根据美国医疗器械促进协会（AAMI）协议，在成人及特定人群（肥胖者和儿童）中使用正常模式和高速模式对欧姆龙M3500血压测量设备进行验证。
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.
作者信息
Chahine Mirna N, Assemaani Nathalie, Sayed Hassan Ghada, Cham Mariam, Salameh Pascale, Asmar Roland
机构信息
Foundation-Medical Research Institutes (F-MRI®), Beirut, Lebanon.
Faculty of Medical Sciences, Lebanese University, Hadath, Lebanon.
出版信息
J Clin Hypertens (Greenwich). 2015 Aug;17(8):622-9. doi: 10.1111/jch.12540. Epub 2015 Apr 2.
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.
本研究旨在根据美国国家标准学会/医疗仪器促进协会（AAMI）/国际标准化组织/81060-2:2009协议，通过在成人及特定人群（肥胖者和儿童）中使用正常模式和高速模式，验证欧姆龙M3500自动示波血压测量仪血压（BP）测量的准确性。该验证在135名患者中进行：100名成人和35名儿童（3至12岁）。结果显示，欧姆龙设备与汞柱式血压计的个体配对测定的平均误差在标准1值（5±8毫米汞柱）范围内。对欧姆龙设备和标准汞柱式血压计每位受试者的平均配对测定分析符合标准2的可接受范围（收缩压<6.71，舒张压<5.77）。欧姆龙M3500血压测量仪在两种速度模式下均符合AAMI协议的标准1和标准2。
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