Validation of the CONTEC08A upper-arm blood pressure monitor in adult Chinese.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2025-06-01 DOI:10.1097/MBP.0000000000000743

Yi Zhou, Yi Zhou, Ruo-Yi Zou, Yan Li, Ji-Guang Wang

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Abstract

Objective: The aim of this study was to evaluate the accuracy of the CONTEC08A oscillometric upper-arm blood pressure (BP) monitor for BP measurement in adults according to the International Organization for Standardization (ISO) 81060-2:2018 and amendment (Amd)1:2020 standard.

Methods: Eighty-five subjects (male 40 and female 45) were recruited to fulfill the age, sex, BP, and cuff distribution criteria of the ISO standard in the general population, and had a mean age of 40.2 years. The same arm sequential BP measurement method was used with three differently sized cuffs for the arm circumference ranging from 18 to 26 cm (small), 22-32 cm (medium), and 22-43 cm (large), respectively, for the test device, and two differently sized cuffs for the arm circumference ≤32 cm (standard) and >32 cm (large), respectively, for the mercury sphygmomanometer.

Results: Two hundred and fifty-five comparison pairs were obtained for analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference SBP/DBP readings was 1.1 ± 6.7/3.0 ± 5.3 mmHg. For validation criterion 2, the SD of the averaged SBP/DBP differences between the test device and reference BP per subject was 5.63/4.68 mmHg.

Conclusion: The automated upper-arm BP monitor CONTEC08A has passed the requirements of the ISO Universal Standard in the general population, and can be recommended for BP measurement in adults.

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CONTEC08A上臂血压计在中国成人中的验证。

目的：本研究的目的是根据国际标准化组织（ISO） 81060-2:2018和修订（Amd）1:2020标准，评估CONTEC08A振荡式上臂血压（BP）监测仪用于成人血压测量的准确性。方法：招募符合一般人群年龄、性别、血压、袖带分布标准的85例受试者，男40岁，女45岁，平均年龄40.2岁。采用相同的手臂顺序血压测量方法，测试装置的臂围分别为18 - 26 cm（小）、22-32 cm（中）和22-43 cm（大），分别为三个不同尺寸的袖口；水银血压计的臂围分别为≤32 cm（标准）和>32 cm（大）。结果：共获得255对对照对进行分析。对于验证标准1，测试装置与参考收缩压/舒张压读数差异的平均值±SD为1.1±6.7/3.0±5.3 mmHg。对于验证标准2，测试装置与参考血压之间的平均收缩压/舒张压差的标准差为5.63/4.68 mmHg。结论：全自动上臂血压监测仪CONTEC08A在普通人群中已通过ISO通用标准的要求，可推荐用于成人血压测量。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.