ConMed Linvatec Advantage Turbo D9920 User manual

ConMed Linvatec Shaver Handpieces
D9920
D9924
W41-261-004AB.book Page 1 Thursday, September 18, 2014 9:28 AM

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 and E9000 are trademarks or registered trademarks
of Linvatec Corporation.
Linvatec Corporation 2014. All Rights Reserved.
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Table of Contents Page
i
1.0 INTRODUCTION
1.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Operating Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3 Environmental Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.4 Warnings and Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.4.1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.4.2 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.5 Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5.1 Handpiece Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5.2 Warnings and Information Symbols . . . . . . . . . . . . . . . . . 7
1.6 Handpiece Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.7 Preoperative Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.0 CLEANING AND STERILIZING
2.1 Cleaning and Washer/Sanitizer Warnings and Precautions . . . . . 10
3.0 Handpiece Cleaning Instructions
3.1 Manual Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2 Sterilization Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2.1 Warnings, Precautions and Notes . . . . . . . . . . . . . . . . . . 12
4.0 TECHNICAL SPECIFICATIONS
4.1 Service Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.2 Shaver Handpiece Technical Specifications . . . . . . . . . . . . . . . . . 14
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Table of Contents Page
ii
4.3 Handpiece Environmental Requirements . . . . . . . . . . . . . . . . . . . 15
5.0 CUSTOMER SERVICE
5.1 Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
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1
1.0 INTRODUCTION
These shaver handpieces come in two styles; no-button and 2-button functionality.
They work with a variety of ConMed Linvatec shaver blades and burs and all are used
in conjunction with several drive consoles; the Advantage® System (D3000 Series),
E9000® System (E9000 Series), and the PowerPro® System (PRO2000 Series) (all
with software version 7.0 or higher).
These shaver handpieces are reusable and are supplied non-sterile and must
be sterilized prior to the first use and after every use.
1.1 Intended Use
The shaver handpieces are designed to operate ConMed Linvatec shaver blades
and burs for resection of bone and soft tissue in arthroscopic, foot, hand,
orthopedic and otolaryngological surgical procedures.
1.2 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.
1.3 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.
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1.4 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: The safety and/or health of the patient, user, or a third party
is at risk. Comply with this warning to avoid injury to the patient, user, or
third party.
PRECAUTION : This contains information concerning the intended use of
the device or accessory. Damage to the equipment is possible if these
instructions are not followed.
NOTE : A note is added to provide additional focused information.
This equipment is designed for use by medical professionals completely
familiar with the required techniques and instructions for use of the
equipment. It is also recommended that personnel study the Drive System
Instruction Manual that the shaver handpiece(s) will be operated with before
attempting to operate, clean or sterilize any shaver handpiece.
Prior to using the device, read and follow all warning and precautionary notices and
instructions marked on the product and included in this manual.
The service interval, as listed on page 13, is required to keep the equipment at its
optimum operating performance.
!
!
!
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1.4.1 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 shaver handpieces and associated blades and burs.
3. Shaver handpieces are supplied non-sterile, clean and sterilize prior to
first use.
4. Sterilize handpieces prior to each use.
5. Prior to each use, inspect handpiece for proper operation and ensure all
accessories are correctly and completely attached to the handpiece. See
“Preoperative Functional Test” on page 9.
6. Do not attach, insert or remove accessories or attachments while the handpiece
is operating.
7. Disposable shaver 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 this single use device has not
been established and subsequent re-use may adversely affect the performance,
safety and/or sterility of the device.
8. After use, shaver 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.
9. Do not use equipment if, upon receipt, package is opened, damaged, or
shows any signs of tampering.
10. Do not use shaver blade or bur if they show any signs of damage.
11. Do not use sterile equipment beyond the expiration date listed on the label.
Sterility of the product cannot be assured beyond the expiration date.
12. Continually check all handpieces 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 thermal
necrosis.
!
2
STERILIZE
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13. Do not use in the presence of flammable anesthetics, gases, disinfecting
agents, cleaning solutions, or any material susceptible to ignition due to
electrical sparking.
14. Avoid contact with cutting tip of blade or bur when locking into handpiece. Tips
are sharp and may cause injury.
15. Do not use burs for plunge cutting. Injury or damage may occur.
1.4.2 Precautions
1. United States Federal law restricts sale of this device to or on the
order of a physician.
2. Handpieces are factory sealed. Do not disassemble or lubricate,
as this may void the warranty. There are no user-serviceable
parts inside.
3. Use only associated ConMed Linvatec attachments and accessories.
4. Handle all equipment carefully. If any equipment is dropped or damaged in any
way, return it immediately for service.
