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

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 blo...

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Main Authors: Saito K, Hishiki Y, Takahashi H
Format: Article
Language:English
Published: Dove Medical Press 2019-03-01
Series:Vascular Health and Risk Management
Subjects:
Online Access:https://www.dovepress.com/validation-of-two-automatic-devices-omron-hem-6232t-and-hem-6181-for-s-peer-reviewed-article-VHRM
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author Saito K
Hishiki Y
Takahashi H
author_facet Saito K
Hishiki Y
Takahashi H
author_sort Saito K
collection DOAJ
description 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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spelling doaj.art-3b6c19185dbd4f849ef77841c51165a02022-12-22T03:42:22ZengDove Medical PressVascular Health and Risk Management1178-20482019-03-01Volume 15475544465Validation 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 2010Saito KHishiki YTakahashi HKanako 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, validationhttps://www.dovepress.com/validation-of-two-automatic-devices-omron-hem-6232t-and-hem-6181-for-s-peer-reviewed-article-VHRMBlood pressure measurementdeviceguidelineInternational Protocolvalidation
spellingShingle Saito K
Hishiki Y
Takahashi H
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
Vascular Health and Risk Management
Blood pressure measurement
device
guideline
International Protocol
validation
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Blood pressure measurement
device
guideline
International Protocol
validation
url https://www.dovepress.com/validation-of-two-automatic-devices-omron-hem-6232t-and-hem-6181-for-s-peer-reviewed-article-VHRM
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