarthrosis: it could be found that the therapy was a success in the 85% of cases, although unfortunately there was no mention of the patient's medical history, any concomitant treatments and there was no follow-up. The authors advanced the hypothesis that shockwave treatment broke the sclerotic bone and produced microcracks, which increased the supply of blood and nutrients to the area, stimulating its healing. In addition, the presence of small bone fragments partially attached to the periosteum could be a further element of osteogenetic stimulation.

The results of Bürger 10 11 and Witzsch studies (et al 12) on the effect of biostimulation on the bone reported a lower success rate (compared to the study of Valchanou and Michailow) but it was possible to observe a complete bone consolidation in 35% of cases and the formation of bone callus in 21%, on a sample of 37 patients.

Another author, Haist 13, took pains to differentiate the results obtained according to whether the type of pseudoarthrosis found in the patient was hypertrophic or atrophic.

While all patients with hypertrophic pseudoarthrosis showed complete healing of the fracture, only 3 out of 13 of those found with atrophic pseudoarthrosis achieved this result.

Schleberger and Senge 14 supported the treatment of this complication by shock waves, also indicating that pseudoarthrosis would have had a better outcome if stabilized in posttreatment with a suitable orthosis (to avoid cutting, rotational and curvature forces), but that it was anyway absolutely necessary to ensure an adequate axial pressure on the treated area.

The first treatments with extracorporeal shockwaves on calcific shoulder tendinopathy began in the 90s: the proven efficacy that ensued allowed to extend the non-invasive treatment also to plantar fasciitis and epicondylitis 15.

Valchanou VD, Michailov P “High Energy Shock waves in the treatment of delayed and non union fractures” – International Orthopeadics (1991); Vol. 15; 181-184 – Springer; 10 Bürger RA, Witzsch U, Haist J, Karnosky V, Ahlers J & Hohenfellner R “ Extracorporeal shock wave therapy of pseudoarthrosis” - J. Urol. (1992( 2’ part, Vol. 147, 260A, abstract 185; 11 Bürger RA, Witzsch U, Haist J, Karnosky V & Hohenfellner R “ Extracorporeal Shock wave therapy of pseudoarthrosis and aseptic osteonecrosis” – J. Endourol (1991); Suppl. 5; S48, Abstract A24; 12 Witzsch U, Bürger RA, Karnosky V & Haist J “Hochenergie-Stoßwellenbehandlung-eine Methode zur Therapie von Pseudoarthrosen” – Urologe A (1992), Vol. 31, A43; 13 Haist J “Die Osteorestauration via Stoßwellenanwendung. Eine neue Möglichkeit zur Therapie der gestörten knöchernen Konsolidierung” in “Die Stoßwelle--Forschung und Klinik” (1995) Edited BY Chaussy C, Eisenberger F, Jocham D, Wilbert Tübingen D – Attempto Verlag, p.157; 14 Schlerberger R and Senge Th “Nicht-Invasive Behandlung nach Versagen der Frakturheilung durch Stoßwellen” in “Aktuelle Aspekte der Osteologie” (1991) Edited by Ittel T, Sieberth G a Matthiass H, New York; Springer-Verlag; 15 Diesh R, Haupt G “Extracorporeal Shockwaves in the treatment of pseudoarthrosis, tendinosis calcarea of the shoulder and calcanear spur” in “Extracorporeal shockwave in orthopeadics” (W.Siebert, M.Buch), cap. 6; 1998 – Springer; 10.1007/978-3-642-80427-4; 9

Biological effects

The results with respect to wound healing revealed that the efficacy of the treatment was strictly dependent on the dose used and that at a low energy dosage it was possible to obtain a concrete stimulation of tissue healing (at the same time, to high dosages corresponded longer recovery times). Furthermore, as concerns the effect of the shock wave on bone tissue, using as outcomes radiological, histological and biochemical analyses, the authors were able to confirm the actual osteogenic potential of this therapy.

