Microlife WatchBP Office AFib (Twin200 AFS)

Device Name:WatchBP Office AFib
Device Model:Twin200 AFS
Manufacturer:Sole: Microlife Corporation, 9F, 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN PRC.
Measuring functions:Blood pressure, Atrial fibrillation
Primary Client Use:Intended for professional use with atrial fibrillation detection
Measurement Site:Upper Arm
Measurement Occurrence:Single and repeated measurements
Availability:Available Currently
Assessment:

The technology used in the Microlife WatchBP Office AFib (Twin200 AFS), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in two validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

It is recommended by Hypertension Canada on the basis of published evidence. It is recommended by the ESH for both manual and automatic professional use.

Device Family:Microlife WatchBP Office (Twin200)D (D DET Equivalence)
Relevant Publications

Chan PH, Wong CK, Pun L, Wong YF, Wong MM, Chu DW, Siu CW. Head-to-Head Comparison of the AliveCor Heart Monitor and Microlife WatchBP Office AFIB for Atrial Fibrillation Screening in a Primary Care Setting. Circulation. 2017 Jan 3;135(1):110-2. Epub: 2016 Dec 27. doi: 10.1161/CIRCULATIONAHA.116.024439. PMID: 28028066.

Afib validation

Wiesel J, Fitzig L, Herschman Y, Messineo FC. Detection of atrial fibrillation using a modified microlife blood pressure monitor. Am J Hypertens. 2009 Aug;22(8):848-52. Epub: 2009 May 28. doi: 10.1038/ajh.2009.98. PMID: 19478793.

The publication describes the use of the Microlife WatchBP Office AFib (Twin200 AFS) in a scientific study.

Stergiou GS, Karpettas N, Protogerou A, Nasothimiou EG, Kyriakidis M. Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation. J Hum Hypertens. 2009 Oct;23(10):654-8. Epub: 2009 Feb 12. doi: 10.1038/jhh.2009.5. PMID: 19279661.

The publication describes the use of the Microlife WatchBP Office AFib (Twin200 AFS) in a scientific study.

Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

Microlife WatchBP Office (Twin200)

Stergiou GS, Tzamouranis D, Protogerou A, Nasothimiou E, Kapralos C. Validation of the Microlife Watch BP Office professional device for office blood pressure measurement according to the International protocol. Blood Press Monit. 2008 Oct;13(5):299-303. doi: 10.1097/MBP.0b013e3283057af6. PMID: 18799957.

ESH-IP:2002 - Pass General population

Kollias A, Ntineri A, Kyriakoulis KG, Stambolliu E, Lagou S, Boubouchairopoulou N, Stergiou GS. Validation of the professional device for blood pressure measurement Microlife WatchBP Office in adults and children according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization standard. Blood Press Monit. 2018 Apr;23(2):112-4. Epub: 2017 Dec 12. doi: 10.1097/MBP.0000000000000307. PMID: 29239866 .

81060-2:2013 - Pass General population