Clinical assessment of the DINAMAP ProCare monitor in an adult population according to the British Hypertension Society Protocol.

摘要

OBJECTIVE: Clinical recommendation of an automated blood pressure device is dependent on assessment according to a recognized protocol. The DINAMAP ProCare monitor is an oscillometric device intended for hospital, physician office or clinic use. The device algorithm was developed and tested against an auscultatory standard to increase comparability, in contrast to previous DINAMAP products that were designed to be accurate compared with an invasive central aortic reference, as specified in the Association for the Advancement of Medical Instrumentation-SP10 Standard (AAMI SP10 Standard: 1992, 2002). This device was validated in an adult population according to the protocol of the British Hypertension Society. METHODS: Local ethics committee approval was obtained and all patients were required to give written informed consent. Nine sequential same-arm measurements, alternating between observer and device, were taken from each patient. Data analysis was performed according to the guidelines of the BritishHypertension Society protocol on 85 patients who fulfilled the blood pressure categories specified by the protocol. RESULTS: The DINAMAP ProCare monitor achieved an A grade for both systolic and diastolic pressures. It also achieved the passing criteria of the ANSI/AAMI SP10 with a mean difference (standard deviation) for systolic and diastolic pressures, respectively, of -0.3 (6.9) and -4.0 (5.9) mmHg. CONCLUSION: The DINAMAP ProCare monitor can be recommended for clinical use in an adult population according to the criteria of the British Hypertension Society.