The Hall PowerPro Attachment Instruction Manual

Proprietary Information This manual contains information deemed proprietary to Linvatec Corporation. The information contained herein, including all of the designs and related materials, is the sole property of ConMed Linvatec and/or its licensors. ConMed Linvatec and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of ConMed Linvatec. ConMed Linvatec reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law.

Linvatec, Hall, PowerPro, PowerProMax, MPower and MPower 2 are trademarks or registered trademarks of Linvatec Corporation.

© Linvatec Corporation 2012, 2014, 2016. All Rights Reserved.

Record the Model and Serial Numbers of all attachments, and date received. Retain for future reference. Attachment Model No.

Serial No

Date

Attachment Model No.

Serial No

Date

Attachment Model No.

Serial No

Date

Attachment Model No.

Serial No

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Attachment Model No.

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Attachment Model No.

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Table of Contents

1.0

2.0

Page

INTRODUCTION 1.1

Intended Use... 1

1.2

Warnings and Precautions... 1 1.2.1

Warnings... 2

1.2.2

Precautions... 2

1.3

Product Photographs and Drawings... 3

1.4

Symbol Definitions... 4 1.4.1

Product Symbols... 4

1.4.2

Warnings and Information Symbols... 4

SYSTEM INSTALLATION AND OPERATION 2.1

Product Description... 6

2.2

Assembly/Installation Instructions... 8

2.3

Radiolucent Drive Adaptor (PRO2514)... 8

2.4

Reaming Attachments... 9 2.4.1

AO Reamer (PRO2040)... 9

2.4.2

AO Reamer (PRO6040)... 10

2.4.3

Aesculap Reamer (PRO2060)... 10

2.4.4

Aesculap Reamer (PRO6060)... 11

2.4.5

Zimmer/Hudson Reamer (PRO2047)... 11

2.4.6

Zimmer/Hudson Reamer (PRO6047)... 12

2.4.7

Hudson Reamer (PRO2065)... 12

2.4.8

Hudson Reamer (PRO6048)... 13

2.4.9

Trinkle Reamer (PRO2329)... 13

2.4.10 DHS Reamer (PRO2080)... 14

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Table of Contents

2.5

2.6

2.7

2.8

2.9

Page

Drilling Attachments... 14 2.5.1

Zimmer/Hudson Drill (PRO2046)... 14

2.5.2

Standard Hudson Drill (PRO2075)... 15

2.5.3

AO Drill (PRO2070)... 15

2.5.4

AO Small Attachment (PRO2038)... 15

2.5.5

AO Drilling Attachment (PRO2138)... 16

2.5.6

Trinkle/AO Attachment (PRO2029)... 16

2.5.7

Mini AO Drill (PRO2039)... 18

Chucks... 18 2.6.1

5/32" (4.0 mm) Chuck (PRO2030)... 19

2.6.2

1/4" (6.5 mm) Chuck (PRO2041)... 19

2.6.3

1/4" (6.5 mm) High Torque Chuck (PRO2042)... 20

2.6.4

1/4" (6.5 mm) High Torque Chuck (PRO6042)... 20

Keyless Chuck... 21 2.7.1

1/8" (3.175 mm) Keyless Chuck (PRO6050)... 21

2.7.2

1/4" (6.5 mm) Keyless Chuck (PRO2250)... 21

Drill/Ream Attachments... 22 2.8.1

AO Drill/Ream (PRO1540)... 22

2.8.2

1/4" Chuck Drill/Ream (PRO1541)... 23

2.8.3

Zimmer/Hudson Drill/Ream (PRO1547)... 23

2.8.4

DePuy/Hudson Drill/Ream (PRO1548)... 24

Wire and Pin Driving Attachments... 24 2.9.1

Wire Drivers... 25

2.9.2

Pin Drivers... 26

2.10 Insertion of Wires and Pins (PRO2028 and PRO2032)... 26 2.11 Insertion of Wires and Pins - Other Models... 27

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Table of Contents

Page

2.12 Sawing Attachments... 28 2.12.1 Sagittal Saw Attachment (PRO2043)... 29 2.12.2 Reciprocating Saw Attachment (PRO2045/PRO6045)... 30 2.13 High Speed Drill Attachment (PRO2033)... 32 2.14 PowerPro PRO7020 Attachment... 34 2.14.1 Installation Instructions... 34 2.14.2 Installing Bur Guards and Extensions (Series 7020-010 thru 7020-016) . . . 35

