Medtronic AF02R Instructions for Use

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Instructions for Use 175002EN G

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend Gold™, Legend Gold Touch™, Legend Platinum™, Midas Rex MR7™, and Midas Rex MR7 Touch™

Customer service

Contact your Medtronic Neurosurgery sales representative or call:

Medtronic Neurosurgery Service Group (800) 433-7080 or (817) 788-6440 RS.DFWrepairs@medtronic.com

Outside the U.S.A., contact your Medtronic regional distributor or Medtronic Neurosurgery representative.

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The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version.

The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Legend™, Legend Gold™, Legend Gold Touch™, Legend Platinum™, Midas Rex™, MR7™, MR7 Touch™, MEDNEXT™, and Triton™. All other trademarks, service marks, registered trademarks or registered service marks are the property of their respective owners in the United States and other countries.

Contents

Glossary .............................................................................................................................................................................................................1

Indications for use .........................................................................................................................................................................................1

Device description ........................................................................................................................................................................................1

Contraindications ..........................................................................................................................................................................................1

No latex policy ................................................................................................................................................................................................1

Important safety instructions ...................................................................................................................................................................1

Warnings ...........................................................................................................................................................................................................1

System warnings ..................................................................................................................................................................................1

Component warnings ........................................................................................................................................................................2

Tools and disposable components warnings ............................................................................................................................2

Legend pneumatic control unit warnings ..................................................................................................................................3

Legend lubricant/diuser cartridge warnings ..........................................................................................................................3

Cautions ............................................................................................................................................................................................................3

Legend system motors ................................................................................................................................................................................4

Legend Gold ..........................................................................................................................................................................................4

Legend Gold Touch .............................................................................................................................................................................4

Legend Platinum..................................................................................................................................................................................4

Legend accessories .......................................................................................................................................................................................5

Legend pneumatic control unit .....................................................................................................................................................5

Regulator ................................................................................................................................................................................................5

Regulator hose .....................................................................................................................................................................................5

Legend instrument case ...................................................................................................................................................................5

Motor wrench .......................................................................................................................................................................................5

Lubricant/diuser cartridge (PA100-A) ........................................................................................................................................5

Adapters ..................................................................................................................................................................................................6

Attachments ..........................................................................................................................................................................................6

Dissecting tools ....................................................................................................................................................................................6

Legend power source requirements ......................................................................................................................................................7

Legend pneumatic connections ..............................................................................................................................................................7

Legend pneumatic motor technical specications ...........................................................................................................................8

Legend system assembly ............................................................................................................................................................................8

Installing the lubricant/diuser cartridge (PA100-A) and connecting the Legend motor to the control unit .........8

Legend pneumatic control unit activation ................................................................................................................................9

Midas Rex MR7 system motors .................................................................................................................................................................10

MR7 ...........................................................................................................................................................................................................10

MR7 Touch ..............................................................................................................................................................................................10

MR7 accessories .............................................................................................................................................................................................11

MR7 pneumatic control unit ............................................................................................................................................................11

Regulator hose .....................................................................................................................................................................................11

MR7 instrument case ..........................................................................................................................................................................11

Motor wrench .......................................................................................................................................................................................11

Lubricant/diuser cartridge (PA700) ............................................................................................................................................11

Attachments ..........................................................................................................................................................................................12

Dissecting tools ....................................................................................................................................................................................12

MR7 power source requirements ............................................................................................................................................................13

MR7 pneumatic connections ....................................................................................................................................................................13

MR7 pneumatic motor technical specications .................................................................................................................................14

MR7 system assembly ..................................................................................................................................................................................14

Installing the lubricant/diuser cartridge (PA700) and connecting the MR7 motor to the control unit ....................14

MR7 pneumatic control unit activation .......................................................................................................................................15

Legend Gold, Legend Gold Touch, Legend Platinum, MR7, and MR7 Touch lock ..................................................................16

Legend Gold Touch and MR7 Touch safety slide ................................................................................................................................16

Legend Gold, Legend Gold Touch, Legend Platinum, MR7, and MR7 Touch tools and attachments .............................17

Dissecting tool nomenclature.........................................................................................................................................................17

General guidelines for attachments and tool applications ............................................................................................................18

Attachment assembly and disassembly ................................................................................................................................................22

Straight attachment ...........................................................................................................................................................................22

Angled attachment .............................................................................................................................................................................23

Fixed footed attachment ..................................................................................................................................................................23

Rotating footed attachment ............................................................................................................................................................24

Contra-angle attachment AC-16 ....................................................................................................................................................24

Metal cutting attachment ................................................................................................................................................................25

Variable exposure straight and angled attachment ...............................................................................................................25

Telescoping tube and telescoping tube base attachment straight (AT10) and angled (AT10A) ................................26

Telescoping curved bur and telescoping base attachment straight (AT10) and angled (AT10A) ..........................26

Perforator (AD01 & AD03) attachment ........................................................................................................................................27

Jacobs chuck attachment .................................................................................................................................................................27

Angled double lock (DK) attachment ..........................................................................................................................................27

J-latch attachment ..............................................................................................................................................................................28

Bone mill attachment.........................................................................................................................................................................28

Material safety data sheet for lubricant .................................................................................................................................................28

Legend system troubleshooting ..............................................................................................................................................................29

Legend motors .....................................................................................................................................................................................29

Legend attachments or telescoping tubes ................................................................................................................................30

Legend dissecting tools ....................................................................................................................................................................31

Disassembly of Legend equipment ........................................................................................................................................................32

Disassembly of MR7 equipment ..............................................................................................................................................................32

Cleaning and sterilization ...........................................................................................................................................................................33

Cleaning brushes .................................................................................................................................................................................33

Legend pneumatic motors reprocessing instructions ...........................................................................................................33

Pneumatic control unit reprocessing instructions ..................................................................................................................34

Attachments/tubes reprocessing instructions ........................................................................................................................34

Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE) ....................................................36

Preventative maintenance .........................................................................................................................................................................36

Legend pneumatic high speed preventive maintenance/service program .................................................................36

Dening maintenance level .............................................................................................................................................................36

Section 1: Preventive maintenance/service schedule: 12 maintenance intervals ...........................................................37

Section 2: Instructions for completing preventive maintenance steps ...........................................................................37

Refurbishing or repairs ................................................................................................................................................................................40

Contact ....................................................................................................................................................................................................40

Midas Rex Legend pneumatic high speed system limited warranty* ........................................................................................40

Symbols ............................................................................................................................................................................................................41

Midas Rex™ Legend™ Pneumatic High-Speed System

Glossary

PCU Pneumatic Control Unit

Indications for use

The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides 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.

Additionally, the Legend System is indicated for the incision/cutting, removal, and drilling of soft and hard tissue, bone, and biomaterials during open and minimally

invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures

• Lumbar Microdiscectomy • Transforaminal Lumbar Interbody Fusion (TLIF)

• Lumbar Stenosis Decompression • Anterior Lumbar Interbody Fusion (ALIF)

• Posterior Lumbar Interbody Fusion (PLIF) • Direct Lateral Interbody Fusion (DLIF)

Device description

The Legend pneumatic high speed system is a powered drill system that is used to remove soft tissue, hard tissue, and bone during surgical procedures. The system consists of a motor that powers/rotates the cutting media, attachments that are used to provide support and stability to the dissecting tools, and dissecting tools that perform the task of removing soft and hard tissue and bone.

The Legend system is comprised of the following:

• Legend Gold, Legend Gold Touch, or Legend Platinum motors • Legend dissecting tools — single use, disposable

• Legend pneumatic control unit with regulator and various connectors • Legend lubricant/diuser — single use, disposable

• Legend attachments

The MR7 system is part of the Legend pneumatic high speed system and is comprised of the following:

• MR7 or MR7 Touch motors • MR7 TRITON adapter (optional)

• MR7 pneumatic control unit with regulator and various connectors • MR7 lubricant/diuser — single use, disposable

The MR7 system uses the same attachments and dissecting tools as the Legend Pneumatic High-Speed 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 in the use of this equipment by being trained in Medtronic Midas Rex Hands-On Workshops or by one of the local authorized representatives.

Contraindications

None.

No latex policy

Medtronic Powered Surgical Solutions (MPSS) guarantees that all Legend equipment and products identied in this manual, manufactured by and/or for MPSS, do not contain latex.

MPSS’s packaging materials, labels, pouches, package inserts, or similar items do not contain latex.

Important safety instructions

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 sta may be involved. Disregarding this information could result in injury to the patient,

operator, and/or operating room sta. 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 sta.

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.

Warnings

System warnings

W1 The Legend pneumatic system operator must be familiar with this Instructions for Use, their precautions, procedures, and safety issues. W2 The Legend pneumatic system and its associated equipment should be used only by qualied medical professionals who are thoroughly trained and

experienced in performing surgery with Medtronic high speed surgical drills. W3 Heavy side loads and/or long operating periods may cause the device to overheat. W4 The Legend pneumatic motors should only be operated when the attachment is in the locked position. W5 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. W6 Use only dissecting tools specically designed for use with this drill system. Match the nomenclature and color code on the tool packaging to the same

nomenclature and color code on the attachment. W7 Do not use the Legend pneumatic system without proper cleaning and sterilization. W8 Do not operate the Legend pneumatic motors in the presence of magnetic resonance imaging (MRI) devices. W9 For metal transection, observe the following safety precautions:

W9a Wear eye protection.

W9b Irrigate well to cool cutting surfaces.

W9c Protect wound site from metal debris.

W9d Use a clamp or grasping device to control loose fragments during transection of any metal component. W10 All service must be performed by Medtronic qualied personnel only. W11 Do not attempt to use a motor that is leaking lubricant. W12 Do not place motor, attachment, and dissecting tool on the patient or in an unsecured location during surgery.

Midas Rex™ Legend™ Pneumatic High-Speed System

W13 Do not pinch, kink, obstruct, cut, tear, or step on the motor/exhaust hose. This may cause the hose to rupture and may injure the patient or user. W14 Do not use damaged, faulty, or modied Legend pneumatic system components. Inspect the system components for damage prior to each use. W15 Do not use components except for Medtronic Midas Rex Legend attachments, Legend dissecting tools, and Legend accessories in combination with a Legend

pneumatic motor. Use of devices other than Legend systems or associated parts or components may cause injury to the patient, operator and/or operating room sta.

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. W16 Do not dissect bone without adequate irrigation to prevent thermal necrosis. W17 Do not operate a Legend pneumatic motor without eyewear protection. W18 Do not use a Legend pneumatic motor if the motor continues to run after releasing the foot pedal or nger control. Return to Medtronic for service. W19 Do not remove Legend Gold Touch motor or MR7 Touch motor from pneumatic control unit unless compressed gas has been released from the hoses. W20 Do not use an overheated device, as it may cause thermal injury to the patient or operator. W21 To avoid injury when using the Legend Gold Touch motor or MR7 Touch motor, ensure the safety slide is in the “O” position before installing the attachment and tool. W22 Place Legend Gold Touch and MR7 Touch motors in Safe mode while not in use.

Component warnings

W23 Do not use any parts other than Medtronic system components as damage or substandard performance could result. W24 Always inspect the components before and after use for any damage. If damage is observed, do not use damaged component until it is repaired by Medtronic

qualied personnel or replaced. Damaged parts may deposit metal shavings on surgical site or may cause injury. W25 Employ visualization, including use of imaging techniques (for example, uoroscopy, image guided surgery) when using rotating powered accessories. Discontinue

powered application in the event of lack of visualization of surgical site. W26 When using Midas Rex Legend variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should

explore the eect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure. W27 Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment, causing patient injury.

To avoid this, motors and attachments should be serviced periodically at intervals recommended by Medtronic. W28 Use adequate irrigation. The use of a tool without irrigation may cause heat buildup resulting in a thermal injury to tissue. W29 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. W30 Do not immerse the system components, except as noted. W31 A device that is not functioning properly should not be used until the unit is repaired and tested by Medtronic to ensure that it is functioning in accordance with

Medtronic specications. W32 When using Midas Rex Legend variable exposure attachments, ensure that the attachment is still in the locked position after each adjustment of the tool exposure.

Attempting to increase the tool exposure too far may result in the attachment accidentally being unlocked. W33 The Legend pneumatic motors will not run properly unless the attachment is in the locked position. W34 Midas Rex Legend pneumatic motors should only be operated when the attachment is in the fully locked position. Smoke and/or excessive heat may be generated

if attachment is not in the fully locked position. This may result in thermal injury to the user or sta. W35 Do not change an accessory with the motor running to prevent laceration of user and/or cross-contamination through compromised glove. W36 Remove Legend footed attachments cautiously and slowly as per instructions to avoid injury to the operator. W37 Do not modify accessories used with the motor. Performance could be diminished with modied accessories. W38 Verify reusable device was cleaned and/or sterilized prior to use. If not, do not use. W39 Sterilize and dry reusable device before storing. Decrease likelihood of cross-contamination with timely sterilization. After each procedure, properly clean and

sterilize all reusable system components. W40 Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor. W41 Ensure proper installation of tool in footed attachment. Failure to follow instructions may result in the tool tip contacting the foot of the attachment causing

damage to the attachment and/or harm to patient. W42 Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization. W43 Any device that has not been used in a four-year period should be serviced by Medtronic to ensure its performance. W44 Ensure the adapter is fully threaded onto the regulator hose and that the adapter is fully threaded/connected to the corresponding wall outlet before operating

the pneumatic system. W45 Do not operate the bone mill attachment without the bowl and cap secured in place. W46 Do not come in contact with the interior of the disposable bowl and cap during bone milling. W47 Do not use the bone mill disposable components for more than one surgical procedure, as this may cause cross-contamination and aect patient safety. W48 Use only Medtronic Legend/MR7 and Legend bone mill disposables in combination with the bone mill attachment. W49 Legend Gold, Gold Touch, and Platinum instrument case (PA400) is not interchangeable with MR7 and MR7 Touch instrument case (PA600). Utilize appropriate

case when sterilizing motors.

