基于可用性工程的ECMO系统设计与研究  

DESIGN AND RESEARCH OF ECMO SYSTEM BASED ON USABILITY ENGINEERING

作　　者：于文杰 徐明洲 李纪念 刘会超 YU WENJIE;XU MINGZHOU;LI JINIAN

机构地区：[1]北京航天长峰股份有限公司

出　　处：《设计》2025年第1期117-121,共5页Design

基　　金：国家重点研发计划“ECMO系统研发”项目:课题五(ECMO系统大动物实验和临床试验研究,编号2020YFC0862905);课题一(ECMO系统方案设计、设备与总体研制及系统产品化,编号:2020YFC0862901)。

摘　　要：三类医疗器械高风险性、复杂程度高,在使用过程中任何微小的错误或不当操作都可能对患者造成严重的伤害甚至危及生命,在设备开发阶段考虑可用性工程相关因素,可提高三类医疗器械使用易用性、安全性。以体外膜肺氧合(extracorporeal membrane oxygenation,以下简称“ECMO”)为例,重点分析了可用性工程在此类产品设计中的应用,具体探讨了设计要素、设计中应注意的特殊性,详细介绍了具体的应用步骤和方法,并总结了ECMO系统设计的基本原则。在此基础上,探讨适用于国内用户的ECMO系统设计方法。该设计方法具有一定的可行性,能够为此类医疗器械的设计提供一定的参考和借鉴。Class III medical devices have high risks and complexity.Any minor errors or improper operations during use may cause serious harm to patients or even endanger their lives.In the equipment development stage,usability engineering related factors should be considered to improve the usability and safety of Class III medical devices.Taking extracorporeal membrane oxygenation(ECMO)as an example,this paper focuses on analyzing the application of usability engineering in the design of such products,specifically exploring design elements,special considerations in design,detailing specific application steps and methods,and summarizing the basic principles of ECMO system design.On this basis,explore an ECMO system design method suitable for domestic users.This design method has certain feasibility and can provide reference and inspiration for the design of such medical devices.

关 键 词：可用性 可用性工程 用户界面 体外膜肺氧合 医疗器械 

分 类 号：TB472[一般工业技术—工业设计]