Clinical evaluation of the efficacy of the Braun PrecisionSensor oscillometric wrist blood pressure monitor for use on adults versus auscultation as defined by ANSI/AAMI SP10-1992

Objective To evaluate the overall performance of a new oscillometric wrist blood pressure monitor (Braun PrecisionSensor, Braun GmbH, Kronberg, German y) as defined by the ANSI/AAMI SP10-1992 guidelines, and to analyze the dat a for the optimized selection of the algorithm that derives the blood press ure values from the oscillometric blood pressure curves. Methods The clinical trial was a multi-center, open, within-subject evaluat ion. Repeated sequential blood pressure measurements were taken on the left wrist using the Braun PrecisionSensor, and on the left upper arm using a T -tube stethoscope and a mercury sphygmomanometer as a standard auscultatory blood pressure measurement device. The reported results are based on a sam ple of 86 adult male and female subjects (57% female, 43% male). Three sets of measurements with each of both devices were evaluated for each individu al. Results Close agreement was obtained between both observers in compliance w ith the ANSI/AAMI SP10-1992 guidelines. The mean values of the differences between the Braun PrecisionSensor and the mercury sphygmomanometer were 0.1 mmHg for systolic and 1.9 mmHg for diastolic blood pressure. The standard deviations were 7.1 mmHg for systolic and 7.0 mmHg for diastolic blood pres sure. The use of an optimized algorithm improved the accuracy of the Braun PrecisionSensor, after which the standard deviations were 6.1 mmHg for syst olic and 6.3 mmHg for diastolic blood pressure. Conclusions The Braun PrecisionSensor satisfies the Association for the Adv ancement of Medical Instrumentation's efficacy and safety criteria for both systolic and diastolic blood pressures with both algorithms analyzed. (C) 2000 Lippincott Williams & Wilkins.