MD ANALYZER is a medical device for the screening diagnostics of the health status of a human, based on the analysis of the thermodynamic parameters of a human body. It provides information on 33 parameters of a human health, including blood formula, biochemical, hemodynamic and metabolic parameters without blood sampling. The ANALYZER does not replace biochemical laboratory analysis or other standard methods of diagnostics, providing information for the physician, which is used to primary diagnosing and determine the localization of possible pathologies, which can be verified and examined using generally accepted in-vitro methods and/or special instrumental methods. 1.1 GENERAL OVERVIEW A number of parameters determined by the ANALYZER were tested during several clinical trials, where their reliability has been confirmed. They are the following: Hemoglobin HGB. g/l, Erythrocytes RBC. x10¹²/l, Leukocytes WBC. x10⁹/l, Segmented neutrophiles. NEUT %, Band neutrophiles. NEUT %, Lymphocytes. LYMPH %, Monocytes.MONO %, Eosinophils. %, Erythrocyte sedimentation rate ESR. mm/h, Hematocrit.HCT %, Thrombocytes. x10⁹/l, Glucose. mmol/l, Calcium (Ca). mmol/l, Magnesium (Mg). mmol/l, Potassium (K). mmol/l, Sodium (Na). mmol/l, Creatinine. μmol/l, Urea. mmol/l, Cholesterol total. mmol/l, Triglycerides (TG). mmol/l, Low-density lipoproteins (LDL). mmol/l, High-density lipoproteins (HDL). mmol/l, Aspartate transaminase (AST). mmol/l, Alanine transaminase (ALT). E/l, Aspartate transaminase (AST). mmol/l, Alanine transaminase (ALT). E/l, Protein, Total. g/l, Bilirubin, Total. μmol/l, Bilirubin, Direct. μmol/l, Beginning of clotting (method of Lee-White). min, End of clotting (method of Lee-White). min, Amylase (W.Т.Caraway). g/l*h, Ceruloplasmin (CP). g/l.
Non-invasive methodology for determining functional, metabolic and hemodynamic parameters of a human body was realized in the specially designed software USPIH-M19 (USPIH), which is used together with the MD ANALYZER. The initial information, which is measured by the MD ANALYZER, includes temperature of the certain points on a human body (5 definite areas on a human body), parameters of environment, as well as the anthropometric data of a patient (age, weight, gender), heart and respiratory rates, which are entered with a keyboard. The input data are used in the algorithmic calculation of human health parameters, carried out by the software USPIH, for the determination of the actual state of a human body. Selection of the points of placement, information about which is the most valuable for the algorithm of calculation, was done on the base of the knowledge about the anatomic location of chemoreceptors on a human body. The location of chosen points is the following: 2 points - are placed on a neck, left and right, at the area of the carotid body. The carotid body is a small cluster of chemoreceptor cells, and supporting sustentacular cells. The carotid body is located in the adventitia, in the bifurcation (fork) of the common carotid artery, which runs along both sides of the neck. The carotid body detects changes in the composition of arterial blood flowing through it, mainly the partial pressure of arterial oxygen, but also of carbon dioxide. It is also sensitive to changes in blood pH, and temperature. Thereby, the carotid body modulates cardiovascular and respiratory function primarily through sympathetic tone. 2 points - are placed in armpits, left and right, at the top of the axillary crease, where arteria axillaris is the closest to the skin surface. Temperature values in this area, first of all, reflect pulmonary regulation of a breathing act, which depends on the work of irritative receptors, Type-J and pulmonary stretch receptors and regulates the volume of oxygen, which is necessary for an organism in the moment of time (with respect to the load, physical activity or resting state); 1 point - is placed near the navel – one sensor is placed near the navel – the abdominal area on the lumbar level was chosen due to the concentration of three large vessels of a body, namely aorta, inferior vena cava and thoracic duct. Temperature of this area influences to the synthesis of essential amino acids and regulatory hormones etc. It is related to the functioning of adrenal glands` chromaffin cells (chemosensory cells), as a negative feedback of O2 sensing, first of all). Process of the device’s development and software’s design was preceded by a huge analytical work for consolidation and systematization of the existing scientific achievements. Thereof, for definition of different parameters of a human health, the software USPIH combined commonly-known equations, practically revised and improved recognized formulas, as well as the invented mathematical algorithms, which have been based however on the evident physiological and biochemical interrelations, described in the number of scientific works of famous and recognized scholars, such as Claude Shannon (Shannon's channel capacity theorem, which applies to living organisms and their products such as communications channels and molecular machines that make choices from several possibilities, 1940s), SJ Singer and GL Nicolson (Henry’s law and Dalton’s law – described in "The fluid mosaic model of the structure of cell membranes", 1972); Goldstein, J.L. and M.S. Brown ("Model of low-density lipoproteins", 1977-1984), A. L. Lehninger (Bioenergetics, 1965; Biochemistry, the Molecular Basis of Cell Structure and Function, 1975), Waldram, J. R. (The Theory of Thermodynamics, 1985), Schneider, T. D. (Theory of molecular machines. I. Channel capacity of molecular machines and Theory of molecular machines II. Energy dissipation from molecular machines, 1991), Shinitzky (Membrane fluidity and cellular functions, 1984), Hensel H. (Thermoreception and Temperature Regulation, 1981), Schmidt, Robert F., Thews, Gerhard (Human Physiology, 2005), etc. Most of the fundamental scientific works concerned the questions of a cell’s structure and work of a cell membrane, appearance and development of different biochemical reactions, which characterize one or another metabolic process, and as a result, heat production and heat loss in a process of vital activity, as well as thermoregulation of a human organism, which is affected by the environmental factors (air temperature, atmospheric pressure, light lux and gaseous compound of air). As a human organism exists and lives due to the million internal chemical reactions, so all vital processes of a body are supported and regulated by chemical reactions, which are subject to the laws of thermodynamics. Temperature affects not only the rate of chemical reactions, but also is the reason of proteins' alteration, phase transition of lipids and changes of water structure. The temperature of body tissues is defined by the ratio of metabolic heat production of cell structures and the rate of heat emission into the environment. Consequently, the heat exchange between an organism and the environment is an essential condition for the existence of a living organism. Violation of the mentioned ratio leads to a change in body temperature. The algorithm of the MD ANALYZER is based on the provisions of the thermal homeostasis of a body and its relationship to changes in blood flow and Cerebrospinal fluid (CSF) dynamics, which are accompanied by the changes of peripheral blood cell composition and hormones, mineral, protein, amino acid, lipid and carbohydrate metabolism, activity of the thrombin-plasmin system (TPS). In fact, TPS determines the number of functioning capillaries per a unit area. TPS activity varies depending on the rate of blood flow in internal organs due to the functioning of a heart, correlated with heat production. Depending on the rate of oxygen delivery to a cell, the changes of blood circulation occur and they accompanied by the changes of temperature characteristics of the reference points, as well as time of their stabilization. The degree of enzymatic, hemodynamic and metabolic activity is defined by the haematopoiesis system and cellular composition of peripheral blood.
