Par Physio-Port
While the technology used in the Par Physio-Port, 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) | ABPM | Manufacturer declaration of equivalence | ||
| ESH (Europe) | ABPM | 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.
PAR Tonoport VI
Abou-Dakn M, Döhmen C, Wenzel S. Validation of the TONOPORT VI ambulatory blood pressure monitor in adults according to the European Society of Hypertension International Protocol revision 2010. J Hum Hypertens. 2017 Feb;31(2):89-92. Epub: 2016 Jul 14. doi: 10.1038/jhh.2016.40. PMID: 27411300.
ESH-IP:2010 - Pass General population (Note: Inflation method)
ESH-IP:2010 - Pass General population (Note: Deflation method)
