INTENDED USE/INDICATIONS FOR USE
The StealthStation FlexENT™ system, with StealthStation™ ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures. Their use is indicated for any medical condition 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
Medical conditions that contraindicate the use of a Medtronic computer-assisted surgery system and its associated applications include any conditions which may contraindicate the medical procedure itself.
WARNINGS AND PRECAUTIONS
- Warning: The system hardware and software should be used only by qualified medical professionals who are trained in performing surgery and familiar with computer-assisted surgery systems.
- Warning: If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system.
- Warning: Inspect all visible system components before use, including the localizers that accompany your system (that is, the side-mount emitter or the flat emitter). If visibly damaged, do not use the system. Abandon use of any component damaged during the procedure. Contact Medtronic Navigation.
- 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. Contact Medtronic Navigation.
- 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. Contact Medtronic Navigation.
- 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: 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 or to the Equipment cleaning and sterilization sheet (9730713). For non-sterilizable components, refer to the StealthStation FlexENT™ cleaning instructions (9736193).
- Warning: Do not open sterile-barrier packages or containers until surgical use.
- Warning: Do not modify the StealthStation FlexENT™ system, components or accessories, without prior written consent from Medtronic Navigation. Prohibited modifications include but are not limited to: altering or repairing system components; updating the operating system, drivers, or anti-virus definitions; 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: The system is not suitable for use in the presence of a flammable, anesthetic mixture with air, oxygen, or nitrous oxide.
- 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-mount emitter, the flat emitter, and the arm assembly that supports the side-mount emitter are not intended for sterile patient contact or interaction. If you place these items in the sterile field, bag or drape them.
- Warning: Do not use the side-mount 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: Metallic or conductive objects in or near the electromagnetic navigation field can degrade navigational accuracy and the navigation volume. If metallic distortion causes excessive error, navigation may be disabled. To restore navigation, move metallic and conductive objects away from the navigation field.
- Warning: Electrical noise in or near the electromagnetic navigation field can degrade navigational accuracy and the navigation volume. If electrical noise introduces excessive error, the system may automatically disable navigation. To restore navigation, move devices that produce electrical noise (such as electrocautery equipment and electric drills) away from the navigation field.
- Warning: RF emitters typically found in an operating room can affect medical electrical equipment, such as the StealthStation FlexENT™ electromagnetic system.
- Warning: Refer to the applicable package inserts and system manual for additional instructions, warnings, and cautions.
- Warning: Before transporting the system cart, shut down the system and stow all components, and remove any loose items from the top of the cart.
- Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
- Caution: The system and its associated applications contain no user-repairable parts. For repair or replacement of any part of the system or application, contact a Medtronic Navigation™ technical support representative.
- Caution: The system mouse, keyboard, side-mount emitter, flat emitter, and articulating arm are not designed for sterilization and may be damaged if sterilization is attempted.
- Caution: For procedures performed with the flat emitter, a surgical table with a radiolucent table top is recommended. If the surgical table has a metal frame or metal side rails, position the flat emitter at least 5 cm (2 in) away from the metal. Positioning the emitter closer may result in reduced navigational accuracy and volume.
- Caution: If the surgical table to be used with the side-mount emitter has a metal frame or metal side rails, position the side-mount emitter at least 25 cm (10 in) away from the metal. Positioning the emitter closer may result in reduced navigational accuracy and volume.
- Caution: Procedures performed with the side-mount emitter mounted to a surgical bed require a surgical bed featuring side rails because the arm assembly that supports the emitter connects to the side rails.