Development and Application Value
Assessment of a Method for Measuring the Quality of Volume Calibration Syringes

doi:10.12114/j.issn.1007-9572.2021.01.037

Abstract

Abstract: Background

Pulmonary examination is a measurement technique in medicine, and the quality of examination equipment is a key factor associated with the accuracy of examination results. Guidelines for mechanical lung function measurements have proposed that the spirometer should be calibrated each time it is used by the calibration cylinder for quality control, so the accuracy of the calibration cylinder will directly associate with that of the spirometer. However, there are no reports on the accuracy, and eligible standards, as well as calibration procedure regarding spirometer calibration cylinders measured by relevant research institutions (including calibration cylinder manufacturers) .

Objective

To develop a method, and use it to measure the performance of volume calibration cylinders commonly applied in China to assess its application value.

Methods

According to the standards for 3 L calibration syringe proposed in the Standardization of Spirometry 2019 Update issued by the American Thoracic Society (ATS) /European Respiratory Society (ERS) , the 1180 cylinder verifier (produced by Hans Rudolph, inc.) was used in the leak test and volume accuracy test for measuring the performance of five brands of imported/domestic calibration cylinders (Two were produced by Germany's CareFusion, and Vyaire, respectively, one by MGC Diagnostics, USA, and the other two by China's Zhejiang U-Breath, and Ningbo Wendi Medical Instrument CO, LTD, respectively) .

Results

Of the five brands of calibration cylinders, 4/5 had less than 1 ml/min in the pressure attenuation leakage test, 4/5 had a volume error of less than 0.5% of the target volume, with an error range of less than 0.05% of the target volume, 3/5 passed both tests.

Conclusion

In this study, the method of directly measuring the change of gas volume of volume calibration cylinder is used for quality detection. The method is simple and feasible. It is recommended that the calibration cylinder should be regularly checked for assuring the accuracy.

Key words: Lung diseases, Respiratory function tests, Respiratory tract diseases, Volume calibration cylinder, Calibration cylinder verifier, Quality control, Leak test

摘要： 背景

肺功能检查是一种医学计量技术，检查设备的质量是影响检查结果的关键环节之一。国内外肺功能检查指南均提出在进行质量控制标准时每次启动肺量计均需经容量定标筒校准，容量定标筒的准确性直接影响肺量计计算指标数值的准确性，但国内外所有研究机构（包括容量定标筒生产厂家）从未对容量定标筒自身的准确性进行校准验证，也无相关操作流程和通过标准。

目的

对国内临床常用肺功能仪容量定标筒进行检测技术性能分析，了解我国常用容量定标筒的性能情况，探索该方法在容量定标筒验证中的应用价值。

方法

2021年7月，根据美国胸科学会（ATS）/欧洲呼吸协会（ERS）在2019年发布的肺量计检查指南更新版中提出的3 L容量定标筒校准的要求，采用美国Hans Rudolph公司1180型容量定标筒验证器对5个品牌容量定标筒（德国CareFusion、德国Vyaire、美国MGC diangostics、中国浙江U-Breath、中国浙江宁波文迪）进行压力泄露测试和容积准确性测试。

结果

5个品牌容量定标筒的压力泄露测试结果小于1 ml/min的占4/5；容积误差小于目标容积的0.5%且误差重复性小于目标容积的0.05%占4/5，两种测试均通过的占3/5。

结论

本研究使用直接测量容量定标筒气体容积变化的方法进行质量检测，方法简便可行，建议定期对容量定标筒进行质量校准。

关键词: 肺疾病, 呼吸功能试验, 呼吸道疾病, 容量定标筒, 容量定标筒验证器, 质量控制, 泄漏测试

CLC Number:

R563R443.6

WU Zhongping, HUANG Ruibo, ZHENG Jinping, GAO Yi.

Development and Application Value Assessment of a Method for Measuring the Quality of Volume Calibration Syringes [J]. Chinese General Practice, 2022, 25(02): 149-152.

吴仲平,黄锐波,郑劲平等. 肺功能仪容量定标筒的质量检测方法的建立及其应用价值对比研究[J]. 中国全科医学, 2022, 25(02): 149-152. DOI: 10.12114/j.issn.1007-9572.2021.01.037.

Figures/Tables 2

References 9

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评价指标		品牌1	品牌2	品牌3	品牌4	品牌5	总体通过率（%）
压力泄露测试
	目标容积（ml）	3 000.000	3 000.000	1 000.000	3 000.000	3 000.000
	目标泄露（ml/min）	0.000	0.000	0.000	0.000	0.000
	实际平均泄露（ml/min）	0.190	0.450	0.100	2.470	0.840	80.00
	泄露平均误差值（ml/min）	0.190	0.450	0.100	2.470	0.840	80.00
	是否通过（Y/N）	Y	Y	Y	N	Y	80.00
容积准确性测试
	目标容积（ml）	3 000.000	3 000.000	1 000.000	3 000.000	3 000.000
	容积平均测量值（ml）	2 994.674	3 003.005	992.219	2 990.861	3 001.187	80.00
	容积平均误差范围（ml）	0.383	0.537	0.520	0.795	0.367	80.00
	容积平均误差值（ml）	-5.326	3.005	-7.781	-9.139	1.187	80.00
	是否通过（Y/N）	Y	Y	N	Y	Y	80.00
两项测试
	是否通过（Y/N）	Y	Y	N	N	Y	60.00

评价指标		品牌1	品牌2	品牌3	品牌4	品牌5	总体通过率（%）
压力泄露测试
	目标容积（ml）	3 000.000	3 000.000	1 000.000	3 000.000	3 000.000
	目标泄露（ml/min）	0.000	0.000	0.000	0.000	0.000
	实际平均泄露（ml/min）	0.190	0.450	0.100	2.470	0.840	80.00
	泄露平均误差值（ml/min）	0.190	0.450	0.100	2.470	0.840	80.00
	是否通过（Y/N）	Y	Y	Y	N	Y	80.00
容积准确性测试
	目标容积（ml）	3 000.000	3 000.000	1 000.000	3 000.000	3 000.000
	容积平均测量值（ml）	2 994.674	3 003.005	992.219	2 990.861	3 001.187	80.00
	容积平均误差范围（ml）	0.383	0.537	0.520	0.795	0.367	80.00
	容积平均误差值（ml）	-5.326	3.005	-7.781	-9.139	1.187	80.00
	是否通过（Y/N）	Y	Y	N	Y	Y	80.00
两项测试
	是否通过（Y/N）	Y	Y	N	N	Y	60.00

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