LEGEND Pneumatic High Speed System GOLD, GOLD TOUCH, PLATINUM Instruction Manual Rev9 Sept 2010

EC REP

Authorized Representative in the Eur

Manufacturer GLOSSARY OF UNIVERSAL SYMBOLS

Glossary of universal symbols

DO NOT Dispose to unsorted munic The following symbols may appear within this manual, on product labeling, or on the product itself: TOOL Attention, see Instructions for Use.

w

Tool ControlSee Instructions for use Attention:

Rx only ! USA TUBE

For U.S. audience only Tube Control Caution: Federal Law (USA) restricts t

GLOSSARY OF UNIVERSAL SYMBOLS United States federal law restricts this device Rx Only

Air Pressure Relief

to sale by or on the order of a physician.

REF

Reference Number

w ! USA Rx only

REF

l n k = J q f m

I l

Attention: See Instructions for use Lot Number

Use with

Lot Number

Multi-Use Disposable Attachment

Sterilized by Gamma Irradiation Sterilized by gamma irradiation

Refurbished

Unlock

Useby by date date Use

Accessory

Lock

Regulator |

On

Bone Mill

Off

Dateof of Manufacture manufacture Date

Unlock

Unlock

Multi-Use Dispos-

Lock

Off Finger-Operated Control

Foot-Operated Control

Regulator Bone Mill

Brush

Brush Control Foot-Operated

Adapter

Off

Finger-Operated Control

Accessory

Motor Finger-Operated Control

On

On

Refurbished

Motor

Lock

EC REP

Catalog Number, Reference Numbe

able Attachment n Serial Number For U.S. audience only Serial Number Caution: Federal Law (USA) restricts this device to sale by or onCase the order of a Instrument physician Case Instrument Quantity Catalog Part Number QuantityNumber, Reference Number, Reorder Number, Lubricant/Diffuser Lubricant/Diffuser k Single use only; do not reuse Lot ForNumber single patient use only. Do not re-use, reDissecting Tool = Is approximately equal to process, or re-sterilize this product. Re-use, Serial Numberor re-sterilization may comre-processing JTool Non-sterile Dissecting promise the structural integrity of the device Quantity and/or create a risk of contamination of the q Sterilized by gamma irradiation device, which could result in patient injury, Single only; do not reuse illness,use or death. f Use by date Approximately equal to Attachment Attachment Is approximately equal to m Date of Manufacture Non-Sterile Control Unit Control Unit Non-sterile Storage Temperatures

Storage Temperatures Temperature Limitations

|

Tube Control

EC REP

Conformité Européene (European C Adapter This symbol means that the device f MDD 93/42/EEC. USA Only

Authorized Representative in the Eu Manufacturer

Manufacturer Foot-Operated Control Do not dispose to Conformité Européene (European Conformity) unsorted municipal DO NOT Dispose to unsorted mun This symbol means that the device fully complies with European Council Directive waste. MDD 93/42/EEC. Tool Control Compliant with European Council Directive TOOL Tool Control MDD 93/42/EEC. Authorized Representative in the European Community Authorized Representative in the European Consult TUBE Tube Control Instructions for Use Community Manufacturer DO NOT Dispose to unsorted municipal waste

Midas Rex Legend High Speed Pneumatic System

TABLE OF CONTENTS GENERAL OPERATING GUIDELINES...2 WARNING SUMMARY...3 INTRODUCTION - 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...14 Operating Room Set Up...16 Power Source Requirements...16 System Connections...16 Pre-Operative Procedures...18 Legend Motor features...22 POST-OPERATIVE PROCEDURES...23 Disassembly of Equipment...23 Sterilization Guidelines...24 LEGEND 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...36 TECHNICAL INFORMATION - Legend System Troubleshooting . ...37 MIDAS REX® LEGEND® SERVICE AND WARRANTY...43

Midas Rex Legend High Speed Pneumatic System

1

General operating Guidelines 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. Contraindications: None 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 Read and understand this instruction manual before use of the LEGEND SYSTEM. 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.

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. ! USA

Rx only Federal Law (USA) restricts this device to sale by or on the order of a physician.

