Validation of the YuWell YE990 medical automatic electronic blood pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018/Amd.1:2020).

Abstract

To validate the accuracy of the YuWell YE990 automated oscillometric upper-arm medical blood pressure (BP) monitor in adults according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal standards (ISO 81060-2:2018 and Amendment 1:2020). Participants were recruited to meet the age, sex, BP, and cuff distribution criteria of the AAMI/ESH/ISO standards. BP was measured using a mercury sphygmomanometer (reference device) and YE990 (test device) following a same-arm sequential protocol with two trained observers and a supervisor. Bland-Altman plots were used to assess agreement, and scatter plots were used to assess the performance across varying arm sizes. Ninety-nine subjects were recruited and 85 were analyzed. The YE990 passed the accuracy requirements of the AAMI/ESH/ISO standards, with mean differences of 0.4 ± 6.31 mmHg for systolic BP and -0.9 ± 6.28 mmHg for diastolic BP for validation criterion 1. For validation criterion 2, the SD of the average BP difference between the test device and reference BP per subject was 5.00/5.70 mmHg (systolic/diastolic). YuWell YE990 meets the AAMI/ESH/ISO universal accuracy standard (ISO 81060-2:2018+Amd.1:2020) and is recommended for clinical use.