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Heine Gamma XXL LF (Wall)

Device Name:Gamma XXL LF
Device Model:M-000.09.323/327 (with/without cuff rest)
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 (Wall) 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 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