Validation of a wrist-type home nocturnal blood pressure monitor in the sitting and supine position according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-9600T

Abstract

The purpose of the present study was to evaluate the performance of the Omron HEM-9600T, an automatic wrist-type device for self BP measurement, in the sitting position with the wrist at heart level and supine position according to the ANSI/AAMI/ISO81060-2:2013 guidelines. In the supine position, we evaluated the device under 3 different conditions: using the supine with sideways palm position, the supine with upwards palm position, and the supine with downwards palm position. After 106 subjects were screened and 21 subjects were excluded, the same 85 subjects (38 men [44.7%] and 47 women [55.3%]) were included in the analyses for each position. The average age of the subjects was 54.5 ± 12.2 years (mean ± SD). The mean wrist circumference was 17.0 ± 2.4 cm. The wrist size distribution fulfilled the requirements of the guidelines. The mean differences between reference BPs and HEM-9600T readings were 1.0 ± 6.7/1.4 ± 5.7 mm Hg, 6.6 ± 7.2/5.5 ± 6.0 mm Hg, 4.8 ± 7.2/4.9 ± 5.8 mm Hg, and 2.1 ± 7.2/2.8 ± 6.8 mm Hg for SBP/DBP in the sitting position, supine with sideways palm position, supine with upwards palm position, and supine with downwards palm position, respectively. In conclusion, the Omron HEM-9600T in the sitting position fulfilled the validation criteria of the ANSI/AAMI/ISO81060-2:2013 guidelines. On the other hand, the accuracies of HEM-9600T in the supine position differed depending on the positioning of the palm, with only the downwards palm-position measurement fulfilling both validation criteria of the ANSI/AAMI/ISO81060-2:2013 guidelines.

Keywords: ANSI/AAMI/ISO81060-2:2013; blood pressure; home nocturnal blood pressure; self-measurement; validation; wrist-type blood pressure monitor.

Conflict of interest statement

The authors have no disclosures to declare.

©2019 Wiley Periodicals, Inc.

Figures

Figure 1

Bland‐Altman plots for the differences between the Omron HEM‐9600T readings and the observer measurements for systolic blood pressure in the sitting position (A), the supine position with sideways palm (B), the supine position with upwards palm (C), and the supine position with downwards palm (D) (N = 255)

Figure 2

Bland‐Altman plots for the differences between the Omron HEM‐9600T readings and the observer measurements for diastolic blood pressure in the sitting position (A), the supine position with sideways palm (B), the supine position with upwards palm (C), and the supine position with downwards palm (D) (N = 255)