CardioPerfect™ Workstation System - Interpretive multichannel electrocardiograph

Intended purpose

The CardioPerfect Workstation system (software and associated accessories) are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various diseases and/or treatment regimens. The CardioPerfect Workstation software also provides non-diagnostic functions such as patient management, data security, search tools for patient and/or test records and support for exporting data to Electronic Medical Record systems. The CardioPerfect Workstation and associated accessories are intended for use by or on the order of a physician in a hospital or clinic setting. Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms. The ECG module also provides optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis. These are presented for review and interpretation by the clinician. Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. The spirometer should only be used with patients able to understand the instructions for performing the test. Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history.