Linvatec Shaver Handpieces Instructions for Use

W41-261-004AB.book Page 2 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.

W41-261-004AB.book Page i Thursday, September 18, 2014 9:28 AM

Table of Contents

1.0

INTRODUCTION 1.1

Operating Principle... 1

1.3

Environmental Directives... 1

1.5

Warnings and Precautions... 2 1.4.1

Warnings... 3

1.4.2

Precautions... 4

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

CLEANING AND STERILIZING 2.1

3.0

Intended Use... 1

1.2 1.4

2.0

Cleaning and Washer/Sanitizer Warnings and Precautions... 10

Handpiece Cleaning Instructions 3.1

Manual Cleaning... 11

3.2

Sterilization Information... 11 3.2.1

4.0

Page

Warnings, Precautions and Notes... 12

TECHNICAL SPECIFICATIONS 4.1

Service Interval... 13

4.2

Shaver Handpiece Technical Specifications... 14

i

W41-261-004AB.book Page ii Thursday, September 18, 2014 9:28 AM

Table of Contents 4.3

5.0

Page

Handpiece Environmental Requirements... 15

CUSTOMER SERVICE 5.1

Assistance... 16

ii

W41-261-004AB.book Page 1 Thursday, September 18, 2014 9:28 AM

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. 1

W41-261-004AB.book Page 2 Thursday, September 18, 2014 9:28 AM

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.

!

2

W41-261-004AB.book Page 3 Thursday, September 18, 2014 9:28 AM

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 2 for single-use only. Do not resterilize or reuse. The ability to STERILIZE 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.

3

W41-261-004AB.book Page 4 Thursday, September 18, 2014 9:28 AM

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. 4

W41-261-004AB.book Page 5 Thursday, September 18, 2014 9:28 AM

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).

5

W41-261-004AB.book Page 6 Thursday, September 18, 2014 9:28 AM

1.5 1.5.1

Symbol Definitions 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).

LOCK UN

Indicates blade collet unlock position

6

W41-261-004AB.book Page 7 Thursday, September 18, 2014 9:28 AM

1.5.2

Warnings and Information Symbols Atmospheric pressure limitation

Flammable Anesthetics Risk of explosion if used in the presence of flammable anesthetics Humidity limitation

Biohazard Risk

REF

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 Consult instructions for use

Manufacturer

Non sterile

Date of Manufacture

2

Do Not Resterilize

STERILE

R

No user service recommended. Refer servicing to qualified ConMed Linvatec service personnel Sterilized using Irradiation

STERILIZE

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 7

W41-261-004AB.book Page 8 Thursday, September 18, 2014 9:28 AM

1.6 1

Handpiece Descriptions 2

1

3

D9920: No Button Shaver Shown

4

5

2

3

D9924: 2- Button Shaver Shown

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 UNLOCK 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 8

W41-261-004AB.book Page 9 Thursday, September 18, 2014 9:28 AM

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.

9

W41-261-004AB.book Page 10 Thursday, September 18, 2014 9:28 AM

2.0 2.1

CLEANING AND STERILIZING 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.

10

W41-261-004AB.book Page 11 Thursday, September 18, 2014 9:28 AM

3.0 3.1

Handpiece Cleaning Instructions 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.

11

W41-261-004AB.book Page 12 Thursday, September 18, 2014 9:28 AM

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 Prevacuum). Individually wrap handpiece and handpiece cord. Follow the recommended minimum sterilization exposure times listed below.

Method

Cycle

Minimum Temperature

Minimum Exposure

Minimum* Dry Cycle

Steam (wrapped)

Pre-Vacuum

270°F (132°C)

4 minutes

8 minutes

*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.

12

W41-261-004AB.book Page 13 Thursday, September 18, 2014 9:28 AM

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.

13

W41-261-004AB.book Page 14 Thursday, September 18, 2014 9:28 AM

4.2

Shaver Handpiece Technical Specifications Advantage Turbo No-button (D9920) and 2-Button (D9924) Shaver Handpieces

Operating Speed:* Torque (Nominal): Length: Diameter: Weight: Cord length: Material: Duty Cycle

500 - 12,000 rpm, Forward/Reverse 500 - 4,000 cpm, Single-and Multi-turn Oscillate 35 in. oz. (24.7 N·cm) 6.1 in (15.5 cm) Approx. 1.25 in. tear drop (3.2 cm) 17.8 oz. (505g) 10 ft. (3m) Non-detachable Anodized Aluminum and Stainless Steel 100% duty cycle with fluid flow

*Operating speeds may vary depending on console, console software revision, and blade/bur selection.

14

W41-261-004AB.book Page 15 Thursday, September 18, 2014 9:28 AM

4.3

Handpiece Environmental Requirements Environmental Conditions

Operating

Storage and Transport

Temperature:

93%

75%

Relative Humidity: 30%

Non-Condensing

Atmospheric Pressure:

15

10%

Non-Condensing

W41-261-004AB.book Page 16 Thursday, September 18, 2014 9:28 AM

5.0 5.1

CUSTOMER SERVICE 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.) (outside U.S.)

Phone:

1-800-237-0169

FAX:

(727)-399-5256

Phone:

+1 (727)-392-6464

FAX:

+1 (727)-397-4540

ConMed Linvatec Regulatory Product Support (within U.S.)

Phone:

1-800-325-5900

(outside U.S.)

Phone:

+1 (727)-392-6464

16