Tools and disposable components warnings

W50 Keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of user and cross-contamination through compromised glove. W51 Operate the tool only after appropriate anatomical landmarks at the intended surgical site have been conrmed. W52 Use care in application of the rotating cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories. W53 Bending or prying may break the accessory, causing harm to patient or user. W54 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed of the motor to prevent vibration. W55 Test for wobble at desired speed prior to use. Discontinue use of accessory if tool tip wobbles and replace accessory to prevent unintended tissue removal. W56 Carefully inspect dissecting tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities, or other defects. Replace any

suspicious dissecting tools with a new one prior to use. W57 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. W58 Tools with “L” identication are longer tools intended for light bone dissection. The increased tool head/stem conguration may aect dissection stability. W59 Do not re-sharpen used tools. Worn tools should be frequently replaced with new ones to ensure eective cutting and control. W60 Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool

are removed from the patient. W61 Do not use metal-cutting tools to cut/resect bone. W62 Use only rotary tools specically designed for use with the Medtronic Midas Rex Legend drill system. W63 Do not use an accessory if its packaging is opened or damaged. Sterility may be compromised if packaging is opened or damaged.

Midas Rex™ Legend™ Pneumatic High-Speed System

W64 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging. W65 Do not use dull tools. Use of dull tools can reduce cutting eectiveness and can cause the motor temperature to increase. W66 Always ensure that the tool is secured in the motor or attachment prior to operating the system. W67 Exposure of tool packaging to light for extended periods of time may cause damage to packaging. W68 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 sta or contamination. Using a dissecting tool that has already been used may aect motor performance. W69 Do not use an attachment and dissecting tool combination if tool ail or excessive vibration occurs. W70 Dissecting tool utes are sharp and may perforate surgical gloves.

Legend pneumatic control unit warnings

W71 Do not use the Legend pneumatic control unit to operate any other systems except for Legend pneumatic motors and TRITON Power Surgical Instrument Systems. W72 Do not disassemble equipment before gas pressure is released from Legend pneumatic control unit and associated hoses. W73 Do not carry Legend pneumatic control unit by the N2 DISS pressure hose. W74 Do not use the pneumatic control unit to operate systems other than the Midas Rex and TRITON pneumatic systems.

Legend lubricant/diuser cartridge warnings

W75 Failure to properly secure Legend lubricant/diuser cartridge may cause injury to operator and/or operating room sta. W76 Do not attempt to remove the lubricant/diuser cartridge while the system is pressurized. W77 Do not use a Legend pneumatic motor without a lubricant/diuser installed. W78 Do not use a lubricant/diuser cartridge if it appears to be damaged, or if the inner foil seal is punctured.

Cautions

C1 When using an angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor. C2 Do not use twist drill or contra-angle tool/attachment at an operating pressure over 80 psi (5.5 bar). C3 Do not kink hoses. Inspect hoses for cracks, tears, or corrosion. C4 The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance. C5 Remove devices from instrument case before placing into washer-disinfector and allow devices to drain. Orient devices in the washer-disinfector by following

manufacturer recommendations. C6 Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. C7 Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. C8 Remove and discard accessories following local regulations for disposal of contaminated materials. C9 Do not run the motor at an operating pressure above or below 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. C10 Do not autoclave the pneumatic adapter. C11 Legend pneumatic control unit and pressure hose should not be sterilized. C12 Do not exceed 1 hour drill time per surgery for a Legend lubricant/diuser. C13 Use only Legend dissecting tools with a Legend pneumatic motor. C14 Do not attempt to remove Legend lubricant/diuser while the motor is in operation. C15 Do not attempt to rell a used lubricant/diuser cartridge. C16 Do not sterilize the lubricant/diuser cartridge. The lubricant/diuser cartridge may melt into the lubricant/diuser housing with potential damage to the

motor. The lubricant/diuser cartridge must be removed from the motor’s lubricant/diuser housing prior to sterilization. C17 When using angled attachments with the Legend Gold Touch, extend the lever on the Finger Control and hold by the attachment. C18 If the motor has an uncomfortable temperature to touch/ hold following sterilization, allow an adequate “cool down” period. C19 If the motor has an uncomfortable temperature to touch/ hold and an adequate “cool down” period was used, check that a new Legend lubricant/diuser is

properly attached to the motor’s lubricant/diuser housing to help cool down motor. Run the motor briey to assist in its cool down. C20 The Legend Gold, Gold Touch, and Platinum lubricant/diuser cartridge (PA100-A) is not interchangeable with the MR7 lubricant/diuser cartridge (PA700).

Ensure you select the appropriate lubricant/diuser cartridge for the motor. C21 During a lengthy surgical procedure with extended motor use, lubricant may drip from lubricant/diuser cartridge. C22 Do not re-use a lubricant/diuser cartridge. It is a single-use product. C23 Remove lubricant/diuser cartridge from motor assembly prior to sterilizing it.

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend system motors

Legend Gold

High speed, high torque pneumatic motor (Figure 1-1) used to dissect bone and biomaterials.

Legend Gold Touch

High speed, high torque pneumatic motor (Figure 1-2) with a variable speed nger control 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 (Figure 1-3), with a reduced sound output and slightly decreased power when compared to the Legend Gold and Gold Touch used to dissect bone and biomaterials.

Warning: Refer to Warnings W1.

1-1

1. Collet

2. Motor case

1-3

1. Collet

2. Motor case

Legend Gold motor Legend Gold Touch motor

3. Swivel

4. Convertible angle

Legend Platinum motor

3. Swivel

4. Fixed angle

5. Hose 1. Extension lever

5. Hose

1-2

2. Collet

4. Finger control

3. Motor case

5. Safety slide

6. Convertible angle

7. Swivel

8. Hose

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend accessories

Legend pneumatic control unit

The Legend pneumatic control unit (Figure 2-1) controls speed of Legend Gold and Platinum motors with a variable speed foot pedal, provides nger/foot control for operation of the Gold Touch Motor, provides a port for Legend motors and a 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. Note: Legend pneumatic control unit is provided with a certied Supply Pressure gauge.

Legend pneumatic control unit has a handle (Figure 2-2) for ease of re-positioning unit while on oor or for carrying the unit. A hole is provided in the base for hanging the unit on a wall hook. Port plugs are attached to prevent debris ingress when a port is not in use.

Caution: Legend pneumatic control unit and pressure hose should not be sterilized. Warning: Refer to Warnings section Legend pneumatic control unit warnings.

Regulator

The Legend Regulator (Figure 2-3) controls the delivery pressure of compressed gas to the Legend pneumatic control unit. The pressure gauges indicate cylinder pressure (right gauge) and delivery pressure (left gauge).

Note: Outlet pressure gauge accurate to +/- 12 psi.

Regulator hose

Connects the gas source to the pneumatic control unit to deliver compressed gas.

Legend instrument case

The instrument case (Figure 2-4) is used to organize equipment and to secure instruments during sterilization and transport.

Motor wrench

Used to align arrows on motor collet flats prior to installation of a Legend attachment (Figure 2-5).

Lubricant/diuser cartridge (PA100-A)

Provides lubrication to Legend motors, diuses spent air from motor, and lters oil from exhausted air.

Note: Each Legend Motor has a lubricant/diuser housing (Figure 2-6) at the end of the motor hose. Legend motors and associated hoses do not contain latex.

The Legend Gold, Gold Touch, Platinum lubricant/diuser cartridge (PA100-A) is not interchangeable with the MR7 lubricant/diuser cartridge (PA700). Ensure you select the appropriate lubricant/diuser cartridge for the motor.

2-1

2-4

Legend pneumatic control unit Legend pneumatic control unit handle Regulator

2-2

2-3

Instrument case Motor wrench Lubricant/diuser

2-5

2-6

1. Delivery pressure gauge

2. Cylinder pressure gauge

Midas Rex™ Legend™ Pneumatic High-Speed System

Adapters

N2 DISS to surgical tool air male SIS adapter gas source (Australia/New Zealand only)

The N2 DISS to surgical tool air male SIS adapter gas source (Figure 3-1) allows for the regulator hose to connect to AUS-SIS wall ttings for surgical tool air. The

functioning of the N2 DISS to surgical tool air male SIS adapter gas source is intended for use in Australia and New Zealand only.

N2 DISS to male Schrader adapter

Allows for the Pneumatic Control Unit’s N2 DISS pressure hose connection to be attached to a Female Schrader in-house gas connection (Figure 3-2). An 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 male Schrader adapter (UK)

The N2 DISS to male Schrader adapter (Figure 3-3) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to a female Schrader (UK)

in-house gas connection. This adapter is for use in the UK only.

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 (Figure 3-4).

N2 DISS to female Schrader adapter

The N2 DISS to female Schrader adapter (Figure 3-5) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to a male Schrader inhouse gas connection.

N2 DISS to surgical tool air male SIS adapter

The N2 DISS to surgical tool air male SIS adapter (Figure 3-6) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to an AUS-SIS surgical tool air in-house gas connection.

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 (Figure 3-7). The in-line oiler must be removed from the Safety Valve Regulator.

3-1

N2 DISS to surgical tool air

male SIS adapter gas source

3-5

N2 DISS to female Schrader adapter

3-2

3-6

N2 DISS to male

Schrader adapter

N2 DISS to surgical tool air

male SIS adapter

3-3

3-7

N2 DISS to male

Schrader adapter (UK)

N2 DISS to WF4 adapter

3-4

N2 DISS to air DISS adapter

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.

Warning: Refer to Warnings W16.

Notes:

• 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 AS14/14-AM straight and AA14/14-AM angled attachments are 14 cm long and have a green color band. All dissecting tools with the prex14

(Example:14MH30) may be used in either the straight or angled attachment.

• Color band on attachment is for visual reference. Match the nomenclature and color code on the attachment with that on the dissecting tool packaging.

Dissecting tools

Legend dissecting tools’ intended use is for cutting bone and biomaterials. Legend dissecting tools are provided as sterile.

Warnings: Refer to Warnings W6, W69, and W70.

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend power source requirements

Table 1: Power source requirements

Motors Required operating

Legend Gold

Legend Gold Touch

Legend Platinum

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.

(dynamic) pressure

80 – 120 psi 100 psi 12 cubic feet/min

5.5 – 8.3 bar 6.9 bar 340 liters/min

80 – 120 psi 100 psi 12 cubic feet/min

5.5 – 8.3 bar 6.9 bar 340 liters/min

80 – 120 psi 100 psi 12 cubic feet/min

5.5 – 8.3 bar 6.9 bar 340 liters/min

Nominal operating (dynamic) pressure

Approximate ow rate

required

Gas type

Nitrogen or dry-ltered compressed air

Legend pneumatic connections

Warning: Refer to Warnings W73.

Caution: If you are using the Midas Rex Safety Valve Regulator instead of the Legend Regulator, you must replace the in-line oiler with the DISS/WF4 adapter before use.

Pneumatic adapter diagram: Gas connection options

1. Regulator hose (N2 DISS) 6. N2 DISS to male Schrader adapter gas source

2. N2 DISS to male Schrader adapter - UK gas source 7. Gas source (N2 DISS)

3. N2 DISS to female Schrader adapter gas source 8. Regulator

4. N2 DISS to surgical tool air male SIS adapter gas source (Australia/New Zealand only) 9. DISS/WF4 adapter

5. N2 DISS to air DISS adapter gas source 10. Regulator (Old Style)

Operating (dynamic) pressure may be checked diagnostically at the Legend or MR7 pneumatic control unit while the motor is running. Operating pressure will decrease slightly from the non-running (static) pressure setting when the motor is activated. Adjust operating pressure as needed at the compressed gas source until supply pressure gauge on Legend or MR7 pneumatic control unit reads within a range of 80 – 120 psi (5.5 –8.3 bar), as required.

To ensure optimal motor performance, set nominal operating pressure to 100 psi (6.9 bar). If the surgeon requests additional power during a procedure, compressed gas source may be turned up to an operating pressure of 120 psi (8.3 bar). To decrease pressure, turn down the in-house compressed gas source or loosen the pressure handle on the regulator. Push down on the pressure relief at the pneumatic control unit to exhaust excess pressure.

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend pneumatic motor technical specications

Table 2. Legend pneumatic motor technical specications

Product Weight (gm)

Legend Gold 143 14.2 1.8

Legend Gold Touch 167 15.5 1.8

Lengend Platinum 100 12.3 1.6

Length (cm) Diameter (cm)

Size

Legend system assembly

Installing the lubricant/diuser cartridge (PA100-A) and connecting the Legend motor to thecontrol unit

Warnings: Refer to Warnings W77 and W78.

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.

2. a. Remove cover from lubricant/diuser (Figure 5-1). b. Do not remove inner foil seal of lubricant/diuser (Figure 5-2).

3. Insert lubricant/diuser into lubricant/diuser housing located at base of motor hose (Figure 5-3).

4. Rotate lubricant/diuser from the unlocked position to the locked position (Figure 5-4). It will come to a complete stop with a tactile click when it is fully seated

and locked into the housing.

