Key result
OMRON M3500 passes AAMI accuracy validation in adult and pediatric populations across measurement speeds.
Why the study?
Does the OMRON M3500 device accurately measure blood pressure compared to standard mercury sphygmomanometers in adults and children?
Cross-Sectional (n=135)
No
Does the OMRON M3500 device accurately measure blood pressure compared to standard mercury sphygmomanometers in adults and children?
The study provides validation that the OMRON M3500 device is accurate for clinical use in normal and high-speed modes among general adults and children.
Answers are grounded in this paper and cite their sources.
Supports OMRON M3500 accuracy per AAMI criteria; leaves open outcome trials before routine adoption.
The present study aimed to validate the accuracy of blood pressure (BP) measurements of the OMRON M3500 automatic oscillometric BP device by using normal- and high-speed modes in adult and specific populations (obese and children) according to American National Standards Institute/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization/81060-2:2009 protocol. The validation was performed in 135 patients: 100 adults and 35 children (aged 3-12 years). The results showed a mean error of the individual paired determinations of the OMRON device and mercury sphygmomanometers within values of criterion 1 (5±8 mm Hg). Analysis of the averaged paired determinations per subject of the OMRON device and standard mercury sphygmomanometer fit within the acceptable ranges of criterion 2 (<6.71 systolic BP and <5.77 diastolic BP). Readings of the OMRON M3500 BP device fulfill criteria 1 and 2 of the AAMI protocol in both speed modes.
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Chahine et al. (2015) conducted a cross-sectional in General population (adults, obese adults, and children) (n=135). OMRON M3500 automatic oscillometric BP device vs. Standard mercury sphygmomanometer was evaluated on Accuracy according to AAMI protocol Criterion 1 (mean error of individual paired determinations) (SBP +1.90 ± 6.35 mm Hg, DBP -3.9 ± 6.49 mm Hg (normal speed mode)). The OMRON M3500 device fulfilled criteria 1 and 2 of the AAMI validation protocol for both normal- and high-speed modes in adult and pediatric populations.
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