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Exhibit �2 Results of independent metrological testing of programs for calculation of the heart rate variability parameters
2.Existing approaches of metrology providing of estimation the HRV-programs Selection of the special section: "Suggestions for Standardization of Commercial Equipment" in well-known international recommendations on HRV (1996) is signaling by itself of existence of the discussed problem. In international recommendations is suggested to utillize the exemplary sequences of RR-intervals with preset HRV-parameters, which are generated by the computer program ("computer simulated signals"). Here is straight specified, that "When commercial equipment is used in studies investigating physiological and clinical aspects of HRV, independent tests of the equipment used should always be required". The last position of Standard is absolute for organization of scientific researches and providing of competition at the market of medical devices and in science. Russian school of HRV has an enormous experience in the scientific providing of HRV. In Russian recommendations of Committee of a new medical technique (protocol N4, 11.04.2000, chairman R.M.Bayevsky) in a section N6: "Information producibility and comparableness" is specified such key point which can be presented as epigraph to similar researches: "The comparableness of records and results of HRV-analysis is meant by possibility of comparison the information, which got from different clinical establishments by different software. Without possibility of such comparison the further development of HRV-methods is impossible. ...if the major parameters of HRV will substantially differentiate depending on the type of the applied apparatus and software, than it is impossible to talk about any progress in area of HRV-analysis". Thus, quite obviously, that without existence of the national system of testing the indicated devices and programs, the national HRV-scholl can not exist at all.In Russia in 2000 a decision of this problem was in the stage of project, because the indicated methodical recommendations offer "As a standard system testing in the future to utillize developed Moscow Institute of Electronic Technique (Zelenograd) complex "HRV-test", which plugs in itself the set of real and generated ECG-signals, and also results of their treatment of analysis of HRV the standard program". That the certain "generator of ECG-signals" and certain "standard program of analysis of HRV is offered". The first position is clear, and the second causes questions, because "standard program" on determination can not be, but can be program which with maximal exactness counts the indexes of HRV set, in the programmatic generator of sequences of kardiokompleksov. At preparation of international symposium on HRV (Kharkov, 2003) in a network the Internet among the members of scientific committee of this symposium was organized discussion of new recommendations on HRV (co-ordinator - prof. M.Yabluchansky). Unfortunately, the fate of these recommendations is unknown us, but the authors of this research participated in the discussion of text of recommendations. Here self-controls from a section: "Requirements to the equipment and software" of insolvent recommendations "... Possibility of the independent testing must be assumed on� all of phases of work (record, reproducing and analysis) on signals with the known properties of variabel'nosti, by the designed computer or from standard databases, regenerate in a numerical form ECG. ... a producer must not know veritable descriptions of HRV of test records and parameters of registration of signal. It is necessary to give a preference the simulirovannym signals of ECG, morphology of which, as well as descriptions of HRV, it must be near to the real registrations. Frequency of discretization, in-use for the generation of such signals must be substantially higher, than frequency, in-use a testable device. ...The proper technology must be used for registration of the fully reproduced signal with the beforehand known parameters of HRV, I.e. a test signal must be made a computer or other technical device. Any exposed distinctions must be analysed in regard to the special descriptions, borne in a test record, by for example enhanceable noise, wander of starting point, etc. The system error of equipment and relative errors must be certain. A technical report on testing must be geared-up exceptionally testing organization regardless of producer of testable devices" As be obvious from a text many moments in this document are more gone into a detail and specified as compared to two previous. Hardness to object what or to the point in this project of methodical recommendations. Remains to regret, that this document is not finished off and did not purchase status of official. Summarizing basic recommendations of these three documents it is possible to select the followings positions: - the metrology testing of apparatus and benchmark HRV routines is an obligatory condition; - testing must be executed independent organization; - to testing drawing on hardwarily-programmatic complexes which generate artificial ECG signal with the set frequency descriptions of ECG and high-frequency of discretization is preferable (no less then 1000 Hz).

