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Heine Gamma XXL LF (Rail)

Device Name:Gamma XXL LF
Device Model:M-000.09.325
Manufacturer:HEINE Optotechnik GmbH & Co. KG, Kientalstra├če 7, 82211 Herrsching a. Ammersee, GERMANY.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Heine Gamma XXL LF (Rail) to measure blood pressure. However, this device appears to be very similar to another device by the same 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneThis 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 usePublished evidence
ESH (Europe)Professional usePublished evidence

Device Family:Heine Gamma XXL LF (Desk)Z, Heine Gamma XXL LF (Rail)Z, Heine Gamma XXL LF (Stand)Z, Heine Gamma XXL LF (Wall)Z (Z Almost Certain)
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.

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