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无创呼吸机质控检测实践方法探讨

Discussion on the practical method of quality control test of non-invasive ventilator
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摘要 目的:无创呼吸机在临床上用于治疗睡眠呼吸暂停综合症及相关疾病,属于急救、生命支持系统仪器装备,其使用质量对于临床治疗安全尤为重要,需研定质量控制检测方法以保障其正常待用。方法:根据无创呼吸机的设计原理,通过人工检查和使用气流分析仪进行“仪器外观、开机检查、通气频率、氧浓度、气道压力、安全报警功能”6个方面的质控检测。结果:制定无创呼吸机质量控制检测记录表,其中结合统计学分析情况,针对实际检测中出现数值偏差情况较多的的氧浓度、气道峰压,提出“氧浓度体积分数在(61~100)%范围时,最大允许误差为±8%(体积分数);气道峰压的基础设定值为10cmH_(2)O、15cmH_(2)O、20cmH_(2)O,并按需以5cmH_(2)O为间隔递增或递减”的建议,与此同时针对使用模拟肺测试通气频率时出现通气频率异常并报警现象,设计出可解决该问题的标准气阻。结论:无创呼吸机质控检测方法切实可行,不仅符合《JJF(京)69-2019无创呼吸机校准规范》《WST 655-2019呼吸机安全管理》《JJF 1234-2018呼吸机校准规范》等有关规范文件的要求,而且通过探索创新完善了氧浓度、气道峰压的检测内容和创新设计出辅助通气频率检测的标准气阻。 The non-invasive ventilator is used to treat sleep apnea syndrome and related diseases in clinic.It is a kind of instrument for first aid and life support.Its quality is particularly important for the safety of clinical treatment.It is necessary to develop quality control detection methods to ensure its normal use.According to the design principle of non-invasive ventilator,the quality control tests of"instrument appearance,startup inspection,ventilation frequency,oxygen concentration,airway pressure,and safety alarm function"are carried out through manual inspection and use of air flow analyzer.A non-invasive ventilator quality control test record form is prepared,which combines statistical analysis;for oxygen concentration and airway peak pressure with large numerical deviation in the actual test,it is proposed that the maximum allowable error is±8%(volume fraction)when the oxygen concentration volume fraction is within the range of 61%-100%and the basic set value of airway peak pressure is 10cmH_(2)O,15cmH_(2)O and 20cmH_(2)O,and it is increased or decreased at intervals of 5cmH_(2)O as needed.At the same time,a standard air resistance is designed to solve the problem of abnormal ventilation frequency and alarm when using simulated lung testing ventilation frequency.The non-invasive ventilator quality control detection method is practical and feasible.The method not only meets the requirements of relevant standard documents such as JJF(Beijing)69-2019 Non-invasive ventilator calibration specification,WST 655-2019 Ventilator safety management,JJF 1234-2018 Ventilator calibration specification,but also improves the detection content of oxygen concentration and airway peak pressure and innovates the standard air resistance for auxiliary ventilation frequency detection through exploration and innovation.
作者 麦达成 肖翔 劳婉仪 黄小坪 胡志勇 王永胜 Mai Dacheng;Xiao Xiang;Lao Wanyi;Huang Xiaoping;Hu Zhiyong;Wang Yongsheng(Equipment Department of Guangzhou Panyu District Central Hospital,Guangzhou 511400,China;Administration office of Guangzhou Panyu District Central Hospital,Guangzhou 511400,China;Electrical office of Guangzhou Panyu Quality and Technical Supervision and Testing Institute,Guangzhou 511400,China;Guangdong Primary Hospital Medical Device Management Branch,Guangzhou 510515,China)
出处 《分析仪器》 CAS 2023年第3期107-112,共6页 Analytical Instrumentation
基金 广州市番禺区科技计划项目(2020-Z04-082) 2021年广东省医学会医学工程学分会青年委员会科研课题(GDMAZZ-10)。
关键词 无创呼吸机 质控检测 氧浓度 气道峰压 标准气阻 Non invasive ventilator Quality control test Oxygen concentration Peak airway pressure Standard air resistance
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