fisioline

fisioline

HIGH FREQUENCY PRESSURE WAVES

FOR A HIGH POWER FOCALIZED ACTION IN DEPTH

fisioline

fisioline 2

100%

DC-20%

DC-20%

DC-20%

DC-20%

Duty-Cycle =

CUTE

TESS

UTI

TESS

UTI

5Watt di picco

Ultrasuono1MHz O.P.A.F.® THERAPY

5Watt di picco

60%0%

Tempo ACCESO<Tempo SPENTO

Tempo ACCESO-Tempo SPENTO

Tempo ACCESO>Tempo SPENTO

Sempre ACCESO

tempo di accensionetempo di accensione+tempo di spegnimento

3Watt di picco

Ultrasuono1MHz O.P.A.F.® THERAPY

5Watt di picco

DIFFERENZA DI PRENETRAZIONE

TRAL’ULTRASUONO A 1MHz

E O.P.A.F.® THERAPY

O.P.A.F.® Therapy High-frequency pressure waves FOR HIGH POWER FOCALIZED ACTION SHOCKS IN DEPTH FISIOLINE® has over 30 years of experience in the production of physiotherapeutic devices for Rehab Therapy, Physical Therapy, Sports Medicine, and Aesthetic Medicine. This extensive technical experience has been a great advantage in designing an innovative High-Frequency Pressure Waves device, the O.P.A.F.® Therapy.O.P.A.F.® Therapy introduces a new method that, by exploiting modulated frequencies and varying emission, provides high power energies to tissues at diff erent depths. The operator can now use an equipment that is safe, eff ective, highly tolerated by patients and usable for multiple pathologies.

O.P.A.F.® THERAPY® THERAPY®

O.P.A.F.®

THERAPY

Incomparable power in your hands

O.P.A.F.® Therapy adopts an innovative multi-frequency piezoelectric disc 1/3 MHz with peak power density 5 Watt/cm2, a basic feature to transfer greats amounts of mechanical energy deep in tissues.

Maximum power transmittedFISIOLINE® introduced the output Stage in Class E to optimize the power transmission to tissues. An instrument to detect the reference signal constantly analyzes the variation of impedance of treated tissues keeping the power density (Watt/cm2) automatically constant as established by the operator. The dispersion of energy is insignifi cant and the emitted energy is actually the selected one. This feature maintains the desired mechanical eff ect through the passing of the pressure wave to the diff erent tissues.

Mechanical effectThermal effectCavitation

TRIPLE ACTION

RELATIONSHIP between PEAK POWER and AVARAGE POWER in O.P.A.F.® Therapy

PEAK POWER 5W

PEAK POWER 3W

AVARAGE POWER MAX3W

AVARAGE POWER MAX3W

100%

DC-20%

DC-20%

DC-20%

DC-20%

Duty-Cycle =

CUTE

TE

SS

UT

I

TE

SS

UT

I

5Watt di picco

Ultrasuono1MHz O.P.A.F.® THERAPY

5Watt di picco

60%0%

Tempo ACCESO<Tempo SPENTO

Tempo ACCESO-Tempo SPENTO

Tempo ACCESO>Tempo SPENTO

Sempre ACCESO

tempo di accensionetempo di accensione+tempo di spegnimento

3Watt of peak

Ultrasound1MHz O.P.A.F.® THERAPY

5Watt of peak

DIFFERENCE OF PENETRATION BETWEEN

THE 1MHz ULTRASOUND AND O.P.A.F.® THERAPY

fisioline

fisioline3

Duty-Cycle =

DC=80%

DC=50%

DC=20%

DC=100%

O.P.A.F.® Therapy is a medical device for ultrasound therapy that can be used autonomously both by doctors and physiotherapists

O.P.

A.F.

® TH

ERAP

Y

Focalization of the emission beam O.P.A.F.® Therapy uses a multifrequency transducer with focalized and modulated beams. By setting diff erent emission times for each frequency, operators obtain a double combined action with a variable eff ect: mechanical and thermal eff ects. The mechanical action reduces and resolves calcifi cations, the immediate release of joints and reabsorption of intramuscular liquids. The thermal eff ect, superfi cial and deep, interacts directly with the displacement of liquids and promotes lymphatic drainage.

Maximum Tolerability of the TreatmentThanks to the high power micro-pulses of O.P.A.F.® Therapy the patient’s tolerability is excellent among high energy pressure waves devices. The pain sensation is signifi cantly lower compared to conventional shockwave devices.

