Human Factors Usability Analysis of the ArthroFree Wireless Surgical Camera

Pearl Griffin, Patrick Polito, Leah Brownlee, Jeff Ustin, Kipum Lee, Craig Conner
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Abstract

Conventional arthroscopy is performed with a narrow tube, the arthroscope, attached to a camera and two cables - one for power and one for fiber-optic light. The cables can be cumbersome, routed across or around the patient, and risk bridging the sterile and nonsterile fields. ArthroFree®, a wireless surgical camera for arthroscopy, features wireless communication and battery power and was designed to eliminate cable-associated burdens. An iterative product development process established the usability of ArthroFree. Feedback on ArthroFree’s design was received from 88 participants (82 surgeons and 6 other medical professionals) on ergonomics, ease of use, image quality, and patient experience following design validation testing (pre-FDA clearance; 76 participants) or clinical evaluation (post-FDA clearance; 12 participants). Participants were trained on the use of ArthroFree and then used the device in a surgical procedure performed on a cadaver, simulated model, or patient. Their experience was evaluated in a 13-statement human factors survey scored using a 5-point Likert scale. ArthroFree scored well in all survey statements, scoring “good” or “excellent” (4.5 mean score), suggesting users’ needs were satisfied in 91.30% of participants. Additionally, one-on-one interviews with surgeons gathered qualitative feedback on their independent experience with the ArthroFree device, providing key support for its introduction to the operating room.
ArthroFree 无线手术相机的人为因素可用性分析
传统的关节镜检查使用一根窄管(即关节镜),连接着一台照相机和两根电缆(一根用于供电,一根用于光纤光)。这些电缆非常笨重,需要穿过或绕过病人,而且有可能在无菌区和非无菌区之间架起桥梁。ArthroFree® 是一种用于关节镜检查的无线手术相机,具有无线通信和电池供电功能,旨在消除电缆带来的负担。迭代产品开发流程确定了 ArthroFree 的可用性。在设计验证测试(FDA 批准前;76 位参与者)或临床评估(FDA 批准后;12 位参与者)之后,88 位参与者(82 位外科医生和 6 位其他医疗专业人员)就人体工程学、易用性、图像质量和患者体验等方面对 ArthroFree 的设计提出了反馈意见。参与者接受了 ArthroFree 的使用培训,然后在尸体、模拟模型或病人的手术过程中使用该设备。他们的体验由 13 项人为因素调查进行评估,采用 5 点李克特量表评分。ArthroFree 在所有调查语句中都获得了 "良好 "或 "优秀"(平均分 4.5 分)的好成绩,表明 91.30% 的参与者的需求得到了满足。此外,对外科医生进行的一对一访谈收集了他们对 ArthroFree 设备独立使用体验的定性反馈,为将该设备引入手术室提供了重要支持。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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