ABSTRACT
This study aimed to validate the accuracy of DBP-6279B, an automated inflationary oscillometric upper-arm blood pressure (BP) monitor, in the sitting position according to the AAMI/ESH/ISO (81060-2â :â 2018â +â Amd.1â :â 2020) universal standard protocol. SBPs and DBPs were measured simultaneously on the same arm in 88 adults (femaleâ :â maleâ =â 47â :â 41) with a mean age of 56.85â years using a mercury sphygmomanometer (two observers) and a DBP-6279B device (one supervisor). The AAMI/ESH/ISO 81060-2â :â 2018 and Amd.1â :â 2020 universal standards for the validation of BP-measuring devices in adults and adolescents were followed. A total of 259 valid pairs of data were used in the analysis. According to Criterion 1, the mean difference of SBP between the test device (DBP-6279B) and the reference device (the mercury sphygmomanometer) was 0.75â mmHg, with a SD of 7.66â mmHg. The mean difference in DBP was 1.13â mmHg, with a SD of 6.14â mmHg. The mean difference of both SBP and DBP was less than 5â mmHg, and the SD was less than 8â mmHg, which met the requirements. According to Criterion 2, the mean difference of SBP between the test device and the reference device was 0.85â mmHg, and the SD was 6.56â mmHg, which was less than 6.88â mmHg and met the requirements. The mean difference in DBP was 1.27â mmHg, and the SD was 5.42â mmHg, which was less than 6.82â mmHg and met the requirements. DBP-6279B fulfilled the requirements of the AAMI/ESH/ISO universal standard (ISO 81060-2â :â 2018â +â Amd.1â :â 2020); hence, it can be recommended for both clinical and self/home BP measurement in adults and adolescents.