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GE Carescape V100

Device Name:Carescape V100
Manufacturer:General Electric Company, 33-41 Farnsworth Street, Boston, MA 02210, UNITED STATES.
Measuring functions:Blood pressure, SpO2, Temperature
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently

While the technology used in the GE Carescape V100, 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.

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

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

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)