Abstract
BackgroundThe spirometer is an important element in lung function examinations, and its accuracy is directly related to the accuracy of the results of these examinations and to the diagnosis and treatment of diseases. Our aim was to conduct a performance analysis of the detection techniques of differential pressure and ultrasonic portable spirometers commonly used in China.MethodsA standard flow/volume simulator was used to analyze the performance (accuracy, repeatability, linearity, impedance, and so on) of portable spirometers, 4 imported and 6 domestic, based on 13 curves generated by different air sources in the ISO 26782:2009 standard. A Bland–Altman diagram was used to evaluate the consistency between the values measured by the spirometers and the simulator.ResultsThe pass rates for accuracy, repeatability, linearity, and impedance for the 10 different portable spirometers were 50%, 100%, 70%, and 70%, respectively. Only 30% (3/10) of the spirometers—2 domestic and 1 imported—met all standards of quality and performance evaluation, while the rest were partially up to standard. In the consistency evaluation, only 3 spirometers were within both the consistency standard range and the acceptability range.ConclusionThe quality and performance of different types of portable spirometers commonly used in the clinic differ. The use of a standard flow/volume simulator is helpful for the standard evaluation of the technical performance of spirometers.
Highlights
A spirometer is a medical device used to record physiological lung volume within the range of vital capacity [1]
In 2009, the International Organization for Standardization (ISO) published “Anesthetic and respiratory equipment—Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)”, in which 13 different volume-time curves were formulated, corresponding to different values of F EV1, forced expiratory volume in 6 s (FEV6), forced vital capacity (FVC) and other indicators [4]
Performance of the spirometers using the ISO 26782:2009 standard In this study, 10 spirometers were tested by air sources generated by 13 waveform signals
Summary
A spirometer is a medical device used to record physiological lung volume within the range of vital capacity [1]. Most of the domestic testing and calibration of the accuracy of spirometers is performed through self-tests of the instrument and the use of standard calibration cylinders. This method is simple and convenient, it is unable to measure forced expiratory volume in the first second (FEV1) and other indicators because there is only a single volume and flow rate that. Different air sources generated by a simulator can be used to test spirometers, and the resulting test value can be compared with the actual value of the simulator to analyze the performance of the instruments.
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