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The aims of this ANSI/AAMI/ISO validation study were to assess the accuracy of the Omron HEM-9210T, developed to utilize a small cuff, a wide-range cuff, and an extra-large cuff in the adult population. If accurate, the wide-range and extra-large cuffs will be of clinical significance in both medical and self-measurement environments.
Individuals were recruited at an independent clinical research center. Eighty-five patients comprised the final analyses.
The mean±SD of the systolic blood pressure (BP) differences between device and reference were 0.5±5.96 mmHg for analysis criterion 1 and 0.5±4.65 mmHg for criterion 2. The data for diastolic BP were -0.5±5.58 for criterion 1 and -0.5±5.01 mmHg for criterion 2. The HEM-9210T passed the Standard's requirements for both systolic and diastolic BP. In particular, both the wide-range and extra-large cuffs gave accurate BP values over the range of arm circumferences of 22-42 and 42-50 cm, respectively.
These newly developed cuffs have great clinical benefit for both medical and self-measurement environments.