Microlife WatchBP Home A (BP 3MX1-3)
The technology used in the Microlife WatchBP Home A (BP 3MX1-3), 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 Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| ESH (Europe) | Self-measurement | Published evidence | ||
| Stride BP | Self-measurement for adults and pregnancy (Preferred) | Equivalence claim without published evidence | ||
Chan PH, Wong CK, Pun L, Wong YF, Wong MM, Chu DW, Siu CW. Diagnostic performance of an automatic blood pressure measurement device, Microlife WatchBP Home A, for atrial fibrillation screening in a real-world primary care setting. BMJ Open. 2017 Jun 15;7(6):e013685. doi: 10.1136/bmjopen-2016-013685. PMID: 28619766. Available from: PMC5577883.
AFib validation
Willits I, Keltie K, Craig J, Sims A. WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension: a NICE Medical Technology Guidance. Appl Health Econ Health Policy. 2014 Jun;12(3):255-65. doi: 10.1007/s40258-014-0096-7. PMID: 24664995. Available from: PMC4026667.
The publication describes the use of the Microlife WatchBP Home A (BP 3MX1-3) in a scientific study.
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 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)
