Clinical evaluation of the Braun BP 3000 Easy Click according to the ANSI/AAMI SP 10:2002

BACKGROUND: Home blood pressure monitoring has been increasingly encouraged as a supplement to measurements in the clinic in the 2003 European Society of Hypertension-European Society of Cardiology and in the Seventh Joint National Committee guidelines. Before marketing, however, blood pressure measuring devices for self-blood pressure monitoring should be independently validated. OBJECTIVE: The main objective of the present study was to examine the clinical accuracy of the Braun BP 3000 (Braun GmbH, Kronberg, Germany) wrist blood pressure measurement device. METHODS: Measurements of systolic and diastolic blood pressure in normotensive and hypertensive individuals were obtained using the mercury sphygmomanometer and the Braun BP 3000 equipment. Repeated sequential blood pressure single-arm measurements comparing the test device and the standard mercury sphygmomanometer were completed according to the American National Standard Institution (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) SP 10:2002 Protocol Guidelines on 90 study participants (270 measurements with each pressurometer). RESULTS: The equipment passed the test of systolic blood pressure measurements for method 1 (270 measurements treated separately) and method 2 (mean values of three observations on 90 patients). The mean+/-SD value was -2.01+/-5.61 (upper limit 5+/-8) and -2.01+/-4.41 (upper limit 2.01+/-6.65), respectively. The device also passed the diastolic blood pressure measurement requirements as the mean+/-SD value for method 1 was -0.97+/-5.52 (upper limit 5+/-8) and for method 2 was -0.97+/-4.87 (upper limit 0.97+/-6.87), respectively. CONCLUSIONS: The data from this study show that the Braun BP 3000 successfully passed the ANSI/AAMI SP 10:2002 requirements.