Accuracy Evaluation of the Omron HEM-7120 Automated Oscillometric Upper-arm Home Blood Pressure Monitor in Children and Adolescents Using the AAMI/ESH/ISO 81060-2:2018 Numerical Criteria

This study evaluated the Omron HEM-7120 automated oscillometric upper-arm home blood pressure monitor in children and adolescents against the numerical accuracy criteria of the AAMI/ESH/ISO Universal Standard. Test readings were compared with mercury auscultatory readings from two physicians using the same-arm sequential method. Three cuffs covered arm circumferences of 12-18, 17-22, and 22-32 cm. Of 90 participants, 85 were analyzed, yielding 255 comparisons. Mean differences were -4.0 ± 5.94 mmHg for systolic and -1.8 ± 7.20 mmHg for diastolic blood pressure, meeting Criterion 1. Participant standard deviations were 5.07 and 6.48 mmHg, below Criterion 2 limits. However, the requirements regarding age, reference-blood-pressure and cuff distributions, reference-measurement variability, and observer qualification were not fully met. The device met numerical criteria in this cohort, but it is not fully validated under the Universal Standard.