Microlife BP A200 Comfort (BP 3MS1-4A)

Description:

The Microlife BP A200 Comfort (BP 3MS1-4A) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a certified 5-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for use only as a reasearch version.

Assessment:

The accuracy of the technology used in the Microlife BP A200 Comfort (BP 3MS1-4A), to measure blood pressure, is certified by Medaval Ltd. It has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	★★★★★ Certified Accuracy	Recent clinical validation; recent protocol with certified adherence; multiple clinical validations
BP	BIHS (UK and IRL)	Self-measurement (Previous)	Published evidence
BP	ESH (Europe)	Self-measurement	Published evidence
BP	Stride BP	Self-measurement for adults	Published evidence
BP	FDA (US)	510(k)	510(k) K153450
BP	MDR Criteria	Self-measurement	Published evidence

Device Family:

Microlife BP A200 (BP 3MS1-4K)B, Microlife BP A200 Comfort (BP 3MS1-4A)B,P,F, Microlife BP A3L Comfort (BP 3GX1-3A, A3L-IMT)P
Legend: B BIHS Derivative, P Stride Equivalence, F FDA 510(k)

Validation Publications:

Bing S, Chen K, Hou H, Zhang W, Li L, Wei J, Shu C, Wan Y. Validation of the Microlife BP A200 Comfort and W2 Slim automated blood pressure monitors in a general adult population according to the European Society of Hypertension and the ANSI/AAMI/ISO 81060-2: 2013 protocols. Blood Press Monit. 2016 Apr;21(2):118-23. Epub: 2015 Dec. doi: 10.1097/MBP.0000000000000169. PMID: 26683381.

ESH-IP:2010 - Pass General population

81060-2:2013 - Pass General population

Medaval Certification Assessment

Certification Image Medaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the Microlife BP A200 Comfort (BP3MS1-4A) upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010 and also the AAMI/ANSI/ISO 81060-2:2013 standard for a general study in adults. Medical Device Assessment. 2016 Aug 5;2016(1605) 8 p. Epub: 2019 Jan 31. Available from: www.medaval.ie.

With proven validity of validation results according to an accepted protocol, the clinical accuracy of the blood pressure measurement technology, used in the Microlife BP A200 Comfort, is certified by Medaval Ltd.