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Validation of the A&D BP UA-1200BLE device for home blood pressure measurement according to the ISO 81060-2

2013 standard

Kario, Kazuomi; Saito, Kimiyo; Sato, Keiko; Hamasaki, Haruna; Suwa, Hiromi; Okura, Ayako; Hoshide, Satoshi

doi: 10.1097/MBP.0000000000000347
Devices and Technology

Objective The aim of this study was to validate the UA-1200BLE device using the ISO 81060-2:2013 standard.

Materials and methods Individuals aged more than 12 years were recruited from among the outpatients and volunteers of Jichi Medical University (Tochigi, Japan). Eighty-five patients were included in the final analyses. Validation was performed using the same-arm sequence protocol as per the ISO 81060-2:2013 standard.

Results The device performed well against the standard; the mean and SD values for the differences between device and observed systolic and diastolic blood pressure values fulfilled both criterion 1 and criterion 2 of the standard (criterion 1: −2.62±6.89 and −0.90±6.63 mmHg, respectively; criterion 2: −2.65±5.36 and −0.91±6.12 mmHg, respectively). The Bland–Altman plots did not show any systematic variation in the error.

Conclusion The UA-1200BLE device had a high level of accuracy and fulfilled all ISO 81060-2:2013 standard requirements in adults with a wide range of arm circumference measurements. It is therefore suitable as a wireless blood pressure monitoring tool in patients with hypertension.

Department of Medicine, Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan

Correspondence to Kazuomi Kario, MD, PhD, Department of Medicine, Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan Tel: +81 285 587 538; fax: +81 285 444 311; e-mail: kkario@jichi.ac.jp

Received May 20, 2018

Received in revised form July 18, 2018

Accepted August 2, 2018

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