Validation of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the ISO 81060-2:2018/AMD 1:2020 Protocol

Abstract

Objective To evaluate the accuracy of the U60EH Wrist Electronic Blood Pressure Monitor in general population according to the Universal Standard (ISO 81060-2:2018/AMD 1:2020). Methods Subjects were recruited to fulfill the age, gender, blood pressure (BP) and cuff distribution criteria of the Universal Standard in a general population using the same arm sequential BP measurement method. A single cuff for wrist sizes 13.5–21.5 cm was used on this test device. Results According to Criterion 1, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, with an SD of 6.48 mmHg. The mean difference of DBP was −0.44 mmHg, with an SD of 5.98 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, the mean difference of SBP between the test device and the reference device was 1.51 mmHg, and the SD was 5.88 mmHg, which was less than 6.78 mmHg and met the requirements. The mean difference of DBP was −0.44 mmHg, and the SD was 5.22 mmHg, which was less than 6.93 mmHg and met the requirements. Conclusion All results passed the Standard (ISO 81060-2:2018/AMD 1:2020) requirements. The U60EH Wrist Electronic Blood Pressure Monitor can be recommended for home and clinical use.