Biological effects

In a 1995 consensus meeting, the German Lithotripsy Society officially recommended the use of shockwave for different therapeutic indications: pseudoarthrosis, bone consolidation delays, enthesopathies (tennis elbow, painful shoulder, calcaneal spine), algia to the soft tissues proximal to the bone components and tendinopathies with extraosseous calcifications.

Concerning pseudoarthrosis, it is still recognized as a first choice non-invasive treatment 16 (in particular for the hypertrophic type).

Starting from the same year (1995), this means started to be used in the treatment of calcific deposits: several studies have shown its great effectiveness in reducing pain and in the lysis of calcifications, in particular using a high energy dose and through local anaesthesia of the area to be treated 17 18 19.

Moreover, a comparative study between the effects of treatment with shock wave and those with arthroscopy 20 shows that the two methods are absolutely superimposable, with the added value of ESWT (Extracorporeal Shock Wave Therapy) being a noninvasive method and with a very low percentage of complications / side effects (follow-up controls of the Daecke et al study).

From further studies 21 carried out at the beginning of the 2000s it was decided to expand the use of the shock wave to the therapy of patellar tendinitis ("jumper's knee"), osteochondritis dissecans and avascular necrosis of the femoral head, with very satisfactory results.

Moreover, for about a decade, ESWT has been used with great effectiveness also in the treatment of hypertonus in spastic syndromes 22 23 and it is also reported a regenerative effect on the nervous tissue and on the spinal structures 24, with reorganization of the cellular memory (pathological) and with an effective action on neurological pain control.

More recently, extracorporeal shockwaves have also been used in aesthetic medicine in the treatment of cellulite and localized adiposity, with excellent results 25.

Haupt G, Dahmen G, Loew M, Haist J, Rompe J-D e Schleberger R “Standortbestimmung der Arbeitsgruppe “Orthopädische Stoßwellenbehandlungen” (1995) in “Die Stoßwelle---Forschung und Klinik” Ed. by Chaussy C, Eisenberger F, Jocham D & Wilbert Tübingen D, Attempto Verlag, pag. 137: 17 Loew M, Jurgowski W, Mau HC, Thomsen M “Treatment of calcifyng tendinitis of rotator cuff by extracorporeal shock waves: a preliminary report” - J Shoulder Elbow Surg (1995); Vol. 4, n.2; 101-106;

DOI: 10.1016/S1058-2746(05)80062-X; 18 Rompe JD, Rumler F, Hopf C, Nafe B, Heine F “Extracorporeal Shock Wave Therapy for calcifying tendinitis of the shoulder” - Clin Orthop Relat Res (1995); 321; page. 196-201 19 Daecke W, Kusnierczak D, Loew M “Long Term Effects of extracorporeal shockwave therapy in chronic calcific tendinitis of the shoulder” - J Shoulder Elbow Surg (2002); Vol. 11; N.5; Page. 476-480;

DOI: 10.1067/mse.2002.126614; 20 Rebuzzi E, Coletti N, Giusto F “Arthroscopy Surgery versus Shock Wave Therapy for chronic calcifying tendinitis of the shoulder” - J Orthop Traumatol (2008) Dec, Vol. 9, n. 4, Page 179-185; 21 Ludwig J, Lauber S, Lauber HJ, Dreisilker U, Hotzinger H “High-energy shock wave treatment of femoral head necrosis in adults” Clin Orthop (2001); n. 387; page 119-125; 22 Lee JY, Kim SN, Lee IS, Jung H, Lee KS, Koh SE “Effects of extracorporeal shock wave therapy on spasticity in patients after brain injuriy: a meta-analysis” J Phys Ther Sci (2014) Vol 26(10), pagg. 1641-1647; 23 Yamaya S, Ozawa H, Kanno H, Kishimoto KN, Sekiguchi A, Tateda S, Yahata K, Ito K, Shimokawa H, Itoi E “Low Energy extracorporeal shockwave therapy promotes vascular endothelial growth factor expression and improves locomotor recovery after spinal cord injury” J Neurosurg (2014) Vol. 121(6), page 1641-1647; 24 Hausner T, Nogradi A “The use of Shockwaves in peripheral nerve regeneration: new perspectives?” Int Rev Neurobiol (2013) Vol 109, page 85-98; 25 Knobloch K, Joest B, Kramer R, Vogt PM “Cellulite and focused extracorporeal shockwave therapy for noninvasive body contouring: a randomized trial” Dermatol Ther (Heidelb) (2013) Vol.3, pagg. 143-155; 26 D’Agostino MC, Craig K, Tibalt E, S. Respizzi “Shock wave as biological therapeutic tool: from mechanical stimulation to recovery and healing, through mechanotransduction” Int J Surg (2015), Vol. ; pagg. 1-7 - DOI: 16