3.0

4.0

MAINTENANCE 3.1

Maintenance Schedule... 37

3.2

Accessories... 39

CUSTOMER SERVICE 4.1

Assistance and Repair... 42

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Table of Contents

Page

iv

1.0

INTRODUCTION

It is recommended that personnel study this manual before attempting to operate Hall® PowerPro® attachments. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices and instructions marked on the product and included in this manual. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Service intervals, as listed in section “3.0 MAINTENANCE”, are required to keep the equipment at its optimum operating performance.

1.1 Intended Use PowerPro attachments are used in conjunction with PowerPro, PowerProMax™, MPower® and MPower® 2 handpieces to perform bone cutting, reaming, drilling, driving screws and sawing. Most drilling, reaming and sawing attachments are interchangeable between the battery, pneumatic, and electrically operated PowerPro, PowerProMax, MPower and MPower 2 handpieces, with the exception of the PRO2045 Reciprocating Saw attachment, and pin and wire drivers. Pin and wire drivers are designated for specific handpieces. Refer to section “2.9 Wire and Pin Driving Attachments” for proper pin and wire driver selection. The fields of application for the attachments used with the associated PowerPro, PowerProMax, MPower and MPower 2 handpieces include: Orthopedic, Osteotomy, Total Joint Arthroplasty, Trauma and Medial Sternotomy procedures.

1.2 Warnings and Precautions Do not bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient. The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. WARNING: A warning contains critical information regarding serious adverse reactions and potential safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a warning may result in injury, death or other serious adverse reactions to the patient and/or surgical staff. PRECAUTION: A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective use of the equipment. Failure to observe the information or procedures presented in a precaution may result in damage to the equipment. NOTE: A note is added to provide additional focused information. This information has no critical effect on the patient or equipment.

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1.2.1 Warnings 1. 2. 3. 4. 5. 6. 7. 8. 9.

Eye protection is recommended when operating equipment. Eye injury may result. It is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories. Do not use equipment if, upon receipt, package is opened, damaged or shows any signs of tampering. Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions or any material susceptible to ignition due to electrical sparking. Continually check all handpieces and attachments for overheating. If overheating is sensed, immediately discontinue use and return equipment for service. Overheating of the bur, bit or blade may cause damage to the bur, bit or blade and may cause thermal necrosis. Do not attach, insert or remove accessories or attachments while the handpiece is operating. Serious injury may occur. Place the handpiece safety mechanism to the SAFE position prior to installation or removal of items. Do not use the High Speed Drill attachment without the appropriate bur guard and a bur of the proper length. The tip of the bur guard should cover the safe line on the bur shaft. Without the stabilization that the proper guard provides, the bur can break and be propelled with great force. Do not use burs for plunge cutting. Tissue damage or injury may occur. When using the PRO2043 Sagittal Saw attachment, placing excessive bending force on the sagittal saw blade may cause the collet to open and release the saw blade. Do not use saw blades to pry, remove bone grafts or as a leverage point. Patient or user injury could occur.

1.2.2 Precautions 1.

United States Federal law restricts sale of this device to or on the order of a physician.

Rx ONLY

2. This device should only be used in compliance with its intended use. 3. Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately for service. 4. Use only associated ConMed Linvatec approved equipment, attachments and accessories. They have been tested and certified to specific medical standards. Using unapproved accessories may result in improper operation, may negatively affect EMC performance and may result in noncompliance to medical standards. 5. The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: • The device or the accessories are improperly used, prepared or maintained; • The instructions in the manual are not adhered to; • Non-authorized persons perform repairs, adjustments or alterations to the device or accessories. 6. There are no user-serviceable parts inside. No modification of this equipment is allowed. 2

