In this study we evaluated operability of a multicomponent system consisting of ECG recorders (made by different manufacturers), signal conversion drivers (matching layers) provided by ECG equipment vendors according to a single technical task, an ECG signal processing and visualization program. Such system registers and processes ECG signal by means of the software unit integrated into the regional medical information system (RMIS). System performance evaluation was carried out to confirm the same reproduction of known waveforms in the original manufacturer’s software and in a unified environment of the RMIS. Test signals and synthetic ECG generated with functional generators were used. Technical specialist used built-in measuring instruments to compare amplitude-time parameters of the signals recorded in proprietary software and RMIS software. This allowed identifying an incorrectly working driver of one of the vendors. The error correction led to the driver processing of the ECG signal adequately, which was confirmed by the check method. The proposed technical solution makes it possible to perform comparative assessment of the ECG quality registration in the manufacturer’s proprietary software and in the RMIS software, to identify incorrect operation of the matching layers at the stage of preclinical studies, and promptly make changes to the software.
References
1. Gazashvili TM, S h koda AS, Morozov SP, et al. Naibolee rasprostranennye elektrokardiograficheskie fenomeny IT-centra otdeleniya funkcional’noj diagnostiki. Rossijskij kardiologicheskij zhurnal. 2020; 25(S2): 38-39. ( In Russ.).
2. Levanov VM, Pereslegina IA, Bezrukova VK, Z h idkov IM. Opyt primeneniya telemedicinskih tekhnologij na fel’dshersko-akusherskih punktah sel’skogo rajona s nizkoj plotnost’yu naseleniya. Z h urnal telemediciny i elektronnogo zdravoohraneniya. 2020; 1:26-35. ( In Russ.).
3. Y u j ND, Malyutina NN, C h ernikova DA. Prakticheskaya znachimost ’ distancionnyh metodov funkcional’noj diagnostiki v sisteme «RZHD - MEDICINA» Sverdlovskoj zheleznoj dorogi. Permskij medicinskij zhurnal. 20 20; 37 (5) : 90–94. ( In Russ.). doi : 10.178l6/pmj37590-94.
4. Karpov O.E., Zamyatin M.N., Vahromeeva M.N., Sivohina N.YU., Subbotin S.A. Cifrovaya EKG: perspektivy razvitiya , preimushchestva i nedostatki. C h ast ’ 2. Vrach i informacionnye tekhnolo gii. 2021; 2: 20-27. ( In Russ.). doi : 1025881/18110193_2021_2_20.
5. Y a kushin M, Gorenkov R, Dvorina O, Y a rockij S. Perspektivy distancionnogo monitoringa serdechno-sosudistoj sistemy v reshenii zadach federal’nogo proekta « Starshee pokolenie ». Cardiomet ry. 2020; 17: 39-48. ( In Russ.). doi : 10.12710/cardiometry.2020.17.3948.
6. Fayn J, Rubel P. An ECG web services portal for standard and serial ECG analysis with enhanced 3D graphical capabilities. Computing in Cardiology. 2017 ; 44: 1-4. doi : 10.22489/CinC.2017.299-222.
7. Kam KL, Yew HT, Hau YW. Introduction of Telecardiology and Challenges in Developing Countries. In: Cardiovascular Engineering. Series in BioEngineering. Springer, Singapore. 202 0. doi : 10.1007/978-981-10-8405-8_5.
8. Wagner P, Strodthoff N Bousseljot RD, et al. PTB-XL, a large publicly available electrocardiography dataset. 2020; 7: 154. doi : 10.1038/s41597-020-0495-6.
9. PTB Diagnostic ECG Database. Available at: https://physionet.org/content/ptbdb/1.0.0/
10. Badilini F, Young B, Brown B, Vaglio M. Archiving and exchange of digital ECGs: A review of existing data formats. Journal of Electrocardiology. 2018; 51(6): S113-S115. doi : 10.1016/j.jelectrocard.2018.07.028.
11. AAMI TIR24 1999 Acquisition and use of physiologic waveform databases for testing of medical devices (rev. 2019).
12. Rubel P, Fayn J, Macfarlane PW, et al. The History and Challenges of SCP-ECG: The Standard Communication Protocol for Computer-Assisted Electrocardiography. Hearts. 2021; 2(3): 384-409. doi : 3390/hearts2030031.
13. GOST R MEK 60601-2-51-2011. Izdeliya medicinskie elektricheskie. Chast ’ 2-51. Chastnye trebovaniya bezopasnosti s uchetom osnovnyh funkcional’nyh harakteristik k registriruyushchim i analiziruyushchim odnokanal’nym i mnogokanal’nym elektrokardiografam. ( In Russ.).
14. IEC 60601-2-51:2003 Medical electrical equipment. Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs.
15. GOST R MEK 60601-2-25-2016. Izdeliya medicinskie elektricheskie. CHast ’ 2-25. CHastnye trebovaniya bezopasnosti s uchetom osnovnyh funkcional’nyh harakteristik k elektrokardiografam. ( In Russ.).