The biological effects of shock waves are strictly dependent on different characteristics: the type of generator used (electrohydraulic, electromagnetic, piezoelectric and pneumatic), the specific characteristics of the acoustic signal, the density of mechanical energy produced by the wave, the physical characteristics of the substrates that the wave must cross and the percentage of water contained within them. 26 Another distinction must be made: if the effects obtained are of direct type (when the wave comes into contact with the tissue and locally there is an expansion followed by a contraction, they are due to changes in intra and extracellular pressure) or indirect (caused by cavitation or the collapse of air bubbles produced by the direct or "initial" effect of the shock wave).

Among the physical characteristics it is very important to consider the acoustic impedance, closely related to each tissue density: the shock wave can be absorbed in different quantities, and then reflected, diffused or refracted.

For example, muscle and adipose tissues have a very low acoustic impedance and this allows the acoustic wave to be almost completely absorbed, and propagated, with a minimum reflection index. 27 As far as energy density is concerned, the effect of disintegration of the shock wave occurs thanks to specific devices for lithotripsy which allow high and focused energy dosages, so as to hit the calculus, shatter it (pulverize it) and allow its expulsion. In this case, the body area to be treated must be carefully identified to avoid damage to the neighbouring tissues.

However, in the case of low (and average) energy dosages therapy (ESWT), although the mechanisms that allow the shock wave to activate some biological reactions are not completely known yet, it is proven that the specific characteristics of some mechanosensitive cells allow the identification, transmission and conversion of the exogenous stimulus into a biological tissue effect (biostimulation, neoangiogenesis, analgesic effect, anti-inflammatory, reabsorption of calcareous deposits in the calcifications).

Specifically, after perceiving and processing the mechanical information deriving from the extracellular environment and due to the propagation of the shock wave in the tissue, these cells convert these biomechanical forces into biochemical responses, which in turn will influence some fundamental functions of the cell (such as migration, proliferation, differentiation and apoptosis) and of its life cycle.

In particular, functional modifications of the cellular organelles (cytoplasmic) have been observed and involve a stimulation of the nuclear functions and an increase of

10.1016/j.ijsu.2015.11.030; 27 NdR: It is of fundamental importance to know the physical properties of the tissues to be treated to guide the operator on a correct therapeutic rationale.

28 Romeo P, Lavanga V, Pagani D, Sansone V “Extracorporeal shock wave therapy in musculoskeletal disorders: a review� - Med Princ Pract 2014; Vol. 23; page 7-13;

Biological effects

Mechanism of action

Biological effects

the production of proteins, nitric acid and of specific angiogenic growth factors (eNOS and VEGF) which in turn determine correct revascularization (neoangiogenesis) and an adequate intake of nutrients (to allow tissue repair 28).

In addition to stem cells and mesenchymal stromal ones, other cells are also directly involved in tissue regeneration, in particular through this mechanism of "mechanotransduction", determined by shock waves: tenocytes, osteocytes and their precursors, endothelial cells and fibroblasts.

