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Meditech ABPM-06
Device Name:
ABPM-06
Manufacturer:
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
Description:
The Meditech ABPM-06 is an ambulatory 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 upper arm. It is intended for ambulatory blood pressure monitoring.
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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Recommendation Recent clinical validation; older protocol
BP BIHS (UK and IRL) ABPM Published evidence
BP Stride BP ABPM for adults and children (Preferred) Published evidence
BP MDR Criteria ABPM Published 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

Relevant Publications:

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.