Par Physio-Port

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 to the Tonoport VI
BP	ESH (Europe)	ABPM	The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.

Device Family:

PAR Tonoport VIB, Par Physio-PortB, Uscom BP+B
Legend: 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)

Uscom BP+

Glenning JP, Sheeran F, Cuthbert J, Harris W, Quinlan C, Mynard JP. Validation of the Uscom BP+ automated oscillometric blood pressure monitor for professional office use in children and adolescents according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018). Hypertens Res.. Epub: 2024 Dec 24. doi: 10.1038/s41440-024-01992-1. PMID: 39719530.

81060-2:2019 - Pass General population (Note: Three standard cuffs: Extra Small (12 cm - 17 cm), Small Adult (16 cm - 24 cm) and Adult (22 cm - 32 cm))

81060-2:2019 - Fail General population (Note: Non-standard wide-range cuff (22 cm - 42 cm))