Validation of the RisingSun RS-651 Blood Pressure Monitor Based on Auscultation in Adults According to the ANSI/AAMI/ISO 81060-2:2013 Standard

Abstract

This study validated the RisingSun RS-651 blood pressure (BP) monitor based on auscultation in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard. The RS-651 device was evaluated in a study of 97 participants. The same arm simultaneous method, as defined in the ANSI/AAMI/ISO standard, was used. The mean differences±standard deviation for criterion 1 were 0.8±2.3 mm Hg for systolic BP (SBP) and −0.1±2.9 mm Hg for diastolic BP (DBP). Analysis for criterion 2 resulted in values of 0.8±1.5 mm Hg for SBP and −0.1±2.1 mm Hg for DBP. All of the data fulfilled the ANSI/AAMI/ISO 81060-2:2013 standard requirements to pass the validation. The RisingSun RS-651 device can be recommended for both clinical and self/home use in adults according to the ANSI/AAMI/ISO 81060-2:2013 standard.