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Microlife BP W100 (BP 3MK1-3)
Device Name:
BP W100
Device Model:
BP 3MK1-3
Manufacturer:
Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood pressure, Arrhythmias
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Belarus, Germany, France, Italy and Russian Federation
Device Manual:
Description:
The Microlife BP W100 (BP 3MK1-3) 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 wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Microlife BP W100 (BP 3MK1-3), 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
BP Medaval Recommendation Older clinical validation; older protocol; multiple clinical validations
BP DHL (DE) General use (2007) Published evidence
BP Stride BP Self-measurement for adults Published evidence
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:

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)

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.

Braun Vitalscan 1 (BBP-2000)

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