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The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use.

The Digi-One System is a small, lightweight, portable digital Transcranial Doppler (TCD) system with an advanced M-mode display which can be connected to any external Windows based PC. It measures the blood flow velocity in the main cerebral arteries non-invasively for circulation diagnosis and HITS (High Intensity Transient Signals) detection using the same Rimed TCD software application as the predicate device. The Digi-One System is a modification of the Digi-Lite System. The hardware was modified using current electronic components, and the software was modified to allow installation on a dedicated PC (such as a laptop device). Otherwise, the functionality of the system remains identical to that of the Digi-Lite system in all aspects, including acoustic power outputs, clinical parameter measurement accuracy, examination modes, available transducers, software menus and commands (with some minor user interface modifications).

The Digi-Lite TCD device is intended for use in the non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use.

The Rimed Transcranial Doppler Systems are based on a PC platform system running under Microsoft Windows XP embedded. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disk, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15" TFT color SVGA that provides 1024 x 768 points graphic resolution. In addition to the main PC card, the system hardware contains one Doppler Card that transmits the ultrasound power, translates the received signals to Doppler shift frequencies, and provides the required signal processing functionality. This card contains analog and digital circuits, a FPGA chip for timing and basic hardware digital signal processing, and a DSP chip for performing general control and digital signal processing algorithms. The complete system contains one Doppler card, two 2 MHz probes, a 1 MHz probe, a 4 MHz probe, and an 8 MHz probe. In addition, a Remote Control unit, printer and Foot Switch can be used.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (PWD, CWD), Adult Cephalic (PWD), Peripheral Vascular (CWD).

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