Validation of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) and the International Organization for Standardization Amendment 1. 2020

Abstract

Objective: To evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure (BP) monitor in general population (for clinic and home BP measurements in adults) 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) and its Amendment 1. 2020.

Methods: Subjects were recruited to fulfill the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumferences 22-32 cm (standard) and 22-45 cm (wide range).

Results: Ninety-two subjects were recruited and 85 subjects were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.3 ± 7.2/2.2 ± 5.5 mmHg (systolic/diastolic). For validation criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 6.1/4.8 mmHg (systolic/diastolic).

Conclusion: The YuWell YE660D oscillometric upper-arm electronic BP monitor has passed the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its Amendment 1. 2020 in adults and hence can be recommended for home and clinical use.

Trial registration: ClinicalTrials.gov NCT number.