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 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

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Midas Rex Legend High Speed Pneumatic System

warning summary

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. The words Warning, Caution and Note carry special meanings and should be carefully reviewed.

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.

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.

Note

This provides special information to make maintenance easier or important operating instructions more clear.

Read and understand warnings before use of the LEGEND SYSTEM.

Important Safety Instructions: 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 and will void manufacturer’s limited warranty. DO NOT interchange components of the Legend System with components from the Medtronic Midas Rex® Classic Motor System, the Midas Rex® III Motor System or the Mednext® Bone Dissecting System and their associated attachments and dissecting tools. DO NOT operate Legend System in a Magnetic Resonance Imaging Suite. DO NOT use a Legend Motor and Legend Attachments before proper cleaning and sterilization protocol is followed. DO NOT dissect bone without adequate irrigation to prevent thermal necrosis. DO NOT operate the Legend Motor without eyewear protection. DO NOT use Legend System components if damage is apparent or if components do not run properly. The Legend System must be inspected for damage prior to each use. • Conduct a visual inspection of the motor’s exhaust hose for cracks or tears. • Check attachments for proper appearance. Install attachment and dissecting tool, then briefly run motor. • Check motor for overheating and leaking lubricant at motor collet. • Check attachment for overheating. • Check dissecting tool for flail. DO NOT attempt to use an overheating motor or attachment. For metal transection, observe the following safety precautions: a. Eyewear protection is essential. b. Irrigate copiously to cool the cutting surfaces. c. Protect the wound site from metal debris. d. Use a clamp or grasping device to control loose fragments during transection of any metal component. Legend Motors or Legend Attachments which fail due to extended use may as a result of such failing allow a component to detach and fall from the motor or attachment and may cause patient injury. Midas Rex Legend High Speed Pneumatic System

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warning summary

Legend Motors: Heavy side loads may cause overheating of the motor to the point where the motor is uncomfortable to hold. a. Never place an overheated motor on the patient or patient draping during surgery. b. Mitigate the overheating by discontinuing use and rest the motor by using intermittently, or wrap the motor/attachment interface with a moist sterile towel. c. If the motor is passed off, the receiver must grasp the motor by the proximal end close to the motor hose. DO NOT attempt to use a motor that is leaking lubricant. Legend Motors which fail due to extended use and/or lubricant seal failure may allow foreign matter to migrate or emit from the tool collet end of the motor. Non-sterile fluid may leak into the surgical site. As a result, measures may be required to protect the patient from infection, per the physician’s discretion. If a Legend Motor requires servicing or refurbishing, return motor to MPSS. DO NOT attempt to change a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state. DO NOT use a Legend motor if the motor continues to run after releasing the foot pedal or finger control. If a Legend Gold Touch Motor or Legend Pneumatic Control Unit requires servicing or refurbishing, return to MPSS to be refurbished. The Legend Motor’s exhaust hose may have an oily film on the external surface from pressure and/or temperature differentials following sterilization. Wipe exhaust hose with a sterile cloth prior to use. After cleaning, if motor continues to have oil on the exhaust hose, return the motor to MPSS to refurbish. DO NOT place motor, attachment and dissecting tool on the patient or in an unsecured location during surgery. ” position to operate a Legend Gold or Legend Platinum DO NOT use Legend Pneumatic Control Unit finger/foot control in the “ Motor. The control is used in the “ ” position only for the Legend Gold Touch Motor. DO NOT install or remove an attachment and dissecting tool from the Legend Gold Touch unless the safety slide is in the “ ” position. DO NOT remove Legend Gold Touch Motor from Pneumatic Control Unit unless compressed gas has been released from the hoses.

