Hartmann Tensoval Duo Control II
Device Name:
Tensoval Duo Control II
Manufacturer:
Paul Hartmann AG, Paul-Hartmann-Straße 12, 89522 Heidenheim, GERMANY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Device Manual:
Click here to download the Device Manual
Description:
The Hartmann Tensoval Duo Control II is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Hartmann Tensoval Duo Control II, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Legacy approval Older clinical validation; older protocol
BP BIHS (UK and IRL) Self-measurement (Previous) Published evidence
BP ESH (Europe) Self-measurement Published evidence
BP Stride BP Self-measurement for adults (Unavailable) (Previously Preferred) Published evidence
Device Family:
Hartmann Tensoval Duo ControlP, Hartmann Tensoval Duo Control IIP
Legend: P Stride Equivalence
Validation Publications:

de Greeff A, Shennan AH. Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010. Blood Press Monit. 2013 Jun;18(3):161-6. doi: 10.1097/MBP.0b013e328360fb52. PMID: 23640067.

ESH-IP:2010 - Pass General population

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.

Hartmann Tensoval Duo Control

De Greeff A, Arora J, Hervey S, Liu B, Shennan AH. Accuracy assessment of the Tensoval duo control according to the British and European Hypertension Societies' standards. Blood Press Monit. 2008 Apr;13(2):111-6. doi: 10.1097/MBP.0b013e3282f3fb2e. PMID: 18347446.

ESH-IP:2002 - Pass General population

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

de Greeff A, Hezelgrave N, Shennan AH. Accuracy assessment of a novel blood pressure measurement device in a South African adult population: Tensoval duo control. Blood Press Monit. 2011 Dec;16(6):304-6. doi: 10.1097/MBP.0b013e32834db648. PMID: 22027814.

ESH-IP:2002 General population (Note: ESH-02 not recognised since 01 July 2011)

Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.

DHL:1999 - Pass General population (Note: 2007)

DHL:2007 - Pass General population (Note: 2011, Normal and Large Cuff)

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