Notes:

• 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 diuser housing. If the cartridge has been pressurized for longer than 4 hours, it should be replaced.

5-1

Lubricant/diuser cover Inner foil (Do not remove) Insert lubricant/diuser Rotate lubricant/diuser

5. Connect the Legend motor oiler housing at the end of the hose to the Legend port on the Legend pneumatic control unit (Figure 5-5).

Warning: Refer to Warnings W14 and W19.

Notes:

• If using the Legend Gold Touch, slide the nger/foot control on the Legend pneumatic control unit to the “ ” position (Figure 5-6).

• This will automatically depress and lock the foot pedal. The control will not lock into the “ ” position unless the motor is connected into the Legend port.

• If using the TRITON Power Surgical Instrumentation System in conjunction with the Legend motor, connect the TRITON hose into the TRITON port on the Legend pneumatic control unit.

5-2

5-3

5-5

Connect the motor hose Lock the nger/foot control

5-4

5-6

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend pneumatic control unit activation

Warning: Refer to Warnings W74.

To activate the Legend Gold or Platinum Motors

1. Install and lock an attachment onto the motor as described under section Legend Gold, Legend Gold Touch, and Legend Platinum attachment assembly and disassembly.

2. Depress the foot pedal on the Pneumatic Control Unit (Figure 6-1). Allow motor to run for approximately 30 seconds. An increase in speed may be noticed as initial lubrication reaches the motor.

a. For the Legend Gold Touch, be certain the nger/foot control on the Legend pneumatic control unit is locked in the “ ” position. b. With the Safety Slide in the “ ” position, install and lock an attachment and dissecting tool as described under section Legend Gold, Legend Gold Touch,

and Legend Platinum attachment assembly and disassembly (Figure 6-2).

c. Lift the Finger Control and pull the Safety Slide to the “ | ” position. Depressing the Finger Control will now activate the motor. Allow motor to run for

approximately 30 seconds. An increase in speed may be noticed as lubrication is provided to the motor (Fig. 6-3).

Note: When using longer attachments with the Legend Gold Touch, the extension lever on the Finger Control may be extended to provide better digital control (Figure 6-4).

3. Operating (dynamic) pressure may be checked diagnostically at the Legend pneumatic control unit while the motor is running. Operating pressure will decrease slightly from the non-running (static) pressure setting when the motor is activated. Adjust operating pressure as needed at the compressed gas source until supply pressure gauge on Legend pneumatic control unit reads within a range of 80 – 120 psi (5.5 – 8.3 bar) as required.

To ensure optimal motor performance, set nominal operating pressure to 100 psi (6.9 bar).

If the surgeon requests additional power during a procedure, compressed gas source may be adjusted to an operating pressure of 120 psi (8.3 bar).

To decrease pressure, turn down the in-house compressed gas source or loosen the pressure handle on the regulator. Push down on the pressure relief at the pneumatic control unit to exhaust excess pressure in the hoses. Then re-adjust pressure as needed.

6-1

Depress the foot pedal Install and

6-2

lock attachment

6-3

Allow motor

to run

6-4

Extend the

nger control lever

Midas Rex™ Legend™ Pneumatic High-Speed System

Midas Rex MR7 system motors

MR7

High speed, high torque pneumatic motor (Figure 7-1) used to dissect bone and biomaterials.

MR7 Touch

High speed, high torque pneumatic motor (Figure 7-2) with a variable speed nger control. This motor is used to dissect bone and biomaterials.

Instruction manual will use the “ ” symbol to indicate information on MR7 Touch.

Warning: Refer to Warnings W1.

7-1

1. Collet

2. Collet ats

2 3

MR7 motor MR7 Touch motor

7-2

3. Motor case

4. Safety slide

3. Motor case

4. Swivel

5. Hose 1. Finger control lever

2. Collet

5. Swivel

6. Hose

Midas Rex™ Legend™ Pneumatic High-Speed System

MR7 accessories

MR7 pneumatic control unit

The pneumatic control unit (Figure 8-1) provides variable speed motor control through a foot pedal. It also allows the user to switch between nger and foot control of the motor (if applicable).

Regulator

The Legend Regulator (Figure 8-2) controls the delivery pressure of compressed gas to the Legend pneumatic control unit. The pressure gauges indicate cylinder pressure (right gauge) and delivery pressure (left gauge).

Note: Outlet pressure gauge accurate to +/- 12 psi.

Regulator hose

Connects the gas source to the pneumatic control unit to deliver compressed gas.

MR7 instrument case

The instrument case (Figure 8-3) is used to organize equipment and to secure instruments during sterilization and transport.

Motor wrench

Used to align arrows on motor collet flats prior to installation of a Legend attachment (Figure 8-4).

Lubricant/diuser cartridge (PA700)

The lubricant/diuser cartridge (Figure 8-5) provides lubrication to the motor and lters oil from exhausted air. Caution: The Legend lubricant/diuser cartridge and the MR7 lubricant/diuser cartridge are not interchangeable.

8-1

8-4

MR7 pneumatic control unit Regulator MR7 instrument case (PA700)

8-2

1. Delivery pressure gauge

2. Cylinder pressure gauge

8-3

Motor wrench Lubricant/diuser cartridge

8-5

Midas Rex™ Legend™ Pneumatic High-Speed System

Adapters

N2 DISS to surgical tool air male SIS adapter gas source (Australia/New Zealand only)

The N2 DISS to surgical tool air male SIS adapter gas source (Figure 9-1) allows for the regulator hose to connect to AUS-SIS wall ttings for surgical tool air. The

functioning of the N2 DISS to surgical tool air male SIS adapter gas source is intended for use in Australia and New Zealand only.

N2 DISS to male Schrader adapter

Allows for the Pneumatic Control Unit’s N2 DISS pressure hose connection to be attached to a Female Schrader in-house gas connection (Figure 9-2). An 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 male Schrader adapter (UK)

The N2 DISS to male Schrader adapter (Figure 3-3) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to a female Schrader (UK)

in-house gas connection. This adapter is for use in the UK only.

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 (Figure 9-4).

N2 DISS to female Schrader adapter

The N2 DISS to female Schrader adapter (Figure 9-5) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to a male Schrader inhouse gas connection.

N2 DISS to surgical tool air male SIS adapter

The N2 DISS to surgical tool air male SIS adapter (Figure 9-6) allows for the pneumatic control unit’s N2 DISS pressure hose connection to be attached to an AUS-SIS surgical tool air in-house gas connection.

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 (Figure 9-7). The in-line oiler must be removed from the Safety Valve Regulator.

TRITON pneumatic adapter

The TRITON adapter (Figure 9-8) allows the TRITON handpiece to be driven by the MR7 pneumatic control unit. It functions much the same way as the TRITON port on the Legend pneumatic control unit, except that it is connected between the control unit and the gas source, rather than being integrated into the control unit.

9-1

N2 DISS to surgical tool air

male SIS adapter gas source

9-5

N2 DISS to female Schrader adapter

9-2

9-6

N2 DISS to male

Schrader adapter

N2 DISS to surgical tool air

male SIS adapter

9-3

9-7

N2 DISS to male

Schrader adapter (UK)

N2 DISS to WF4 adapter TRITON pneumatic adapter

9-4

N2 DISS to air DISS adapter

9-8

Attachments

are marked and color-coded to correspond with their associated dissecting tools.

Warning: Refer to Warnings W16.

Notes:

• 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 AS14/14-AM straight and AS14/14-AM angled attachments are 14

cm long and have a green color band. All dissecting tools with the prex 14 (14MH30) may be used in either the straight or angled attachment.

• Color band on attachment is for visual reference. Match the nomenclature and color code on the attachment with that on the dissecting tool packaging.

Dissecting tools

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

Warnings: Refer to Warnings W6, W69, and W70.

Midas Rex™ Legend™ Pneumatic High-Speed System

MR7 power source requirements

Table 3: Power source requirements

Motors Required Operating

MR7

MR7 Touch

Caution: Do not run the motor at an operating pressure above or below 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.

(Dynamic) Pressure

80 – 120 psi 100 psi 12 cubic feet/min

5.5 – 8.3 bar 6.9 bar 340 liters/min

80 – 120 psi 100 psi 12 cubic feet/min

5.5 – 8.3 bar 6.9 bar 340 liters/min

Nominal Operating

(Dynamic) Pressure

Approximate Flow Rate

Required

Gas Type

Nitrogen or Dry-Filtered Compressed Air

MR7 pneumatic connections

Warning: Refer to Warnings W73.

Caution: If you are using the Midas Rex Safety Valve Regulator instead of the Legend Regulator, you must replace the in-line oiler with the DISS/WF4 adapter before use.

Pneumatic adapter diagram: Gas connection options

1. Regulator hose (N2 DISS) 6. N2 DISS to male Schrader adapter gas source

2. N2 DISS to male Schrader adapter - UK gas source 7. Gas source (N2 DISS)

3. N2 DISS to female Schrader adapter gas source 8. Regulator

4. N2 DISS to surgical tool air male SIS adapter gas source (Australia/New Zealand only) 9. DISS/WF4 adapter

5. N2 DISS to air DISS adapter gas source 10. Regulator (Old Style)

Midas Rex™ Legend™ Pneumatic High-Speed System

MR7 pneumatic motor technical specications

Table 4. MR7 pneumatic motor technical specications

Product Weight (gm)

MR7 121 14.0 1.8

MR7 Touch 145 15.9 1.8

Length (cm) Diameter (cm)

Size

MR7 system assembly

Installing the lubricant/diuser cartridge (PA700) and connecting the MR7 motor to the control unit

1. Set the non-running (static) pressure to 80–120 psi (5.5–8.3 bar) at the gas source. Operating (dynamic) pressure may be adjusted later.

2. Hold the lubricant/diuser cartridge perpendicular to the housing (Figure 11-1), and press the cartridge’s circular tting onto the housing’s circular receptacle (Figure11-2), breaking the foil seal.

3. Rotate the cartridge down until it clicks into place.

4. Verify that the locked symbol on the cartridge is lined up with the notch on the housing (Figure 11-3).

Warnings: Refer to Warnings W77 and W78.

Caution: Do not use an MR7 motor without a lubricant/diuser installed.

11-1

Aligning the lubricant/diuser

cartridge with the housing

5. Connect the oiler housing at the end of the hose to the motor port on the top of the pneumatic control unit, by swinging the port cover to the side and pressing

the end of the hose into the port (Figure 11-4).

Warning: Refer to Warnings W75.

Notes:

• If using the MR7 Touch motor, slide the control slide on the pneumatic control unit to the “ ” position (Figure 11-5). This will automatically depress and lock the foot pedal. The control will not lock into the “ ” position unless the motor hose is connected into the motor port. When the motor hose is removed from the motor port, the foot pedal will return to normal position.

• If using the TRITON Power Surgical Instrumentation System in conjunction with the MR7 motor, use the optional TRITON adapter to connect the TRITON hose. Refer to the documentation accompanying the adapter for connection instructions.

• The motor’s exhaust hose may have an oily lm on the external surface from pressure and/or temperature dierentials following sterilization. Wipe the exhaust hose with a sterile cloth prior to use. If motor continues to have oil on the exhaust hose, return the motor to MPSS for refurbishing.

Warning: Refer to Warnings W22.

Prior to installation of a Legend attachment and dissecting tool, ensure that the arrows on the motor collet ats are aligned (Figure 11-6). If the arrows are not aligned, use the motor wrench to turn the collet at closest to the motor case until its arrow is aligned with the arrow on the other collet at.

11-2

Pressing the cartridge

onto the housing

11-3

Correctly installed

lubricant/diuser cartridge

Midas Rex™ Legend™ Pneumatic High-Speed System

MR7 pneumatic control unit activation

Note: In order to activate the MR7 Touch motor, the safety slide on the nger control switch must be in the “|” position, and the control slide on the foot control must

be in the “On” (nger control) position. The control slide will not lock in the “On” (nger control) position unless a motor is connected to the motor port.

To activate the MR7 or MR7 Touch motors

1. Activate the motor by pressing on the foot control pedal (Figure 11-4) or by pressing on the nger control lever (MR7 Touch motor only).

2. Adjust operating pressure as needed at the compressed gas source until supply pressure gauge on pneumatic control unit reads within a range of 80–120 psi (5.5–8.3 bar) as required. Operating pressure (with motor running) will decrease slightly from the non-running (static) pressure setting when the motor is activated.

Note: To decrease pressure, turn down the in-house compressed gas source or loosen the pressure handle on the regulator. Push down on the pressure relief at the

pneumatic control unit to exhaust excess pressure in the hoses. Then re-adjust pressure as needed.

11-4

Connecting the motor Finger/foot control slide

11-5

11-6

Aligning the collet at

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend Gold, Legend Gold Touch, Legend Platinum, MR7, and MR7 Touch lock

Legend Gold, Legend Gold Touch, Legend Platinum, MR7, and MR7 Touch motors should only be operated when the attachment is in the locked position on the motor.

12-1

Motor will operate Motor will not operate

12-2

Legend Gold Touch and MR7 Touch safety slide

The Legend Gold Touch will operate with the safety slide in the “ | ” position and will not operate with the safety slide in the “ ” position.

