Heine Gamma XXL LF (Rail)
Device Name:
Gamma XXL LF
Device Model:
M-000.09.325
Manufacturer:
HEINE Optotechnik GmbH & Co. KG, Kientalstraße 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
Device Specifications:
Description:
The Heine Gamma XXL LF (Rail) is a rail-mounted manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use.
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 a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | This is a manual device. Equivalence to a validated device is possible but this has not been tested to MDR requirements. |
| BP | BIHS (UK and IRL) | Professional use | Published evidence |
| BP | ESH (Europe) | Professional use | Published evidence |
Device Family:
Heine Gamma XXL LF (Desk)Z, Heine Gamma XXL LF (Wall)Z, Heine Gamma XXL LF (Rail)Z, Heine Gamma XXL LF (Stand)Z
Legend: Z Almost Certain
Legend: 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.
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