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Stealth-Midas System for Navigated Drilling in Spinal Surgical Procedures

for Precisely Locating Anatomical Structures in Open or Percutaneous Procedures with powered drilling

Indications, Safety, and Warnings

  • It is important that the Stealth-Midas system operator be familiar with the system User's Guide, its precautions, procedures, and safety issues.
  • The Stealth-Midas system and its associate applications should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic computer-assisted surgery systems.
  • The Stealth-Midas system and its associated applications should be used only as an adjunct for surgical guidance. It is not a replacement for the surgeon's knowledge, expertise, or judgment.
  • Do not operate the Stealth-Midas system in the presence of Magnetic Resonance Imaging devices.
  • Ensure that the Reference Frame is properly secured to anatomy before navigating. Neglecting to verify that the Reference Frame is secured could result in navigational inaccuracy if the hardware moves in relation to the anatomy after registration is complete.
  • Operate the Stealth-Midas only after appropriate anatomical landmarks and the intended surgical site have been confirmed.
  • During navigation, and after decompression and/or distraction, frequently confirm navigational accuracy by touching the tip of the Stealth-Midas on known anatomical points and comparing the position of the Stealth-Midas tip in the image with its physical location.
  • Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced.
  • Heavy side loads and/or long operating periods may cause the device to overheat.
  • Always secure the secondary lock to eliminate motion between the dissecting tool and the tracker, which could impact navigation accuracy.
  • The Stealth-Midas motor should only be operated when the attachment is in the locked position.
  • DO NOT verify the handpiece for navigation with the handpiece running to prevent device damage or deposit metal shavings on the surgical site.
  • The Stealth-Midas is a precision surgical instrument. With precision instruments, excessive force, beyond the design strength of the instruments, can be caused by even simple manual overloading.
  • Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery.
  • Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious dissecting tools with a new one prior to use.
  • Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment. Confirm that the dissecting tool package label indicates Stealth-Midas (Stealth-Midas) if navigation is required.
  • Do not use the Stealth-Midas system before proper cleaning and sterilization.
  • The tracker is permanently affixed to the Stealth-Midas motor and should not be removed at any time.
  • If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system.
  • Always re-verify the Stealth-Midas in the software when changing dissecting tools, attachments, or attachment orientation.
  • Clinical Navigation Software Application prevents the simultaneous localization with multiple trackers with incompatible geometries. Use only one Navigated Stealth-Midas Motor per procedure.
  • Do not apply force when verifying dissecting tools.
  • Refer to the MR7 Instructions for Use and Synergy Spine & Trauma Pocket Guide for additional instructions, warnings, and cautions.