Oregon Ssmart Talking (BPU321OS)
While the technology used in the Oregon Ssmart Talking (BPU321OS), 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 there is no evidence provided on a validation of the other device.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | Self-measurement | Manufacturer declaration of equivalence | ||
| ESH (Europe) | Self-measurement | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. | ||
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.
Oregon BPU 330
Li L, Zhang X, Yan C, Liang Q. Validation of the Oregon Scientific BPU 330 for self-monitoring of blood pressure according to the International Protocol. Vasc Health Risk Manag. 2008;4(5):1121-5. PMID: 19183762. Available from: PMC2605325.
ESH-IP:2002 - Pass General population
