Vascular Health and Risk Management (Mar 2019)
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
Abstract
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
