BIOL therapy apparatus. Clinical trials, Ukraine 2009

At the request of the Department of Regulatory Policy in the Sphere of Medication and Medical Products in Health System No. 18.2ВМ - 2493/н dated August 26, 2009, clinical trial has been performed for a medical-purpose product LOW INTENSITY MICROWAVE AND DECIMETER WAVE THERAPY APPARATUS “BIOL” as per specification ТУ У 33.1-22716816-002:2009, manufactured by “Biopromin” Ltd (Ukraine).

The trial has been performed from August 26, 2009 to September 14, 2009 at Kyiv Regional Hospital No.2. According to the report of clinical trials the device BIOL can be effectually used in medical practice in Ukraine: 

“LOW INTENSITY MICROWAVE AND DECIMETER WAVE THERAPY APPARATUS “BIOL” as per Specification ТУ У 33.1-22716816-002:2009, manufactured by “Biopromin” Ltd (Ukraine), is designed for therapeutic influence on tissues and inner organs of a patient by low-intensity electromagnetic field in the frequency band of 100-1500 MHz.

The apparatus influences tissues and inner organs of a patient by low-intensity electromagnetic field in the frequency band of 100-1500 MHz. Emitted electromagnetic waves result in the oscillatory effect in the human body, thus stimulating activity of the physical and chemical processes in the body. Penetrating power of the decimeter waves in tissue makes up 8-11 cm at an average. Skin and subcutaneous fat thickness have no significant influence on reflection coefficient and absorption coefficient of the decimeter waves.

The apparatus is recommended to be used in medical institutions, medical and preventive treatment facilities, in health resorts and out-patient institutions.

As a result of performed trial, over 100 physiotherapeutic procedures have been carried out, MPP has been used for therapeutic influence on the patients with the following diseases: intercostal neuralgia, osteochondrosis, rhinolaryngitis, rhinosinusitis, osteoarthrosis, rhinitis. Age of the patients varies from 19 to 74 years. During usage of BIOL, 80% of patients have exhibited state improvement (pain syndrome has been assuaged by 40%, course of clinical presentations of the upper respiratory tract diseases has been shortened by 20%), and 20% of patients exhibited no changes in the course of a disease. No side effects or aggravation in the patient conditions have been observed.

According to the results of trial, safety functions, provided by the manufacturer, and medical risk have been highly evaluated. Possibility of infliction of harm to a patient or operator is practically ruled out if the apparatus is operated in accordance with the operation manual.

According to the results of trial, it has been established that MPPs are convenient to use, ergonomic, properly functioning; local irritation, allergic effects have not been observed in any case.

BIOL meets the technical and sanitary requirements of the Ministry of Health of Ukraine, which is confirmed by the Record of Preclinical Examination.

Program of clinical trials (copy of the original document and translation into English)

 

Report of clinical trials (copy of the original document and translation into English)

 

Conclusion of ethics commission (copy of the original document and translation into English)