ORTHOPULSE RADIAL EDITION APPLICATION BROCHURE
INTRODUCTION REGENERATIVE SOLUTIONS FOR YOUR PATIENTS AND PRACTICE OUR COMMITMENT To promote the innovation and advancement of leading regenerative medicine technologies and to improve patient outcomes by introducing non-invasive solutions to medical professionals, like you At CuraMedix, we believe that advances in regenerative medicine technologies particularly non-operative products and procedures are and will continue to transform patient care. Drawing on the experience of physicians around the world and the medical and technical expertise of our partners, we re dedicated to introducing innovative products, procedures and techniques that treat root cause, accelerate the healing process, reduce expenditures, and improve the overall patient experience. Since 1980 when acoustic waves were first used to disintegrate kidney stones, the medical potential of this treatment has been continuously developing in a wide range of fields. Today, Extracorporeal Pulse Activation Technology (EPAT ) is a treatment that is setting new standards in regenerative medicine and is being used to successfully treat a number of indications in orthopedics, aesthetics, urology, and wound care. This application brochure has been created for you to serve as a reference guide to the handling and application of the device. Included in the brochure are examples of indications, recommended treatment steps, protocols, settings, techniques and images, to give new users a clear and easy overview of how to operate the system and achieve optimal results. As with any other new modality, the treatment success will increase the more experience the medical professional gains with the operation and use of the EPAT device. Your success with your new EPAT device is important to us. Please do not hesitate to contact us if you have questions or need additional information. As an emerging leader in non-operative healing solutions, we look forward to both working with and helping you. This application brochure is not intended to replace the unit s instruction manual. Please refer to the manual for more detailed information. 2
CONTENTS INNOVATIVE TECHNOLOGIES FOR ADVANCED HEALING Regenerative Solutions for Your Patients and Practice... 02 Contents... 03 Applicators/s for D-Actor Handpiece... 04 V-Actor Handpiece... 05 Applicators/s for V-Actor Handpiece... 06 Indications/Contraindications... 07 EPAT Treatment... 08 Foot Pain... 09 Heel Pain... 10 Lower Extremity Pain... 11 Lower Extremity Pain... 12 Knee Pain... 13 Pelvis and Hip Pain... 14 Elbow Pain... 15 Shoulder Pain... 16 Trigger Points/Myofascial Pain... 17 Treatment Guide... 18 3
APPLICATORS/TRANSMITTERS FOR D-ACTOR HANDPIECE s Data Indications Geometry of waves/ Penetration depth A6, Ø 6 mm, Acoustic wave acupuncture AkuSt transmitter, acoustic pressure waves Energy density at max. pressure at transmitter tip 0.32 mj/mm 2 0 40 mm T10, Ø 10 mm, Trigger transmitter, acoustic pressure waves Myofascial trigger points, 0.38 mj/mm 2 0 40 mm C15, Ø 15 mm, CERAma-x, EPAT transmitter, acoustic pressure waves R15, Ø 15 mm, EPAT transmitter, acoustic pressure waves Tendon and/or tendon insertional pain Tendon and/or tendon insertional pain 0 40 mm 0.45 mj/mm 2 0.38 mj/mm 2 DI15, Ø 15 mm, Deep Impact transmitter,»energy Beam«F15, Ø 15 mm,»focus-lens«transmitter, energy focus area Deep-seated disorders, trigger points, chronic disorders, high energy requirements, ideal combination with D20-S/D35-S transmitter for muscular problems Close to surface pain areas, masticatory muscles, neck, individual triggers 0 40 mm 0 60 mm 0.63 mj/mm 2 0.16 mj/mm 2 0 20 mm 4 D20-S, Ø 20 mm, D-ACTOR transmitter, acoustic pressure waves and vibration pulses, max. pressure up to 5 bar D20-T, Ø 