12-3

12-5

Legend Gold Touch

motor will operate

MR7 Touch motor will operate MR7 Touch motor will not operate

12-4

12-6

Legend Gold Touch

motor will not operate

In addition, the Legend Gold Touch and the MR7 Touch will not operate if the nger/foot control on the pneumatic control unit is in the “ ” position, unless the

foot pedal is activated also.

Legend Gold Touch motor will not operate. MR7 Touch motor will not operate.

12-7

12-8

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend Gold, Legend Gold Touch, Legend Platinum, MR7, and MR7 Touch tools and attachments

Dissecting tool nomenclature

Warning: Refer to Warnings W6.

Part numbers for dissecting tools follow a standard naming convention (Figure 13). A basic part number consists of ve characters, representing the associated attachment

length, the tool-head shape, and the tool-head diameter. Part numbers can also include a variety of prexes to identify specic attachment types, as well as a variety of

suxes to provide additional information about the dissecting tool. Tools that use a design taken from the Mednext line are designated by an additional “-MN” sux.

Dissecting tool nomenclature naming convention

9 M H 3 0

1234

1. Optional prex

2. Attachment length, x centimeters (Ex. 9 = 9 cm)

3. Tool head shape, xx form/function (Ex. MH = Match Head)

Tool number prexes Tool number suxes

Note: A single part number will use only one prex. Note: More than one sux may be combined in a

Prex Tool attatchments Sux Tool head shape modiers

Tool head shape (form/function) Sux Tool head cutting modiers Sux Tool length modiers

Curved Burr

Footed attachments

Spinal with Distal bend

Spinal with Proximal bend

Telescoping tube

Trans-Nasal

Acorn

Ball

Cylinder

Hole Maker

Hole Saw

Metal Cutting

Match Head

Oval

Reverse Taper

Tapered or side cutter

Twist Drill

4. Tool head diameter, x.x millimeters (Ex. 30 = 3.0 mm)

5. Optional sux

6. Optional “-MN” sux

single part number.

DXF

-MN

Ball end

Barrel

2-Flute Match style

Pear shaped

Spiral utes

3-Flute or SymmeTRI

Carbide

Diamond

Diamond Coarse

Diamond Fine

Diamond Extra Coarse

Diamond Extra Fine

Fine

MedNext style

Coarse

Extra Fine

Pxx

Mxx

Long

Short

Plus ‘xx’ mm (for example, P15 = Plus 15mm)

Minus ‘xx’ mm

Midas Rex™ Legend™ Pneumatic High-Speed System

General guidelines for attachments and tool applications

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

Surgical application Commonly used attachments Commonly used dissecting tools

Spine 8-B

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

Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etcetera.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Oval

Helical cutting utes and curved design blend acorn and ball styles to vary dissection eciency with approach angle. For decortication, laminotomy, entry hole, nerve decompression, osteophyte removal, etcetera.

Hole maker and hole saw

Matched sets of hole makers and hole saws are ecient and eective for interbody fusion.

Cylinder

Eective bone sculpting and planing. For graft shaping, debridement, corpectomy, decortication, interbody fusion, fusion takedown, etcetera.

Acorn

Curved design varies dissection eciency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etcetera.

Telescoping Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etcetera.

Spine Footed Tapered

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

Reverse tapered

Semi-trapezoidal shape with helical cutting utes and a smooth cutting tip designed for ecient bone sculpting and planing. For graft shaping, debridement, and decortication.

Midas Rex™ Legend™ Pneumatic High-Speed System

Surgical application Commonly used attachments Commonly used dissecting tools

Neurosurgical–cranial 7-6ST straight or angled

8-B

9-M 10-9ST straight or angled 14-AM straight or angled 15-A straight or angled

Footed Tapered

Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etcetera.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Twist drill

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

Acorn

Curved design varies dissection eciency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etcetera.

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

General surgery and plastic surgery (craniofacial/

maxillofacial/

sternotomy)

Ear, nose, and throat (otology, neurootology)

7-6ST straight or angled

8-B

9-M 10-9ST straight or angled 14-AM straight or angled

7-6ST straight or angled 10-9ST straight or angled

Match head

Elongated spherical design allows controlled, delicate dissection. For entry hole, nerve decompression, osteophyte removal, sinus dissection, etcetera.

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Tapered

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

Twist drill

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

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Midas Rex™ Legend™ Pneumatic High-Speed System

Surgical application Commonly used attachments Commonly used dissecting tools

Orthopaedics 8-B

9-M 14-AM straight or angled 21-TU 26-R

Footed Telescoping

Biometals/bioceramics/

MC Metal cutter

biomaterials

Ball

Helical cutting utes dissect bone or cement eectively from a wide variety of approach angles. For debridement, decortication, sinus dissection, etcetera.

Tapered

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

Acorn

Curved design varies dissection eciency with varied approach angles. For entry hole, laminotomy, bone shaping, debridement, corpectomy, decortication, fusion takedown, etcetera.

Cylinder

Eective bone sculpting and planing. For graft shaping, debridement, corpectomy, decortication, interbody fusion, fusion takedown, etcetera.

Cutting utes or diamond wheel design remove metals, ceramics and other biomaterials eectively from a variety of approach angles. For cutting rods, pins, plates, implants, screws, etcetera.

Midas Rex™ Legend™ Pneumatic High-Speed System

Table 5: Glossary

Surgical procedures Tool head designs

LM Lumbar Microdiscectomy PH Pilot Hole MH

Lumbar Stenosis

LSD

Decompression

Posterior Lumbar Interbody Fusion (PLIF)

Transforaminal Lumbar Interbody Fusion (TLIF)

LIF

Anterior Lumbar Interbody Fusion (ALIF)

Direct Lateral Interbody Fusion (DLIF)

FT Fusion Takedown MI Minimally Invasive procedure T Fluted dissecting tool, cutting utes to allow faster, and ecient bone removal.

LT Laminotomy TA

FRT Foramenotomy MC Metal Cutting dissecting tool to facilitate the cutting and shaping of metal.

Surgical application - Spine

Incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials.

LM LSD LIF FT LT FRT PH ND OR DB DC CT MI

ND Nerve Decompression BA

OR Osteophyte Removal AC

DB Debridement CY Cylinder dissecting tool eective in bone sculpturing and planning.

DC Decortication HM/S

CT Corpectomy OV

Table 6: General guidelines for attachment and tool applications

Commonly used attachments

Match Head dissecting tool with an elongated spherical design allows controlled, delicate dissection.

Ball dissecting tool, cutting utes to dissect bone or cement eectively from a wide variety of approach angles.

Acorn dissecting tool, curved design varies dissection eciency with varied approach angles and eective in bone shaping.

Hole Maker/Hole Saw dissecting tool, matched sets of hole makers and hole saws are ecient and eective.

Oval dissecting tool with helical cutting utes and curved design blend acorn and ball styles to vary dissection eciency with approach angle.

Tapered dissecting tool with slender design for precise dissection with minimal bone loss.

Tools

MH BA AC CY HM/S OV T TA MC

X X X X X X X X X X X X X

X X X  X X X X X X X X X

X X X X X X X X X X X X X

X X X  X X X X X X X X X

Straight

Angled

Base Tube

Straight Straight Angled Curved

Angled

Footed

Curved burs

Contra angle

X X X X X X X X 

X X X   X X  

       X 

X X     X  

X       X 

X X X X X X X X X X X X X

ASMC

        X

Midas Rex™ Legend™ Pneumatic High-Speed System

Attachment assembly and disassembly

Warnings: W6, W24, W33, W34, W52, and W54 apply to all Legend attachments.

Prior to installation of a Legend Attachment and Dissecting Tool onto a Legend Motor, ensure that arrows on the motor collet ats are in proper alignment (Figure 14-1). If the arrows are not aligned, use the Legend motor wrench (Figure 14-2) 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).

Notes:

• A Legend Attachment will not seat onto a Legend Motor if the arrows on the collet ats are not in alignment.

• Do not use any other components except for the Legend Motor Wrench to align arrows on motor collet.

• Before installation of attachment and dissecting tool on the Legend Gold Touch Motor, ensure that the safety slide is in the “ ” position

(Figure14-3).

Straight attachment

Note: An attachment will not seat on the motor if the arrows on the collet

ats are not in alignment.

Assembly:

1. Slide a straight attachment over the motor collet aligning the triangular arrows on the attachment and the motor case (Figure 15-1).

An audible click, heard and perceptible by touch, conrms that the

attachment is fully seated.

2. Insert the tool into the attachment with a slight rotational motion

(Figure15-2). An audible click, heard and perceptible by touch, conrms

that the tool is fully seated.

3. Rotate the attachment in the direction indicated by arrow on the attachment until the attachment alignment mark is directly in line with the locked symbol (Figure 15-3). You will hear two clicks as the attachment is rotated. Note: Only when the second click is heard is the attachment fully

seated and the collet brake fully released.

4. Gently pull on the tool to ensure that it is locked into the motor. Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

14-1

Motor collet alignment Safety slide in the ‘O’ position

14-2

Turn the rotational collet

15-1

15-2

15-3

Straight attachment assembly

14-3

Disassembly:

1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up as in Figure 15-4.

2. Remove the dissecting tool from the attachment and discard the tool

(Figure 15-5).

3. Use thumb and index nger to lift the attachment o of the motor

(Figure 15-6).

15-4

15-5

15-6

Straight attachment disassembly

Midas Rex™ Legend™ Pneumatic High-Speed System

Angled attachment

Warnings: Refer to Warnings W40. Caution: When using an angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor.

Notes:

• A dissecting tool may be installed and locked in the attachment before the angled attachment is installed onto the motor.

• Angled and straight attachments with the same length, marking, and color band share the same dissecting tools.

Assembly:

1. With the tool lock in the unlocked position, insert a tool into the angled attachment with a slight rotational motion (Figure 16-1). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

2. Rotate the tool lock/unlock sleeve in the direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 16-2).

3. Gently pull on the tool to ensure that it is locked into the motor. Note: Tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

4. Slide the angled attachment over the motor collet aligning the triangular arrows on the attachment and the motor case. An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

5. Rotate the attachment in the direction indicated by the arrow until attachment alignment mark is directly in line with the locked symbol. You will hear two clicks as the attachment is rotated. Note: Only when the second click is heard is the attachment fully seated and the collet brake fully released.

6. Verify that both the attachment to motor alignment mark and the tool lock alignment mark are directly in line with the locked symbols (Figure 16-3).

Disassembly:

1. Rotate the tool lock to the unlocked position to remove the tool from the attachment.

2. Rotate the attachment to the unlocked position and lift attachment o of the motor.

Fixed footed attachment

Warning: Refer to Warnings W41.

16-1

16-2

16-3

17-1

Angled attachment assembly

Fixed footed attachment assembly

Assembly:

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 17-1). An audible click, heard and perceptible by touch, conrms that the attachment is fully seated.

2. Slide the xed footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case (Figure17-2).

3. Pull the xed footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 17-3).

4. Check to ensure a gap exists between the tip of the tool and the foot of the attachment. This will prevent damage to the attachment and/or injury to patient.

Disassembly:

1. To remove the xed footed attachment, hold the motor in the palm of your hand. Push the sleeve on the xed footed attachment distally while rotating the attachment to the unlocked position on the motor case and then release the sleeve.

2. To avoid injury from the dissecting tool, use thumb and index nger to cautiously and slowly lift the attachment o of the motor and away from the dissecting tool.

3. Pull the dissecting tool out of the motor collet and discard the tool.

17-2

17-3

Fixed footed attachment assembly

Fixed footed attachment assembly Tool gap

17-4

Midas Rex™ Legend™ Pneumatic High-Speed System

Rotating footed attachment

Notes:

• Rotating and xed footed attachments with the same length, marking, and color band share the same dissecting tools.

• The footed end of the attachment has 360° of unrestricted rotation.

Warning: Refer to Warnings W41.

18-1

Rotating footed attachment assembly

Assembly:

1. Insert a dissecting tool into the motor collet with a slight rotational motion (Figure 18-1). An audible click, heard and perceptible by touch,

conrms that the attachment is fully seated.

2. Slide the rotating footed attachment over the dissecting tool onto the motor aligning triangular arrows on the attachment and the motor case

(Figure 18-2).

3. Pull the rotating footed attachment towards the motor and rotate the attachment to the locked position on the motor case (Figure 18-3).

4. Check to ensure a gap exists between the tip of the tool and the foot

of the attachment. This will prevent damage to the attachment and/or

injury to patient.

Disassembly:

1. Hold the motor in palm of hand. Rotate the attachment to the unlocked position. In this position, the arrows in the attachment and motor will line up.

2. Use thumb and index nger to lift the attachment o of the motor.

3. Remove the dissecting tool from the motor collet and discard the tool.

Contra-angle attachment AC-16

Assembly:

Note: The static pressure to the motor should be set to 80 psi (5.5 bar).

1. Slide the contra-angle attachment over the motor collet aligning triangular arrows on the attachment and the motor case.

2. Rotate the attachment to the locked position on the motor case (Figure 19-1).

3. Rotate the attachment head’s lever laterally to the open position and insert a

dissecting tool (Figure 19-2).

4. Align the at in the tool with the corresponding at in the attachment and fully insert tool into the attachment.

5. Close lever (Figure 19-3) to lock tool in the attachment.

6. Gently pull on the dissecting tool shaft to ensure it is locked in the attachment.

18-2

18-3

Rotating footed attachment assembly

Rotating footed attachment assembly Tool gap

19-1

19-2

Contra-angle attachment AC-16 assembly

Attachment assembly Attachment assembly

19-3

18-4

Disassembly:

1. Rotate the lever on the attachment head laterally to unlock the tool and then remove the dissecting tool.

2. Discard the dissecting tool.

3. Rotate the AC-16 attachment to the unlocked position and lift the attachment o

of the motor.

