Par Physio-Port
Device Name:
Physio-Port
Manufacturer:
PAR Medizintechnik GmbH & Co. KG, Platinum, Sachsendamm 6, 10829 Berlin, GERMANY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Availability according to Countries or Regions:
Ireland
Device Manual:
Device Specifications:
Description:
The Par Physio-Port is an ambulatory blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | BIHS (UK and IRL) | ABPM | Manufacturer declaration of equivalence |
| BP | ESH (Europe) | ABPM | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. |
Device Family:
Validation Publications for Equivalent Devices:
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)