The method of interpreting this analysis report is based on ECG Buddy v1.0.6.X.
For more detailed interpretation methods and performance, please refer to the IFU (Instructions for Use).
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The analysis report is provided in Graphical View (left image) and Numeric View (right image).
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The graphical view presents the type and probability of heart rhythm represented by the analyzed ECG and graphically displays digital biomarkers for 10 major emergency situations and cardiac dysfunctions.
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The Numeric View displays the scores for the 10 digital biomarkers in a tabular format.
1. Heart rhythm and probability
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Displays the heart rhythm type and probability based on the ECG image analysis results.
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The types of heart rhythms analyzed and provided by ECG Buddy are as follows:
Types of Heart Rhythms
1.
Sinus(-origin) Rhythm
2.
Atrial Fibrillation
3.
Atrial Flutter
4.
PSVT (Paroxysmal Supraventricular Tachycardia)
5.
Atrial(-origin) Rhythm
6.
Frequent Premature Beats
7.
Electronic Pacemaker
8.
Pre-Excitation
9.
Ventricular Tachycardia
10.
Second-degree Block
11.
Third-degree Block
2. Risk of Emergency situation and Cardiac dysfunctions (Digital Biomarkers)
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The risk level for each digital biomarker is indicated by a blue dot.
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The meaning of the graph colors is shown in the right image, and they are based on the thresholds that achieve the expected sensitivity and specificity.
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The criteria vary slightly by condition, so please refer to the condition-specific standards for interpretation.
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When specificity is high, the likelihood of having the condition when the test is positive increases, but in cases of low prevalence, the chance of false positives also increases, so please be cautious.
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When sensitivity is high, the likelihood of missing the condition when the test is negative decreases, but in cases of high prevalence, the chance of false negatives increases, so please be cautious.
When using this product based on the provided sensitivity and specificity, it is recommended to use thresholds that take into account the patient's overall clinical information, condition, and hospital policy.
Types of Digital biomarker
1.
Critical Condition: The risk of shock, respiratory failure, cardiac arrest within 24 hours (requiring intensive care).
2.
Acute Coronary Syndrome (ACS): The risk of ACS, including STEMI, NSTEMI, and UA.
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ST segment Elevation Myocardial Infarction (STEMI): Risk of ST-elevation myocardial infarction.
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Myocardial Injury: Risk of myocardial injury.
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Pulmonary Edema: Risk of pulmonary edema.
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Large Pericardial Effusion: Risk of large pericardial effusion or cardiac tamponade caused by it.
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Left Ventricular Dysfunction: Risk of left ventricular dysfunction with EF < 40%.
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Right Ventricular Dysfunction: Risk of right ventricular dysfunction.
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Pulmonary Hypertension: Risk of moderate or higher pulmonary hypertension.
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Severe Hyperkalemia: Risk of severe hyperkalemia with K > 6.0mEq/L.