Journal Article

Validation of the RBP‐9000c Oscillometric Blood Pressure Monitor in the General Population According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ International Organization for Standardization Universal Standard

Yang, Shijie, Miao, Huanhuan, Zhang, Yuqing, Zhou, Zhanyang

2025

Overview

The aim of this study was to evaluate the accuracy of the single upper‐arm cuff oscillometric blood pressure (BP) monitor RBP‐9000 c developed for office and home blood pressure measurement in the general population 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). Subjects were recruited to fulfill the age, gender, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in the general population using the same‐arm sequential BP measurement method. The test device incorporates a single built‐in cuff suitable for 17–42 cm arm circumference. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.4 ± 6.7/3.3 ± 6.3 mmHg (systolic/ diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.28/5.32 mmHg (systolic/diastolic). The RBP‐9000c oscillometric device for office and home BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) in the general population and can be recommended for clinical and self‐use at home. Trial Registration: ChiCTR2300075747

• Publisher: John Wiley & Sons, Inc,Wiley
• Subject: Accuracy / Adult / Aged / Blood pressure / Blood Pressure - physiology / Blood Pressure Determination - instrumentation / Blood Pressure Determination - methods / Blood Pressure Determination - standards / blood pressure monitoring / Blood Pressure Monitoring, Ambulatory - instrumentation / Blood Pressure Monitoring, Ambulatory - methods / Blood Pressure Monitoring, Ambulatory - standards / Blood Pressure Monitors - standards / Cardiac arrhythmia / Europe / Female / Humans / Hypertension / Hypertension - diagnosis / Hypertension - physiopathology / International organizations / ISO protocol / Male / Middle Aged / Original / Oscillometry - instrumentation / Oscillometry - methods / Oscillometry - standards / Personal information / Reference Standards / Reproducibility of Results / validation / Validation studies