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
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.
Journal of clinical hypertension