LEGEND EHS Electric High Speed System Instruction Manual Rev7

GLOSSARY OF UNIVERSAL SYMBOLS

w

Attention: See Instructions for use

Unlock

j

Part Number / Catalog number / Reference Number

Lock

U.S. audience only / Rx only For Caution: Federal Law (USA) restricts this device to sale by or on the order

D

On

C

Off

of a physician AC Power

l

Lot Number

n

Serial Number

O

Quantity

a

Single use only; do not reuse

@

Foot Control

=

Is approximately equal to

$

Speed Increase

S

Non-sterile.

%

Speed Decrease

Q

Sterilized by gamma irradiation

U m q

p

y

#

h

Type BF Handpiece

Equipotential Point

Use by date

i

Date of Manufacture

s Forward (default) / Reverse selector

Manufacturer

r

Authorized Representative in the European Community

e

Conformité Européene (European Conformity)

Storage Temperatures Protective Earth

DO NOT Dispose to unsorted municipal waste TOOL

Tool Control

TUBE

Tube Control

This symbol means that the device fully complies with European Council Directive MDD 93/42/EEC.

High Voltage Irrigation

Fuse

g

v

EMC Compliance Mark UL Mark UL Classified with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 2FF7 UL Classified for Canada with respect to electric shock, fire, mechanical, and other hazards only in accordance with CAN/CUSA C22.2 UL 601-1 Medical Equipment Certified for Canada 2FF7

English

TABLE OF CONTENTS

GENERAL OPERATING GUIDELINES... 2 WARNING SUMMARY... 3 INTRODUCTION – Legend EHS System Components... 6 Legend EHS Motors... 6 Non-Disposable Legend EHS Accessories... 6 Legend EHS Console... 6 Legend EHS Cables... 7 Legend EHS Instrument Case... 7 Legend Attachment Cleaning Nozzle... 8 Legend Motor Wrench... 8 Legend EHS Foot Control... 8 Legend Attachments... 9 Disposable Legend EHS Accessories... 10 Legend Dissecting Tools... 10 Cleaning Brushes... 11 General Guidelines for Attachment and Dissecting Tool Applications... 12 – 13 OPERATING ROOM SET UP... 14 Power Source Requirements... 14 PRE-OPERATIVE PROCEDURES... 15 LEGEND EHS MOTOR FEATURES... 19 POST-OPERATIVE PROCEDURES... 20 Disassembly of Equipment... 20 Cleaning... 21 Sterilization Guidelines for Legend EHS Motors, Motor Cables, Attachments and Telescoping Tubes... 23 LEGEND ATTACHMENTS AND DISSECTING TOOLS... 24 Straight Attachments... 24 Angled Attachments... 25 Footed Attachments... 26 Contra-Angle Attachment... 27 Metal Cutting Attachment... 28 Telescoping Attachment... 29 Perforator Attachment... 30 Jacobs Chuck Attachment... 31 TECHNICAL INFORMATION... 32 Legend EHS System Classification and Rating... 32 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions... 32 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity... 33 Legend EHS System Troubleshooting... 34 Legend EHS Console Error Codes... 40 LEGEND EHS SERVICE AND WARRANTY... 41

Midas Rex Legend EHS System

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GENERAL OPERATING GUIDELINES The MIDAS REX® LEGEND EHS® – Electric High Speed System (“Legend EHS System”) is intended for use in surgical procedures for the following medical applications: Neurosurgical Spine Orthopaedic Surgery General Surgery ENT Maxillofacial Craniofacial Contraindication: None The Legend EHS System is comprised of the following: Legend EHS Motor, Legend EHS Stylus Motor Legend EHS Console Legend EHS Foot Control Legend EHS Cables Legend Attachments Legend Dissecting Tools – single use, disposable

NOTE

The Legend EHS System is designed to be used with Legend Attachments and Dissecting Tools.

