Indications, Safety, and Warnings

StealthStation Navigation System

For full details, please refer to your System Manual.

Intended Use

Your Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or 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, such as the skull, a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks 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

Do not modify the StealthStation S7 System.

The system and its associated applications should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic computer-assisted surgery systems.

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.

If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system.

Accessory equipment connected to the analog and digital interfaces of the Medtronic 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: 3^rd 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: 3^rd Edition. If in doubt, contact technical support or your local Medtronic Navigation, Inc. representative.

The system is not suitable for use in the presence of a flammable, anesthetic mixture with air or oxygen or nitrous oxide.

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.

Inspect all instruments before use. If visibly damaged, do not use the instrument.

Inspect all system components before use. If visibly damaged, do not use the system.

Discard before use any pre-sterilized component whose sterile packaging appears to be compromised.

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.

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.

Do not open sterile-barrier packages or containers until surgical use. At time of use, inspect barrier for breach. If the sterile barrier was breached before surgical use, reprocess all devices contained in the package.

The StealthStation S7 System is not intended to be operated on battery power alone while instruments are connected to a patient.

To reduce the potential of electrical shock, the operator should not simultaneously touch the patient and the system input/output panel, mouse, keyboard, or batteries.

To avoid risk of electrical shock, the StealthStation S7 System must only be connected to a supply mains with protective earth.

The StealthStation S7 System should not be connected to a wired network while in the patient vicinity to avoid electric coupling to non-medical equipment.

Do not transport the carts in an undocked position. Carts must be properly placed in the transport position and docked together before moving. To secure the system from unwanted lateral movement (for example, on an incline), lock all the castor wheels of the docked system.

The StealthStation S7 System Staff Cart contains a high fidelity stereo system for music playback from a user provided audio player. This system may be capable of sound levels which can lead to permanent hearing loss at high volume. The volume is controlled at the user provided audio player. For hearing safety, follow all warnings prescribed by the user provided player. If these warnings are not available or understood, do not exceed a 50% volume output from the audio player.

The following 2 warnings are from the AXIEM system manual:

Use of the AXIEM™ system may interfere with implantable device communication. Do not use the portable AXIEM™ system while programming or interrogating any implantable device.

Use of the AXIEM™ system may interfere with patient monitoring equipment. Position the AXIEM™ system 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 AXIEM™ system and call technical support.

Precautions

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

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 technical support representative.

Verify that all relevant instrumentation has been properly cleaned and sterilized before surgery. Clean and sterilize the components according to the parameters in the Equipment Cleaning and Sterilization sheet (9730713). Clean non-sterilizable equipment according to the parameters in the Non-Sterilizable Equipment Cleaning sheet (9733205).

The system has been successfully tested against the requirements of IEC 60601-1-2. However, RF interference could hamper its operation or the operation of other nearby electrical devices. If you suspect either of these conditions, move the conflicting equipment farther apart, separate the equipment with an RF barrier, or discontinue use of the system.

Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system.

The system mouse is not designed for sterilization, and may be damaged if sterilization is attempted.

System components are fragile. Use care when handling system components.

Before moving the system cart(s), shut down and stow all components, remove any loose items from the top of the cart(s), and dock the carts together (if applicable).

Avoid dripping any fluids into any enclosure on the StealthStation S7 System. Disconnect the power and allow the system to dry if you suspect fluids may have entered any part of the system.

The Staff cart storage drawer has a maximum load capacity of ten pounds 3.8 kg (8 lb).

The following 5 precautions are from the AXIEM system manual:

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.

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.

System components, including the Mobile Emitter, are fragile. Use care when handling system components.

Do not drop system components or mishandle them in such a manner as to cause them physical damage. 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.

The AXIEM™ system is not sterilizable. Properly clean the system following the protocol in the Universal Cleaning and Sterilization instructions (9733205).

O-arm Surgical Imaging System

For full details, please refer to your System Manual.

Intended Use:

The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm Imaging System is compatible with certain Image Guided Surgery Systems.

United States law restricts this device to sale, distribution, and use by or on the order of a physician.

Use of Video Graphics Printer

Printouts from the optional Video Graphics Printer are not intended to be used for diagnostic purposes. The printer's primary use is for physician reference and documentation.

Use of the DVD/CD RW Drive

Information stored on DVDs is not intended to be used for diagnostic purposes. The primary use of such information is for physician reference and documentation.

Equipment Users

Users of the O-arm Imaging System should be trained, licensed, and/or certified in the proper use of medical x-ray equipment and its medical applications. Users should read this user manual and the labels on the Image Acquisition System (IAS) and the Mobile View Station (MVS).

Safety Overview

Potential hazards exist in the use of medical electronic devices and X-ray systems such as the O-arm Imaging System. Personnel using the equipment should understand the safety issues, emergency procedures, and the operating instructions provided in the User Manual.

PoleStar Surgical MRI System

For full details, please refer to your System Manual.

Intended Use

The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician. The images produced by the PoleStar reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR (nuclear magnetic resonance) properties that determine image structure are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and T2*. When interpreted by trained physicians, these images provide information that can be useful in determining a diagnosis.

