Polo Friz Hernan, Sega Roberto, Facchetti Rita, Primitz Laura, Beltrame Luca, Bombelli Michele
ISTRA, San Gerardo Hospital, Centre of Chronic Degenerative Diseases, Milan, Italy.
Blood Press Monit. 2008 Apr;13(2):107-10. doi: 10.1097/MBP.0b013e3282f13f9b.
Blood pressure (BP) 'Cardiette BP one' system (BP 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.
The evaluation included before-use calibration, in-use assessment, after-use calibration, and static device validation that involved 85 participants.
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 <or=5, <or=10, and <or=15 mmHg, the device was graded 'A' for systolic and diastolic BP, for low, median, and high BP values.
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.
“Cardiette BP one”血压系统（BP one）是一款符合现行医疗器械法规在意大利生产的示波法动态血压监测仪。我们决定采用英国高血压学会1990年发布并于1993年修订的用于评估血压测量设备准确性的方案，来确定BP one测量的准确性。
评估包括使用前校准、使用中评估、使用后校准以及涉及85名参与者的静态设备验证。
血压计手动读数与该设备自动读数之间的平均差值，收缩压为-0.36±5.74（均值±标准差），舒张压为2.52±4.87。根据与汞柱式血压计标准相差≤5、≤10和≤15 mmHg的测量值百分比，该设备在收缩压和舒张压方面，对于低、中、高血压值均被评为“A”级。
根据1993年修订的英国高血压学会方案所指明的标准，BP one记录仪在收缩压和舒张压方面均可归类为“A”级。