5. Prior to each use, perform the following:
• Inspect all equipment for proper operation.
• Ensure all attachments and accessories are correctly and completely attached to
the handpiece.
• Perform the required Performance Tests for each associated handpiece prior to each use.
6. 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.
7. 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.
8. Do not handle the handpiece by the cord. Do not pull on the cord to remove it
from the Console.
9. Running the shaver blade or bur without fluid flow (dry) may cause damage to
the handpiece. When operating burs at higher than 6000 rpm, you must ensure
fluid is flowing through the handpiece BEFORE activating the handpiece.
Failure to do so may cause the bur hubs to melt due to excessive heat.
!
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10. 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.
11. 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.
12. 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.
13. 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).
14. Do not stall handpieces, damage can occur.
15. After each use, thoroughly clean the handpiece, attachments and accessories
(See “CLEANING AND STERILIZING” on page 10).
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1.5 Symbol Definitions
1.5.1 Handpiece Symbols
Handpiece direction selection button (forward, reverse,
oscillate). Will also convert to Speed Increase button
(see step 4, “Handpiece Descriptions” on page 8 for
more information).
Handpiece ON/OFF button. Will also convert to Speed
Decrease button (see step 4, “Handpiece Descriptions”
on page 8 for more information).
Indicates blade collet unlock position
U
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1.5.2 Warnings and Information Symbols
Atmospheric pressure
limitation Flammable Anesthetics - Risk of explosion if used in
the presence of flammable
anesthetics
Biohazard Risk Humidity limitation
Catalog Number Indicates handpiece should
not be immersed in any fluid
Caution, consult
accompanying documents Indicates product should not be oiled or lubricated
Caution: Federal Law
restricts this device to sale
by or on the order of a
physician
Manufacturer
Consult instructions for use Non sterile
Date of Manufacture No user service
recommended. Refer
servicing to qualified
ConMed Linvatec service
personnel
Do Not Resterilize Sterilized using Irradiation
Do Not Re-use Temperature Limition
Do Not Use if package is
damaged Use by date
Eye Protection Required Waste Electronics and
Electrical Equipment
(WEEE) Symbol. Regarding
European Union end-of-life
of product
REF
2
STERILIZE
STERILE R
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1.6 Handpiece Descriptions
The information below pertains to the Turbo (D9920, D9924) shaver handpieces.
All these handpieces are equipped with sensors that automatically select the
proper speed range for the attached blade or bur. A maximum operating speed of
12,000 rpm in the forward and reverse direction and 4,000 cpm in oscillate for
shaver blades are attainable.
The 2-Button Shaver Handpiece (D9924) is 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. Window indexing and handpiece operating speed control can
be controlled from within the sterile field, as explained below.
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.
Controlling speed using the buttons on the D9924: 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
D9920: No Button Shaver Shown D9924: 2- Button Shaver Shown
12 3
12 3 45
U
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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.
5. ON/OFF Button - Press and release to turn the shaver handpiece on and
off.
Controlling window indexing using the buttons on the D9924: 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.
6. 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 D9924, 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.
1.7 Preoperative Functional Test
Prior to each use, perform the following preoperative functional test:
1. Insert a bur or blade into the handpiece by aligning one of the slots in the collet
with the key on the blade/bur hub. Gently pull on the cutting accessory 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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2.0 CLEANING AND STERILIZING
2.1 Cleaning and Washer/Sanitizer Warnings and
Precautions
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 prior to cleaning.
3. After use, shaver blades and burs may be a potential biohazard and
should be handled in accordance with acceptable medical practice and
applicable local and national requirements.
4. Do not lubricate handpieces.
5. Never immerse the handpieces. Corrosion to handpiece may
occur resulting in decreased handpiece performance.
6. 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.
7. 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.
8. 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.
9. Never clean equipment in an ultrasonic cleaner.
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3.0 Handpiece Cleaning Instructions
3.1 Manual Cleaning
Clean handpieces as soon as possible after use.
1. Disconnect the handpiece cord from the console and remove all accessories
from the handpiece before cleaning.
2. Thoroughly scrub the handpiece and handpiece cord with a clean, soft brush
dampened, not saturated, with a mild, pH-balanced detergent. Remove all traces
of blood, coagulated material, disinfectant, stains, etc.
3. Place the suction control valve in the fully open position. Clean the suction tube
thoroughly with a cleaning brush until all debris is removed.
