REPUBLICAN DERMATO-VENEROLOGIC DISPENSARY

Protocol of Medical Tests

APPARATUS FOR INFRARED THERAPY “Biofon” (UROGENITAL)

Izhevsk

1. TEST GROUNDS

Apparatus for IR-therapy (urogenital) “Biofon”. Medicotechnical requirements for research and development.

Extract from Certificate No. 4 10.10.97 of Committee on Modern Medical Technologies under Ministry of Health, Russian Federation.

2. TEST PLACE AND TIME

2.1. Republican Dermatologic and Venerologic Dispensary.

2.2. Start of the test January 16, 1998.

3. SPECIFICATIONS

3.1. The “Biofon” Apparatus (urogenital) is meant for physiotherapy of urethroprostatitis of chlamydia and postchlamydia etiology.

3.2. The Apparatus is meant for use in clinics and out-patient departments.

3.3. The Apparatus is powered by 2.8-3.2 V internal power source (two 1.5V elements of Energizer type).

3.4. Current consumption is no more than 0.1A.

3.5. Weight: 0.3kg.

3.6. Dimensions: 150x80x30 mm.

3.7. Apparatus contains an infrared source.

3.8. IR-radiation power: between 0.1-1 mW.

3.9. Treatment session duration: 24± 1 s.

3.10. The apparatus provides control and indication of the following parameters on a built-in character indicator:

- session duration

- number of session

- operating mode

- regenerations number

- number of sessions programmed

- power supply discharge.

3.13. The apparatus provides light and sound signaling of switching on, procedure start and finish, a sound signaling of procedure start and finish.

3.14. Time for operation mode setting after switching on does not exceed 1s.

4. MEDICAL TESTING PROCEDURE

Medical Tests with “Biofon” Apparatus for IR-therapy (urogenital) has been conducted without basic antibiotic therapy in compliance with methodology set forth in The “Operating Manual for “Biofon” Apparatus ÅÈÔÞ 941527.001 ÐÝ” for two months Testing Programme is given in Appendix 1. The “Biofon” Apparatus is set up on the table on the level of the patient’s breast at a distance of 0.5...1.0 m.

Follow-up Patients went through a complex clinical and laboratory examination.

To diagnose chlamydia infection scrapes were examined by direct immunofluorescence method (DIF) with “Chlamonoscreen” monoclonal antibodies (“Niarmedic” Co).

Chlamydia antibodies in blood serum were determined by enzyme immunoassay (ETA), “Vector Best Co”.

Test for ureaplasma, gonorrhea and trichomonada infections were performed with cultural and bacterioscopic methods.

Condition of genitalia was also evaluated clinically, including bimanual examination for women and prostatic gland palpation and two-glass urine test for men.

5. CHARACTERISTICS OF THE PATIENTS

In the course of “Biofon” Apparatus clinical tests 47 patients were treated for chlamydiosis (25 women and 22 men).

Average age of women was 26.7 years, of men - 28.3 years. Disease duration was from 5 months to 8 years (3.4 years in average). Most of the patients were married couples (15 couples). Among men: unmarried - 4, divorced - 3; among women: unmarried - 6, divorced - 4.

In most of the cases both sexual partners underwent a treatment course with the “Biofon” Apparatus for IR-therapy. 22 patients were stated to have undegone antibiotic therapy, among them 14 have got more than two courses of antibacterial treatment.

All the patients had clinical signs of urogenital chlamydia infection (Table 1). Subjective asymptomatic course of the disease prevaled in male patients (82%). Only 4 of them complained of feeling tense in urethra, urethra lips “sticking”, mucus discharge, pain in perineum, irradiating into scrotum and rectum. Clinical examination revealed that all the patients were having symptoms of the disease, but 1/3 of them - complications. Half of the female patients complained of burning and itching sensations and pain in the external genital organs, anal region and pain in the small pelvis, irradiating into perineum, disuric effects, vaginal discharges.

6. MEDICAL TEST RESULTS

Clinical laboratory curability control was held in a month after the treatment course was finished. 38 patients (25 women and 13 men) underwent a control examination. Negative results for DIF and IFA were obtained in 30 cases (19 women and 11 men). Positive results were obtained in 8 cases (6 women and 2 men). Thus, treatment efficiency makes up 78.9%. Five women and 2 men stated subjectively that their condition had improved, in 7 women and two men the condition had not changed.

Clinical symptoms remained in more than a half of cases. Maximum efficiency of treatment was marked for uncomplicated cases and shorter disease duration.

Thus, the “Biofon” Apparatus for IR-therapy proved to be very effective for treatment of urogenital chlamydiosis.

7. CONCLUSION

The “Biofon” Apparatus for IR-therapy is effective for treatment of urogenital diseases, caused by chlamydia.

In the course of medical tests etiological curability has been achieved with 78.9% patients.

Indications for the apparatus use are diseases of chlamydia etiology.

Contraindications have not been revealed.

“Biofon” Apparatus for IR-therapy is a compact, device, simple to use and easily to handle by personnel. Advantages of the apparatus are: arelatively low number of procedures (1-2 times a week), minimal treatment session duration, noninvasivity of the method, complete absence of contraindications, high clinical efficiency.

8. RECOMMENDATIONS BASED ON TEST RESULTS

The “Biofon” Apparatus for IR-therapy (urogenital) is designed for treatment of widely-spread urogenital infections in clinics and out-patient departments The “Biofon M501” Apparatus for IR-therapy is recommended for serial production and use in medical practice.

SignatureBychkova N.Y.