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

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.

Keywords: AAMI; ANSI; ISO81060-2:2013; blood pressure; blood pressure monitor; self-measurement; validation; wearable.

Conflict of interest statement

Dr Mitsuo Kuwabara, Ms Kanako Harada, and Ms Yukiko Hishiki are employees of Omron Healthcare Co., Ltd.

©2019 Wiley Periodicals, Inc.

Figures

Figure 1

Appearance of a watch‐type wearable BP monitor (Omron HEM‐6410T‐ZM or HEM‐6410T‐ZL)

Figure 2

Bland‐Altman plots for the differences between the Omron HEM‐6410T‐ZM readings and the observer measurements for SBP (A) and DBP (B) (N = 255), and the differences between the Omron HEM‐6410T‐ZL readings and the observer measurements for SBP (C) and DBP (D) (N = 255)