🏠
📞  +353 1 6643768
 
📧  info@medaval.ie
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, 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:
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 and 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
Medaval ★★ Recommendation Recent clinical validation; recent protocol
BIHS (UK and IRL) ABPM Published evidence
Hypertension Canada ABPM (Gold) Published evidence
Japanese Society of Hypertension Self-measurement and professional use (2019-2021) Published evidence
Stride BP ABPM for adults (Preferred) Published evidence
AMA VDL (US) ABPM Published evidence
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