Validation of TMB-2285-BT wrist blood pressure monitor in general population according to the ISO 81060-2:2018 + Amd.1:2020 Protocol

The objective of this study is to evaluate the accuracy of the wrist blood pressure (BP) monitor (TMB-2285-BT) in general population according to international standard of ISO 81060-2:2018+Amd.1:2020. The TMB-2285-BT BP monitor is an oscillometric device measuring BP from wrist. A single cuff for wrist sizes of 13.5-21.5 cm was used for the test device. The study was performed according to the 'International Standard (ISO 81060-2:2018 + Amd.1:2020) protocol' using the same-arm sequential BP measurement method. Subjects ( n ≥ 85) fulfilling the age, gender, BP, and cuff distribution criteria of the protocol were enrolled. For criterion 1, the mean difference of SBP and DBP between the test device and the reference device was -0.27 mmHg and -0.80 mmHg, respectively. For criterion 2, the SD of the averaged paired determinations of SBP and DBP for the test device and the reference device was 2.60 and 2.06 mmHg, respectively, both of which were less than 6.95 and 6.89 mmHg. The accuracy of the test device fulfilled the requirements of the criterion 1 and 2 of ISO 81060-2:2018 + Amd.1:2020. The TMB-2285-BT wrist BP monitor can be recommended for home BP measurement for general population.