Validation of the YuWell YE900 oscillometric blood pressure monitor for professional office use in adults and children according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)

Abstract

Objective: To evaluate the accuracy of the YuWell YE900 oscillometric upper-arm professional office blood pressure monitor in adults and children according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

Methods: Subjects were recruited to fulfill the age, sex, blood pressure and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in adults and children (aged 3-12 years) using the same arm sequential blood pressure measurement method. Three cuffs of the test device were used for arm circumference 18-22 cm (small), 22-32 cm (medium) and 32-42 cm (large).

Results: Ninety-two subjects were recruited, and 85 (50 adults and 35 children) were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was 1.7 ± 6.62/3.1 ± 5.76 mmHg (systolic/diastolic). For validation criterion 2, the SD of the averaged blood pressure differences between the test device and reference blood pressure per subject was 5.25/5.13 mmHg (systolic/diastolic).

Conclusion: The YuWell YE900 professional electronic blood pressure monitor has passed the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in adults and children and can be recommended for clinical use.

Trial registration: ClinicalTrials.gov NCT04379323.