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HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/110V. The system is intended for use in hospital cardiac catheterization laboratories. The Monitoring System (comprising the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC) is a medical product of the Class IIa (RL 93/42/EWG, Appendix IX).

HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/110V. The system is intended for use in hospital cardiac catheterization laboratories. The Monitoring System (comprising the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC) is a medical product of the Class IIa (RL 93/42/EWG, Appendix IX).

The Enterprise Visual Medical System(TM) is classified as a picture archive and communications system. It is a software only solution developed by Emageon Inc., that utilizes off the shelf software, standard computer workstations and standard storage devices that allow authorized physicians and authorized healthcare professionals to acquire, access, visualize and store digital medical images, and data associated with the images, across the enterprise using advanced content management and clinical workflow through a graphical user interface. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D Volume Rendering, Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, DICOM Image Note export, Presentation States, Annotation and Measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, archiving of digital mammography images provided that systems cleared via a cleared 510(k) are used and that digitized secondary captures of those images are not viewed for assisting in diagnosis, utilization of third-party electronic templates, the display of Standard Uptake Value, recording of third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data.

Emageon Inc.'s EVMS™ software is integrated client-server software package comprised of features that were previously cleared in Vortex ™, 510(k): K012097, and Ultravisual™, 510(k) K042008. The main difference is that the software will now allow display Standard Uptake Value measurements, MPR on irregular data sets and in oblique planes, and automatic region growing, the naming conventions of the components have been modified, the design architecture and the overall design and development process in order to synchronize the existing compliance to the federal QSR 21 CFR, Part 820 with ISO 13485:2003 and ISO 14971:2000/Amd 1 .: 2003(E).