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The STarFix Designer Software is part of the WayPoint Stereotactic System. The WayPoint Stereotactic System is intended to be used with commercially available stereotactic system for neurological procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

FHC, Inc. STarFix™ Designer software is an advanced image-based neurosurgical planning software application designed for generating patient specific frames (FHC, Platform) primarily for Deep Brain Stimulation (DBS) Proedures and stereo-electroencephalography (SEEG) by means of the WayPoint™ Stereotactic platforms. The STarFix™ Designer offers the following core features: - Image import and registration - Open and manipulate CT and MR images for surgical planning - . Rigid registration between CT and MR images, with user-selected reference scan of either modality. - Automatic localizer extraction - Extract localizers from preoperative CT manually or automatically - I Manually place localizers on MR scans - Manual refinement of localizer position - Patient specific 2D and 3D visualization of anatomical landmarks: AC, PC, MP - Trajectory planning ● ● - DBS STarFix™ Platform frame modeling ● - . Multi-Oblique STarFix™ Platform frame modeling - . Export and import planning data, including images, for transfer on another computer or to be saved for easy reference during the surgery - Save the plan any time during the planning session The STarFix™ Designer provides a modern design, built to ease user interaction, and allow fast and efficient planning for the WayPoint™ Platforms and ultimately, the implantation of DBS electrodes. With safety as a primary concern, all planning elements need to be verified and marked explicitly before a platform model can be built. The user interface is guiding the necessary planning steps, by using numbered menus and intuitive labeling, along with a minimum of application settings and common actions arranged in the form of a toolbar dedicated to either 2D or 3D operations.

The VFS1 Bipolar Electrosurgical Generator is indicated for use in micro, macro, and endoscopic bipolar irrigation, cutting and coagulating of tissue and the coagulation of blood vessels in all types of surgery.

The VFS1 Bipolar Electrosurgical Generator (referred to as generator or VFS1 Generator) is designed to cut and coagulate living human tissue during surgical procedures. The system provides 1 MHz Radio Frequency (RF) energy that is user/operator selectable based on the surgical procedure undertaken. The generator is configured for bipolar output and is earth isolated, to minimize leakage current, thus providing increased patient comfort and safety. The system will be provided with safety features that are continuously monitored and will provide warnings and/ or alerts when critical parameters exceed specified limits. The VFS1 Generator is designed to cut and coagulate living tissue during surgical procedures. The system includes a bipedal footswitch. The generator is equipped with a tone generator to provide audible feedback each time cutting, or coagulation is performed. The generator incorporates a variable-rate irrigation pump to provide saline flow during procedures. The VFS1 Generator is compatible with a variety of reusable bipolar products; i.e., insulated mirror finish bipolar forceps, disposable nonstick bipolar instruments as well as disposable bipolar cords and tubing products. Items that are included in the system are: - VFS1 generator -CO 840 - . Footpedal- CO 841

The microTargeting™ Guideline 4000 5.0 System is intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments.

The microTargeting™ Guideline 4000™ 5.0 System is an electrophysiological recording and stimulation system designed primarily for functional neurosurgery procedures. The system provides high quality and research-grade recordings on both microelectrodes and macroelectrodes, including low-frequency signals on externalized DBS leads, improved signal quality, decreased noise susceptibility, improved user experience with redesigned software, new intraoperative data analysis options, and an updated user interface to support touch screens and multiple high-resolution monitors. Additionally, it provides simultaneous constant-current and constant-voltage stimulation capabilities that include multiple weighted sources and return paths as well as complex and arbitrary stimulation waveforms. The software provides an intuitive patient management system, as well as advanced visualization and analysis methods for both single-unit recording and low-frequency signals (LFP, SEEG etc.). A fully configured system consists of a Core Module, a notebook PC, an 8-channel UE interface unit, a remote, an optional second 8-channel LF interface and an optional synchronization unit.

The FHC microTargeting™ XL STar™ Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

When used in conjunction with commonly available stereotactic systems, the microTargeting "M XL STar™ Drive System allows a neurosurgeon to precisely position intracranial microelectrodes, stimulating electrodes, lesion electrodes and other instruments during functional neurosurgical procedures. microTargeting™ XL STar™ Drive System Components - microTargeting™ XL STarTM Drive . - insertion tubes - verification probe ● - sterilization case ● - cleaning brushes . Device Mounting Hardware and other Components Additional components for device mounting include hardware specifically designed to interface between the microTargeting™ XL STar™ Drive system and other stereotactic frames or instruments, and also include optional components to increase utility. - Adapters to fit Radionics and Leksell stereotactic systems . - microTargeting controller firmware based on user specifications of drive travel.

