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).
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 egg handle (9734410),
Medtronic straight handle (9733734), quick connect ratcheting handle (G900000), or 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.”
PROCESSING - GENERAL CONSIDERATIONS
Definitions
Cleaning is the removal of organic soil. Effective cleaning:
▪ Minimizes organic soil transfer from one patient to another.
▪ Prevents accumulation of residual soil throughout the product’s use life.
▪ Allows for successful follow up sterilization. Adequate processing is contingent upon the thoroughness of cleaning.
Cleaning is the initial step and sterilization occurs later in processing and is intended to kill microorganisms to reduce likelihood
of transmission and possibilities of infection. To ensure acceptable processing, there should be no delay between steps in this
document.
Bloodborne Pathogens
Universal precautions for handling instruments after use should be observed by all hospital personnel according to OSHA
Standard 29 CFR 1910.1030 regarding occupational exposure to bloodborne pathogens.
Thorough Cleaning of Instruments
It is critical all reusable instruments are thoroughly cleaned by the hospital prior to use and after each use following specific
cleaning steps listed in this document. Ineffective or incomplete cleaning can hinder subsequent sterilization.
Automated Cleaning
A fully automated washer/disinfector cycle is not recommended as the sole cleaning method. Manual cleaning is required.
Manual Cleaning
Disinfection agents such as sanitizing and chemical solutions act to reduce microbes on surfaces but may not act as cleaners.
Other types of soaps or detergents may not clean to an appropriate level of cleanliness. Enzymatic cleaning agents are
recommended. This type of cleaner was shown to effectively remove organic soils, such as blood, from instruments. Cleaning
instructions were validated by Medtronic using an enzymatic cleaner.
Cleaning Agents and Cleaning Tools
The following cleaning agents, solutions, or tools should not be used:
▪ Saline solution.
▪ Alkaline cleaning agents.
▪ Solutions containing chlorine (e.g. bleach) or aldehydes (e.g. glutaraldehyde).
▪ Formalin, mercury, chlorides, bromides, iodides, or Ringer's solution.
▪ Metal brushes or scouring pads.
The use of neutral pH enzymatic cleaners and soft bristled brushes and soft pipe cleaners are recommended.
Proper Handling After Use
Do not allow the instruments to dry after use and prior to cleaning. Cleaning and subsequent sterilization may be hindered when
blood or bloody solutions are allowed to dry on instruments.
Cleaning Instructions - Point of Use
1. Remove visible soil from instruments using non-shedding wipes.
2. Place instruments in a tray of water or cover with damp towels. Instruments should be cleaned within 30 minutes of use to
minimize potential for drying.
Cleaning Instructions - Dedicated Cleaning Area
1. Immediately transport the tray containing covered instruments to a work area dedicated to further processing.
2. Rinse instruments under running tap water for 3 minutes.
3. Scrub instruments with an appropriately-sized soft bristle brush to aid in the removal of visible soil. Scrub inside any lumens
or cavities.
4. Repeat steps 2 and 3 until visible soil is removed.
5. Using tap water, prepare enzymatic cleaning solution according to the manufacturer’s instructions, dilution
recommendations, and temperatures.
6. Place instruments in enzymatic cleaner, completely submerged, and soak for 45-60 minutes.
7. Remove instruments from enzymatic cleaner and rinse under running tap water for 3 minutes. Flush lumens or cavities in
the water stream.
8. Using tap water, prepare a second enzymatic cleaning solution according to the manufacturer’s instructions, dilution
recommendations, and temperatures in an appropriately-sized sonicator.
9. Place instruments in enzymatic cleaner, completely submerged, and sonicate for 45-60 minutes.
10. Remove instruments from the sonicator and rinse using running tap water for 3 minutes. Flush lumens or cavities in the
water stream.
11. Repeat rinsing step 10 using de-ionized water for an additional 3 minutes.
12. Dry instruments using clean, absorbent, non-shedding wipes.
13. Carefully inspect instruments, including any lumens and cavities, to ensure contamination is removed. If soil is still present,
repeat the cleaning process or contact Medtronic immediately to arrange for disposal or replacement. Do not proceed with
processing of a soiled instrument.
Disinfection
Working ends must be sterilized before initial use, or in adherence to these processing instructions before re-use. Disinfection
using solutions or chemicals is unnecessary and not recommended.
Sterilization Instructions
Only sterile products should be placed in the operative field. Unless marked sterile and clearly labeled as such in an unopened
sterile package provided by Medtronic, instruments used in surgery must be sterilized by the hospital before use.
The following sterilization instructions were validated to a sterility assurance level of 10
1. Wrap or pouch the instruments.
2. Inspect packaging to ensure no rips, punctures, or seal failures are present in or on packaging before loading into the
sterilizer.
3. Load instruments into the sterilizer by following the sterilizer manufacturer’s recommended loading procedures and load
configurations.
4. Follow the sterilizer manufacturer’s recommended procedures to program the sterilizer with sterilization cycle parameters in
Table 2 and Table 3.
-6
.
Table 2: Sterilization cycle parameters for the US and its territories
Method Cycle Temperature Exposure time
Minimum dry time
1
Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes
For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization
according to these parameters to minimize risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments
that could come into contact with the central nervous system.
Table 3: Sterilization cycle parameters for medical facilities outside the US and its territories
Method Cycle Temperature Exposure time
Minimum dry time
1
Steam Gravity displacement 273°F (134°C) 20 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 20 Minutes 30 Minutes
1
Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient atmospheric
pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.
Note: chamber size and chamber load differences may exist between industrial and health care facility sterilizer models.
Sterilization parameters listed in Tables 2 and 3 can be achieved in both health care facility and larger, industrial sterilizer
models. Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment.
Sterilization cycles listed in Table 3 are not considered by the Food and Drug Administration (FDA) to be standard sterilization
cycles. It is the user’s responsibility to use only sterilizers and accessories (e.g. sterilization wraps, sterilization pouches,
chemical indicators, biological indicators, and sterilization cassettes) cleared by the FDA for selected sterilization cycle
specifications (time and temperature).
FURTHER INFORMATION
Recommended directions for use (surgical operative techniques) are available at no charge upon request. If further information
is required, contact Medtronic.
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
©2021 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: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
EXPLANATION OF SYMBOLS
Authorized representative in the European Community/
European Union
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Batch code
Manufacturer
Catalogue number
For US audiences only
This device complies with applicable European Union
regulations and directives.
This device complies with applicable European Union
regulations and directives.
Non-sterile
Consult instructions for use at this website.
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