Beate Beime, Carsten Bramlage, Ralf Krüger, Cornelia Deutsch, Gesine van Mark, Peter Bramlage and Beate Botta
Aim of this study was to validate the Microlife BP B3 AFIB/ enterprise resource planning (ERP) No: BP3KT1-3 N blood pressure (BP) monitor according to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 81060–2:2019 in adolescents and adults from a general population.
A total of 255 valid BP comparisons were performed for the present validation analysis. The mean ± SD difference between the test and the reference device was 0.70 ± 7.05 mmHg for SBP (pass criterion ≤5 mmHg) and −0.85 ± 4.70 mmHg for DBP (pass criterion ≤5 mmHg) with the SD below the required value of ≤8 mmHg. The mean ± SD of the intraindividual
differences between the test and the reference device was 0.70 ± 5.87 mmHg for SBP (pass criterion for the SD ≤6.90 mmHg) and −0.85 ± 4.19 mmHg for DBP (pass criterion for the SD ≤6.88 mmHg).
The Microlife BP B3 AFIB/ERP No: BP3KT1-3 N has passed the criteria of the ANSI/AAMI/ISO 81060–2:2019 protocol and can be recommended for home BP measurements in adolescents and adults. Blood Press Monit XXX: 000–000 Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
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