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

• Published in: The journal of clinical hypertension (Greenwich, Conn.) Vol. 21; no. 4; pp. 463 - 469
• Main Authors: Kuwabara, Mitsuo, Harada, Kanako, Hishiki, Yukiko, Kario, Kazuomi
• Format: Journal Article
• Language: English
• Published: United States John Wiley and Sons Inc 01.04.2019
• Subjects: Adult; Aged; ANSI/AAMI/ISO81060‐2:2013; blood pressure; Blood Pressure Determination - instrumentation; Blood Pressure Measurement; Blood Pressure Monitoring, Ambulatory - methods; Blood Pressure Monitoring, Ambulatory - statistics & numerical data; Blood Pressure Monitors - statistics & numerical data; Blood Pressure Monitors - trends; Circadian Rhythm - physiology; Equipment Design; Female; Guidelines as Topic; home nocturnal blood pressure; Humans; Male; Middle Aged; Original Paper; self‐measurement; Sitting Position; Supine Position - physiology; validation; Wrist - anatomy & histology; Wrist - physiology; wrist‐type blood pressure monitor; wrist-type blood pressure monitor; blood pressure; self-measurement; home nocturnal blood pressure; ANSI/AAMI/ISO81060-2:2013; validation
• ISSN: 1524-6175; 1751-7176; 1751-7176
• DOI: 10.1111/jch.13464

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.