Metal cutting attachment

Warning: Refer to Warnings W61.

Note: The metal cutting attachment uses the tungsten carbide or diamond wheel

dissecting tools. All metal cutting dissecting tools have an “MC” attachment prex in their nomenclature (for example, MC254 and MC30). Metal cutting dissecting tools cannot be installed into any other attachment.

Assembly:

1. Slide the metal cutting attachment over the motor collet aligning triangular marks on the attachment and the motor case. An audible click, heard and perceptible by touch, conrms that the attachment is fully seated.

2. Rotate the attachment to the locked position on the motor case.

3. Unscrew tool lock sleeve several turns and while holding the attachment upright, insert a dissecting tool into the attachment.

4. Rotate the dissecting tool until it drops into position and is fully seated (Figure 20).

5. Lock the tool in the attachment by rotating the locking sleeve in the direction shown on the attachment until the tool is secured.

6. Gently pull on the tool to ensure that it is secured in the attachment.

Disassembly:

1. Unscrew the tool lock with several turns, then withdraw the dissecting tool. Note: Do not rotate past the point where resistance is felt.

2. Discard tool.

3. Rotate the attachment to the locked position on the motor case and lift attachment o of the motor.

Midas Rex™ Legend™ Pneumatic High-Speed System

Metal cutting attachment

Variable exposure straight and angled attachment

Warning: Refer to Warnings W26.

Note: The variable exposure attachments can be distinguished from standard attachments by the dual color bands

on the attachment. Match the color band on the attachment to the color code on the dissecting tool packaging.

Assembly:

1. Assemble the variable exposure straight attachment using the Straight attachment Assembly instructions and the variable exposure angled attachments using the Angled attachment Assembly instructions.

2. After assembly, use the tube adjustment ring to adjust the exposure of the dissecting tool (Figure 21). With the tool pointing away from you, turn the ring to the right to increase the length of the tube, thereby decreasing the exposure of the tool. Turn the ring to the left to decrease the length of the tube, thereby increasing the exposure of the tool.

Disassembly:

Remove the variable exposure straight attachment using the Straight attachment Disassembly instructions and the variable exposure angled attachments using the Angled attachment Disassembly instructions.

Variable exposure attachment assembly

Midas Rex™ Legend™ Pneumatic High-Speed System

Telescoping tube and telescoping tube base attachment – straight (AT10) and angled (AT10A)

Assembly:

1. Assemble the telescoping base attachment straight (AT10) or angled (AT10A) to the motor using the Straight attachment Assembly instructions (Figure 22-1).

2. Insert the base end of the telescoping tube into the AT10, or AT10A attachment until the hub is fully seated. To secure the tube, turn the tube locking ring on the AT10, or AT10A attachment until nger tight (Figure 22-2). Note: Do not over tighten.

3. Verify that the telescoping tube is secure by gently pulling on the tube.

4. Rotate the tool locking ring to the unlocked position.

5. Insert the tool into the telescoping tube. Apply a slight amount of inward pressure on the tool (Figure 22-3). An audible click, heard and perceptible by touch, conrms that the tool is fully seated.

6. Turn the tool locking ring to the locked position (Figure 22-4).

7. Verify that the tool is secured by gently pulling on the tool.

8. To vary the tube position/tool exposure, rotate the tube locking ring toward the unlocked position, re-position the tube, then rotate the tube locking ring toward locked position until nger tight. Note: Do not over tighten.

9. Gently pull on the dissecting tool, then the tube, to ensure they are secure.

Disassembly:

1. Rotate the tube locking ring towards the unlocked position.

2. Rotate the tool locking ring to the unlocked position.

3. Remove the tool and then the telescoping tube from the AT10, or A10A attachment.

4. Discard the tool.

5. Rotate the AT10, or AT10A attachment to the unlocked position on the motor

case and lift the attachment o the motor.

22-1

22-2

22-3

22-4

Telescoping tube attachment assembly

Telescoping curved bur and telescoping base attachment straight (AT10) and angled (AT10A)

Assembly:

1. Assemble the attachment straight (AT10), or angled (AT10A) using the Straight attachment Assembly instructions.

2. Insert the base end of the curved bur into the AT10, or AT10A attachment until the hub is fully seated. To lock in place, turn the tube locking ring until nger tight (Figure 23-1). Note: Do not over tighten.

3. Verify that the hub is in place by gently pulling on the tool.

4. Seat the tool in the AT10, or AT10A attachment by gently pushing on the bur

(Figure 23-2). An audible click, heard and perceptible by touch, conrms that

the tool is fully seated. Verify tool is seated by checking the bur head

exposure as shown in Figure 23-2.

5. Rotate the tool locking ring until the tool lock alignment mark is directly in line with the locked symbol (Figure 23-3).

6. Verify that the bur is secured by gently pulling on the bur.

7. Prior to initial use, soak the cooling sleeve by dipping it into a cup of saline or

deionized (DI) water (Figure 23-4).

8. During use, copiously irrigate the cooling sleeve and bur by dribbling saline

or DI water along the entire length of the cooling sleeve.

Disassembly:

1. Rotate the tube locking ring towards the unlocked position.

2. Rotate the tool locking ring to the unlocked position.

3. Remove the curved bur from the AT10, or AT10A attachment.

4. Discard the curved bur.

5. Rotate the AT10, or AT10A attachment to the unlocked position on the motor case and lift the attachment o the motor.

23-1

Telescoping curved bur and telescoping base

attachment straight (AT10) and angled (AT10A) assembly

1. Cooling sleeve

23-2

23-3

23-4

Curved bur cooling

Attachment assembly

Midas Rex™ Legend™ Pneumatic High-Speed System

Perforator (AD01 & AD03) attachment

Notes:

• A cranial perforator device may be installed in the attachment before the perforator attachment is installed on the motor.

• Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.

• Consult the cranial perforator device labeling for recommended speed specications.

Assembly:

1. Assemble the attachment onto the motor using the Straight attachment Assembly instructions.

2. To install a cranial perforator device with a hudson shank, pull back proximally on the collar of the perforator attachment. Insert a device and release the collar to its original position (Figure 24).

3. The speeds achievable by the AD01 and AD02 attachments are provided in Table 7.

Disassembly:

1. Pull back proximally on the collar of the perforator attachment and then remove the cranial perforator device.

2. Rotate the perforator attachment to the unlocked position and lift the attachment o of the motor.

Table 7: Maximum speed of perforator attachments with Legend pneumatic motors

Pneumatic motors

Gas pressure

(dynamic)

80 psi 100 psi 120 psi

AD01 output

speed (maximum)

660 rpm 820 rpm 890 rpm

AD03 output

speed (maximum)

850 rpm 1050 rpm 1140 rpm

Jacobs chuck attachment

Assembly:

1. Assemble the attachment onto the motor using the Straight attachment Assembly instructions.

2. Install the Jacobs chuck key as shown in Figure 25 and rotate it counterclockwise to open the ridged collar.

3. Insert drill bit and tighten collar by turning the Jacob’s Chuck key clockwise (Figure 25) until the tool is secure.

Disassembly:

1. Using the Jacobs key, open the collar.

2. Remove and discard the drill bit.

3. Rotate the Jacobs chuck attachment to the unlocked position and lift the attachment o of the motor.

Perforator attachment assembly

Jacobs chuck attachment assembly

Angled double lock (DK) attachment

Notes:

• Angled attachments with the same length, marking, and color band share the same dissecting tools.

• You can insert and lock a tool in the attachment before the angled attachment is installed on the motor.

Assembly:

1. Assemble the attachment onto the motor using the Angled attachment Assembly instructions.

2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, conrms that the tool is fully seated (Figure 26-1).

3. Rotate the tool lock in direction indicated by arrow until the tool lock alignment mark is directly in line with the locked symbol (Figure 26-2).

4. Pull on the tool to ensure that it is secured in the attachment.

5. The tool should rotate freely. If not, unlock the attachment, re-seat the tool, and re-lock the attachment.

6. Verify that both the attachment to motor and the tool-lock alignment mark is directly in line with the corresponding locked symbol.

Disassembly:

1. To remove the attachment, hold the motor in the palm of your hand, and push the sleeve on the attachment distally while turning the attachment to the unlocked position (Figure 26-3).

2. Release the sleeve and remove the attachment.

26-1

26-2

26-3

Angled double lock (DK) attachment assembly

Angled double lock (DK) attachment disassembly

Midas Rex™ Legend™ Pneumatic High-Speed System

J-latch attachment

This attachment is designed for use with

industry standard J-latch dissecting

tools. Refer to the dissecting tool’s

labeling for information on specic

operating requirements and limitations.

27-1

J-latch attachment assembly J-latch attachment assembly

27-2

Assembly:

1. Assemble and secure the attachment onto the motor using the Straight attachment Assembly instructions (Figure 27-1).

2. Insert the tool into the attachment with a slight rotational motion. An audible click, perceptible by touch, conrms that the tool is fully seated (Figure 27-2).

3. Turn the tool lock sleeve in the direction shown on the attachment to lock the tool (Figure 27-3). Pull on the shaft of the dissecting tool to verify tool is secure.

27-3

J-latch attachment assembly

Disassembly:

1. Turn the tool lock sleeve in the direction shown on the attachment to unlock the tool (Figure 27-3).

2. Remove the dissecting tool from the attachment and discard it.

3. Rotate the attachment on motor to the unlocked position.

4. Lift the attachment o of the motor.

Bone mill attachment

Refer to manual 175013 for instructions for use and reprocessing instructions.

Safety data sheet for lubricant

Safety Data Sheet on lubricant used in Legend lubricant/diuser is available by contacting Medtronic Regulatory Aairs Department or Medtronic Technical Service at telephone numbers listed in this manual.

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend system troubleshooting

If Legend components require servicing or refurbishing, return components to 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.

Problem Possible cause Recommendations

Legend motors

Motor does not run or is low on power. Hoses not properly connected. Check all connections from compressed gas source to motor.

Operating pressure inadequate. Check gas supply to the Pneumatic Control Unit at Supply Pressure

Attachment not properly installed and locked onto the motor (possible smoking condition).

Motor sterilized with single use, disposable lubricant/diuser cartridge attached to the motors lubricant/diuser housing.

Foot Pedal on Pneumatic Control Unit not properly functioning.

Motor stalls or will not spin. Manually spin the dissecting tool then activate the motor. If motor

Legend Gold Touch will not run after checking possible causes listed previously for all Legend motors.

Motor continues to run. Pneumatic Control Unit is not properly

Motor is missing a component or a component has detached from the motor.

Motor rotates, but an abnormal noise

is heard.

Motor/collet displays excessive rust. Incorrect cleaning or sterilization method.

Motor is leaking lubricant. Motor failed. Do not use. Return the motor to MPSS to be serviced.

Oily lm on green exhaust hose of motor following sterilization.

Hose ruptures. Hose pinched, kinked, obstructed, or stepped on. Do not use. Return the motor to MPSS to be serviced.

Motor is heating to an uncomfortable temperature to touch/hold.

Finger/Foot control on the Pneumatic Control Unit not activated.

Safety slide in " " position.

functioning.

Finger control is not properly functioning. Return the motor to MPSS to be serviced.

Motor failed. Do not use. Return the motor to MPSS to be serviced.

Lubrication inadequate. Check for proper installation of the Legend lubricant/diuser. If

Motor's exhaust hose damaged or cut, or internal pressure hose detached.

Bearings of motor or attachment worn. Change attachment to isolate location of problem to the attachment or

Attachment not in proper locked position (possible smoking condition).

Use of chlorine based or corrosive cleaning agents. Aging.

Oily lm on hose due to pressure and/or temperature diertials following sterilization.

Inadequate "cool down" period following sterilization.

Lubrication inadequate. Check for proper installation of a new Legend lubricant/diuser into

Attachment transferring heat to motor. Change the attachment to isolate locations of heating to the

Heavy side loading during dissection. Discontinue use and rest the motor by using intermittently or wrap the

Inadequate irrigation. Ensure adequate irrigation to surgical site during bone dissection.

guage. Pressure may need to be increased according to compressed gas requirements.

Removed and re-install attachment and dissecting tool to ensure proper installation and locking of attachment onto motor.

Do not use. Return the motor to MPSS to be serviced.

Check for obstruction under foot pedal. If foot pedal continues not to function properly, return the Pneumatic Control Unit to MPSS to be serviced.

continues to stall, then return the motor to MPSS to be serviced.

Push nger/foot control on Pneumatic Control Unit to the " " position.

Move safety slide to " | " position.

Depressurize system. Return the Pneumatic Control Unit to MPSS to be serviced.

problem persists, replace the Legend lubricant/diuser. If problem persists, return the motor to MPSS to be serviced.

Do not use. Depressurize system. Return the motor to MPSS to be serviced.

motor. Return the motor and/or attachment to MPSS to be serviced.

See instructions for proper locking of attachments.

Return the motor to MPSS to be serviced.

If lubricant entered surgical site, treat patient per physician's discretion.

Wipe the external surface of the motor hose with a sterile cloth prior to use. After wiping with a sterile cloth, if motor continues to have oil on the hose, do not use. Return the motor to MPSS to be serviced.

