Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-6410T-ZM and HEM-6410T-ZL.

根据 ANSI / AAMI / ISO81060 - 2: 2013 指南验证两种手表型可穿戴式血压监测器: Omron HEM - 6410T - ZM 和 HEM - 6410T - ZL 。

• 影响指数: 2.885
• 发表时间: 06 2019
• 来源期刊: J Clin Hypertens (Greenwich)
• DOI: 10.1111/jch.13499
• PMID: 30803128
• 文章类型: Journal Article
• 中科院分区: Q3
• 方向: 医学
• 作者列表: Kuwabara M,Harada K,Hishiki Y,Kario K

关键词: AAMI; ANSI; ISO81060-2:2013; blood pressure; blood pressure monitor; self-measurement; validation; wearable

Mesh: Aged; Biological Variation, Population; Blood Pressure Monitoring, Ambulatory / instrumentation; Blood Pressure Monitors / supply & distribution trends; Case-Control Studies; Equipment Design / instrumentation statistics & numerical data; Female; Guidelines as Topic; Humans; Japan / epidemiology; Male; Masked Hypertension / diagnosis physiopathology; Middle Aged; Reproducibility of Results; Wearable Electronic Devices / supply & distribution trends

Abstract

There is growing evidence of the clinical significance of daytime masked hypertension (MHT) and blood pressure (BP) variability (BPV). Recently, watch-type wearable devices for self-BP measurement have become available. Such devices might be promising tools to identify patients with daytime MHT or large BPV in their real-life conditions. The present study aimed to validate the accuracy of the Omron HEM-6410T-ZM and the Omron HEM-6410T-ZL, which are automatic watch-type wearable devices for self-BP measurement, according to the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 guideline. Watches were held with the wrist at heart level. The mean differences between reference BPs and HEM-6410T-ZM readings were -0.9 ± 7.6/-1.1 ± 6.1 mm Hg for systolic BP (SBP)/diastolic BP (DBP) for criterion 1, and -0.9 ± 6.8/-1.1 ± 5.5 mm Hg for SBP/DBP for criterion 2. The mean differences between reference BPs and HEM-6410T-ZL readings were 2.4 ± 7.3/0.7 ± 7.0 mm Hg for SBP/DBP for criterion 1, and 2.4 ± 6.5/0.7 ± 6.5 mm Hg for SBP/DBP for criterion 2. The Omron HEM-6410T-ZM and the Omron HEM-6410T-ZL both fulfilled both validation criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 guidelines.

摘要

越来越多的证据表明白天隐匿性高血压（MHT）和血压（BP）变异性（BPV）的临床意义。最近,用于自我BP测量的手表型可穿戴设备已经可用。这种设备可能是在现实生活中识别白天MHT或大型BPV患者的有希望的工具。本研究旨在验证欧姆龙HEM-6410T-ZM和欧姆龙HEM-6410T-ZL的准确性，它们是用于自我血压测量的自动手表型可穿戴设备，根据美国国家标准协会的说法，Inc/医疗器械促进协会/国际标准化组织（ANSI/AAMI/ISO）81060-2：2013指南。腕部将手表保持在心脏水平。标准1的收缩压（SBP）/舒张压（DBP）参考BP和HEM-6410T-ZM读数之间的平均差异为-0.9±7.6/-1.1±6.1mmHg，标准2的SBP/DBP为-0.9±6.8/-1.1±5.5mmHg。参考BP和HEM-6410T-ZL读数之间的平均差异对于标准1的SBP/DBP为2.4±7.3/0.7±7.0mmHg，对于标准2的SBP/DBP为2.4±6.5/0.7±6.5mmHg。OmronHEM-6410T-ZM和OmronHEM-6410T-ZL均符合ANSI/AAMI/ISO81060-2:2013指南的验证标准1和2。