Validation of Datascope Accutorr Plus™ using British Hypertension Society (BHS) and Association for the Advancement of Medical Instrumentation (AAMI) protocol guidelines

使用英国高血压学会 (BHS) 和医疗器械促进协会 (AAMI) 协议指南对 Datascope Accutorr Plus™ 进行验证

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Abstract

OBJECTIVE: To assure the accuracy and reliability of blood pressure measurement by non-invasive blood pressure monitor using Datascope Accutorr Plus™ (Paramus, NJ, USA) against mercury manometer, among adult male participants. METHOD: Eighty participants from a family physician's office at a teaching hospital were recruited. One hundred and sixty measurements of blood pressure were performed according to BHS technique protocol. STATISTICAL ANALYSIS: Descriptive analysis was done according to the AAMI and BHS protocol guidelines. The limits of agreement between the device and the standard were plotted using the method of Bland and Altman plot. RESULTS: The mean difference ± SD between the Datascope Acutorr Plus™ and observer was 2.7 ± 5.2 mm Hg and 1.5 ± 3.26 mm Hg for systolic and diastolic blood pressure, respectively. Datascope Acutorr Plus™ obtained A/A grading for both systolic and diastolic blood pressure. CONCLUSION: Datascope Accutorr Plus™ (Paramus, NJ, USA) satisfies BHS and AAMI validation protocols for both systolic and diastolic BP and may be recommended for everyday use for BP monitoring at home and in clinical use for adult population.

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