VALIDATION OF THE INBODY BPBIO750 OSCILLOMETRIC BLOOD PRESSURE MONITOR FOR PUBLIC SPACES (KIOSK) ACCORDING TO THE AAMI/ESH/ISO UNIVERSAL STANDARD

Abstract

Objective: To evaluate the accuracy of the upper-arm cuff oscillometric blood pressure (BP) monitor InBody BPBIO750 developed for self-measurement by adults in public spaces (kiosk) in 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). Design and method: 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. The device has a fixed hole to insert the user's arm with a single implanted upper-arm cuff. Results: A 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 (N = 255) 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 individual (N = 85) was 5.00/4.63 mmHg (systolic/diastolic). Conclusions: The InBody BPBIO750 oscillometric device for BP measurement in public spaces 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.