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.