Motor must be allowed to cool down following steam sterilization. Run motor for 2 minutes. If motor continues to overheat, return the motor to MPSS to be serviced.

the motor's lubricant/diuser housing.

attachment or the motor. If attachment is source of heat, return the attachment to MPSS to be serviced. If the motor is the source of heat, return the motor to MPSS to be serviced.

motor interface with a moist sterile towel. If the motor continues to overheat, return the motor to MPSS to be serviced.

Midas Rex™ Legend™ Pneumatic High-Speed System

Problem Possible cause Recommendations

Legend attachments or telescoping tubes

Attachment of Telescoping Tube

has uncomfortable temperature to

touch/hold.

Colorband on Attachments/ Telescoping Tubes fades or discolors.

Attachment/Telescoping Tube displays excessive rust.

Attachment/Telescoping Tube is

bent, loose, damaged or missing a

component.

Attachment will not properly seat onmotor.

Attachment has excess lubrication. Over lubrication during cleaning process. Visually inspect and wipe the excess lubrication.

Diculty removing tool from

attachment.

Footed attachment has a component

missing from leg/foot area.

Overheating of 16-MF Contra-Angle Attachment.

Perforator running too slow. Pressure set incorrectly. Check the pressure setting at the foot control.

Heat from worn attachment/tube bearings. Do not use. Try another attachment/tube. Return the over-heated

Attachment/tube unclean due to improper cleaning procedures.

Heavy side loading during dissection. Discontinue use and rest the attachment by using intermittently, try

Incorrect cleaning or sterilization method. Use the nomenclature markings on the attachment to match with a

Use of chlorine based or corrosive cleaning agents. Telescoping tubes are multi-use disposable.

Aging.

Incorrect cleaning or sterilization method. Do not use. Return the attachment to MPSS to be serviced. Dispose of

Use of chlorine based or corrosive cleaning agents. Telescoping tubes are multi-use disposable.

Aging.

Attachment mishandled or failed due to excessive use.

Motor collet ats are not in proper alignment. Use Legend motor wrench to rotate the at closest to the motor case

Worn components in attachment.

Improper cleaning.

Use of re-processed tools.

Use of unauthorized re-furbisher.

Attachment damaged by dissecting tool drilling out part or all of leg/foot area.

Improper cleaning of motor collet leading to

debris in collet.

Use of cleaning tools not recommended by Medtronic.

Contra-Angle attachment operates by a set

of internal gears to engage the drive shaft.

It is normal for some heat to be generated approximately 2 cm from the distal end of the attachment and at the right angle head.

attachment to MPSS to be serviced.

Telescoping tubes are multi-use disposable. If the problem is resolved

with a new telescoping tube, discard the over-heated tube.

Check that appropriate cleaning procedures are being followed.

another identical attachment or wrap the attachment interface with a moist sterile towel. If the attachment continues to overheat, return the attachment to MPSS to be serviced.

corresponding dissecting tool or return to MPSS to be serviced.

the telescoping tube.

Do not use. Return the attachment to MPSS to be serviced. Dispose of the telescoping tube.

Telescoping tubes are multi-use disposable.

until its marker is aligned with the marker on the at farthest away from the motor case.

Return to MPSS for service.

Do not use. Return the attachment and the motor to MPSS to be serviced.

Verify pressure setting is at 80 psi (5.5 bar).

Do not use if the heat continues or is excessive.

Return the attachment to MPSS to be serviced.

Midas Rex™ Legend™ Pneumatic High-Speed System

Problem Possible cause Recommendations

Legend dissecting tools

Dissecting tool ails. Device other than a Legend Dissecting Tool used. Do not use. Replace with a Legend dissecting tool.

Worn attachment/tube bearings. Do not use. Try another attachment/tube to isolate location of problem.

Attachment/tube and tool combination improper.

If proper attachment/tube and tool combination is being used, motor may be damaged.

Dissecting tool's size and geometry may contribute to ailing at certain speeds.

Excessive vibration. Dissecting tool's size and geometry may create

Dissecting tool sterile packaging damaged. Tool outside the tube or tube opened.

Expired Shelf Life. Old product–Dissecting tool may no longer

Dissecting tool will not seat properly in motor collet or angled attachment collet.

Dissecting tool rusts. Incorrect storage. Do not use. Reurn to MPSS.

Dissecting tool fractures or breaks. Excessive pressure. Remove all tool debris from patient.

Dissecting tool dull. Extended use. Change to a new tool.

excessive vibration at certain speeds.

Shipping damage–Dissecting tool is not longer sterile.

be sterile.

Debris in collet of angled attachment or motor. Clean the angled attachment or motor thoroughly as per instructions. If

Device other than Legend Dissecting Tool being used.

Reprocessed unused dissecting tool. Do not use.

Reprocessed tool. Check if the processed tool was used.

Tool failure. Contact MPSS customer service or sales representative.

Reprocessed tool. Check if the reprocessed tool was used.

Incorrect geometry. Contact MPSS customer service or sales representative.

If ail is produced by a specic attachment, return attachment to MPSS to be serviced. Dispose of telescoping tube. Telescoping tubes are multi-use disposable.

Do not use. Check for the correct nomenclature and color code on the dissecting tool packaging to the same nomenclature and color code on the attachment/tube.

Do not use. Return the motor to MPSS to be serviced.

Increase or decrease speed by changing the pressure setting or foot/ nger control.

Do not use if ailing persists. Change to a dierent dissecting tool.

Increase or decrease the speed by changing the pressure setting or foot/nger control. Change to a dierent dissecting tool.

Do not use. Contact MPSS customer service or sales representative.

cleaning does not correct the problem, do not use.

Return the angled attachment or motor to MPSS to be serviced.

Do not use. Replace with a Legend dissecting tool.

Midas Rex™ Legend™ Pneumatic High-Speed System

Disassembly of Legend equipment

1. Depressurize the system.

a. Turn o the tank or wall outlet compressed gas source.

b. Release pressure from the hose by depressing the pressure relief on the pneumatic control unit (Figure 28-1).

Warning: Refer to Warnings W72.

2. Disconnect hoses. Release motor hose from the pneumatic control unit by holding the motor’s exhaust hose rmly and depressing the Legend port connection

(Figure 28-2).

Notes:

• When releasing the Legend Gold Touch, depressing the Legend port connection will automatically release the “ ” position on the nger/foot control to the “ “ position. The foot pedal will move upward to its non-running position.

• If using the TRITON Power Surgical Instrumentation System, hold the TRITON blue hose rmly and remove by turning TRITON quick connect coupler

clockwise (Figure 28-3).

3. Discard the lubricant/diuser cartridge. Unscrew the lubricant/diuser cartridge from the housing and discard according to local regulations (Figure 28-4).

Note: During removal of the lubricant/diuser cartridge, oil residue may be present. An absorbent cloth may be used to facilitate removal.

4. Remove attachment and tool. Follow the applicable disassembly instructions in the attachment disassembly sections and discard tool according to local regulations.

28-1

Legend disassembly Legend disassembly TRITON System Legend disassembly

28-2

28-3

28-4

Disassembly of MR7 equipment

1. Depressurize the system.

a. Turn o the compressed gas at the source.

b. Press the pressure relief button on the pneumatic control unit to release

remaining gas.

Warning: Refer to Warnings W72.

2. Disconnect hoses. Release the motor hose from the control unit by holding

the hose rmly and pressing the motor port connection button (Figure 29).

3. Discard the lubricant/diuser cartridge. Remove the lubricant/diuser cartridge from the housing and discard it according to local regulations.

4. Remove the attachment and tool. Follow the applicable disassembly

instructions in the attachment disassembly sections and discard tool according to local regulations.

MR7 disassembly

1. Motor port connection button 2. Pressure relief button

Midas Rex™ Legend™ Pneumatic High-Speed System

Cleaning and sterilization

Devices should be cleaned and then sterilized per the instructions below: Reprocessing Instructions are subject to change. Refer to manuals.medtronic.com for current Reprocessing Instructions.

Notes:

• The reprocessing instructions provided below have been validated by the manufacturer as being capable of preparing the product for re-use. It remains the

responsibility of the processor to ensure that the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This normally requires validation and routine monitoring of the process.

• All validations performed per AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical

device manufacturers.

Medtronic recommends incineration of devices that have directly contacted patients suspected or conrmed with a Transmissible Spongiform Encephalopathy (TSE)/ Creutzfeldt-Jakob disease (CJD) diagnosis.

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.

Legend pneumatic motors reprocessing instructions

Warnings and cautions

Limitations on reprocessing

Point of use Follow hospital procedures.

Containment and transportation

Preparation for decontamination

Preclean instructions prior to use in an automated washer

Cleaning: Automated Caution: Do not use ultrasonic cleaner. Review the washer-disinfector warning above, before using this cleaning method.

Do not soak/submerge devices. Do not use ultrasound to clean devices. Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide,

formic acid, or solutions containing glutaraldehyde. The use of a washer-disinfector for cleaning may cause a degradation in performance. Allow an adequate cooling period after steam sterilization. Legend Gold, Gold Touch, and Platinum instrument case (PA400) is not interchangeable with MR7 and MR7 Touch instrument case (PA600).

Utilize appropriate tray when sterilizing motors.

The product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse. Verify functionality prior to re-use.

It is recommended that devices are reprocessed as soon as is practical following use.

Remove attachment from Legend Gold, Legend Gold Touch, and Legend Platinum motors and MR7 and MR7 Touch motors. Remove and discard tool according to local regulations. Do not soak devices.

Rinse devices under running tap water with collet pointed down until no visible soil is noticed. A nylon brush may be used to aid in cleaning. Remove devices from instrument trays before placing into washer. Verify devices are visually clean prior to placing in instrument washer. Orient devices in the washer to ensure maximum exposure to the cleaning agents. Clean per recommended washer cycle below.

Legend automated wash cycle using a neutral enzymatic detergent (pH 6.0-8.0)

Phase Recirculation time Water temperature Detergent type

Pre-wash 2 minutes (02:00) Cold water Not applicable

Wash 5 minutes (05:00) 66°C (151°F) (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute (01:00) Hot tap water Not applicable

Table 8. Disposable cleaning brush dimensions

Internal bore diameter Brush length

1.2 mm 20 cm (8 in)

2.4 mm 41 cm (16 in)

3.2 mm 41 cm (16 in)

Cleaning: Manual Wipe all external surfaces of the motor and cable with a cloth dampened with a neutral enzymatic detergent, pH 6.0-8.0.

Brush motor case and collet with a nylon brush dampened with a neutral enzymatic detergent. Rinse motor thoroughly under running water, collet end pointed down. Dry collet and motor with lint-free towel. Verify that devices are visually clean after manual cleaning. Rinse thoroughly with tap water.

Disinfection Follow hospital procedures.

Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped or wrapped with up to two layers of 1-ply polypropylene wrap

The instrument cases are not interchangeable. For sterilizing the Legend Gold, Gold Touch, and Platinum motors, use insturment case (PA400). For sterilizing the MR7 and MR7 Touch motors, use instrument case (PA600).

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend pneumatic motors reprocessing instructions

Sterilization Note: The temperatures and times for sterilization are the minimum required.

Legend 100% Ethylene Oxide (EO) sterilization parameters

Preconditioning

51-59 °C (124-138 °F), 70 ±5 % relative humidity, Time: 30 minutes (30:00)

Legend Gold, Legend Gold Touch, Legend Platinum, MR7, and MR7 Touch steam sterilization

Cycle Pre-vac Gravity Pre-vac Pre-vac

Temperature 132°C (270°F) 132°C (270°F) 134°C (273°F) 134°C (273°F)

Time 4 minutes (04:00) 25 minutes (25:00) 3 minutes (03:00) 18 minutes (18:00)

Drying 15 minutes (15:00) 15 minutes (15:00) 10 minutes (10:00) 20 minutes (20:00)

STERRAD Not validated for use with low temperature hydrogen peroxide gas plasma sterilization.

Sterilization temperature

51-59 °C (124-138 °F)

Relative humidity EO concentration

70 +/- 5 % 725 +/- 25 mg/L 4 hours 51-59 °C (124-138

Gas exposure (full-cycle)

Aeration

°F), 18 hours

Maintenance, inspection, and testing

Storage Store with other sterile devices.

Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired. Verify functionality prior to re-use.

Pneumatic control unit reprocessing instructions

Cleaning: Manual 1. Dampen a cloth with a neutral enzymatic detergent, pH 6.0-8.0, or a phenol based disinfectant, mixed according to manufacturer’s

instructions.

2. Wipe the foot pedal with the damp cloth until visually clean.

3. Dry the unit with a clean, non-abrasive cloth.

Attachments/tubes reprocessing instructions

Warnings and cautions

Limitations on reprocessing

Point of use Follow hospital procedures.

Containment and transportation

Preparation for decontamination

Preclean instructions prior to use in an automated washer

formic acid, or solutions containing glutaraldehyde. The use of a washer-disinfector for cleaning may cause a degradation in performance. Allow an adequate cooling period after steam sterilization.

The product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse. Verify functionality prior to re-use.

It is recommended that devices are reprocessed as soon as is practical following use.

Detach attachment from motor. Remove and discard tool according to local regulations. Do not soak devices.

Rinse attachments/tubes under running tap water, until no visible soil is noticed. Attachments with moving parts must be actuated through their full range of motion under running tap water. While rinsing under running tap water, an appropriately sized nylon brush must be used internally (for straight, footed attachments and

telescoping tubes only) and/or externally to aid in cleaning attachments. Remove devices from instrument trays before placing into washer. Variable exposure attachments (AVAXX, AVAXXDK, AVSXX) must be placed in the washer with their tube in the fully extended position. Verify devices are visually clean prior to placing in instrument washer. Orient devices in the washer to ensure maximum exposure to the cleaning agents. Clean per recommended washer cycle below.