The combined action of the two emission frequencies, 1/3 MHz, provokes diff erent physiological eff ects on treated tissues. The variation of the number of pulses (from 1.000.000 to 3.000.000) inside a low frequency modulating (100 Hz), off ers the professional the capability to separately set both the mechanical and thermal eff ects. The variation of the action times through a Frequency Switching, ex.: 2” at 1 MHz and 4” to 3 MHz, allows the operator to deliver high energy and powerful mechanical short pulses, deep in tissues. With this operative technique, superfi cial nervous receptors are minimally activated, making the treatment highly tolerated by the patients.

Variation of the Emission Frequencies and Modulation

Therapeutic result: Eff ectiveness from the fi rst session O.P.A.F.® Therapy is eff ective immediately from the fi rst session on many pathologies such as shoulder impingement, bursitis, trigger fi nger, articular rigidity, Dupuytren's contracture, muscle contractures and fi brous adhesions.

THE FOCAL PRESSURE WAVE for physiotherapeutic use

turn on timeturn on time + turn off time

Time ON < Time OFF

Time ON = Time OFF

Time ON > Time OFF

Always ON

fisioline

fisioline 4

Rehabilitation, Physiotherapy, Traumatology, and Sports Medicine

Indications for effective, safe and customizable therapy

INDICATIONS

Infl ammation

Stiff ness and joint degeneration

Sciatica

Neuritis in general

Muscular pathologies: antalgic eff ects, relaxing eff ects, de-fi brotic action, trophic eff ects

Scar adhesions

Dupuytren's contracture

Epicondylitis: anti-infl ammatory insertional and relaxing treatment

Shoulder pathologies

Musculotendinous calcifi cations:with the O.P.A.F.® Therapy frequency switching,

operators can treat calcifi cations with a great “disrupting” action that is well-tolerated by patients

Tendinous pathologies: the focus of treatment is to resolve tendinopathies in both chronic and acute phases

Ligamentous pathologies: the focus of

treatment is fi r pain relief and reduction of infl ammation

fisioline

fisioline5

Physioaesthetics and Aesthetic Medicine

The high peak power of the generated waves amplifi es the mechanical eff ect with a greater energy to break up fat cells and cellulite fi brous bands. O.P.A.F.® Therapy is an eff ective response for treating cellulite, fat and venous stasis. The O.P.A.F.® Therapy generates pressure waves that mobilize excess fat deposits, and increases tissue temperature, thus stimulating cellular metabolism and vasodilatation. Adipose tissue is broken down into small particles that can be easily drained using the Modulo Beauty Med or Modulo mobile draining electro-stimulators. The new handpieces for the face, together with the handpiece for the body, makes this technology versatile and a complete system.

INDI

CATI

ONS

Podiatry O.P.A.F.® Therapy is essential for the Podiatrist to treat the following pathologies: • Calcaneal spur• Plantar Fasciitis and Metatarsalgia • Distortions• Fibrous adhesions• Arthritis and Arthrosis• Proximal tibial tendinitis• Disorders of the fl exor muscles (treatment focus is pain relief and/or reduction of

infl ammation) • Ligaments pathologies (treatment focus is pain relief and/or reduction of infl ammation)• Tendinopathy Popliteal Ligaments • Triceps Sural Disorder (treatment focus is pain relief and/or reduction of infl ammation) • Tendinitis and tendinosis• Bursitis• Hallux valgus (treatment focus is pain relief and/or reduction of infl ammation)

The biological answer to the treatment with O.P.A.F.® Therapy is the vascularization of the treated tissues and activation of new cells, essentials in healing processes. This results in relief of pain and promotion of tissue regeneration. After the treatment with O.P.A.F.® Therapy, tissues react with an increase in metabolic activity.In chronic diseases, the healing processes can be induced or accelerated. The natural healing processes are stimulated without the use of drugs or invasive interventions. Usually, the therapy is performed without sedation (and the treated area is shaved). Common treated pathologies O.P.A.F.® Therapy in veterinary include osteoperiostitis, neoarthrosis, epicondylitis, insertional and no-insertional desmitis, acute and chronic tendinopathies, fi brosis reduction, calcification. The operator uses diff erent handpiece dimensions to treat small, medium and big animals.

Veterinary

123

fisioline

fisioline 6

WIZARDWIZARDWIZARD

WIZARD

Wizard and the Pathology Library A unique feature of O.P.A.F.® Therapy is the Wizard, a step-by-step digital guide to use the device. Thanks to an intuitive software, the Wizard leads the Doctor and the Physiotherapist in selecting over 50 therapeutic preset protocols focused on severe and chronic pathologies. With the Wizard, the operator can select, modify and keep always under control the functions and operatives parameters. O.P.A.F.® Therapy provides the operator the option to create customized programs for a patient and indicated for specific pathologies or areas to be treated.

