Ref 4103-126-000 Pin Collet Instructions for Use Ref F July 2016

Pin Collet 4103-126-000

Instructions For Use

ENGLISH (EN) ESPAÑOL (ES) DEUTSCH (DE) FRANÇAIS (FR) ITALIANO (IT) NEDERLANDS (NL) SVENSKA (SV) DANSK (DA) 2016-07

SUOMI (FI) PORTUGUÊS (PT) POLSKI (PL) ΕΛΛΗΝΙΚΑ (EL) 日本語 (JA) 中文 (ZH) 한국어 (KO) 4103-126-702 Rev-F

Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM

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EN

4103-126-702 Rev-F

Introduction

Indications for Use

This instructions for use manual contains information intended to ensure the safe, effective and compliant use of your product. Keep and consult this reference manual during the life of the product. This manual is intended for in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information. For additional information, including safety information, in-service training, or current literature, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

See the instructions for use supplied with the handpiece.

Contraindications None known.

For Use With DESCRIPTION

REF

System 4 Rotary Handpiece

4103-000-000

System 5 Rotary Handpiece

4203-000-000

Dual Trigger Rotary Handpiece

4205-000-000

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Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM

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4103-126-702 Rev-F

User/Patient Safety

EN

Accessories

WARNINGS: • Before using this equipment, or any component compatible with this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use. • Only healthcare professionals trained and experienced in the use of this medical device should operate this equipment. • Upon initial receipt and before each use, operate the equipment and inspect each component for damage. DO NOT use any component if damage is apparent. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the care instructions manual supplied with the handpiece. • 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.

WARNINGS: • Use only Stryker-approved components and accessories unless otherwise specified. DO NOT modify any component or accessory. • DO NOT reuse, reprocess, or repackage a device that is intended for single use only. Failure to comply may lead to infection or cross-infection and result in patient and/or healthcare staff injury. See the instructions for use supplied with the handpiece.

Definitions The symbols located on the equipment and/or labeling are defined in this section and/or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment.

S

Small Diameter Pins

0.079-0.102 inch [2.0-2.6 mm]

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Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM

L

Large Diameter Pins

0.106-0.126 inch [2.7-3.2 mm]

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EN

4103-126-702 Rev-F

Features

Instructions WARNINGS: D

E C

A B

• ALWAYS place the handpiece in the SAFE mode while the handpiece is idle, before installing or removing any accessory or attachment, or when passing the handpiece to another person. • DO NOT attempt to insert or remove any cutting accessory or attachment while the handpiece is operating.

To Install the Attachment See the instructions for use supplied with the handpiece.

To Insert the Pin A

Pre-adjust Knob – Used to prepare the collet to accept the correct pin diameter size.

B

Knob Pin Holes (2) – Used to receive the knob pin.

C

Knob Pin – Used to insert into either the small or large pre-adjust knob pin hole.

D

Nose – Allows the insertion of the pin into the collet.

E

Clamping Lever – Used to clamp or grasp the pin before insertion or removal.

1. Set the pre-adjust knob for a small (S) or large (L) pin diameter range by pulling and rotating the knob until S aligns with S or L aligns with L, respectively. NOTE: Make sure the knob retracts and locks in place when the symbols align.

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Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM

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4103-126-702 Rev-F

2. Insert the pin into the nose of the collet or into the back cap of the handpiece until the desired length pin extends from the nose. NOTE: Make sure the pin extends far enough through the collet to allow the collet to hold the pin before squeezing the clamping lever. 3. Remove the handpiece from the SAFE mode to allow rotary drill operation. 4. Place the handpiece trigger in the FORWARD orientation as required. 5. Squeeze the clamping lever against the handpiece handle to grasp pin. 6. Hold the pin against the bone. Press the FORWARD handpiece trigger to drive the pin into the bone. 7. To obtain additional pin length perform the following steps. 7. 1. Release the clamping lever of the collet. 7. 2. Pull the handpiece back from the bone to allow more pin length between the handpiece and bone. 7. 3. Squeeze the clamping lever to grasp the pin. 7. 4. Press the FORWARD handpiece trigger to drive the pin into the bone.

EN

To Remove the Pin 1. Place the handpiece trigger in the REVERSE orientation as required. 2. Squeeze the clamping lever to grasp the pin. 3. Pulling the handpiece and pin away from the bone, press the REVERSE handpiece trigger to remove the pin from the bone.

To Remove the Attachment See the instructions for use supplied with the handpiece.

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

Troubleshooting See the instructions for use supplied with the handpiece.

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Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM

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Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM

Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM

Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210 2016-07

4103-126-702 Rev-F

Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM

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Signature History Report Version

Signature

Role

Event Date

Vote

F

Mehrotra Abhishek

CA_Owner

2016-06-22 09:04:08 EDT

Continue

F

Pearson, Dawn

Editor

2016-07-20 11:09:08 EDT

Continue

F

Mehrotra Abhishek

CA_Owner

2016-07-20 12:12:10 EDT

Continue

F

Unger, Lauren

CA_Marketing Manager

2016-07-20 12:44:23 EDT

Approve

F

Sidow, Brian

CA_Clinical Sciences 2016-07-20 12:57:37 EDT

Approve

F

Brown Donna

CA_Product Safety

2016-07-20 18:10:15 EDT

Approve

F

Raghu Varun

CA_Product Design Engineer

2016-07-21 08:49:01 EDT

Approve

F

Modi Karankumar

CA_Regulatory Affairs

2016-07-21 14:29:07 EDT

Approve

F

Wippich, Caitlin

CA_Quality Engineer

2016-07-21 17:19:03 EDT

Approve

F

Snell, Tami

Document Control

2016-07-22 08:19:56 EDT

Complete

F

Schrauben Haley

Editor

2016-08-30 11:11:44 EDT

Continue

F

Mehrotra Abhishek

CA_Owner

2016-09-20 15:44:26 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

CN140178

CA Number

CA165528

NPD Disposition Plan

Print Date: Sep 21, 2016 02:12:36 PM 0000000958, Rev. F Effective Date: Sep 21, 2016 11:14:29 AM