Validation of the Microlife WatchBP O3 (BP3SZ1-1) upper-arm, oscillometric blood pressure device in pregnancy according to ISO 81060-2:2018.

Abstract

To assess the accuracy of the Microlife WatchBP O3 upper-arm, oscillometric blood pressure (BP) device, suitable for clinic, home, and ambulatory use, in a pregnant population. This device was assessed according to the ISO 81060-2:2018 protocol in 45 pregnant women, including women with gestational hypertension and pre-eclampsia. Two cuff sizes were available for arm circumferences of 22-32 and 32-42 cm. Nine sequential same-arm measurements were obtained from each participant, alternating between the test device and auscultation. Forty-nine women were included, and four were excluded. Data from 45 women, including 14 women with gestational hypertension and 15 women with pre-eclampsia, were analyzed according to the protocol. The mean difference with SDs were 0.6 ± 7.9 mmHg for SBP and 3.4 ± 6.0 mmHg for DBP. The Microlife WatchBP O3 upper-arm, oscillometric BP device passed the criteria of the ISO 81060-2:2018 standard in normotensive pregnant women, women with gestational hypertension, and women with pre-eclampsia.