Legend Attachments: DO NOT use a dissecting tool without the appropriate attachment as injury may occur to patient and/or operator. DO NOT use excessive pressure, such as bending or prying, on attachments or dissecting tools. This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff. DO NOT use a Legend Attachment if any part of the attachment appears to be bent, loose, missing or damaged. If a Legend Attachment requires servicing or refurbishing, return attachment to MPSS. DO NOT force or modify any attachment or dissecting tool to fit a Legend Motor. Heavy side loads and/or long operating periods may cause overheating of the attachment to the point where the attachment is uncomfortable to hold. a. Never place an overheated attachment on the patient or patient draping during surgery. b. Mitigate the overheating by discontinuing use and rest the attachment by using intermittently, or wrap the attachment interface with a moist sterile towel. c. If the attachment is passed off, the receiver of the attachment must handle cautiously. Remove Legend Footed Attachments cautiously and slowly per instructions to avoid injury to the operator.

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Midas Rex Legend High Speed Pneumatic System

warning summary

Legend Dissecting Tools: DO NOT use a dissecting tool without the appropriate attachment as injury may occur to patient, operator and/or operating room staff. DO NOT use or re-process a dissecting tool that has already been used. Using a dissecting tool that has already been used may cause injury to the patient, operator and/or operating room staff. Using a dissecting tool that has already been used may affect motor performance and will void manufacturer’s limited warranty. DO NOT use excessive pressure, such as bending or prying, on attachments or dissecting tools. This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff. DO NOT use an attachment and dissecting tool combination if flail or vibration occurs. DO NOT use metal cutting dissecting tools on bone. DO NOT use a twist drill or contra-angle dissecting tool at an operating pressure over 80 psi (5.5 bar). DO NOT use a dissecting tool if the sterile packaging is damaged. If a dissecting tool package is opened, but the tool is not used or contaminated, the tool can be re-sterilized by steam sterilization. Remove tool from all original packaging and place into an approved autoclave package. Steam sterilize as follows: High Vacuum Steam 270° F (132° C) for 5 minutes Gravity Displacement 270° F (132° C) for 15 minutes The re-sterilized tool must be used promptly following re-sterilization. If rust or corrosion is encountered after re-sterilization, do not use the re-sterilized tool. Dissecting tool flutes are sharp and can perforate surgical gloves. Always handle with care. Do not spin, twist, or pull a tool by grasping the flutes. Gently pull on dissecting tool shaft to ensure that it is fully seated and properly installed in motor.

Legend Pneumatic Control Unit: DO NOT use the Legend Pneumatic Control Unit to operate any other systems except for Legend Motors and TRITON® Power Surgical Instrument Systems. DO NOT disassemble equipment before gas pressure is released from Legend Pneumatic Control Unit and associated hoses. DO NOT carry Legend Pneumatic Control Unit by the N2 DISS pressure hose.

Legend Lubricant/Diffuser: Failure to properly secure Legend Lubricant/Diffuser may cause injury to operator and/or operating room staff. During a lengthy surgical procedure with extended motor use, lubricant may drip from lubricant/diffuser.

Midas Rex Legend High Speed Pneumatic System

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6

Midas Rex Legend High Speed Pneumatic System

INTRODUCTION

LEGEND SYSTEM COMPONENTS LEGEND MOTORS: LEGEND GOLD

High speed, high torque pneumatic motor used to dissect bone and biomaterials.

LEGEND GOLD Collet Flats

Motor Case

Collet

LEGEND GOLD TOUCH

High speed, high torque pneumatic motor with a variable speed finger control. This motor may be used to dissect bone and biomaterials. Instruction Manual will use “ ” symbol to indicate information on Legend Gold Touch.

LEGEND PLATINUM

High speed, compact pneumatic motor, with a reduced sound output and slightly decreased power when compared to the Legend Gold and Gold Touch. This motor may be used to dissect bone and biomaterials.

Note

Hose

Swivel

Convertible Angle

LEGEND GOLD TOUCH

Finger Control

Extension Lever

Safety Slide

Collet Flats

Swivel Hose

Collet

Motor Case

Convertible Angle

LEGEND PLATINUM Collet Flats

Motor Case

Collet

Fixed Angle Hose

Swivel

Lubricant/Diffuser Housing

Each Legend Motor has a Lubricant/Diffuser housing at the end of the motor hose. Legend motors and associated hoses do not contain latex.

Warning 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 and will void manufacturer’s limited warranty.

