Abstract
This paper reports on the design of the GUI component of the PV1000, a fully-functional, cost-efficient pandemic ventilator developed during the COVID-19 pandemic. Our main objective in designing the user interface was to expose the rich features of the ventilator, which are on-par with many commercial medical devices, through an interface that is simple to use even by medical staff with little prior experience with ventilators. We present an agile development process which is intended to address the fast changing and potentially unclear requirements of a pandemic. This is to address the specific situation where domain experts as well as specific hardware have shortages, resulting in recurring changes in requirements. This occurs in conjunction with the collaboration of developers, not all of whom are familiar with the development of medical devices. Despite the pandemic situation, we have made a deliberate decision to use existing software engineering tools such as continuous integration. Additionally, we are employing a multi-platform development framework in order to utilise the resulting advantages, for example, if there are changes in requirements. We present and discuss the system, hardware and software architecture of the components that allow users to interact with the device. The focus here is on the dynamic generation of parts of the software architecture, which enables rapid adaptation to changing conditions on the part of the software. The user interface is evaluated through a user survey, where the majority of participants describe the interface as clear and intuitive. The entire ventilator was evaluated in one animal trial and fortunately never had to be used on humans. The next step is to convert the setup into an open source project that can be used as a research platform for ventilators.
Zusammenfassung
In diesem Beitrag wird das Design der GUI-Komponente des PV1000 vorgestellt, eines voll funktionsfähigen, kosteneffizienten Pandemie-Beatmungsgeräts, das während der COVID-19-Pandemie entwickelt wurde. Ziel der Gestaltung der Benutzeroberfläche war, die umfangreichen Funktionen des intensivbeatmungsfähigen Gerätes über eine Oberfläche zugänglich zu machen, die auch von medizinischem Personal mit wenig Erfahrung mit Beatmungsgeräten einfach zu bedienen ist. Der Entwicklung liegt ein agiler Entwicklungsprozess zugrunde, der den sich schnell ändernden und potenziell unklaren Anforderungen einer Pandemie gerecht werden soll. Dies soll der besonderen Situation begegnen, dass es an Fachleuten und spezifischer Hardware mangelt. In Verbindung mit der Zusammenarbeit von Entwicklern, die nicht alle mit der Entwicklung medizinischer Geräte vertraut sind, führt dies zu wiederkehrenden Änderungen der Anforderungen. Trotz der Pandemiesituation wurden bestehende Software-Engineering-Werkzeuge wie eine kontinuierliche Integration und ein Multi-Plattform-Entwicklungsframework eingesetzt. Die System-, Hardware- und Softwarearchitektur der Komponenten, die dem Benutzer die Interaktion mit dem Gerät ermöglichen, werden vorgestellt. Die entwickelte Oberfläche wurde in einer Nutzerbefragung getestet, in der die Teilnehmer die Oberfläche als übersichtlich, intuitiv und insgesamt als gut durchdachtes Konzept beschrieben. Das vollständige Beatmungsgerät wurde in einem Tierversuch evaluiert und musste nie am Menschen eingesetzt werden. Im nächsten Schritt soll der Aufbau in ein Open-Source-Projekt überführt werden, das als Forschungsplattform für Beatmungsgeräte genutzt werden kann.
About the authors
Lavinia Goldermann received a master’s degree in computer science from RWTH Aachen University, Germany. Since 2023 she has been working as a Ph.D. candidate at the Chair for Embedded Software, RWTH Aachen University.
Stefan Rakel received a master’s degree in computer science from RWTH Aachen University, Germany. Until 2022 he was with the Chair for Embedded Software, RWTH Aachen University.
Mateusz Buglowski received a master’s degree in computer science from RWTH Aachen University, Germany. Until 2023 he was with the Chair for Embedded Software, RWTH Aachen University.
Armin Mokhtarian received a master’s degree in computer science from RWTH Aachen University, Germany. Since 2019 he has been working as a Ph.D. candidate at the Chair for Embedded Software, RWTH Aachen University.
Alexandru Kampmann received a master’s degree in computer science from RWTH Aachen University, Germany. Since 2018 he has been working as a Ph.D. candidate at the Chair for Embedded Software, RWTH Aachen University.
Armin Janß received a Dr.-Ing. degree from RWTH Aachen University, Germany in 2016. Since he has been working as group leader at the Chair of Medical Engineering, RWTH Aachen University.
Okan Yilmaz received a master’s degree in Electrical Engineering, Information Technology, and Computer Engineering from RWTH Aachen University, Germany. Since 2019 he has been working as a Ph.D. candidate at the Chair of Medical Engineering, RWTH Aachen University.
Frank Beger received a diploma in industrial design from the University of Wuppertal, Germany. Since 1997 he has been managing director of Beger Design, Cologne, Germany, specialising in the conception and design development of medical devices. His focus is on the safe operability and user-friendliness of workflows with complex medical devices.
Marian Walter is Senior Scientist and deputy head at the Chair for Medical Information Technology, RWTH Aachen University, Germany. His current research interests include noncontact monitoring techniques, signal processing, and feedback control in medicine.
Steffen Leonhardt is a full professor and heads the Chair for Medical Information Technology at RWTH Aachen University. He holds a M.S. in computer engineering from SUNY at Buffalo, NY, USA, a Ph.D. in control engineering from TU Darmstadt and a M.D. from J. W. Goethe U, Frankfurt.
Stefan Kowalewski is full professor for embedded software at RWTH Aachen University with research in development methods for embedded, possibly safety-critical control software.
André Stollenwerk is group leader for biomedical engineering at the Chair for Embedded Software at RWTH Aachen University, Germany. His research focus is data driven safety measures for intensive care applications.
Acknowledgment
We gratefully want to acknowledge the whole PV1000 team and all contributing chairs and institutes from RWTH Aachen university, which enabled the development of the whole pandemic ventilation machine. Additionally, we want to thank the individuals but also companies that donated to the non-profit organization AC4Health, which gave us financial support for the needed hardware.
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Research ethics: Not applicable.
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Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: The presented research was conducted on an honorary base by those involved.
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Data availability: The raw data of the user study is available via the RWTH Aachen University publications server.
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