Keeler Classic
Assessment:
While the technology used in the Keeler Classic, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.
| 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 | Manufacturer declaration of equivalence to a device without published evidence | ||
| ESH (Europe) | Professional use | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. | ||
Device Family:Keeler Big Ben RoundB, Keeler Big Ben SquareB, Keeler ClassicB, Keeler PalmB, Keeler WindsorB, Riester Big Ben Round DeskB, Riester Big Ben Round FloorB, Riester Big Ben Round RailB, Riester Big Ben Round WallB, Riester Big Ben Square DeskB, Riester Big Ben Square FloorB, Riester Big Ben Square RailB, Riester Big Ben Square WallB, Riester E-Mega (1-tube)B, Riester E-Mega (2-tube)B, Riester ExactaB, Riester Minimus IIB, Riester Minimus IIIB, Riester Precisa NB, Riester Precisa N shock-proofB, Riester R1 Shock-ProofB, Riester ri-sanB (B BIHS Derivative)
