Tensiomed Arteriograph 24
Device Name:
Arteriograph 24
Device Model:
TD3
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 and PR
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
Device Manual:
Description:
The Tensiomed Arteriograph 24 is an ambulatory blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
While the technology used in the Tensiomed Arteriograph 24, to measure blood pressure, has been declared, on the manufacturer website, as being equivalent to that used in a clinically validated device, 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 |
None |
Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
Device Family:
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.
Tensiomed Arteriograph TL2
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.)
