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 a validated device by the same (OEM) manufacturer but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Accuracy Assessment | Recommendation | Basis | ||
---|---|---|---|---|
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