ConMed Linvatec D4240 User manual

ConMed Linvatec Shaver Handpieces
D4200/D9820
D4240/D9824

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, Advantage, PowerPro, E9000 and Ergo are trademarks
or registered trademarks of Linvatec Corporation.
Linvatec Corporation 2014. All Rights Reserved.

Table of Contents Page
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1.0 INTRODUCTION
1.1 Operating Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2 Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.3 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.4 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.5 Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.5.1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.5.2 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1.6 Environmental Directives . . . . . . . . . . . . . . . . . . . . . . . . . .6
1.7 Product Photographs and Drawings . . . . . . . . . . . . . . . . . . 6
1.8 Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.8.1 Product Symbols . . . . . . . . . . . . . . . . . . . . . . . . . .7
1.8.2 Warnings and Information Symbols . . . . . . . . . . .7
2.0 SYSTEM INSTALLATION AND OPERATION
2.1 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
2.1.1 Handpiece Descriptions . . . . . . . . . . . . . . . . . . .10
2.1.2 Shaver Blades, Bur Description . . . . . . . . . . . . .11
2.2 Assembly/Installation Instructions . . . . . . . . . . . . . . . . . . 11
2.2.1 Shaver Blade Installation and Removal . . . . . . .11
2.3 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
2.4 Preoperative Functional Test . . . . . . . . . . . . . . . . . . . . . . .13
3.0 MAINTENANCE
3.1 Cleaning Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
3.1.1 Warnings, Precautions and Notes . . . . . . . . . . . .14
3.1.2 Manual Cleaning Instructions . . . . . . . . . . . . . . .15
3.2 Sterilization Information . . . . . . . . . . . . . . . . . . . . . . . . . .16

Table of Contents Page
ii
3.2.1 Warnings, Precautions and Notes . . . . . . . . . . . .16
3.2.2 Sterilization Instructions . . . . . . . . . . . . . . . . . . .17
3.3 Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
3.4 Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
4.0 TECHNICAL SPECIFICATIONS
4.1 Product Technical Specifications. . . . . . . . . . . . . . . . . . . .20
4.1.1 Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
4.2 Product Environmental Requirements. . . . . . . . . . . . . . . .22
4.2.1 Environmental Technical Specifications. . . . . . .22
4.2.2 Electromagnetic Requirements . . . . . . . . . . . . . .22
4.3 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
5.0 CUSTOMER SERVICE
5.1 Assistance and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

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1.0 INTRODUCTION
It is recommended that personnel study this manual before attempting
to operate, clean, or sterilize this or associated equipment. 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 “3.4 Maintenance
Schedule”, are required to keep the equipment at its optimum operating
performance.
1.1 Operating Principle
The shaver handpiece is electrically powered by the surgical console to provide
high speed, rotary force to the accessory (shaver blade, shaver bur or
attachment) for tissue resection. The shaver handpiece is controlled by
operating buttons on the handpiece or using a footswitch. A suction source is
connected to the shaver handpiece to draw tissue into the shaver blade and
remove tissue from the surgical site.
Consult the associated ConMed Linvatec surgical console instruction manual
prior to operating this equipment.
1.2 Indications for Use
The D9820/D9824 Shaver Handpieces, and their accessories perform cutting of
soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand,
and Orthopedic surgical procedures.
The D4200/D4240 Shaver Handpieces, and their accessories perform cutting of
soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand,
Orthopedic, and Otolaryngological surgical procedures.
1.3 Intended Use
Same as Indications for Use above.

