摘要
目的基于远隔缺血预适应(Remote Ischemia Preconditioning,RIPC)原理,研制一款用于预防术后谵妄的谵妄防治仪。方法根据医疗器械的相关标准和RIPC原理进行样机研制,样机主要由主机和袖带组成。袖带与主机内部的气泵和电磁阀组成袖带式加压阻断装置,实现RIPC训练功能。屏幕与主控模块进行串口通信,用户通过屏幕控制训练的启停,及查询和保存训练信息。样机制作完成后,对其压力控制性能、血压准确度、气密性和电气安全性能进行测试验证。结果样机的压力误差控制在±5 mmHg以内,且与松下血压计所测收缩压和舒张压数据差异无统计学意义(P>0.05)。样机响应速度快,气密性良好,噪声水平低于60 dB,电气安全性能符合GB 9706.1-2020标准。结论本文研制的设备适用于谵妄脑障碍疾病患者的预防训练,为预防术后谵妄提供了一种新的思路。
Objective To develop a delirium prevention and treatment device for preventing postoperative delirium based on the principle of remote ischemia preconditioning(RIPC).Methods The prototype was developed based on the relevant standards of medical devices and the principle of RIPC.The prototype was mainly composed of the main unit and the cuff.The cuff type pressurization blocking device was formed by the cuff,together with the air pump and solenoid valve inside the main unit,to achieve the RIPC training function.The screen communicated with the main control module via serial port.Users controlled the start and stop of training,as well as query and save training information through the screen.After the prototype was fabricated,the pressure control performance,blood pressure accuracy,air tightness and electrical safety performance were tested and verified.Results The pressure error of the prototype was controlled within±5 mmHg,and there was no statistically significant difference compared with the systolic and diastolic blood pressure data measured by the Panasonic blood pressure monitor(P>0.05).The prototype had a fast response speed,good air tightness,a noise level lower than 60 dB,and its electrical safety performance complied with the GB 9706.1-2020 standard.Conclusion The equipment developed in this paper is applicable to the preventive training of patients with delirious brain disorders,providing a new idea for the prevention of postoperative delirium.
作者
陈璐
陶慧孙
张盛昭
魏登荣
尹靓
梁振
CHEN Lu;TAO Huisun;ZHANG Shengzhao;WEI Dengrong;YIN Liang;LIANG Zhen(School of Biomedical Engineering,Anhui Medical University,Hefei Anhui 230012,China;Anesthesiology Department,Hefei BOE Hospital,Hefei Anhui 230011,China;Department of Equipment,The Affiliated Chuzhou Hospital of Anhui Medical University,Chuzhou Anhui 239001,China)
出处
《中国医疗设备》
2025年第6期37-43,共7页
China Medical Devices
基金
安徽高校自然科学研究重大项目(KJ2020ZD16)。
关键词
术后谵妄
远隔缺血预适应
谵妄防治仪
预防训练
压力误差
气密性
样机研制
postoperative delirium
remote ischemic preconditioning
delirium prevention and treatment device
preventive training
pressure error
air tightness
prototype development
