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标题：Validation of the Omron HEM-1040 Blood Pressure Monitor According to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 Protocol
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作者：Hakuo Takahashi ; Kanako Saito
期刊名称：Vascular Health and Risk Management
印刷版ISSN：1176-6344
电子版ISSN：1178-2048
出版年度：2020
卷号：Volume 16
页码：571-575
DOI：10.2147/VHRM.S287016
出版社：Dove Medical Press Ltd
摘要：Objective :The accuracy of the Omron HEM-1040 automated oscillometric upper-arm blood pressure (BP) monitoring device, designed for home self-measurements in adult populations, was tested according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 protocol. Methods :The requirements of this protocol were precisely followed with the recruitment of 85 individuals in whom sequential systolic BP (SBP) and diastolic BP (DBP) were measured in the same (left) arm and who fulfilled the inclusion criteria involving the ranges of arm circumference, SBP, and DBP. Results :The mean device-observer difference in the 255 separate pairs of BP data was -2.7 ± 7.14 mmHg for SBP and -3.3 ± 5.70 mmHg for DBP. The data were in accordance with criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤ 5 ± ≤ 8 mmHg). In addition, the mean device-observer difference in the 85 participants was -2.7 ± 5.89 mmHg for SBP and -3.3 ± 4.99 mmHg for DBP, fulfilling criterion 2 with a standard deviation of ≤ 6.39 mmHg for SBP and ≤ 6.09 mmHg for DBP. Conclusion :The OMRON HEM-1040 BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard. © 2020 Takahashi and Saito.
关键词：accuracy;blood pressure monitoring device;protocol;standard;validation