Medtronic 960364 Instructions for Use

LandmarX® ENT Image Guidance System

FESS Frame

Reference Frame, TouchLite Adapter, and Touch Pad are not included in the kit; it is shown for illustrative purposes only.

Product Information & Instructions

Rx Only

The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual without notice and without incorporating those changes to products already sold. Released
documents are available to view or print at manuals.medtronic.com.

The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: LandmarX™. All other trademarks, service marks, registered trademarks, or registered service marks are
the property of their respective owners in the United States and other countries.

Indications for use

The LandmarX® Image Guided Surgery System, utilizing the FESS Frame, is indicated for otorhinolaryngological, head/neck surgery, or stereotactic surgery
where a reference to a rigid anatomic head or neck structure (such as the intranasal area or sinus) can be identied relative to a CT or MRI based model of the
anatomy.
Important Note: When the LandmarX® System is used with other medical devices, such as implants, please refer to the packaging inserts for those devices for
any labeling limitations.

Intended use

The LandmarX® FESS Frame is intended to be used intraoperatively with the LandmarX® ENT Image Guidance Surgery System as a mounting platform for the
LandmarX® Reference Frame (REF # 960632).

Device description

The LandmarX® FESS Frame is designed to provide a safe, compact and convenient intraoperative mounting platform for the LandmarX® Reference Arc (REF
# 960632). The FESS Frame is xed to the patient’s head with a silicone strap.

Contraindications

The FESS Frame is contraindicated for:

• Patients with circulatory diseases whose skin may be prone to damage from pressure from the contact pads.

• Patients with topical treatments or oils that cannot/should not be removed.

• Unusual soft tissue sensitivity, or damaged tissue at or near the intended mounting areas.

Complications

In the event that the LandmarX® System improperly registers the images or provides incorrect orientation of the images, the lesion could be missed if the
surgeon relies solely on the LandmarX® System for surgical guidance. In order to minimize complications, the protocol for use of the LandmarX® System is
to be followed. Following the LandmarX® System protocols precisely will minimize complications. In addition, the LandmarX® System is to be used only as
an aid for verication of the anatomy, during surgical procedures that are the standard of surgical practice. The LandmarX® System has been designed to
avoid mis-registration (errors in the correlation of imaged data to surgical data), however, the surgeon must verify the correct orientation of images before
the LandmarX® System is used. The LandmarX® System should be congured to report the Sustained Accuracy Checkpoint at various times throughout the
surgical procedure.

Warnings

The LandmarX® System is an image-guided stereotactic device and as such is intended as an intraoperative adjunctive aid for the diagnostic image display
and presentation of localization information. The LandmarX® System is not in any way, shape, or form intended to replace or supplant the standard and
proven methods used by the surgeon prior to or during surgery. The LandmarX® System is not intended as a replacement for standard lm to diagnose and
plan surgery, nor is the LandmarX® System intended to replace or relieve the surgeon’s responsibility for intraoperative guidance and procedural decision­making. The LandmarX® System is a tool that provides adjunctive information to aid the surgeon during the decision-making process.

• Overtightening of the strap may cause pressure-related injuries such as bruising, skin marks, or nerve damage.

• If the strap is adjusted intraoperatively, the patient must be re-registered.

• If any movement of the patient’s head or accidental jarring occurs during the procedure, it is imperative to perform a Sustained Accuracy Checkpoint

and re-register the patient if required.

Precautions

The LandmarX® System is to be used only as an aid to the surgeon’s skill and knowledge. The surgeon should not rely exclusively upon the LandmarX® System
for anatomical reference.

• The use of the LandmarX® System should be aborted under the following circumstances:

• The data set violates the imaging protocol (software warning).

• The surgeon cannot verify the data set (CT or MRI scan data).

• The “Frame Geometry” error appears (software warning).

• The Optical Probes cannot be veried for accuracy (software warning).

• The images on the LandmarX® System are not registered within an acceptable degree of accuracy for the intended procedure (software warning).

• A non user-replaceable component of the LandmarX® System discontinues function.

FESS frame mounting

1. Visually inspect silicone head strap and contact pads for cuts, nicks, cracks or deterioration prior to each use.
Note: It is recommended to replace the silicone head strap and the contact pads after fty (50) autoclave cycles (slight discoloration may occur after
several autoclave cycles). Replacement strap and contact pads are available by ordering REF # 960363 and REF # 960364 respectively.

2. Determine mounting location and orientation.

3. With alcohol wipe, clean the intended mounting area of oils or substances that may induce contact pad slippage. Allow to dry before proceeding
further.

4. Place FESS Frame strap under patient’s head around the occipital region, and centered laterally without distorting the ears (see Figure A).
NOTE: When mounting the FESS Frame special attention should be paid to the alignment/relationship between the strap and the patient’s ear.

5. Place FESS Frame on the patient’s forehead, centered laterally, and with the lower edge of the contact pads just superior to the patient’s brow ridge (see
Figure A).

6. Pull the strap up to the swivel arm pins, and hook the strap onto the pins with light tension. Check to be sure the strap is centered laterally, and that the
extra strap length is roughly equal on the left and right side.

7. Increase the tension on the straps by working back and forth from right to left one hole at a time until the headset is suciently stable and resistant to
slippage (test by pushing on headset/reference arc to simulate user applied forces during calibration). It is important to ensure that the tension on the
left and right strap is even to prevent lateral drift during surgery.

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