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Dinamap Carescape V100

Device Name:Carescape V100
Manufacturer:GE Medical Systems Ltd. (Dinamap), Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, UNITED KINGDOM.
Measuring functions:Blood pressure, SpO2, Temperature
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single and intermittent measurements
Availability:Available Currently
Description: The Dinamap Carescape V100 is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for bedside patient monitoring.
Assessment:

While the technology used in the Dinamap 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
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 (DPC 100X-EN)P, Dinamap ProCare 100B,P, Dinamap ProCare 200B, Dinamap Procare 420B, GE Carescape V100B (B BIHS Derivative, P Stride Equivalence)
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 (DPC 100X-EN)

de Greeff A, Reggiori F, Shennan AH. Clinical assessment of the DINAMAP ProCare monitor in an adult population according to the British Hypertension Society Protocol. Blood Press Monit. 2007 Feb;12(1):51-55. doi: 10.1097/MBP.0b013e3280858b73. PMID: 17303988.

BHS:1993 - Pass (A/A) General population

SP10:1992 - Pass General population

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)