Validation Of The Single-Cuff Oscillometric Blood Pressure Monitor Inbody Bpbio750 For Public Spaces According To The Association For The Advancement Of Medical Instrumentation/European Society Of Hypertension/International Organization For Standardization Universal Standard

ObjectiveThe aim of this study was to evaluate the accuracy of the single upper-arm cuff oscillometric blood pressure (BP) monitor InBody BPBIO750 developed for self-measurement by adults in public spaces (kiosk) 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).MethodsSubjects 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.ResultsA total of 102 subjects were recruited and 85 were analyzed [mean age 56.7 +/- 15.4 (SD) years, 40 men, arm circumference 32.3 +/- 5.3 cm, range 22-42 cm]. For validation criterion 1, the mean +/- SD of the differences between the test device and reference BP readings was 2.2 +/- 6.1/-2.2 +/- 5.2 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.00/4.63 mmHg (systolic/diastolic).ConclusionThe InBody BPBIO750 device fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use in adults.