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<ul><li><p>MIDAS REX LEGENDPneumatic High-Speed System</p><p>Instruction Manual</p><p>Rx Only</p></li><li><p>Glossary of universal symbols</p><p> Midas Rex Legend High Speed Pneumatic System</p><p>The following symbols may appear within this manual, on product labeling, or on the product itself:</p><p>Attention, see Instructions for Use. Tube Control</p><p>United States federal law restricts this device to sale by or on the order of a physician.</p><p>Air Pressure Relief</p><p>Reference Number Use with</p><p>Lot Number Multi-Use Dispos-able Attachment</p><p>Serial Number Instrument Case</p><p>Quantity Lubricant/Diffuser</p><p>For single patient use only. Do not re-use, re-process, or re-sterilize this product. Re-use, re-processing or re-sterilization may com-promise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.</p><p>Dissecting Tool</p><p>Approximately equal to Attachment</p><p>Non-Sterile Control Unit</p><p>Sterilized by Gamma Irradiation Refurbished</p><p>Use by date Accessory</p><p>Date of manufacture Regulator</p><p>Temperature Limitations Bone Mill</p><p>Unlock Motor</p><p>Lock Brush</p><p>On Adapter</p><p>Off USA Only</p><p>Finger-Operated Control Manufacturer</p><p>Foot-Operated Control Do not dispose to unsorted municipal waste.</p><p>Compliant with European Council Directive MDD 93/42/EEC.</p><p>Tool Control</p><p>Authorized Representative in the European Community</p><p>Consult Instructions for Use</p><p>GLOSSARY OF UNIVERSAL SYMBOLS</p><p>Midas Rex Legend High Speed Pneumatic System</p><p>w Attention: See Instructions for useFor U.S. audience onlyCaution: Federal Law (USA) restricts this device to sale by or on the order of a physician</p><p>Catalog Number, Reference Number, Reorder Number, Part Number</p><p>l Lot Number</p><p>n Serial Number</p><p>Quantity</p><p>k Single use only; do not reuse</p><p>= Is approximately equal to</p><p>J Non-sterile</p><p>q Sterilized by gamma irradiation</p><p>f Use by date</p><p>m Date of Manufacture</p><p>Storage Temperatures</p><p>Unlock</p><p>Lock</p><p>| On</p><p>Off</p><p>Finger-Operated Control</p><p>Foot-Operated Control</p><p>Conformit Europene (European Conformity)This symbol means that the device fully complies with European Council Directive MDD 93/42/EEC. </p><p>Authorized Representative in the European Community</p><p>Manufacturer</p><p>DO NOT Dispose to unsorted municipal waste</p><p>TOOL Tool Control</p><p>TUBE Tube Control</p><p>Rx only</p><p>REF</p><p>! USA</p><p>EC REP</p><p>Rx OnlyGLOSSARY OF UNIVERSAL SYMBOLS</p><p>Midas Rex Legend High Speed Pneumatic System</p><p>w Attention: See Instructions for useFor U.S. audience onlyCaution: Federal Law (USA) restricts this device to sale by or on the order of a physician</p><p>Catalog Number, Reference Number, Reorder Number, Part Number</p><p>l Lot Number</p><p>n Serial Number</p><p>Quantity</p><p>k Single use only; do not reuse</p><p>= Is approximately equal to</p><p>J Non-sterile</p><p>q Sterilized by gamma irradiation</p><p>f Use by date</p><p>m Date of Manufacture</p><p>Storage Temperatures</p><p>Unlock</p><p>Lock</p><p>| On</p><p>Off</p><p>Finger-Operated Control</p><p>Foot-Operated Control</p><p>Conformit Europene (European Conformity)This symbol means that the device fully complies with European Council Directive MDD 93/42/EEC. </p><p>Authorized Representative in the European Community</p><p>Manufacturer</p><p>DO NOT Dispose to unsorted municipal waste</p><p>TOOL Tool Control</p><p>TUBE Tube Control</p><p>Rx only</p><p>REF</p><p>! USA</p><p>EC REP</p><p>GLOSSARY OF UNIVERSAL SYMBOLS</p><p>Midas Rex Legend High Speed Pneumatic System</p><p>w Attention: See Instructions for useFor U.S. audience onlyCaution: Federal Law (USA) restricts this device to sale by or on the order of a physician</p><p>Catalog Number, Reference Number, Reorder Number, Part Number</p><p>l Lot Number</p><p>n Serial Number</p><p>Quantity</p><p>k Single use only; do not reuse</p><p>= Is approximately equal to</p><p>J Non-sterile</p><p>q Sterilized by gamma irradiation</p><p>f Use by date</p><p>m Date of Manufacture</p><p>Storage Temperatures</p><p>Unlock</p><p>Lock</p><p>| On</p><p>Off</p><p>Finger-Operated Control</p><p>Foot-Operated Control</p><p>Conformit Europene (European Conformity)This symbol means that the device fully complies with European Council Directive MDD 93/42/EEC. </p><p>Authorized Representative in the European Community</p><p>Manufacturer</p><p>DO NOT Dispose to unsorted municipal waste</p><p>TOOL Tool Control</p><p>TUBE Tube Control</p><p>Rx only</p><p>REF</p><p>! USA</p><p>EC REP</p><p>IMulti-Use Disposable Attachment</p><p>Instrument Case</p><p>Lubricant/Diffuser</p><p>Dissecting Tool</p><p>Attachment</p><p>Control Unit</p><p>Refurbished</p><p>Accessory</p><p>Regulator</p><p>Bone Mill</p><p>Motor</p><p>Brush</p><p>Adapter</p></li><li><p>Midas Rex Legend High Speed Pneumatic System 1</p><p>Table of ConTenTs</p><p>GENERAL OPERATING GUIDELINES ...............................................................................................................................................................2WARNING SUMMARY ............................................................................................................................................................................................3INTRODUCTION Legend System Components ..........................................................................................................................................7 Legend Motors ..............................................................................................................................................................................................7 Non-Disposable Legend Accessories .........................................................................................................................................................8 Legend Pneumatic Control Unit .................................................................................................................................................8 Legend Regulator ..........................................................................................................................................................................8 Legend Instrument Cases ............................................................................................................................................................8 Legend Adapters ...........................................................................................................................................................................9 Legend Cleaning Nozzle ..............................................................................................................................................................9 Legend Attachments ...................................................................................................................................................................10 Disposable Legend Accessories ................................................................................................................................................................11 Legend Lubricant/Diffuser ........................................................................................................................................................11 Cleaning Brushes ........................................................................................................................................................................11 Legend Dissecting Tools ............................................................................................................................................................12 