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

Alpert, Bruce S.

doi: 10.1097/MBP.0000000000000250
Devices and Technology

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.

Conclusion These newly developed cuffs have great clinical benefit for both medical and self-measurement environments.

University of Tennessee Health Science Center, Memphis, Tennessee, USA(Retired)

Correspondence to Bruce S. Alpert, MD, 1350 Poplar Ridge Dr, Memphis, TN 38120, USA Tel: +1 901 229 3719; fax: +1 901 757 8181; e-mail:

Received February 2, 2017

Received in revised form February 7, 2017

Accepted February 9, 2017

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