Stryker Navigated MIS Jig-A Bedienungsanleitung

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

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

• 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.

• 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.

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

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

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.

Instructions

3 Mount Tracker on Tracker Adapter

3.1 Mount the Tracker onto the interface of the

Tracker Adapter.

Cross pin must engage

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

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)

Andere Handbücher für Navigated MIS Jig-A

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