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Aponorm Mobil Basis 3G
Device Name:
Mobil Basis 3G
Manufacturer:

OBL: WEPA Apothekenbedarf GmbH & Co KG (Aponorm), Am Fichtenstrauch 6-10, 56204 Hillscheid, GERMANY.

OEM: 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:
Germany
Device Manual:
Click here to download the Device Manual
Description:
The Aponorm Mobil Basis 3G is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Aponorm Mobil Basis 3G, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP DHL (DE) General use (Latest: 2016) Manufacturer declaration of equivalence
BP Stride BP Self-measurement for adults Equivalence claim without 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 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

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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