The WayPoint™ Stercotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microclectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

The WayPoint™ Stereotactic System. (WPS System) accurately locates and rigidly supports neurosurgical or other surgical instruments relative to specific anatomical structures or targets, thus facilitating microelectrode recording, stimulation, data collection, device implantation and other surgical procedures. The WPS System provides patient-customized stereotactic fixtures designed to be secured on skull-based anchor mounting sets to hold and align surgical instruments with patient anatomy and to allow selected targets to be reached with sub-millimeter accuracy. The WPS System consists of several components that work together to become a stereotactic system. These components are: - 1) the WayPoint™ Stereotactic Anchor System: - 2) the WayPoint™ Stereotactic Platform Adapter: - 3) Device mounting hardware for the Platform; and, - 4) WayPoint™ compatible Planning software such as: - a. WayPoint™ Planner; or, - b. VoXim®Planning software. The WayPoint™ Stereotactic Anchor/Locator System provides tools and components for the temporary implantation of anchors to be used as reference points and mounting sets for the surgical procedure. The WPS System software designs a Stereotactic Platform Adapter that will mount to the WayPoint™ Stereotactic Anchor System. For each surgical instrument or device to be mounted to the Stereotactic Platform Adapter, suitable hardware is provided to act as a secure interface and allow flexibility in targeting, if required. The two existing software components of the WPS System (WayPoint™ Planner and VoXim® microTargeting™ Planning software) provide tools to create a Stereotactic Platform Adapter from scanned patient images.

The FHC microTargeting™ STar Drive™ System is intended to be used with commercially available positioning systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

When used in conjunction with commonly available stereotactic systems, the microTargeting™ STar Drive™ System allows a neurosurgeon to precisely position intracranial microelectrodes, stimulating electrodes, lesion electrodes and other instruments during functional neurosurgical procedures. microTargeting™ STar Drive™ System Components - microTargeting™ STar Drive™ . - optional lower guide . - lead holder with lead /lesion stop . - . verification probe - sterilization case . - cleaning brushes Device Mounting Hardware and other Components Additional components for device mounting include hardware specifically designed to interface between the microTargeting TM STar Drive™ system and other stereotactic frames or instruments, and also include optional components to increase utility. - Adapters to fit Radionics, Leksell, Leibinger RM, Leibinger ZD. . FHC MicroTargeting™ Platform and Medtronic-IGN NeXframe stereotactic systems - ♥ single electrode insertion tube set - . array electrode insertion tube set - . lesion insertion kit and depth stops - . custom microelectrode depth stops

The microTargeting® Guideline 4000 system is intended to assist in functional neurosurgical procedures where recording from and stimulation of brain motor and sensory neurons will aid in the placement of depth electrodes.

The microTargeting® Guideline 4000 is designed for intraoperative electrophysiological microelectrode recording, stimulation, data collection, analysis and storage.

The FHC microTargeting® Electrodes are intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.

The FHC microTargeting® Electrode is for intra-operative single unit recording and stimulation during functional neurosurgery.

The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, DBS™ electrodes or other instruments in the brain or nervous system.

The microTargeting® Drive System with maTrix drive mount permits the accurate positioning of microelectrodes, stimulating electrodes, DBS electrodes, lesion positioning on thereficeroded, climataling aerous in the brain and nervous system and is adaptable to all major stereotactic systems. microTargeting™ Drive System Components - microTargeting™ drive - maTrix™ drive mount and lower guide - maTrix™ guide bushings - DBS™ holder with DBS/lesion stop - verification probe - sterilization case - cleaning brushes - hex wrench microTargeting™ Drive System Accessories - Radionics adaptor - Leksell adaptor - BrainLab adaptor - Leibinger RM adaptor - Leibinger ZD adaptor - Leibinger Ost-Reg™ (STarFix™) adaptor - NeuroMate™ adaptor - single electrode insertion tube set - array electrode insertion tube set - lesion insertion tube kit and depth stops - custom microelectrode depth stops

The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system.

The microTargeting® Drive System with permits the accurate positioning of microelectrodes, stimulation electrodes, lesion electrodes, biopsy probes and other instruments in the brain and nervous system and is adaptable to all major stereotactic systems. The current microTargeting® Drive System allows the user to add position display capability or add power assist and position display capabilities.