PERFORMANCE EVALUATION OF CONTEMPORARY SPIROMETERS

PERFORMANCE EVALUATION OF CONTEMPORARY SPIROMETERS
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DOI:
10.1378/chest.97.2.288
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发表时间:
1990-02-01
期刊:
影响因子:
9.6
通讯作者:
JENSEN, RL
JENSEN, RL
中科院分区:
医学1区
文献类型:
--
作者:
NELSON, SB;GARDNER, RM;JENSEN, RL

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对来自37个不同来源的62个肺活量计进行了综合评估,采用两部分方案:校准注射器和动态波形测试。所有测试都是在环境空气中进行的。校准注射器测试检查了肺活量计在不同条件下准确测量3l校准注射器输出的能力。根据这些数据确定了每种呼吸计的准确性、FVC体积线性度和稳定性。42个肺活量计中,只有5个能准确测量出3l校准注射器的肺活量。3%。动态波形测试包括将24种标准波形从计算机控制的气泵引入肺活量计。将FVC、FEV1和FEF25-75%的值与每个波形的实际值进行比较,以确定性能等级。在测量24种标准波形时,只有35种(56.5%)的肺活量计表现可接受。9件(14.5%)是“勉强”,18件(29.0%)是“不能接受”。62个肺活量计中有59个(95%)是计算机化的。在被评估的计算机化系统中,发现了25%的软件错误。虽然使用3l注射器进行质量控制是必要的,但与动态波形测试相比,使用3l校准注射器进行简单的肺活量计验证测试不足以评估肺活量计的性能。动态波形测试是准确测量和验证肺活量计系统性能可接受性的必要条件。
A comprehensive evaluation of 62 spirometers from 37 different sources was performed using a two-part protocol: calibrated syringe, and dynamic waveform testing. All testing was done with ambient air. Calibrated syringe testing examined the ability of the spirometers to accurately measure the output of a 3 L calibrating syringe under varying conditions. The accuracy, FVC volume linearity, and stability of each spirometer was determined from these data. All but five of 42 spirometers accurately measured a 3 L calibrating syringe to within .+-. 3 percent. Dynamic waveform testing consisted of introducing 24 standard waveforms into the spirometer from a computer-controlled air pump. The values of FVC, FEV1, and FEF25-75% were compared to the actual values for each waveform to determine a performance rating. Only 35 (56.5 percent) of the spirometers performed acceptably when measuring the 24 standard waveforms. Nine (14.5 percent) were marginal and 18 (29.0 percent) were unacceptable. Fifty-nine (95 percent) of the 62 spirometers were computerized. Software errors were found in 25 percent of the computerized systems evaluated. Although using a 3 L syringe for quality control purposes is essential, simple testing of spirometers with a 3 L calibrating syringe for validation purposes was inadequate to assess spirometer performance when compared to dynamic waveform testing. Dynamic waveform testing is essential to accurately measure and validate acceptability of spirometer system performance.