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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, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
Hypertension CanadaProfessional use (Gold)Manufacturer declaration of equivalence
ESH (Europe)Professional usePublished evidence
Stride BPOffice use for adults, children and obese adults (Preferred)Equivalence claim without published evidence

Device Family:Microlife WatchBP Office (Twin200)D,P, Microlife WatchBP Office 2G (BP 3SK1-3B)P, Microlife WatchBP Office ABI (Twin200 ABI)B,P, Microlife WatchBP Office AFib (Twin200 AFS)D,P, Microlife WatchBP Office Central (Twin200 CBP)P, Riester RBP-100B, Welch Allyn ProBP 2400B (B BIHS Derivative, D DET Equivalence, P Stride 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: 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 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

Microlife WatchBP Office ABI (Twin200 ABI)

Masiero S, Saladini F, Benetti E, Palatini P. Accuracy of the Microlife large-extra large-sized cuff (32-52 cm) coupled to an automatic oscillometric device. Blood Press Monit. 2011 Apr;16(2):99-102. doi: 10.1097/MBP.0b013e328344c73c. PMID: 21346560.

ESH-IP:2002 - Pass General population

Saladini F, Benetti E, Masiero S, Palatini P. Accuracy of Microlife WatchBP Office ABI monitor assessed according to the 2002 European Society of Hypertension protocol and the British Hypertension Society protocol. Blood Press Monit. 2011 Oct;16(5):258-61. doi: 10.1097/MBP.0b013e32834af72e. PMID: 21885961.

ESH-IP:2002 - Pass General population

BHS:1993 - Pass (A/A) General population

Palatini P, Fania C, Gasparotti F. Accuracy of the WatchBP office ABI device for office blood pressure measurement over a wide range of arm sizes. Blood Press Monit. 2018 Apr;23(2):117-9. doi: 10.1097/MBP.0000000000000312. PMID: 29406326.

81060-2:2013 - Pass General population (Note: Arm circumferences 15 cm to 46 cm; 4 cuff sizes)

Microlife WatchBP Office Central (Twin200 CBP)

Cheng HM, Sung SH, Shih YT, Chuang SY, Yu WC, Chen CH. Measurement accuracy of a stand-alone oscillometric central blood pressure monitor: a validation report for Microlife WatchBP Office Central. Am J Hypertens. 2013 Jan;26(1):42-50. doi: 10.1093/ajh/hps021. PMID: 23382326.

SP10:2002 - Fail General population (Note: IA validation cuff BP (n=255/85))

SP10:2002 - Pass Central BP (n=255/85) (Note: IA validation)