Medtronic NAVG3606010 Instructions for Use

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.

Functional Inspection

Make certain of the following:

▪ The parts intended to move do so freely without sticking, binding, or grinding.
▪ Springs return the handle of the instrument to its original position.
▪ Retention tabs hold appropriate mating parts and are not damaged.
▪ The instrument will function as intended with the appropriate mating parts.
▪ Ball detents will hold mating parts and are free from damage.
▪ Sharp edges are sharp to the touch and are not dull, have no nicks, or any other damage.
▪ Tips meet when appropriate.

DIRECTIONS FOR USE

The instruments are precision devices, which may incorporate a measuring function and have uses as described on the label. Those
instruments which incorporate a depth measuring function have an accuracy level equivalent to ±0.1mm.

Use with the IPC™ POWEREASE™ System

See the IPC™ POWEREASE™ System package insert (M726750B246) for instructions on how to set up and operate the IPC™
POWEREASE™ System.

Using the POWEREASE™ Adapter is optional. See the POWEREASE™ Adapter package insert (9734925) for instructions on using
the adapter with the POWEREASE™ Driver.

1. Place single-use sterile spheres on each of the four NavLock™ Tracker stems. Push each sphere onto the stem until it “clicks”
into place. Make sure the sphere is firmly seated on the stem.

2. Place the instrument into the NavLock™ Tracker.
A. Insert the proximal end of the instrument shaft until it is fully seated in the NavLock™ Tracker.

B. Verify the tool is secured in the NavLock™ Tracker by making sure it cannot be pulled out of the device.

3. Attach the NavLock™ Tracker assembly to the POWEREASE™ Driver (Figure 1).
A. On the POWEREASE™ Driver, pull back and hold the quick disconnect to unlock the collet.

Note: The quick disconnect must be held in the unlocked position ① when inserting or removing tools.

B. Insert the proximal end of the NavLock™ Tracker assembly into the collet.
C. Align the flat sides of the instrument shaft with the marks on the collet ⑧ and insert into the collet until fully seated (Figure 2).
D. Release the quick disconnect to place the assembly in the locked position ②.

E. Verify the NavLock™ Tracker assembly is secured in the POWEREASE™ Driver by ensuring it cannot be pulled out of the

device.

Table 1: POWEREASE™ Driver

①

Quick Disconnect Unlocked

②

Quick Disconnect Locked

③

Mechanized Working Collar Locking Pins (2)

④

Variable Speed Trigger

4. Verify the assembly.
A. For Synergy™ Spine Version 2.1 and higher, select the current NavLock™ Tracker color and corresponding instrument from

the instrument list (tool card) in the procedure software.

Note: these instruments cannot be used with revisions prior to 2.1.

B. Ensure the instrument has green status (i.e. it is being tracked by the StealthStation™ system) on the screen.
C. Face the NavLock™ Tracker array toward the camera.
D. Place the instrument tip straight into the reference frame divot.

E. Press the footswitch or wait for the system to verify.

5. In the procedure software, select the appropriate instrument that corresponds to the instrument being used in the procedure.
A. While in the Navigate task, click the Select Tip button.

B. Select the instrument type and size from the list in the Select Tip flyout.

6. Refer to the Synergy™ Spine & Trauma Pocket Guide for additional navigation instructions.

When using the POWEREASE™ Driver with navigation, avoid any bending of the instrument by applying direct force only along the
instrument assembly axis (Figure 3).

⑤

Finger Sensor Trigger

⑥

NIM-ECLIPSE Cable Connector

⑦

Mode Select Switch

⑧

Flat Side Indicators

Instructions for Manual Use

1. Place single-use sterile spheres on each of the four NavLock™ Tracker stems. Push each sphere onto the stem until it “clicks”

into place. Ensure the sphere is firmly seated on the stem.

2. Place the instrument into the NavLock™ Tracker.
A. Insert the proximal end of the instrument shaft until it is fully seated in the NavLock™ Tracker.

B. Verify the instrument is secured in the NavLock™ Tracker by ensuring it cannot be pulled out of the device.

3. Secure the handle to the NavLock™ Tracker assembly. Note: Use only the Medtronic Ratcheting Handle G170059.
A. Retract the collar on the handle and snap the proximal end of the instrument shaft into the handle.

B. Verify the handle is secured to the instrument by ensuring it cannot be pulled out of the device.

4. Continue with steps 4 through 6 in the section entitled “Use with the IPC™ POWEREASE™ System.”

FURTHER INFORMATION

In case of complaint, or for supplementary information, contact Medtronic.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.
©2018 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Figure 1: POWEREASE™ Driver

Figure 2: Instrument Seating in POWEREASE™ Driver

Figure 3: POWEREASE™ Assembly

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Authorized representative in the European Community

CAUTION: Federal law (USA) restricts these devices to sale
by or on the order of a physician.

Do not re-use

Batch code

Manufacturer

Catalogue number

For US audiences only

The device complies with European Directive MDD
93/42/EEC

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

The device complies with European Directive MDD
93/42/EEC

Sterilized using irradiation

Use-by date

Consult instructions for use at this website.