Affiliation:
1. Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, USA
Abstract
Objective
The objective of this report was to describe the validation of the A&D UM-212BLE automated oscillometric sphygmomanometer to the ISO 81060-2, 2018 protocol. The device is specifically designed for enhanced office and out-of-office programmability.
Methods
A combined pediatric (n = 35) and adult (n = 50) population was studied at Clinmark LLC in Louisville, Colorado, USA. Same-arm sequential testing was performed following the ISO 81060-2, 2018 requirements. Five cuffs were tested with a total arm circumference range from 12 to 50 cm. Reference readings were done by two blinded observers performing simultaneous auscultation.
Results
For validation of Criterion 1 the mean ± SD (mmHg) of the device minus the reference differences were 3.94 ± 6.89 for SBP and 2.09 ± 6.68 for DBP. Both passed the Standard limits for Criterion 2; the systolic(S)SD achieved was 5.56 (5.70 permitted) and the diastolic(D)SD was 6.01 (6.62 permitted). All other Standard requirements were met.
Conclusions
The UM-212BLE passed all requirements. The features that make this device clinically superior include settings for automated office BP, variable pressure inflation, dual measurement modes (oscillometry, auscultation), the wide range of cuffs tested, automated irregular heartbeat detection, and full validation in a pediatric population. The inclusion of all of these features makes the UM-212BLE a highly attractive device for both office and out-of-office BP estimation.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Advanced and Specialized Nursing,Assessment and Diagnosis,Cardiology and Cardiovascular Medicine,General Medicine,Internal Medicine
Cited by
2 articles.
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