Size Dimension Chart for Reference Cuff Validation and Limitations in Current Recommendations.

Abstract

International standards used for device validation protocols require that the reference cuff conform to a width and length that is 37 to 50% and 75 to 100% of the arm circumference, respectively. However, there is no published chart of appropriate width and length dimensions across the range of arm circumferences. Our objective was to create a chart that could be used to guide reference cuff selection and compare recommended dimensions with two common cuff systems. Arm circumferences, ranging from 22 to 52cm were used to create a reference table for width and length requirements. Arm circumferences were grouped following the American Heart Association recommendation for cuff sizes. Cuff dimension data was extracted from the website of a cuff system commonly used for validations (the Baum Corporation) and compared both the American Heart Association recommendations and Baum sizes with the recommended reference dimensions. There were discrepancies in size naming conventions between the Baum Corporation and the American Heart Association cuff systems. Moreover, there were gaps in both systems where the cuff would not be recommended for validation (31-32cm for Baum and 30-31cm for the American Heart Association). Neither system had cuffs that could be used for the largest arm circumferences. Our chart highlights the need for more than one cuff system in validation studies and the critical need for cuffs that could be used for validation among larger arm circumferences.