EMC
VI-14
VI.5 Analyzing Electrocardiograph Intended Use
Diagnostic application
The Glasgow Program is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether
this be in a hospital or primary care setting. Analysis of the ECG signals is accomplished with algorithms that provide
measurements, graphical presentations and interpretations for review by the user. It is capable of diagnosing
commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular
hypertrophy, abnormal ST-T changes and common abnormalities of rhythm. Conduction defects and other
abnormalities such as prolonged QT interval are also reported. It is not designed for interpretation of exercise
electrocardiograms.
Intended population
The Glasgow 12-lead ECG analysis is intended for use in adults and children of any age from birth upwards. It makes
significant use of the patient’s age and gender and indeed operates at the level of days in the case of neonates.
Intended location
The monitor is intended to be used in hospital by trained professional healthcare.
Diagnostic accuracy
The Glasgow algorithm analysis has high sensitivity for detecting cardiac abnormalities as is evidenced by the results
presented in the following section. In short, the algorithm aims for the highest sensitivity at a high specificity
although there is always a tradeoff between one and the other.
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