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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

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 BP 3BT0-A

Cuckson AC, Reinders A, Shabeeh H, Shennan AH; British Hypertension Society. Validation of the Microlife BP 3BTO-A oscillometric blood pressure monitoring device according to a modified British Hypertension Society protocol. Blood Press Monit. 2002 Dec;7(6):319-24. PMID: 12488652.

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

Reinders A, Cuckson AC, Lee JT, Shennan AH. An accurate automated blood pressure device for use in pregnancy and pre-eclampsia: the Microlife 3BTO-A. BJOG. 2005 Jul;112(7):915-20. PMID: 15957992.

BHS:1993 - Pass (A/B) Pregnancy and pre-eclampsia (n=105; 35 x: normotensive, non-proteinuric HBP, pre-eclampsia)

Nouwen E, Snijder M, van Montfrans G, Wolf H. Validation of the Omron M7 and Microlife 3BTO-A blood pressure measuring devices in preeclampsia. Hypertens Pregnancy. 2012;31(1):131-9. Epub: 2011 Feb 18. doi: 10.3109/10641955.2010.544799. PMID: 21332327.

ESH-IP:2002 - Fail Pre-eclampsia

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:1999 - Pass General population (Note: 2001)

Microlife BP A100

Bonso E, Dorigatti F, Palatini P. Accuracy of the BP A100 blood pressure measuring device coupled with a single cuff with standard-size bladder over a wide range of arm circumferences. Blood Press Monit. 2009 Oct;14(5):216-9. doi: 10.1097/MBP.0b013e328330d3f8. PMID: 19734782.

ESH-IP:2002 - Pass General population

Bonso E, Saladini F, Zanier A, Benetti E, Dorigatti F, Palatini P. Accuracy of a single rigid conical cuff with standard-size bladder coupled to an automatic oscillometric device over a wide range of arm circumferences. Hypertens Res. 2010 Nov;33(11):1186-91. Epub: 2010 Aug 5. doi: 10.1038/hr.2010.146. PMID: 20686489.

ESH-IP:2002 - Pass General population

Microlife BP A100 Plus

Stergiou GS, Giovas PP, Neofytou MS, Adamopoulos DN. Validation of the Microlife BPA100 Plus device for self-home blood pressure measurement according to the International Protocol. Blood Press Monit. 2006 Jun;11(3):157-60. PMID: 16702824.

ESH-IP:2002 - Pass General population

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

ESH-IP:2002 - Pass General population

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:1999 - Pass General population (Note: 2007)

Microlife WatchBP Home (BP 3MX1-1)

Stergiou GS, Giovas PP, Gkinos CP, Patouras JD. Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to the International Protocol. Blood Press Monit. 2007 Jun;12(3):185-8. PMID: 17496469.

ESH-IP:2002 - Pass General population

Chung Y, de Greeff A, Shennan A. Validation and compliance of a home monitoring device in pregnancy: Microlife WatchBP home. Hypertens Pregnancy. 2009;28(3):348-59. doi: 10.1080/10641950802601286. PMID: 19263287.

BHS:1993 Pregnancy and pre-eclampsia (n=45; 15 pre-eclampsia) (Note: BHS results not in abstract)

Clark K, Snowball O, Nzelu D, Kay P, Kametas NA. Validation of the Microlife WatchBP Home blood pressure device in pregnancy for medium and large arm circumferences. Blood Press Monit. 2018 Jun;23(3):171-4. doi: 10.1097/MBP.0000000000000315. PMID: 29596069.

BHS:1993 - Pass (A/A) Pregnancy; Arm circumference 22 cm to 31 cm (n=51)

BHS:1993 - Pass (B/A) Pregnancy; Arm circumference 32 cm to 52 cm (n=46)

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)