You will definitely ask these questions, when you hear about the device ANESA

How does the divice measure the parameters?

Briefly speaking, determination is based on measurement of temperature in certain biologically active points of a human body, accounting other initial data about a patient and parameters of environment as well. All the information is analyzed by the software USPIH, according to the special mathematical algorythm. The rersults are generated into a report/survey with more than 100 parameters of health state (example of a survey). The methodology, main algorithm of calculation and correlations, described in the patents, were tested and corrected during the device's development, in accordance with real processes in a human organism. Unfortunately, we couldn’t give such kind of information to anybody else, because it’s our know-how.

You also can find the information about the methods in Theory about methods

The methods has been described in more than 50 publications mostly in Russian journals (some of them are listed here) and in the patents:

1. Malykhin A. et al: Patent of Ukraine UA 22161A "Method of assessment of hemodynamic disorders» Bulletin No.2 from 30.04.1998

2. Malykhin A. et al: Patent of Ukraine № 3028 A61V5/02 Bulletin №10 from 15.10.2004 "Method of diagnosis of autonomic-vascular paroxysms."

3. Malykhin A, Pulavskyi A et al: Certificate of intellectual properties for the computer software USPIH, No.24934 from 10.07.2008 

4. Malykhin A et al: Patent of Ukraine №60890 Bulletin №12 from 25.06.2011 "PROCESS OF NON-INVASIVE DETERMINATION OF HOMEOSTASIS PARAMETERS OF THE BIOLOGICAL MEDIA OBJECT." 

 

Could the results of test on a device ANESA be used instead of classical laboratory blood test?

First of all, the device ANESA is used for screening estimation/examination and diagnostic of human organism. It is express diagnostic system, which can help a doctor with diagnosing. It is not blood analyzer, thus it couldn’t replace the blood laboratory. The results of testing on ANESA includes more than 100 parameters, not only the blood formula or biochemical parameters.

What is the accuracy of the device ANESA?

Please note, that there is no one official document or Directive in the world regarding comparison tests for invasive and non-invasive devices (in vitro versus in vivo). Nevertheless, we've done the comparison of parameters with classical biochemical test laboratory. The tests were carried out in accredited and certified laboratories. It is necessary to notice also, that not all the parameters could be compared in accredited laboratories. That’s why, we mentioned it in our Technical Construction Files (submitted to ITC as the main document for certification) and in the User’s Manual that some of parameters are considered as approved (tested in accredited laboratory), and others are recommended for usage (tested in certified laboratories in different time).

Based on the latest results of clinical studies, made in accredited laboratory of the Ukrainian Research and Practical Centre for Emergency and Disaster Medicine of the Ministry of Health of Ukraine, from May till June 2012, it was determined that the test medical device ensures necessary repeatability of test blood values with the confidence interval of 95%. The list of approved parameters includes: Haemoglobin, Lymphocytes, Monocytes, Stab neutrophils, Concentration of total protein, AST (Aspartate aminotransferase), ALT (Alanine aminotransferase), ESR. Other parameters were tested in different certified laboratories, located in different countries. Thus, we can assert that the medical device ANESA ensures necessary repeatability of test blood values with the confidence interval of 95% in comparison with certified haematology analysers.

From 2006 (when the method was certified at the first time) till nowadays, we are continuing to test the device ourselves. In cooperation with the Institute of Neurology, Psychiatry and Narcology of Academy of Medical Science of Ukraine, we have been tested the patients by the device ANESA and send their samples of blood to the classical laboratories, which are working in the Institute or together with the Institute (Regional Clinical Psychiatry Hospital No.3 and Alfa Labservice LTD). The results have been compared. The latest report includes the comparison results for 116 patients, which were tested from January 2013 till May 2013. (english version of the report can be downloaded here). The number of compared parameters is bigger, than approved one (17 parameters).

Speaking in general, people always try to compare the results of our device and laboratory test directly, but it's not the right way, and it is confirmed by medical experience. For example, if the device ANESA gives the parameter stab neutrophils 1% and laboratory test gives 2%, direct comparison will show the difference 100%! BUT, in reality, for a medical purpose, such difference doesn't matter. Such difference is not significant, because both parameters are in the normal range.

 

Who can use the device ANESA?

ONLY DOCTORS can use the device ANESA. Moreover, all users/doctors should be trained specialy. The device seems to be very easy to use...But, it is necessary to note, if a doctor wasn't trained, he/she isn't able to use the device properly. In case the sensors are put not correct, the results in the report will be wrong and couldn't be analyzed. Also, this is the one of reasons why we require only doctors as users of the device. A person without medical background will not understand if the received report is useful or not (if it is necessary to correct the sensors placing and make the test again or not, etc.).

 

Where could the device be used?

Mainly private doctors or family doctors use our devices in their work. Mainly, because they need the information about the state of a patient's health fast. So, a doctor receives quick answer and decides what to do: he can send a patient to a laboratory for verification; or send him/her to a hospital, in case of serious situation with health; or prescribes a medicine and then monitors the process of treatment.

At the same time, the device is successfuly used in hospitals, clinics, medical research institutes, sanatoriums and wellness centers.

 

Where is the device being worked?

Our devices work in Europe (Hungary, Slovakia, Slovenia, Netherland, Czech Republic, Serbia, Romania, Italy, Austria, Spain), China, Egypt, Latin America (Mexico, Columbia, Equador, Salvador), Russia, Belorussia, Kazakhstan, and, of course, in Ukraine. 

 

What is the metrological traceability of the device?

Our device ANESA uses 64-bit microprocessors DS18D20, manufactured by Dallas Semiconductor/Maxim Integrated Products (USA) for the temperature measurements. The manufacturer of microprocessors calibrates every single DS18B20 to ensure the accuracy of the temperature readings (units in K), in accord with the published datasheet. Each individual chip is adjusted as necessary to bring it into compliance. The production test equipment is calibrated using standards that are traceable to NIST (the official letter from Maxim Integrated Products Co. is here).

Our engineers make additional control of each purchased batch of microprocessors, according to specialy developed methods and procedure of temperature verification .

At the same time, we need to note, that any metrological verification couldn’t be applicable for the parameters in our tests, because all of them are mathematically determined, and not measured (the same concerns biochemical equipment in laboratories: no one parameter of blood can be verified by metrological methods).