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Microlife WatchBP Office ABI (Twin200 ABI)

Device Name:WatchBP Office ABI
Device Model:Twin200 ABI
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:Arm and Ankle
Measurement Occurrence:Single and repeated measurements
Availability:Available Currently
Assessment:

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

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
BIHS (UK and IRL)Professional use for adults and obese adultsPublished evidence
Hypertension CanadaProfessional use (Gold)Published evidence
ESH (Europe)Professional usePublished evidence
Stride BPOffice and hospital use for adults, children and obese adults (Preferred)Published evidence plus equivalence claim
MDR CriteriaProfessional usePublished 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)
Validation Publications

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)

Relevant Publications

Kollias A, Xilomenos A, Protogerou A, Dimakakos E, Stergiou GS. Automated determination of the ankle-brachial index using an oscillometric blood pressure monitor: validation vs. Doppler measurement and cardiovascular risk factor profile. Hypertens Res. 2011 Jul;34(7):825-30. Epub: 2011 May 19. doi: 10.1038/hr.2011.53. PMID: 21593742. Available from: www.nature.com.

ABI validation using doppler reference

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 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)