20 mm, D-ACTOR transmitter, acoustic pressure waves and vibration pulses, max. pressure up to 5 bar D35-S, Ø 35 mm, D-ACTOR transmitter, acoustic pressure waves and vibration pulses, max. pressure up to 5 bar Myofascial trigger points, muscle- and connective tissue, dissyndrome), treatment of deep-seated muscles (e. g. piriformis muscle, gluteus minimus muscle) For athletes in professional sports, deep-seated muscle trigger, bio-mechanical stimulation, saves energy, reduces pulses, extends handpiece life cycle Myofascial trigger therapy, muscle and connective tissue, back muscles, skin elasticity, trigger-diagnose, dissolusyndrome), treatment of deep-seated muscles (e. g. piriformis muscle, gluteus minimus muscle) 0 50 mm 0 60 mm 0 50 mm 0.48 mj/mm 2 0.63 mj/mm 2 0.46 mj/mm 2
V-ACTOR HANDPIECE V-ACTOR mechanism of action of vibration therapy Benefits and effects 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 of microcirculatory processes. The The fine fine resonance thus thus produced produced en- ensures that that nutrients are are supplied and and returned returned through through the smallest the smallest vascular vascular and and lymphatic lymphatic channels channels of the extracellular of the extracellular matrix. This matrix. function This cannot function be managed cannot by be managed the cardiovascular by the cardiovascular system. Reduced system. physiological Reduced physiological muscle vibrations muscle adversely vibrations affect the cellular affect supply. the cellular This may supply. produce This may a convulsive produce tendency a convulsive and tendency cause painful and adversely cause muscle painful hardening muscle in the hardening form of trigger in the form points. of trigger points. The V-ACTOR enables targeted application of vibration of vibration pulses pulses to the to tissue. the Microcirculation is improved is improved and metabolic and metabolic waste products waste products and toxins and are toxins removed are tissue. Microcirculation removed via the blood via the and blood lymph. and Elongation lymph. of Elongation fascia and of muscle fascia fibres and muscle by means fibres of the by means V-ACTOR of the restores V-ACTOR normal restores muscle normal tone as muscle shortening tone as muscle and hardening shortening is and eliminated. is hardening eliminated. V10 Treatment of specific muscle points V25 Tissue massage and muscle smoothing V40 Treatment of large muscle areas Mode of action of the V-ACTOR handpiece 5
APPLICATORS/TRANSMITTERS FOR V-ACTOR HANDPIECE ESWT Vibration heads for V-ACTOR handpiece Vibration heads Data Indications Geometry of waves/ Penetration depth V10, Ø 10 mm, V-ACTOR ball transmitter, high-frequency vibration treatment Selective treatment of muscles V25, Ø 25 mm, V-ACTOR transmitter, high-frequency vibration treatment Muscle smoothing, massage along the muscle bundles, lympatic drainage 0 30 mm V40, Ø 40 mm, V-ACTOR transmitter, high-frequency vibration treatment Massage of large muscles after EPAT 0 30 mm 0 30 mm 6
INDICATIONS/CONTRAINDICATIONS The OrthoPulse systems can be used to treat the following indications, among others: Foot and Ankle Pain Lower Extremity Pain Knee Thigh Pelvis and Hip Pain Upper Extremity Pain Hand and Wrist Elbow Forearm/Upper Arm Shoulder Spine and Back Pain Myofascial Trigger Points Note: For the duration of the treatment, it is necessary that patients discontinue any/all NSAIDs and drink plenty of water before and after treatment. Please refer to 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. Medical professionals and patients should wear suitable ear protection during treatment. Patients should be offered ear plugs for use. Treatment with the OrthoPulse systems 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 EPAT treatment Note: Generally speaking, acoustic pressure 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 OrthoPulse systems: 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 treatment session. 7
