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October 3, 2026Blood Pressure MonitoringOpen Access

Validation of the ARM-30F-XL arm blood pressure monitor with multiple cuff sizes according to the International Standard ISO 81060-2:2018+Amd 2:2024

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Key result

ARM-30F-XL blood pressure monitor meets ISO accuracy standards vs. standard mercury sphygmomanometry.

  • MD 1.69 mmHg for SBP, -2.16 mmHg for DBP
  • n=97

Why the study?

The accuracy and safety of the ARM-30F-XL arm blood pressure monitor across multiple cuff sizes for arm circumferences of 22–52 cm required validation according to the International Standard ISO 81060-2:2018+Amd 2:2024.

Does the ARM-30F-XL arm blood pressure monitor accurately measure blood pressure compared to a mercury sphygmomanometer in individuals with an arm circumference of 22-52 cm?

Population

97 subjects with arm circumference 22–52 cm

Comparison

ARM-30F-XL device vs mercury sphygmomanometer

Design

Validation study according to ISO 81060-2:2018+Amd 2:2024

Authors

YQYonghua QiuWHWei HanJiangsu UniversityLLLijun Liu

Discussion

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Implication

Supports wide-range cuff validation in large arms; leaves open outcome trials before routine adoption.

Key Points

  • To assess the accuracy and safety of the ARM-30F-XL blood pressure monitor across multiple cuff sizes according to the ISO 81060-2:2018+Amd 2:2024 standard.
  • Recruited 97 subjects with arm circumferences ranging from 22 to 52 cm from hospital patients, companions, and routine health exam attendees.
  • Evaluated the accuracy of the noninvasive ARM-30F-XL monitor against a reference standard mercury sphygmomanometer following ISO protocol criteria.
  • Under Criterion 1, the mean difference between test and reference devices was 1.69 mmHg (SD 5.00 mmHg) for SBP and −2.16 mmHg (SD 4.45 mmHg) for DBP, meeting the protocol threshold of mean difference ≤ ±5 mmHg and SD < 8 mmHg.
  • Under Criterion 2, the intra-individual standard deviation was 4.00 mmHg for SBP (cutoff < 6.73 mmHg) and 3.73 mmHg for DBP (cutoff < 6.58 mmHg), meeting all ISO validation requirements.

Study Design

Type

Observational (n=97)

Structured PICO

Does the ARM-30F-XL arm blood pressure monitor accurately measure blood pressure compared to a mercury sphygmomanometer in individuals with an arm circumference of 22-52 cm?

P
Population
97 subjects with an arm circumference of 22–52 cm recruited from a hospital setting.
E
Exposure
ARM-30F-XL arm blood pressure monitor
C
Comparator
Mercury sphygmomanometer
O
Outcome
Accuracy of the noninvasive BP module (mean difference and standard deviation of SBP and DBP)surrogate

Main Result

Mean Difference: 1.69

The ARM-30F-XL arm blood pressure monitor meets international standards for accuracy and is recommended for clinical and home use in individuals with arm circumferences of 22-52 cm.

Cite This Study

Qiu et al. (2026) reported an observational. ARM-30F-XL arm blood pressure monitor vs. Mercury sphygmomanometer was evaluated on Mean difference in systolic and diastolic blood pressure according to ISO 81060-2:2018+Amd 2:2024 criteria (MD 1.69 mmHg for SBP, -2.16 mmHg for DBP). The ARM-30F-XL blood pressure monitor met ISO accuracy requirements compared to a mercury sphygmomanometer, with a mean difference in SBP of 1.69 mmHg and DBP of -2.16 mmHg.

synapsesocial.com/papers/6ac09ae91652f928be544d2ehttps://doi.org/10.1097/mbp.0000000000000830
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Validation of the DBP-1333b upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018+Amd.1:2020)2024 · 4 citations
  2. 2Validation of the DBP-8278B Wrist-type Fully Automatic Blood Pressure Monitor in the general population according to the ISO 81060-2:2018/AMD 1:2020 protocol2024 · 1 citations
  3. 3Validation of the Arm-Type Fully Automatic Blood Pressure Monitor DBP-62F4B-P in adolescents and adults according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (ISO 81060-2:2018+Amd 2:2024) standard2026
  4. 4Validation of the JOYTECH DBP-6286B arm-type fully automatic digital blood pressure monitor in adults or adolescents with large arm circumference according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018 + Amd.1:2020)2026
  5. 5Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less2024 · 1 citations