Chest
Volume 97, Issue 2, February 1990, Pages 288-297
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Performance Evaluation of Contemporary Spirometers

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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.

(Chest 1990; 97:288–97)

Section snippets

METHODS

All testing was performed with ambient air at about 21°C, relative humidity 30 percent and 647 mm Hg barometric pressure. Using ambient air allowed testing the spirometers under best-case conditions, and eliminated potential uncertainties related to the actual temperature and humidity of gases delivered to the flow or volume sensors. The spirometers used a variety of patient connections with varying dead-space volumes. The variable volumes and connections would have introduced unpredictable

RESULTS

Sixty two spirometers were obtained from 37 sources comprising spirometers from the United States, United Kingdom, Germany, Holland, and Japan. At least one spirometer from each of the major United States vendors was tested. Thirty-three (53 percent) of the spirometers were volume-based, and 29 (47 percent) were flow-based. Fifty-nine (95 percent) were computerized.

Table 1 alphabetically lists the 62 spirometers tested and the source. The type of spirometer, software version, type of computer,

DISCUSSION

The performance criteria used were based on the ATS recommendations3 and earlier testing and standardization criteria.4, 5, 7 The major changes from the earlier methods were additional waveforms, more sophisticated end of test criteria, and a relaxation of the limits of acceptability, which were all based on studies published since the 1979 ATS recommendations.5, 7

An important addition to the earlier ATS recommendations was the allowance of a 5 percent random error rate. The authors felt that

ACKNOWLEDGMENTS

We thank the spirometer manufacturers, vendors and users who participated in our testing. Also we thank Steven L. Berlin for technical assistance in doing some of the more recent testing. Device 28 was provided to us by the Harvard School of Public Health and is being used for the “Acid Aerosol Health Effects in North American Children Study.” We thank them for making the equipment available.

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Evaluation results and listing of brand names does not constitute endorsement or approval by the University of Utah, the authors, or the American College of Chest Physicians.

Manuscript received May 8; revision accepted June 22.

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