Validation of the Omron HEM-7380T (HCR-7728T) blood pressure monitor in the general population according to the international organization for standardization 81060-2:2018 + Amd.1:2020 and Amd.2:2024.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE

Blood Pressure Monitoring Pub Date : 2026-04-30 DOI:10.1097/MBP.0000000000000803

Hakuo Takahashi, Nobuki Yakura, Mitsuo Kuwabara

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引用次数: 0

Abstract

Objective: This study aimed to validate the accuracy of Omron HEM-7380T (HCR-7728T), an automated deflationary oscillometric upper-arm blood pressure (BP) monitor, according to the international organization for standardization (ISO) 81060-2 : 2018 + Amd1 : 2020 and Amd2 : 2024 protocols (ISO standards).

Methods: Accuracy was assessed by alternately measuring systolic BP (SBP) and diastolic BP (DBP) in the same arm using the test device and a mercury sphygmomanometer. All participants met the inclusion criteria outlined in the protocol.

Results: A total of 85 patients were included (43 males and 42 females), with a mean age of 63.9 ± 10.3 years and a mean arm circumference of 26.7 ± 5.4 cm. Regarding Criterion 1, the mean ± SD of the differences between the test device and reference BP was 0.1 ± 6.85 mmHg for SBP and 0.9 ± 5.41 mmHg for DBP, fulfilling the ISO requirement of less than or equal to 5 ± less than or equal to 8 mmHg. For Criterion 2, the SD values were 0.1 ± 5.69 mmHg for SBP and 0.9 ± 4.95 mmHg for DBP, satisfying the required thresholds of less than or equal to 6.95and less than or equal to 6.88, respectively. The results indicated that this device conforms to the ISO standards.

Conclusion: Omron HEM-7380T fulfilled criteria 1 and 2 of the protocol. Therefore, the device is considered sufficiently accurate for BP measurements in the general population.

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欧姆龙hm - 7380t （HCR-7728T）血压监测仪在普通人群中根据国际标准化组织81060-2:2018 + Amd.1:2020和Amd.2:2024进行验证。

目的：本研究旨在根据国际标准化组织（ISO） 81060-2: 2018 + Amd1: 2020和Amd2: 2024协议（ISO标准）验证欧姆龙HEM-7380T （HCR-7728T）自动紧缩型振荡上臂血压（BP）监测仪的准确性。方法：使用试验装置和水银血压计交替测量同一臂收缩压（SBP）和舒张压（DBP），评估准确性。所有参与者均符合方案中列出的纳入标准。结果：共纳入85例患者（男43例，女42例），平均年龄63.9±10.3岁，平均臂围26.7±5.4 cm。对于标准1，测试装置与参考血压差值的平均值±SD为收缩压0.1±6.85 mmHg，舒张压0.9±5.41 mmHg，满足ISO小于等于5±小于等于8 mmHg的要求。对于标准2，收缩压的SD值为0.1±5.69 mmHg，舒张压的SD值为0.9±4.95 mmHg，分别满足小于等于6.95和小于等于6.88的要求阈值。结果表明，该装置符合ISO标准。结论：欧姆龙HEM-7380T满足方案标准1和标准2。因此，该装置被认为对一般人群的血压测量足够准确。

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.