Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol.

IF 2.6 Q2 PERIPHERAL VASCULAR DISEASE

Vascular Health and Risk Management Pub Date : 2024-07-22 eCollection Date: 2024-01-01 DOI:10.2147/VHRM.S468382

Hakuo Takahashi, Shingo Yamashita, Nobuki Yakura

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引用次数: 0

Abstract

Purpose: The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol.

Methods: The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions.

Results: In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled.

Conclusion: The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.

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验证欧姆龙 HEM-1026 (HCR-1901T2/HCR-1902T2)：根据通用协议验证家庭血压监测设备的准确性。

目的：根据国际标准化组织 (ISO) 81060-2:2018+amendment (Amd)1:2020 协议，对欧姆龙 HEM-1026 (HCR-1901T2 / HCR-1902T2) 监测上臂血压 (BP) 的性能进行了验证：对符合纳入标准（包括协议规定的臂围范围、收缩压和舒张压）的 101 名参与者进行了设备评估。数据验证和分析按照制造商的说明进行：在 ISO 81060-2:2018+Amd 1:2020 验证程序（标准 1）中，测试设备与参考血压之间差异的平均值±标准差（SD）为 -2.1 ± 7.24/-0.6 ± 5.63 mmHg（收缩压/舒张压）。这些数据符合 ISO81060-2:2018+Amd1:2020 ≤5±≤8 mmHg 的要求。两名观察者和欧姆龙 HEM-1026 之间的平均差异为：收缩压 -2.1 ± 5.71 mmHg，舒张压 -0.6 ± 4.81 mmHg，符合标准 2，收缩压 SD ≤ 6.62，舒张压 SD ≤ 6.91。结论：欧姆龙 HEM-1026 血压计符合 ISO 81060-2:2018+Amd 1:2020 验证标准的要求，可推荐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

Vascular Health and Risk Management PERIPHERAL VASCULAR DISEASE-

CiteScore

4.20

自引率

3.40%

发文量

109

审稿时长

16 weeks

期刊介绍： An international, peer-reviewed journal of therapeutics and risk management, focusing on concise rapid reporting of clinical studies on the processes involved in the maintenance of vascular health; the monitoring, prevention, and treatment of vascular disease and its sequelae; and the involvement of metabolic disorders, particularly diabetes. In addition, the journal will also seek to define drug usage in terms of ultimate uptake and acceptance by the patient and healthcare professional.