Read and understand this instruction manual before use of the LEGEND EHS SYSTEM. The Legend EHS Motors are described in this Instruction Manual as the “Legend EHS Motor” or “EHS Motor”. The Legend EHS Stylus Motor is described as the “Stylus Motor.” The LEGEND EHS 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, associated attachments, and dissecting tools, by being trained in Midas Rex® Institute Hands-On Workshops or by one of the local authorized representatives. If Legend EHS components require servicing or refurbishing, contact Medtronic Powered Surgical Solutions Repair Services for a return authorization and instructions for returning the components. Medtronic Powered Surgical Solutions provides quality assured service by factory-trained personnel who will utilize genuine MIDAS REX® LEGEND EHS® parts as required. All Legend EHS motors, motor cables, and attachments returned for servicing or refurbishing should be properly cleaned and sterilized prior to shipping according to the directions provided in this Instruction Manual.

/ 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 EHS Instruction Manual, or contact your Medtronic Neurologic Technologies sales representative, or call: Medtronic Powered Surgical Solutions Technical Support: 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 Medtronic Regional Distributor or Medtronic Neurological Sales Representative. Environmental conditions for transport and storage: Ambient temperature of between -40°C and 70°C, Relative humidity between 30% and 75%, Atmospheric pressure between 500 hPa and 1060 hPa. 2

Midas Rex Legend EHS System

w 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.

NOTE

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

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.

Read and understand warnings before use of the LEGEND EHS SYSTEM.

Important Safety Instructions: NOTE

The surgeon should become familiar with the operational characteristics of each tool and attachment combination at various speeds prior to use.

WARNING

General: DO NOT use any other components except for Midas Rex Legend Attachments, Legend Dissecting Tools and Legend accessories in combination with a Legend EHS or Stylus Motor. Use of devices with other than Legend EHS Systems or associated parts or components may cause injury to the patient, operator and/or operating room staff. Use of devices with other than Legend EHS 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 EHS System with components from the 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 the Legend EHS System in a Magnetic Resonance Imaging Suite. DO NOT use Legend EHS Motors or Legend Attachments before following proper cleaning and sterilization protocols. DO NOT dissect bone without adequate irrigation to prevent thermal necrosis. DO NOT operate the Legend EHS Motors without protective eyewear. DO NOT attempt to run the Legend EHS motors immediately after autoclaving. Allow an adequate "cool down" period (Typically 1 hour). DO NOT use the Legend EHS System in the presence of flammable anesthetics. DO NOT use Legend EHS System components if damage is apparent or if components do not run properly. The Legend EHS System must be inspected for damage prior to each use. • Conduct a visual inspection of the cables for cracks, tears or corrosion. • Check attachments for proper appearance. Install attachment and dissecting tool, then briefly run motor. • Check motor for overheating. • Check attachment for overheating. • Check dissecting tool for flail. • Check for bent or missing pins in cable connectors. DO NOT attempt to use an overheating motor or attachment. Consult the Legend Bone Mill product insert before use with the Legend EHS System. For metal transection, observe the following safety precautions: a. Protective eyewear 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 EHS 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. Electrical contacts must be properly dried prior to use.

Midas Rex Legend EHS System

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WARNING SUMMARY

WARNING SUMMARY

Legend EHS 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 or attachment 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, when not in use, 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 cable. 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 EHS System if the motor continues to run after releasing the foot pedal. If a Legend EHS System requires servicing or refurbishing, return system to Medtronic Powered Surgical Solutions. DO NOT immerse the Legend EHS System Motor or Cables. DO NOT place motor, attachment and dissecting tool on the patient or in an unsecured location during surgery. DO NOT kink EHS motor cables.

Legend EHS Console: DO NOT open or disassemble the console. There are no user serviceable parts inside. Refer all servicing to Medtronic Powered Surgical Solutions. DO NOT immerse the console. DO NOT sterilize. DO NOT connect any cables or equipment to the console unless the cables and equipment are approved for use by Medtronic Powered Surgical Solutions as documented in the appropriate Instructions for Use and Classified by UL for use with this system.

