Datascope Accutorr V

Description:

The Datascope Accutorr V 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 Datascope Accutorr V, 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 Datascope Accutorr V 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 for adults and children	Manufacturer declaration of equivalence
BP	ESH (Europe)	Professional use for adults and children	Published evidence

Device Family:

Datascope Accutorr VB, Datascope Accutorr PlusB
Legend: 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.

Datascope Accutorr Plus

Anwar YA, Tendler BE, McCabe EJ, Mansoor GA, White WB. Evaluation of the Datascope Accutorr Plus according to the recommendations of the Association for the Advancement of Medical Instrumentation. Blood Press Monit. 1997 Apr;2(2):105-110. PMID: 10234101.

SP10:1992 - Pass General population

White WB, Herbst T, Thavarajah S, Giacco S. Clinical evaluation of the Trimline blood pressure cuffs with the Accutorr Plus Monitor. Blood Press Monit. 2003 Jun;8(3):137-40. PMID: 12900592.

SP10:2002 - Pass General population

Trimline blood pressure cuffs used

Wong SN, Tz Sung RY, Leung LC. Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children. Blood Press Monit. 2006 Oct;11(5):281-91. PMID: 16932037.

ESH-IP:2002 - Pass Children

Khawaja RA, Qureshi R, Mansure AH, Yahya ME. Validation of Datascope Accutorr Plus™ using British Hypertension Society (BHS) and Association for the Advancement of Medical Instrumentation (AAMI) protocol guidelines. J Saudi Heart Assoc. 2010 Jan;22(1):1-5. Epub: 2010 Mar 10. doi: 10.1016/j.jsha.2010.03.001. PMID: 24936124. Available from: PMC4051388.

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

SP10:1996 - Pass General population