Validation of an automatic device for the self-measurement of blood pressure in sitting and supine positions according to the ANSI/AAMI/ISO81060-2

Abstract

AIM: We evaluated the performance of the Omron HEM-9700T, an automatic upper-arm-type device for the self-measurement of blood pressure (BP), in the sitting and supine positions according to the ANSI/AAMI/ISO81060-2:2013 guidelines. PARTICIPANTS AND METHODS: We screened 106 participants for the validation study in both positions. After excluding 21 participants, a total of 85 participants [38 (44.7%) men; 47 (55.3%) women] with mean±SD age of 54.5±12.2 years (range: 21-78 years) were included. Their arm circumference was 27.5±1.4cm (range: 17.9-40.8cm). The arm circumference distribution met the ANSI/AAMI/ISO81060-2:2013 requirement. The participants' BP measurements alternated between the use of a conventional mercury sphygmomanometer and the automatic device according to the ANSI/AAMI/ISO81060-2:2013 guidelines to measure their BP. RESULTS: The mean differences between reference BPs and HEM-9700T readings in the sitting and supine positions were -0.6±6.4/1.3±5.5 and -1.0±6.2/1.9±5.4mmHg for systolic BP/diastolic BP, respectively. CONCLUSION: The Omron HEM-9700T fulfilled the validation criteria of the ANSI/AAMI/ISO81060-2:2013 guidelines for both the sitting and supine positions.