Fusion ENT Navigation System

Indications, Safety, and Warnings

This website provides excerpts from our user manuals. It is important to consult the full system manuals for the most updated information.

Fusion ENT Navigation System

Indications

Your Medtronic Navigation^® computer-assisted surgery system and its associated applications are intended as an aid for locating anatomical structures and planning surgical trajectories in open and percutaneous 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 can be identified relative to diagnostic images of the anatomy.

Contraindications

Medical conditions which contraindicate the use of a Medtronic computer-assisted surgery system and its associated applications include any medical conditions which may contraindicate the medical procedure itself.

Warnings and Precautions

Warnings

• Warning:  Do not modify the Fusion^® system.
• Warning:  The system and its associated applications should be used only by qualified medical professionals who are trained on, and familiar with the proper operation of, Medtronic Navigation computer-assisted surgery systems.
• Warning:  The system and its associated applications should be used only as an adjunct for surgical guidance. They are not a replacement for the surgeon’s knowledge, expertise, or judgment.
• Warning:  If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system.
• Warning:  To avoid risk of electrical shock, the Fusion system must only be connected to a supply mains with protective earth.
• Warning:  To avoid risk of electrical shock, do not touch the Fusion system Input/Output (I/O) panel and the patient at the same time.
• Warning:  Accessory equipment connected to the analog and digital interfaces of the Medtronic Navigation computer-assisted surgery system must be certified according to the applicable IEC standards (e.g., IEC 60601-1 for medical equipment, UL60601-1, and CSA C22.2 No. 601-1-M90). Furthermore all configurations shall comply with the system standard IEC 60601-1-1 or the system requirements of Clause 16  IEC 60601-1: 3rd Edition. Any person who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1-1 or the system requirements of Clause 16 IEC 60601-1: 3rd Edition. If in doubt, contact technical support or your local Medtronic Navigation representative.
• Warning:  The system is not suitable for use in the presence of a flammable, anesthetic mixture with air or oxygen or nitrous oxide. Position the system at least 25 cm from any source of flammable gas.
• Warning:  Some system components may contain batteries. Do not recharge or disassemble batteries. Do not dispose of batteries in fire. Observe local regulations concerning battery disposal.
• Warning:  Discard before use any pre-sterilized component whose sterile packaging appears to be compromised or whose expiration date has passed. 
• Warning:  Do not re-process, re-sterilize, or re-use any single-use device. Attempts to re-process or re-sterilize a single-use device may be ineffective and may compromise its structural integrity. Any re-use creates a risk of contamination which could result in patient injury, illness, or death. 
• Warning:  There is currently no effective sterilization method for components that are tainted with the infectious agent that causes Creutzfeld-Jakob Disease (CJD). Therefore, you must discard immediately after surgery any components that come into contact with biologic material from patients who carry or are suspected to carry this infectious agent. As a precaution, drape all non-disposable components that could otherwise come into contact with such material. 
• Warning:  The system has been tested for compatibility with Medtronic implantable cardiac device families. Interference testing indicates that the system does not adversely affect the function of these devices and does not constitute a patient hazard. 
• Warning:  Use of the system may interfere with implantable device communication. Do not use the system while programming or interrogating any implantable device. 
• Warning:  Use of the system may interfere with patient monitoring equipment. Position the Fusion system cart and Mobile Emitter as far as possible from any such equipment, and use interference filtering if possible. If you continue to experience interference, abort use of the system and call technical support.
• Warning:  Do not use the AXIEM™ Emitter in ambient (room) temperatures greater than 33°C (92°F).
• Warning:  Because the position of the anatomy is defined by the position of the patient reference, it is important to ensure that the reference does not move with respect to the anatomy from the time of registration or image acquisition until navigation is complete. Slippage or rotation of the reference with respect to the anatomy after registration will result in inaccurate navigation.

Precautions

• Caution:  Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
• Caution:  This system is not sterilizable. Properly clean the system following the protocol in the Universal Cleaning and Sterilization instructions (9733025).
• Caution:  The Fusion system and its associated applications contain no user-repairable parts. For repair or replacement of any part of the system, contact your technical support representative.
• Caution:  Verify that all necessary instrumentation has been properly cleaned and sterilized before surgery. Refer to the Equipment Cleaning and Sterilization sheet (9730713) for cleaning and sterilization instructions. For non-sterilizable components, refer to the Non-Sterilizable Equipment Cleaning sheet (9733205).
• Caution:  The system does not contain an uninterruptible power supply (UPS). The system must remain connected to an external source of power.
• Caution:  Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system.
• Caution:  System components, including the Mobile Emitter, are fragile. Use care when handling system components.
• Caution:  Do not drop or mishandle the system components in such a manner as to cause physical damage to the components. This may impair device function. Even if the component works immediately after being dropped, operational damage may have occurred that may not be observed until some future time. 
• Caution:  Maximum load 600 VA. Do not apply loads in excess of 600 VA. Current exceeding 600 VA will overload the isolation transformer. The outlets inside the Fusion system are intended to power only Medtronic qualified subsystems. 
• Caution:  Metallic objects in or near the navigation field can degrade navigational accuracy. If metallic distortion causes excessive error, navigation will be disabled. To restore navigation, remove metallic objects from the navigation field.
• Caution:  Electrical noise in or near the navigation field can degrade navigational accuracy. If electrical noise introduces excessive error, the system will automatically disable navigation. To restore navigation, remove devices that produce electrical noise (such as electro-cautery equipment and electric drills) from the navigation field.
• Caution:  The system cart, mouse, keyboard, Mobile Emitter, Emitter Holder, and Emitter Holder Clamp are not designed for sterilization and may be damaged if sterilization is attempted.
• Caution:  The field strength directly at the face of the Emitter, outside of the navigation region, may exceed limits for occupational exposure according to the ICNIRP and for the General Public per ANSI/IEEE. Limit the duration of operator and patient contact with the stronger magnetic fields at the face. Specifically, do not allow the Emitter to directly contact the patient for the duration of the procedure.
• Caution:  The cart drawer is intended to hold only the system keyboard and mouse.
• Caution:  The top of the cart is designed as a working surface. It is not intended to be used for storage.
• Caution:  Before moving the Fusion system cart, turn off system power, unplug from the power outlet, and remove any loose items from the top of the cart.
• Caution:  Prior to use, examine accessory components for damage, deterioration, deformation, and abuse. Do not attempt to use any accessory that appears to be bent or otherwise damaged.