Medtronic NAV2001 Instructions for Use

Medtronic Navigated Reusable

M708348B430E Rev. E

Instruments for use with
StealthStation™ and IPC™
POWEREASE™ Systems

2021-08-04

IMPORTANT INFORMATION ON THE MEDTRONIC NAVIGATED REUSABLE
INSTRUMENTS FOR USE WITH STEALTHSTATION™ AND IPC™ POWEREASE™
SYSTEMS

DESCRIPTION

Medtronic Navigated Reusable Instruments are spine preparation instruments manufactured from 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 computer­assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field.

Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. These instruments
are also compatible with Medtronic’s IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver.

INTENDED USE

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws
during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures.
Medtronic Navigated Reusable 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.

Do not implant instruments.
If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic.
Medtronic does not and cannot warrant the use of this instrument nor any component parts upon which repairs were 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 patients or

operative personnel.

▪ Improper maintenance, handling, or poor cleaning procedures can render instrument unsuitable for their intended purpose

or even dangerous to patients or surgical staff.

▪ It is important the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels and

forces applied while correcting the position of instrumentation are not excessive, such that it might cause injury to patients.

▪ 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.
▪ Never expose instruments to temperatures >135°C that may modify physical characteristics.
▪ Extreme care should be taken to ensure instruments remain in good working order. During the procedure, successful use of

instruments is extremely important. Instruments should not be bent or damaged. Misuse of instruments resulting in
corrosion, “freezing-up”, scratching, loosening, bending, or fracture of any or all sections of instruments may inhibit or
prevent proper function.

▪ These instruments should be carefully placed in trays, cleaned after each use, and stored in a dry environment.
▪ Do not use instruments for any action for which they were not intended.
▪ Regularly review the operational state of instruments and, if necessary, make use of repair and replacement services.
▪ To avoid injury or navigation inaccuracy, instruments should be carefully examined for functionality or damage before use.

Damaged instruments should not be used. Additional back-up instruments should be available.

▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in

successful use. Further, proper selection and compliance of patients greatly affect results.

▪ Proper patient selection and operative care are critical to success of surgery and avoidance of injury during surgery. Read

and follow all product information supplied by the manufacturer of implants or 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 stresses involved in their use.

▪ Some surgeries require use of instruments which incorporate a measuring function. Ensure these are not worn and surface

engravings are clearly visible.

POTENTIAL ADVERSE EFFECTS

▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints.
▪ Infection if instruments are not properly cleaned and sterilized.
▪ Pain, discomfort, or abnormal sensations resulting from the presence of instruments.
▪ 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 instruments.
▪ 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 patients, physical injury to operating staff, and/or increased operating time that may result from

disassembly of multi-component instruments occurring during surgery.

▪ 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 results.

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information 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

Packages for components should be intact upon receipt. All sets should be checked for completeness and all components
should be checked for signs of damage before use. Damaged packages or products should not be used and should be returned
to Medtronic.

Instruments used in surgery must be cleaned and sterilized by the hospital before use.
Remove packaging material prior to sterilization. Only sterile instruments should be used in surgery. Always immediately clean

and re-sterilize instruments used in surgery. Instruments should be thoroughly cleaned before re-sterilization. This process must
be performed before handling, or before returning product to Medtronic.

EXAMINATION

Instruments must always be examined by the user before surgery.
Examination should be thorough and must include a visual and functional inspection of working surfaces, pivots, racks, spring or

torsional operation and the presence of 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 working ends or tips. Working ends should be free of cracks, sharp edged gouges, and other

damage. When applicable, 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:

▪ Parts intended to move do so freely without sticking, binding, or grinding.
▪ Springs return the handle of the instrument to its original position.
▪ Retention mechanisms hold appropriate mating parts and are not damaged.
▪ Instruments function as intended with the appropriate mating parts.
▪ Ball detents 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.
▪ Ratcheting mechanisms are functional. This includes handles, latches, and other mechanisms. All teeth should be present

and functional.

▪ Driver tips are not worn beyond functional use. If necessary, mate the instrument with the appropriate part.

DIRECTIONS FOR USE

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

Unless labeled for single use, instruments may be re-used.

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. 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 tool is secured in the NavLock™ Tracker by ensuring 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

⑤

Finger sensor trigger

⑥

NIM-ECLIPSE cable connector

⑦

Mode select switch

⑧

Flat side indicators

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

4. Verify the assembly.
A. For Synergy™ Spine Version 1.7, select the current NavLock™ Tracker color and corresponding instrument from the

instrument list (tool card) in the procedure software. For Synergy™ Spine & Trauma software version 2.0 and later,
select the appropriate NavLock™ tool card.

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 bending the instrument by applying direct force only along the
instrument assembly axis (Figure 3).