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.
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