Accuracy evaluation of the 'Cardiette BP one' ambulatory blood pressure monitor

Objective Blood pressure (BP) 'Cardiette BP one' system (1313 one) is an oscillometric ambulatory BP monitor manufactured in Italy in conformity to current regulations for medical devices. We decided to determine the accuracy of measures made with BP one, using the protocol of the British Hypertension Society published in 1990, and revised in 1993, for evaluating the accuracy of BP measurement devices. Methods The evaluation included before-use calibration, in-use assessment, after-use calibration, and static device validation that involved 85 participants. Results The mean difference between manual readings with sphygmomanometer and automatic ones with the device were -0.36 +/- 5.74 (mean +/- SD) for systolic values and 2.52 +/- 4.87 for diastolic values. On the basis of the percentages of measurements differing from the mercury sphygmomanometer standard by <= 5, <= 10, and <= 15 mmHg, the device was graded 'A' for systolic and diastolic BP, for low, median, and high BP values. Conclusion On the basis of the standards indicated by the 1993 modified British Hypertension Society protocol, the BP one recorder can be classified as 'A' grade both for systolic and diastolic pressure.