Microlife BP B3 AFib Advanced
Device Name:
BP B3 AFib Advanced
Manufacturer:
Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood pressure, Atrial fibrillation
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Belarus, Switzerland, Spain, Croatia, Lithuania, Latvia, Netherlands, Portugal, Saudi Arabia and South America
Description:
The Microlife BP B3 AFib Advanced is an automatic blood pressure monitor. Accuracy claims for its blood pressure measurement technology are being verified by Medaval. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The Microlife BP B3 AFib Advanced is included in a current validation and equivalence audit, by Medaval. Validation details will be posted when this has been completed.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Audit | Validation under audit |
| BP | Stride BP | Self-measurement for adults (Preferred) | Equivalence claim without published evidence |
Device Family:
Aponorm Basis Control 4GP, Aponorm Basis Control Plus 4GP, Aponorm Professional Control 4GP, Microlife BP B2 Basic (BP 3KA1-3N)B,P, Microlife BP B2 Easy (BP 3KA1-1E)P, Microlife BP B3 AFib (BP 3KT1-3N)B,P, Microlife BP B6 Connect (BP 3KV1-5X)P, Microlife BP B1 ClassicB,P, Microlife BP B3 BT (BP 3KT1-4B)P, Microlife BP B3 AFib AdvancedP, Microlife BP B3 Basic (BP 3KT1-3F)P, Microlife BP B3 Plus (BP 3KT1-4F)P, Microlife BP B6 BasicP, Microlife BP B6 Advanced ConnectP
Legend: B BIHS Derivative, P Stride Equivalence
Legend: B BIHS Derivative, P Stride Equivalence
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Microlife BP B3 AFib (BP 3KT1-3N)
Beime B, Bramlage C, Krüger R, Deutsch C, van Mark G, Bramlage P, Botta B. 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. Blood Press Monit. 2021 Aug 1;26(4):299-304. Epub: 2021 Mar 15. doi: 10.1097/MBP.0000000000000530. PMID: 33734119.
81060-2:2019 - Pass General population