Legend Attachments: DO NOT use a dissecting tool without the appropriate attachment as injury may occur to the patient and/or operator. DO NOT use excessive pressure, such as bending or prying, on attachments or dissecting tools. This may cause the tool to bend or break and cause injury to the 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 Medtronic Powered Surgical Solutions. DO NOT force or modify any attachment or dissecting tool to fit a Legend EHS or Stylus Motor. Consult the Legend Bone Mill product insert before use with the Legend EHS System. 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 the attachment cautiously. Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.

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Midas Rex Legend EHS System

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 re-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 speed over 62,000 rpm. 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. Remove tool from 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 EHS Foot Control: DO NOT use the Legend EHS foot control to operate any systems other than Legend EHS. DO NOT open or disassemble the Foot Control. There are no user serviceable parts inside. Refer all servicing to Medtronic Powered Surgical Solutions. DO NOT sterilize the Foot Control.

Legend EHS Foot Control Cables and Motor Cables: DO NOT use cables with cracks, tears or corrosion. DO NOT use cables with bent or missing connector pins. DO NOT kink EHS cables.

Legend EHS Power Cable: DO NOT use power cable with cracks, tears or corrosion. DO NOT use power cable with bent or missing connector pins.

Midas Rex Legend EHS System

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WARNING SUMMARY

INTRODUCTION

LEGEND EHS COMPONENTS LEGEND EHS MOTOR

LEGEND EHS MOTOR High speed, high torque, reversible electric motor used to dissect bone and biomaterials at selectable speeds from 10,000 to 75,000 rpm.

LEGEND STYLUS MOTOR

LEGEND STYLUS MOTOR

A smaller compact high speed, high torque, reversible electric motor used to dissect bone and biomaterials at selectable speeds from 3,000 to 75,000 rpm. The Stylus motor cable is integral with the Handpiece and is not removable from the motor.

NOTE Legend EHS Motors and associated cables do not contain latex.

WARNING DO NOT use any other components except for Midas Rex® Legend® Attachments, Legend Dissecting Tools, and Legend accessories in combination with Legend EHS Motors. Use of devices other than Legend EHS System or associated parts or components may cause injury to the patient, operator and/or operating room staff. Use of devices other than Legend EHS System or associated parts or components will damage the motor and attachments and will void manufacturer’s limited warranty.

LEGEND EHS CONSOLE

NON-DISPOSABLE LEGEND ACCESSORIES:

Power Switch

Handpiece Connector

No-Load Speed Setting UP & DOWN buttons

Foot Control Connector

Display

LEGEND EHS CONSOLE Controls the no-load speed of the Legend EHS Motors in a range of speed from 10,000 rpm for EHS motor and from 3,000 rpm for Stylus motor up to 75,000 rpm. The digital display indicates motor type, speed setting, and forward or reverse direction when the console is powered " |", but the motor is not operating. When operating the motor, the motor speed is displayed.

Air Vents

Irrigation Port

Power Cord 6

Fuse Drawer

Equipotential Point

Power Module

Midas Rex Legend EHS System

NON-DISPOSABLE LEGEND ACCESSORIES (continued) Legend EHS Cables

Legend EHS Cables

LEGEND EHS MOTOR CABLE Connects the EHS motor / handpiece to the console. The cable is 4.57 meters (15 feet) in length and color-coded green with a 4-pin connection. EHS Motor cables are available with and without special console-end grounding connector (black boot).

STYLUS MOTOR/CABLE ASSEMBLY

Black Boot

EHS Handpiece Cables

Stylus Handpiece & Cable

Power Cord

Green Boots

Connects the Stylus motor / handpiece to the console and grounds the handpiece. The cable is 4.57 meters (15 feet) in length and color-coded black with a 4-pin connection. The Stylus Motor Cable is integral with the Handpiece and is not removable from the motor.

