Zhihao Jiang, Rahul Mangharam PRECISE Center University of Pennsylvania.

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  • Slide 1
  • Zhihao Jiang, Rahul Mangharam PRECISE Center University of Pennsylvania
  • Slide 2
  • Over 600,000 cardiac medical devices recalled from 1990-2000 40% of recent recalls were due to software issues Implantable Pacemaker Implantable Cardioverter-Defibrillator (ICD)
  • Slide 3
  • Two leads in heart chambers Deliver electrical signals when heart rate is low Device malfunction may result in death or injury Flawed devices are recalled
  • Slide 4
  • Pacemaker – Autonomous device with minimum human interaction – Limited diagnostic/therapy capability – Its safety is evaluated regarding to its environment – Evaluation requires extensive domain knowledge The physical plant is stochastic: – Complex dynamics of the heart – Interaction between the heart and other parts of the body
  • Slide 5
  • Domain Expert Safety/Efficacy Requirements
  • Slide 6
  • Domain Expert Software Engineer Safety/Efficacy Requirements Software specifications
  • Slide 7
  • Domain Expert Software Engineer Electrical engineer Safety/Efficacy Requirements Software specifications Implementation
  • Slide 8
  • Domain Expert Software Engineer Electrical engineer Safety/Efficacy Requirements Software specifications Implementation
  • Slide 9
  • Examining documents before device released to the market – Software specifications – Justification of the specifications – Test reports Responsibility on manufactures Issue recalls when incidents happen Domain Expert Software Engineer Electrical engineer Safety/Efficacy Requirements Software specifications Implementation
  • Slide 10
  • Domain Expert Software Engineer Electrical engineer Safety/Efficacy Requirements Software specifications Implementation System model
  • Slide 11
  • Domain Expert Software Engineer Electrical engineer Safety/Efficacy Requirements Software specifications Implementation Safety/Efficacy properties System model Environment model Model Checking
  • Slide 12
  • Conformance Testing Test Generation Domain Expert Software Engineer Electrical engineer Safety/Efficacy Requirements Software specifications Implementation Safety/Efficacy properties System model Test Cases Environment model Model Checking
  • Slide 13
  • Refractory Time V out RestERPRRPRest Refractory Time V out RestERPRRPRest node path node
  • Slide 14
  • Node AutomataPath Automata
  • Slide 15
  • Level of detail AbstractionRefinement
  • Slide 16
  • Abstraction TCTL Safe? No Yes Heart Pacemaker Timed automata model Physician Physiological requirements No Bug found System Safe Refinement Valid? Counter- examples Ambiguous? No Yes Model Checker H0H0 H1H1 H2H2 H3H3 H4H4
  • Slide 17
  • Quantitative Verification – Cost functions Oxygen demand/debt Battery consumption for the device – Evaluate algorithms with same objectives – Optimal parameter setting for specific patient Patient-specific heart model learning
  • Slide 18
  • “Let our heart catch bugs before your heart does.”

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