The tenocytes in particular are recognized as cells sensitive to mechanical stress and it is believed that the shock wave acts directly on them by stimulating their mitogenic response (i.e. in cell proliferation and duplication) 29. Specifically, after processing the mechanical stimulus, we see: a reduced expression of several metalloproteinases and interleukins (MMPs and Ils), an adequate regulation of cellular vitality and proliferation, the expression of several typical tendon markers and anti-inflammatory cytokines.

Furthermore, ESWT is a stimulus for the proliferation and synthesis of collagen, increases the expression of lubricin and allows the increase (in vitro) of the functional activities of the tenocytes produced as a result of tendon damage (proliferation and migration) that contribute to determine a correct morphofunctional regeneration of the structure.

Bone tissue is probably the biological substrate in which the effects of the shock wave are more clearly outlined. The osteocytes in fact possess a high mechanical sensitivity as well as their precursors (osteoblasts).

In vitro experiments show that the shock wave acts not only directly on bone and periosteal tissue, but is also able to regulate the continuous "communication" (and programming) between osteoblasts and osteoclasts and bone vasculature.

In detail, the effects observed at bone level include: a direct stimulation of osteoblasts and periosteum cells, an osteogenic differentiation of mesenchymal cells and an accelerated migration of osteoblasts. Moreover (as it happens for the tendinocytes) the expression of angiogenic growth factors (eNOS and VEGF) starts, the synthesis of nitric oxide at the endothelial level and the proliferation of nuclear antigens which, besides the opening of new vessels, they result in an increase in blood supply that provides the district with nutrients essential for tissue regeneration.

This stimulation is not limited only to the bone cells but also extends to the periosteum: the consequent inhibition of the prosteoclastogenic factors modulates the osteoclastic activity of bone remodelling.

The same effects of activation of angiogenic factors, structural remodelling and biostimulation are also found for the other mechanosensitive cells present in the treatment area and stressed by the shock wave.

Chen Yj, Wang KD, Yang KD, Kuo YR, Huang HC, Huang YT, Sun YC, Wang FS “Extracorporeal shock waves promote healing of collagenase induced Achille tendinitis and increse TGF-beta1 and IGF expression� - J Orthop Res Vol. 22 n. 4 (2004 Jul); page 854-861;

29

Shockwave is the Winform device that revolutionizes the classic concept of therapeutic shockwave. The field of action of the ESWT devices described in the previous chapter is thus greatly amplified, thanks to the synergic interaction of the shock wave with diathermy and transdermal vehiculation.

[For specific details about the two technologies, see our dossiers "diathermy" and "transdermal vehiculation": physical principle and interactions].

Diathermy allows the modification of the extracellular matrix with an increase in the percentage of water in the area (nb the greater contribution of water to the treated structure allows a high absorption of the shock wave with a minimum percentage of refraction or dispersion of the same wave), an increase of mitochondrial activity and of the sodium-potassium pump. There is an initial effect of neoangiogenesis which is emphasized following stimulation of the shock wave. A greater flow of blood supply allows the intake of nutrients to the area being treated and a more rapid disposal of inflammatory catabolites.

This process, through the vehiculation of specific active ingredients (in particular oxygenozone) has an extensive anti-inflammatory, analgesic and anti-oedema effect.

A true biostimulation is thus obtained, which leads to the regeneration of the tissue and a restoration of the structure, which will allow a more timely functional recovery.

Traditional pulse

ShockWave Dual Power pulse

Biological effects

Shockwave dual power

Biological effects

Biological effects of ShockWave •

neoangiogenesis;

•

restoration of supply and nourishment of the ischemic areas;

•

acceleration of the flogistic and lesional and perilesional healing effects (anti-inflammatory effect);

•

analgesic effect;

•

biostimulation: tissue regeneration (consolidation delays, pseudoarthrosis, tendon and muscle lesions ...), rapid reabsorption of calcareous deposits (calcifications);

•

nourishing and trophic effect on the biological structures involved in the treatment;

•

anti-oedema and draining effect;

•

quick return to functional activity.

