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A&D TM-2430

Device Model:TM-2430
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 ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

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.

Accuracy AssessmentRecommendationBasis
Medaval RecommendationOlder clinical validation; older protocol; multiple clinical validations
BIHS (UK and IRL)ABPMPublished evidence
Hypertension CanadaABPM (Gold)Published evidence
ESH (Europe)ABPM for adults and childrenPublished evidence
Japanese Society of HypertensionSelf-measurement and professional use (2016-2018)Published evidence
Stride BPABPM for children (Preferred)Published evidence
AMA VDL CriteriaSatisfies stated criteria510(k) K992808 plus BHS:1993 validation

Validation Publications

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)

Relevant Publications

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.