CUNSTCAMERA (CABINET OF CURIOSITIES) OF CLINICAL SCIENCE

Exhibit �2
Results of independent metrological testing of programs for calculation of the heart rate variability parameters

2.Existing approaches of metrology providing of estimation the HRV-programs

Selection of the special section: "Suggestions for Standardization of Commercial Equipment" in well-known international recommendations on HRV (1996) is signaling by itself of existence of the discussed problem. In international recommendations is suggested to utillize the exemplary sequences of RR-intervals with preset HRV-parameters, which are generated by the computer program ("computer simulated signals"). Here is straight specified, that "When commercial equipment is used in studies investigating physiological and clinical aspects of HRV, independent tests of the equipment used should always be required".
The last position of Standard is absolute for organization of scientific researches and providing of competition at the market of medical devices and in science. Russian school of HRV has an enormous experience in the scientific providing of HRV. In Russian recommendations of Committee of a new medical technique (protocol N4, 11.04.2000, chairman R.M.Bayevsky) in a section N6: "Information producibility and comparableness" is specified such key point which can be presented as epigraph to similar researches:
"The comparableness of records and results of HRV-analysis is meant by possibility of comparison the information, which got from different clinical establishments by different software. Without possibility of such comparison the further development of HRV-methods is impossible. ...if the major parameters of HRV will substantially differentiate depending on the type of the applied apparatus and software, than it is impossible to talk about any progress in area of HRV-analysis". Thus, quite obviously, that without existence of the national system of testing the indicated devices and programs, the national HRV-scholl can not exist at all.In Russia in 2000 a decision of this problem was in the stage of project, because the indicated methodical recommendations offer "As a standard system testing in the future to utillize developed Moscow Institute of Electronic Technique (Zelenograd) complex "HRV-test", which plugs in itself the set of real and generated ECG-signals, and also results of their treatment of analysis of HRV the standard program".
That the certain "generator of ECG-signals" and certain "standard program of analysis of HRV is offered". The first position is clear, and the second causes questions, because "standard program" on determination can not be, but can be program which with maximal exactness counts the indexes of HRV set, in the programmatic generator of sequences of kardiokompleksov.

At preparation of international symposium on HRV (Kharkov, 2003) in a network the Internet among the members of scientific committee of this symposium was organized discussion of new recommendations on HRV (co-ordinator - prof. M.Yabluchansky). Unfortunately, the fate of these recommendations is unknown us, but the authors of this research participated in the discussion of text of recommendations. Here self-controls from a section: "Requirements to the equipment and software" of insolvent recommendations
"... Possibility of the independent testing must be assumed on� all of phases of work (record, reproducing and analysis) on signals with the known properties of variabel'nosti, by the designed computer or from standard databases, regenerate in a numerical form ECG.
... a producer must not know veritable descriptions of HRV of test records and parameters of registration of signal. It is necessary to give a preference the simulirovannym signals of ECG, morphology of which, as well as descriptions of HRV, it must be near to the real registrations. Frequency of discretization, in-use for the generation of such signals must be substantially higher, than frequency, in-use a testable device.
...The proper technology must be used for registration of the fully reproduced signal with the beforehand known parameters of HRV, I.e. a test signal must be made a computer or other technical device. Any exposed distinctions must be analysed in regard to the special descriptions, borne in a test record, by for example enhanceable noise, wander of starting point, etc. The system error of equipment and relative errors must be certain. A technical report on testing must be geared-up exceptionally testing organization regardless of producer of testable devices"
As be obvious from a text many moments in this document are more gone into a detail and specified as compared to two previous. Hardness to object what or to the point in this project of methodical recommendations. Remains to regret, that this document is not finished off and did not purchase status of official.
Summarizing basic recommendations of these three documents it is possible to select the followings positions:
- the metrology testing of apparatus and benchmark HRV routines is an obligatory condition;
- testing must be executed independent organization;
- to testing drawing on hardwarily-programmatic complexes which generate artificial ECG signal with the set frequency descriptions of ECG and high-frequency of discretization is preferable (no less then 1000 Hz).

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