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.
StealthStation® Navigation System
O-arm® Surgical Imaging System
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.
What effect, if any, the electromagnetic field generated by the AXIEM™ Mobile Emitter may have on pregnancy has not been assessed. Surgeons are advised to bear this in mind and use the AXIEM system judiciously around pregnant women.
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.
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 respective IEC standards (eg, IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1. 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. If in doubt, contact technical support or your local 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.
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 StealthStation 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 mouse, keyboard, or batteries.
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 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.
The AXIEM Emitter must not be used in ambient temperatures greater than 30°C (86°F).
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 Scanner System is a magnetic resonance diagnostic device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D 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 a trained physician, these images provide information that can be useful in making a diagnosis.
The PoleStar Navigation 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 Navigation 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.
Note: The PoleStar magnetic field is confined to the volume between the magnet poles and its immediate area. Surgical tools and systems outside the magnetic field will not be affected by the PoleStar's presence. Life support equipment as well as instruments that remain in the surgical field during scans must be MRI-compatible. All other instruments should be of a non-ferromagnetic material.
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.
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 respective IEC standards (for example, IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1. 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. If in doubt, contact technical support or your local 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 25 cm from any source of flammable gas.
Some system components may contain batteries. Batteries can explode if mishandled. 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.
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 ten pounds each.
System components are fragile. Use care when handling system components.
Maximum load 100-112 V (220-240 V) at 50/60 Hz 5.0 A (5.0 A). Do not apply electrical current in excess of 5.0 A on the internal power strip. Current exceeding 5.0 A will overload the isolation transformer.
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 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.
What effect, if any, the electromagnetic field generated by the AXIEM Mobile Emitter may have on pregnancy has not been assessed. Surgeons are advised to bear this in mind and use the AXIEM system judiciously around pregnant women.
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.
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 respective IEC standards (eg, IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with the system standard IEC 60601-1-1. 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. If in doubt, contact technical support or your local 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.
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 StealthStation 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 mouse, keyboard, or batteries.
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 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.
The AXIEM Emitter must not be used in ambient temperatures greater than 30°C (86°F).