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The design and implementation of software for medical devices is challenging due to their rapidly increasing functionality and the tight coupling of computation, control, and communication. The safety-critical nature and the lack of existing industry standards for verification, make this an ideal domain for exploring applications of formal modeling and analysis. In this paper, we use a dual chamber implantable pacemaker as a case study for modeling and verification of control algorithms for medical devices in UPPAAL. We present detailed models of different components of the pacemaker based on the algorithm descriptions from Boston Scientific. We formalize basic safety requirements based on specifications from Boston Scientific as well as additional physiological knowledge. The most critical potential safety violation for a pacemaker is that it may lead the closed-loop system into an undesirable pattern (for example, Tachycardia). Modern pacemakers are implemented with termination algorithms to prevent such conditions. We show how to identify these conditions and check correctness of corresponding termination algorithms by augmenting the basic models with monitors for detecting undesirable patterns. Along with emerging tools for code generation from UPPAAL models, this effort enables model driven design and certification of software for medical devices.
Medical Devices, Implantable Pacemaker, Software Verification, Cyber-Physical Systems
Date Posted: 17 November 2011