7. Prior to each use, perform the following: • Ensure all accessories are correctly and completely attached. Refer to section “2.2 Assembly/ Installation Instructions”. •Always inspect for bent, dull or damaged blades or drill bits before each use. Do not attempt to straighten or sharpen. Do not use if damaged. After use, dispose of properly. •Reaming attachments and saw attachments (Reciprocating Saw - PRO2045/PRO6045, Sagittal Saw - PRO2043) are not designed to be used in any screw, tap or oscillate modes. Operate only in the drill mode. •The PRO2045 Reciprocating Saw attachment can ONLY be used on PowerProMax Battery “Modular” handpieces and the PowerPro discontinued PRO2200E Electric Two-trigger “Modular” handpiece. 8. Handpieces are factory sealed. Do not disassemble or lubricate, as this may void the warranty. 9. Clean and sterilize attachments and associated accessories according to instructions for use. Refer to the attachments inserts.

1.3 Product Photographs and Drawings The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.

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1.4 Symbol Definitions 1.4.1 Product Symbols DRILL

Indicates the attachment is set in the drill mode for speeds and torques suitable for drilling operations

REAM

Indicates the attachment is set in the ream mode for speeds and torques suitable for reaming operations

1.4.2 Warnings and Information Symbols

Catalog Number

Serial Number

Manufacturer

Date of Manufacture

Consult Instructions for Use

Refer to Instruction Manual/ Booklet (for critical safety instruction). The color is blue.

Caution

DEHP Symbol

EC REP

Authorized Representative in the European Community

Rx ONLY

Prescription Only: Federal Law restricts this device to sale by or on the order of a physician

No User Service Recommended. Refer servicing to qualified ConMed Linvatec service personnel

Non Sterile

Sterile

STERILE EO

CE Mark of Conformity

2797

Sterile - Sterilized Using EO

STERILE

R

Sterile - Sterilized Using Irradiation

Do Not Steam Sterilize

Do Not Sterilize

Do Not Resterilize

Do Not Reuse (for Single Use Only)

Do Not Use Oil

Do Not Use for Plunge Cutting

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Eye Protection Required

Biohazard Risk

Do Not Immerse

QTY

Quantity

Type B Applied Part

Type BF Applied Part

UL Classification Mark

UL Recognized Components

Rating Fuse

Fuse Location

Alternating Current

Protective Earth Ground

Equipotentiality (Equipment Potential)

Non-Ionizing Electromagnetic Radiation (RF Symbol)

Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Use by Date

Fragile

This Side Up

Do Not Use if Package is Damaged

Keep Dry

Warning: Corrosive Substance

Warning: Electrical Hazard/High Voltage

Waste Electrical and Electronic Equipment (WEEE) Symbol. Regarding European Union end-of-life of product, indicating separate collection for electrical and electronic equipment Recycle. Batteries contain materials which must be recycled or disposed of properly. The disposal of batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-866-426-6633, or outside the U.S. contact your local ConMed Linvatec representative for additional information on battery disposal or recycling.

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2.0

SYSTEM INSTALLATION AND OPERATION

2.1 Product Description PowerPro attachments are interchangeable between all battery, pneumatic, and electrically operated PowerPro, PowerProMax, MPower and MPower 2 “Modular” handpieces, with the exception of the PRO2045 Reciprocating Saw attachment, and pin and wire drivers, and are color coded by function for easy identification. The PRO2045 Reciprocating Saw attachment can ONLY be used on PowerProMax Battery “Modular” handpieces and the PowerPro discontinued PRO2200E Electric Two-trigger “Modular” handpiece. • Reciprocating Saw Attachment (PRO2045) for use with PRO5100M, PRO5200M and PRO5250M PowerProMax Battery “Modular” handpieces and the PowerPro discontinued PRO2200E Electric Two-trigger “Modular” handpiece • Reciprocating Saw Attachment (PRO6045) for use with all MPower, MPower 2, PowerPro Electric II, and PowerPro Pneumatic “Modular” handpieces • Sagittal Saw (PRO2043) • AO Small Attachment - (PRO2038) • AO Drilling Attachment (PRO2138) • Trinkle/AO (PRO2029) • Mini/AO Drill (PRO2039) • Zimmer/Hudson Drill (PRO2046) • Standard Hudson Drill (PRO2075) • AO Drill (PRO2070) • AO Reamer (PRO2040) • AO Drill/Ream Attachment 1:1/5:1 Ratios (PRO1540) • AO/ASIF Reamer 5:1 Ratio (PRO6040) • Aesculap Reamer (PRO2060) • Aesculap Reamer 5:1 Ratio (PRO6060) • Zimmer/Hudson Reamer (PRO2047) • Zimmer/Hudson Reamer 5:1 Ratio (PRO6047) • Zimmer/Hudson Drill/Ream Attachment 1:1/5:1 Ratios (PRO1547) • Hudson Reamer (PRO2065) • Hudson Reamer 5:1 Ratio (PRO6048) • DePuy/Hudson Drill/Ream Attachment 1:1/5:1 Ratios (PRO1548) 6