Midas Rex Legend High Speed Pneumatic System

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INTRODUCTION

NON-DISPOSABLE LEGEND ACCESSORIES:

Legend Pneumatic Control Unit

Controls speed of Legend Gold and Platinum Motors with a variable speed foot pedal, provides finger/foot control for operation of the Gold Touch Motor, supplies port for Legend motors and port for Triton® Power Surgical Instrument System. N2 DISS pressure hose is 20’ long. A longer Medtronic Midas Rex N2 DISS pressure hose is available and may be changed on-site.

Legend Pneumatic Control Unit Finger/Foot Control

Supply Pressure

Legend Port N2 DISS Pressure Hose

Triton Port

Legend Port Plug Pressure Relief

Triton Port Plug

Note

Legend Pneumatic Control Unit is provided with a certified Supply Pressure gauge.

Back

Handle

Legend Pneumatic Control Unit has a handle for ease of re-positioning unit while on floor or for carrying unit. A hole is provided in the base for hanging unit on a wall hook. Port plugs are attached to prevent debris ingress when a port is not in use.

Caution • Use Legend Pneumatic Control Unit to operate only the Legend Motors and/or TRITON® Power Surgical Instrument Systems. • Legend Pneumatic Control Unit and pressure hose should not be sterilized.

Legend Regulator

Controls the delivery pressure of compressed gas to the Legend Pneumatic Control Unit. The pressure gauges monitor cylinder pressure (right gauge) and delivery pressure (left gauge).

Foot Pedal

Base Hole

Front

Legend Regulator Cylinder Pressure Gauge

Delivery Pressure Gauge

Legend Instrument Cases

Used to organize, customize and contain Legend equipment. Available in several sizes with individual labeled tray inserts.

8

Legend Instrument Case

Midas Rex Legend High Speed Pneumatic System

INTRODUCTION N2 DISS to Male Schrader Adapter

NON-DISPOSABLE LEGEND ACCESSORIES (continued) Legend Adapters: N2 DISS to MALE Schrader Adapter

N2 DISS to Air DISS Adapter

Allows for the Pneumatic Control Unit’s N2 DISS pressure hose connection to be attached to a Female Schrader in-house gas connection. A N2 DISS to Female Schrader Adapter is also available for connection of the Pneumatic Control Unit’s N2 DISS pressure hose to a Male Schrader in-house gas connection.

N2 DISS to Air DISS Adapter

Allows for the Pneumatic Control Unit’s N2 DISS pressure hose connection to be attached to an Air DISS in-house gas connection.

N2 DISS to WF4 Adapter

Legend Attachment Cleaning Nozzle

N2 DISS to WF4 Adapter

Allows for the Pneumatic Control Unit’s N2 DISS pressure hose connection to be attached to a Midas Rex Safety Valve Regulator previously used for Midas Rex Classic or Midas Rex III Motors. The in-line oiler must be removed from the Safety Valve Regulator.

Legend attachment Cleaning Nozzle

Allows for recommended aerosol spray cleaner to be used in cleaning procedures.

Legend Motor Wrench

Midas Rex Legend High Speed Pneumatic System

Legend MOTOR WRENCH

Used to align arrows on motor collet flats prior to installation of a Legend attachment.

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INTRODUCTION

NON-DISPOSABLE LEGEND ACCESSORIES (continued)

LEGEND ATTACHMENTS - Provides support and stability to the rotating dissecting tool.

Legend® motor attachments are available in various designs to facilitate a variety of surgical procedures. Attachments vary in length, diameter, and overall design. They are marked and color-coded to correspond with their associated dissecting tools. A few of the Legend® attachments available are listed in the table below. Attachment

Example

Standard Straight Attachments

AS09

Standard Angled Attachments

AA14

Straight Variable Exposure Attachments

AVS07

Angled Variable Exposure Attachments

AVA07

Fixed Footed Attachments

AF01

Other Details/Options

.

Rotating Footed Attachments

AF01R

Telescoping Attachments

AT10 (base) The telescoping attachment requires the use of the AT10 attachment TT12A (tube) base, as well as a telescoping tube. Tubes are available in straight, curved, or hooded form.

