Validation of the validity of the new wrist-type fully automatic blood pressure monitor: DBP-2242 according to ISO 81060-2:2018+AMD 1:2020

Author:

Jin Yuehong1,Bei Xiaoming2,Jin Ying1

Affiliation:

1. Gastroenterology Department and

2. Gastroenterology Department, Suzhou Ninth Hospital affiliated to Soochow University, Suzhou, Jiangsu Province, China

Abstract

Objective Evaluation of the accuracy of the wrist-type fully automatic blood pressure (BP) monitor: DBP-2242 in adolescent and adult populations according to ISO 81060-2 : 2018+Amd.1 : 2020. Methods BP measurements were taken from the subjects using the same-arm sequential method, and BP data measured by a mercury sphygmomanometer was used as the standard. Results This study analyzed 262 sets of data from 89 subjects. According to criterion 1, the mean difference between the SBP of the test and reference devices was −0.57 ± 7.31 mmHg, and the DBP was −2.27 ± 7.17 mmHg, which is in accordance with the requirements. According to criterion 2, the average difference between the SBP was −0.57 ± 6.25 mmHg and the DBP was −2.27 ± 5.99 mmHg, which is in accordance with the requirements. Conclusion Wrist-type fully automatic BP monitor: DBP-2242 complies with ISO 81060-2 : 2018+Amd.1 : 2020 and can be used for BP measurement in adolescent and adult populations.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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