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心脏除颤仪在生命周期不同阶段的能量释放调查与分析OACSTPCD

Investigation and analysis of energy release of cardiac defibrillator at different stages of lifecycle of that

中文摘要英文摘要

目的:针对心脏除颤设备的不同生命周期阶段,分析除颤设备能量输出的性能特征,提升管理水平以保证设备使用的安全有效.方法:回顾性分析2015-2022年医院在用(含期间报废设备)的861290、CardioServ等10个型号的90台除颤设备,统计分析除颤设备的能量输出检测数值、计算释放能量误差.将使用初期(设备启用前3年)的36台除颤仪按照年份分为启用第1、2和3年,比较3年设备能量输出数据.将使用正常期(使用中期)数量最多的型号A和型号B除颤仪(41台)依据2018-2000年3年的能量释放校准数据,分析两个型号设备在100 J预置值时释放能量的差异.分析2015-2022年报废期的8台能量输出超限设备的能量释放误差.结果:使用初期3组设备数据,设备启用的第1、2年除颤仪在预置值的能量释放值100、150和200 J比较,差异均无统计学意义(t=-1.17、-0.17、-0.58,P>0.05);设备启用的第1、3年测量值比较,差异均无统计学意义(Z=-0.70、-0.38、-0.86,P>0.05).在对正常期设备的能量释放重复测量方差分析中,不同型号41台设备在100 J预置点的能量释放比较,差异有统计学意义(F=4.40,P<0.05).能量超差的除颤仪从初期开始能量释放一直偏高,且随预置能量增加,相对误差增大,设备重复性好,预置能量(x)与释放能量(y)之间符合线性关系(R2=0.9985).在用除颤设备中,>100 J预置点的能量输出合格率为97.68%.结论:不同型号除颤设备能量释放的均值在合格范围内略有差异,能量输出仍是除颤设备应重点关注的性能指标,应结合设备的维护维修数据深入分析,掌握设备运行状态,优化质量控制策略,确保除颤器临床使用的安全性.

Objective:To analyze the performance characteristics of the energy output of defibrillation device at different lifecycle stages of the equipment,and to improve the level of management,so as to ensure the safety and effectiveness of using the device.Methods:A total of 90 defibrillation devices of using 10 types included 861290 and CardioServ(included scrapped devices)during the period of 2015-2022 were retrospectively analyzed.The detected data of energy output of defibrillation device were analyzed as statistical method,and the error of releasing energy was calculated.A total of 36 defibrillation devices that were in the early stages of use(at the first three years of device use)were divided into the first year,the second year and the third year,and the data of energy outputs of devices among three years were compared.The data of the type A and type B defibrillation devices,which were the largest number of devices in the normal stage of use(the middle stage of use),were calibrated according to the energy release in the three years between 2018 and 2000.The difference of releasing energy at the preseted value of 100J between the two types of devices was analyzed.Finally,the errors of energy releases of 8 devices,which energy outputs exceeded the deadline,in the scrap period between 2015 and 2022 were summarized.Results:In the data of three groups of devices in the early stages of use,the differences at the first and second year of device use among 100J,150J and 200J of the energy releases of the preseted values were significant(t=-0.17,-0.17,-0.58,P>0.05).The difference of the measured values between the first and third years of device use was not significant(Z=-0.70,-0.38,-0.86,P>0.05).The results of variance analysis of repeated measurement of the energy releases of the devices in normal stage indicated that the difference of the energy release at 100J preseted point among different types of 41 devices was significant(F=4.40,P<0.05).The energy release of type X defibrillator appeared constantly high,and the relative error increased with the increasing of preseted values.The repeatability of the device was better,and the relationship between preseted energy(x)and release energy(y)conformed to linear relationship(R2=0.9985).In these defibrillation devices that were using,the qualified rate of energy output of>100J preseted point was 97.68%.Conclusion:There is slight difference in the mean value of energy release between different type of defibrillation devices within the qualified range,and the energy release still is a performance indicator that should be highly focused for defibrillation devices.We should combine with the maintenance and repair data of device to conduct in-depth analysis,so as to grasp the operating status of the device,and optimize the strategy of quality control,and ensure the safety of defibrillator in clinical use.

李东;王晓龙;谢峰;王宇坤;柳渊;李晓虹;白玫

首都医科大学宣武医院医学工程处 北京 100053北京市计量检测科学研究院化学分析与生物医药研究所 北京 100029

预防医学

除颤仪能量释放生命周期

DefibrillatorEnergy releaseLifecycle

《中国医学装备》 2024 (003)

39-43 / 5

10.3969/j.issn.1672-8270.2024.03.008

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