Background This study aimed to validate the accuracy of the YuWell YE990 automated oscillometric upper-arm blood pressure (BP) monitor in pregnant adults according to the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Common Criteria Universal Standard (ISO 81060-2:2018 + Amd.1:2020). Methods Participants with normotension, hypertension without proteinuria, or pre-eclampsia were enrolled in this study. BP measurements were performed using a calibrated mercury sphygmomanometer (reference) and a YE990 device (test) following a same-arm sequential protocol conducted by two trained observers. Results A total of 46 participants (138 paired readings) were included in the final analysis. For criterion 1 of the standard, the mean difference between the test and reference devices was −2.9 ± 6.9 mmHg for systolic BP (SBP) and 0.0 ± 6.5 mmHg for diastolic BP (DBP), both within the required limits. For criterion 2, the subject-level SDs were 5.6 mmHg for SBP and 5.7 mmHg for DBP, also satisfying the ISO thresholds of 6.30 and 6.95 mmHg, respectively. Conclusion YuWell YE990 met all accuracy criteria specified by the ISO 81060-2:2018 + Amd.1:2020 standard and is recommended for clinical use in pregnant populations.
Du et al. (Tue,) studied this question.