Stryker Navigated MIS Jig-A User manual

1
Navigated MIS Jig-A
REF 6003-200-010
Navigated MIS Jig-B
REF 6003-200-020
Tracker Adapter
REF 6003-200-030
TD6003200700 2018-01-11 Rev. D
IMPORTANT INFORMATION FOR YOUR
NAVIGATION SYSTEM
File in your maintenance records
Instructions For Use
Patent
US and Corresponding Foreign
Patents Pending

2
Important Information
WARNING - CAUTION - NOTE
Please read this manual and follow its instructions carefully. The words WARNING, CAU-
TION and NOTE carry special meanings and should be carefully observed.
WARNING: The personal safety of the patient and user may be affected. Disregarding
this information could result in injury to the patient and/or user.
CAUTION: These instructions point out special service procedures or precautions that
must be followed to avoid damaging the instrument.
NOTE: This provides special information to make maintenance easier or
important instructions clearer.
An exclamation mark within a triangle displayed on the product is intended
to alert the user to the presence of important operating and maintenance
instructions in this manual.
Intended Use of the Navigated
MIS Jig
The Navigated MIS Jig is intended as a
dedicated cutting block system to support
computer-assisted surgery. The instrument
is intended for any medical condition in
which the use of computer-assisted sur-
gery may be appropriate and where a ref-
erence to rigid anatomical structures such
as, but not limited to, the femur or tibia can
be identied.
The Navigated MIS Jig consists of:
• Navigated MIS Jig-A
REF 6003-200-010
• Navigated MIS Jig-B
REF 6003-200-020
• Tracker Adapter REF 6003-200-030
• Screwdriver REF 6003-100-100
Function and Features

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• Inspect the Navigated MIS Jig before rst
and every use as recommended. Clean
as instructed. Refer to the disassem-
bling, cleaning and inspection instruc-
tions contained in this manual.
• Performing procedures with the Navi-
gated MIS Jig other than those speci-
ed 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 Usesup-
plied with the Tracker for specic user/
patient safety warnings related to the
Tracker.
• To ensure the proper functioning of
the Navigated MIS Jig, follow the as-
sembling instructions explained in this
manual carefully.
User/Patient Safety
WARNINGS:
• Read and understand this information.
Familiarization with the Stryker®Naviga-
tion System prior to use is important.
Only trained personnel are to use this
system. Refer to the Instructions For
Use supplied with the Navigation Sys-
tem.
• Prior to each use, the Navigated MIS
Jig should be checked for loose com-
ponents and damage. DO NOT use
if these conditions exist. If service is
required, contact your Stryker Naviga-
tion sales representative immediately.*
• 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 atness. For inspec-
tion, insert the saw blade into the slot
of the Cutting Guide. Use saw blades
with 0.05 in. (1.27 mm) thickness. The
blade must be ush with the surface of
the slot to ensure navigation accuracy.
If the blade clamps or has signicant
play due to wear and/or damage, re-
place the Cutting Guide. Stryker Saw
Blades REF 2108180000 are validated
by Stryker as suitable.

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• Ensure that the Tracker is locked onto
the Tracker Adapter. Verify that the
cross pin is engaged. Failure to comply
may compromise navigation accuracy.
Refer to the instructions contained in
this manual for further information.
• When mounting the Tracker choose the
Tracker orientation which ensures vis-
ibility of the Tracker’s LEDs to the cam-
era. Rotate the Tracker on the Adapter
until the LEDs face the camera. Failure
to comply may compromise the visibil-
ity of the Tracker.
• Check the Tracker on the Adapter for
rotability.
• For xation use suitable pins. Failure
to comply may compromise naviga-
tion accuracy. Use 1/8 in. (3.175 mm)
headless pins. Permissible tolerance is
0.125 ± 0.001 in. (3.175 ± 0.0025 mm). Dur-
ing insertion verify that the pins do not
clamp or have a signicant play. Stryk-
er Pins REF 7650-1038 are validated
by Stryker as suitable. Prior to surgery
verify pin suitability.
User/Patient Safety
WARNINGS:
• When assembling, choose the locking
position of the Tracker Adapter on the
Cutting Guide which ensures visibility
of the Tracker’s LEDs to the camera,
also in case of overweight patients.
Failure to comply may compromise the
visibility of the Tracker.
• Prior to surgery verify that the Tracker
Adapter is properly engaged on the
Cutting Guide. The Adapter is properly
assembled when the green marking is
visible and no rotation is possible. Re-
fer to the instructions contained in this
manual for further information.
• It is part of the user’s responsibility of
due care to ascertain prior to use the
safety and effectiveness of the com-
bination of the Navigated MIS Jig with
the saw blade/pins by means of the
listed technical specications.
• If the saw blade and/or the pins do not
have the stated characteristics, they
must not be used with the Navigated
MIS Jig.
• In case of the slightest suspicion of in-
compatibility or risks, the user must not
use the Navigated MIS Jig in combina-
tion with the third party products.
• If any play between the Tracker/Track-
er Adapter/Cutting Guide is suspected,
contact your Stryker Navigation sales
representative immediately.

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1 Adjust to Neutral Position
1.1 Insert the screwdriver into the screwdriver
interface.
1.2 Rotate the screwdriver until the Cutting
Guide is set to the 0 marking.
Instructions

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Tracker Adapter
Release Button
Instructions
2 Mount Tracker Adapter on Cutting
Guide
2.1 Press the Release Button and insert
the base of Tracker Adapter into the Cutting
Guide.
2.2 For Tracker/camera alignment choose
between the two adjustment angles of the
Adapter on the Cutting Guide.
2.3. Release the Button and rotate
the Adapter until the Button snaps in the
required position. Verify that the Adapter is
correctly engaged in the Cutting Guide.
Cutting Guide

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CORRECT engaging shows
green marking
INCORRECT engaging
hides green marking
INCORRECT engaging shows gap
between Adapter and Cutting Guide
2.4 Double check that the Tracker
Adapter is engaged and secure.

