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.

The Omron HEM-7120 met Criterion 1 for both systolic and diastolic blood pressure in children and adolescents.

• Mean differences between device and mercury auscultatory reference were -4.0 ± 5.94 mmHg for systolic BP.
• Mean differences for diastolic BP were -1.8 ± 7.20 mmHg.
• Of 90 participants enrolled, 85 were analyzed, yielding 255 paired comparisons.
• Reference readings came from two physicians using the same-arm sequential method.

The device met Criterion 2 for both systolic and diastolic blood pressure.

• Standard deviations of the averaged per-participant differences were 5.07 mmHg for systolic and 6.48 mmHg for diastolic BP.
• Both values were below the Criterion 2 limits.

The device systematically underestimated systolic and diastolic blood pressure relative to mercury auscultation on average.

• Mean device-minus-reference differences were negative for both systolic (-4.0 mmHg) and diastolic (-1.8 mmHg) BP.
• The systolic bias was larger in magnitude than the diastolic bias.

The study design used three cuff sizes covering a range of arm circumferences.

• Cuffs covered arm circumferences of 12-18 cm, 17-22 cm, and 22-32 cm.
• Each participant's readings were compared sequentially against mercury auscultatory readings.

Several requirements of the Universal Standard protocol were not fully met, so the device is not considered fully validated.

• Unmet requirements included age distribution, reference-blood-pressure distribution, and cuff distribution.
• Reference-measurement variability and observer qualification requirements were also not fully met.
• The authors conclude the device met numerical criteria in this cohort but is not fully validated under the Universal Standard.