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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:

While the technology used in the A&D UM-102B, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.

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