Validating the accuracy of Omron J760 electronic blood pressure monitor in the general population according to AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020.

IF 1.8 4区医学 Blood Pressure Pub Date : 2025-12-01 Epub Date: 2025-02-25 DOI:10.1080/08037051.2025.2469264

Bihua Chen, Guorong Chen, Hong Jiang, Ya Sun, Jie Chen, Dan Wang, Mingzhi Chen, Jia Shi, Yan Peng, Yimin Cheng, Cheng Yang, Yuanyuan Ding, Jin Su, Ming Liu, Fulai Shen, Yicheng Qiu, Yi Shen, Qiyun Cao, Jiayu Su

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Abstract

Purpose: The accuracy of the Omron J760 electronic blood pressure (BP) monitor for upper arm BP measurement in the adult general population was validated following the AAMI/ESH/ISO (ISO 81060-2:2018) + Amd1:2020 protocol. We expect that this device can be used for home blood pressure monitoring, with its measurements serving as a clinical reference.

Methods: Subjects meeting the age, gender, BP, and cuff distribution criteria as specified by the AAMI/ESH/ISO (ISO 81060-2:2018) + Amd1:2020 were recruited. BP measurements were conducted using the same-arm sequential method. The test device cuff was suitable for arm circumferences ranging from 22.0 cm to 42.0 cm.

Results: Eighty-nine participants were initially recruited, 85 were evaluated after excluding 4 participants. The mean age of the participants was 48.5 ± 15.17 years. For validation criterion 1, the mean ± standard deviation (SD) of the differences between the test device and the reference BP measurements were 0.2 ± 5.74 mmHg for systolic BP and -0.9 ± 4.69 mmHg for diastolic BP. These results met the AAMI/ESH/ISO (ISO 81060-2:2018)+Amd1:2020 standard, which requires differences of ≤5 ± ≤8 mmHg. For validation criterion 2, the mean differences between the test device and the reference device were 0.2 ± 5.10 mmHg for systolic BP and -0.9 ± 4.30 mmHg for diastolic BP. This criterion was satisfied with criterion 2 of ≤6.95 mmHg for systolic BP and ≤6.88 mmHg for diastolic BP.

Conclusion: The Omron J760 electronic BP monitor meets the requirements of the AAMI/ESH/ISO (ISO 81060-2:2018)+Amd 1:2020 validation standard.

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根据 AAMI/ESH/ISO (ISO 81060-2:2018) + AMD1:2020 验证欧姆龙 J760 电子血压计在普通人群中的准确性。

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来源期刊

Blood Pressure Medicine-Cardiology and Cardiovascular Medicine

CiteScore

3.20

自引率

5.60%

发文量

期刊介绍： For outstanding coverage of the latest advances in hypertension research, turn to Blood Pressure, a primary source for authoritative and timely information on all aspects of hypertension research and management. Features include: • Physiology and pathophysiology of blood pressure regulation • Primary and secondary hypertension • Cerebrovascular and cardiovascular complications of hypertension • Detection, treatment and follow-up of hypertension • Non pharmacological and pharmacological management • Large outcome trials in hypertension.