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
i
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

1
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.

2
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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3
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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4
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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5
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).

6
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.

7
1.8 Symbol Definitions
1.8.1 Product Symbols
1.8.2 Warnings and Information Symbols
Handpiece direction selection
button (forward, reverse,
oscillate). Will also convert to
Speed Increase button (see step
4, “2.1.1 Handpiece
Descriptions” for more
information).
Indicates blade collet
unlock position
Handpiece ON/OFF button. Will
also convert to Speed Decrease
button (see step 4, “2.1.1
Handpiece Descriptions” for
more information).
Suction ON/OFF
Catalog Number Serial Number
Manufacturer Date of Manufacture
Consult Instructions for Use
Refer to Instruction Manual/
Booklet (for critical safety
instruction)
Caution DEHP Symbol
Authorized Representative
in the European Community CE Mark of Conformity
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
U
N
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K
REF
SN
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EC REP

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Non Sterile Sterile
Sterile - Sterilized Using EO 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
Eye Protection Required Biohazard Risk
Do Not Immerse 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
STERILE
STERILE EO
STERILE R
2
STERILIZE
QTY
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9
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 1-800-237-0169, 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
2.1.1 Handpiece Descriptions
All these handpieces are equipped with sensors that automatically select
the proper speed range for the attached blade or bur. For operating speeds,
please refer to Section “4.0 TECHNICAL SPECIFICATIONS”. The
2-Button Shaver Handpieces (D4240, D9824) are also equipped with a
DIRECTION SELECT button to change between forward, reverse, and
oscillate, and an ON/OFF button to control the handpiece from within the sterile
field.
1. Blade Locking Collet - To insert a blade or bur, align the key on
the blade hub with one of the slots in the collet. Completely push
the hub into the collet to lock it into place. Pull on the blade to
ensure it is locked. To remove the blade, rotate and hold the collet in the
“UNLOCK” direction and remove the blade.
2. Suction Port Valve - Manually controls suction flow. Move towards the
front of the handpiece to open, or increase flow. Move towards the back of
the handpiece to restrict or stop flow. To attain maximum performance while
resecting tissue or bone, the suction port valve must be in the fully open
position.
3. Suction Port - Connects to the suction line for aspiration.
4. DIRECTION SELECT Button - Press and release to select the
direction of blade rotation between forward, reverse and oscillate.
5. ON/OFF Button - Turns handpiece on or off.
D4200: No Button Shaver Shown D4240: 2- Button Shaver Shown
123123
45
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2.1.2 Shaver Blades, Bur Description
1. Cutting tip.
2. Shaver blade/bur hub- connects to the shaver handpiece.
3. Alignment key.
2.2 Assembly/Installation Instructions
2.2.1 Shaver Blade Installation and Removal
To insert a shaver blade or bur:
1. Align the key on the blade hub with one of the slots in the collet.
2. Completely push the hub into the collet to lock it into place.
3. Pull on the blade to ensure it is locked.
To remove the blade or bur:
1. Rotate and hold the collet in the “UNLOCK” direction.
2. Remove the blade.
3
2
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12
2.3 Operating Instructions
To control the suction flow rate, move the suction port valve towards the front
of the handpiece to increase flow and move the suction port valve towards the
back of the handpiece to restrict or stop flow. To attain maximum performance
while resecting tissue or bone, the suction port valve must be in the fully open
position.
These shaver handpieces can be operated using a footswitch or the control
buttons on the handpiece. For the footswitch operating instructions, please refer
to the surgical console instruction manual.
For shaver handpiece operation using the buttons on the handpiece (D4240 and
D9824):
Press and release to turn the shaver handpiece on and off.
Controlling window indexing using the buttons: The following operation
applies only when the handpiece is NOT running. When the handpiece ON/
OFF button is pressed and held, the console beeps once and the blade window
starts to rotate (index) slowly at 6 rpm. When the window position of the blade
is found (generally window completely open or window completely shut),
release the ON/OFF button. The handpiece will return the blade window to this
location when it is stopped.
Controlling speed using the buttons: The following operation applies only when
the handpiece is NOT running. When the handpiece DIRECTION SELECT
button is held for 1.5 seconds, the console beeps twice. Then the handpiece
DIRECTION SELECT button changes to the Increase Speed button. The ON/
OFF button changes to the Decrease Speed button. This enables the surgeon to
change the handpiece operating speed from the sterile field. If no button is
pressed for 1.5 seconds, the console beeps twice and returns to normal button
functionality.
Turbo Mode Using Ultra Series Shaver Blades and D4000/D4000A Drive
Console with console software revision V 2.0 or higher: The following applies to
the D9824, and D4240 Shaver handpieces and only when it is actively running in
oscillate mode. When the ON/OFF button is pressed and held for approximately
1 second, the handpiece will run in the preset forward mode for as long as the
ON/OFF button is held down. Release the ON/OFF button and the handpiece
will resume running in the oscillate mode. When the DIRECTION SELECT
button is pressed and held for approximately 1 second, the handpiece will run in
the preset reverse mode for as long as the DIRECTION SELECT button is held
down. Release the DIRECTION SELECT button and the handpiece will resume
running in the oscillate mode.