Contra-Angle Attachment

AC16

Metal Cutting Attachment

ASMC

Perforator Attachment

AD01

5/32” Jacobs Chuck Attachment

AD02

Bone Mill Attachment

BM100

Available in 800 RPM or 1000 RPM form.

Warning 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 and will void manufacturer’s limited warranty.

Note

Angled and straight attachments with the same length, marking and color band share the same dissecting tool. Curved and straight telescoping tubes with the same length, marking and color band share the same dissecting tool. Example: The 14-AM straight and 14-AM angled attachments are 14 cm long, marked 14-AM and have a green color band. All dissecting tools with the prefix 14 (14MH30) may be used in either the 14-AM straight or 14-AM angled attachment. Color band on attachment is for visual reference. Match the nomenclature on the attachment with the nomenclature on the dissecting tool packaging.

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Midas Rex Legend High Speed Pneumatic System

INTRODUCTION

DISPOSABLE LEGEND ACCESSORIES Legend Lubricant/Diffuser

Provides lubrication to Legend Motors, diffuses spent air from motor and filters oil from exhausted air.

Legend Lubricant/Diffuser Diffuser

Caution • DO NOT exceed 1 hour drill time per surgery for a Legend Lubricant/Diffuser. • DO NOT re-use a used Legend Lubricant/Diffuser

Inner Foil Seal for Lubrication Cover

Legend Lubricant/Diffuser is a single use, disposable product. • DO NOT steam or EO sterilize the Legend Lubricant/ Diffuser. The lubricant/diffuser will melt into the lubricant/diffuser housing with potential damage to the motor. The lubricant/diffuser must be removed from the motor’s lubricant/diffuser housing prior to sterilization.

TELESCOPING TUBES

Telescoping Tube

Provides support to the rotating dissecting tool. Telescoping tubes are disposable following multiple uses and should be discarded when heat or excessive vibration is noticed or insertion of tools becomes difficult.

Cleaning Brushes

Used to clean debris from lumen of attachments and telescoping tubes. Sized for an internal bore diameter of 3.2 mm, 2.4 mm or 1.2 mm in Legend Attachments and Telescoping Tubes.

Tube

Cleaning Brushes

3.2 mm

2.4 mm

1.2 mm

Midas Rex Legend High Speed Pneumatic System

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INTRODUCTION

DISPOSABLE LEGEND ACCESSORIES (continued) LEGEND DISSECTING TOOLS

Legend Dissecting Tools’ intended use is for cutting bone and biomaterials. Legend Dissecting Tools are provided as sterile.

Note

Dissecting tool’s size and geometry may contribute to excessive vibration at certain speeds. Increase or decrease speed by changing pressure setting or foot/finger control. Change to a different dissecting tool. Dissecting tools with “L” indentification are longer tools intended for light bone dissection. The increased dissecting tool stem/head configuration may affect dissection stability. Surgeons should familiarize themselves with the performance of the dissecting tools before use.

Caution • • • •

DO NOT use any other dissecting tool other than Legend Dissecting Tools with a Legend Motor. Match the nomenclature and color code on the Legend Dissecting Tool packaging to the same nomenclature and color code on the Legend Attachment. Use only Legend Dissecting Tools with a Legend Motor. Legend Dissecting tools are single use devices.

Warning DO NOT use or re-process a dissecting tool that has already been used. Using a dissecting tool that has already been used may cause injury to the patient, operator and/or operating room staff. Using a dissecting tool that has already been used may affect motor performance and will void manufacturer’s limited warranty. DO NOT use an attachment and dissecting tool combination if tool flail or excessive vibration occurs. DO NOT use a twist drill or contra-angle dissecting tool at an operating pressure over 80 psi (5.5 bar).

Note Match the nomenclature and color code on the Legend Dissecting Tool packaging to the same nomenclature and color code on the Legend Attachment.

