Key result
Microlife BP3T01-1B passes ISO accuracy standards, differing from mercury sphygmomanometry by ~3 mmHg systolic.
Why the study?
Accurate blood pressure measurement requires validated devices using established protocols to ensure reliable hypertension diagnosis and management.
Does the Microlife BP3T01-1B automated upper-arm blood pressure measuring device accurately measure blood pressure compared to a reference mercury sphygmomanometer in adults and adolescents?
Observational (n=85)
Does the Microlife BP3T01-1B automated upper-arm blood pressure measuring device accurately measure blood pressure compared to a reference mercury sphygmomanometer in adults and adolescents?
The Microlife BP3T01-1B automated upper-arm blood pressure monitoring device meets the ISO 81060-2:2018-11 validation criteria and is accurate for clinical use in adults and adolescents.
Answers are grounded in this paper and cite their sources.
Validates Microlife BP3T01-1B per ISO criteria in tested ages; extends validation data but leaves open outcome correlations in practice.
BACKGROUND: Accurate measurement of blood pressure (BP) is crucial for the diagnosis and ongoing management of hypertension. Only devices that have been validated using an established protocol should be used to measure BP. The aim of this study was to validate the Microlife BP3T01-1B, an automated upper-arm BP measuring device, according to the DIN EN ISO 81060-2:2018-11 (ANSI/AAMI/ISO 81060-2:2018) standard protocol. METHODS: BP measurements were performed in 85 adults and adolescents (age range: 13-86 years) using the same-arm sequential method of the DIN EN ISO 81060-2:2018-11 protocol, alternating between the test device and a reference mercury sphygmomanometer. RESULTS: A total of 255 valid comparisons were available for the analysis of criterion 1. The mean ± SD difference between the test device and the reference device values was -2.56 ± 7.53 mmHg for SBP and -3.10 ± 5.65 mmHg for DBP. The mean differences met the pass criterion of less than or equal to ±5 mmHg and the SD values met the pass criterion of ≤8 mmHg. All 85 participants were included in the analysis of criterion 2. The mean ± SD intraindividual difference between the test and reference devices was -2.56 ± 6.15 mmHg for SBP and -3.10 ± 4.85 mmHg for DBP. Both were within the required pass range of SD ≤6.43 mmHg for SBP and SD ≤6.20 mmHg for DBP. CONCLUSION: The Microlife BP3T01-1B BP monitoring device fulfilled the criteria of the DIN EN ISO 81060-2:2018-11 (ANSI/AAMI/ISO 81060-2:2018) protocol in a general population and can be recommended for the measurement of BP in adults and adolescents.
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Botta et al. (2024) conducted an observational in General population (n=85). Microlife BP3T01-1B automated upper-arm BP measuring device vs. Reference mercury sphygmomanometer was evaluated on Mean difference in systolic blood pressure between test and reference device (MD -2.56 ± 7.53 mmHg). The Microlife BP3T01-1B device met the ISO 81060-2:2018 validation criteria with a mean systolic blood pressure difference of -2.56 ± 7.53 mmHg compared to a mercury sphygmomanometer.
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