Abstract
In this paper, we put forward a systematic method to analyze, control and evaluate the safety issues of medical robotics. We created a safety model that consists of three axes to analyze safety factors. Software and hardware are the two material axes. The third axis is the policy that controls all phases of design, production, testing and application of the robot system. The policy was defined as hazard identification and safety insurance control (HISIC) that includes seven principles: definitions and requirements, hazard identification, safety insurance control, safety critical limits, monitoring and control, verification and validation, system log and documentation. HISIC was implemented in the development of a robot for urological applications that was known as URObot. The URObot is a universal robot with different modules adaptable for 3D ultrasound image-guided interstitial laser coagulation, radiation seed implantation, laser resection, and electrical resection of the prostate. Safety was always the key issue in the building of the robot. The HISIC strategies were adopted for safety enhancement in mechanical, electrical and software design. The initial test on URObot showed that HISIC had the potential ability to improve the safety of the system. Further safety experiments are being conducted in our laboratory.
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