General Guidelines for Attachment and Tool Applications ..................................................................................................................14Operating Room Set Up ..........................................................................................................................................................................................16 Power Source Requirements ......................................................................................................................................................16 System Connections ...................................................................................................................................................................16PRE-OPERATIvE PROCEDURES ......................................................................................................................................................................18LEGEND MOTOR fEATURES .............................................................................................................................................................................22POST-OPERATIvE PROCEDURES ...................................................................................................................................................................23 Disassembly of Equipment ........................................................................................................................................................................23 Sterilization Guidelines ..............................................................................................................................................................................24LEGEND ATTACHMENTS AND DISSECTING TOOLS ..............................................................................................................................27 Straight Attachments ..................................................................................................................................................................................27 Angled Attachments ...................................................................................................................................................................................28 Variable Exposure Attachments................................................................................................................................................................29 Rotating Footed Attachments ...................................................................................................................................................................30 Footed Attachments ...................................................................................................................................................................................31 Contra-Angle Attachment .........................................................................................................................................................................32 Metal Cutting Attachment .........................................................................................................................................................................33 Telescoping Attachment ............................................................................................................................................................................34 Perforator Attachment ...............................................................................................................................................................................35 Jacobs Chuck Attachment .........................................................................................................................................................................36TECHNICAL INfORMATION LEGEND SYSTEM TROUbLESHOOTING ......................................................................................37MIDAS REX LEGEND SERvICE AND WARRANTY ..................................................................................................................................43</p></li><li><p>2 Midas Rex Legend High Speed Pneumatic System</p><p>General operaTinG Guidelines</p><p>The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motors provide power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.</p><p>Contraindications: None</p><p>The LEGEND System is comprised of the following: Legend Gold, Legend Gold Touch or Legend Platinum Motors Legend Pneumatic Control Unit with Regulator and various connectors Legend Attachments Legend Dissecting Tools single use, disposable Legend Lubricant/Diffuser single use, disposable</p><p>Read and understand this instruction manual before use of the LEGEND SYSTEM. </p><p>The LEGEND SYSTEM is designed for use by medical professionals familiar with powered surgical instrumentation. The surgeon is responsible for learning the proper techniques in the use of this system, as inappropriate use may potentially be harmful. It is strongly recommended that the surgeon and dedicated operating room personnel are knowledgeable with the use of this equipment by being trained in Medtronic Midas Rex Hands-On Workshops or by one of the local authorized representatives.</p><p>If Legend components require servicing or refurbishing, return components to Medtronic Powered Surgical Solutions (MPSS) for quality assured service by factory-trained personnel who will utilize genuine MEDTRONIC MIDAS REX LEGEND parts as required. All Legend System components returned for servicing or refurbishing should be properly cleaned and sterilized prior to shipping. Rx only Federal Law (USA) restricts this device to sale by or on the order of a physician.</p><p>For Questions or Problems, consult the Legend Instruction Manual, or contact your Medtronic Neurologic Technologies sales representative, or call: Medtronic Powered Surgical Solutions (MPSS) Technical Service: 8 a.m. to 6 p.m. (Central Standard Time) Telephone: 800-643-2773 or 817-788-6400</p><p>Outside the U.S.A., contact your nearest Medtronic Regional Distributor or Medtronic Neurological Sales Representative or call U.S.A. Telephone 817-788-6400</p><p>! USA</p></li><li><p>Midas Rex Legend High Speed Pneumatic System 3</p><p>warninG summary</p><p> This symbol is used to alert the reader to important safety and precautionary information. When displayed on the actual device or packaging, it refers the user to the instruction manual.</p><p>The words Warning, Caution and Note carry special meanings and should be carefully reviewed.</p><p> WARNING The personal safety of the patient, operator and/or operating room staff may be involved. Disregarding this information could result in injury to the patient, operator and/or operating room staff.</p><p> CAUTION These instructions point out special service procedures or precautions that must be followed to avoid damaging the instrument. A damaged instrument could result in injury to the patient, operator, and/or operating room staff.</p><p>NOTE This provides special information to make maintenance easier or important operating instructions more clear.</p><p>Read and understand warnings before use of the LEGEND SYSTEM. </p><p>Important Safety Instructions: </p><p> WARNING General:DO NOT use any other components except for Medtronic Midas Rex Legend Attachments, Legend Dissecting Tools and Legend accessories in combination with a Legend Motor. Use of devices other than Legend Systems or associated parts or components may cause injury to the patient, operator and/or operating room staff. Use of devices other than Legend Systems or associated parts or components will damage the motor and attachments a...</p></li></ul>