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The VascuView TAP Ultrasound System with probe Model #HL.7.5/40/64D is intended for diagnostic imaging of the human body for the following clinical applications, as illustrated in the Diagnostic Indications for Use Form which can be found in Attachment 5A: Pediatric, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Peripheral Vessels which include Intra-Venous and Perioherally-Inserted Central Catheters, as well as vascular structures and surrounding vascular regions such as nerve bundles and various structures for free hand placement of needles/catheters. The VascuView TAP Ultrasound System is not intended for fetal or ophthalmic applications.

The VascuView TAP Ultrasound System is a high-frequency ultrasonic imaging system intended to be used for assisted vascular access of veins and arteries, in addition to other vascular access applications such as the real-time viewing of perigheral vascular structures and their surrounding regions in order to provide quidance for the placement of needles and catheters within these structures. The system software runs on Windows XP Professional Operating System and utilizes features of the Windows interface to direct the operation of the system and maintain patient records; providing a user-friendly environment for clinical applications. The VascuView TAP System consists of the following components: - UL and TUV 60950 Approved Tablet PC with Integrated Outer Enclosure . A Kiosk tablet oc is provided with a UL approved Medical-grade power supply and Medical-grade power cord. The VascuView TAP ultrasound system consists of an integrated carrying handle. probe holder, cord wrap, table stand, and shock absorbent corner bumpers. The pc includes a large 12.1" TFT XGA LCD wide angle display which facilitates an intuitive touch screen control interface with clear-cut functionality and preset settings to ameliorate image optimization. Additionally, the oc provides for the operation of the software, as well as the storage of archived images and video clips. - . Ultrasound Beam-former PCB with 64-element Linear Array Probe The handheld ultrasound probe Model #HL7.5/40/64D and beam-former PCB consists of a sixtyfour element pulsed linear array capable of capturing both images and videos in four different modes of operation: B-Mode, Split Screen Dual B-Mode, Color Doppler (CFM), and B-Mode with Doppler (PWD). The probe is connected to the pc via the included SCSI cable and operates within a frequency range of 5MHz -- 10MHz, which allows for the visualization of surface vessels at scan depths up to 9cm. The transducer material is made of a gold plated polymer membrane and a biocompatible nose cone sufficient for its use (Silicon). - . VascuView TAP System Software All features and controls of the system are provided for in the VascuView TAP software which comes pre-loaded onto the tablet pc. The software uses an icon-based interface whereby the user can select any of the primary functional screens at any time by clicking on an icon located on the screen, for that function. The software enables ultrasound image storage and display, measurement functions, enhancements, and printing. All parameters within the hard-coding of the VascuView TAP software program are fixed, therefore the user cannot make any adjustments to the operation of the transducer that will have an effect on the radiated field (i.e. center frequency, aperture, focus, field of view, sample rate, etc.)

The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guidance for placement of needles and catheters in these structures. The VascuView ultrasound system is not intended for fetal or ophthalmic applications.

The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guidance for placement of needles and catheters in these structures. The VascuView system consists of the following components: Ultrasound Probe and Cable, Tablet PC, VascuView Software.