The technology used in the A&D TM-2433, 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||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|Japanese Society of Hypertension||Self-measurement and professional use (2016-2019)||Implied equivalence to the A&D TM-2430|
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.
Palatini P, Frigo G, Bertolo O, Roman E, Da Cortà R, Winnicki M. Validation of the A&D TM-2430 device for ambulatory blood pressure monitoring and evaluation of performance according to subjects' characteristics. Blood Press Monit. 1998 Aug;3(4):255-60. PMID: 10212363.
BHS:1993 - Pass (A/A) General population
SP10:1992 - Pass General population
Yip GW, So HK, Li AM, Tomlinson B, Wong SN, Sung RY. Validation of A&D TM-2430 upper-arm blood pressure monitor for ambulatory blood pressure monitoring in children and adolescents, according to the British Hypertension Society protocol. Blood Press Monit. 2012 Apr;17(2):76-9. doi: 10.1097/MBP.0b013e328351d4a4. PMID: 22391521.
BHS:1993 - Pass (A/B) Children and adolescents (n=61)