Gold Boots

LEGEND EHS FOOT CONTROL CABLE Connects foot control to the console. The cable is 4.57 meters (15 feet) in length and color-coded gold with a 6-pin connection.

Foot Control Cable

Black Boot EHS Motor Cable without Ground (both ends)

LEGEND EHS CONSOLE POWER CABLE Connects console to the wall electrical source.

LEGEND INSTRUMENT CASE Used to organize, customize, and contain Legend equipment. Available in a 3/4 DIN size with an individually labeled insert tray.

Green Boot Locking Ring

EHS Motor Cable with Ground (console end) Black Boot

Legend Instrument Case

Stylus Motor Cable (console end) Black Boot

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INTRODUCTION

INTRODUCTION

NON-DISPOSABLE LEGEND ACCESSORIES (continued) Legend Attachment Cleaning Nozzle

LEGEND ATTACHMENT CLEANING NOZZLE Allows recommended aerosol spray cleaner to be used in cleaning procedures.

Legend Motor Wrench

LEGEND MOTOR WRENCH Used to align arrows on motor collet flats prior to installation of a Legend Attachment.

LEGEND EHS FOOT CONTROL

LEGEND EHS FOOT CONTROL A variable position foot pedal with a reverse rotation button. Legend EHS Foot Control has an optional available hoop for ease of re-positioning the foot control on the floor.

CAUTION • • •

Use Legend EHS Foot Control to operate only the Legend EHS Motors. DO NOT autoclave Legend EHS Foot Control or Foot Control Cable. DO NOT carry Legend EHS Foot Control by the cable.

FOOT CONTROL COVER Optional hoop for ease of repositioning the foot control on the floor.

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Midas Rex Legend EHS System

NON-DISPOSABLE LEGEND ACCESSORIES (continued) LEGEND ATTACHMENTS - Provides support and stability to the rotating dissecting tool. LEGEND ATTACHMENTS

REORDER NUMBER

MARKING

STRAIGHT ATTACHMENTS

AS07

7-6ST

APPROX. LENGTH

INTERNAL DIAMETER

COLOR BAND

7 cm

2.4 mm

Yellow

AS08

8-B

8 cm

2.4 mm

Red

AS09

9-M

9 cm

3.2 mm

Blue

AS10

10-9ST

10 cm

2.4 mm

Purple

AS14

14-AM

14 cm

3.2 mm

Green

AS15

15-A

15 cm

2.4 mm

Orange

AS21

21-TU

21 cm

3.2 mm

Ochre

AS26

26-R

26 cm

3.2 mm

Gray

AA07

7-6ST

7 cm

2.4 mm

Yellow

AA10

10-9ST

10 cm

2.4 mm

Purple

AA14

14-AM

14 cm

3.2 mm

Green

AA15

15-A

15 cm

2.4 mm

Orange

AF01

F1-B5

9 cm

2.4 mm

Light Green

AF02

F2-B1

10 cm

2.4 mm

Light Blue

AF03

F3-S

12 cm

3.2 mm

White

AT10

-

-

-

-

TUBE – STRAIGHT

TT9

T9

9 cm

1.2 mm

Teal

TUBE – CURVED

TT9C

T9

9 cm

1.2 mm

Teal

TUBE – STRAIGHT

TT12

T12

12 cm

1.2 mm

Light Purple

TUBE – CURVED

TT12C

T12

12 cm

1.2 mm

Light Purple

TUBE – STRAIGHT

TT15

T15

15 cm

1.5 mm

Brown

TUBE – STRAIGHT

TT17

T17

17 cm

1.5 mm

Navy Blue

CONTRA-ANGLE ATTACHMENT

AC16

16-MF

16 cm

3.2 mm

Pink

METAL CUTTING ATTACHMENT

ASMC

MC

9 cm

3.2 mm

Peach

PERFORATOR ATTACHMENT - 800 rpm

AD01

Perforator Driver

13 cm

N/A

None

5/32" JACOBS CHUCK ATTACHMENT

AD02

Jacobs Chuck

12 cm

N/A

None

PERFORATOR ATTACHMENT - 1000 rpm

AD03

Perforator Driver

13 cm

N/A

None

ANGLED ATTACHMENTS

FOOTED ATTACHMENTS

TELESCOPING ATTACHMENT TELESCOPING ATTACHMENT BASE

Refer to LIT 250006EN for a complete list of attachments and tools.