• Trinkle Reamer (PRO2329) • DHS Reamer (PRO2080) • 1/8" (3.175 mm) Keyless Chuck (PRO6050) • 1/4"(6.5 mm) Keyless Chuck (PRO2250) • 5/32" (4.0 mm) Chuck (PRO2030) • 1/4"(6.5 mm) Chuck (PRO2041) • 1/4"(6.5 mm) High Torque Chuck (PRO2042) • 1/4"(6.5 mm) High Torque Chuck, 5:1 Ratio (PRO6042) • 1/4"(6.5 mm) High Torque Chuck 1:1/5:1 Ratios (PRO1541) • Radiolucent Drive Adapter Attachment (PRO2514) • High Speed Drill Attachment (PRO2033) • Multi-Purpose High Speed Drill Attachment (PRO7020) • Wire Driver (PRO5128) for use with the PRO5100M PowerProMax Battery handpiece • Wire Driver (PRO5228) for use with the PRO5200M or PRO5250M PowerProMax handpieces • Wire Driver (PRO2028) for use with the PowerPro discontinued PRO2200E Electric Two-trigger “Modular” handpiece • Wire Driver (PRO6128) for use with the PRO6100 PowerPro Electric II, PRO6150 PowerPro Pneumatic, PRO6200 MPower and PRO6200M MPower 2 “Modular” handpieces • Wire Driver (PRO6228) for use with the PRO6202 or PRO6212MPower and PRO6202M or PRO6212M MPower 2 Battery “Modular” handpieces • Pin Driver (PRO5132/PRO5132-4) for use with the PRO5100M PowerProMax Battery “Modular” handpiece • Pin Driver (PRO5232/PRO5232-4) for use with the PRO5200M or the PRO5250M PowerProMax Battery “Modular” handpieces • Pin Driver (PRO2032) for use with the PowerPro discontinued PRO2200E Electric Two-trigger “Modular” handpiece • Pin Driver (PRO6132/PRO6132-4) for use with the PRO6100 PowerPro Electric II, PRO6150 PowerPro Pneumatic, PRO6200 MPower and PRO6200M MPower 2 “Modular” handpieces • Pin Driver (PRO6232/PRO6232-4) for use with the PRO6202 or PRO6212 MPower and PRO6202M or PRO6212M MPower 2 Battery “Modular” handpieces • Pin Driver (PRO6140) custom option available upon request, for use with PRO6100 PowerPro Electric II, PRO6150 PowerPro Pneumatic, PRO6200 MPower and PRO6200M MPower 2 “Modular” handpieces • Pin Driver (PRO6240) for use with the PRO6100 PowerPro Electric II, PRO6150 PowerPro Pneumatic, PRO6200 MPower PRO6200M MPower 2 “Modular” handpieces and PRO6202 or PRO6212 MPower and PRO6202M or PRO6212M MPower 2 Battery “Modular” handpieces

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2.2 Assembly/Installation Instructions All attachments for the PowerPro, PowerProMax, MPower and MPower 2 “Modular” handpieces connect/disconnect in the same manner. To connect an attachment: 1. Place the handpiece in the SAFE position. 2. Orient the attachment shaft with the handpiece opening. 3. Insert the shaft and press them until they snap together.

