基于人因工程理论开展中医药装备可用性测试的应用举隅OA

Objective Regarding the usability testing requirements for medical device registration,there are currently no publicly disclosed typical examples within the industry,this study integrates human factors engineering theory with the application requirements of traditional Chinese medicine(TCM)diagnosis and treatment environments.By utilizing a self-built usability testing platform,we conducted formative testing focused on user interface validation,analyzing task operations and completion levels in virtual simulation environments,aiming to establish a representative example for usability evaluation of TCM equipment.Methods First,a TCM diagnosis and treatment behavior model was constructed based on cognitive load theory.Using a synchronized human-machine-environment cloud platform,we recorded physician-patient-device interactions(exemplified by a self-developed acupuncture chair)through audiovisual monitoring(behavior tracking and task node annotation),eye tracking,and facial expression analysis.Quantitative analysis of task completion outcomes(including successful operations,operational errors,operational difficulties,and near-miss operations)was performed during user interface validation.Subsequently,interviews were conducted to document user-reported pain points for qualitative analysis.Finally,psychometric questionnaires were administered to assess user satisfaction,perceived safety,and convenience.Results Among 120 executed tasks,15 operational errors,4 operational difficulties,and 5 near-miss operations were recorded.Conclusion Medical device usability evaluation in China is still in its early stages.Aligning with usability standards and addressing the need for localized TCM equipment development,this study establishes a reusable research framework to provide theoretical and practical insights for addressing challenges in traditional medical device registration.