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
Year: 2025
Type: article
Abstract: 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. 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. 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. The Omron J760 electronic BP monitor meets the requirements of the AAMI/ESH/ISO (ISO 81060-2:2018)+Amd 1:2020 validation standard. This study tested the accuracy of the Omron J760 electronic blood pressure monitor using international standards. Participants were selected based on specific criteria for age, gender, blood pressure, and arm size, as required by the AAMI/ESH/ISO (ISO 81060-2:2018)+Amd1:2020 standard. Blood pressure was measured using the same arm for consistency, and the monitor's cuff fits arm with circumferences between 22.0 cm and 42.0 cm. Out of 89 people recruited, 85 were included in the final analysis. The differences between the Omron J760 and a standard reference device were small: 0.2 mmHg (plus or minus 5.74 mmHg) for systolic blood pressure and -0.9 mmHg (plus or minus 4.69 mmHg) for diastolic blood pressure, meeting the required standards that allow differences of up to 5 mmHg on average, with a standard deviation of up to 8 mmHg. A second set of criteria was also met, with differences of 0.2 mmHg (plus or minus 5.10 mmHg) for systolic and -0.9 mmHg (plus or minus 4.30 mmHg) for diastolic blood pressure, meeting the standards of 6.95 mmHg and 6.88 mmHg respectively. The findings of this study indicate that the Omron J760 electronic BP monitor complies with the ISO 81060–2:2018 + Amd 1:2020 standards and accurately measures BP in the general adult population with an arm circumference of 22-42 cm.
Source: Figshare
Authors: Chen, Bihua, Chen, Guorong, Jiang, Hong, Ya, Sun, Chen, Jie, Wang, Dan, Chen, Mingzhi, Shi, Jia, Peng, Yan, Cheng, Yimin, Yang, Cheng, Ding, Yuanyuan, Su, Jin, Liu, Ming, Shen, Fulai, Qiu, Yicheng, Shen, Yi, Cao, Qiyun, Su, Jiayu
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6902268605
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