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Braun Vitalscan 1 (BBP-2000)

Device Name:Vitalscan 1 [aka Precisionsensor BP-2000]
Device Model:BBP-2000
Manufacturer:

OBL: B. Braun Melsungen AG, Carl-Braun-Straße, 134212 Melsungen, GERMANY.

OEM: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN PRC.

Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Braun Vitalscan 1 (BBP-2000), 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

Device Family:Braun Vitalscan 1 (BBP-2000)D, Microlife BP W100 (BP 3MK1-3)D (D DET Equivalence)
Validation Publications

Wessig K, Hollinger S, Schmalzhaf I, Lenz T. Clinical evaluation of the efficacy of the Braun PrecisionSensor oscillometric wrist blood pressure monitor for use on adults versus auscultation as defined by ANSI/AAMI SP10-1992. Blood Press Monit. 2000 Aug;5(4):239-45. PMID: 11035867.

SP10:1992 - Pass General population

Relevant Publications

Uen S, Weisser B, Wieneke P, Vetter H, Mengden T. Evaluation of the performance of a wrist blood pressure measuring device with a position sensor compared to ambulatory 24-hour blood pressure measurements. Am J Hypertens. 2002 Sep;15(9):787-92. PMID: 12219873.

Measurements from the Braun Vitalscan 1 (BBP-2000) [aka Precisionsensor BP-2000] are compared to those from the A&D TM-2430, 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.

Microlife BP W100 (BP 3MK1-3)

Palatini P, Dorigatti F, Bonso E, Ragazzo F. Validation of Microlife BP W100 wrist device assessed according to the European Society of Hypertension and the British Hypertension Society protocols. Blood Press Monit. 2009 Feb;14(1):41-4. doi: 10.1097/MBP.0b013e32831e30d2. PMID: 19252436.

ESH-IP:2002 - Pass General population

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)