CLINICAL TRIALS

APPROVED BY:Professor of Moscow State Stomatological University(Seal, Signature) D BY:Professor of Moscow State Stomatological University (Seal, Signature)

1. The tests of magneto acoustic device “MAGOFON-01” have been conducted at the physiotherapy department (МГМСУ) 6.03.2000 and 5.03.2000.

2. For the tests were presented:

a) device -1

b) The engineering specifications

3. Medical tests have been conducted under the program and procedures of physiotherapy department and the enterprise — developer. The number of patients is 101, the number of procedures per course of treatment -6-21, the procedure time -from 5 to 20 min daily or in a day.

4. «MAGOFON-01» corresponds to requirements of the technical assignment. It was used to treat arthritis and arthrosis of joints , radiculitis, ostiochondrosis, masticatory spasm, paradontit, alveolotis, both bones, teeth fracture, hematoma of injury and cicatrix, contructure, genyantritis, chronic colitis, constipation, neuritis, neuralgia, idiopathic hypertensia, putting off(takin g out) of fatigue. Positive effect was observed in 71% of patients: the pains have decreased, the phenomena of an inflammation have abated, resorption ofcicatrixes, improvement of joints movability, injury, fracture adhesion, normalization of arterial pres sure, rising of capacity for work.

5. The device meets medical requirements to its functional characteristics, has been in use for 136 hours without breakages, it is easy to operate and has a good design. It is designed for personal usage. The device is re commended for series production.

Head of the Physiotherapy Department,

Professor O.I. Efanov.

APPROVED BY: The Head Physician of Municipal Clinic № 1 Named after N.I. Pirogov: (Signature)/ Rutkovsky O.V / Dated: March 2nd , 2000

THE PROTOCOL

Of medical tests of the portable device for magneto acoustic physiotherapy

«MAGOFON-01»

Designed by Yelatma Instrument-Making Enterprise

-Foundation: resolution of a commission on apparatuses and devices of Committee of New Medical Technique of the Ministry of Public Health of Russian Federation (protocol № 10 of 15.11.99-The portable device for magneto acoustic physiotherapy MAGOFON-01, designed by Yelatma has been tested at Municipal Hospital №1 named after N.I. Pirogov in a period from 01.28 till 01.03.2000.

-One sample of the device MAGOFON 01, technical passport and act of technical tests has been presented to conduct the test.

-Flux density of the device: 30 mT

-Frequency of acoustic range: 0.02-20 KHz, produced noise is weak intensity.

-Electric safety of the device is Class II.

-65 procedures, for 15-20 of minutes each, were conducted, during the period of <-3ts.

-Main diseases: Chronic vein failure with trophic disorders. The sound, at device

operation, renders a positive psychological affect on patient.

-Indications and contraindication for use - generally accepted for magneto therapy ofpresent induction

-The device is innovative, simple and convenient in use. Design is good.

- There were no failures in the device operation.

-The portable device for magneto acoustic physiotherapy MAGOFON-01 is possible to recommend to serial output both for use in medical establishments and individual personal usage.

The Manager of Physiotherapy Department of Municipal Clinic №1 named after N.I.

Pirogov, Moscow (signature) Pfaphius S.I.

APPROVED BY: The Head of the Central Military Clinical Hospital, ”Arkhangelskoe”, Colonel of Medical Services Seal, Signature Podshibyakin S.E Date: 3.03.2000

PROTOCOL

Of magneto acoustic device «MAGOFON-01» medical tests

1. The reason for tests conducting. Resolution of a commission for apparatuses and devices used in physiotherapy of committee on a new medical technique of Ministry for Pub lic Health of Russian Federation (protocol № 10ofl5.11.99)

2. The place of tests conducting: the Central Military Clinical Hospital “Arkhangelskoe”, Moscow Region, Krasnogorodsry.

3. The time of tests conducting:

Beginning: 03.02.2000

Ending: 03.03.2000

4. Brief description

The device “MAGOFON-01″ is intended for making thermotherapy effect to the human organism with the help of both variable inhomogeneous magnetic field and vibroacoustic oscillation. Magnetic induction amplitude value on the working surface is 30+9. Acoustic range frequency is 0.02-20kHz. Spectral density of acoustical pressure of nose on distance of 300 mm to device is 1 Pa ( of the frequency band from 0.02 to 20 kHz) The device provides the run of the device in repeated -short time regimen during 6 hours: 20 minutes- work, 20 minutes – break.

5. The reason of tests: Assessment of medico-technical characteristics of the device.

6. Order of tests conducting: The medical tests have been carried out in accordance with “Program and procedure of medical acceptance tests 6Ж3.293.014ПmM.

7. Description of the patients: Clinical studies were performed on 30 patients: 25 men, 5 women at the age of 40-65 year old. All patients were divided into groups as following:

a) Vertebral ostiochondrosis with radicular syndromes -5 patients. There were used the daily labile par avertable influence, the number of procedure -12-15 for 10-15 minutes.

b) Epicondylitis -2 patients. The influence on the affected areas of tissue : for 10-15 minutes and 10-15 procedures, per course daily.

c) Bone fractures in a stage of ostial callosities forming -1 patient, the connection of the device with the affected area through plaster bandage. The procedure time is 10-15 minutes daily. The course of treatment is 15 procedures.

d) Posttraumatic joint contracture the course of treatment is 10 procedures. The used methodic: influence on the damaged joint for 15-20 minutes, the course of treatment is 15-20 procedures.

e) Hematoma of the front surface of the right femur-1 patient. The used methodic; influence on trauma area for 15-20 minutes, the course of treatment is 10 procedures.

f) Postoperative cicatrix after aorto-coronary shunting -10 patients. The used methodic: influence on the operative area for 15-20 minutes, the course of treatment is 10 procedures.

g) Chronic prostatitis -1 patient. The used methodic; influence on the perineum area for 20 minutes, the course of treatment is 10 procedures.

i) Consequences of radial nerve trauma -1 patient. . The used methodic: influence along the damaged nerve for 20 minutes, the course of treatment is 15 procedures.

j) Bronchial asthma -2 patients. The used methodic: the influence on the upper third of thoracic bone, the side and back parts of thorax for 15-20 minutes, the course of treatment is 15 procedures. 8. The results of the tests.

The course of treatment is 10-15-20 procedures, daily. The procedure time is 10-15-20 minutes for the appropriate zones. The rating of efficiency in complex treatment is 80 %. The tolerance of the procedures is good, the negative effect is not revealed.

9. Conclusion.

In the basis of the physiological operation o f magnetic and vibroacoustic action of the device “AMA -01″ is the use of variable magnetic field and mechanical acoustical wave. The patient feels the slight vibration and the pleasant feeling of warmth during the procedure. In same cases the treatment by the device is carried out through light clothes. The methods varied in each concrete case, providing maximum effect (minimum duration of procedure at the beginning and gradual growth of its duration; twice a day; in a day). By design, the device is made a s the open loop magnetic wire, with the copper winding on it. The electrical circuit consists of the capacitor, elements of the signal system and resistor.

10. Reference

The device is technically reliable, has good operation qualities, high clinical efficiency. Going out from the above, the device can be recommended to a serial production for use both, as in medical preventive establishments so in home conditions.

The Head of Physiotherapeutic Department

Colonel of Medical Services: Yu. Kudryashov

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