ConMed Linvatec MC9840 Manuale utente

ConMed Linvatec

Small Shaver Handpieces

MC9840

E9005

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 MicroChoice are

trademarks or registered trademarks of Linvatec Corporation.

Table of Contents Page

1.0 INTRODUCTION

1.1 Operating Principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

1.2 Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

1.3 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

1.4 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

1.8.1 Product Symbols . . . . . . . . . . . . . . . . . . . . . . . . . .6

1.8.2 Warnings and Information Symbols . . . . . . . . . . .7

2.0 SYSTEM INSTALLATION AND OPERATION

2.1 Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

2.1.1 Handpiece Descriptions . . . . . . . . . . . . . . . . . . . .9

2.1.2 Tubing Sets Descriptions . . . . . . . . . . . . . . . . . .10

2.1.3 Shaver Blades, Bur Description . . . . . . . . . . . . .10

2.2 Assembly/Installation Instructions . . . . . . . . . . . . . . . . . .11

2.2.1 Shaver Blade Installation and Removal . . . . . . .11

2.2.2 Irrigation Tubing Set Installation . . . . . . . . . . . .12

2.3 Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

2.4 Preoperative Functional Test. . . . . . . . . . . . . . . . . . . . . . .13

Table of Contents Page

3.0 MAINTENANCE

3.1 Cleaning Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

3.1.1 Warnings, Precautions and Notes . . . . . . . . . . . .14

3.1.2 Manual Cleaning Instructions . . . . . . . . . . . . . . .14

3.2 Sterilization Information . . . . . . . . . . . . . . . . . . . . . . . . . .15

3.2.1 Warnings, Precautions and Notes . . . . . . . . . . . .15

3.2.2 Sterilization Instructions . . . . . . . . . . . . . . . . . . .16

3.3 Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

3.4 Maintenance Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . .18

4.0 TECHNICAL SPECIFICATIONS

4.1 Product Technical Specifications. . . . . . . . . . . . . . . . . . . .19

4.1.1 Handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

4.2 Product Environmental Requirements. . . . . . . . . . . . . . . .21

4.2.1 Environmental Technical Specifications. . . . . . .21

4.2.2 Electromagnetic Requirements . . . . . . . . . . . . . .21

4.3 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

5.0 CUSTOMER SERVICE

5.1 Assistance and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

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 handpieces are electrically powered by Conmed Linvatec surgical

consoles to provide high speed, rotary force to the accessory (shaver blade

and/or shaver bur) for tissue resection. The shaver handpieces are controlled

by 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 MC9840 Handpiece, and its accessories, performs the cutting of soft

tissue and bone. The fields of application include: Orthopedic, Arthroscopic,

Otolaryngological, Hand, and Foot surgical procedures.

The E9005 Handpiece, and its accessories, performs the resection of soft

tissue and bone. The fields of application include: Otolaryngology, and

Orthopedic surgical procedures.

1.3 Intended Use

Same as Indications for Use above.

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.

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.

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.

14. Running the shaver blade or bur without fluid flow (dry) may cause damage

to the handpiece. Failure to do so may cause the bur hubs to melt due to

excessive heat.

15. 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.

16. 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.

17. 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).

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 Electronic 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.

1.8 Symbol Definitions

1.8.1 Product Symbols

Suction ON/OFF

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