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Cordiana Dx16 is a web-based software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary records, consisting of measurements, text and digitized waveforms, with associated reports and documents. Users do not need to download or install any additional software or plug-ins to use the zero-footprint browser client. Cordiana Dx16 provides authenticated users the ability to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools. Cordiana Dx16 is intended for use by healthcare professionals, including (but not limited to) physicians, nurses and medical technicians, trained on the use of the software. Cordiana Dx16 is intended to be used in hospitals or facilities providing patient care, where cardiopulmonary studies are stored in a remote storage system, such as a Picture Archive and Communication System (PACS), with which records, reports and documents can be queried, retrieved and stored using DICOM or similar interface standards. Cordiana Dx16 does not provide storage of records or associated reports and documents, does not modify the original record and waveform information, and is not intended for real-time monitoring. Indications for use of Cordiana Dx16 are quantification and reporting of cardiopulmonary function of patients (adults and children of any age from birth upwards) with suspected disease to support the physicians in the diagnosis. Cordiana Dx16 does not provide automated determination of fiducial points, interpretative statements, or patient diagnosis.

Cordiana Dx16 is a web-based software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary studies from various cardio-pulmonary device manufacturers. The studies are stored in open standardized formats in a remote storage system, such as a Picture and Communication System (PACS) or a Vendor Neutral Archive (VNA). Cordiana Dx16 does not provide own storage of records or associated reports and does not modify records or the original waveform information stored on the remote storage system. Authenticated users can use Cordiana Dx16 to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools. The system consists of two logical parts which are installed, configured and maintained as one: - A web server, which is installed centrally in a hospital's IT infrastructure. The Gateway serves as a stateless server to the browser clients. It also serves as a client to the remote storage system, such as the PACS/VNA, with which records, reports and documents are queried, retrieved and stored using the DICOM standard. - Zero-footprint browser clients, which are loaded and updated on demand as single-page applications into an HTML5 enabled web-browser. Users do not need to download or install any additional software or plugins to use the clients. Cordiana Dx16, when used as intended with a remote storage system, acts as a traditional cardiopulmonary data management system, such as an ECG Management System. The clients can optionally be integrated ("embedded") as-is with an external application which provides authentication and workflow support. When authentication is done in the external application, the externally authenticated user's credentials are passed to Cordiana Dx16 using Single Sign-On Authentication. When the external application provides workflow support, the search screens are bypassed, and the user is brought directly to a requested study. Cordiana Dx16 does not store studies or patient related information in the browser clients, does not directly communicate with cardiographs or other acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to quantify measurements (e.g. intervals and amplitudes) or provide diagnostic statements. Cordiana Dx16 functions as a non-real-time system and is not intended for real-time monitoring.