w WARNING DO NOT use any other components except for Midas Rex® Legend® Attachments, Legend Dissecting Tools and Legend accessories in combination with a Legend EHS or Stylus Motor. Use of devices other than Legend EHS Systems or associated parts or components may cause injury to the patient, operator and/or operating room staff. Use of devices other than Legend EHS Systems or associated parts or components will damage the motor and attachments and will void manufacturer’s limited warranty.

NOTE

Legend Attachments and Legend Dissecting Tools must be used with the Legend EHS System or with the Legend® Pneumatic High Speed System consisting of the Legend Gold, Gold Touch and Platinum Motors. Installation and removal of the attachments and dissecting tools are identical for all Legend Motors. Angled and straight attachments with the same length, marking and color band share the same dissecting tools. Curved and straight telescoping tubes with the same length, marking and color band share the same dissecting tools. 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 before matching the color band on the attachment with the dissecting tool packaging. Midas Rex Legend EHS System

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INTRODUCTION

INTRODUCTION

DISPOSABLE LEGEND ACCESSORIES LEGEND DISSECTING TOOLS: Legend Dissecting Tools’ intended use is for cutting bone and biomaterials. Legend Dissecting Tools are provided as sterile. Legend Dissecting Tools must only be used with the Legend EHS System, consisting of the EHS and Stylus motors, or with Legend Pneumatic High Speed System, consisting of the Legend Gold, Gold Touch, and Platinum motors.

NOTE • The surgeon should become familiar with the operational characteristics of each tool and attachment combinationat various speeds prior to use. • Dissecting tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new dissecting tool. • Dissecting tools with “L” identification are longer tools intended for light bone dissection. The increased dissecting tool head/stem configuration may affect dissection stability. • Surgeons should familiarize themselves with the performance of the dissecting tools before use.

CAUTION • DO NOT use any dissecting tools other than Legend Dissecting Tools with a Legend EHS or Stylus Motor. • Match the nomenclature and color code on the Legend Dissecting Tool packaging to the same nomenclature and color code on the Legend Attachment. •

a Legend Dissecting tools are single use devices.

WARNING • DO NOT re-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 flail or vibration occurs. • DO NOT use a twist drill or contra-angle dissecting tool at an operating speed over 62,000 rpm.

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:

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Midas Rex Legend EHS System

DISPOSABLE LEGEND ACCESSORIES (continued) Additional Dissecting Tool Identification following Dissecting Tool Head Diameter DIAMOND COATED DISSECTING TOOLS:

Ball – Diamond

Available in: D

Diamond, e.g., 15MH30D

DC

Diamond, coarse, e.g., 10BA50DC

DX

Diamond, extra coarse, e.g., 15CY65DX

BALL DISSECTING TOOLS:

Match Head – Diamond, coarse

Available in: L

Long ball - elongated tool stem, e.g., 7BA20L-MN

F

Fine ball - fine fluted head, e.g., 7BA40F-MN

C

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

Long cylinder - elongated cylinder head design, e.g., 14CY50L

B

Ball tip cylinder - rounded tip design on cylinder shape, e.g., 14CY50B

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

Telescoping Tube

Tube

Cleaning Brushes 3.2 mm

2.4 mm

1.2 mm

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INTRODUCTION

INTRODUCTION GENERAL GUIDELINES FOR ATTACHMENT AND DISSECTING 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

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…

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

Telescoping

Footed

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

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…

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

Telescoping

Footed

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

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

Midas Rex Legend EHS System

GENERAL GUIDELINES FOR ATTACHMENT AND DISSECTING 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

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

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…

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

Twist Drill Helical design with stop produces a hole with a precise depth. Ideal for plating…

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…

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…

ENT 7-6ST straight or angled

Ball Helical cutting flutes dissect bone effectively from a wide variety of approach angles. For mastoidectomy, acoustic neuroma, cochlear implant, labyrinthectomy...

