Accuracy of the WatchBP O3 device for ambulatory blood pressure monitoring according to the new criteria of the ISO81060-2 2018 protocol.

Abstract:

OBJECTIVE:The aim of the study was to determine the accuracy of the Microlife WatchBP O3 monitor for ambulatory blood pressure (BP) measurement according to the new ISO81060-2 2018 protocol. METHODS:The WatchBP O3 was first tested in 97 subjects from the general population (mean age, 71.3 years; 48 men) using four cuffs of different sizes. In a second study, 36 subjects (mean age, 72.9 years; 18 men) underwent stress testing on a cycle ergometer in order to increase their heart rate by 15% or more. RESULTS:In the general population, the mean device-observer difference was 1.3 ± 3.2 mmHg for systolic BP and was 0.7 ± 3.2 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also, criterion 2 was satisfied being the SDs of the 97 participants well below the maximum values required by the protocol (6.82 and 6.90 mmHg, respectively). During the ambulatory monitoring study, the average heart rate increase was 20.3% (range 15.4-28.9%). The mean device-observer difference was 1.5 ± 2.8 mmHg for systolic BP and was 1.7 ± 2.6 mmHg for diastolic BP. Also, these data were in agreement with criterion 1 of the protocol. CONCLUSIONS:These data show that the Microlife WatchBP O3 monitor satisfied the ISO 81060-2:2018 standard requirements for a general population across a wide range of arm sizes and that also the protocol criteria for validation of devices intended for ambulatory BP monitoring were fulfilled.

journal_name

Blood Press Monit

authors

Fania C,Lazzaretto I,Fontana U,Palatini P

doi

10.1097/MBP.0000000000000459

subject

Has Abstract

pub_date

2020-10-01 00:00:00

pages

285-290

issue

5

eissn

1359-5237

issn

1473-5725

pii

00126097-202010000-00010

journal_volume

25

pub_type

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