On the design and development of a handheld electrocardiogram device in a clinical setting.

Autor:	Zepeda-Echavarria A; Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Ratering Arntz NCM; Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Westra AH; Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., van Schelven LJ; Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Euwe FE; Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Noordmans HJ; Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Vessies M; Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., van de Leur RR; Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Hassink RJ; Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Wildbergh TX; Department of Cardiology, Meander Medical Center, Amersfoort, Netherlands., van der Zee R; Stichting Cardiovascular Biologie, Delft, Netherlands., Doevendans PA; Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.; Netherlands Heart Institute, Utrecht, Netherlands.; Department of Cardiology, Central Military Hospital, Utrecht, Netherlands., van Es R; Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands., Jaspers JEN; Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
Jazyk:	angličtina
Zdroj:	Frontiers in digital health [Front Digit Health] 2024 Aug 09; Vol. 6, pp. 1403457. Date of Electronic Publication: 2024 Aug 09 (Print Publication: 2024).
DOI:	10.3389/fdgth.2024.1403457
Abstrakt:	Cardiovascular diseases (CVDs) are a global burden that requires attention. For the detection and diagnosis of CVDs, the 12-lead ECG is a key tool. With technological advancements, ECG devices are becoming smaller and available for home use. Most of these devices contain a limited number of leads and are aimed to detect atrial fibrillation (AF). To investigate whether a four-electrode arrangement could provide enough information to diagnose other CVDs, further research is necessary. At the University Medical Center Utrecht in a multidisciplinary team, we developed the miniECG, a four-electrode ECG handheld system for scientific research in clinical environments (TRL6). This paper describes the process followed during the development of the miniECG. From assembling a multidisciplinary team, which includes engineers, cardiologists, and clinical physicians to the contribution of team members in the design input, design, and testing for safety and functionality of the device. Finally, we detail how the development process was composed by iterative design steps based on user input and intended use evolution. The miniECG is a device compliant for scientific research with patients within Dutch Medical Centers. We believe that hospital-based development led to a streamlined process, which could be applied for the design and development of other technologies used for scientific research in clinical environments. Competing Interests: PD and RZ own stock in HeartEye B.V., a company also active in the field of handheld ECG devices. RL and RE own stock in Cordys Analytics, a spin-off of the UMC doing ECG-AI analysis. The remaining authors have no conflicts of interest to declare. (© 2024 Zepeda-Echavarria, Ratering Arntz, Westra, van Schelven, Euwe, Noordmans, Vessies, van de Leur, Hassink, Wildbergh, van der Zee, Doevendans, van Es and Jaspers.)
Databáze:	MEDLINE
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