ALP K2 DM-3000 - Medaval

Description:

The ALP K2 DM-3000 is a desk (tabletop) automatic mercury-free sphygmomanometer. 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 professional use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the ALP K2 DM-3000 to measure blood pressure. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant 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.

Device Family:

ALP K2 DM-3000Z, Nissei DM-3000Z
Legend: Z Almost Certain

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.

Nissei DM-3000

Tasker F, De Greeff A, Shennan AH. Development and validation of a blinded hybrid device according to the European Hypertension Society protocol: Nissei DM-3000. J Hum Hypertens. 2010 Sep;24(9):609-16. Epub: 2010 Jan 28. doi: 10.1038/jhh.2009.113. PMID: 20107491. Available from: www.nature.com.

ESH-IP:2002 - Pass General population

Stergiou GS, Karpettas N, Kollias A, Destounis A, Tzamouranis D. A perfect replacement for the mercury sphygmomanometer: the case of the hybrid blood pressure monitor. J Hum Hypertens. 2012 Apr;26(4):220-7. Epub: 2011 Sep 8. doi: 10.1038/jhh.2011.77. PMID: 21900952.

ESH-IP:2010 - Pass General population (Note: Modified protocol)