A-A-51945
4. Unit shall provide immediate analysis of patient ECG at the bedside by the unit’s internal microprocessor vice using a central computer in the absence of a medical officer. Hard copy shall be automatically annotated with a statement “Unconfirmed Report” to alert personnel to the limitations of interpretation validity.
5. Shall include mobile cart and internal memory storage for a minimum of fifty (50) annotated 10 sec, 12 lead ECG’s. Digital tape storage is permissible.
6. The mobile cart shall be designed to accommodate all equipment required for a fully operational system.
7. Data furnished shall include patient information, accurate parameter measurements, morphological interpretation and rhythm analysis. There shall be an area for operator editorial or text input. Text shall be entered via the keyboard at the cart. Hard copy shall contain a statement that the analysis is unconfirmed if editing confirmation has not occurred. Unit shall be capable of at least 3 lead simultaneous disclosure of a 10 second ECG. Lead selection shall be operator selectable from 3 to 12 leads with access to the following lead groups: bipolar, unipolar extremely and unipolar precordial. All leads shall be clearly anatomically labeled.
8. Integral software shall generate annotated physiological parameters acquired from the analysis of raw data and ultimately generate a feasible morphological interpretation. Physiological parameters identified shall be at least heart rate, Pr interval, QRS duration, QT and QT corrected and electrical axis measurement. Morphological interpretation shall encompass conduction blocks, ventricular hypertrophies, infarctions, ST and T wave abnormalities, atrial enlargement, premature beats, supraventricular tachyarrhythmias, ventricular tachyarrhythmias, bradyarrhythmias, junctional arrhythmias, ventricular pre-excitation, and facilitate discernment of pulmonary disease and drug effects.
9. Unit shall be defibrillator protected to at least 360 joules.
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