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Instructions
3 Mount Tracker on Tracker Adapter
3.1 Mount the Tracker onto the interface of the
Tracker Adapter.
Cross pin must engage

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4 PrealignandPrexateCuttingGuideon
Bone
4.1 Position the Cutting Guide on the bone with
preadjusted varus/valgus, exion/extension and
resection level settings for preliminary xation.
4.2 For preliminary xation insert a 1/8 in. (3.175 mm)
headless pin into the swivel of the adjustment block
as depicted in the detail above.
5 Varus/ValgusandFlexion/Extension
Alignment
5.1 Align the Cutting Guide according to the varus/
valgus and exion/extension setting as displayed on
the navigation screen.
Hole for 1/8 in. (3.175
mm) headless pin
insertion
Adjustment
Block

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Instructions
6 FixateAdjustmentBlock
6.1 Insert two1/8 in. (3.175 mm) headless pins
into the adjustment block for xation as depicted
in the detail above. Ensure that the adjustment
block is stable and can not move relative to the
bone.
Hole for 1/8 in. (3.175 mm) headless pin
insertion (4 total)

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7 Adjust Resection Level
7.1 Use the screwdriver as depicted above for
resection level adjustment. The scale is not
calibrated. Refer to the navigation screen for
adjustment.
8 FinalFixationofCuttingBlock
8.1 Insert two 1/8 in. (3.175 mm) headless pins
into the cutting block forxation as depicted in
the detail above.
8.2 Remove the Tracker Adapter by pressing
the Release Button.
Cutting Block
Hole for 1/8 in. (3.175 mm) headless pin
insertion (4 total)

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Disassembling Instructions for
Cleaning
Prior to cleaning and sterilization follow thein-
structions below for optimum cleaning and
sterilization performance:
1 Remove Tracker and Tracker Adapter.
2 Remove all pins.
3 Insert the screwdriver into the screwdriver
interface.
4 Rotate the screwdriver until the Cutting
Guide is set to the +4 marking.
Instructions
9 Bone Cut
9.1 Insert the blade for cut.
9.2 Proceed to cut.

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Cleaning Recommendations
Inspection Recommendations
We recommend visual inspection after
cleaning prior to sterilization. Refer to the
Cleaning and Sterilization Guide.
We recommend manual precleaning and
machine cleaning method. The Navigated
MIS Jig has cleaning group IV. Refer to the
Cleaning and Sterilization Guide.
Sterilization Recommendations
To obtain optimum performance and help
prevent product damage, it is essential
that the following sterilization procedure
is followed for the Navigated MIS Jig. For
the pins, refer to the Instructions For Use
supplied with the pins.
Pre Vac - 3 Pre-vacuumed sterilizer
cycles
- 270-273° F (132-134° C)
- Double wrapping or double
packed in sterilization
pouches
- 4 min minimum exposure
- 10 min minimum drying time
270° F - Gravity Displacement Sterilizer
Gravity - 270-273° F (132-134° C)
- Double wrapping or double
packed in sterilization
pouches
- 35 min minimum exposure
- 10 min minimum drying time
Flash - Gravity Displacement Sterilizer
Gravity - 270-273° F (132-134° C)
- Unwrapped
- 10 min preheating time
- 10 min minimum exposure
- 10 min minimum drying time
The Sterilization Recommendation‘s vali-
dation is based on ANSI/AAMI/ISO 11134
protocol.The respective individual laws,
standards, directives and instructions of
each country must be followed and have
priority of the specied procedure (e.g.
ash gravity). It remains to the user to con-
sider this and to acquire the corresponding
information.

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Troubleshooting Guidelines
Handling and Storage
To ensure the longevity, performance and safety of this equipment, package in the origi-
nal packaging materials when storing or transporting.
Inspect
PROBLEM
The Tracker can not rotate
or be mounted onto inter-
face and does not lock in
position.
The Tracker Adapter does
not t into Cutting Guide/
jams.
The pin can not be inserted/
jams.
The saw blade can not be
inserted, has too much play,
or jams.
Resection level can not be
set.
CAUSE
The interface is bent/
damaged.
The interface is bent/
damaged.
The pin is bent, dam-
aged or
not properly sized.
The blade is bent, dam-
aged or not properly
sized.
The slot is worn.
The cutting/adjustment
block slides jam.
ACTION
Return Tracker and Tracker
Adapter to service.
Return Tracker Adapter and Cut-
ting Guide to service.
Replace if damaged or not suit-
able.
Replace if damaged or not suit-
able.
Replace.
Return to service.

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Specications*
Model: Navigated MIS Jig-A REF 6003-200-010
Navigated MIS Jig-B REF 6003-200-020
Tracker Adapter REF 6003-200-030
Size: 40.5 x 43.1 x 11 mm(1.57 x 1.69 x 0.43 in.) Tracker Adapter
54.5 x 25 x 31 mm (2.14 x 0.9 x 1.24 in.) Jig A/B
Weight: 130 g (4.58 oz) with Tracker Adapter assembled
Material: Stainless steel
Temperature:
Relative Humidity:
Atmospheric Pressure:
*Specications listed are approximate and may vary slightly from unit to unit.
-
n.a.
n.a.
Operation Storage and Transport
10 - 10
40° C 75° C
10 10
95 % 95 %

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Manufactured and Distributed by:
Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
79111 Freiburg, Germany
t: [phone]
Distributed by:
Stryker Navigation
4100 East Milham Avenue
Kalamazoo, MI 49001 USA
t: 1 269 323 7700
Translated Equivalent:TD6003200713