Dinamap ProCare 200
The technology used in the Dinamap ProCare 200, to measure blood pressure, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication. While this technology has also 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.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BIHS (UK and IRL)||Professional use||Manufacturer declaration of equivalence|
Lee CG, Park HM, Shin HJ, Moon JS, Hong YM, Kim NS, Ha IS, Chang MJ, Oh KW. Validation study of the Dinamap ProCare 200 upper arm blood pressure monitor in children and adolescents. Korean J Pediatr. 2011 Nov;54(11):463-9. Epub: 2011 Nov 30. doi: 10.3345/kjp.2011.54.11.463. PMID: 22253643. Available from: PMC3254892.
ESH-IP:2010 - Fail Children and adolescents (n=45)
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.
Dinamap ProCare 100
Reinders A, Reggiori F, Shennan AH. Validation of the DINAMAP ProCare blood pressure device according to the international protocol in an adult population. Blood Press Monit. 2006 Oct;11(5):293-6. PMID: 16932038.
ESH-IP:2002 - Pass General population