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A&D UM-102B

Device Model:UM-102B
Manufacturer:Sole: A&D Company Ltd., 3-23-14 Higashi-Ikebukuro, Toshima-Ku, 170-0013 Tokyo, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the A&D UM-102B, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneThis is a manual device. Equivalence to a validated device is possible but this has not been tested to MDR requirements.
Japanese Society of HypertensionProfessional use (2019)Implied equivalence to the A&D UM-101

Device Family:A&D UM-101J, A&D UM-102AJ, A&D UM-102BJ (J JHS Implied 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.

A&D UM-101

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