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Microlife WatchBP O3 Ambulatory (2G) (BP 3SZ1-1)

Device Name:WatchBP O3 Ambulatory (2G)
Device Model:BP 3SZ1-1
Manufacturer:Sole: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN PRC.
Measuring functions:Blood pressure, Atrial fibrillation
Primary Client Use:Intended for both ABPM and professional use with atrial fibrillation detection
Measurement Site:Upper Arm
Measurement Occurrence:Single, repeated and intermittent measurements
Availability:Available Currently
Description: The Microlife WatchBP O3 Ambulatory (2G) (BP 3SZ1-1) is a clinically validated and 2-star automatic blood pressure monitor. Measurements are taken from the upper arm and, with atrial fibrillation detection, it is intended for both ABPM and single measurement professional use.
Assessment:

The technology used in the Microlife WatchBP O3 Ambulatory (2G) (BP 3SZ1-1), 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
Medaval★★ RecommendationRecent clinical validation; recent protocol
Stride BPABPM for adults (Preferred)Equivalence claim without published evidence

Device Family:Microlife WatchBP O3 (BP 3MZ1-1)P, Microlife WatchBP O3 AFib Ambulatory (BP 3MZ1-1A)P, Microlife WatchBP O3 Ambulatory (2G) (BP 3SZ1-1)P (P Stride Equivalence)
Validation Publications

Fania C, Lazzaretto I, Fontana U, Palatini P. Accuracy of the WatchBP O3 device for ambulatory blood pressure monitoring according to the new criteria of the ISO81060-2 2018 protocol. Blood Press Monit. Epub: 2020 Jun 23. doi: 10.1097/MBP.0000000000000459.

81060-2:2018 - Pass General population

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 WatchBP O3 (BP 3MZ1-1)

Ragazzo F, Saladini F, Palatini P. Validation of the Microlife WatchBP O3 device for clinic, home, and ambulatory blood pressure measurement, according to the International Protocol. Blood Press Monit. 2010 Feb;15(1):59-62. doi: 10.1097/MBP.0b013e32833531ca. PMID: 20075717.

ESH-IP:2002 - Pass General population

Stergiou GS, Tzamouranis D, Nasothimiou EG, Karpettas N, Protogerou A. Are there really differences between home and daytime ambulatory blood pressure? Comparison using a novel dual-mode ambulatory and home monitor. J Hum Hypertens. 2010 Mar;24(3):207-12. Epub: 2009 Jul 16. doi: 10.1038/jhh.2009.60. PMID: 19609285.

ESH-IP:2002 - Pass General population

Azaki A, Diab R, Harb A, Asmar R, Chahine MN. Questionable accuracy of home blood pressure measurements in the obese population - Validation of the Microlife WatchBP O3® and Omron RS6® devices according to the European Society of Hypertension-International Protocol. Vasc Health Risk Manag. 2017;13:61-9. Epub: 2017 Feb 27. doi: 10.2147/VHRM.S126285. PMID: 28280348. Available from: PMC5338962. eCollection 2017.

ESH-IP:2010 - Fail Obese subjects (BMI ≥ 30 kg/m²)