The interface of O.P.A.F.® Therapy displays the parameters on a large 7” Touch Screen color display that remotely reads and gives the operator the complete control of the device performance.

WITH THE INNER FINDER

PATHOLOGY

BODY AREA

N. PROGRAM

SAVING DATA SETS

100 FREE STORAGE LOCATIONS 100 FREE STORAGE LOCATIONS

PROTOCOLS WITH UP TO 4 PHASESPROTOCOLS WITH UP TO 4 PHASES

CREATION OF PERSONALIZED PROGRAMS

RAPID RESEARCH FIBROUS ADHESIONS

EPICONDYLITIS AND EPITROCLEITISEPICONDYLITIS AND EPITROCLEITIS

PLANTAR FASCIITIS PLANTAR FASCIITIS

SCAPULOHUMERAL PERIARTHRITISSCAPULOHUMERAL PERIARTHRITIS

FREQUENCY

DUTY-CYCLE DUTY-CYCLE

FREQUENCY SWITCHINGFREQUENCY SWITCHING

DURATIONDURATION

MORE THAN PRESET PROTOCOLS

SELECTION FREE PROTOCOL

THE FUTURE is WIZARD your PERSONAL TUTOR in every phase

50

fisioline

fisioline7

CREATION OF PERSONALIZED PROGRAMS

Multimedia videos associated to treatments

Fisioline® introduces an useful innovation: the pairing of preset therapeutic protocols to their illustrating video tutorials, always available, updatable and usable directly from the device console, showing the steps to be followed by operator and patient during therapies.

The training materials provide experienced and new operators rapid use of O.P.A.F.® Therapy.

O.P.A.F.® ASSISTANT

O.P.A.F.® Assistant, your PERSONAL COACHCrash course for O.P.A.F.® Therapy is available in your technology

ASSI

STAN

T

Fisioline® srlBorgata Molino, 29 • 12060 VERDUNO (CN) • ITALY Tel.: +39.0172.470432-0172.470433 • Fax.:+39.0172.470891http://www.fisioline.com • e-mail:fisioline@fisioline.com

CERT. 9120. FISI

UNI EN ISO9001:2008

CERT. 9124. FIS2

ISO13485:2012

fisioline

fisioline Tech

nica

l fea

ture

s and

size

s of t

he d

evic

es d

escr

ibed

her

ein

may

be

subj

ect t

o ch

ange

, bas

ed o

n te

chno

logi

cal e

volu

tion

and

cons

tant

impr

ovem

ents

to p

rodu

ction

.Ed

. 05/

17

O.P.A.F.® Therapy

STANDARD ACCESSORIES

N° 1 Applicator for O.P.A.F.® Therapy 1-3MHz diameter 55 mm (contact surface 24 cm2)

N° 1 Carrying case N° 1 Bottle of gel

OPTIONAL ACCESSORIES N° 1 Applicator for O.P.A.F.® Therapy Ø 21 mmN° 1 Applicator for O.P.A.F.® Therapy Ø 35 mm

REFERENCE STANDARDS

EN 60601-1 (IEC 60601-1), CEI 62-5

EN 60601- 2-5 (IEC 60601-2-5), CEI 62-23

EN 60601-1-2 (IEC 60601-1-2), CEI 62-50

EN 60601-1-6 (IEC 60601-1-6), CEI 62-138

EN 61689 (IEC 1689), CEI 87-7

mark: device complying with Directive 93/42/CEE, modified by the Directive 2007/47/CE, and with Directive 2004/108/CE.

CARATTERISTICHE TECNICHE

TECHNICAL FEATURESTechnical classification electromedical equipment Class I type BFCommercial classification high frequency ultrasound device in Class EMedical device class IIb (Dir. 93/42/CEE, modified by the Directive 2007/47/CE)

Emission frequency 1-3MHz ± 5% by means of an A.F.S. (Automatic Frequency Switching) device

Peak power density 5W/cm2

Average power density 3W/cm2

Output channels N. 1 for O.P.A.F.® TherapyContact control device visual and acoustic plus self-calibration

Operating modes continuous and pulsed emission with adjustable duty-cycle from 10% to 90%

Power supply voltage 230V (115V upon request)Network frequency 50-60 HzAbsorbed power 80VASmart Interface large Touch Screen color TFT 7” displayElectronic Timer programmable 1-30min with digital displayAcoustic and visual warning right contact, electrode check and end treatmentCustom program storages large preset protocols database for pathologiesUser programs customizable programs with up to 4 phasesTraining Video tutorials audio-video systemUpgradable via USB port USB to upgrade system / protocols / audio-videoDimensions 350x265x150mmWeight 5Kg

M A D E I N I T A L Y

TECHNICAL FEATURES