Legend Dissecting Tool Nomenclature: 9MH30

9 cm attachment length for use in 9-M attachment Match Head dissecting tool tip design

7 cm attachment length for use in 7-6ST straight or angled attachment

Classic legacy nomenclature (reference only)

7BA40-MN

Mednext tip design 4.0 mm dissecting tool head diameter

≈ 24B6ST

Mednext legacy nomenclature (reference only)

Ball dissecting tool tip design 8 cm attachment length for use in F2-B1 footed attachment or 8-B attachment

≈ M-8

3.0 mm dissecting tool head diameter

F2/8TA23

2.3 mm dissecting tool head diameter

≈ B-1

Classic legacy nomenclature (reference only)

Tapered dissecting tool tip design

8TD114

8 cm attachment length for use in 8-B attachment Twist Drill dissecting tool tip design 12

4.0 mm depth stop 1.1 mm dissecting tool head diameter

Midas Rex Legend High Speed Pneumatic System

INTRODUCTION

DISPOSABLE LEGEND ACCESSORIES (continued) Additional Dissecting Tool Identification following Dissecting Tool Head Diameter Diamond Coated Dissecting Tools:

Available in:

D Diamond, e.g., 15MH30D DC Diamond, coarse, e.g., 10BA50DC DX Diamond, extra coarse, e.g., 15CY65DX

Ball Dissecting Tools:

Available in: L F C

Ball – Diamond

Match Head – Diamond, coarse

Long ball - elongated tool stem, e.g., 7BA20L-MN Fine ball - fine fluted head, e.g., 7BA40F-MN Carbide ball, e.g., 7BA40C-MN

Tapered Dissecting Tools:

Cylinder – Diamond, extra coarse

Available in: S

Spiral cutting flute, e.g., F2/8TA23S

Cylinder Dissecting Tools:

Available in: L B

Long cylinder - elongated cylinder head design, e.g., 14CY50L Ball tip cylinder - rounded tip design on cylinder shape, e.g., 14CY50B

Midas Rex Legend High Speed Pneumatic System

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INTRODUCTION General Guidelines For Attachment and Tool Applications

These are general guidelines for dissecting tool applications and are not an all-inclusive listing. SURGERY

COMMONLY USED LEGEND ATTACHMENTS COMMONLY USED TYPES OF LEGEND DISSECTING TOOLS

SUGGESTED LEGEND MOTOR(S)

SPINE Match Head Elongated spherical design allows controlled, delicate dissection. For laminotomy, foramenotomy, entry hole, nerve decompression, osteophyte removal… Ball Helical cutting flutes dissect bone from a variety of approach angles. For debridement, decortication, corpectomy, osteophyte removal…

8-B 9-M 14-AM straight or angled 15-A straight or angled

Oval Helical cutting flutes and curved design blend acorn and ball styles to vary dissection efficiency with approach angle. For decortication, laminotomy, entry hole, nerve decompression, osteophyte removal… Hole Maker/Saw Matched sets of Hole Makers and Hole Saws are efficient and effective for interbody fusion… Cylinder Effective bone sculpturing and planing. For graft shaping, debridement corpectomy, decortication, interbody fusion, fusion takedown…

Legend Gold Legend Gold Touch

Acorn Curved designs varies dissection efficiency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown…

Telescoping

Match Head Elongated spherical design allows controlled, delicate dissection. For laminotomy, foramenotomy, entry hole, nerve decompression, osteophyte removal…

Footed

Tapered Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, laminectomy…

NEUROSURGICAL – CRANIAL Match Head Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, mastoidectomy, acoustic neuroma, skull base…

7-6ST straight or angled 8-B 9-M 10-9ST straight or angled 14-AM straight or angled 15-A straight or angled

Ball Helical cutting flutes dissect bone from a variety of approach angles. For debridement, decortication, entry hole, nerve decompression, mastoidectomy, acoustic neuroma… Twist Drill Helical design with stop produces a hole with a precise depth. Ideal for plating…

Legend Gold Legend Platinum

Acorn Curved design varies dissection efficiency with varied approach angles. For entry hole, bone shaping, debridement…

14

Telescoping

Match Head Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, mastoidectomy, acoustic neuroma, skull base…

Footed

Tapered Slender design for precise dissection with minimal bone loss. For craniotomy, transection, osteotomy…

