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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

Wessig, Kerstina b; Hollinger, Stefanb; Schmalzhaf, Irisb; Lenz, Tomasa

Devices and Technology

Objective To evaluate the overall performance of a new oscillometric wrist blood pressure monitor (Braun PrecisionSensor, Braun GmbH, Kronberg, Germany) as defined by the ANSI/AAMI SP10-1992 guidelines, and to analyze the data for the optimized selection of the algorithm that derives the blood pressure values from the oscillometric blood pressure curves.

Methods The clinical trial was a multi-center, open, within-subject evaluation. 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 sample of 86 adult male and female subjects (57% female, 43% male). Three sets of measurements with each of both devices were evaluated for each individual.

Results Close agreement was obtained between both observers in compliance with 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 pressure. The use of an optimized algorithm improved the accuracy of the Braun PrecisionSensor, after which the standard deviations were 6.1 mmHg for systolic and 6.3 mmHg for diastolic blood pressure.

Conclusions The Braun PrecisionSensor satisfies the Association for the Advancement of Medical Instrumentation's efficacy and safety criteria for both systolic and diastolic blood pressures with both algorithms analyzed.

aJohann Wolfgang Goethe–Universität, Frankfurt, Germany.bBraun GmbH, Kronberg, Germany.

Correspondence to Kerstin Wessig, Am Winkelbach 10, D-61476 Kronberg, Germany. Tel: +49 6173 92 68 0; fax: +49 6173 92 68 12; e-mail: kerstin.wessig@wessig-consulting.com Request for reprints to Iris Schmalzhaf, Braun GmbH, Frankfurter Straße 145, 61476 Kronberg, Germany. Tel: +49 6173 30 13 51; fax: +49 6173 30 21 32; e-mail: iris_schmalzhaf @gillette.com

Previous Presentations:

A short summary of the clinical study was presented at the 7. Meeting of the Section of Hypertension Diagnostics of the German Hypertension League (7. Jahrestagung der Sektion Hochdruckdiagnostik, May 5, 2000)

Potential conflict of interest: None.

© 2000 Lippincott Williams & Wilkins, Inc.