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Scala DB-61M

Device Model:DB-61M
Manufacturer:Scala Electronic GmbH, Ruhlsdorferstraße 95, 14532 Stahnsdorf, 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
Description: The Scala DB-61M is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and 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 Scala DB-61M, 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.

Accuracy AssessmentRecommendationBasis
MedavalLegacy approvalOlder clinical validation; older protocol
DHL (DE)General usePublished evidence
ESH (Europe)Self-measurementThe DHL recommendation

Validation Publications

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)