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 : 2025-01-31 DOI:10.1097/MBP.0000000000000743

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

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引用次数: 0

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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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.