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NavStationIrad EMT is intended to be an intraoperative image guided computer assisted navigation system for minimally invasive interventions for interventional radiology. NavStationIrad EMT can be used in combination with imaging systems that create a 3D-based model of the anatomy, like Computer Tomography (CT) or C-Arm systems. It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic relevant regions of the patient. The system also allows the planning of trajectories and displays the planning information together with the simulated image of a tracked needle on a computer monitor screen. At the same time movements of the patient are taking into account. The device is intended for use in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.

The navigation system NavStationIrad EMT is a software and hardware tool to plan different trajectories to selected targets and to place tools (e.g. biopsy needles) with navigation control inside the selected targets. The navigation system can be used within the scope of interventional radiology. The navigation station consists of an industrial PC with integrated touch screen as user interface and dedicated navigation software. The PC is mounted on a mobile rack. For image acquisition the navigation system is connected to a C-arm system with CT option. For the communication of the navigation system with the imaging system, a DICOM network application using the DICOM standard protocol is used. In order to place the patient safe and comfortable on the intervention table we use a patient fixation device BodyFix Medical Intelligence (510(k) Number: K001052). In order to track navigation devices the electromagnetic (EM) tracking system is used. The EM tracking system consists of a field generator producing an alternating electromagnetic field for operation. The EM field induces a voltage in small coils implemented in the tips of the tracked navigation devices. The voltage is measured by the EM tracking system and used to calculate the current position and orientation of the coil inside the EM field thus determining the sensor coordinates in five degrees of freedom (DoF). The navigation hardware (PC, Monitor, Rack and tracking system) are combined to NaviBase. NaviBase is a CE labeled hardware and software platform for all navigation systems of CAS innovations and part of this technical file. As devices electro-magnetic-needles with small coils embedded in their tips are used. For image-to-patient registration a patient panel/reference panel (PP) is used. With the panel it is possible to map the patient image space to the physical space. This procedure is called registration. To control residual patient motion, an additional tracked device (skin marker/skin sensor) is used. The tracking system is able to detect the sensor and send its position relative to the PP to the navigation system. The patient motion is visualized at the monitor and the physician is able to recognize the motion and can react on it accordingly.