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Validation of the Microlife BP B3 AFIB in adults and adolescents according to the ANSI/AAMI/ISO 81060-2:2019 protocol

Beate Beime, Carsten Bramlage, Ralf Krüger, Cornelia Deutsch, Gesine van Mark, Peter Bramlage and Beate Botta

Objective

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.

Results

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).

Conclusion

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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