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.

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.