Heine Gamma XXL LF (Stand)
There appears to be no peer-reviewed clinical validation information available on the technology used in the Heine Gamma XXL LF (Stand) to measure blood pressure. However, this device appears to be very similar to a validated device by the same 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 | This is a manual device. Equivalence to a validated device is possible but this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | Professional use | Published evidence | ||
| ESH (Europe) | Professional use | 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.
Heine Gamma XXL LF (Desk)
Dorigatti F, Bonso E, Zanier A, Palatini P. Validation of Heine Gamma G7 (G5) and XXL-LF aneroid devices for blood pressure measurement. Blood Press Monit. 2007 Feb;12(1):29-33. PMID: 17303985.
ESH-IP:2002 - Pass General population