Biological effects

Therapeutic instructions adhesive capsulitis “Frozen Shoulder”

calcifications

enthesitis

epitrocleitis epicondylitis carpal tunnel osteitis pubis chronic-degenerative arthropathies

muscular spasticity

bone consolidation delays

pseudoarthrosis

chondropathies

tarsal tunnel

plantar fasciitis calcaneal spur

Morton’s Neuroma

Biological effects

ReCell Applications

Arms To eliminate imperfections and flaccidity with the protocols dedicated to tone and liposculpture.

Buttocks For all the problems related to the buttocks, it eliminates imperfections, making the gluteus firm, voluminous and sculptural.

Abdomen It eliminates imperfections due to “tummy fat� and effectively fights severe flaccidity.

Saddlebags It tones and firms by deeply smoothing the skin, eliminating all localised adiposities.

Inner and outer thigh Tones and firms both the inner and outer thigh with dedicated protocols, eliminating fibrotic and Oedematous cellulitis.

Biological effects

Biological effects

Flaccidity of the arms

After 10 treatments, the skin is clearly rehydrated, tight and well recompacted.

After 13 treatments the skin is recompacted, with a clear reduction in localised adiposity.

Biological effects

Adiposity

Biological effects

Buttocks

After 6 treatments the skin is smooth and the “orange peel� effect has clearly decreased.

After 13 treatments the skin is recompacted, with a clear reduction in saddlebags.

Biological effects

Saddlebags

Biological effects

Stretch marks

Follow up 5 months after the last of 13 treatments: stretch marks did not reappear.

Biological effects

Technical specifications

The first painless Acoustic Wave.

ShockWave Dual Power is the innovative device for focused shock wave therapies in multimodal mode SHOCKDUAL® and SHOCKFOCUS®.

patented SHOCKDUAL® mode, based on the principle of therapeutic synergy, allows the therapy to be delivered following an optimal biological process.

The

The return of water, obtained by means of diathermic biostimulation, allows the shock waves to implode and

shockwave

propagate more easily than with any other

technology available on the market. The therapeutic process is

completed by the possibility to vehiculate, at the same time, active principles in water-soluble form.

ShockWave Dual Power is the only shockwave device that is totally the patient.

painless for

ShockWave Dual Power is able to detect tissue modifications and absorptions, providing the operator with the certainty

of repeatable therapeutic results.

ShockWave Dual Power has a library of preset programs that allow the operator to

easily and intuitively choose the treatment to be applied.

Technical specifications Programs

Treatments can be set by choosing the appropriate protocol from the library of programs, divided by pathology. It is also possible to create custom programs and save them in the device memory.

SIVSEA and SCE

ShockWave Dual Power uses and displays two fundamental parameters to manage and understand the effects induced to the tissue. The domain of SIVSEA and SCE are part of the industrial patents that ShockWave Dual Power owns.

Handpieces

ShockWave Dual Power has patented SHOCKDUAL® handpieces with synergic emission of Sound Wave, Tecar and Transdermal vehiculation with heads to treat small, medium and large surfaces as well as the SHOCKFOCUS® handpiece for selective and superfocused treatment.

Guaranteed safety

ShockWave Dual Power has safety systems that actively intervene if excess energy is given to the patient, thereby eliminating any errors.

Safety is guaranteed by a “watch dog” system that constantly checks that the software is working correctly.

Technical specifications

Preset programs Supraspinatus

Epicondyle

Frozen shoulder Carpal tunnel

Rhizarthrosis

Trochant. bursitis (hip)

Piriformis

Osteitis pubis Low back pain

Muscle damage Fractures

Ankle Sprain Protocol

Calcaneal spur

Software Library of preset programs divided by pathology to perform experimental treatments effectively tested on athletes of the highest level (Italian Volleyball Federation, Benetton rugby, etc.) and on thousands of patients in the Medical Centres of Study and Research Winform.

The easiest way to access the great Winform experience in the field of physical therapy.