Midas Rex™ Legend™ Pneumatic High-Speed System

Attachments/tubes reprocessing instructions

Cleaning: Automated Caution: Do not use ultrasonic cleaner. Review the washer-disinfector warning above, before using this cleaning method.

Legend attachments/tubes automated cleaning - neutral enzymatic detergent (pH 6.0-8.0)

Phase Recirculation time Water temperature Detergent type

Pre-wash 2 minutes (02:00) Cold water Not applicable

Wash 5 minutes (05:00) 66°C (151°F) (set point) Neutral enzymatic detergent, pH 6.0-8.0

Rinse 1 minute (01:00) Hot tap water Not applicable

Legend attachments/tubes automated cleaning - alkaline detergent (pH 8.0 -10.5)

Phase Recirculation time Water temperature Detergent type

Pre-wash 2 minutes (02:00) Cold tap water Not applicable

Wash 5 minutes (05:00) 43°C (109°F) (set point) Alkaline detergent with pH 8.0 - 10.5

Rinse 1 minute (01:00) Hot tap water Not applicable

Thermal rinse 1 minute (01:00) 90°C (194°F) (set point) Not applicable

Puried water rinse 1 minute, 30 seconds (01:30) 66°C (151°F) (set point) Not applicable

Cleaning: Manual Wipe all attachments and telescoping tubes with a cloth, dampened with a surgical instrument cleaning solution.

Immerse the head of contra-angle attachments in surgical instrument cleaning solution and run the motor for 1 minute. Other attachments and tubes may be mechanically agitated in cleaning solution, but not soaked or immersed. A nylon brush dampened with a surgical instrument cleaning solution may be used to clean the external surfaces and internal connecting

surfaces of the attachments and tubes. Straight attachments, footed attachments and telescoping straight tubes have special cleaning brushes sized to the attachment’s or

telescoping tube’s internal diameter. Push the brush wet with surgical instrument cleaning solution through the attachment or telescoping tube from rear to front to loosen and remove debris trapped inside.

Move any moveable parts back and forth to allow solution to thoroughly clean attachment, for example, sleeve on footed attachment, perforator attachment.

Clean variable exposure attachments without adjusting the tube length rst, then with the tube fully extended, and nally with the tube fully retracted.

Rinse thoroughly with tap water.

Drying and lubrication

Disinfection Follow hospital procedures.

Packaging For sterilization, place devices in instrument tray. Devices may be unwrapped or wrapped with up to two layers of 1-ply polypropylene wrap.

Sterilization Note: The temperatures and times for sterilization are the minimum required.

Thoroughly dry attachments. An air gun may be used to blow moisture out from rear to front of attachment. Note: Medtronic no longer recommends using the Legend attachment cleaning nozzle (PA120), as this may cause some attachments to overheat.

Using an aerosol spray lubricant (such as Pana Spray), perform the following steps to lubricate attachments: Holding the can approximately 10-15 cm (3-6 inches) away from the attachment, spray all components that move, rotate, or slide with

three quick squirts. Articulate movable components to ensure proper lubrication. Remove excess lubricant with a clean cloth.

For sterilizing the attachment and tubes, either the PA400 instrument case or the PA600 instrument case may be used.

Legend attachments/tubes steam sterilization

Cycle Gravity Pre-vac Pre-vac (FR/WHO) Pre-vac (UK)

Temperature 132°C (270°F) 132°C (270°F) 134°C (273°F) 134°C (273°F)

Time 25 minutes (25:00) 4 minutes (04:00) 18 minutes (18:00) 3 minutes (03:00)

Drying 15 minutes (15:00) 15 minutes (15:00) 20 minutes (20:00) 10 minutes (10:00)

STERRAD Do not use low temperature hydrogen peroxide gas plasma sterilization due to lumen internal diameter and

length restrictions.

STERIS Do not use liquid peracetic acid sterilization due to immersion procedure.

Legend attachments/tubes 100% Ethylene Oxide (EtO) sterilization parameters

Preconditioning

51-59 °C (124-138 °F), 70 ±5 % relative

humidity, Time: 30 minutes (30:00)

Maintenance, inspection, and testing

Storage Store with other sterile devices.

Inspect devices for any damage before and after each use. If damage is observed, do not use the device until it is repaired. Verify functionality prior to re-use.

Sterilization temperature

51-59 °C (124-138 °F)

Relative humidity

70 +/- 5 % 725 +/- 25 mg/L 4 hours 51-59 °C (124-

EtO Cconcentration

Gas exposure (full-cycle)

Aeration

138 °F), 18 hours

Midas Rex™ Legend™ Pneumatic High-Speed System

Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE)

MPSS will not authorize or accept the return of MPSS products that directly contact patients or is contaminated with a patient’s body uids who is suspected or conrmed with a Transmissible Spongiform Encephalopathies / Creutzfeldt-Jakob Disease (TSE/CJD) diagnosis. Furthermore, MPSS recommends that all MPSS products used on a patient conrmed with a TSE diagnosis be incinerated. Contact your Sales Representative for replacement of product incinerated under this policy or for temporary equipment while original equipment is quarantined. Contact MPSS Regulatory Aairs Department for additional information regarding TSE contamination. MPSS dissecting tools used on a patient suspected of a TSE/CJD diagnosis must be incinerated.

If TSE/CJD is excluded as a diagnosis, the quarantined reusable equipment may be returned for use after appropriate cleaning, decontamination and sterilization.

Hospital personnel should contact their infection control personnel for current procedures and policy for reusable equipment processing when suspect of contamination with Creutzfeldt-Jakob Disease (CJD) or other Transmissible Spongiform Encephalopathies (TSE).

Reusable devices that have been used on patients with suspected Creutzfeldt-Jakob Disease (CJD) or other Transmissible Spongiform Encephalopathies (TSE) should

be quarantined and not reused until diagnosis is conrmed or excluded. Reusable devices should be quarantined after having been cleaned, decontaminated, sterilized and packed in a ridged sealed container until nal diagnosis.

Preventative maintenance

Legend pneumatic high speed preventive maintenance/service program

The Midas Rex Legend Pneumatic High Speed System preventive maintenance/service program has been developed to assist you in getting the greatest ownership value from your Midas Rex Legend Pneumatic High Speed System, while helping to maximize its performance, safety and reliability. The scheduled preventive maintenance/service program is in addition to the required routine cleaning after each use. Please refer to the following preventive maintenance information for the specic steps necessary to maintain Midas Rex Legend Pneumatic High Speed System.

Dening maintenance level

The following scheduled maintenance information is provided as a guide to assist the customer in getting the greatest ownership value from their Midas Rex Legend

Pneumatic System, while helping to maximize its performance, safety and reliability. This scheduled maintenance program is in addition to the required routine cleaning after each use. (The scheduled maintenance program is one of three programs, Limited Warranty, and Extended Maintenance Agreement are the other two,

intended to help you keep your system in good condition.) The maintenance information is divided into two sections. Section 1 contains the preventive maintenance/service schedule. How much scheduled maintenance a Midas Rex Legend Pneumatic System requires depends upon

how often it is used and the conditions to which it is subjected, such as cleaning and sterilization. The demands on pneumatic systems can vary greatly from facility to

facility. Twelve maintenance intervals have been dened. The time interval is determined by tool usage per year per system and has been identied as levels A, B, C, or D

in accordance in Table 9.

Table 9: Maintenance level

Maintenance level

A 150–200 12–16* 3 months

B 100–149 8–11 4 months

C 50–99 4–7 5 months

D <50 <4 6 months

*A motor with usage rates greater than 16 uses per month should be returned for factory maintenance at a 6-month interval.

Note: Failure to follow recommended service and preventive maintenance schedules for attachments may prevent tool from being secured properly.

Identifying and following the scheduled maintenance level for a Midas Rex Legend Pneumatic System will assist in reducing the potential for unanticipated down time as a result of wear.

The preventive maintenance schedule found in Section 1 details the specic checkpoints that are recommended and its associated interval. It also provides a convenient place to document your system’s maintenance history. If any of these checkpoints indicate wear or damage, DO NOT USE. Return the respective product to MPSS for service.

The maintenance checkpoints have been designed for a facility’s Biomedical Department or equivalent to perform. Section 2 contains the detailed instructions for servicing the Midas Rex Legend Pneumatic System in accordance with the Twelve Maintenance Intervals. Your Midas Rex Legend Pneumatic System has a limited warranty for a period of 1 year from the date of purchase for Gold, Gold Touch, and Platinum Motors, Hoses,

Pneumatic Control Unit with Pressure Hose, Regulator, Adapters, and Instrument Cases and Trays. Th e Attachments and Telescoping Tubes have a limited warranty

for a period of 90 days from the date of purchase. Aft er the warranty period, any costs incurred for repair/refurbishing become the responsibility of the customer. Th is limited warranty does not include the cost associated with any of the factory level service requirements identi ed in the Preventive Maintenance Schedule.

Extended Maintenance Agreements are available. Please refer to the  rst page insert for the Business Reply Card to obtain further information.

For service, please call 817-788-6440 or toll free 1-800-335-9557 to schedule. For additional or replacement products, please call 817-788-6400 or toll free 1-800-433-7080 to order.

Number of tools used per motor per year

Usage rate uses per month per motor Time interval

Midas Rex™ Legend™ Pneumatic High-Speed System

Section 1: Preventive maintenance/service schedule: 12 maintenance intervals Date of system purchase:__________________ Maintenance level:__________________

Scheduled maintenance (See Section 2 for details)

Scheduled maintenance

1st

2nd

3rd

4th

5th

6th

7th

8th

9th

10th

11th

12th

Attachments: Straight, footed, perforator, Jacobs Chuck, and telescoping Attachments: Angled, contra, and metal cutting

□ Etching and color ring remain legible and distinguishable. □ Attachment tube and base are clean and free of debris. □ Attachment has no loose components. □ (Straight/footed) Attachment tip shows no signs of wear or deformation. □ Footed attachment foot is not bent. □ Collet on perforator or Jacobs Chuck drive attachment shows no signs of

wear or deformation.

□ Connect the attachment to the motor and run for 3 minutes. Motor case,

attachment base and tip do not become uncomfortably hot to the touch.

□ Repeat for each straight, footed, telescoping, perforator, and Jacobs Chuck

drive attachment in this system.

□ Note: Telescoping tubes are multi-use disposable. Discard if excessive heat or

vibration is present.

If any damage, excessive rust/corrosion, or wear is observed with the product, or if action is required beyond cleaning, do not use the product and return to MPSS for service.

Level A months

 3  4  5  6

 6  8  10  12

 9  12  15  18

 12  16  20  24

 15  20  25  30

 18  24  30  36

 21  28  35  42

 24  32  40  48

 27  36  45  54

 30  40  50  60

 33  44  55  66

 36  48  60  72

Level B months

Level C months

Level D months

Date performed Performed by

Factory service recommended - contact Medtronic

□ Etching and color ring remain legible and distinguishable. □ Attachment tube and base are clean and free of debris. □ Attachment has no loose components. □ Attachment tip shows no signs of wear or deformation. □ Connect the angled or metal cutting attachment to the motor and run for

3 minutes. Motor case, attachment base, knuckle and tip do not become

uncomfortably hot to the touch. □ Head to tube joint for the contra-angled attachment is stable, that is, no play. □ Connect the contra-angled attachment to the motor and run for 1 minute at

62,000rpm. Motor case, contra-angled attachment base, knuckle and tip do

not become uncomfortably hot to the touch □ Repeat for each angled, contra-angled or metal cutting attachment in this

system.

Section 2: Instructions for completing preventive maintenance steps

Scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, 11

Motor

1. Visually inspect the exhaust (green) hose and ensure that it does not have any nicks, cracks, holes, tears, or other visible signs of wear.

2. Wipe the external surface of the exhaust (green) hose with a cloth. Perform the heat and seal check below (Step 6) and then inspect the hose. If an oily lm remains on the hose, do not use and return the motor to MPSS for service.

3. Visually inspect the Lubricant/Diuser connection and ensure that the seals are present and that the connection area does not show any signs of damage that would prevent the lubricant cartridge from tting properly.

4. Visually inspect the air tting and ensure that it does not exhibit any signs of damage.

5. Visually inspect the etching and ensure that it remains legible.

6. Heat and Seal Check a. Attach and lock a straight or footed attachment onto the motor. Check to ensure that there is a tactile feel and an audible click when the attachment is

locked on the motor. b. Connect the motor to a Foot Control unit attached to a compressed gas source. c. Run the motor for 5 minutes. d. Feel the motor case and the attachment base and ensure they are not uncomfortably hot to the touch. e. Remove the Attachment and visually inspect the tool collet area, and the  nger control valve area (for Gold Touch Motors) for any signs of oil.

7. (Gold Touch only) Run the motor for a short duration and then release the  nger control lever. If the motor continues to run aft er the  nger control lever is released, do not use and return the motor to MPSS for service.

8. (Gold Touch only) Visually inspect the  nger control lever and safety slide for any signs of debris or damage. Ensure the lever moves freely.

Midas Rex™ Legend™ Pneumatic High-Speed System

Attachments: Straight, footed, perforator, Jacobs Chuck, and telescoping

Telescoping tubes are multi-use disposable and do not receive scheduled maintenance.

