Validation of the Artsana CSI 610 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension.
BACKGROUND
There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies.


OBJECTIVE
This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol.


METHODS
Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants).


RESULTS
The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure.


CONCLUSIONS
According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.
Pini
Claudio
C
Department of Medicine, S. Anna Hospital, Cantù, Como, Italy. claudio.pini@hsacomo.org
Pastori
Marco
M
Baccheschi
Jordan
J
Omboni
Stefano
S
Parati
Gianfranco
G
D000328:Adult; D001331:Automation; D001794:Blood Pressure; D001795:Blood Pressure Determination / Q000295:instrumentation / Q000379:methods; D015924:Blood Pressure Monitors / Q000592:standards*; D004582:Electronics, Medical / Q000295:instrumentation* / Q000379:methods / Q000592:standards*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D009819:Office Visits; D009991:Oscillometry / Q000295:instrumentation / Q000379:methods / Q000592:standards; D012015:Reference Standards; D015203:Reproducibility of Results; D012955:Societies, Medical