title: Validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2: 2013 with two novel cuffs: wide-range and extra-large.
abstract: 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±4.65 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.
  
  
  CONCLUSIONS
  These newly developed cuffs have great clinical benefit for both medical and self-measurement environments.
authors.affiliation: University of Tennessee Health Science Center, Memphis, Tennessee, USA(Retired).
authors.forename: Bruce S
authors.initials: BS
authors.lastname: Alpert
mesh_terms: D000328:Adult; D001132:Arm / Q000033:anatomy & histology; D001794:Blood Pressure; D001795:Blood Pressure Determination / Q000295:instrumentation*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000503:physiopathology; D008297:Male; D012680:Sensitivity and Specificity