Validation of the RisingSun RS-651 Blood Pressure Monitor Based on Auscultation in Adults According to the ANSI/AAMI/ISO 81060-2:2013 Standard.
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.
School of Biological Science and Medical Engineering, Beihang University, Beijing, China.
Jin
J
She
Department of Respiratory Diseases, Chinese PLA (People's Liberation Army) General Hospital, Beijing, China.
Xizhou
X
Guan
Aviation Medicine Engineering Center, Institute of Aviation Medicine, Beijing, China.
Yanyong
Y
Liu
Aviation Medicine Engineering Center, Institute of Aviation Medicine, Beijing, China.
Haiyan
H
Xiang
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001314:Auscultation; D001795:Blood Pressure Determination / Q000145:classification / Q000295:instrumentation*; D015924:Blood Pressure Monitors / Q000592:standards*; D004867:Equipment Design; D005260:Female; D006801:Humans; D006973:Hypertension / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D055815:Young Adult