Validation of the YuWell YE680B upper-arm blood pressure monitor in adults according to the ANSI/AAMI/ISO 81060-2: 2013 standard.

Abstract

To evaluate the accuracy of the YuWell YE680B oscillometric upper-arm blood pressure monitor for clinic and home blood pressure measurements in adults according to the American National Standards Institute/the Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard. Eighty-five subjects (male 46 and female 39) with a mean age of 44.6 years were recruited to fulfill the age, sex, blood pressure, and cuff distribution criteria of the ANSI/AAMI/ISO standard in the general population using the same arm sequential blood pressure measurement method. Two differently-sized cuffs were used for arm circumferences 22-32 cm (medium) and 22-45 cm (large), respectively, for the test device, and for arm circumferences ≤32 cm (standard) and >32 cm (large), respectively, for the mercury sphygmomanometer. A total of 255 comparison pairs were obtained for analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference systolic/diastolic blood pressure readings was -2.2 ± 7.2/-3.9 ± 5.2 mmHg. For validation criterion 2, the SD of the averaged systolic/diastolic blood pressure differences between the test device and reference blood pressure per subject was 5.70/4.67 mmHg. The automated upper-arm blood pressure monitor YuWell YE680B has passed the requirements of the ANSI/AAMI/ISO81060-2:2013 standard, and hence can be recommended for blood pressure measurement in the general population.