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The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format. Such Digitized Images will be visualized and archivied by independent DICOM entities.

The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format. Such Digitized Images will be visualized and archivied by independent DICOM entities.

CD writer (CD-R STATION) is intended solely for the engraving of DICOM compliant images from a local area network and the CD reader (VRS-2000) is used for viewing the images either from the CD or directly from a local area network. The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R Station and VRS-2000 are used only for running the software and to temporarily buffer the images / reports to and from the CD and local area network.

The CD-R STATION & VRS-2000 is comprised of two principle assemblies: a personal computer and a monitor. The CD-R STATION is to be interfaced to a local area network to receive DICOM compliant images which may then be recorded onto a CD. The VRS-2000 is a stand alone station which reads DICOM compliant images from a CD and displays them on a computer monitor. The media (CD) is not to be used as an archiving media, but rather only as a transportable media to review images and reports. The internal hard disks of the CD-R STATION & VRS-2000 are used only for running the software and to temporarily buffer the images / reports which are to and from the CD.

Vascular image archiving, processing, analysis, management and communication.

The VIEW Archiving Station represents the first generation of Electromed International's vascular image archiving and communication stations. The VIEW Archiving Station is intended for vascular image archiving, processing, analysis, management, and communication as the Cinenet Cardiac Image Network with the exception of analysis which is available as an option with the Cardiac Image Management System (CIMS). Some of the features offered in the VIEW Archiving Station are: vascular image processing (zoom, panning, edge enhancement, contrast), analysis (left and right ventricular functions, quantitative coronary analysis), and communication (printing of reports and sending of exam information in DICOM or Electromed encapsulation over a local area network, including images). Images are acquired in real-time on both products. The VIEW Archiving Station may be interfaced directly with the majority of image digitizers available in todays angiographic systems. It may be linked to video signals of 1249 lines at 25 images/sec or even 1049 lines at 30 images/sec. The video signal is then re-sampled in real time to yield a signal of 625 lines which then may be recorded on a laser video disc by the CRV. The View Archiving Station is comprised of two principle assemblies: the Electronic Cabinet; and the User Console which is connected solely to the Electronic Cabinet. Unlike the Cinenet Cardiac Image Network which uses digital videocassettes as the archiving media, the VIEW Archiving Station archives it's images on laser video discs and the exam information on internal hard disks. Each uniquely numbered laser video disc holds approximately 48 minutes (24 per side) of recording time, 35-45 examinations. The internal hard disks encompasses records that contain patient and exam information along with the referenced video laser disk ID number, which in turn, contains the recorded images. Approximately 100,000 records can be maintained on the internal hard disks at the present time. The Cinenet Cardiac Image Network incorporates a Data Storage Library which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval, whereas the VIEW Archiving Station acts as a stand alone unit whereby the laser video discs are manually inserted when prompted. The VIEW Archiving Station is to be connected to a 230V (±10%), 50/60Hz, 10A power source. The configurable and add-on options being offered with the VIEW Archiving Station are: Room Loop Playback (the viewing of inages on a remote monitor in the orocedure room). Table Side Joystick (remote console in the procedure room to control the playback of recorded images); SVHS Copier (the recording of exams onto a SVHS tape); and a High Definition Printing of reports, including reference images at 1200cpi and 256 gray scale levels, via an ethernet local area network). Since the VIEW Archiving Station can transmit information and images in a Dicom compliant format, via an ethernet local area network, a CD-R Station may be connected to record exams onto a transportable media (CD). The CD-R Station is not part of this 510(k) submission. Since the options or combination of options, as stated above, are available as an integral part of the VIEW Archiving Station, the device will inevitably be offered in various configurations while maintaining the intended use and technological characteristics presented here within.