Validating the accuracy of Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure according to the ISO 81060-2:2018+Amd 1:2020 protocol in the general population.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2024-10-01 Epub Date: 2024-05-21 DOI:10.1097/MBP.0000000000000708

Hakuo Takahashi, Shingo Yamashita, Nobuki Yakura

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引用次数: 0

Abstract

Purpose: The performance of the Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018 (E) and amendment (Amd)1:2020 protocol.

Methods: The device was used to assess 98 participants who fulfilled the inclusion criteria, including the range of arm circumference and systolic and diastolic BP, in accordance with the protocol. Data validation and analysis were performed according to the manufacturer's instructions.

Results: In the ISO validation procedure (criterion 1), the mean ± SD of the differences between test device readings and reference BP was 0.3 ± 6.17/3.6 ± 5.26 mmHg (systolic/diastolic). These data fulfilled the ISO requirements of ≤5±≤8 mmHg. The mean differences between the observer measurements and Omron HEM-7372T1-AZAZ (BP5460) readings were 0.3 ± 4.82 mmHg for systolic BP and 3.6 ± 4.78 mmHg for diastolic BP, fulfilling criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP. Therefore, two ISO criteria were fulfilled.

Conclusion: The Omron HEM-7372T1-AZAZ BP monitor fulfilled the requirements of the ISO validation standard. This device can be recommended for home BP measurements in the general population.

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验证欧姆龙 HEM-7372T1-AZAZ (BP5460) 根据 ISO 81060-2:2018+Amd 1:2020 协议在普通人群中监测血压的准确性。

目的：根据国际标准化组织（ISO）81060-2:2018（E）和修正案（Amd）1:2020 协议，对欧姆龙 HEM-7372T1-AZAZ (BP5460) 监测上臂血压（BP）的性能进行了验证：使用该设备对 98 名符合纳入标准（包括臂围范围、收缩压和舒张压）的参与者进行了评估。数据验证和分析按照制造商的说明进行：在 ISO 验证程序（标准 1）中，测试设备读数与参考血压之间差异的平均值（± SD）为 0.3 ± 6.17/3.6 ± 5.26 mmHg（收缩压/舒张压）。这些数据符合国际标准化组织的要求，即 ≤5±≤8 mmHg。观察者测量值与欧姆龙 HEM-7372T1-AZAZ (BP5460)读数的平均差为：收缩压 0.3 ± 4.82 mmHg，舒张压 3.6 ± 4.78 mmHg，符合标准 2，SBP 的 SD 值≤6.95，DBP 的 SD 值≤5.89。因此，符合 ISO 的两项标准：结论：欧姆龙 HEM-7372T1-AZAZ 血压计符合 ISO 验证标准的要求。建议将此设备用于普通人群的家庭血压测量。

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.