Midas Rex Legend High Speed Pneumatic System

INTRODUCTION

General Guidelines For Attachment and Tool Applications (continued) These are general guidelines for dissecting tool applications and are not an all-inclusive listing. SURGERY

COMMONLY USED LEGEND ATTACHMENTS COMMONLY USED TYPES OF LEGEND DISSECTING TOOLS

SUGGESTED LEGEND MOTOR(S)

GENERAL SURGERY and PLASTIC SURGERY (CRANIOFACIAL/MAXILLOFACIAL/STERNOTOMY) Match Head Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection…

7-6ST straight or angled 8-B 9-M 10-9ST straight or angled 14-AM straight or angled

Ball Helical cutting flutes dissect bone or cement effectively from a wide variety of approach angles. For debridement, decortication, sinus dissection…

Legend Gold Legend Platinum

Tapered Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, entry hole, suture hole, midface advancement… Twist Drill Helical design with stop produces a hole with a precise depth. Ideal for plating…

EAR, NOSE and THROAT 7-6ST straight or angled 10-9ST straight or angled

Ball Helical cutting flutes dissect bone or cement effectively from a wide variety of approach angles. For debridement, decortication, mastoidectomy, facial recess, cochlear implant bed, ossiculoplasty, labyrinthectomy, middle fossa approach, acoustic neuroma…

Legend Platinum

ORTHOPAEDICS Ball Helical cutting flutes dissect bone or cement effectively from a wide variety of approach angles. For debridement, decortication, cement removal, acetabular revision…

8-B 9-M 14-AM straight or angled 21-TU 26-R Footed Telescoping

Tapered Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping, suture hole… Acorn Curved designs varies dissection efficiency with varied approach angles. For bone shaping, debridement, decortication, cement removal, acetabular revision…

Legend Gold Legend Gold Touch

Cylinder Effective bone sculpturing and planing. For graft shaping, debridement, decortication, cement removal, acetabular revision…

Footed

Tapered Slender design for precise dissection with minimal bone loss. For transection, osteotomy, graft harvesting, bone shaping…

BIOMETALS/BIOCERAMICS/BIOMATERIALS MC

Metal Cutter Cutting flutes or diamond wheel design remove metals, ceramics and other biomaterials effectively from a variety of approach angles. For cutting rods, pins, plates, implants, screws…

Midas Rex Legend High Speed Pneumatic System

Legend Gold Legend Gold Touch Legend Platinum

15

OPERATING ROOM SET UP

POWER SOURCE REQUIREMENTS Motors

Required Operating (Dynamic) Pressure

Nominal Operating (Dynamic) Pressure

Approximate Flow Rate Required

Gas Type

Legend Gold

80 – 120 psi

100 psi

12 cubic feet/min

Nitrogen or Dry-Filtered

5.5 – 8.3 bar

6.9 bar

340 liters/min

Compressed Air

Legend Gold Touch

80 – 120 psi

100 psi

12 cubic feet/min

Nitrogen or Dry-Filtered

5.5 – 8.3 bar

6.9 bar

340 liters/min

Compressed Air

Legend Platinum

80 – 120 psi

100 psi

12 cubic feet/min

Nitrogen or Dry-Filtered

5.5 – 8.3 bar

6.9 bar

340 liters/min

Compressed Air

Caution DO NOT run a Legend Motor at an operating pressure below or above the required operating pressure range. Operating pressure below 80 psi (5.5 bar) may not provide proper lubrication to the motor. Operating pressure above 120 psi (8.3 bar) may damage or reduce the life of the motor.

SYSTEM CONNECTIONS - Assembly for In-House Compressed Gas Source In-house Gas Source with N2 DISS

In-house Gas Source with Female Schrader

N2

Pressure regulated in-house gas source with Female Schrader connection

N2

N2

Pressure regulated in-house gas source with N2 DISS connection

N2

N2 DISS to Male Schrader Adapter N2 DISS Pressure Hose

N2 DISS Pressure Hose

Pneumatic Control Unit

Pneumatic Control Unit

In-house Gas Source with N2 DISS connects to N2 DISS Pressure Hose on Pneumatic Control Unit.

