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

Q: What is the clinical evidence from this study?

Study design: Cross-Sectional. Population: Blood pressure measurement validation in children and adolescents (n=85). Intervention: Omron HEM-7120 automated oscillometric upper-arm home blood pressure monitor vs. Calibrated mercury sphygmomanometer (Diplomat-presameter) simultaneous dual-observer auscultation. Primary outcome: Mean device-minus-reference systolic blood pressure (SBP) difference across 255 paired comparisons (AAMI/ESH/ISO Universal Standard Criterion 1) (MD -4.01 mmHg (SD 5.94 mmHg) for SBP; MD -1.83 mmHg (SD 7.20 mmHg) for DBP).

Q: What does this research mean for the field?

The Omron HEM-7120 automated oscillometric blood pressure monitor meets the AAMI/ESH/ISO numerical accuracy criteria for systolic and diastolic blood pressure in children and adolescents, despite not fulfilling all protocol requirements for full validation. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Tipanan Pisithkul; Kwanchai Pirojsakul

doi:10.1111/jch.70370

October 1, 2026Journal of Clinical HypertensionOpen Access

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

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Key result

Omron HEM-7120 meets pediatric BP accuracy criteria with a ~4 mmHg mean systolic difference.

MD -4.01 mmHg (SD 5.94 mmHg) for SBP; MD -1.83 mmHg (SD 7.20 mmHg) for DBP
n=85

Figures

Why the study?

The accuracy of the Omron HEM-7120 automated oscillometric upper-arm home blood pressure monitor in children and adolescents against the AAMI/ESH/ISO Universal Standard numerical criteria was evaluated.

Does the Omron HEM-7120 automated oscillometric upper-arm home blood pressure monitor meet the numerical accuracy criteria of the AAMI/ESH/ISO 81060-2:2018 Universal Standard compared with mercury sphygmomanometry in children and adolescents?

Key Points

To evaluate the accuracy of the Omron HEM-7120 automated oscillometric upper-arm blood pressure monitor in pediatric participants using the AAMI/ESH/ISO Universal Standard numerical criteria.
Assessed blood pressure in 85 analyzed children and adolescents (mean age 11.4 ± 3.3 years) providing 255 comparisons across three cuff sizes (12–18, 17–22, and 22–32 cm).
Compared oscillometric device measurements against simultaneous reference auscultation from two observers using the same-arm sequential method.
Tested adherence against Criterion 1 (mean difference ≤ 5 mmHg, SD ≤ 8 mmHg) and Criterion 2 (participant-level standard deviation limits) alongside protocol distribution requirements.
Criterion 1 was met with mean differences of -4.01 ± 5.94 mmHg for systolic blood pressure and -1.83 ± 7.20 mmHg for diastolic blood pressure across 255 paired comparisons.
Criterion 2 was met with participant-level standard deviations of 5.07 mmHg for systolic and 6.48 mmHg for diastolic blood pressure, both below allowable limits of 5.64 mmHg and 6.71 mmHg.
Full validation was not achieved because protocol criteria were unmet for age distribution (42 participants aged > 12 years vs ≥ 50 required), high blood pressure ranges, cuff distribution, and reference variability (only 65 of 85 participants, or 76.5%, met both limits).

Study Design

Type

Cross-Sectional (n=85)

Blinding

Two observers were blinded to each other's readings and to the test-device display

Multicenter

No

Structured PICO

Does the Omron HEM-7120 automated oscillometric upper-arm home blood pressure monitor meet the numerical accuracy criteria of the AAMI/ESH/ISO 81060-2:2018 Universal Standard compared with mercury sphygmomanometry in children and adolescents?

P

Population

85 children and adolescents aged 3-18 years (mean age 11.4 years, 58.8% female, 38.8% with kidney disease) evaluated in a single-center cross-sectional device validation study in Thailand.

E

Exposure

Omron HEM-7120 automated oscillometric upper-arm home blood pressure monitor using three cuff sizes covering arm circumferences of 12-32 cm: Omron GS Cuff SS (12-18 cm, used with an air plug connector), HEM-CS24 small cuff (17-22 cm), and HEM-CR24 medium cuff (22-32 cm), evaluated via the same-arm sequential procedure.

C

Comparator

Simultaneous dual-physician auscultation using a calibrated mercury sphygmomanometer (Diplomat-presameter) and dual-head teaching stethoscope with three reusable V-Lok cuffs (10-19 cm, 18-26 cm, and 25-35 cm), blinded to each other's readings and the test-device display.

O

Outcome

Numerical accuracy according to Criteria 1 and 2 of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018): test-minus-reference blood pressure differences and standard deviations for systolic blood pressure (SBP) and diastolic blood pressure (DBP) across 255 paired comparisons (Criterion 1) and participant-level mean differences across 85 participants (Criterion 2).surrogate

Main Result

Mean Difference: -4.01

The Omron HEM-7120 met the numerical accuracy thresholds of the AAMI/ESH/ISO Universal Standard in children and adolescents, but protocol deviations prevent full formal validation and unrestricted clinical recommendation.

Limitations

Only 42 participants older than 12 years were enrolled, below the required minimum of 50.
Participants with high reference BP were underrepresented, and protocol-specified upper-BP distribution thresholds were not met.
The lower half of the 12-18 cm cuff range included 38.9% of participants (below the required 40%), and only 65 of 85 participants met both reference-BP variability limits.
Observers did not undergo formal 50-measurement pre-study qualification or audiometry, and entry measurements (R0 and T0) were not consistently documented.
The 12-18 cm cuff was not listed by the manufacturer as compatible with the HEM-7120 and was used with an air plug connector; single-center tertiary-care cohort with 38.8% having kidney disease limits generalizability.
Only 42 participants older than 12 years were enrolled, rather than the required minimum of 50.
The lower half of the 12-18 cm cuff range included 38.9% of participants (below the required 40%), and only 65 of 85 participants (76.5%) met both reference-BP variability limits.
Observers did not undergo the formal 50-measurement pre-study qualification or audiometry, and entry measurements (R0 and T0) were not consistently documented.
The 12-18 cm cuff was not listed by the manufacturer as compatible with the HEM-7120 (used with an air plug connector), and the single-center tertiary-care cohort with 38.8% kidney disease limits generalizability.

Implication

Should not yet change pediatric BP monitoring practice; leaves open need for protocol-compliant validation studies in children.

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.

Discussion

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Cite This Study

Pisithkul et al. (2026) conducted a cross-sectional in Blood pressure measurement validation in children and adolescents (n=85). Omron HEM-7120 automated oscillometric upper-arm home blood pressure monitor vs. Calibrated mercury sphygmomanometer (Diplomat-presameter) simultaneous dual-observer auscultation was evaluated on Mean device-minus-reference systolic blood pressure (SBP) difference across 255 paired comparisons (AAMI/ESH/ISO Universal Standard Criterion 1) (MD -4.01 mmHg (SD 5.94 mmHg) for SBP; MD -1.83 mmHg (SD 7.20 mmHg) for DBP). The Omron HEM-7120 met AAMI/ESH/ISO numerical accuracy criteria in children with mean differences of -4.01±5.94 mmHg for SBP and -1.83±7.20 mmHg for DBP, though protocol requirements were not fully met.

synapsesocial.com/papers/6ae5317cf47c78c6bae4b97e https://doi.org/10.1111/jch.70370

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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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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