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 a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
| 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
