The technology used in the A&D TM-2430, to measure blood pressure, has passed in clinical validation studies, between general and young populations, according to recognised standard protocols, as published in peer-reviewed publications.
|Medaval||★ Recommendation||Older clinical validation; older protocol; multiple clinical validations|
|BIHS (UK and IRL)||ABPM||Published evidence|
|Hypertension Canada||ABPM (Gold)||Published evidence|
|ESH (Europe)||ABPM for adults and children||Published evidence|
|Japanese Society of Hypertension||Self-measurement and professional use (2016-2019)||Published evidence|
|Stride BP||ABPM for children (Preferred)||Published evidence|
|AMA VDL Criteria||Satisfies stated criteria||510(k) K992808 plus BHS:1993 validation|
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)
Uen S, Weisser B, Wieneke P, Vetter H, Mengden T. Evaluation of the performance of a wrist blood pressure measuring device with a position sensor compared to ambulatory 24-hour blood pressure measurements. Am J Hypertens. 2002 Sep;15(9):787-92. PMID: 12219873.
The publication describes the A&D TM-2430 being used as a reference device for comparison with the Braun BP-2000.
Islam SMS, Cartledge S, Karmakar C, Rawstorn JC, Fraser SF, Chow C, Maddison R. Validation and Acceptability of a Cuffless Wrist-Worn Wearable Blood Pressure Monitoring Device Among Users and Health Care Professionals: Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Sep 14;7(10):e14706. doi: 10.2196/14706. PMID: 31628788 . Available from: mhealth.jmir.org.
The publication describes the A&D TM-2430 being used as a validation control device.