Tensiomed Arteriograph TL2 - Medaval

Tensiomed Arteriograph TL2

Device Name:

Arteriograph

Device Model:

TL2

Manufacturer:

OBL: Tensiomed Ltd., Kétújfalu str. 163, H-1182 Budapest, HUNGARY.

OEM: Tensiomed Ltd. (Medexpert), Kétújfalu str. 163, H-1182 Budapest, HUNGARY.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for professional use including central aortic pressure

Measurement Site:

Upper Arm

Measurement Occurrence:

Single and intermittent measurements

Availability:

Available Currently

Device Manual:

Click here to download the Device Manual

Description:

The Tensiomed Arteriograph TL2 is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for professional use including central aortic pressure.

Assessment:

The technology used in the Tensiomed Arteriograph TL2, to measure blood pressure, has been assessed, in a general population, according to a non-standard protocol. It has also been declared, on the manufacturer website, as being equivalent to that used in a clinically validated device, but no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has not been shown to have been clinically validated.

Device Family:

Tensiomed Arteriograph 24Y, Tensiomed Arteriograph TL2Y
Legend: Y Internal declaration

Validation Publications:

Horváth IG, Németh A, Lenkey Z, Alessandri N, Tufano F, Kis P, Gaszner B, Cziráki A. Invasive validation of a new oscillometric device (Arteriograph) for measuring augmentation index, central blood pressure and aortic pulse wave velocity. J Hypertens. 2010 Oct;28(10):2068-2075. doi: 10.1097/HJH.0b013e32833c8a1a. PMID: 20651604.

IA protocol (n=55) (Note: SBP only assessed. Accuracy is claimed on the basis of errors falling within BHS Grade B. Error -0.56 ± 8.50 mmHg.)

Relevant Publications:

Baulmann J, Schillings U, Rickert S, Uen S, Düsing R, Illyes M, Cziraki A, Nickering G, Mengden T. A new oscillometric method for assessment of arterial stiffness: comparison with tonometric and piezo-electronic methods. J Hypertens. 2008 Mar;26(3):523-528. doi: 10.1097/HJH.0b013e3282f314f7. PMID: 18300864.

Validation of pulse wave velocity and augmentation index functions against the AtCor SphygmoCor and Alam (formerly Artech) Complior.

Parati G, De Buyzere M. Evaluating aortic stiffness through an arm cuff oscillometric device: is validation against invasive measurements enough? J Hypertens. 2010 Oct;28(10):2003-2006. doi: 10.1097/HJH.0b013e32833f0e93. PMID: 20844367. Available from: journals.lww.com.

The publication is a letter or correspondence in which the Tensiomed Arteriograph TL2 is referenced.

Rezai MR, Goudot G, Winters C, Finn JD, Wu FC, Cruickshank JK. Calibration mode influences central blood pressure differences between SphygmoCor and two newer devices, the Arteriograph and Omron HEM-9000. Hypertens Res. 2011 Sep;34(9):1046-51. Epub: 2011 Jul 14. doi: 10.1038/hr.2011.75. PMID: 21753770. Available from: www.nature.com.

Measurements from the Tensiomed Arteriograph TL2 are compared to those from the Omron M9000 and the Sphygmocor, though not in a formal validation.

Trachet B, Reymond P, Kips J, Vermeersch S, Swillens A, Stergiopulos N, Segers P. Validation of the Arteriograph working principle: questions still remain. J Hypertens. 2011 Mar;29(3):619. doi: 10.1097/HJH.0b013e328343cdc1. PMID: 21317726. Author reply 620.

The publication is a letter or correspondence in which the Tensiomed Arteriograph TL2 is referenced.

Horváth IG, Lenkey Z, Cziráki A. Validation of the Arteriograph working principle: questions still remain. J Hypertens. 2011 Mar;29(3):620. doi: 10.1097/HJH.0b013e328343cdd1. Author reply to 619.

The publication is a letter or correspondence in which the Tensiomed Arteriograph TL2 is referenced.

Trachet B, Reymond P, Kips J, Vermeersch S, Swillens A, Stergiopulos N, Segers P. Validation of the arteriograph working principle: questions still remain - reply 2. J Hypertens. 2011 Aug;29(8):1662-1663. doi: 10.1097/HJH.0b013e328348f06d. PMID: 21750440. Author reply 1663-1664.

The publication is a letter or correspondence in which the Tensiomed Arteriograph TL2 is referenced.

Horváth IG, Lenkey Z, Cziráki A. Reply to the letter of B. Trachet et al. J Hypertens. 2011 Aug;29(8):1663-1664. doi: 10.1097/HJH.0b013e328348f07d. Author reply to 1663-1664.

The publication is a letter or correspondence in which the Tensiomed Arteriograph TL2 is referenced.

Díaz A, Bia D, Zócalo Y. Impact of Methodological and Calibration Approach on the Association of Central and Peripheral Systolic Blood Pressure with Cardiac Structure and Function in Children, Adolescents and Adults. High Blood Press Cardiovasc Prev.. 2019 Dec;26(6):509-534. Epub: 2019 Oct 30. doi: 10.1007/s40292-019-00346-0. PMID: 31667753.

Nine estimates of SBP, two Arteriograph [1) Peripheral, 2) Central by auto-calibration], four IEM Mobil-O-Graph [3) Peripheral, 4) Central by brachial SBP and DBP calibration, 5) Central by brachial MAP and DBP calibration, 6) Central by calculated MAP and brachial DBP calibration] and three by aortic root ultrasound images with diameter waveform recalibration based on [7) Arteriograph calculated MAP and brachial DBP, 8) Mobil-O-Graph brachial MAP and DBP, 9) Mobil-O-Graph calculated MAP and brachial DBP] were compared.