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.
Nolly
Héctor
H
Hypertension Center and National Council of Research, Mendoza, Argentina. nolly@supernet.com.ar
Romero
Marcelo
M
Nolly
Alejandro
A
Silva
Martin
M
Nolly
Mariela
M
D000328:Adult; D000368:Aged; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation*; D015924:Blood Pressure Monitors / Q000592:standards*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D019722:Sphygmomanometers; D014953:Wrist / Q000098:blood supply