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Validation of the OMRON M3500 Blood Pressure Measuring Device Using Normal‐ and High‐Speed Modes in Adult and Specific Populations (Obese and Children) According to AAMI Protocol
Authors:Mirna N. Chahine PhD  Nathalie Assemaani MSc  Ghada Sayed Hassan MD  Mariam Cham MD  Pascale Salameh PharmD  MPH   PhD  Roland Asmar MD
Affiliation:1. Foundation‐Medical Research Institutes (F‐MRI®), Beirut Lebanon ; 2. Faculty of Medical Sciences, Lebanese University, Hadath Lebanon ; 3. Faculty of Pharmacy, Lebanese University, Hadath Lebanon
Abstract: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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