The principle of functioning of the MD ANALYZER is based on measurement of temperature in the certtain points of a human body (as mentioned above), taking into account other initial data about the patient and parameters of the environment. Five sensors, connected to the MD Analyzer, measure temperature in definite points with accuracy not less than 0.07ºС. MD Analyzer processes signals, coming from sensors placed on the body of a patient and converts these signals into a digital form. Temperature values, measured by sensors, are converted into the information value "bit" and are sent to the central microcontroller of the MD ANESA®/AMP/DAD-ANI® Model 19. Given data are processed by the microcontroller at first and then by the PC's software, after that, it is possible to view and print the results. So, all the information is processed by the specially designed software USPIH, located in the microcontroller and on a PC, becoming the base for the report/survey with 131 parameters of health. The device has five temperature sensors (digital thermal microprocessors), which are to be placed onto definite points of a human body (bifurcation of the right and left neck artery (two points), right and left armpit (two points), umbilical area (one point). The sensor, which measures the parameters of environment, such as atmospheric pressure, is installed inside the MD. Prior to an examination, the five sensors are to be placed on a patient, and the initial data of the patient (gender, weight and age), breath rate and pulse rate (measured with pulse oximeter or manually, when the patient is in a supine position) should be input into the patient's card using the interface of the software USPIH, installed on a PC. The software USPIH manages the process of measurement, data collection and processing. Calculation of the data of blood parameters is made by the special calculation algorithm named by Malykhin-Pulavskyi method (Ukrainian Patent No. 60890, 39250, 3546 A61B5). At the end of each examination, a qualified medical professional receives the report. Besides parameters, there will be a prompt for a qualified medical professional about possible diagnosis at the end of a report. It is not a final diagnosis, it is only preliminary PC conclusion.
Medical Device for Noninvasive Screening Diagnostics ANESA®/AMP/DAD-ANI® Model 19 is intended for the measurement of thermodynamic values on the surface of skin at specific points of a human body, which are subsequently processed by the software USPIH in combination with the initial data of the patient (sex, age, weight, manually measured heart and respiratory rate) and parameters of the environment (atmosphere pressure is measured automatically), with further representation in the form of a report with health parameters and preliminary conclusion on deviations in the state of health to which attention should be paid, (machine prompt). The qualified medical professional is able to estimate human health or recommend special examinations/tests/procedures for a diagnosis clarification based on the comprehensive approach including the analysis of the received primary screening diagnostic report, patient’s history/complaints and presence of manifested symptoms and signs. As the method of the MD ANESA/AMP/DAD-ANI is noninvasive, fast and safe, and the results are multi-informative, so such testing will be useful for determining the range of further specific diagnostic procedures, i.e. scope of focus. Using this information, a qualified, trained and experienced medical professional is able to identify existing pathologies and/or suspicious disorders of health. Therefore, the combination of the MD ANALYZER with other methods of diagnostics will be the most beneficial for the most accurate diagnosing of the patient health state. Given that, it can be concluded such a screening device will be useful both in an admission department of a hospital and in a private clinic, general practitioner’s or a family doctor's cabinet. In addition, usage of the Analyzer in rehabilitation and recovery centers will be helpful for estimating the efficiency of applied treatment and physiological procedures (e.g. UHF and laser therapy, mud and mineral baths, etc.). Surely, attention should be paid to the contraindications and warning for use. Based on the current knowledge and practical experience with the MD ANALYZER, the manufacturer warns about a number of contraindication
The full use of operability of the MD ANALYZER is able in conjunction with a computer. One of software part (external) is to be installed on a PC. It allows to enter the data of a patient, keep records, display the process of measurement and the results of calculation. The MD ANALYZER can work via Bluetooth or USB cable. The appropriate icons are highlighted in the software interface. As the MD ANALYZER powered from the built-in battery, the level of battery indicator and battery charging indicator are also available in the interface. Using the MD ANALYZER without a PC is possible only for a battery recharge. The charger and USB cable from the complete set are to be connected to the unit. Then the charger is plugged into the power socket. Green LED on the front panel of the unit will blink while charging. When the battery is full, the LED will light without blinking.