BIOMETALS/BIOCERAMICS/BIOMATERIALS MC

Midas Rex Legend EHS System

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…

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INTRODUCTION

OPERATING ROOM SET UP

POWER SOURCE REQUIREMENTS Electrical Power Requirements for Legend EHS System:

100-240 Vac, 50/60 Hz, 2 A

SYSTEM CONNECTIONS: Console Power Cable styles available for various countries: Continental Europe:

North America: USA, Barbados, Belize, Bolivia, Canada, Columbia, Ecuador, Venezuela

Japan EA603

EA600 United Kingdom, Ireland, Hong Kong, Malaysia, Singapore

Austria, Belgium, Finland, France, Germany, Greece, Korea, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden

EA602

Switzerland

Australia, New Zealand

EA601

EA605

Israel

Italy, Chile

China

EA609

EA611

EA604

Denmark

India, South Africa

Argentina

EA610

EA607

EA608

EA606

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Midas Rex Legend EHS System

1. Connect Legend EHS Console to electrical power source. Place Legend EHS Console on a flat, stable surface. DO NOT block air vents in back of console. Connect the Legend EHS Console Power Cable to the power receptacle on the back of the Legend EHS Console. Connect other end of Legend EHS Console Power Cable to a properly grounded electrical power source.

Air Vents 3. Connect Legend EHS Motor Control Cable. The Legend EHS Motor Control Cable Boot and the console’s motor receptacle are both color-coded green. Connect the Legend EHS Motor Control Cable (EA200) to the Legend EHS Motor. Insert the other end of the cable into the motor receptacle on the front of the Legend EHS console by aligning red dots. The Stylus Motor Control Cable is integral with the Handpiece and is not removable from the motor. Insert the console end (black boot) into the motor receptacle on the front of the Legend EHS Console.

2. Connect Legend EHS Foot Control Cable.

Red Alignment Dots

The Legend EHS Foot Control Cable Boot and the console’s foot control receptacle are both color-coded gold. Connect either end of the Legend EHS Foot Control Cable, by aligning the red dots, to the Legend EHS Foot Control Unit. Insert the other end of the cable into the foot control receptacle on the front of the console by aligning red dots.

CAUTION DO NOT carry or drag the foot control by the cable.

Midas Rex Legend EHS System

4. Turn on the Legend EHS Console. Turn the power switch on the Legend EHS Console to the " D " position. A green indicator light will come on inside the power switch. Listen for beeps at start-up of console. The console digital display will show the default no-load speed setting of 70,000 rpm for the EHS motor or 60,000 rpm for the Stylus motor, in the forward direction.

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PRE-OPERATIVE PROCEDURES

PRE-OPERATIVE PROCEDURES

5. Check alignment of arrows on motor collet flats. Prior to installation of a Legend Attachment and Dissecting Tool onto the Legend EHS or Stylus Motor, ensure that arrows on the motor collet flats are in proper alignment.

6. Install a Legend Attachment and Dissecting Tool. Straight attachment installation is listed below. For more detailed information on all the various attachment and dissecting tool installation procedures, refer to the Attachment and Dissecting Tool Section.