1. Visually inspect the etching and color ring to ensure it remains legible and the color is distinguishable.

2. Visually inspect the attachment tube and base for any signs of debris or damage.

3. Visually and physically inspect (pulling and twisting by hand) the attachment for any loose or loosening components. If any components are loose, do not use and return the attachment to MPSS for service.

4. (Straight/Footed) Visually inspect the attachment tip for any signs of wear. The tip should remain round with no evidence of deformation.

5. (Footed) Visually inspect the foot. The foot and/or leg of the attachment should not be bent or damaged.

6. (Perforator and Jacobs Chuck) Visually inspect the perforator collet for any signs of wear or deformation.

7. Heat Check a. For telescoping attachment, insert an appropriate telescoping tube into the base. b. Attach and lock the attachment onto the motor. Check to ensure that there is a tactile feel and an audible click when the attachment is locked on the motor.

c. Connect the motor to a Foot Control unit attached to a compressed gas source. d. Run the motor for 5 minutes. e. Feel the motor case, the attachment base, and the attachment tip (except Telescoping) to ensure they are not uncomfortably hot to the touch.

8. Repeat steps 1-7 for each straight/footed/perforator/Jacobs Chuck attachment that is part of this system.

Attachments: Angled, contra, and metal cutting

1. Visually inspect the etching and color ring to ensure it remains legible and the color is distinguishable.

2. Visually inspect the attachment tube and base for any signs of debris or damage.

4. Visually inspect the attachment tip for any signs of wear. The tip should remain round with no evidence of deformation.

5. Heat Check Angled and Metal Cutting Attachment a. Attach and lock the attachment onto the motor. Check to ensure that there is a tactile feel and an audible click when the attachment is locked on the motor. b. Connect the motor to a Foot Control unit attached to a compressed gas source.

c. Run the motor for 5 minutes. d. Feel the motor case, the attachment base, the knuckle (angled area for angled attachment only), and the attachment tip to ensure they are not

uncomfortably hot to the touch.

6. (Contra) Visually inspect the head to tube joint for the contra-angled attachment for stability; that is, there is no loosening of this joint.

7. Heat Check Contra-Angled Attachment a. Attach and lock the contra-angled attachment onto the motor. Check to ensure that there is a tactile feel and an audible click when the attachment is locked

on the motor.

b. Connect the motor to a Foot Control unit attached to a compressed gas source.

c. Run the motor for 1 minute. d. Feel the motor case, the attachment base, the knuckle (contra-angled area), and the attachment tip to ensure they are not uncomfortably hot to the touch.

8. Repeat steps 1-7 for each angled/contra-angled/metal cutting attachment that is part of this system.

Foot control and regulator

1. Visually inspect the air ttings and supply hose for any signs of blockage, damage, or wear.

2. Static Gage Check a. Connect the foot control/regulator to a compressed gas source. b. Pressurize the foot control/regulator.

c. Conrm that the gage is functional.

NOTE: This is a static functional test only. The pressure gages should be placed on your facility’s routine calibration schedule and be assessed for accuracy

during its regular calibration date.

3. (Foot Control) Pressure Relief Button Check a. Connect the foot control to a compressed gas source. b. Pressurize the foot control.

c. Turn o the compressed gas source. d. Press the Pressure Relief Button. e. Conrm that the compressed gas has been released and the gage on the foot control drops to zero.

4. (Foot Control) Finger/Foot Control Switch Functionality Check a. Place the switch in the “ ” position. b. Conrm the foot pedal is depressed.

c. Place the switch in the “ ” position. d. Conrm the foot pedal is released.

5. (Foot Control) Visually inspect the Legend and TRITON port plugs for any signs of wear or damage and conrm that they remain connected to the foot control.

6. (Foot Control) Visually inspect the foot control pedal for any build-up of debris or indication of damage. Ensure the pedal moves freely.

7. (Foot Control) Pedal Check a. Attach a Gold or Platinum motor to the foot control. b. Connect the foot control to a compressed gas source.

c. Depress the foot control and run the motor for a short duration. d. Release the foot control and observe the motor.

NOTE: If the motor continues to run aft er the foot pedal control lever is released, do not use and return the foot control to MPSS for service.

Midas Rex™ Legend™ Pneumatic High-Speed System

Scheduled maintenance intervals 4, 12

Motor, attachments: straight, footed, perforator, Jacobs Chuck, telescoping, angled, contra, and metal cutting

At these maintenance intervals it is important that the units be returned to MPSS for factory level inspection and service. Please call 817-788-6440 or toll free 1-800335-9557 to schedule. As a reminder, the costs associated with any of the factory level service requirements are not included in the limited warranty. Extended Maintenance Agreements are available. Please refer to the rst page insert for the Business Reply Card to obtain further information.

Telescoping tubes are multi-use disposable and do not receive scheduled maintenance.

Contra-angled attachment

The Contra-angled attachment does not contain user or factory serviceable components and must be replaced at the 4th, 8th, and 12th maintenance intervals. Please call 817-788-6400 or toll free 1-800-433-7080 to order.

Foot control and regulator

1. Visually inspect the air ttings and supply hose for any signs of blockage, damage, or wear.

2. Static Gage Check a. Connect the foot control/regulator to a compressed gas source. b. Pressurize the foot control/regulator. c. Conrm that the gage is functional.

Note: This is a static functional test only. The pressure gages should be placed on your facilities routine calibration schedule and be assessed for accuracy

during its regular calibration date.

3. (Foot Control) Pressure Relief Button Check a. Connect the foot control to a compressed gas source. b. Pressurize the foot control. c. Turn o the compressed gas source. d. Press the Pressure Relief Button. e. Conrm that the compressed gas has been released and the gage on the foot control drops to zero.

4. (Foot Control) Finger/Foot Control Switch Functionality Check a. Place the switch in the “ ” position. b. Conrm the foot pedal is depressed. c. Place the switch in the “ ” position. d. Conrm the foot pedal is released.

5. (Foot Control) Visually inspect the Legend and TRITON port plugs for any signs of wear or damage and conrm that they remain connected to the foot control.

6. (Foot Control) Visually inspect the foot control pedal for any build-up of debris or indication of damage. Ensure the pedal moves freely.

7. (Foot Control) Pedal Check a. Attach a Gold or Platinum motor to the foot control. b. Connect the foot control to a compressed gas source. c. Depress the foot control and run the motor for a short duration. d. Release the foot control and observe the motor. If the motor continues to run after the foot pedal control lever is released, do not use and return the foot

control to MPSS for service.

Scheduled maintenance intervals 8

Motor, attachments: straight, footed, perforator, Jacobs Chuck, telescoping, angled, contra, and metal cutting; foot control, and regulator

At this maintenance interval it is important that the units be returned to MPSS for factory level inspection and service. Please call 817-788-6440 or toll free 1-800335-9557 to schedule. As a reminder, the costs associated with any of the factory level service requirements are not included in the limited warranty. Extended Maintenance Agreements are available. Please refer to the rst page insert for the Business Reply Card to obtain further information.

Telescoping tubes are multi-use disposable and do not receive scheduled maintenance.

Contra-angled attachment

Midas Rex™ Legend™ Pneumatic High-Speed System

Refurbishing or repairs

When the Midas Rex Legend Pneumatic High Speed System requires servicing or refurbishing, contact MPSS Repair Services for a return authorization and

instructions for returning the equipment to MPSS, Fort Worth, Texas. MPSS provides quality assured service by factory-trained personnel who will utilize genuine

Midas Rex Legend parts as required.

Contact:

Medtronic Powered Surgical Solutions

4620 North Beach Street Fort Worth, Texas 76137 USA US Help Line (800-335-9557)

RS.DFWrepairs@medtronic.com

Peak performance, reliability and maximum service life from your Midas Rex Legend System may be assured by using only those Midas Rex Legend products for your Midas Rex Legend System that are manufactured by and sold through MPSS, Fort Worth, Texas. While MPSS guarantees complete compatibility among its products within a specic product line, the dissecting tools are designed for single-use only, and Medtronic disclaims any responsibility when reprocessed dissecting tools are used. If you would like more information about the patient and product risks associated with reprocessed tools, please contact the number or e-mail address listed above.

Due to safety and environmental concerns, MPSS requests the return of pneumatic high speed motors for proper disposal at the end of the product life cycles.

Midas Rex Legend pneumatic high speed system limited warranty*

(U.S. Customers Only)

A. This Limited Warranty provides the following assurance to the purchaser of a Medtronic Midas Rex Legend Pneumatic High Speed System. The Midas Rex Legend

Pneumatic High Speed System includes the motor, foot control, instrumentation cases and trays (hereafter referred to as Motor Components), the attachments,

dissecting tools and other accessories not listed above and telescoping tubes (hereafter referred to as Accessory Components) and jointly referred to as Legend

Pneumatic High Speed System, unless specically noted. i. Should a Motor Component fail to function within normal tolerances due to a defect in materials or workmanship within a period of one year from the date

of shipment of the new Motor Component, or 180 days from the date of shipment of the serviced or refurbished Motor Component to the purchaser (but not

less than the one year period from the date of shipment of the new Motor Component), or

ii. Should an Accessory Component fail to function within normal tolerances due to a defect in materials or workmanship within a period of 90 days from the

date of shipment of a new Accessory Component or serviced or refurbished Accessory Component to the purchaser, Medtronic will at its option: (a) issue a credit to the purchaser of the replacement Motor Component or Accessory Component equal to the Purchase Price, as dened in Subsection A(3), against

the purchase of any same Motor Component or Accessory Component requested as its replacement, or, (b) provide a functionally comparable replacement Motor Component or Accessory Component at no charge.

iii. As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original or current functionally comparable, or replacement Motor

Component or Accessory Component.

B. To qualify for this Limited Warranty, these conditions must be met:

i. The Legend Pneumatic High Speed System must be used in accordance with the labeling and Instruction Manual provided with the products. ii. Only Legend Pneumatic High Speed System dissecting tools that are manufactured, authorized, and quality controlled by Medtronic may be used. iii. No reprocessed dissecting tools may be used. iv. The Legend Pneumatic High Speed System may not be damaged by accident, abuse, misuse or tampering. v. The Legend Pneumatic High Speed System may not be modied without the written permission of Medtronic.

C. This Limited Warranty is limited to its express terms. In particular:

i. Except as expressly provided by this Limited Warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES

BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE LEGEND PNEUMATIC HIGH SPEED SYSTEM TO FUNCTION WITHIN NORMAL TOLERANCES WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, NEGLIGENCE, STRICT LIABILITY, OR OTHER TORT OR OTHERWISE.

ii. This Limited Warranty is made only to the purchaser. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING BUT NOT

LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW,

CUSTOM OR OTHERWISE.

iii. The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law.

If any part or term of this Limited Warranty is held to be illegal, unenforceable or in conict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be aected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the purchaser specic legal rights. The purchaser

may also have other rights that vary from state to state. iv. No such express or implied warranty to the purchaser shall extend beyond the period specied in A(1) above. v. This Limited Warranty shall be the exclusive remedy available to any person. vi. No person has any authority to bind Medtronic to any representation, condition, or warranty, except this Limited Warranty.

*This Limited Warranty is provided by Medtronic Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, Texas 76137-4116. It applies only in the United

States. Areas outside the United States should contact their local Medtronic representative for terms of the warranty.

After the warranty period, any costs incurred for repair/refurbishing become the responsibility of the customer. This limited warranty does not include the cost associated with any of the factory level service requirements identied in the preventive maintenance schedule. Extended maintenance agreements are available.

EC REP

STERILE

Control Unit

Dissecting Tool

REGULATOR

Symbols

The following symbols can appear on this device and related packaging.

Midas Rex™ Legend™ Pneumatic High-Speed System

Compliant with European Council Directive MDD 93/42/EEC

Authorized Representative in the European Community

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Consult Instructions for Use

Attention, see Instructions for Use.

Air Pressure Relief

Do Not Dispose Of This Product In The Unsorted Municipal Waste Stream. Dispose Of This Product According to Local Regulations. See Recycling.Medtronic.com for Instructions On Proper Disposal Of This Product.

If the single use symbol is on the device label then this device is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise 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.

Non-Sterile

Sterilized using Irradiation

Finger-Operated Control

Foot-Operated Control

+ XX °C + XX °F

Temperature Limitation

Manufacturer

Date of Manufacture

Use By Date

Serial Number

Catalog Number

Lot Number

Quantity

Is Approximately Equal To

Use With

Unlocked

Locked

Accessory

Adapter

Attachment

Brush

Control Unit

Lubricant/Diuser

Refurbished

! USA

Dissecting Tool

Instrument Case

Lubricant/Diuser

Motor

Refurbished

Regulator

Multi-Use Disposable Attachment

USA Only

O

Tool Control

Tube Control

Diameter

Part Number

Do not use if package is open or damaged

Package Quantity

May be covered by U.S. Patents:

EC REP

2019-06

Medtronic.com/patents

Made in USA. Printed in USA.

Medtronic Powered Surgical Solutions

4620 North Beach Street

Fort Worth, Texas 76137 USA

+1 800 643 2773

Medtronic B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen The Netherlands +31 45 566 8000

Medtronic Australian Sponsor:

Medtronic Australasia Pty Ltd

2 Alma Road

Macquarie Park, NSW 2113 Australia

medtronic.com

manuals.medtronic.com

Medtronic AF02R Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual