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Hartmann Tensoval Duo Control
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:
Available Currently
Availability according to Countries or Regions:
Germany
Description:
The Hartmann Tensoval Duo Control is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood pressure measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:
The technology used in the Hartmann Tensoval Duo Control, to measure blood pressure, has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval Recommendation Older clinical validation; older protocol; multiple clinical validations
BIHS (UK and IRL) Self-measurement Published evidence
DHL (DE) General use (2007, 2009, 2011) Published evidence
ESH (Europe) Self-measurement Published evidence
Stride BP Self-measurement for adults (Preferred) Published evidence
Device Family:
Hartmann Tensoval Duo ControlP , Hartmann Tensoval Duo Control IIP
Legend: P Stride Equivalence
Validation Publications:

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)

Relevant Publications:

Farsky S, Benova K, Krausova D, Sirotiaková J, Vysocanova P. Clinical blood pressure measurement verification when comparing a Tensoval duo control device with a mercury sphygmomanometer in patients suffering from atrial fibrillation. Blood Press Monit. 2011 Oct;16(5):252-7. doi: 10.1097/MBP.0b013e328349a4da. PMID: 21914986.

Measurements from the Hartmann Tensoval Duo Control are compared to those from a standard mercury sphygmomanometer in atrial fibrillation, though not in a formal validation.

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 II

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