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Change Healthcare Cardiology Hemodynamics™ is intended for complete physiological/hemodynamic monitoring. clinical data acquisition, medical image and data processing, and analytical assessment. Change Healthcare Cardiology Hemodynamics™ is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. Change Healthcare Cardiology Hemodynamics™ is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other patient/procedural data management is needed. User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended patient monitoring or in situations where arrhythmia detection is required.

The Change Healthcare Cardiology Hemodynamics™ device is a hemodynamic monitoring system for monitoring vital signs, performing measurements and calculations, documenting procedure and patient data and interfacing to other systems and devices during and after procedures in the area of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed. Change Healthcare Cardiology Hemodynamics™ also acquires patient information from other hospital information systems and makes hemodynamic information available to them. It facilitates interfacing with hospital information systems and cardiac image management, archiving and reporting systems. Change Healthcare Cardiology Hemodynamics™ incorporates the Argus PB-3000 vital signs monitoring device (K221056), manufactured by Schiller AG, which provides patient monitoring via: - ECG leads - Invasive Blood Pressure (connected to non-Change Healthcare transducers) - SpO2 finger clip - Non-invasive blood pressure (NIBP) cuff - Temperature probe - Thermal Dilution Cardiac output temperature probe (connected to non-Change Healthcare Cardiac Output catheter) - CO2 (connected to non-Change Healthcare cannulas or intubation tubes) Argus PB-3000 monitoring device is provided with compatible accessories (cables, sensors, cuffs, probes, etc). Appendix L of the Change Healthcare Cardiology Hemodynamics User Guide includes a List of qualified PB-3000 accessories. Change Healthcare Cardiology Hemodynamics™ is composed of: - A control and documentation unit (Information System) that is used for administration, performing measurements, recording full disclosure, taking samples and entering procedure notes and overall data input and management of the patient and procedure data. - A Clinical System that incorporates the RT Monitor and the Front-end (which incorporates the Schiller Argus PB-3000 device). The clinical system is responsible for acquiring, analyzing, and displaying patient vitals and other pertinent clinical data. The data is displayed on monitors. Change Healthcare Cardiology Hemodynamics™ uses an interface that displays patient data, procedure data, waveforms, and numeric values. The performing physician views the monitor, and conveys instructions and procedure notes to the technician, who operates the application using a touch screen, keyboard and mouse, for maximum convenience. The control and documentation unit (Information System) can function independently from the Clinical unit and therefore can be setup without the clinical unit for instances where only patient/procedure documentation is required. In addition, the Change Healthcare Cardiology Hemodynamics™ system can receive and/or export data from 3rd party devices and systems. One such utilization is the ability to import monitored parameter data from 3rd party bedside monitors for documentation purposes as part of the patient's log (part of the Holding Area Charting configuration). This import is performed via the utilization of FDA cleared Capsule's SmartLinx software (K200856) that is intended for clinical information management through networks with independent devices. Physicians can instruct the technician to configure the appearance, content and layout of the display on the monitors that display the patient's vitals and other pertinent clinical data (real-time monitors) and to perform real-time functions and measurements using the tools that exist in the control and documentation unit. This pane can be shown or hidden at any time by clicking Procedure Control in the display control bar. Each pane in the real-time controls area can be expanded to show more content and contracted to save space when that content is not needed. Changes should be made only upon request or instruction of the physician. The clinical system resides on a dedicated computer to ensure that it is not vulnerable to failure of the network or the backend computer on which the application resides. In case of application failure, the system knows how to restart itself and restore a stable OS environment on the computer. Watchdogs are in place to prevent failure.

Change Healthcare Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources. Change Healthcare Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration. Change Healthcare Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting. Change Healthcare Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.

Change Healthcare Cardiology™ is a software application intended to run on a client/server array in a physical or virtual hosting environment to allow: - Importation of images in DICOM format, final reports, and various discrete data elements - Review, editing, management and synchronization of patient information and procedure data - Storage and management of data elements (images, reports, discrete data, and so on) for long term archive and disaster recovery purposes - Review, performance and editing of measurements - Creation, editing and confirmation of procedure reports - Distribution of procedure reports and results to other systems in file or discrete data element formats - Integration with 3rd party software components to provide additional image review, measurement tools, reporting and/or data import/export capabilities - Departmental administrative tasks such as managing charges and billing, departmental stock inventory levels, and so on. New additional features and functionalities in this version and subject of this submission include: - Reporting module was redesigned on web based technology improving former reporting version capabilities: - New Change Healthcare Cardiology Vascular Ultrasound Report: - Step-by-step design to accommodate the user's workflow - Enhanced Vascular Diagrams - Enhanced efficiency of filling in clinical findings - Predefined content ease data insertion - New Change Healthcare Cardiology Adult Echo Report: - Step-by-step design to accommodate the user's workflow - Improved data display - Enhanced efficiency of filling in clinical findings - Change Healthcare Cardiology Reference Viewer was renewed and is now fully zero footprint - Change Healthcare Cardiology Web was aligned with Change Healthcare Cardiology™ client capabilities: - Added functionalities to the procedure list - Improved viewer display and functionalities - Enhanced measurements in the viewer - Added DICOM protocol transfer capabilities - Launch of additional viewing third parties - Report Editor has been enhanced to allow administrators to perform a broader range of customizations. They can customize: - The new Change Healthcare Cardiology Vascular Ultrasound Report - The new Change Healthcare Cardiology Adult Echo Report - Adaptive Archiving and IOCM (Imaging Object Change Management) were built for VNA (Vendor Neutral Archive) interoperability as the DICOM Archive - Added security, privacy and cybersecurity enhancements

McKesson Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources. McKesson Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration. McKesson Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting. McKesson Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.

McKesson Cardiology™ is an image processing system. The device consists of the following components and accessories: software application: database server; web server; application server: image and document storage server and media: long-term archive and disaster recovery media; and client application workstation. New additional features and functionalities in this version and subject of this submission include: - MC-D (distributed web client application) patient list was redesigned as a browser based procedure list application - Procedure priority indication new display of procedure priority level - MRN aggregation option to review aggregated list of all patient procedures in MC-D for patients with multiple procedures from different facilities - VNA Interoperability Imaging Object Change Management (IOCM) - Vascular report redesigned as a browser based module - Multi-facility Support - New platform qualifications - EMR integration enhancements - -Added security, privacy and cybersecurity enhancements