Microlife BP B3 AFib (BP 3KT1-3N)
Device Name:
BP B3 AFib
Device Model:
BP 3KT1-3N
Manufacturer:
Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood Pressure, PR and 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, France, Croatia, Ireland, Italy, Netherlands, Portugal, Serbia, Russian Federation, Saudi Arabia and South America
Description:
The Microlife BP B3 AFib (BP 3KT1-3N) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Microlife BP B3 AFib (BP 3KT1-3N), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; recent protocol
BP BIHS (UK and IRL) Self-measurement and professional use Published evidence
BP Stride BP Self-measurement for adults (Preferred) Published evidence
BP MDR Criteria Self-measurement Published evidence
Device Family:
Aponorm Basis Control 4GP, Aponorm Basis Control Plus 4GP, Aponorm Professional Control 4GP, Aponorm Basis Control Plus Bluetooth 4GZ, 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, Microlife BP B1 Standard (BP HJA2-0)P, Microlife BP B4 BT (BP HJB2-D)P
Legend: B BIHS Derivative, P Stride Equivalence, Z Almost Certain
Validation Publications:

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.

81060-2:2018 - Pass General population

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 B6 Connect (BP 3KV1-5X)

Menti A, Ntousopoulos V, Lempidaki P, Bakalakou KR, Komnianou A, Mariglis D, Ntaskagianni E, Kollias A, Stergiou GS. Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Microlife BP3KV1-5X (BP B6 Connect) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018). Blood Press Monit. Epub: 2025 Sep 10. doi: 10.1097/MBP.0000000000000771. PMID: 40931782.

81060-2:2018/Amd 1:2020/Amd 2:2024 - Pass General population

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