Literature DB >> 29140801

Validation of the Microlife BP A3 PC upper arm blood pressure monitor in patients with diabetes mellitus according to the ANSI/AAMI/ISO 81060-2: 2013 protocol.

Beate Beime1, Ralf Krüger1, Gertrud Hammel2, Peter Bramlage1, Cornelia Deutsch1.   

Abstract

OBJECTIVE: The aim of the present study was to validate the blood pressure (BP) measurement device, Microlife BP A3 PC, in patients with diabetes mellitus, according to the ANSI/AAMI/ISO 81060-2:2013 protocol. PATIENTS AND METHODS: In 85 individuals aged 56-88 years, with predefined criteria for diabetes mellitus, BP measurements on the upper arm were performed alternately using the Microlife BP A3 PC and a standard mercury reference sphygmomanometer. A total of 333 comparisons were included for analysis.
RESULTS: The mean difference between the Microlife BP A3 PC and the reference was -1.5±6.3 mmHg for systolic BP (SBP) and -1.3±5.2 mmHg for diastolic BP (DBP) according to criterion 1 of the protocol. For SBP, a total of 209 of the 333 measurements were within the range of 5 mmHg (62.8%), whereas the corresponding numbers for DBP were 232 of 333 (69.7%). For criterion 2, the intraindividual differences for the test device and the reference were -1.50±4.73 mmHg for SBP and -1.30±4.55 mmHg for DBP, thus being within the defined ranges provided by the protocol.
CONCLUSION: The Microlife BP A3 PC fulfilled the requirements of criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 protocol and can also be recommended for BP measurement in diabetic patients.

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Year:  2018        PMID: 29140801     DOI: 10.1097/MBP.0000000000000302

Source DB:  PubMed          Journal:  Blood Press Monit        ISSN: 1359-5237            Impact factor:   1.444


  1 in total

1.  Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS).

Authors:  Farahnaz Joukar; Sara Yeganeh; Mohammadreza Naghipour; Soheil Hassanipour; Hossein-Ali Nikbakht; Fariborz Mansour-Ghanaei
Journal:  Med Devices (Auckl)       Date:  2020-09-03
  1 in total

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