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Dinamap Procare 420

Device Name:Procare 420
Manufacturer:GE Medical Systems Ltd. (Dinamap), Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, UNITED KINGDOM.
Measuring functions:Blood pressure
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

While the technology used in the Dinamap Procare 420, 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 AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Professional useManufacturer declaration of equivalence
ESH (Europe)Professional useThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Dinamap Carescape V100B, Dinamap ProCare 100B, Dinamap ProCare 200B, Dinamap Procare 420B, GE Carescape V100B (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.

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)