Uscom BP+
Device Name:
BP+
Manufacturer:
Uscom Ltd., Suite 2, Level 8, 66 -74 Clarence Street, Sydney, NSW 2000, AUSTRALIA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use including central aortic pressure
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Device Specifications:
Description:
The Uscom BP+ is an automatic 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 professional use including central aortic pressure.
Assessment:
While the technology used in the Uscom BP+, 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) | Professional use | Manufacturer declaration of equivalence |
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)