The technology used in the A&D UM-102A, 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.
|Medaval||None||This is a manual device. Equivalence to a validated device is possible but this has not been tested to MDR requirements.|
|Japanese Society of Hypertension||Professional use (2019-2020)||Non-compliant (to MEDDEV 2.7/1 rev 4) equivalence to the A&D UM-101|
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.
Stergiou GS, Giovas PP, Gkinos CP, Tzamouranis DG. Validation of the A&D UM-101 professional hybrid device for office blood pressure measurement according to the International Protocol. Blood Press Monit. 2008 Feb;13(1):37-42. doi: 10.1097/MBP.0b013e3282c9acb0. PMID: 18199922.
ESH-IP:2002 - Pass Without "mark button"
ESH-IP:2002 - Fail With "mark button"
Pruijm MT, Wuerzner G, Glatz N, Alwan H, Ponte B, Ackermann D, Burnier M, Bochud M. A new technique for simultaneous validation of two manual nonmercury auscultatory sphygmomanometers (A&D UM-101 and Accoson Greenlight 300) based on the International protocol. Blood Press Monit. 2010 Dec;15(6):322-5. doi: 10.1097/MBP.0b013e32833f56a8. PMID: 20827175.
ESH-IP:2002 - Pass General population
Davis GK, Roberts LM, Mangos GJ, Brown MA. Comparisons of auscultatory hybrid and automated sphygmomanometers with mercury sphygmomanometry in hypertensive and normotensive pregnant women: parallel validation studies. J Hypertens. 2015 Mar;33(3):499-505; discussion 505-6. doi: 10.1097/HJH.0000000000000420. PMID: 25380148.
BHS:1993 - Pass (A/A) Normotensive (n=170) and hypertensive (n=170) pregnancy