Visomat Double Comfort (24056) (v2)

Description:

The Visomat Double Comfort (24056) (v2) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the Visomat Double Comfort (24056) (v2), to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Stride BP	Self-measurement for adults	Equivalence claim without published evidence

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 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.

Visomat Double Comfort (24050) (v1)

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