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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