EPAT TREATMENT Treatment Make sure the patient is in a comfortable position. Always use gel for coupling to ensure perfect acoustic wave transmission. Position the handpiece at a right angle 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 treatment session. In general, 3 to 6 treatment sessions are necessary at intervals of once per week. The individual treatment steps must be performed in the correct order. Treatment steps of acoustic wave treatment Step 1: R-SW (1500 3500 pulses) Select one of the following according to the depth of the target area and the patient s pain tolerance: F15, R15 or DI15. Apply acoustic waves locally to the painful spots until the nature of the pain changes (patient s biofeedback). Step 2: R-SW (2000 4000 pulses) Use the D20-S transmitter for large area dynamic muscle smoothing and mobilisation of fascia and muscle fibres. Step 3: V-ACTOR (5000 10000 pulses) To round off a successful treatment, 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 10000 extra pulses per treatment session. Step 1: R-SW : F15, R15, DI15 Parameters: ; Number of pulses: 1500 3500 Step 2: R-SW : D20-S Parameters: ; Number of pulses: 2000 4000 Step 3: V-ACTOR Parameters: 35 Hz; 2.0 3.0 bar Number of pulses: 5000 10000 Good to know... Good to know... EPAT 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 EPAT 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 acoustic pressure 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 treatment. 8
FOOT PAIN ASSOCIATED WITH METATARSALGIA Step 1: R-SW Pulses/session 3000 R15 DI15 Step 2: R-SW Pulses/session 3000 D20-S Step 3: V-ACTOR Pulses/session 3000 5000 2.0 2.6 bar 35 Hz Vibration head V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. The applicator/transmitter should be selected according to the required penetration depth. 9
HEEL PAIN ASSOCIATED WITH TRIGGER POINTS, TENDON AND/OR TENDON INSERTION PAIN Step 1: R-SW Pulses/session 3000 R15 DI15 Step 2: R-SW Pulses/session 3000 D20-S Step 3: V-ACTOR Pulses/session 3000 5000 2.0 2.6 bar 35 Hz Vibration head V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. The applicator/transmitter should be selected according to the required penetration depth. 10
LOWER EXTREMITY PAIN ASSOCIATED WITH TRIGGER POINTS, TENDON AND/OR TENDON INSERTION PAIN Step 1: R-SW Pulses/session 3000 R15 C15 Step 2: R-SW Pulses/session 2000 D20-S D20-T Step 3: V-ACTOR Pulses/session 3000 5000 2.0 2.6 bar 35 Hz Vibration head V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. The applicator/transmitter should be selected according to the required penetration depth. 11
LOWER EXTREMITY PAIN ASSOCIATED WITH POSTERIAL TIBIAL STRESS SYNDROME, TRIGGER POINTS, TENDON AND/OR TENDON INSERTION PAIN Step 1: R-SW Pulses/session 2000 2.6 3.0 bar R15 F15 Step 2: R-SW Pulses/session 3000 2.6 3.0 bar D20-S Step 3: V-ACTOR Pulses/session 3000 5000 2.0 2.6 bar 35 Hz Vibration head V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. The applicator/transmitter should be selected according to the required penetration depth. 12
KNEE PAIN ASSOCIATED WITH TRIGGER POINTS, TENDON AND/OR TENDON INSERTION PAIN Step 1: R-SW Pulses/session 2000 R15 C15 Step 2: R-SW Pulses/session 2000 2.6 3.0 bar D20-S Step 3: V-ACTOR Pulses/session 3000 5000 2.6 3.0 bar 35 Hz Vibration head V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. The applicator/transmitter should be selected according to the required penetration depth. 13
