Technol Health Care. 2024;32(1):9-18. doi: 10.3233/THC-220905.
At present, robust quality criteria and methods for the assessment of Peak inspiratory flow meter performance are lacking.
A standard flow-volume simulator for quality control analyses of an inhalation assessment device was utilized with different simulated resistance levels in order to propose a quality testing method and associated standard for this device type.
A standard flow-volume simulator was utilized to assess the performance of an In-Check DIAL® (Device I) and an intelligent inhalation assessment device (Device P) at a fixed volume and flow rate. Indices used to evaluate these two instruments included repeatability, accuracy, linearity, and impedance.
Both devices exhibited good repeatability (<± 3 L/min). The difference between test results and standard simulator values for Device P was less than ± 5 L/min at resistance level R1 but higher than ± 5 L/min at resistance levels R2-5, while Device I were greater than 5 L/min at all resistance levels. The relative error for Device P was <± 10% at resistance levels R1, R2, and R4, but > 10% at resistance levels R3 and R5. The relative error values for Device I at all five resistance levels were > 10%. Device P passed the linearity test at the R2 resistance level, while Device I partially passed the linearity test at all five resistance levels.
Standard monitoring methods and standards provide a valuable approach to the more reliable clinical assessment and application of these instruments.
目前，缺乏评估峰流速仪性能的稳健质量标准和方法。
利用具有不同模拟阻力水平的标准流量-体积模拟器，为吸入评估设备的质量控制分析提出一种质量测试方法和相关标准。
利用标准流量-体积模拟器，在固定容量和流速下评估 In-Check DIAL®（设备 I）和智能吸入评估设备（设备 P）的性能。用于评估这两种仪器的指标包括重复性、准确性、线性度和阻抗。
两种设备的重复性均较好（<±3 L/min）。设备 P 的测试结果与标准模拟器值的差值在 R1 阻力水平下小于±5 L/min，但在 R2-5 阻力水平下大于±5 L/min，而设备 I 在所有阻力水平下均大于 5 L/min。设备 P 的相对误差在 R1、R2 和 R4 阻力水平下<±10%，但在 R3 和 R5 阻力水平下>10%。设备 I 在所有五个阻力水平下的相对误差值均>10%。设备 P 在 R2 阻力水平下通过了线性测试，而设备 I 在所有五个阻力水平下部分通过了线性测试。
标准监测方法和标准为这些仪器更可靠的临床评估和应用提供了有价值的方法。
