Development of verification framework for a component to be integrated in medical devices

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master_Monga_Hitesh_2024.pdf (4.65 MB)

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School of Electrical Engineering | Master's thesis
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Date

2024-09-30

Department

Major/Subject

Communications Engineering

Mcode

ELEC3029

Degree programme

Master's Programme in Computer, Communication and Information Sciences

Language

en

Pages

77

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Abstract

Blood Pressure (BP) is a vital physiological parameter used to assess cardiovascular health and diagnose conditions such as hypertension. Non-invasive Blood Pressure (NiBP) measurement, particularly the oscillometric method, is widely used to measure BP in clinical and non-clinical settings due to its simplicity and patient comfort. Despite its advantages, ensuring the accuracy and safety of NiBP devices, especially under various clinical conditions, remains a significant challenge. This work aims to develop a verification framework for the NiBP Standard Parameter Module (a component designed by GE Healthcare) to integrate into patient monitoring systems for automated and real-time BP measurements. The framework ensures compliance with regulatory standards such as ISO 13485 and IEC 80601-2-30 while maintaining optimal performance and accuracy. Moreover, following the methodologies used in this work, this framework can be applied to verify the functionalities of other NiBP devices, irrespective of the manufacturer. The framework employs both automated and semi-automated testing methods to validate the module's performance across various clinical scenarios. Continuous integration is employed in this framework to ensure ongoing system validation throughout the development process. In addition, risk-based testing approaches are utilized to account for unexpected errors and adverse conditions in clinical environments. The implemented framework uses advanced automation testing practices to ensure the NiBP standard parameter module operates accurately and consistently in patient monitoring devices while keeping patient safety a priority.

Description

Supervisor

Manner, Jukka

Thesis advisor

Korhonen, Ilkka

Keywords

non-invasive blood pressure monitoring, verification framework, test automation, software testing, test automation, medical device verification

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https://urn.fi/URN:NBN:fi:aalto-202411207215

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[dipl] Sähkötekniikan korkeakoulu / ELEC