Medtronic Navigated Sterile
M708348B558E Rev. C
Instruments for use with
StealthStation™ and IPC™
POWEREASE™ Systems
2018-06-13
IMPORTANT INFORMATION ON THE MEDTRONIC NAVIGATED STERILE INSTRUMENTS
FOR USE WITH STEALTHSTATION™ AND IPC™ POWEREASE™ SYSTEMS
DESCRIPTION
Medtronic Navigated Sterile Single Use Instruments are spine preparation instruments made of high grade stainless steel. These
instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing
Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery
system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field.
Medtronic Navigated Sterile Single Use Instruments are compatible with Medtronic's IPC™ POWEREASE™ System when connected
to the POWEREASE™ Driver.
INTENDED USE
Medtronic Navigated Sterile Single Use Instruments are intended to be used during the preparation and placement of Medtronic
screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive,
procedures. Medtronic Navigated Sterile Single Use Instruments are specifically designed for use with the StealthStation™ System,
which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model,
fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Sterile Single Use Instruments are also compatible
with the IPC™ POWEREASE™ System.
DO NOT IMPLANT THE INSTRUMENTS
If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic. Any available surgical
techniques will be provided at no charge.
Medtronic does not and cannot warrant the use of this instrument nor any of the component parts upon which repairs have been
made or attempted, except as performed by Medtronic or an authorized Medtronic repair representative. Implied warranties of
merchantability and fitness for a particular purpose or use are specifically excluded.
WARNINGS
▪ Breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may cause injury to the patient or operative
personnel.
▪ Improper handling can render the instrument unsuitable for its intended purpose or even dangerous to the patient or surgical
staff.
▪ It is important the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels and the
forces applied while correcting the position of the instrumentation is not excessive, such that it might cause injury to the patient.
▪ During navigation, it is important to frequently confirm navigational accuracy by touching the tip of the instrument on known
anatomical points, including accuracy checkpoints, and comparing the position of the instrument tip in the image with its physical
location.
PRECAUTIONS
▪ Excessive force applied by instruments to implants can dislodge devices, particularly hooks.
▪ Extreme care should be taken to ensure this instrument remains in good working order. During the procedure, successful
utilization of this instrument is extremely important. Instruments should not be bent or damaged in any way. Misuse of
instruments resulting in corrosion, “freezing-up”, scratching, loosening, bending, or fracture of any or all sections of an instrument
may inhibit or prevent proper function.
▪ Do not use this instrument for any action for which it was not intended.
▪ To avoid injury or navigation inaccuracy, the instrument should be carefully examined for functionality or damage prior to use. A
damaged instrument should not be used. Additional back-up instruments should be available.
▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in the
successful utilization of the system by the surgeon. Further, the proper selection and the compliance of the patient will greatly
affect the results.
▪ Proper patient selection and operative care are critical to the success of the surgery and avoidance of injury during surgery.
Read and follow all other product information supplied by the manufacturer of the implants or the instruments.
▪ Special precautions are needed during pediatric use. Care should be taken when using instruments in pediatric patients since
these patients can be more susceptible to the stresses involved in their use.
▪ Some surgeries require the use of instruments which incorporate a measuring function. Ensure these are not worn and any
surface engravings are clearly visible.
POSSIBLE ADVERSE EFFECTS
▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints.
▪ Pain, discomfort, or abnormal sensations resulting from the presence of the instrument.
▪ Nerve damage due to surgical trauma.
▪ Dural leak in cases of excessive load application.
▪ Impingement or damage of close vessels, nerves, and organs by slippage or misplacement of the instrument.
▪ Damage due to spontaneous release of clamping devices or spring mechanisms of certain instruments.
▪ Cutting of skin or gloves of operating staff.
▪ Bony fracture in cases of deformed spine or weak bone.
▪ Tissue damage to the patient, physical injury to operating staff, and/or increased operating time that may result from the
disassembly of multi-component instruments occurring during surgery.
▪ The methods of use of instruments are determined by the user's experience and training in surgical procedures. A successful
result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions
may compromise the results.
Physician note: although the physician is the learned intermediary between the company and the patient, the important
medical information given in this document should be conveyed to the patient.
For US Audiences Only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
This device should be used only by physicians familiar with the device, its intended use, any additional instrumentation, and any
available surgical techniques.
PACKAGING
This device is supplied sterile and is clearly labeled as such on the package label. The sterility can only be assured if the packaging
is intact upon receipt. This product is intended for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse,
reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the
device, which could result in patient injury, illness, or death. Medtronic assumes no liability for products which have been resterilized
by health care facilities.
All devices should be checked to ensure there is no damage prior to use. Damaged packages or products should not be used and
should be returned to Medtronic.
Only sterile instruments should be used in surgery.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper function of the
device.
EXAMINATION
Instruments must always be examined by the user prior to surgery.
Examination should be thorough and must include a visual and functional inspection of the working surfaces, pivots, racks, spring or
torsional operation and the presence of any cracks, bending, deformation, or distortion, and that all components are complete.
Never use instruments with obvious signs of damage or that are incomplete or otherwise nonfunctional.
Visual Inspection
Make certain of the following:
▪ Laser etchings, engravings, and other markings are legible.
▪ No cracks are present in instrument handles or any part of the instrument.
▪ Discoloration, corrosion, stains, or rust do not exist.
▪ There is no handle/shaft separation, and the handle-to-shaft connection is secure.
▪ No cuts or gouges in silicone are present.
▪ There is no damage (cuts, tears, etc.) to insulation.
▪ There is no damage to the working ends or tips. The working ends should be free of cracks, sharp edged gouges, and other
damage. When applicable, the working ends should be sharp.
▪ The instrument tip and/or shaft is not bent.
▪ There is no damage to threads.
▪ All parts are present and free of damage and deterioration. Examples of parts that may be missing, loose, or damaged include
set screws, springs, curved springs, pins, and prongs.
▪ Mating ends are free of damage (nicks, gouges, bends, etc.) that would interfere with the mating function.
▪ Cannulated instruments with a guide wire or other insertion tool are visually checked.
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