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USER MANUAL DO-LBL-06035(L)
| MyoVista® Wavelet ECG (
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ECG™) 12-Lead Cardiac Testing Device
General Overview
MyoVista
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ECG Device Development
The MyoVista
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ECG Information is developed by HeartSciences . The technology was developed in
response to a substantial amount of recent research linking most forms of heart disease with diastolic
dysfunction . It is based on years of research by HeartSciences . It provides analysis of ECG information
using frequency domain information obtained using wavelet signal processing in addition to
conventional ECG information . It can be used to assist in determining patient risk for relaxation
abnormalities associated with left ventricular diastolic dysfunction (LVDD) . The MyoVista
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ECG
Device extensively uses age and sex-based criteria . The quote below describes the relationship
between heart disease and diastolic dysfunction and underlines the importance of understanding
patient risk related to diastolic dysfunction . The article was published in American Heart Association’s
Circulation publication .
LV diastolic dysfunction and Prognosis AHA Circulation 2012 Feb 14; 125(6): 743–745. Dalane W. Kitzman, MD and
William C. Little, MD
“It is remarkable that serial evaluation of LV diastolic function could be such a powerful predictor of all-
cause mortality, not just cardiovascular death….…normal LV diastolic function requires normal function and
integration of left ventricular ejection, relaxation, and structure and is an active energy requiring process. Thus,
diastolic performance is sensitive to nearly all of the common pathological processes that affect cardiovascular
function.”
The MyoVista
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ECG Device was developed to include conventional ECG data and MyoVista
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ECG
Information and Analysis .
Conventional 12-Lead ECG Waveform
The MyoVista Device provides conventional 12-lead ECG waveforms . These waveforms represent
the overall direction and magnitude of the heart’s electrical potential during the cardiac cycle by
measuring depolarization and repolarization over time from 12 different directions . The waveform is
a graph representing voltage versus time . The sampling rate is 500 samples per second .
Glasgow Interpretative Analysis
The Glasgow Interpretive Analysis software provides an interpretation of the conventional resting
12-lead ECG . It can recognize and report ECG abnormalities such as myocardial infarction, acute
myocardial infarction, ventricular hypertrophy, ST-T abnormalities, and other common abnormalities
of rhythm . Defects in electrical conduction and other anomalies are also reported .
HeartSciences has validated the implementation of the Glasgow library code within the MyoVista
Software application using the Glasgow 1000 ECG validation database and has confirmed the
MyoVista Code fully operates in accordance with the Glasgow reference software .
To verify that the Glasgow algorithm library on the MyoVista Device works as expected, the records
of Glasgow 1000 ECG Validation Database have been processed as inputs to the MyoVista Device
containing the Glasgow Analysis program, which produced the analysis results to match the results
provided by Glasgow Royal Infirmary .
Note: Glasgow results are independent of MyoVista
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ECG Information results. Reference
VAL-10007 for HeartSciences MyoVista Statement of Validation and Accuracy of Glasgow 12-
Lead ECG Analysis Program.
