PP.31.06: VALIDATION OF THE OMRON(R) M3500 BLOOD PRESSURE MEASURING DEVICE IN THE ADULT AND SPECIFIC POPULATIONS (OBESE AND CHILDREN) ACCORDING TO THE AAMI PROTOCOL. (June 2015)

• Record Type: Journal Article
• Authors: Chahine, M.; Assemaani, N.; Sayed-Hasan, G.; Chami-Chebbo, M.; Salameh, P.; Asmar, R.
• Is Part Of: Journal of hypertension. Volume 33(2015)Supplement 1
• Publication Date: 2015-06
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000468671.14118.7c
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objective: The present study was designed to validate the accuracy of the blood pressure (BP) measurements of a professional device for office use, the OMRON® M3500 automatic oscillometric BP device, by using the normal and high speed modes in the adult and specific populations (obese and children), according to the ANSI/AAMI/ISO/ 81060–2:2009 Protocol. Design and method: The AAMI Protocol includes a total number of 135 subjects, 100 in the adult population (>12 years) with at least 30 % male subjects and 30 % female subjects, and an additional 35 children aged between 3 and 12 years, on which the validation is performed. For each subject, twelve sequential same-arm BP measurements using the Omron (6 for normal and 6 for high speed modes) and the mercury sphygmomanometer were performed. Results: The results showed a mean error of the individual paired determinations of the Omron and the mercury sphygmomanometers of +1.9 ± 6.35 mmHg / -3.9 ± 6.49 mmHg in the normal speed mode for the systolic BP and diastolic BP, respectively, as well as +1.3 ± 6.15 mmHg and -2.6 ± 6.59 mmHg in the high speed mode for the systolic BP and diastolic BP, respectively (criterion 1: 5 ± 8 mmHg). Analysis of the averaged paired determinations per subject of the Omron and the standard mercury sphygmomanometer showed values of 5.14 mmHg and 5.57 mmHg in the normal speed mode for the systolic BP and diastolic BP, respectively, as well as 4.76 mmHg and 5.37 mmHg in the high speed mode for the systolic BP and diastolic BP, respectively (criterion 2: acceptable values < 6.71 and < 5.77 respectively). Conclusions: In conclusion, readings of the OMRON® M3500 automatic oscillometric BP device using the normal and high speed modes for BP determinations in adults and 2 specific populations (children and obese) fulfill the criteria 1 and 2 of the AAMI protocol; therefore, this device can be used in clinic.