The PoleStar Surgical MRI System and its associated applications are intended as an aid for precisely locating anatomical structures 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 such as the skull, can be identified relative to a CT- or MR-based model of the anatomy.

Warning: This device may be used only as ordered by a physician. Use of this device for indications not specified in the Intended Use statement is limited to investigational purposes only.

Contraindications

Medical conditions which contraindicate the use of the PoleStar Surgical MRI system and its associated applications include any medical conditions which may contraindicate the medical procedure itself.

Although MRI does not use ionizing radiation to produce images, some important safety considerations should still be observed. These concern the use of magnetic fields, radio frequency energy, time-varying magnetic fields, and magnetic field gradients.

The use of the MRI system is contraindicated for patients with electrically, magnetically, or mechanically activated devices such as, but not limited to:

Cardiac pacemakers
Bio/neuro stimulators

The use of the MRI system is contraindicated for patients with passive devices such as, but not limited to:

Intracranial aneurysm clips
Artificial valves

unless the physician is certain that the implants are not magnetically active and cannot cause any damage.

The use of the MRI system is contraindicated for patients with embedded metallic fragments or shrapnel resulting from accidents or military service.

General Warnings and Precautions

Refer to the User Manual for MR-specific warnings and cautions, safety guidelines, patient and personnel screening procedures, and patient emergency procedures.

Warnings

The system and its associated applications should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic computer-assisted surgery systems.

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.

Visually inspect scanner covers integrity before use. Don't use the system if the covers appear broken or damaged.

If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system.

Accessory equipment connected to the analog and digital interfaces of the Medtronic 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: 3^rd 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: 3^rd Edition. If in doubt, contact technical support or your local Medtronic Navigation, Inc. representative.

The system is not suitable for use in the presence of a flammable, anesthetic mixture with air or oxygen or nitrous oxide.

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.

Discard before use any pre-sterilized component whose sterile packaging appears to be compromised.

Do not re-process, re-sterilize, or re-use single-use devices. Attempts to re-process or re-sterilize these devices may be ineffective and may compromise their structural integrity. Any re-use creates a risk of contamination which could result in patient and hospital staff injury, illness, or death.

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.

Precautions

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

The system has been successfully tested against the requirements of IEC 60601-1-2. However, RF interference could hamper its operation or the operation of other nearby electrical devices. If you suspect either of these conditions, move the conflicting equipment farther apart, separate the equipment with an RF barrier, or discontinue use of the system.

Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system.

The system and its associated applications contain no user-repairable parts. This system must be installed, maintained, and serviced only by certified personnel. For repair or replacement of any part of the system or application, contact a technical support representative.

Do not modify the system in whole or in part without written approval from the manufacturer.

The system should undergo regular Planned Maintenance by certified service personnel. The frequency of the maintenance and its contents will be defined by Technical Support.

Do not connect any third-party equipment to the system without written approval from a technical support representative.

Before moving the system cart(s), shut down all components and remove any loose items from the top of the cart(s). To avoid contaminating the inside of the cart(s), clean the power cord(s) before retracting or coiling.

The system mouse is not designed for sterilization, and may be damaged if sterilization is attempted.

Cart storage drawers have a maximum load capacity of 3.8kg (8lb) each.

System components are fragile. Use care when handling system components.

Do not step on the black cables retractor. This may damage the scanner.

In case system disposal is required, contact Technical Support.

Fusion ENT Navigation System

For full details, please refer to your System Manual.

Intended Use

Your Medtronic computer-assisted surgery system and its associated applications are intended as an aid for locating anatomical structures and planning surgical trajectories in open or 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

Do not modify the Fusion^® system.

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.

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.

If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system.

To avoid risk of electrical shock, the Fusion^® system must only be connected to a supply mains with protective earth.

To avoid risk of electrical shock, do not touch the Fusion^® system Input/Output (I/O) panel and the patient at the same time.

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. 606-1-M90). Furthermore all configurations shall comply with the system standard IEC 60601-1-1 or the system requirements of Clause 16 IEC 60601-1: 3^rd 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: 3^rd Edition. If in doubt, contact technical support or your local Medtronic Navigation representative.

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 25cm from any source of flammable gas.

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.

Discard before use any pre-sterilized component whose sterile packaging appears to be compromised or whose expiration date has passed.

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.

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.

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.

Use of the system may interfere with implantable device communication. Do not use the system while programming or interrogating any implantable device.

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.

Precautions:

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

This system is not sterilizable. Properly clean the system following the protocol in the Universal Cleaning and Sterilization instructions (9733205).

The Fusion^® system and its associated applications contain no user-repairable parts. For repair or replacement of any part of the system or application, contact a technical support representative.

Verify that all relevant 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).

The system does not contain an uninterruptible power supply (UPS). The system must remain connected to an external source of power.

Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system.

System components, including the Mobile Emitter, are fragile. Use care when handling system components.

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.

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.

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.

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.

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.

StealthStation® Spine Surgery Imaging and Surgical Navigation