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2.4 Preoperative Functional Test
Prior to each use, perform the following preoperative functional test:
1. Insert a bur or blade into the handpiece. Gently pull on the cutting acces-
sory to ensure it is properly seated.
2. Verify that the console properly recognizes the handpiece and cutting accessory.
3. Press the direction select button or footswitch to ensure that it functions properly.
4. Run the handpiece for less than 5 seconds at a speed less than 1500 rpm to
observe any abnormal noises, vibrations or heat rise.
5. If any operating difficulties occur, return the handpiece for service.

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3.0 MAINTENANCE
3.1 Cleaning Information
3.1.1 Warnings, Precautions and Notes
1. Follow universal precautions for protective apparel when handling
and cleaning contaminated instruments.
2. Clean instruments within 30 minutes after use to minimize the potential of
blood and debris drying.
3. Never clean equipment in an ultrasonic cleaner.
4. Always disconnect the handpiece cord prior to cleaning.
5. Always detach accessories from equipment prior to cleaning.
6. Never clean handpieces with bleach, chlorine-based detergents, liquid or
chemical disinfectants, or any products containing sodium hydroxide (such
as, INSTRU-KLENZ or Buell Cleaner). These products degrade the
anodized aluminum coating and may result in reduced handpiece reliability.
7. For aluminum surfaces, a neutral-pH agent should be used. To prevent
corrosion, avoid contact with strong alkaline solutions (pH over 10.5) or
agents containing iodine or chlorine. Follow universal precautions for
protective apparel when handling and cleaning contaminated instruments.
8. Prior to using a washer/sanitizer, consult product labeling on all
washer/sanitizer cleaning solutions for compatibility with aluminum. Use
of a washer/sanitizer may decrease the life expectancy of the handpiece.
Refer also to section “1.5 Warnings and Precautions” and section.
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3.1.2 Manual Cleaning Instructions
1. Thoroughly scrub the handpiece and attachments with a clean, soft brush
dampened, not saturated, with a mild, pH-balanced detergent. Remove all
traces of blood, debris, and stains.
2. Place the suction control valve in the fully open position. Clean the suction
tube thoroughly with a cleaning brush until all debris is removed.
3. Using a low-velocity spray of water, spray into the collet. Ensure the collet
operates smoothly and that no debris is binding the internal mechanism of
the collet. Clean until all debris is removed.
4. To clean the cannulated section of the handpiece and attachment, feed the
wire end of a cleaning brush through the cannulation of the handpiece or
attachment. Pull the brush completely through and repeat until all debris is
removed.
5. Manipulate all moving parts of the handpiece to ensure all debris is removed.
If not, clean again until all debris is removed.
6. Keeping the nose of the handpiece pointed downward, rinse under running
water to remove all traces of soap. Rinse all attachments in the same manner.
7. Flush the surfaces free of tap water with distilled water to prevent metal
discoloration.
8. Gently shake the equipment free of water and wipe the surfaces with a clean,
lint-free towel.
9. Visually inspection handpiece and accessories under good light conditions to
check for visible soil and/or corrosion.
10. Perform functional checks according to section “2.4 Preoperative
Functional Test”. Check mating accessories closely for proper assembly.
11. Remove and repair any damaged equipment. Repeat Manual Cleaning
Instructions as necessary.

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3.2 Sterilization Information
3.2.1 Warnings, Precautions and Notes
1. The use of disinfecting solutions for an exterior instrument wipe
will not sterilize the equipment and is not recommended.
2. Do not sterilize equipment or accessories using Ethylene Oxide (EtO).
3. Do not sterilize equipment or accessories using a STERIS system or by
comparable sterilization methods.
4. Do not sterilize equipment or accessories in cold sterilants like CIDEX.
5. Always detach accessories from equipment prior to sterilization.
6. Do not use equipment while warm. Allow adequate time for cooling prior
to use. Cool by exposure to room temperature. Operation of equipment
that is not completely cool or dry may decrease performance and/or
reliability.
7. When sterilizing equipment and attachments in a system sterilization tray,
use the recommended sterilization parameters in its instruction manual.
8. Do not “Peel Pack” handpieces for sterilization. Sterilization in a sealed
pouch traps moisture which can cause damage.
9. The suction control valve, if one exists, must be in the fully open position
during sterilization.
10. Attachments with collet mechanisms must be sterilized with the collet
fully open.
11. An eight (8) minute minimum dry cycle must be run on all equipment and
attachments every time the product is sterilized. Failure to use a dry cycle
on the products may lead to reduced product performance or premature
product failure.
Refer also to section “1.5 Warnings and Precautions”.
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