Medtronic NAV4680005 Technical Manual

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2021

Navigated

Anterolateral Disc Prep

Instruments

DIRECTIONS FOR USE M333023W214 Rev. 1.0

MEDTRONIC

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Contents

ALO Instrument Use with StealthStaion Navigation ..................................................................................... 2

ALO Instrument Use with Mazor Robotics:................................................................................................... 3

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ALO Instrument Use with StealthStaion Navigation

Attach the Spheres to a blue Reference Frame from the Spine Referencing Set and the NavLock Trackers from the NavLock Set. Check the Spheres to ensure they are secure. Next, attach the NavLock Trackers to the instruments. Place each instrument tip into the divot in the blue Reference Frame and hold perpendicular and visible to the camera until a confirmation color is seen. Use the tracking view in the lower right of the screen to ensure the camera is tracking the Reference Frame and instrument correctly.

• Successful verification is indicated by a chime and a transition to green on the instrument

toolcard.

• Failed verification is indicated by a “bonk” sound and indicates that the instrument may be

positioned improperly in the divot or is bent/ damaged. Inspect the instrument; if it is bent/ damaged, do not use.

• If no sound is heard when the instrument is touched to the divot, this may indicate that the

camera cannot see either the instrument or the frame.

Helpful Hint: Assigning an instrument to a specific-colored NavLock Tracker will eliminate the need to switch the tracker from one instrument to the next throughout the procedure.

Helpful Hint: OR Staff can verify instruments before the surgeon enters prior to reference frame placement.

Important: Navigated Disc Prep instruments are verified with default instruments and not the actual tip.

On the StealthStation System, select the "Tool" tab to select the appropriate navigated instrument tip. Insert the navigated instruments into the appropriate NavLock Tracker and confirm accuracy by touching the tip of the instrument on a known anatomical point. The discs can now be removed using Navigated Anterolateral Disc Preparation Instruments, Navigated Lateral Disc Preparation instruments, and general instruments until the desired discectomy is achieved.

The surgeon can perform a thorough discectomy in the usual fashion. Kerrisons and Pituitaries are used to perform thorough discectomies. A Large Cobb can be passed along both endplates to release the contralateral annulus. Cobbs can be used to pry disc away from bony endplates. Curettes can be used to remove disc and prepare endplates. Rasps and Shavers can be used to prepare endplates. Distractors can be used to open disc space prior to trialing. The osteotome can be used to remove osteophytes and other bony protrusions.

General instruments for discectomy and endplate preparation can be used per the surgeon's preference.

Important: Make sure the navigated disc prep instruments were verified with a default tip such as an awl or tap. Use the "Tool" tab when choosing the applicable tip for the disc prep working end.

Important: The Quick-Connect Handle is compatible with the navigated curettes and rasp instruments only. No impaction forces, such as malleting, should be applied to the Quick-Connect Handle as this will damage the instrument and prevent the removal of the NavLock from the instrument.

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ALO Instrument Use with Mazor Robotics:

To help ensure accurate screw placement in addition to navigation enabled placement of an interbody device, adhere to the surgical sequence as follows:

• Imaging and registration

• Pedicle preparation

• Screw placement

• Interbody placement

• Rod and set screw placement

Helpful Hint: The Medtronic consultant will be provided with a Navigation Code to enable the navigation of approved implant systems.

From the Home screen in the software, tap the Setup Process function button, then select Instrument Setup from the dropdown menu. The instruments are categorized into multiple groups. Choose the desired Patient Reference Frame to add it to the procedure Tool Card pane. Note that only one Reference Frame can be added into a procedure at a time. Attach the Spheres to the patient reference frame from the Patient Reference Set. Attach the spheres to the NavLock™ Trackers from the Stealth Navigation Tracker Set. Press the Spheres onto the trackers until they snap into place and then check to ensure they are secure. Next, attach the NavLock™ Trackers to the instruments.

Important: Passive spheres are a single-use disposable product and should not be preprocessed. Do not reprocess, re-sterilize, or reuse any single-use device.

All NavLock™ Trackers and navigated instruments may be verified with the Reference Frame on the sterile back table before the patient is in the OR. Place the tip of each instrument into the divot on the patient reference frame. Hold the instrument perpendicular and visible to the navigation camera until confirmation is received. Use the tracking view in the lower right of the instrument setup screen to ensure the camera is tracking the Reference Frame and instrument.

• Successful verification is indicated by a chime.

• Failed verification is indicated by a negative “bonk” and indicates that the instrument may be

positioned improperly in the divot or is bent/damaged. Inspect the instrument; if it is bent/damaged, do not use.

• If no sound is heard when the instrument tip is placed into the divot, this may indicate that the

camera cannot see either the instrument or the reference frame.

Helpful Hint: Instruments may only be verified in the Reference Frame divots. Instruments cannot be verified using the arm guide accuracy check-point.

Helpful Hint: Passive spheres may become coated with fluid or debris during use, hindering their ability to reflect light. If this occurs, wipe away the debris with a soft, sterile cloth (the cloth may be wet, but make sure to dry each sphere thoroughly). Keep extra spheres available as replacements during a case.

Helpful Hint: Assigning an instrument to a specific-colored NavLock™ Tracker will eliminate the need to switch the tracker from one instrument to the next throughout the procedure.

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If using the Schanz screw and Schanz arm/bridge, access, retraction, navigated decompression and

Consult instructions for use at this website.

interbody insertion should occur after the bone mount has been disconnected.

After robotic guidance of screw preparation and insertion is complete and prior to moving on to navigated interbody steps, it is recommended to perform the Accuracy Check to ensure navigation is still accurate and the patient reference frame hasn’t experienced motion.

After disconnecting the robotic system from the patient, the access, retraction, navigated decompression, and interbody insertion steps may proceed.

Important: Do not re-snapshot after the patient has been disconnected from the Bone Mount (during lateral interbody navigation steps). The accuracy check in this scenario will be modified: navigation accuracy should only be checked on known patient anatomy. If the user attempts to select Snapshot after they have started utilizing interbody navigation capabilities, a warning will pop up advising against taking a new snapshot.

On the workstation, select the "Tool" tab to select the appropriate navigated instrument tip. Insert the navigated instruments into the appropriate NavLock™ Tracker and confirm accuracy by touching the tip of the instrument on a known anatomical point. The discs can now be removed using Navigated Anterolateral Disc Preparation Instruments, Navigated Lateral Disc Preparation instruments, and general instruments until the desired discectomy is achieved.

Important: The Quick-Connect Handle is compatible with the navigated curettes and rasp instruments only. No impaction forces, such as malleting, should be applied to the Quick-Connect Handle as this will damage the instrument and will prevent the removal of the NavLock™ Tracker from the instrument.