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
Authors Takahashi H, Saito K
Received 15 October 2020
Accepted for publication 10 December 2020
Published 29 December 2020 Volume 2020:16 Pages 571—575
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 4
Editor who approved publication: Dr Daniel A. Duprez
Hakuo Takahashi,1 Kanako Saito2
1Department of Cardiology, Biwako Central Hospital, Otsu City, Shiga 520-0834, Japan; 2Department of Technology Development, Omron Healthcare Co., Ltd, Mukou City, Kyoto, Japan
Correspondence: Hakuo Takahashi
Department of Cardiology, Biwako Central Hospital, 1-21-27, Hieidaira, Otsu City, Shiga 520-0016, Japan
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.
Keywords: blood pressure monitoring device, accuracy, protocol, standard, validation