Neuroma Morton

Technical specifications

Maximum customisation The most demanding therapist can create and save new therapeutic protocols, personalising them according to the needs of each individual patient. Possibility to modify the frequency, the number of strokes, the intensity level of each single therapeutic element of the synergic system for shockwaves dual power.

Technical specifications

Preset programs Saddlebags Adiposity

Flaccidity

Flaccidity

Cellulite

Software Library of preset programs divided by imperfections for treatments that have been tested effectively, proven by thousands of clients in Beauty Parlours that have adopted the Winform methods. The easiest way to access the great Winform experience in the field of aesthetics.

Maximum customisation.

The most demanding therapist can create and save new treatments, personalising them according to the needs of each individual client.

Possibility of modifying the frequency, the number of strokes and the intensity of each element of the synergic system.

Technical specifications The most demanding therapist can create and save new therapeutic protocols, personalising them according to the needs of each individual patient. Possibility of modifying the frequency, the number of strokes and the intensity of each therapeutic element of the synergic system for dual power shockwaves.

Technical specifications

Technical specifications

Handpieces SHOCKFOCUS® handpiece is specific for the application of focused shockwaves.

The particular shape of the contact surface allows to provide selective and precise treatments, while maintaining the pressure of the beam constant and reaching anatomical areas that are difficult to treat with classic handpieces.

Ergonomic handle and soft touch surfaces. Shell with high resistance to falls

The patented handpiece SHOCKDUAL® is a concentrate of technology and design.

Treatment head with “Multimodal shockwave” technology, the new revolutionary system for shockwaves with synergic action

by Winform Medical engineering for a deep and painless effect.

Integrated system for detecting and transmitting skin impedance data and measuring the energy absorbed by the patient (Joule Control System).

Bright feedback of successful contact and correct execution of the treatment.

Ergonomic handle and soft touch surfaces. Shell with high resistance to falls.

35 mm

Shockwave

Transdermal delivery and TECAR

Technical specifications

Power:

200 Watts absorbed

Max power:

9 Watt/cm2 per stroke

Display:

TFT 10.2�

Medical device vers.:

Class IIb classified according to 93/42/EC

Compatible handpieces

MANSKWP Bipolar handpiece for large areas with AISI 316 stainless steel electrodes for combined shockwave and vehiculation treatments.

MANSKW Bipolar handpiece for medium areas with AISI 316 stainless steel electrodes for combined shockwave and vehiculation treatments.

MANSKWF Focus handpiece with AISI 316 stainless steel electrode for focused treatment in small areas.

Assessment kit KITVAL02

TERCAM Digital thermal camera for thermographic detection of the tissues.

Power:

200 Watts absorbed

Max power:

9 Watt/cm2 per stroke

Display:

TFT 10.2�

Medical device vers.:

Class IIb classified according to 93/42/EC

Compatible handpieces

MANSKWPT Bipolar handpiece for large areas with AISI 316 stainless steel electrodes for combined shockwave and vehiculation treatments.

MANSKWT Bipolar handpiece for medium areas with AISI 316 stainless steel electrodes for combined shockwave and vehiculation treatments.

MANSKWFT Focus handpiece with AISI 316 stainless steel electrode for focused treatment in small areas.

Assessment kit KITVAL02

TERCAM Digital thermal camera for thermographic detection of the tissues.

Optional accessories

STAWF01 Stand with wheels that makes it easier to move the device inside the centre.

Technical specifications

PORTABLE

YOUR VALUE OUR PASSION YOUR SUCCESS

ed. 1 rev.2_ 03/08/2020 cod. DPSWDP_ENG

University La Sapienza of Rome, IFO Hospitaller Physiotherapeutic Institutes-Rome, Local Health Care Unit of: Milan, Venice, Palermo, Florence, Padua, Udine, Treviso

WINFORM Medical Engineering srl T. +39 0421 222026 info@winformweb.it www.winformweb.it