Datascope Accutorr V
While the technology used in the Datascope Accutorr V, 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.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BIHS (UK and IRL)||Professional use for adults and children||Manufacturer declaration of equivalence|
|ESH (Europe)||Professional use for adults and children||Published evidence|
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