陈嘉绪，张少伟，周颖，杨昌玮，孟恬，陈秋婷，许贤春，胡文涵上海理工大学医疗器械与食品学院，上海　200093

基于眼动技术的医疗器械说明书可用性评估

陈嘉绪，张少伟，周颖，杨昌玮，孟恬，陈秋婷，许贤春，胡文涵
上海理工大学医疗器械与食品学院，上海200093

目的为今后能够对医疗器械使用说明书的可用性进行准确可靠的评价并提出合理的改进意见，提出一种基于眼动技术的可用性评估方法。方法利用一台Tobii眼动仪进行测试，根据得出的眼动数据建立初步可用性初步评估眼动模型，并且利用SPSS对不同兴趣区下的眼动数据，如:注视时间长度、访问时间长度、首次注视时间等进行单因素方差分析和多重比较，分析得出不同医疗器械说明书下被试的视觉行为差异以及说明书可用性差异。结果结合调查问卷发现眼动模型可靠准确，且利用方差分析和多重比较法能够定量地反映出说明书可用性的差异和需要改进的兴趣区。 结论利用眼动技术，可以在被试的视觉行为和可用性指标间建立一种定量、精准的关系及评价体系，从而为今后医疗器械说明书的可用性评估及改进提供了一种可靠的方法。

眼动技术；可用性评估；眼动模型；方差分析

［Abstract］Objective To accurately and reliably evaluate the availability of medical device instructions in the future and provide rational improvement suggestions and availability evaluation method based on eye movement technique.Methods A Tobii eye tracker was used for test，and the eye movement model was initially established according to the eye movement data，and the availability was initially evaluated，and the eye movement data such as visual fixation time，access time and initial visual fixation time under different interest areas were given factor analysis of variance and multiple comparisons by SPSS，and the differences in the visual behavior of subjects and instruction availability of different medical device instructions were analyzed.Results The questionnaire showed that the eye movement model was reliable and accurate，which can quantificationally reflect the instruction availability difference and interest areas needing improvement by using variance analysis and multiple comparison method.Conclusion A quantitative and accurate correlation and assessment system can be built between the visual behavior of subjects and availability index by using the eye movement technique thus providing a reliable method of availability evaluation and improvement of future medical device instructions.

［Key words］Eye movement technology；Availability evaluation；Eye movement model；Variance analysis

概念清晰的说明书对医疗器械的安全使用起着重要作用。可用性测试可以评估使用书存在的缺点并提供改进意见。往往医疗器械厂家认为可读性很强的信息，在用户看来却并非如此。因此，针对医疗器械使用说明书，生产商需要进行可用性评估从而确保使用书是有效的，这对防止用户因误读说明书而导致违规操作有着重要意义。……