Aligned a. Slide straight attachment over motor collet aligning triangular arrows on the attachment and motor case. A tactile and audible click will be observed when the attachment is fully seated.

a

Unaligned Rotational Collet

Stationary Collet

If the arrows are not aligned, use the Legend Motor Wrench to turn the rotational collet (closest to the motor case) until its arrow is aligned with the arrow on the stationary collet (farthest away from the motor case.)

b. Insert the dissecting tool into the attachment with a slight rotational motion. A tactile and audible click is observed indicating that the tool is fully seated.

b

CAUTION Match the nomenclature and color code on the Legend Dissecting Tool packaging to the same nomenclature and color on the Legend Attachment. Allow adequate “cool down” period following steam sterilization.

NOTE A Legend Attachment will not seat onto the Legend EHS or Stylus Motor if the arrows on the collet flats are not aligned. DO NOT use any other components except for the Legend Motor Wrench to align arrows on motor collet.

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Midas Rex Legend EHS System

c. Rotate attachment to the " " position on the motor case. Attempt to pull the tool out of the attachment to ensure that it is properly locked into place. If the tool does not rotate freely, unlock the attachment, re-seat the tool and lock the attachment.

c

To adjust the motor no-load speed setting, stop operation of the motor. Use the increase or decrease arrows on the Legend EHS Console to set desired speed. The no-load speed setting is the speed of the motor when it is operational, but not cutting bone. Once the cutting of bone begins, the speed will decrease depending on how aggressive a cut is being made.

NOTE The Legend EHS and Stylus Motors attempts to maintain a known starting position for the dissecting tool. This may result in a small rotational movement of the tool, if it is rotated away from the starting position. This is normal operation and should not cause undue alarm nor does it indicate that the system is malfunctioning.

CAUTION Legend EHS and Stylus Motors should only be operated when the attachment is in the " " position.

DO NOT use a twist drill or contra-angle dissecting tool at an operating speed over 62,000 rpm. 7. Operation of the Legend EHS Motors. Activate the Legend EHS and Stylus Motors by depressing the foot pedal on the Legend EHS Foot Control.

NOTE

The no-load speed setting of the motor may only be changed when the motor is not running and has come to a complete stop. Duty Cycle (To avoid overheating): For continuous use in operating room temperatures up to 40°C (104°F), the Legend EHS Motor model EM-100A is rated for a cutting time of 3 minutes, model EM100 is rated for 90 seconds, both at 70,000 rpm, and the Stylus Motor is rated for 3 minutes at 60,000 rpm, all followed by 25 minutes of rest. For normal operating room temperatures (typically 20°C / 68°F) the Legend EHS Motor model EM100-A is rated for a continuous cutting time of 10 minutes and the model EM100 is rated for 3 minutes, both followed by 25 minutes of rest. The Legend Stylus Motor is rated for continuous cutting indefinitely at 60,000 rpm. The Legend EHS Motor model EM100-A is rated for intermittent use of 20 seconds ON / 20 seconds OFF, indefinitely at 70,000 rpm. The model EM100 motor is rated 20 cycles of 20 seconds ON / 20 seconds OFF, followed by 25 minutes of rest.

NOTE

The surgeon should become familiar with the operational characteristics of each tool and attachment combination at various speeds prior to use.

WARNING DO NOT use an attachment and dissecting tool combination if flail or vibration occurs.

Midas Rex Legend EHS System

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PRE-OPERATIVE PROCEDURES

PRE-OPERATIVE PROCEDURES

8. Operation of Reverse Rotation. To engage the reverse rotation feature of the Legend EHS and Stylus Motor, stop operation of the motor. Step one time on the reverse button located on the top of the foot control.

NOTE

Reverse rotation may only be selected when the motor is not running and has come to a complete stop.

In the reverse rotation mode, the Legend EHS Console’s audible indicator will sound out three consecutive beeps to alert the operator each time the motor is operated in reverse. The "Forward" or "Reverse" direction will also be indicated on the console’s digital display.

To return to forward rotation of the motor, stop the motor and step on the reverse button at the foot control. The console’s digital display will indicate that forward rotation has been selected.

CAUTION The motor must not be operating when changing speed or directional rotation of the motor.

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Midas Rex Legend EHS System