Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010
Authors Saito K, Hishiki Y, Takahashi H
Received 19 September 2018
Accepted for publication 16 January 2019
Published 6 March 2019 Volume 2019:15 Pages 47—55
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 3
Editor who approved publication: Dr Bojan Jelaković
Kanako Saito,1 Yukiko Hishiki,1 Hakuo Takahashi2
1Department of Technology Development, Omron Healthcare Co, Ltd., Mukou City, Kyoto, Japan; 2Department of Cardiology, Biwako Central Hospital, Otsu City, Shiga, Japan
Objective: The performance of Omron HEM-6232T and Omron HEM-6181 for monitoring blood pressure (BP) at the wrist was validated in accordance with the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) and the European Society of Hypertension International Protocol revision 2010 (ESH IP2).
Methods: Three trained medical technologists validated the performance of these devices by comparing data obtained from these devices with those obtained using a standard mercury sphygmomanometer.
Results: The mean differences between the devices and mercury readings for SBP and DBP were as follows: HEM-6232T, –0.4±6.7 mmHg and 1.6±5.4 mmHg, respectively; HEM-6181, –0.7±6.2 mmHg and –0.7±5.2 mmHg, respectively, satisfying the ANSI/AAMI/ISO protocol. The mean device–observer measurement difference was –0.9±5.7 mm Hg and 0.2±4.6 mm Hg for SBP and 0.5±4.9 mm Hg and 1.4±3.5 mm Hg for DBP, for HEM-6232T and HEM-6181, respectively, satisfying part 1 of the ESH-IP2. All differences for SBP and DBP in both devices satisfied part 2 of the ESH-IP2. The number of absolute differences in the values obtained using the devices and those measured by the observers fulfilled the requirements of the ANSI/AAMI/ISO and the ESH IP2.
Conclusion: The Omron HEM-6232T and HEM-6181 devices met all the requirements of the ANSI/AAMI/ISO and the ESH IP2.
Keywords: blood pressure measurement, device, guideline, international protocol, validation
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