GE Carescape V100

Description:

The GE Carescape V100 is a patient monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements are taken from the upper arm and oxygen saturation measurements are taken from the finger. It is intended for bedside patient monitoring.

Assessment:

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. There appears to be no peer-reviewed clinical validation information available on the technology used in the GE Carescape V100 to measure peripheral oxygen saturation.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Professional use	Manufacturer declaration of equivalence to the Dinamap Procare 100

Device Family:

GE Carescape V100B, Dinamap Procare 420B, Dinamap Carescape V100B, Dinamap ProCare 100B,P, Dinamap ProCare 200B, Dinamap ProCare (DPC 100X-EN)P
Legend: 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)