In-house Gas Source with Female Schrader connects to the N2 DISS to Male Schrader Adapter. Connect Adapter to N2 DISS Pressure Hose on Pneumatic Control Unit.

In-house Gas Source with Air DISS AIR

AIR

N2

N2

Pressure regulated in-house gas source with Air DISS

N2 DISS to Air DISS Adapter

N2 DISS Pressure Hose

Pneumatic Control Unit

In-house Gas Source with Air DISS connects to the N2 DISS to Air DISS Adapter. Connect Adapter to N2 DISS Pressure Hose on Pneumatic Control Unit. 16

Midas Rex Legend High Speed Pneumatic System

OPERATING ROOM SET UP

POWER SOURCE REQUIREMENTS (continued)

SYSTEM CONNECTIONS - Assembly for Cylinder Compressed Gas Source Cylinder with Legend Regulator Cylinder Pressure Gauge Delivery Pressure Gauge

Adjust Pressure Handle N2

N2

DISS Pressure Hose

CGA 580 Fitting Legend Regulator Pneumatic Control Unit

Cylinder with Legend Regulator connects to N2 DISS Pressure Hose on Pneumatic Control Unit

Cylinder with Midas Rex Safety Valve Regulator Step 1 Remove In-Line Oiler.

Step 2 a. The N2 DISS to WF4 Adapter connects to the Regulator. b. Connect the elbow adapter to the regulator, then connect the N2 straight adapter to the elbow adapter. c. Connect Pneumatic Control Unit Pressure Hose on to the N2 DISS Adapter.

DISS/WF4 Adapter

OFF

N 50 50

N2

DISS Pressure Hose

In-line Oiler

Remove In-Line Oiler with connecting pipe

Safety Valve Regulator

Caution Do not use MIDAS REX In-line oiler system with the Legend System.

Midas Rex Legend High Speed Pneumatic System

Pneumatic Control Unit

Safety Valve Regulator with In-line Oiler Removed

17

pre-operative procedures 1. Set Legend System non-running (static) pressure between 80–120 psi (5.5–8.3 bar) at compressed gas source. Operating (dynamic) pressure may be adjusted as needed when the motor has an attachment and dissecting tool installed and is running. (See Pre-operative Procedure #9) 2. a. Remove cover from Lubricant/Diffuser. b. Do not remove inner foil seal of Lubricant/Diffuser.

2a

2a

4. Rotate Lubricant/Diffuser from “ ” position to “ ” position. It will come to a complete stop with a tactile click when it is fully seated and locked into the housing.

4

Warning Failure to properly secure Legend Lubricant/Diffuser may cause injury to operator and/or operating room staff.

Note The lubrication rate is pre-set by the factory and, therefore, should not be altered. Cartridges should not be left under pressure for more than 4 hours. If this occurs, an audible air leak may be heard from the diffuser housing. If the cartridge has been pressurized for longer than 4 hours, it should be replaced.

3. Insert Lubricant/Diffuser into lubricant/diffuser housing located at base of motor hose.

Caution 3

• DO NOT use a Legend Motor without a lubricant/diffuser installed in the motor’s lubricant/diffuser housing. • DO NOT use a Legend Lubricant/Diffuser if it appears to be damaged or if inner foil seal is punctured. • DO NOT exceed 1 hour drill time per surgery for a Legend Lubricant/Diffuser. • DO NOT attempt to remove Legend Lubricant/Diffuser while the motor is in operation. • DO NOT re-use a used Legend Lubricant/Diffuser. Legend Lubricant/Diffuser is a single use, disposable product. • DO NOT refill a used Legend Lubricant/Diffuser. • DO NOT steam or EO sterilize the Legend Lubricant/ Diffuser. The lubricant/diffuser will melt into the lubricant/diffuser housing with potential damage to the motor. The lubricant/ diffuser must be removed from the motor’s lubricant/ diffuser housing prior to sterilization.

Do not sterilize. Lubricant/diffuser will melt. 18

Midas Rex Legend High Speed Pneumatic System