GE Tonoport V
There appears to be no peer-reviewed clinical validation information available on the technology used in the GE Tonoport V to measure blood pressure. However, this device appears to be very similar to another device by the same (OEM) manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BIHS (UK and IRL)||ABPM||Published evidence|
|ESH (Europe)||ABPM||Published evidence|
|Stride BP||ABPM for adults||Published evidence|
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.
PAR Tonoport V
O'Brien E, Atkins N, Murphy A, Lyons S. Validation of the TONOPORT V ambulatory blood pressure monitor according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults. Blood Press Monit. 2003 Dec;8(6):255-60. PMID: 14688556.
ESH-IP:2002 - Fail General population
Haensel A, Utech K, Langewitz W. Validation of TONOPORT V blood-pressure measuring monitor in adults. J Hum Hypertens. 2005 Sep;19(9):745-9. PMID: 15951741.
ESH-IP:2002 - Pass General population