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Modeling and Verification of a Dual Chamber Implantable Pacemaker

机译:双腔植入式起搏器的建模与验证

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摘要

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.
机译:由于医疗设备的功能迅速增加以及计算,控制和通信的紧密结合,因此用于医疗设备的软件的设计和实现具有挑战性。由于安全性至关重要,并且缺少现有的验证行业标准,因此这成为探索形式化建模和分析应用程序的理想领域。在本文中,我们以双腔可植入起搏器为例,对UPPAAL中医疗设备的控制算法进行建模和验证。我们根据Boston Scientific的算法描述,介绍起搏器不同组件的详细模型。我们根据Boston Scientific的规范以及其他生理知识来规范基本的安全要求。对心脏起搏器而言,最严重的潜在安全隐患是可能导致闭环系统进入不良状态(例如心动过速)。现代起搏器采用终止算法来实现,以防止此类情况发生。我们展示了如何通过使用检测不良模式的监视器扩充基本模型来识别这些情况并检查相应终止算法的正确性。借助新兴的工具来从UPPAAL模型生成代码,这项工作使模型驱动的设计和医疗设备软件的认证成为可能。

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