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Summary of Contents for ConMed Linvatec D4240
- Page 1 ConMed Linvatec Shaver Handpieces D4200/D9820 D4240/D9824...
- Page 2 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.
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Page 3: Table Of Contents
Table of Contents Page INTRODUCTION Operating Principle ....... 1 Indications for Use....... . 1 Intended Use . - Page 4 Table of Contents Page 3.2.1 Warnings, Precautions and Notes ... .16 3.2.2 Sterilization Instructions ....17 Troubleshooting .
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Page 5: Introduction
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. -
Page 6: Contraindications
Contraindications None 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. - Page 7 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).
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Page 8: Precautions
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. - Page 9 (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.
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Page 10: Environmental Directives
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. Product Photographs and Drawings The pictures in this manual are for reference only. Items shown may not represent the actual product. -
Page 11: Symbol Definitions
DEHP Symbol Authorized Representative CE Mark of Conformity in the European Community No User Service Prescription Only: Federal Recommended. Refer Law restricts this device to servicing to qualified sale by or on the order of a ConMed Linvatec service physician personnel... - Page 12 Non Sterile Sterile Sterile - Sterilized Using Sterile - Sterilized Using EO Irradiation Do Not Steam Sterilize Do Not Sterilize Do Not Reuse (for Single Use Do Not Resterilize Only) STERILIZE Do Not Use for Plunge Do Not Use Oil Cutting Eye Protection Required Biohazard Risk...
- Page 13 Fragile This Side Up Do Not Use if Package is Keep Dry Damaged Warning: Electrical Hazard/ Warning: Corrosive High Voltage 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.
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Page 14: System Installation And Operation
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. -
Page 15: Shaver Blades, Bur Description
2.1.2 Shaver Blades, Bur Description 1. Cutting tip. 2. Shaver blade/bur hub- connects to the shaver handpiece. 3. Alignment key. 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. -
Page 16: Operating Instructions
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. -
Page 17: Preoperative Functional Test
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. -
Page 18: Maintenance
MAINTENANCE 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. -
Page 19: Manual Cleaning Instructions
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. -
Page 20: Sterilization Information
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. -
Page 21: Sterilization Instructions
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. -
Page 22: Troubleshooting
Troubleshooting Table 2: Troubleshooting Guide Symptom Possible Cause Corrective Action • Handpiece cord Handpiece does not • Securely connect handpiece not connected cord to controller. operate. securely. • Handpiece faulty. • Return for service. Error Messages • Handpiece and/or • Replace handpiece. If “MOTOR OVER System faulty. -
Page 23: Maintenance Schedule
Service at ConMed Linvatec at the recommended service interval is mandatory to keep your product warranties in effect. Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the equipment or equipment failure. -
Page 24: Technical Specifications
TECHNICAL SPECIFICATIONS Medical electrical equipment complies with and was tested with respect to electric shock, fire, electromagnetic compatibility, mechanical and other specified hazards only, in accordance with UL60601-1, CAN/CSA C22.2 No. 601.1-M90, IEC60601-1:1988 +A1:1991 +A2:1995, ES60601-1:2005 +A1: 2009 +A2: 2010, CAN/CSA C22.2 No.60601-1-1-08 and IEC60601-1:2005 +C1:2006 +C2:2009. - Page 25 Ergo No-button (D4200) and 2-Button (D4240) Shaver Handpieces Classification: Class I (intended for connection to Class I surgical console). Type rating of applied part is dependent on surgical console. Protection Ingress of IPX0 (ordinary) Fluids: Mode of Operation: Intermittent Loading...
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Page 26: Product Environmental Requirements
Non-Condensing Atmospheric Pressure: 4.2.2 Electromagnetic Requirements Refer to appropriate drive console instruction manual for electromagnetic requirements. Accessories Only use ConMed Linvatec shaver blades and burs. Description Attachments D9900 Thorne Chuck 5/32 in Attachment (for use with D4200 and D4240 only) -
Page 27: Customer Service
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. Returning products for any reason requires an authorized Service Request (S.R.) number prominently displayed on the box and included on all paperwork. - Page 30 525 French Road Utica, NY 13502-5994 USA (727) 392-6464 EC REP Customer Service: 1-800-237-0169 MDSS GmbH FAX: (727) 399-5256 Schiffgraben 41 International FAX: +1 (727) 397-4540 D-30175 Hannover, Germany email: customer_service@conmed.com www.conmed.com All rights reserved. W41-260-004 Rev. AC 10/2014...
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