Ref 4103-133-000 Keyless Drill Attachment Instructions for Use Rev N July 2016

Keyless Drill Attachment REF

4103-133-000

Instructions For Use

ENGLISH (EN) ESPAÑOL (ES) DEUTSCH (DE) FRANÇAIS (FR) ITALIANO (IT) NEDERLANDS (NL) SVENSKA (SV) DANSK (DA) SUOMI (FI) PORTUGUÊS (PT) NORSK (NO) POLSKI (PL) ΕΛΛΗΝΙΚΑ (EL) 日本語 (JA) 中文 (ZH) 한국어 (KO) 2016-07

4103-133-700 Rev-N

Print Date: Sep 21, 2016 10:54:00 AM 0000000996, Rev. N Effective Date: Sep 21, 2016 10:33:30 AM

www.stryker.com

EN

4103-133-700 Rev-N

For Use With

Instructions

For use with System 4 Rotary Handpiece REF 4103-000-000 or System 5 Rotary Handpieces REF 4203-000-000 and REF 4205-000-000.

WARNING: You must manually close the chuck jaws to secure the accessory. Operating the handpiece to automatically close the jaws on the accessory may result in injury to the user. 1. Open the chuck jaws by holding the attachment with the knurled ring in one hand and turning the collar with the other hand. 2. Insert the cutting accessory and make certain it is centered in the jaws. 3. Close the jaws by holding the collar and turning the knurled ring until tight. 4. Tug the cutting accessory to ensure it is secure. 5. Visually verify that the cutting accessory is centered in the jaws. 6. Install the attachment in the handpiece.

User/Patient Safety WARNINGS: ▪▪ Before using this equipment, or any components compatible with this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use. ▪▪ Upon initial receipt and before each use, operate the equipment and inspect each component for damage. DO NOT use any equipment if damage is apparent. ▪▪ Upon initial receipt and before each use, clean and sterilize the equipment as indicated. ▪▪ DO NOT disassemble or service this equipment without the authorization of the manufacturer. ▪▪ Check all moving parts for free movement. Be alert for unusual sounds or vibrations, and note the operating speed. ▪▪ Use only Stryker approved accessories. Other accessories may cause tissue damage to patient and/or injury to healthcare staff, delay surgery if not functioning optimally, or cause damage to the handpiece. DO NOT modify any accessory to fit the handpiece. ▪▪ All cutting accessories are single use only. DO NOT reuse. ▪▪ ALWAYS place the handpiece in the SAFE mode while the handpiece is idle, before installing or removing any accessory, or when passing the handpiece to another person. NOTE: For additional information, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

Knurled Ring

Collar

Troubleshooting Problem: The accessory wobbles. Cause: The accessory extends too far from the distal end of the attachment, is the wrong size, or is not properly centered in the attachment. Action: Reinsert the accessory. If wobble occurs, the bit may be worn or damaged. Try a different accessory. If wobble persists, return the attachment for repair.

Care Instructions For processing instructions and disposal/ recycle information, see the care instructions manual supplied with the handpiece.

2

www.stryker.com

Print Date: Sep 21, 2016 10:54:00 AM 0000000996, Rev. N Effective Date: Sep 21, 2016 10:33:30 AM

Print Date: Sep 21, 2016 10:54:00 AM 0000000996, Rev. N Effective Date: Sep 21, 2016 10:33:30 AM

Print Date: Sep 21, 2016 10:54:00 AM 0000000996, Rev. N Effective Date: Sep 21, 2016 10:33:30 AM

2016-07

4103-133-700 Rev-N

Print Date: Sep 21, 2016 10:54:00 AM 0000000996, Rev. N Effective Date: Sep 21, 2016 10:33:30 AM

www.stryker.com

Signature History Report Version

Signature

Role

Event Date

Vote

N

Mehrotra Abhishek

CA_Owner

2016-06-21 11:13:09 EDT

Continue

N

Pearson, Dawn

Editor

2016-07-20 11:19:34 EDT

Continue

N

Mehrotra Abhishek

CA_Owner

2016-07-20 12:17:49 EDT

Continue

N

Unger, Lauren

CA_Marketing Manager

2016-07-20 12:41:14 EDT

Approve

N

Sidow, Brian

CA_Clinical Sciences 2016-07-20 12:59:40 EDT

Approve

N

Brown Donna

CA_Product Safety

2016-07-20 15:05:13 EDT

Approve

N

Raghu Varun

CA_Product Design Engineer

2016-07-21 08:45:07 EDT

Approve

N

Modi Karankumar

CA_Regulatory Affairs

2016-07-21 11:19:58 EDT

Approve

N

Wippich, Caitlin

CA_Quality Engineer

2016-07-21 17:06:22 EDT

Approve

N

Pulliam Sylvia

Document Control

2016-07-22 07:48:49 EDT

Complete

N

Schrauben Haley

Editor

2016-08-30 11:14:08 EDT

Continue

N

Mehrotra Abhishek

CA_Owner

2016-09-20 15:53:02 EDT

Approve

NOTE: IF THIS REPORT IS BLANK, PLEASE SEE WINDCHILL ECN FOR SIGNATURES.

Related Information CR Number

CR0212150

CR Class

DMR-Commercially Released

Originating Entity

INST: Kalamazoo

Origin

Standards Revision

Initial CR Approval Date

01/16/2015 15:25:17

CN Number

CN140180

CA Number

CA165562

NPD Disposition Plan

Print Date: Sep 21, 2016 10:54:00 AM 0000000996, Rev. N Effective Date: Sep 21, 2016 10:33:30 AM