Validation of the validity of the new wrist-type fully automatic blood pressure monitor: DBP-2242 according to ISO 81060-2:2018+AMD 1:2020

Abstract

Objective: Evaluation of the accuracy of the wrist-type fully automatic blood pressure (BP) monitor: DBP-2242 in adolescent and adult populations according to ISO 81060-2 : 2018+Amd.1 : 2020.

Methods: BP measurements were taken from the subjects using the same-arm sequential method, and BP data measured by a mercury sphygmomanometer was used as the standard.

Results: This study analyzed 262 sets of data from 89 subjects. According to criterion 1, the mean difference between the SBP of the test and reference devices was -0.57 ± 7.31 mmHg, and the DBP was -2.27 ± 7.17 mmHg, which is in accordance with the requirements. According to criterion 2, the average difference between the SBP was -0.57 ± 6.25 mmHg and the DBP was -2.27 ± 5.99 mmHg, which is in accordance with the requirements.

Conclusion: Wrist-type fully automatic BP monitor: DBP-2242 complies with ISO 81060-2 : 2018+Amd.1 : 2020 and can be used for BP measurement in adolescent and adult populations.