Stryker 6007-015-000 User manual

1
IMPORTANT INFORMATION: File in your records
Insertion Tool
REF 6007-015-000
2016-10-14 TD6007015700 Rev. E
Instructions For Use
CE conformity:
Essential Requirements of Medical
Device Directive 93/42/EEC
Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 1 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT

2
Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 2 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT

3
User/Patient Safety
WARNINGS:
• Read and understand this information. Familiar-
ization with the Stryker Navigation System prior
to use is important. Only trained personnel are
to use this system.
• Prior to each use, instruments should be oper-
ated and inspected for any loose components or
damage. DO NOT use if these conditions exist.
Contact your Stryker Navigation sales represen-
tative immediately in this case.
• Performing procedures with instruments other
than those specied in these instructions or out-
side of their intended use compromises naviga-
tion accuracy.
• Clean and sterilize instruments before rst and
every use.
• Prior to surgery, this product should be checked
with the Stryker Navigation System to ensure it
is functioning properly.
Important Information
WARNING - NOTE
Please read this manual and follow its instruc-
tions carefully. The words WARNING and NOTE
carry special meanings and should be carefully
reviewed.
WARNING: The personal safety of the patient and
user may be involved. Disregarding this
information could result in injury to the
patient and/or user.
NOTE: This provides special information to make
maintenance easier or important
instructions clearer.
An exclamation point 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.
• Use this manual with the Instructions For Use
supplied with the Anchoring / Revision Pins
for further User/Patient Safety Warnings and
instructions related to the Pins.
Intended Use of the Navigation
System
The Stryker Navigation System is intended as a
planning and intraoperative guidance system to
enable open or percutaneous computer aided sur-
gery. The system is indicated for any medical con-
dition in which the use of computer aided surgery
may be appropriate, and where a reference to a
rigid anatomical structure can be identied relative
to the operative eld.
Intended Use of the Insertion Tool
The Insertion Tool is a component of the Hip,
Trauma, Knee and Spine Modules of the Stryker
Navigation System.
The Insertion Tool is to be used with the Stryker
System Platform, standard Stryker surgical in-
strumentation and the Stryker Navigation System
Software Modules for Knee, Hip, Trauma and Spine
surgery.
• DO NOT service instruments. Instruments do
not contain parts that a user can service. Con-
tact your Stryker Navigation sales representa-
tive in this case.
Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 3 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT

4
Function and Features
The Insertion Tool REF 6007-015-000 is used for
bone insertion of Revision / Anchoring Pins and
for xation of any device which is locked with 5mm
square head screws (e.g. the Stryker Hoffman cou-
pling REF 6002-800-000).
Instruction Steps for 5mm Square Head Screw
Fixation
1 Mount to Screw
• Mount the screw to the Insertion Tool Interface.
Seegure1.
2 Apply
• Fixate screw.
Instructions
Insertion Tool Interface for
5mm Square Head Screws, Pins
Figure 1: Insertion Tool and 5mm Square Head
Screw
5mm Square Head Screw
Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 4 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT

5
4. Remove from Pin
•After Pin insertion and proper orientation, pull
the holding mechanism back and remove the
Insertion Tool.
Figure 2: Insertion Tool
Attached to Anchoring Pin
Insertion Tool Handle
(Align with Sensor Array)
Cross Pin
Instructions (cont'd)
Instruction Steps for Pin Fixation
1 Mount Insertion Tool to Pin
• Pull the holding mechanism back.
• Align the cross pin with the Insertion Tool
Handle (g.2). RefertotheInstructionsFor
 UsesuppliedwiththePin.
• After proper alignment, mount the Pin to the
Insertion Tool Interface. Seegure1.
• Release the holding mechanism to let it snap by
a forward movement.
During Pin xation, take care that the Insertion Tool
Handle is aligned with the sensor array to ensure
visibility of the Tracker's LEDs for navigation.
WARNING:
3. Align with Sensor Array
2 Insert Pin into Bone
• For Pin insertion, apply a gentle force while
rotating.
Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 5 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT

6
Sterilization Recommendations
Follow the recommendations contained in this
manual.
Hi Vac:
• Pre-vacuumed sterilizer
• 270-273°F (132-134°C)
• Wrapped or unwrapped
• 4-minute minimum exposure time
• 8-minute minimum dry time
270°F Gravity:
• Gravity displacement sterilizer
• 270-273°F (132-134°C)
• Wrapped in an instrument tray or fully perforated
sterilization box
• 35-minute minimum exposure time
• 8-minute minimum dry time
Sterilization Recommendations
Validation based on AAMI protocol
Specications*
Model: REF 6007-015-000
Size: 6.7 inch [170 mm] length (with
Handle)
0.5 inch [12 mm] diameter
Material: Stainless Steel
Elastosil
Weight: 0.3 lb. [155 g]
*Specications listed are approximate and may vary slightly from unit to unit.
Storage and Handling
To ensure the longevity, performance and safety of this
equipment, package in original packaging materials
when storing or transporting.
Instrument Preparation Instructions
Table 1: Cleaning Groups
Inspection Recommendations
Inspect the Insertion Tool prior to sterilization.
RefertotheCleaningandSterilizationGuide
REFTD6000005750.
1. Disconnect always the Insertion Tool from the
Pin / 5mm square head screw.
2. Proceed to cleaning.
Cleaning Recommendations
We recommend machine cleaning method.
RefertotheCleaningandSterilizationGuide
REFTD6000005750forcleaningsafetyandcaution
notes,cleaningequipmentanddetailedcleaning
instructions.
Refertotable1.
Instrument Group
Insertion Tool III
Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 6 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT

Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 7 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT

TranslatedEquiv.:TD6007015713
Manufactured and distributed by:
Stryker Leibinger GmbH & Co. KG
Bötzinger Str. 41
79111 Freiburg, Germany
t: [phone]
Distributed by:
Stryker Navigation
4100 East Milham Avenue
Kalamazoo, MI 49001, USA
t: [phone]
U.S. Patents: www.stryker.com/patents
Stryker Corporation or its divisions or other afliated entities
own, use or have applied for the following trademarks or
service marks: Stryker.
All other trademarks are trademarks of their respective owners
or holders.
Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 8 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT

Signatures for document: TD6007015700 Insertion Tools IFU EN
Document Number: D0000055196NAV
Date: 2016-10-14 07:35:44.0
Revision: A
ECR Number:
ECN Number:
This document has been signed using an electronic signature within Windchill. To access the original source
document and relevant information, please access the system directly.
Approval Information
Group Approval Role Name Date Vote
No signatures found
Number: D0000055196NAV
Revision: AState: Production Released
Date Released: Oct 14, 2016 07:35:44 GMT
Page 9 of 9
Printed Date: Jul 12, 2018 11:05:55 GMT