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Datascope Accutorr V

Device Name:Datascope Accutorr V
Manufacturer:

Brand: SOMA Technology Inc., 166 Highland Park Drive, Bloomfield, CT 06002, UNITED STATES.

OBL: Mindray North America, 800 Macarther Blvd, Mahwah, NJ 07430, UNITED STATES.

OEM: Datascope Corp. (Maquet/Getinge), 1300 MacArthur Blvd, Mahwah, NJ 07430, UNITED STATES.

Measuring functions:Blood pressure, SpO2, Temperature, ECG, Respiration, EtCO2
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single and intermittent measurements
Availability:Available Currently
Assessment:

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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Professional use for adults and childrenManufacturer declaration of equivalence
ESH (Europe)Professional use for adults and childrenPublished evidence

Device Family:Datascope Accutorr PlusB, Datascope Accutorr VB (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