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Microlife BP 3AC1-2
Device Model:
BP 3AC1-2
Manufacturer:
Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Description:
The Microlife BP 3AC1-2 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 upper arm. It is intended for professional use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the Microlife BP 3AC1-2, to measure blood pressure, has been compared to a clinically validated device, but not according to a protocol compliant 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 ESH (Europe) Self-measurement Published evidence
Device Family:
Microlife BP 3AC1-1B,D, Microlife BP 3AC1-1 PCB,D, Microlife BP 3AC1-2D
Legend: B BIHS Derivative, D DET Equivalence
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 3AC1-1

Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two devices for self-measurement of brachial blood pressure according to the International Protocol of the European Society of Hypertension: the SEINEX SE-9400 and the Microlife BP 3AC1-1. Blood Press Monit. 2005 Dec;10(6):325-331. doi: 10.1097/00126097-200512000-00008. PMID: 16330959.

ESH-IP:2002 - Pass General population

de Greeff A, Reggiori F, Anthony J, Shennan A. The Microlife 3AC1: an accurate blood pressure measurement device in pregnancy and pre-eclampsia. J Hypertens. 2006;24(suppl 4):S279 P14.475. Abstract.

BHS:1993 - Pass (A/A) Pregnancy (n=29)

SP10:1992 - Pass Pregnancy (n=29)

BHS:1993 - Pass (B/A) Pre-eclampsia (n=16)

SP10:1992 - Pass Pre-eclampsia (n=16)

This study was published as an abstract only. As there is no peer-reviewed complete paper, the results can be considered as advisory only.

Microlife BP 3AC1-1 PC

Thompson AM, Eguchi K, Reznik ME, Shah SS, Pickering TG. Validation of an oscillometric home blood pressure monitor in an end-stage renal disease population and the effect of arterial stiffness on its accuracy. Blood Press Monit. 2007 Aug;12(4):227-232. doi: 10.1097/MBP.0b013e328108f544. PMID: 17625395.

ESH-IP:2002 - Pass ESRD (n=33)

Xu J, Wu Y, Su H, Hu W, Li J, Wang W, Liu X, Cheng X. The value of a BP determination method using a novel non-invasive BP device against the invasive catheter measurement. PLoS One. 2014 Jun 23;9(6):e100287. doi: 10.1371/journal.pone.0100287. PMID: 24955577. Available from: PMC4067298.

IA protocol General population (Note: IA validation (n≤48))

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