Validation of the Hanvon FY730 upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018).

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2025-01-14 DOI:10.1097/MBP.0000000000000742

Hao Chen

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引用次数: 0

Abstract

This study evaluates the measurement accuracy of the Hanvon FY730 upper-arm blood pressure (BP) monitor, which uses the Korotkoff sound method, in compliance with the AAMI/ESH/ISO universal standard (ISO 81060-2:2018). A clinical trial involving 86 eligible adults was conducted, and data were analyzed based on standardized protocols. The mean differences between the device and reference measurements for systolic blood pressure (SBP) and diastolic blood pressure (DBP) were -0.37 mmHg (SD: 2.25 mmHg) and -0.17 mmHg (SD: 2.02 mmHg), respectively. Standard deviations for SBP (≤6.93 mmHg) and DBP (≤6.95 mmHg) met the required thresholds. A total of 258 effective paired measurements demonstrated that the Hanvon FY730 provides highly consistent results compared with reference methods, with all deviations falling within acceptable limits. The study also confirmed the device's reliability across a wide range of arm circumferences (22-36 cm) and BP levels (SBP: 90-188 mmHg, DBP: 53-107 mmHg). These findings confirm that the Hanvon FY730 complies with ISO 81060-2:2018 standards, demonstrating its suitability for accurate BP monitoring in clinical, personal, and home settings.

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根据AAMI/ESH/ISO通用标准（ISO 81060-2:2018）对汉王FY730上臂血压计进行验证。

本研究根据AAMI/ESH/ISO通用标准（ISO 81060-2:2018），对采用Korotkoff声法的汉王FY730上臂血压监测仪的测量精度进行了评估。对86名符合条件的成人进行了临床试验，并根据标准化方案对数据进行了分析。收缩压（SBP）和舒张压（DBP）与参考测量值的平均差异分别为-0.37 mmHg （SD: 2.25 mmHg）和-0.17 mmHg （SD: 2.02 mmHg）。收缩压（≤6.93 mmHg）和舒张压（≤6.95 mmHg）的标准差符合要求的阈值。共有258个有效的成对测量表明，与参考方法相比，汉王FY730提供了高度一致的结果，所有偏差都在可接受的范围内。该研究还证实了该设备在大范围臂周（22-36厘米）和血压水平（收缩压：90-188 mmHg，舒张压：53-107 mmHg）下的可靠性。这些研究结果证实，汉王FY730符合ISO 81060-2:2018标准，证明了其在临床、个人和家庭环境中准确监测血压的适用性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.