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.
Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | ★ Recommendation | Older clinical validation; older protocol; multiple clinical validations |
BP | BIHS (UK and IRL) | Professional use for adults and children | Published evidence |
BP | ESH (Europe) | Professional use for adults and children | Published evidence |
BP | Stride BP | Office and hospital use for adults | Published evidence |
BP | FDA (US) | 510(k) | 510(k) K970061,, K983575 |
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
Adler C, Ellert U, Neuhauser HK. Disagreement of the two oscillometric blood pressure measurement devices, Datascope Accutorr Plus and Omron HEM-705CP II, and bidirectional conversion of blood pressure values. Blood Press Monit. 2014 Apr;19(2):109-17. doi: 10.1097/MBP.0000000000000037. PMID: 24583967.
Measurements from the Datascope Accutorr Plus are compared to those from the Omron HEM-705CP II, though not in a formal validation.
Sarganas G, Kuhnert R, Gohlisch C, van der Giet M, Neuhauser H. Comparison of two blood pressure oscillometric devices: Datascope Accutorr Plus and Mobil-O-Graph PWA and conversion of blood pressure values from one device to the other. Blood Press Monit. 2020 Feb;25(1):42-49. Epub: 2019 Oct 15. doi: 10.1097/MBP.0000000000000409. PMID: 31633519.
Measurements from the Datascope Accutorr Plus are compared to those from the IEM Mobil-O-Graph PWA, though not in a formal validation.