On Software Architecture for Measuring Device Applicable in Medicine Based on Scanning Microcalorimeter Example

Author: Manana Khachidze
Co-authors: Maia Archuadze, Magda Tsintsadze, Davit Khachidze
Keywords: Measuring Device, Software
Annotation:

Modern medical devices used in diagnostics are mostly equipped with computer controlled modules. These modules have the corresponding software designed to meet international standards [1-3]. Usualy these devices combine different measurement tools, the main functionality of which is based on the withdrawal of a specific test-calculations based on patient or diagnostic materials [4]. The scanning micro-calorimeter is a tool that allows the blood serum denaturation curves to be obtained. As on blood plasma / serum calorimetric curve it is clearly shown the heat peeks, which corresponds to melting of the main proteins in the plasma / serum, it is possible to use this data for cancer diagnostics. In order to enable wider application of scanning microcilometer in medical diagnostics, software development for calorimetry management is necessary [8]. The following functionality modules must be developed for this purpose: 1 . Management of temperature and time-sessions during the process of test-calculations; 2. Transformation of calorimeter analog signal to digital signal; 3. Presentation of the received signal as a normalized curve; 4. Storing of the relevant information on specific measurements in the database; 5. Comparison of specific test-calculation to date in knowledge base in order to determine the possible diagnosis. Individual modules might be considered as an autonomous program with dynamic interchange and reliable storage of data. 1. ISO 14971:2012. 2012. Medical devices - Application of risk management to medical devices. 2. IEC/TR 80002-1, 2009. Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software 3. European Commission. 2016. Summary list of titles and references harmonised standards under Directive 93/42/EEC for Medical devices. http://ec.europa.eu/growth/single-market/european-standards/harmonisedstandards/medical-devices/ 4. M. McHugh, F. McCaffery, and V. Casey, “Standalone software as an active medical device,” in Communications in Computer and Information Science, 2011, vol. 155 CCIS, no. 2011, pp. 97–107. 5. Monaselidze J, Lezhava T, Khachidze D, Gorgoshidze M, Kiladze M, Lomidze E, Tvauri G,Barbakadze SH, Kikaleishvili L, Ramishvili M, Nemsadze G. The possibilities of DSC in breast cancer study and diagnostics. International Scientific Conference on Physical Research Methods in Medicine. Proceedings I. Tbilisi: 2011. pp. 177-80. 6. Monaselidze J, Tevdoradze T, Zibzibadze M, Alibegashvili M, Ramishvili L, Gordeziani M, Kotrikadze N. The study of blood serum proteins in patients with mammary gland tumours. J Biol Phys Chem 2012; 19-22 7. Khachidze DG, Monaselidze JR. Independent denaturation of albumin and globulin in human blood serum. Biofizika 2000; 45: 325- 328 8. დ.ხაჩიძე, მ.ხაჩიძე, ნ.ხაჩიძე. სიმსივნურ დაავადებათა მიკროკალორიმეტრული დიაგნოსტიკის მხარდამჭერი საინფორმაციო სისტემის ლოგიკური სქემა. საქართველოს ტექნიკური უნივერსიტეტის ა.ელიაშვილის მართვის სისტემების ინსტიტუტის შრომათა კრებული # 17, 2013. გვ.185-190.