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Meditech ABPM-06

Device Name:ABPM-06
Manufacturer:Sole: Meditech Ltd., Mikszath Kalman utca 24, 1184 Budapest, HUNGARY.
Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

The technology used in the Meditech ABPM-06, 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)Published evidence
MDR CriteriaABPMPublished evidence

Validation Publications

Hermányi Z, Pokoly B, Visolyi G, Barna I. Evaluation of Meditech ABPM-06 ambulatory blood pressure measuring device, according to the European Society of Hypertension, the British Hypertension Society and the International Organization for Standardization Protocol. Blood Press Monit. 2019 Aug;24(4):208-211. Epub: 2019 May 30. doi: 10.1097/MBP.0000000000000385. PMID: 31162148.

81060-2:2013 - Pass General population

ESH-IP:2010 - Pass General population (Note: See Blood Press Monit. 2020 Jan;25(1):59-60.)

BHS:1993 - Pass (A/A) General population

Sheppard JP, Lacy P, Chapman N, Clark C, McManus RJ; British and Irish Hypertension Society Blood Pressure Measurement Working Party. Reporting of the Meditech ABPM-06 ambulatory blood pressure device validation study. Blood Press Monit. 2020 Feb;25(1):59-60. doi: 10.1097/MBP.0000000000000425. PMID: 31876570. Available from: journals.lww.com.

This is a letter describing protocol violations in the ESH-IP 2010 validation of the Meditech ABPM-06. See Blood Press Monit. 2019 Aug;24(4):208-211.