Validation of the RBP‐9801 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

Abstract

Abstract The aim of this study was to evaluate the accuracy of the single upper‐arm cuff oscillometric blood pressure (BP) monitor RBP‐9801 developed for office and home BP 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 fulfil the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. A total of 105 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.3 ± 6.4/3.1 ± 5.8 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.24/5.03 mmHg (systolic/diastolic). The conclusion is that the RBP‐9801 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 clinic and self‐use at home.

Keywords

• accuracy
• blood pressure monitoring
• ISO protocol
• Validation