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Microlife BP B6 Advanced Connect
Device Name:
BP B6 Advanced Connect
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
Description:
The Microlife BP B6 Advanced Connect is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. 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 B6 Advanced Connect, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP Stride BP Self-measurement for adults (Preferred) Equivalence claim without published evidence
Device Family:
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, Kr├╝ger 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