Safety compliance of robotic exoskeleton for upper limb rehabilitation

• Main Author: Dupo, Voltaire B.
• Format: text
• Language: English
• Published: Animo Repository 2018
• Subjects: Robotics in medicine—Safety regulations; Biomedical Engineering and Bioengineering; Robotics
• Online Access: https://animorepository.dlsu.edu.ph/etd_masteral/6329; https://animorepository.dlsu.edu.ph/context/etd_masteral/article/13392/viewcontent/Safety_Compliance_of_Robotic_Exoskeleton2.pdf
• Institution: De La Salle University

The rapid development of medical robotics in academic research projects and the need for compliance of medical equipment required by national regulatory standards a method and framework is needed to revise or develop robotic projects to meet the standards for medical devices and safety requirements prior to undergoing any pre-clinical trial. Medical robotics has a different approach from industrial robotics since it has a close proximity of robots and humans with at times direct transfer of energy thru assistive movements done by a medical robot. In the Philippines guidelines such as these are not in existences due to lack of regulatory direction, This study used current standards OSHA 1910.303, IEC 60601, IEC 80601, ICNIRP 98, RIA R15, CISPR 11 and 22 to create an evaluation tool that can be used to ascertain the safety compliance of a medical robot. Upon further examination it was determined that specific approaches to evaluate and conduct an analysis for electrical safety, risk analysis and a approach to define situational awareness for each robot was needed. The study created a document that outlines how conduct electrical safety testing for new medical robots with determination of equipment type and class and an evaluation tool for electromagnetic compliance, an approach to evaluate risk of new medical robot systems using Weibull Analysis, Fault Tree Analysis and the ISO 14971 recommendations was also created to determine probabilities of failure and risk level values for any robot and a basic approach to create a situational awareness framework using the evaluation tool. These developed tools where applied to the Agapay Upper Limb Robotic Exoskeleton which is a medical rehabilitation medicine robot developed by De La Salle University. Use of the tool aided in reducing device risk level from high risk to low risk device and aided in the preparation of the device for pre-clinical safety testing using human test subjects.