Validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2: 2019 protocol. Issue 4 (August 2021)

• Record Type: Journal Article
• Authors: Beime, Beate; Bramlage, Carsten; Krüger, Ralf; Deutsch, Cornelia; van Mark, Gesine; Bramlage, Peter; Botta, Beate
• Is Part Of: Blood pressure monitoring. Volume 26:Issue 4(2021)
• Publication Date: 2021-08
• Subjects: American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization -- blood pressure monitor -- Microlife BP B3 AFIB -- validation; Blood pressure -- Measurement -- Periodicals; Blood Pressure Determination -- Periodicals; Blood Pressure Monitoring, Ambulatory -- Periodicals; Blood Pressure Monitors -- Periodicals; Hypertension -- Periodicals; 612.140287
• DOI: 10.1097/MBP.0000000000000530
• Languages: English
• ISSNs: 1359-5237

Abstract

Abstract : 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. Methods: BP measurements on the upper arm were performed in 85 subjects (age range 12–88 years), using the Microlife BP B3 AFIB and a standard mercury reference sphygmomanometer. 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.