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

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.