Dinamap Carescape V100
While the technology used in the Dinamap Carescape V100, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but there is no evidence provided on a validation of the other device.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| 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 | ||
| ESH (Europe) | Professional use | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. | ||
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
Ni H, Wu C, Prineas R, Shea S, Liu K, Kronmal R, Bild D. Comparison of Dinamap PRO-100 and mercury sphygmomanometer blood pressure measurements in a population-based study. Am J Hypertens. 2006 Apr;19(4):353-60. PMID: 16580569.
Ad Hoc protocol Multi-Ethnic with atherosclerosis
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
Dinamap ProCare 200
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)
