Abstract
OBJECTIVE: A new automated and adjustable blood pressure (BP) system has been developed to improve the accuracy of BP measurements on public-use health stations. This self-fitting BP system includes a mechanical cuff that wraps down to the user's arm prior to bladder inflation. The purpose of this study was to validate the adaptable BP system (ABPS) using the current standards from the Association for the Advancement of Medical Instrumentation (AAMI). METHODS: The AAMI/ISO 81060:2013 standards for clinical validation of non-invasive automated arterial BP measurement devices were followed precisely using the same arm sequential method. For each participant, BP was measured over multiple trials by trained observers alternating a reference sphygmomanometer with the ABPS. All study requirements were met with 85 qualifying participants, each with 3 valid paired determinations. RESULTS: The mean difference between ABPS BP and reference BP using all 255 paired determinations was -2.4 ± 7.7 mmHg for systolic and 1.7 ± 5.7 mmHg for diastolic. The standard deviation of the averaged paired determinations per participant was 6.3 mmHg for systolic and 5.2 mmHg for diastolic. Arm circumference measurements had a mean error of -2.1 ± 2.4 cm (R(2) = 0.87). A new prediction model for arm circumference was validated using a holdout dataset (R(2) = 0.94). CONCLUSION: The results of the study confirm that the ABPS met all benchmarks established by the AAMI. The device accurately measures BP across a wide range of arm circumferences (24-44 cm) and is suitable for use by individuals to self-monitor BP.