Visomat Double Comfort (24050) (v1)

Description:

The Visomat Double Comfort (24050) (v1) 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 self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The accuracy of the technology used in the Visomat Double Comfort (24050) (v1), 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
BP	BIHS (UK and IRL)	Self-measurement	Published evidence
BP	ESH (Europe)	Self-measurement	Published evidence
BP	Stride BP	Self-measurement for adults	Published evidence

	Consumer Body	Year(s)	Level	Comment
BP	Stiftung Warentest (DE)	Previous: 2018	Satisfactory

Device Family:

Visomat Comfort E (24016) (v2)D, Visomat Double Comfort (24050) (v1)D,P, Visomat Double Comfort (24056) (v2)P
Legend: D DET Equivalence, P Stride Equivalence

Validation Publications:

Masiero S, Fania C, Palatini P. Validation of the UEBE Visomat Double Comfort upper arm blood pressure monitor, in auscultation mode, for clinic use and self-measurement in a general population, according to the European Society of Hypertension International Protocol, revision 2010. Blood Press Monit. 2011 Aug;16(4):208-10. doi: 10.1097/MBP.0b013e328348b6a0. (Details from: journals.lww.com).

ESH-IP:2010 - Pass In auscultatory mode

Masiero S, Fania C, Palatini P. Validation of the UEBE Visomat Double Comfort upper arm blood pressure monitor, in oscillometric mode, for clinic use and self-measurement in a general population according to the European Society of Hypertension International Protocol, revision 2010. Blood Press Monit. 2011 Oct;16(5):262-4. doi: 10.1097/MBP.0b013e32834b6694. PMID: 21885959.

ESH-IP:2010 - Pass In oscillometric mode

Medaval Certification Assessment

Certification Image Medaval Ltd. Accreditation assessment of the blood pressure measurement technology used in the UEBE Visomat Double Comfort upper arm monitor, as validated according to the European Society of Hypertension International Protocol revision 2010. Medical Device Assessment. 2016 Aug 5;2016(1609) 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 Visomat Double Comfort, is certified by Medaval Ltd.