摘要
目的 目前国内外对基于微振动检测的呼吸监测装置的灵敏度、准确性评价尚未形成统一、有效的评价方法和平台,阻碍了该类产品的进一步发展。为了便于开展时微振动检测的呼吸监测装置的性能评价,本文提出研制基于凸轮往复运动的模拟振动发生平台。方法 通过控制器将模拟信号经过功率放大后,驱动凸轮结构按照设定的振动幅度和频率给柔性腔体施加振动压力,产生类似于人体体表产生的微位移。由于人体呼吸、咳嗽等动作产生单元不同,需要各个振动单元独立工作,在多个振动头的紧密配合下,最终经柔性腔体调制后产生类似于人体的共振信号。结果 实测数据显示,系统可依据临床测试数据,由专业人员对波形进行编辑后输入系统,输出正常呼吸、低通气、呼吸暂停、哮喘、咳嗽5种波形;幅度、频率可调。结论 本研究研制的测试平台可对基于微振动检测的呼吸监测装置开展相关测试,有利于科学有效地评价微振动检测的呼吸监测装置的性能和抗扰度,有助于形成合理的微振动检测的呼吸监测装置质量评价规范。
Objective There was no unified and effective evaluation method and platform for the sensitivity and accuracy assessment of respiratory monitoring devices based on micro-vibration detection at home and abroad,which had hindered the further development of such products.In order to facilitate the performance evaluation of the respiratory monitoring device for micro-vibration detection,this paper aim to proposes the development of a simulated vibration generation platform based on the reciprocating motion of cam.Methods By amplifying the analog signal through a the controller,the cam structure was driven to apply vibrational pressure to the flexible cavity according to the set vibration amplitude and frequency,generating microdisplacement similar to that generated by the human body surface.Due to the different generating units of human breathing,coughing and other actions,each vibration unit needed to work independently.Under the close cooperation of multiple vibrating heads,the resonance signal similar to the human body was ultimately generated after modulation by the flexible cavity.Results The measured data showed that the system could be input with edited waveforms by professionals according to the clinical test data.It could output five waveforms:normal breathing,hypoventilation,apnea,asthma and cough;the amplitude and frequency were adjustable.Conclusion In general,the developed testing platform can carry out relevant tests on respiratory monitoring devices based on micro-vibration detection,which is beneficial for scientifically and effectively evaluating the performance and immunity of respiratory monitoring devices based on micro-vibration detection.It helps to form a reasonable quality evaluation specification for respiratory monitoring device based on micro-vibration detection.
作者
李澍
冉琳
李佳戈
李静莉
LI Shu;RAN Lin;LI Jiage;LI Jingli(Institute for Medical Devices Control,National Institutes for Food and Drug Control,Beijing 102629,China;Department of Biomedical Engineering,Chongqing University,Chongqing 400044,China)
出处
《中国医疗设备》
2023年第12期35-40,共6页
China Medical Devices
基金
国家重点研发计划(2019YFC1711702)。
关键词
驱动凸轮结构
微振动检测
呼吸监测装置
抗扰性测试
drive cam structue
micro-vibration detection
respiratory monitoring device
immunity test