Validation of the DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor in the general population according to the ISO 81060-2:2018/AMD 1:2020 protocol.

Abstract

The aim of this study was to evaluate the accuracy of the DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor in the general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). The test monitor was used to measure SBP and DBP and pulse rate in the wrists using the oscillometric method. According to this protocol using the same-arm sequential blood pressure measurement method, subjects were recruited to fulfill the age, sex, blood pressure, and cuff distribution criteria of the Universal Standard. A single cuff for wrist sizes of 13.5-21.5 cm was used. A total of 85 subjects were included in this study. According to Criterion 1, the mean difference in SBP between the test device and the reference device was 0.89 mmHg, with a SD of 7.76 mmHg. The mean difference of DBP was -1.44 mmHg, with a SD of 6.23 mmHg. The mean difference between SBP and DBP was less than 5.0 mmHg, and the SD was less than 8.0 mmHg, which met the requirements. According to Criterion 2, the SD of the mean differences of SBP between the test device and the reference device per subject was 5.65 mmHg, which was less than 6.88 mmHg and met the requirements. The SD of the mean differences of DBP between the test device and the reference device per subject was 5.61 mmHg, which was less than 6.78 mmHg and met the requirements. The DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor met the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018/AMD 1 : 2020). It can be recommended for home and clinical use.