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

ABSTRACT

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.