Validation of the FF680 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 : 2024-11-14 DOI:10.1097/MBP.0000000000000735

Hao Chen

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Abstract

This study evaluated the accuracy of blood pressure measurement in adults using FF680 electronic blood pressure monitors with the Korotkoff-Sound method, in accordance with the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) universal standards (ISO 81060-2 : 2018). The study was conducted at Shijiazhuang People's Hospital and lasted 56 days, from May 26 to 21 July 2023. Participants, drawn from an adult demographic, underwent data verification and analysis with strict adherence to the trial protocol. For the FF680 electronic blood pressure monitor using the Korotkoff-Sound method, data from 85 valid participants were analyzed. The findings revealed mean differences (standard deviations) of -0.66 mmHg (2.45 mmHg) for SBP and -0.28 mmHg (2.09 mmHg) for DBP. SBP and DBP had standard deviations of ≤6.9 mmHg and ≤6.95 mmHg, meeting the standard requirements. FF680 devices are recommended for adult blood pressure monitoring because they meet the AAMI/ESH/ISO universal requirements (ISO 81060-2 : 2018).

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根据 AAMI/ESH/ISO 通用标准（ISO 81060-2:2018）对 FF680 上臂式血压计进行验证。

本研究根据美国医学仪器促进协会/欧洲高血压学会/国际标准化组织（AAMI/ESH/ISO）通用标准（ISO 81060-2 : 2018），评估了使用 FF680 电子血压计以 Korotkoff-Sound 法测量成人血压的准确性。研究在石家庄市人民医院进行，从 2023 年 5 月 26 日至 7 月 21 日，历时 56 天。参与者来自成年人群，严格按照试验方案进行了数据验证和分析。对于使用 Korotkoff-Sound方法的 FF680 电子血压计，对 85 名有效参与者的数据进行了分析。结果显示，SBP 和 DBP 的平均差（标准差）分别为-0.66 毫米汞柱（2.45 毫米汞柱）和-0.28 毫米汞柱（2.09 毫米汞柱）。SBP 和 DBP 的标准偏差分别为 ≤6.9 mmHg 和 ≤6.95 mmHg，符合标准要求。FF680 设备符合 AAMI/ESH/ISO 通用要求（ISO 81060-2 : 2018），因此推荐用于成人血压监测。

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.