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Image of the Stealth AXiS™ ENT Navigation system, its components, and accessories.

Indications, Safety, and WarningsIntended use / Indications for useThe Stealth AXiS™ ENT Surgical System, with the Stealth AXiS™ ENT clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous ENT procedures. Their use is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.This can include, but is not limited to, the following procedures:

Functional endoscopic sinus surgery (FESS)

Endoscopic skull base procedures

Lateral skull base procedures

ContraindicationsNoneDevice descriptionThe Stealth AXiS™ ENT Surgical System is a computer-assisted surgery system that is composed of a platform, clinical application, surgical instruments, and a referencing system (which includes patient and instrument trackers). The system tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient. The Stealth AXiS™ ENT clinical application helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures.Patient images can be displayed by the ENT clinical application from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The surgeon may also create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the clinical application displays how the actual instrument tip position and trajectory relate to the pre-surgical plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the Stealth AXiS™ ENT Surgical System can serve to guide this judgment.Stealth AXiS™ Core is composed of the workstation cart and the optional camera cart, which contain the key navigation components including the localizers and the computer with the operating system.Compatibility and installationThe clinical application may be used on a Stealth AXiS™ planning station in an office environment, a Stealth AXiS™ computer assisted surgery system in an operating room or office environment, or optionally from a web browser or a connected computer if the remote planning feature has been enabled on a Stealth AXiS™ planning station.To use the remote planning feature, the connected computer must meet the minimum system performance requirements, operating system and browser compatibility requirements and be able to access the planning server on the network. Configuring a planning station as a planning server requires the installation of a software license by qualified Medtronic personnel and further configuration by hospital staff. See the Stealth AXiS™ IT Guide for server and web browser configuration instructions.The clinical application is compatible with Stealth AXiS™ systems and Medtronic navigational instruments.The clinical application is installed by Medtronic service personnel only. If you have any questions about your clinical application installation, contact Medtronic Technical Services.Note: When the Stealth AXiS™ clinical application is used with other medical devices, see the user instructions for those devices for additional labeling limitations.Navigational accuracyUnder representative worst-case configuration, the Stealth AXiS™ ENT Surgical System with the Stealth AXiS™ ENT clinical application has demonstrated performance in 3D positional accuracy with a mean error ≤2.0 mm and in trajectory angle accuracy with a mean error ≤2.0 degrees. The positional error is defined as the Euclidean distance from target to instrument tip at final point of insertion. The trajectory angle error is the angle between the planned surgical trajectory and trajectory of the instrument at final point of insertion. Depending on the surgical procedure and the particular instruments used, the resulting navigational accuracy may be negatively impacted.This performance was determined using an anatomically representative phantom and utilizing a subset of system components and features that represent the worst-case combination of all potential system components in a clinically relevant workflow. The test configuration included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm.WarningsRefer to the applicable package inserts and system manual for additional instructions, warnings, and cautions.

Warning: The system hardware and clinical application should be used only by qualified medical professionals who are trained in performing surgery and familiar with computer-assisted surgery systems.

Warning: Abort use of the system if navigation seems inaccurate and steps to restore accuracy are unsuccessful.

Warning: Inspect all visible system components before use, including the localizers that accompany your system (that is, the side emitter or the flat emitter). If visibly damaged, do not use the system. Abandon use of any component damaged during the procedure. Contact Medtronic technical services.

Warning: Inspect sterile device packaging and expiration date before use. Do not use any pre-sterilized device whose sterile packaging appears to be compromised or whose expiration date has passed. If sterile device packaging is compromised or damaged, contact Medtronic technical services.

Warning: Prior to use, examine instruments and blades for damage and deterioration. Do not use any bent, damaged, or compromised instruments or blades. Periodically inspect instruments or blades for damage during their use. Abandon use of any instruments or blades bent or damaged during the procedure. If instruments and blades are bent, damaged, or compromised, contact Medtronic technical services.

Warning: Do not reprocess, resterilize, or reuse any single-use device. Attempts to reprocess or resterilize a single-use device may be ineffective and may compromise its structural integrity. Any reuse creates a risk of contamination which could result in patient injury, illness, or death.

Warning: Disposable devices are provided in sterile condition for single use only. After use, dispose of single-use devices according to local and national regulations.

Warning: Device components may be supplied in a non-sterile condition and must be cleaned and sterilized prior to use. Verify that all necessary instrumentation has been properly cleaned and sterilized before surgery. For sterilizable components, refer to the cleaning and sterilization instructions that accompany the component. For non-sterilizable components, refer to the Stealth AXiS™ ENT Surgical System Cleaning and Disinfection Instructions.

Warning: Do not open sterile-barrier packages or containers until surgical use.

Warning: Do not modify the Stealth AXiS™ ENT Surgical System, components or accessories, without prior written consent from Medtronic Navigation. Prohibited modifications include but are not limited to: altering, repairing, or replacing system components; altering software provided by Medtronic; updating the operating system or drivers; and installing any software that is not provided by Medtronic. Secure the system to prevent unauthorized modifications. Unauthorized modifications could render the system unsafe or ineffective for its intended use.

Warning: Use care during handling, storage, and cleaning of instruments to prevent physical injury and deformation of the instrument tip.

Warning: Do not allow fluid to enter the electrical components of tracked instruments.

Warning: Do not reuse or reprocess a device where transmissible spongiform encephalopathy agents or Creutzfeldt-Jakob disease contamination is suspected or confirmed. Incinerate the potentially contaminated device according to national guidelines.

Warning: To prevent cross-contamination, always handle, transport, and reprocess devices that contact the central nervous system separately from other devices.

Warning: To avoid potential exposure to blood-borne pathogens and chemicals, use appropriate Personal Protective Equipment when handling or disposing of Medtronic devices.

Warning: The side emitter and the flat emitter are not intended for sterile patient contact or interaction. If you place these items in the sterile field, follow proper aseptic technique guidelines to bag or drape them prior to use.

Warning: Do not use the side emitter or the flat emitter in ambient (room) temperatures greater than 30°C (86°F). Exceeding this temperature limit could result in navigational inaccuracy or patient or user harm from excessive temperatures.

Warning: RF emitters typically found in an operating room can affect medical electrical equipment performance, such as the Stealth AXiS™ electromagnetic localization system.

Warning: Before transporting the system carts, shut down the system and stow all components, dock the monitors, dock the camera on the camera cart, close all storage compartments, and remove any loose items from the top of the carts.

Warning: The system and its associated applications contain no user-repairable parts. For repair or replacement of any part of the system or application, contact Medtronic technical services.

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