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Par Physio-Port

Device Name:Physio-Port
Manufacturer:Sole: 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
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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)ABPMManufacturer declaration of equivalence
ESH (Europe)ABPMThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Par Physio-PortB, PAR Tonoport VIB, Uscom BP+B (B BIHS Derivative)
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)