PROTOCOL No. 96 of July 21, 2007
0 conducting medical tests of the hardware and software complex "DIANEL", produced by LLC "Center of Information Technologies "NELIAN", Russia 1. Medical tests were carried out during the period from 06/18/2007 to 07/21/2006 in the psychophysiological laboratory of the center of traditional medicine and rehabilitation treatment. 2. The purpose of the tests is to assess the qualitative and functional characteristics of the hardware and software complex "DIANEL", produced by LLC Center for Information Technologies "NELIAN", Russia and its application in the medical practice of medical institutions in the Russian Federation. 3. Reasons for conducting the tests : Application for registration of a medical device. Protocol of technical tests of the laboratory for carrying out acceptance technical and testing of medical devices FSUE "NPP "Cyclone-Test" No. 0729-1-07. Technical conditions TU 9442-008-76433581-2007 for hardware and software "DIANEL" complex 4. For testing, a sample of the "DIANEL" hardware and software complex was presented as a set, produced by "NELIAN Information Technology Center" LLC, Russia. User guide. 5. Technical characteristics of the tested product and its purpose: The hardware-software complex “DIANEL”, produced by LLC “Center of Information Technologies “NELIAN”, Russia, is intended for assessing psychophysiological and stress-adaptive changes in the human body. The hardware and software complex "DIANEL" is a non-invasive diagnostic device for determining the galvanic skin response method (registration of bioelectrical activity of the skin) as an indicator of the involuntary reaction of the autonomic nervous system. In conditions of increasing stress factors and stress-induced diseases, the development and creation of means of psychophysiological support and rehabilitation is an important task. The psycho-emotional sphere significantly influences the degree of adaptation of the individual to external conditions. Therefore, there is an increasing need to develop systems using psychological influence factors. Such means can be used to monitor representatives of certain professions (machinist, operator, driver, etc.) that require increased attention and quick reactions in stressful situations and for the prevention and treatment of certain neuropsychic and psychosomatic diseases (peptic ulcer, hypertension, etc. .). Contraindications for the use of the hardware and software complex “DIANEL”, produced by LLC “Center for Information Technologies “NELIAN”. Russia are the presence of severe somatic and mental illnesses in patients. High requirements for psychophysiological rehabilitation systems (accuracy of information acquisition, automation of diagnostic management, real-time operation, reliability, ease of use, documentation of results) dictate the need to use them in the form of modern hardware and software complexes. The hardware and software complex "DIANEL" includes: a device (analog-to-digital converter) with a power supply two channels of electrodes (for taking readings in both hands of the patient) LED emitter audio headphones "Dianel" software The program ensures the operation of the complex as in open-loop mode To record the parameters of the galvanic skin response, the sessions also use factors that are widespread in everyday life and have an undoubted therapeutic effect, such as color and music. The principle of operation of the DIANEL complex is based on the use of a modification of the Feret method - the relaxation-activation test technique. allowing indirectly through changes in skin conductivity of the fingertips and processing of measurement results using a special program to obtain information about changes in the homeostasis of the human body. To obtain information on electrodermal conductivity, current pulses of about 2 μA are applied to sensors located at the tips of the 4.5 fingers. The received information is amplified, converted and sent via USB to a computer, where the received data is processed using a special program. Under the influence of psychophysiological processes, a change in the body's homeostasis occurs and leads to a change in the galvanic skin response, which leads to a change in electrical skin conductivity. Changes in the characteristics of electrocutaneous conductivity signals carry diagnostic information about the physiological and pathological conditions of the body. 6. Contents of the protocol: Clinical trials of the hardware and software complex “DIANEL”, produced by LLC “Center for Information Technologies “NELIAN”. Russia were carried out in the psychophysiological laboratory of the center of traditional medicine and rehabilitation treatment. During the period of clinical trials, a comprehensive psychophysiological examination was carried out with control by generally accepted clinical diagnostic methods of 137 patients aged 18-64 years, including those with disorders of psycho-physiological adaptation against the background of somatic diseases (heart disease). but vascular pathology is mainly hypertension, stage I-II. - 24 people, coronary heart disease - 11 people, peptic ulcer of the stomach and duodenum - 35 people, other cardiovascular diseases and diseases of the digestive system - 5 people); increased irritability, excitability, disorders due to vascular diseases of the brain - 41 people; patients with mental overload and lifestyle disorders - 32 people. The hardware and software