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Z-Box is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures. Z-Box is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as: - Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous) - Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms - ENT Procedures - Orthopedic surgical procedure

The Z-Box System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Z-Box uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery. Z-Box will consist of following basic components: - High Resolution color liquid crystal display (LCD) touch screen monitor - Uninterruptible Power Supply (UPS) - Central Processing Unit (CPU) - Isolation Transformer - Keyboard and Mouse - Optical Detector (on wheeled-base pedestal) - Operating Room Cart - Tool and accessories surgical tools and accessories instrumented with LEDs or reflective markers - dMIS kit surgical instrument kit containing IGS tools and accessories and dMIS key - dMIS key electronic storage media containing disposable software application

The Voyager is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide oxientation and reference information during intra-operative procedures. The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a tigid anatomical structure may be made, such as: - . Intra-crania surgical procedures involving space occupying lessons or malformations (including soft tissue, vascular and osseous) - Spinal surgical procedures involving spinal stabilization, neutal decompression, or ● resection of spinal neoplasms - ENT Procedures . - Orthopedic surgical procedures ●

The Voyager System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Voyager uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal and external patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.

FluoroLab Plus will be used for navigational guidance to position instruments during surgical procedures. It will provide a method of navigational guidance of tools through the use of a standard C-arm fluoroscope to capture images and an optical camera for instrument tracking. This increase in control will free the surgeon from the iterative process conventionally used, reduce the length of the surgical procedure, and enable minimally invasive procedure. In addition, since only two fluoroscopic images are needed, the exposure to X-rays is greatly reduced. FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images. Surgeon will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.

FluoroLab Plus is an integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments using at least two captured fluoroscopic images. The acquired images are displayed on a flat panel monitor. Surgical tools and accessories are instrumented with LEDs or small reflective markers. Their positions and orientations are continuously tracked by an optical camera and updated in reference to the fluoroscopic images to provide constant navigational guidance to the target. FluoroLab Plus will consist of following basic components: 1) Registration phantom 2) Calibration grid 3) Fluoroscopic image intensifier system (C-arm) 4) Computer workstation with monitor and video acquisition box 5) Ergonomic cart 6) FluoroLab Plus software application 7) Optical camera with Tool Interface Unit (TIU) 8) Tools and accessories surgical tools and accessories instrumented with LEDs or reflective markers

The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle. The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.

The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to more accurately position drill guides, screw drivers, needles, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to accurately position an end-effector over the desired surgical area, and two approximately orthogonal images are captured with a standard flouroscope. The two images are displayed on computer monitors and used to perform accurate intra-operative planning. The plan consists of specifying the instrument entry point, and sagittal and transverse orientations. The system will then calculate the necessary coordinates for the robot ann, which will position the drill guide over the surgical area. The Fluorotactic Guidance System Mk. I system will consist of four components: 1) Robot arm 2) Registration/drill guide artifact 3) Fluoroscopic image intensifier system (C-arm) 4) Personal computer (PC) with a Data Translation image acquisition card and two monitors The robot arm will hold a registration artifact which is transparent to X-rays over the patient in proximity to the desired surgical area. This artifact has eight steel balls embedded such that when the C-arm is used to capture images of the area, the balls will create fiducial shadows on the image. Two images will be required, an Anterior/Posterior (A/P) view and a Sagittal view. The PC will receive the image data from the C-Arm and display it on two monitors. The surgeon will indicate the desired positioning of the drill by manipulating a virtual guidewire on the screens. The software will then use the fiducial location information to calculate the coordinates for the positioning of the drill guide, and the robot arm will move to the new orientation.