Validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2:2013 with two novel cuffs: wide-range and extra-large

Objective 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. Methods Individuals were recruited at an independent clinical research center. Eighty-five patients comprised the final analyses. Results 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 +/- 4.65mmHg for criterion 2. The data for diastolic BP were -0.5 +/- 5.58 for criterion 1 and -0.5 +/- 5.01mmHg 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. Conclusion These newly developed cuffs have great clinical benefit for both medical and self-measurement environments. Copyright (C) 2017 Wolters Kluwer Health, Inc. All rights reserved.