16. IEC 60601-2-25:2011 Medical electrical equipment. Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
17. Rekomendacii po metrologii R 50.2.009-2011. Gosudarstvennaya sistema obespecheniya edinstva izmerenij. Elektrokardiografy , elektrokardioskopy i elektrokardioanalizator y. Metodika poverki. ( In Russ.).
2. Levanov VM, Pereslegina IA, Bezrukova VK, Z h idkov IM. Opyt primeneniya telemedicinskih tekhnologij na fel’dshersko-akusherskih punktah sel’skogo rajona s nizkoj plotnost’yu naseleniya. Z h urnal telemediciny i elektronnogo zdravoohraneniya. 2020; 1:26-35. ( In Russ.).
3. Y u j ND, Malyutina NN, C h ernikova DA. Prakticheskaya znachimost ’ distancionnyh metodov funkcional’noj diagnostiki v sisteme «RZHD - MEDICINA» Sverdlovskoj zheleznoj dorogi. Permskij medicinskij zhurnal. 20 20; 37 (5) : 90–94. ( In Russ.). doi : 10.178l6/pmj37590-94.
4. Karpov O.E., Zamyatin M.N., Vahromeeva M.N., Sivohina N.YU., Subbotin S.A. Cifrovaya EKG: perspektivy razvitiya , preimushchestva i nedostatki. C h ast ’ 2. Vrach i informacionnye tekhnolo gii. 2021; 2: 20-27. ( In Russ.). doi : 1025881/18110193_2021_2_20.
5. Y a kushin M, Gorenkov R, Dvorina O, Y a rockij S. Perspektivy distancionnogo monitoringa serdechno-sosudistoj sistemy v reshenii zadach federal’nogo proekta « Starshee pokolenie ». Cardiomet ry. 2020; 17: 39-48. ( In Russ.). doi : 10.12710/cardiometry.2020.17.3948.
6. Fayn J, Rubel P. An ECG web services portal for standard and serial ECG analysis with enhanced 3D graphical capabilities. Computing in Cardiology. 2017 ; 44: 1-4. doi : 10.22489/CinC.2017.299-222.
7. Kam KL, Yew HT, Hau YW. Introduction of Telecardiology and Challenges in Developing Countries. In: Cardiovascular Engineering. Series in BioEngineering. Springer, Singapore. 202 0. doi : 10.1007/978-981-10-8405-8_5.
8. Wagner P, Strodthoff N Bousseljot RD, et al. PTB-XL, a large publicly available electrocardiography dataset. 2020; 7: 154. doi : 10.1038/s41597-020-0495-6.
9. PTB Diagnostic ECG Database. Available at: https://physionet.org/content/ptbdb/1.0.0/
10. Badilini F, Young B, Brown B, Vaglio M. Archiving and exchange of digital ECGs: A review of existing data formats. Journal of Electrocardiology. 2018; 51(6): S113-S115. doi : 10.1016/j.jelectrocard.2018.07.028.
11. AAMI TIR24 1999 Acquisition and use of physiologic waveform databases for testing of medical devices (rev. 2019).
12. Rubel P, Fayn J, Macfarlane PW, et al. The History and Challenges of SCP-ECG: The Standard Communication Protocol for Computer-Assisted Electrocardiography. Hearts. 2021; 2(3): 384-409. doi : 3390/hearts2030031.
13. GOST R MEK 60601-2-51-2011. Izdeliya medicinskie elektricheskie. Chast ’ 2-51. Chastnye trebovaniya bezopasnosti s uchetom osnovnyh funkcional’nyh harakteristik k registriruyushchim i analiziruyushchim odnokanal’nym i mnogokanal’nym elektrokardiografam. ( In Russ.).
14. IEC 60601-2-51:2003 Medical electrical equipment. Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs.
15. GOST R MEK 60601-2-25-2016. Izdeliya medicinskie elektricheskie. CHast ’ 2-25. CHastnye trebovaniya bezopasnosti s uchetom osnovnyh funkcional’nyh harakteristik k elektrokardiografam. ( In Russ.).
16. IEC 60601-2-25:2011 Medical electrical equipment. Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
17. Rekomendacii po metrologii R 50.2.009-2011. Gosudarstvennaya sistema obespecheniya edinstva izmerenij. Elektrokardiografy , elektrokardioskopy i elektrokardioanalizator y. Metodika poverki. ( In Russ.).
For citation
Shutov D.V., Popov A.A., Shulkin I.M., Akhmetov R.N., Drozdov D.V., Morozov S.P. Technical tests of the hardware and software complex for electrocardiogram recording and processing. Medical doctor and information technology. 2022; 1: 50-61. (In Russ.). doi : 1025881/18110193_2022_1_50
Keywords