Abstract

This paper presents a safety analysis of a Robotic Fracture Surgery System using the Systems-Theoretic Process Analysis (STPA). It focuses particularly on hazards caused by the human in the loop. The robotic system and operating staff are modeled including information flow between different components of the system. The analysis has generated a set of requirements for the system design that can ultimately mitigate the identified hazards, as well as a preliminary set of human factors that can improve safety.

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