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1.4 Contraindications
None
1.5 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 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.
1.5.1 Warnings
1. Eye protection is recommended when operating equipment. Eye
injury may result.
2. It is the surgeon's responsibility to be familiar with the appropriate
surgical techniques prior to use of the equipment and its associated
accessories.
3. Do not use equipment if, upon receipt, package is opened,
damaged, or shows any signs of tampering.
4. 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.
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5. Do not use sterile equipment beyond the expiration date listed on the label.
Sterility of the product cannot be assured beyond the expiration date.
6. Do not excessively bend or kink the handpiece cord. Always inspect
cords for signs of excessive wear or damage, or bent, broken or missing
pins within the connector(s). If any wear or damage is found, discontinue
use and replace handpiece immediately. Using a damaged power cord
could possibly cause injury.
7. Handpieces are supplied non-sterile. Clean and sterilize prior to
each use.
8. Do not contact the moving parts on the handpieces. Injury to the
operator may occur.
9. Continually check handpiece for overheating. If overheating is sensed,
immediately discontinue use and return equipment for service.
Overheating of the blade or bur may cause damage to the blade or bur and
may cause burns or thermal necrosis.
10. While handpiece is not in use do not place on patient/surgical drapes.
Place handpiece on mayo stand.
11. Do not immerse the equipment in fluids. Immersion may render
the device inoperable.
12. Failure to follow the specified service interval could result in
reduced instrument performance or overheating of the handpiece.
Overheating can lead to possible burn injury to the patient or
medical personnel. Rotation of handpiece usage per day will assist with
proper performance. (Refer to section “3.4 Maintenance Schedule”).
13. Do not attach, insert or remove accessories or attachments while the
handpiece is operating. Injury to the operator and/or damage to the
equipment may occur. Place the handpiece safety mechanism in the
“safe” position prior to installation or removal of items.
14. Avoid contact with cutting tip of blade or bur when locking into
handpiece. Tips are sharp and may cause injury.
15. After use blades, burs and tubing sets may be a potential biohazard
and should be handled and disposed in accordance with acceptable
medical practice and applicable local and national requirements.
16. Do not use burs for plunge cutting. Injury or damage may occur.
17. Disposable blades and burs are supplied sterile and are for single-
use only. Do not resterilize or reuse. The ability to effectively clean
and re-sterilize these single use devices has not been established and
subsequent re-use may adversely affect the performance, safety and/or
sterility of the devices.
18. Do not use shaver blade or bur if they show any signs of damage.
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1.5.2 Precautions
1. United States Federal law restricts sale of this device to or on
the order of a physician.
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 and accessories.
Using unapproved accessories may result in improper operation, and may
result in non-compliance 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.
7. Prior to each use, perform the following:
• Ensure all accessories are correctly and completely attached. (Refer to
section “2.2 Assembly/Installation Instructions”).
• Perform the required Preoperative Functional Tests for the equipment and
accessories. (Refer to section “2.4 Preoperative Functional Test”).
8. Clean and sterilize all the equipment and associated accessories according to
instructions for use. (Refer to section “3.1 Cleaning Information” and
section “3.2 Sterilization Information”).
9. Handpieces are factory sealed. Do not disassemble or lubricate, as
this may void the warranty.
10. Always inspect for bent, dull or damaged blades or burs before
each use. Do not attempt to straighten or sharpen. Do not use if damaged.
11. After each use, thoroughly clean the handpiece, attachments and
accessories. (Refer to Section “3.0 MAINTENANCE”).
12. Do not stall handpieces, damage can occur.
13. Do not handle the handpiece by the cord. Do not pull on the cord to
remove it from the surgical console. Damage can occur.
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14. Running the shaver blade or bur without fluid flow (dry) may cause damage
to the handpiece or may cause the bur hubs to melt due to excessive heat.
15. Running standard shaver blades above 6,000 rpm may generate excessive
particulate. Only Ultra Series shaver blades are intended to run 12,000 rpm
maximum speed.
16. Direct contact of the rotating cutting edge of shaver blades and burs with
metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas,
or other instruments can cause damage to the devices. If contact does occur,
shaver blades can break, seize, or shed metal particles. Shaver blade or bur
should be examined for damage and replaced if necessary.
17. Do not apply excessive loading on the shaver blade or bur. Cutting
performance is not increased with force. Excessive force or using shaver
blades or burs as a lever can cause damage to the device including
permanent deformation, shedding of metal (wear), motor seizure, and
overheating.
18. If shaver blade clogs, use ConMed Linvatec Declogger (E9315) to declog
shaver blade. Shaver blades or burs may also be declogged by removing the
inner assembly of the shaver blade from the outer assembly and clearing any
tissue from the window or aspiration hole. DO NOT disassemble Prebent
Shaver Blades with catalog number ending in “M” or “MT” (i.e., C9299M
and 42ULT-ZZ-MT).

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1.6 Environmental Directives
WEEE Directive [2002/96/EC] on Waste Electrical and Electronic
Equipment. This statement only applies to European countries with
regard to the Waste Electrical and Electric Equipment (WEEE)
European Directive.
The WEEE symbol on the product or its packaging indicates that this product
must not be disposed of with other waste. Instead, it is your responsibility to
dispose of your waste equipment by handing it over to a designated collection
point for the recycling of Waste Electrical and Electronic Equipment. The
separate collection and recycling of your waste equipment at the time of
disposal will help conserve natural resources and ensure that it is recycled in a
manner that protects human health and the environment. For more information
about where you can drop off your medical equipment at the end of its useful
life for recycling, please contact ConMed Linvatec.
1.7 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.