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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 ROC.

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
Device Manual:
Click here to download the Device Manual
Description:
The Braun Vitalscan 1 (BBP-2000) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Legacy approval Older clinical validation; older protocol
Device Family:
Aponorm Mobil Basis 3GP, BIOS W100 (Precision 6.0) (V1)Z, BIOS W100 (Precision 6.0) (V2)Z, Braun Vitalscan 1 (BBP-2000)D, Microlife BP W100 (BP 3MK1-3)D,P
Legend: D DET Equivalence, P Stride Equivalence, Z Almost Certain
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)

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