Page 15 of 25
L011-61
Rev. F0
2019-08-08
10. Install center positioner in center hub. The tab on the center positioner should be positioned opposite the hub
thumbknob. Examine burr hole to ensure entry area is clear. If necessary, remove the center hub and install the entry
offset hub.
11. Mount inserter on the center positioner and tighten the thumbknob. The thumbknob of the inserter should be in
alignment with the tab of the positioner.
12. Insert the MRI safe insertion tube with the stylet in through the center hole. Ensure that the insertion tube enters the brain
without hitting the edges of the burr hole.
WARNING: Incorrect thumbknob orientation may affect
targeting accuracy.
WARNING: The entry offset hub creates a new trajectory
which is orthogonally offset 3mm from original at
approximate entry depth, and coincides with the original at
the target.
WARNING: If any error or erratic function is observed,
discontinue use of the WayPoint™ Inserter System
immediately and evaluate the potential impact to
patient safety before continuing its unmitigated use.
WARNING: Always confirm the tightness of thumbknobs
before beginning the procedure.
WARNING: While often snug, all tubes used with the
WayPoint™ Inserter System have been designed to be
inserted and removed by hand. Any other tool should be
used only as a last resort.
WARNING: The insertion tube will enter the brain at this
stage.
WARNING: Never move the insertion tube in the brain with-
out a stylet or lead inside.
WARNING: The stylet should not be removed until tube is
inserted in brain.
WARNING: The insertion tube and stylet are fragile and
should be handled with care.
WARNING: When there is an insertion tube in the brain, ev-
ery effort should be made to minimize lateral forces to the
WayPoint™ Inserter System as it can translate into significant
lateral movements of the tube in the brain.
WARNING: The insertion tube has no electrical conductivity
and cannot be used as an electrical common.
