History of development

Since 1992, Malykhin Anatolii was researching and trying to define the correlations between the biochemical indices of human body and parameters of blood formula.

To summarize the results of researches and further work in this direction, the software USPIH was designed, in 2000. At that time, the software processed the data of blood tests (complete blood test), received from the traditional laboratory. On this basis, the software was able to determine other parameters: biochemical, hemodynamic and metabolic parameters of a human body.

Improving of the software was carried out in cooperation with specialists of the Physical and Technical Institute of Low Temperature of Academy of Sciences of Ukraine. Analysing the existing version of the software, the inventor realized that there are controversial moments in the determining of some parameters (sometimes, there were no correlations between biochemical and metabolic parameters, or the correlation was very poor). The software was not able to give logical answers in such cases.

The researches have moved to the next phase, when Dr.Malykhin understood, that determining the temperature on biologically active points of a body is very important and informative: received information allows determining relationship between the work of a body and its temperature. The next logical step was the development of a device, which is capable to receive such important information and measure the temperature on active points simultaneously, in real time.

New software was designed for such a device, mostly based on the methodology used in the software USPIH. The new software was designed together with Pulavskyi Anatolii, director of research and production company "Biopromin" LTD. Systemic analysis of the results showed their high potential. Thus the new hardware-software complex was developed, which received the name "Noninvasive hemogram analyzer AMP."

The development of methodology became the base for more than 50 publications (in Russian and Ukrainian languages), 3 patents of Ukraine and methodic recommendations "Noninvasive determination of blood, metabolic and hemodynamic parameters of human body." On the basis of this development, in 2005., Malykhin Anatolii defended his dissertation at the Institute of Noosphere Technology of Academy of Natural Sciences of Russian Federation, with a dedicated multi-disciplinary council of the Higher Attestation Commission of the Russian Federation. Anatolii Malykhin became a doctor of medical science, in the sphere "Neurology and chemistry, laboratory work." In 2006, he also has prepared and published a monograph "Autonomic-vascular paroxysmal states and thermoregulation of the body."

During 2006 to 2007, the analyzer AMP has passed clinical trials successfully and has been certified in Ukraine and Europe. The Quality Management System of the company "Biopromin", as the manufacturer of medical equipment, was confirmed and certified according to the ISO 13485:2003 and ISO 9001:2000. In 2008, the analyzer AMP has been registered in the Russian Federation, and in 2010 - in China, Belarus and Kazakhstan. Active work in the fields of certification and registration of the device is going in other countries.

After 2006, clinical trials have been carried out each year from 2007 till 2012. According to the subsequent clinical trials and systemic analysis of the results, the software USPIH has been substantially modified. The version USPIH 10 was designed, where mathematical algorithm was extremely improved. USPIH 10 has got absolutely different interface from the software USPIH 6. Both versions are not compatible. The new device has been required for the new software, and it was developed: Automatic Noninvasive Express Screening Analyzer ANESA.

1. Main advantages and new functions in the software USPIH 10:

1.1. the number of parameters has been added, USPIH 10 gives 130 parameters;

1.2. ANESA has got a built-in self-control system of indicating and monitoring of each external microprocessor, used in five cables for measurements;

1.3. USPIH 10.0 has a built-in system for checking the contacting of the microprocessors with the skin of a patient while measuring. It allows monitoring the process of measurement: a doctor could control the process of measurement and avoid possible errors, occurring during measurement, influencing to the results finally. (It is described in the User’s manual, pg.35-37);

1.4. visual control of measurement was designed: there is a graph of changes of temperature values in USPIH 10. A doctor can monitor the changes of temperature coming from each microprocessor during measurement. Each colour line of the graph corresponds with the cable for measurement;

1.5. comparing of parameters in dynamics: it is possible to choose from 1 to 9 parameters for comparing. The results of comparison are displayed as graph for each chosen parameter, where the value of parameter is indicated according to date of measurement;

1.6. user’s interface became easier for use: most of the functions are indicated by icons/pictures. It reduces the number of possible errors, while a doctor fill in a patient's card in database  (e.g. icons for gender identification: “male” and “female”);

1.7.  a report after measurement can be generated according to the wishes of a user/doctor: a doctor can choose the parameters, which should be displayed and printed; a doctor is able to set a parameter to any group (as he/she wishes) in a report;

1.8.  all the patients in a database can be grouped according to the characteristics, which are important for a doctor (e.g. disease, age, location, etc.);

1.9. all the tests for one patient are kept in the one record in a database under one name, in different folders (named by the date of test);

1.10.  searching function: by a name of a patient, by the date or period of test;

1.11.  automatic update of the software is provided;

1.12. additional protection of the software with a password:  a user/doctor can set his/her personal password for access to the database and software USPIH 10.

 

2. Except the new software USPIH 10, the hardware of the new device ANESA has been modified, too:

2.1. ANESA is performed in several models. The model with Tablet PC is available now;

2.2. ANESA has significant differences in the schematic diagram;

2.3. ANESA uses a new main microprocessor, which makes the mathematical calculation and located on PCB;

2.4. ports for cables with measuring microprocessors were changed: each cable is connected to the devices separately (each cable can be replaced in case of damaging independently now);

2.5. type of cables were changed: it is easier to differentiate the cables by colour now, because every cable has different colour, the possible errors or confusion are minimized;

2.6. the protection key (Guardant Key) is built-in now: possibility of loss or stolen is minimized.

2.7. the device ANESA was developed in accordance with the requirements of international standard EN 60601-1 3rd.ed.: 2005-12. Successfully carried out technical trials are confirmed by the Test Report No.414102190AE1 dd 2013-02-25 and the Test Report No.414102190AL1 dd 2013-02-28 accordingly.

Thus the device ANESA is a completely new device, which uses improved mathematical algorithms for data analysis and processing (software USPIH 10.0) and has different electronic components and construction.