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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

DOI https://doi.org/10.2147/VHRM.S287016

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
Tel +81-775290201
Fax +81-775020116
Email takahash304@gmail.com

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

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