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.

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

Ngôn ngữ: eng

Ký hiệu phân loại: 133.594 Types or schools of astrology originating in or associated with a

Thông tin xuất bản: England : Blood pressure , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 662068

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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