3
•
Performing procedures with the Navi-
gated MIS Jig other than those speci-
fied in these instructions or outside
of their intended use will compromise
navigation accuracy.
• Do not service this device. It contains
no parts that the user can service. If
service is required, contact your Stryk-
er Navigation sales representative.
• Refer to the instructions for use sup-
plied with the tracker for specific warn
-
ings related to the tracker.
• Prior to surgery verify that the Tracker
Adapter is properly engaged on the
cutting guide. The Tracker Adapter is
properly assembled when the green
marking is visible and no rotation is
possible. Failure to comply may com-
promise navigation accuracy.
• Ensure that the tracker is locked onto
the Tracker Adapter. Verify that the
cross pin is engaged. Failure to comply
may compromise navigation accuracy.
• If any play between the tracker/Tracker
Adapter/cutting guide is suspected,
contact your Stryker Navigation sales
representative.
• When mounting the tracker choose
the tracker orientation which ensures
visibility of the tracker’s LEDs to the
camera. Rotate the tracker on the
Tracker Adapter until the LEDs face the
camera. Failure to comply may com-
promise the visibility of the tracker.
• For fixation use suitable pins. During
insertion verify that the pins do not
clamp or have a significant play. Failure
to comply may compromise navigation
accuracy.
NOTE:
The user and/or patient should report any
serious product-related incident to both the
manufacturer and the national competent
authority where the user and/or patient is
established.
User/Patient Safety
WARNING
• Read and understand this information.
File it in your maintenance records.
Familiarization with the Stryker naviga-
tion system prior to its use is important.
Refer to the instructions for use sup-
plied with the navigation system
.
• Prior to each use, the Navigated MIS
Jig should be checked for loose com-
ponents and damage. Do not use if
these conditions exist.
•
Prior to surgery inspect the cutting
guide slot for damage. For resection
accuracy, replace the cutting guide if
the slot is suspected of damage that
has changed its geometry.
• Prior to surgery inspect the cutting
guide slot for wear. For resection accu-
racy, replace cutting guide if the slot is
suspected of wear that has changed its
geometry (e.g. slot surface is uneven,
broken off).
• Prior to surgery inspect the Navigated
MIS Jig for slot flatness. For inspection,
insert the saw blade into the slot of
the cutting guide. The saw blade must
be flush with the surface of the slot to
ensure navigation accuracy. If the saw
blade clamps or has significant play
due to wear or damage, replace the
cutting guide.
• Clean and sterilize the instruments
before every use.
Refer to the Guide
for Cleaning, Disinfection and Steam-
Based Sterilization (TD6000005750).
• The healthcare provider performing any
procedure is responsible for determin-
ing the appropriateness of using the
product and for the specific technique
for each patient. Stryker, as a manufac-
turer, does not recommend a specific
surgical procedure.