To disconnect an attachment: 1. Twist the attachment collet-lock in the direction of the arrow. 2. Remove the attachment.

2.3 Radiolucent Drive Adaptor (PRO2514)

To attach a radiolucent drive attachment: 1. Place the handpiece in the SAFE position. 2. Slide the radiolucent drive attachment onto the adaptor until it is completely seated against the collar of the adaptor.

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NOTE: Refer to the manufacturer’s instructions on the proper use of the radiolucent drive. PRECAUTION: Do not drive screws or tap holes with this adaptor.

2.4 Reaming Attachments All reaming attachments are geared down to provide higher torque levels for acetabulum and femoral reaming, hip screws or any procedure where high torque is necessary. NOTE: Reaming attachments should only be used in the “Drill” mode and are not indicated to be used in the screw, tap or oscillate modes. To attach accessories to Reamer attachments: 1. Place the handpiece in the SAFE position. 2. Pull the collet sleeve back and insert the accessory shank into the collet. 3. Release the collet sleeve. 4. Gently tug on the accessory shank to verify it is properly seated in the attachment. 2.4.1 AO Reamer (PRO2040)

Specifications: Collet: Accepts large hex AO reamers Cannulation: 5.1 mm Gear Ratio: 3:1 Color Ring: Teal/Red 9

2.4.2 AO Reamer (PRO6040)

Specifications: Collet: Accepts large hex AO reamers Cannulation: 4.0 mm Gear Ratio: 5:1 Color Ring: Teal/Teal 2.4.3 Aesculap Reamer (PRO2060)

Specifications: Collet: Accepts Aesculap Reamers Cannulation: 5.1 mm Gear Ratio: 3:1 Color Ring: Brown/Red

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2.4.4 Aesculap Reamer (PRO6060)

Specifications: Collet: Accepts Aesculap Reamers Cannulation: 4.0 mm Gear Ratio: 5:1 Color Ring: Brown/Brown 2.4.5 Zimmer/Hudson Reamer (PRO2047)

Specifications: Collet: Accepts Zimmer, Hall Series 3®, Hall Series 4® and Hudson accessories Cannulation: 4.2 mm Gear Ratio: 3:1 Color Ring: Blue/Red

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2.4.6 Zimmer/Hudson Reamer (PRO6047)

Specifications: Collet: Accepts Zimmer, Hall Series 3, Hall Series 4 and Hudson accessories Cannulation: 4.0 mm Gear Ratio: 5:1 Color Ring: Blue/Blue 2.4.7 Hudson Reamer (PRO2065)

Specifications: Collet: Accepts Zimmer, Hall Series 3, Hall Series 4 and Hudson accessories Cannulation: 4.2 mm Gear Ratio: 3:1 Color Ring: Orange/Red

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2.4.8 Hudson Reamer (PRO6048)

Specifications: Collet: Accepts Zimmer, Hall Series 3, Hall Series 4 and Hudson accessories Cannulation: 4.0 mm Gear Ratio: 5:1 Color Ring: Orange/Orange 2.4.9 Trinkle Reamer (PRO2329)

Specifications: Collet: Accepts Trinkle type accessories Cannulation: 4.2 mm Gear Ratio: 3:1 Color Ring: Purple/Red

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2.4.10 DHS Reamer (PRO2080)

Specifications: Collet: Accepts Synthes®, DHS® and DCS® reamer accessories Cannulation: 4.2 mm Gear Ratio: 3:1 Color Ring: Green/Red

2.5 Drilling Attachments To attach accessories to Drill and AO attachments: 1. Place the handpiece in the SAFE position. 2. Pull the collet sleeve back and insert the accessory shank into the collet. 3. Release the collet sleeve. 4. Gently tug on the accessory shank to verify it is properly seated in the attachment. 2.5.1 Zimmer/Hudson Drill (PRO2046)

Specifications: Collet: Accepts Zimmer, Hall Series 3, Hall Series 4 and Hudson accessories Cannulation: 4.2 mm Color Ring: Blue

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