Gima Domino (32803)
Device Name:
Domino
Device Model:
32803
Manufacturer:
Gima S.p.A., Via Marconi 1, 20060 Gessate Milano, ITALY.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Description:
The Gima Domino (32803) is a desk (tabletop) or wall-mounted automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. 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 Gima Domino (32803) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and 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 | Not recommended | This device has not been shown to have been clinically validated. |
Device Family: