A&D TM-2441
Device Model:
TM-2441
Manufacturer:
A&D Company Ltd., 3-23-14 Higashi-Ikebukuro, Toshima-Ku, 170-0013 Tokyo, JAPAN.
Measuring functions:
Blood Pressure, PR and Atrial fibrillation
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
Availability according to Countries or Regions:
Australia, Canada, Ireland, Japan and United States
Device Manual:
Click here to download the Device Manual
Description:
The A&D TM-2441 is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the A&D TM-2441, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; recent protocol
BP BIHS (UK and IRL) ABPM Published evidence
BP Hypertension Canada ABPM (Gold) Published evidence
BP Japanese Society of Hypertension Professional use (2019-2025) Published evidence
BP Stride BP ABPM for adults and diabetes mellitus (Preferred) Published evidence
BP AMA VDL (US) ABPM for adults Published evidence
BP MDR Criteria ABPM Published evidence
Device Family:
A&D TM-2655J,P, A&D TM-2655P (V2)J, A&D TM-2440B,P, A&D TM-2441B,P, A&D TM-2655VPJ
Legend: B BIHS Derivative, J JHS Implied Equivalence, P Stride Equivalence
Validation Publications:

Kario K, Hoshide S, Saito K, Sato K, Hamasaki H, Suwa H, Tomitani N. Validation of the TM-2441 ambulatory blood pressure measurement device according to the ISO 81060-2 2013 standard. Blood Press Monit. 2019 Feb;24(1):38-41. Epub: 2018 Nov 29. doi: 10.1097/MBP.0000000000000357. PMID: 30507622.

81060-2:2013 - Pass General population (Note: Primary 85-subject study)

81060-2:2013 - Pass General population (Note: 35-subject exercise study, as required for ABPM devices)

Both the main and exercise studies are completed; 13 subjects were included in both studies.

Relevant Publications:

Kario K, Shimbo D, Tomitani N, Kanegae H, Schwartz JE, Williams B. The first study comparing a wearable watch-type blood pressure monitor with a conventional ambulatory blood pressure monitor on in-office and out-of-office settings. J Clin Hypertens (Greenwich). 2020 Feb;22(2):135-141. Epub: 2020 Jan 19. doi: 10.1111/jch.13799. PMID: 31955505.

Measurements from the A&D TM-2441 are compared to those from the Omron Heartguide BP8000-M (HEM-6410T-ZM) or the BP8000-L (HEM-6410T-ZL), though not in a formal validation.

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 TM-2655

Kobalava ZD, Kotovskaya YV, Babaeva LA, Moiseev VS. Validation of TM-2655 oscillometric device for blood pressure measurement. Blood Press Monit. 2006 Apr;11(2):87-90. PMID: 16534410.

BHS:1993 - Pass (A/A) General population

A&D TM-2655P (V2)

Kobalava ZD, Kotovskaya YV, Babaeva LA, Moiseev VS. Validation of TM-2655 oscillometric device for blood pressure measurement. Blood Press Monit. 2006 Apr;11(2):87-90. PMID: 16534410.

BHS:1993 - Pass (A/A) General population

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