4. Using a low-velocity spray of water, spray into the collet while rotating the
collet back and forth. Ensure the collet operates smoothly and that no debris is
binding the internal mechanism of the collet. Clean 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. Rinse under running water to remove all traces of soap. Flush the surfaces free
of tap water with distilled water to prevent metal discoloration.
7. Gently shake the equipment free of water and wipe the surfaces with a clean,
lint-free towel.
3.2 Sterilization Information
Steam sterilization is safe and effective and has no contraindications for
sterilizing shaver handpieces.
Inspection Recommendations
1. Inspect device prior to sterilization.
2. Generally, unmagnified visual inspection under good light conditions is
sufficient. All parts of the devices should be checked for visible soil and/or
corrosion.
3. Functional checks should be performed where possible.
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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 “Peel Pack” handpieces for sterilization. Sterilization in a sealed pouch
traps moisture which can cause damage.
3. The suction control valve must be in the fully open position during sterilization.
4. Do not use handpieces while warm. Allow adequate time for cooling prior to
use. Cool by exposure to room temperature. Operation of a handpiece that is not
completely cool or dry may decrease performance and/or reliability.
Handpieces may be processed in a pre-vacuum steam sterilizer (Steam Pre-
vacuum). Individually wrap handpiece and handpiece cord. Follow the
recommended minimum sterilization exposure times listed below.
*PRECAUTION: An eight (8) minute minimum dry cycle must be run
on all handpieces 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.
Method Cycle Minimum
Temperature
Minimum
Exposure
Minimum*
Dry Cycle
Steam (wrapped) Pre-Vacuum 270°F (132°C) 4 minutes 8 minutes
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4.0 TECHNICAL SPECIFICATIONS
I.E.C. Equipment Classification: Class I (intended for connection to Class I
surgical console), IPX0 (ordinary) Type of applied part is dependent on surgical
console.
The system was tested and complies with UL 60601-1, 1st edition, CAN/CSA
C22.2 NO. 601.1, IEC 60601-1, 2nd Edition including Amendments 1 and 2.
The system was also tested and complies with IEC 60601-1-2 as follows: 1) The
system may not cause harmful interference; 2) The system will accept interference
received, including interference that might cause undesirable operation.
If interference occurs, separate the instruments by moving one away from the
other. For more information contact customer service.
4.1 Service Interval
All Shavers have a 12 month service interval.
WARNING: 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.
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4.2 Shaver Handpiece Technical Specifications
*Operating speeds may vary depending on console, console software revision, and
blade/bur selection.
Advantage Turbo
No-button (D9920) and 2-Button (D9924) Shaver Handpieces
Operating Speed:* 500 - 12,000 rpm, Forward/Reverse
500 - 4,000 cpm, Single-and Multi-turn Oscillate
Torque (Nominal): 35 in. oz. (24.7 N·cm)
Length: 6.1 in (15.5 cm)
Diameter: Approx. 1.25 in. tear drop (3.2 cm)
Weight: 17.8 oz. (505g)
Cord length: 10 ft. (3m) Non-detachable
Material: Anodized Aluminum and Stainless Steel
Duty Cycle 100% duty cycle with fluid flow
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4.3 Handpiece Environmental Requirements
Environmental
Conditions Operating Storage and Transport
Temperature:
Relative Humidity:
Atmospheric
Pressure:
75%
30%
Non-Condensing
93%
10%
Non-Condensing
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5.0 CUSTOMER SERVICE
5.1 Assistance
If you need technical assistance regarding the use or application of this product, or
you encounter a problem that requires servicing or repair, contact ConMed Linvatec
Customer Service at 1-800-237-0169 or your ConMed Linvatec Sales Representative.
Outside the U.S. contact your local ConMed Linvatec Representative.
Report any events involving injuries or malfunctions to the ConMed Linvatec
Regulatory Product Support Department.
Returning products for any reason requires an authorized Service Request (S.R.)
number prominently displayed on the box and included on all paperwork. Refer
to this number if making inquiries about the repair status. Please call ConMed
Linvatec Customer Service and provide the following information to obtain an
S.R. number prior to returning any product for repair:
• Product Number
• Serial Number / Lot Number
• Original Invoice Number
• Date of Purchase
• Detailed description of the problem
ConMed Linvatec
Attn.: Customer Service Dept.
11311 Concept Boulevard
Largo, Florida 33773-4908 USA
Customer Service (within U.S.) Phone: [phone]
FAX: [phone]
(outside U.S.) Phone: [phone]
FAX: [phone]
ConMed Linvatec Regulatory Product Support
(within U.S.) Phone: [phone]
(outside U.S.) Phone: [phone]
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