L011-81 (Rev B0, 2017-08-25)
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1. Adjust the stereotactic positioning system for the desired trajectory and depth.
2. Fully insert the stylet into the insertion tube, then insert the insertion tube with stylet into the
stereotactic positioning system.
3. Withdraw the stylet from the insertion tube and set aside.
4. Insert the electrode into the insertion tube.
5. Refer to the directions for use associated with the electrode.
6. After use, withdraw the electrode from the insertion tube.
7. Withdraw the insertion tube from the stereotactic positioning system.
8. Proceed with cleaning instructions for non sterile insertion tubes, otherwise place the insertion tube
and stylet in an approved sharps disposal container according to hospital protocol.
Pre-Use Check:
WARNING:
As the most critical component of a procedure, delicate insertion tubes should
always be carefully inspected before use because damage to them can cause targeting errors
and impact patient safety. Handle insertion tubes and spacer tubes carefully to prevent bending.
WARNING:
Check to be certain that tubes are straight; with the collar over the edge, roll the
insertion tube over a flat surface or in the measuring fixture slot.
English
• Rx only: Caution
- Federal law (USA) restricts this device to sale by or on the order of a physician.
• Patients with a microTargeting™ Insertion Tube inserted intracranially should not be exposed to the
electromagnetic fields produced by magnetic resonance imaging (MRI). Use of intraoperative MRI
may cause heating, movement, or induced voltages in the microTargeting™ Insertion Tube.
• In the event that a patient must be defibrillated via electric shock, the microTargeting™ Insertion
Tube should be withdrawn prior to defibrillation.
• To prevent electrical shock hazard DO NOT connect microTargeting™ Insertion Tubes to any line volt-
age source or any unknown power source.
• Never move the insertion tube in the brain without a stylet or microelectrode inside.
• When there is an insertion tube in the brain, every effort should be made to minimize lateral forces
to the drive/stereotactic system.
• Do not use insertion tubes other than those which have been specifically designed for use with
your drive/stereotactic system.
• Microelectrode Recording (MER) involves the use of sterile metal probes which are inserted into
the brain during surgery. This use may cause a hemorrhage with a known adverse event effect
rate of 1-2%.
• The insertion tube is not intended to be used as a cauterizing conductor.
• Do not modify insertion tubes.
• Never use the microelectrode insertion tube without the lead insertion tube installed first.
• Products listed in this DFU must be used by trained personnel.
• Improper cable connections may cause erroneous results including unintended stimulation through
metal contacts in the brain.
• While often snug, all tubes used with the microTargeting™ STar™ Drive System have been designed
to be inserted and removed by hand or by using the STar™ Insertion Tube Extractor. Any other tool
should be used only as a last resort and indicates system repair may be necessary.
WARNINGS:
Procedural Instructions:
• Sterile Medical Device – Do NOT resterilize.
• Do not use the contents if there is any evidence of damage to the package or
package seal that could compromise sterility.
• For single patient use only
• Do not reuse; reusing single-use medical devices could lead to serious patient injury.
Sterile Insertion Tubes:
