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The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on them. The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device. As with any procedure of this sort, the physician conducting the examination must exercise sound medical judgment in the selection of patients for this product, and be skilled in interpreting the echocardiographic data obtained from intra-vascular ultrasound devices. The IVUS option is intended to be used with a Vingmed Color Flow Mapping (CFM) imaging system to apply ultrasound energy from an intra-vascular catheter to: - · Produce 2D images that can be used to detect abnormalities. - · Store images in the CFM system or via the CFM system to other storage media. Images can be retrieved from the CFM system or storage media for measurement and analysis.

The IVUS consists of a basic scanner unit integrated into the CFM 775/800 ultrasound system. The basic scanner unit consists of a card rack mounted into the CFM 775/800; a video switch board mounted into the CFM 775/800 card rack; cables for interconnections; a connector for the motor drive and components that are common with the CFM 775/800. These common components include the keyboard and display, connectors for ECG and AUX, power supply, and internal computer (EchoPac) for video grabbing and archival (CFM 800 only), and peripherals such as a VCR printer. The system is used with specified off-the-shelf motor pod and ultrasound catheters not manufactured by Vingmed Sound A/S.