complex “DIANEL” was used before the start of the psychocorrection course and after its completion. At the beginning of the rehabilitation session, the background value of the galvanic skin response parameters was recorded using the DIANEL hardware and software complex (activation or relaxation indicators) in the absence of any impact. Then the current psychological state of the tested patient was assessed using the reduced Luscher test (the test allows you to assess the psychological state of a person at a given moment in time according to the sequence of colors selected in order of preference from the eight proposed). The test result is expressed as a reactivity coefficient - a formalized value characterizing the degree of agitation or depression of the patient being tested. The value of the reactivity coefficient obtained as a result of the reduced Luscher test was compared with the nominal value (1.6), on the basis of this a conclusion was made about the psychological state of the tested patient - excited or depressed, and the musical influence was selected accordingly - calming or stimulating. Music was played using the computer's built-in CD-ROM drive from standard CDs through regular sound speakers. The test musical exposure interval was set, and the dynamics of the galvanic skin response parameters during this interval was assessed. Based on the results of the Luscher test and changes in the parameters of the galvanic skin response during the music test, the parameters of color exposure were determined - the direction of the color range and the initial color. The color effect on the DIANEL hardware and software complex is formed using an LED emitter and a monitor screen. Color and musical images, influencing the tested patient, lead to changes in the galvanic skin response. Measuring the galvanic skin response parameter during the exposure process, linking the instantaneous values of this parameter to the color that is reproduced on the monitor screen, form feedback loops of the system, of which there are two: audio - negative discrete and visual - positive, quasi-continuous. Color and musical effects are generated in feedback mode according to the galvanic skin response parameter using the “DIANEL” hardware and software complex of the fingertips of the tested patient.
Test results: A clinical trial showed that the DIANEL hardware-software complex, produced by NELIAN Information Technology Center LLC, Russia, is a functional product. Research conducted using the DIANEL hardware and software complex indicates that. that exposure to color and music is an effective means of psychological support for the patient being tested. A more meaningful visual impression is achieved by using a visual series formed from slide files displayed on the monitor screen. Indicators of galvanic skin response are a resistant parameter that affects the current psychophysiological state of a person and his reaction to various influences of a physical, emotional, intellectual nature, as well as the constitutional type of emotional response. By examining the galvanic skin response of patients to various test influences, the expected reaction to which is known (sound, light, smell, emotional-intellectual tests), one can assess the degree of stability of the functional state. With repeated observations, changes in the dynamics of the galvanic skin reaction can be used to judge changes in a person’s functional resistance to certain influences. The use of two sensors in the DIANEL hardware and software complex to measure electrocutaneous conductivity from both hands of the patient provides additional information for diagnosing symmetry/asymmetry of physiological processes. Assessment of psychological state is often done on the basis of psychological tests, questionnaires, etc. and is subjective. Registration of galvanic skin response indicators using the DIANEL hardware and software complex, along with other methods, can help to objectify a person’s psychological state, as it allows one to visualize the obtained data, both in the form of cartograms and frequency graphs. The effectiveness of using the DIANEL hardware and software complex to determine the dynamics of the psychocorrection process in patients with diseases of the cardiovascular and digestive systems, and vascular lesions of the brain has been established. Thus, the use of the DIANEL hardware and software complex made it possible to improve the level of assessment of the psychophysiological state of patients, to carry out dynamic control over the psychological and, to a certain extent, physiological state, the process and effectiveness of treatment, and to optimize further psychocorrection. The user manual corresponds to the purpose of the DIANEL complex.
Conclusions:
The hardware and software complex “DIANEL”, produced by LLC Center for Information Technologies “NELIAN”, Russia, meets the declared characteristics and can be recommended for use in medical practice in the Russian Federation. The product is recommended for registration with the Federal Service for Surveillance in Healthcare and Social Development.
Chairman of the commission: Head. Scientific and Methodological Department Academician of the Medical and Technical Academy of the Russian Federation, Candidate of Medical Sciences V. Galik
Members of the commission: Head of the psychophysiological laboratory of the Center for Traditional Medicine and Rehabilitation Treatment S. Esin