Linvatec Shaver Handpieces Instruction Manual

Table of Contents 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

1.6

2.0

1.5.1

Warnings... 2

1.5.2

Precautions... 4

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

SYSTEM INSTALLATION AND OPERATION 2.1

2.2

Product Description...10 2.1.1

Handpiece Descriptions...10

2.1.2

Shaver Blades, Bur Description...11

Assembly/Installation Instructions...11 2.2.1

3.0

Page

Shaver Blade Installation and Removal...11

2.3

Operating Instructions...12

2.4

Preoperative Functional Test...13

MAINTENANCE 3.1

3.2

Cleaning Information...14 3.1.1

Warnings, Precautions and Notes...14

3.1.2

Manual Cleaning Instructions...15

Sterilization Information...16

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Table of Contents

Page

3.2.1

Warnings, Precautions and Notes...16

3.2.2

Sterilization Instructions...17

4.0

3.3

Troubleshooting...18

3.4

Maintenance Schedule...19

TECHNICAL SPECIFICATIONS 4.1

Product Technical Specifications...20 4.1.1

4.2

4.3

5.0

Handpieces...20

Product Environmental Requirements...22 4.2.1

Environmental Technical Specifications...22

4.2.2

Electromagnetic Requirements...22

Accessories...22

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 singleuse 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.

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1.8

Symbol Definitions

1.8.1

Product 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).

LOCK UN

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).

1.8.2 REF

! EC REP

Suction ON/OFF

Warnings and Information Symbols Catalog Number

SN

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

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STERILE

2

STERILIZE

EO

Non Sterile

STERILE

Sterile

Sterile - Sterilized Using EO

STERILE

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

QTY

Do Not Immerse

~

R

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

8

Fragile

This Side Up

Do Not Use if Package is Damaged

Keep Dry Warning: Electrical Hazard/ High Voltage

Warning: Corrosive Substance

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 2.1 2.1.1

1

SYSTEM INSTALLATION AND OPERATION Product Description Handpiece Descriptions

2

3

1 4 5

D4200: No Button Shaver Shown

2

3

D4240: 2- Button Shaver Shown

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 UNLOCK 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.

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2.1.2

Shaver Blades, Bur Description

3

1

2

1. Cutting tip. 2. Shaver blade/bur hub- connects to the shaver handpiece. 3. Alignment key.

2.2 2.2.1

Assembly/Installation Instructions 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.

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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 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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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”.

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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 3.2.1

Sterilization Information 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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3.2.2

Sterilization Instructions

Steam sterilization is safe and effective and has no contraindications for sterilizing this equipment. 1. Individually wrap handpiece and accessories. 2. Follow the recommended minimum sterilization exposure times listed below. 3. Use the recommended tray parameters in its instruction manual when sterilizing handpieces and attachments in a system sterilization tray. Handpieces and attachments may be processed in a pre-vacuum steam sterilizer (Steam Pre-vacuum) or in a gravity (downward) displacement sterilizer (Steam Gravity). Minimum recommended sterilization exposure times are as follows:

Table 1: Sterilization Parameters 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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