PELVIS AND HIP PAIN ASSOCIATED WITH TRIGGER POINTS, TENDON AND/OR TENDON INSERTION PAIN Step 1: R-SW Pulses/session 2000 2.8 3.6 bar R15 DI15 Step 2: R-SW Pulses/session 2000 2.0 3.0 bar D20-S D20-T Step 3: V-ACTOR Pulses/session 3000 5000 2.0 2.6 bar 35 Hz Vibration head V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. The applicator/transmitter should be selected according to the required penetration depth. 14
ELBOW PAIN ASSOCIATED WITH TRIGGER POINTS, TENDON AND/OR TENDON INSERTION PAIN Step 1: R-SW Pulses/session 2000 R15 F15 Step 2: R-SW Pulses/session 2000 D20-S Step 3: V-ACTOR Pulses/session 3000 5000 35 Hz Vibration head V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. The applicator/transmitter should be selected according to the required penetration depth. 15
SHOULDER PAIN ASSOCIATED WITH TRIGGER POINTS, TENDON AND/OR TENDON INSERTION PAIN Step 1: R-SW Pulses/session 3000 R15 DI15 Step 2: R-SW Pulses/session 2000 D20-S D20-T Step 3: V-ACTOR Pulses/session 3000 5000 2.0 2.6 bar 35 Hz Vibration head V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. The applicator/transmitter should be selected according to the required penetration depth. 16
TRIGGER POINTS/MYOFASCIAL PAIN Step 1: R-SW Step 2: R-SW Step 3: V-ACTOR Plantar foot muscles Pulses/session 3000 1500 3000 5000 2.0 3.0 bar 1.8 2.8 bar 2.0 2.6 bar 12 Hz 21 35 Hz /vibration head R15 or C15 D20-S V25 Calf muscle shortening Pulses/session 3000 3000 3000 5000 2.4 5.0 bar 2.4 5.0 bar 2.0 2.6 bar 10 Hz 21 35 Hz /vibration head R15 or DI15 D20-S or D20-T V25 Thigh adductors Pulses/session 2000 2000 3000 5000 2.2 4.0 bar 2.2 4.0 bar 2.0 2.6 bar 10 Hz 21 35 Hz /vibration head R15 or DI15 D20-S or D35-S V25 Shortened thigh muscles Pulses/session 3000 3000 3000 5000 2.4 5.0 bar 2.4 5.0 bar 2.0 2.6 bar 10 Hz 21 35 Hz /vibration head R15 or T10 D20-S or D35-S V25 Lumbago Pulses/session 2000 2000 3000 5000 2.2 3.6 bar 2.2 3.6 bar 2.0 2.6 bar 10 Hz 21 35 Hz /vibration head R15 or T10 D20-S V25 Dorsalgia Pulses/session 2000 2000 3000 5000 1.8 2.8 bar 1.8 2.8 bar 2.0 2.6 bar 10 Hz 21 35 Hz /vibration head R15 or C15 D20-S V25 17
TREATMENT GUIDE Step 1: R-SW Step 2: R-SW Step 3: V-ACTOR Cervical pain Pulses/session 3000 2000 3000 5000 1.0 4.0 bar 2.0 3.6 bar 2.0 2.6 bar 10 Hz 21 35 Hz /vibration head R15 or T10 D20-S V25 Periarticular shoulder pain Pulses/session 1000 1000 3000 5000 1.6 2.6 bar 1.6 2.6 bar 2.0 2.6 bar 10 Hz 21 35 Hz /vibration head R15 or C15 D20-S V25 Forearm muscles Pulses/session 2000 2000 3000 5000 1.6 2.8 bar 1.6 2.8 bar 2.0 2.6 bar 10 Hz 21 35 Hz /vibration head R15 or C15 D20-S V25 Note The specified lower energy level is the recommended energy setting at which treatment should be started. The energy level should always be selected according to the patient s pain tolerance. The specified maximum energy level should not be exceeded. Generally speaking, acoustic pressure 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 applicator/transmitter should be selected according to the required penetration depth. 18
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Tel: +1 877-699-8399 Tel: 401-333-6500 info@curamedix.com www.curamedix.com Important Information for U.S. Customers: Certain devices and references made herein to specific indications of use may have not received clearance or approval by the United States Food and Drug Administration. Practitioners in the United States should first consult with their local CuraMedix representative in order to ascertain product availability and specific labeling claims. Federal (USA) law restricts certain devices referenced herein to sale, distribution, and use by, or on the order of a physician, dentist, veterinarian, or other practitioner licensed by the law of the State in which she/he practices to use or order the use of the device. 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. 2015