Legend Pneumatic HS System Legend Gold Touch, Platinum, MR7, MR7 Touch Instructions for Use Jun 2019

Customer service Contact your Medtronic Neurosurgery sales representative or call: Medtronic Neurosurgery Service Group (800) 433-7080 or (817) 788-6440 [email protected] Outside the U.S.A., contact your Medtronic regional distributor or Medtronic Neurosurgery representative. EN To obtain a copy of this manual in your local language contact your local Medtronic representative or go to manuals.medtronic.com. FR Pour obtenir un exemplaire de ce manuel dans votre langue, veuillez contacter votre représentant Medtronic local ou visiter la page manuals.medtronic.com. IT Per ottenere una copia del presente manuale nella lingua locale, contattare il rappresentante Medtronic di zona o visitare la pagina manuals.medtronic.com. DE Eine Kopie dieses Handbuchs in der jeweiligen Landessprache kann vom örtlichen Medtronic-Vertreter angefordert oder unter manuals.medtronic.com bezogen werden. ES Para obtener una copia de este manual en su idioma local, póngase en contacto con su representante local de Medtronic o visite manuals.medtronic.com. NL Neem contact op met uw vertegenwoordiger van Medtronic of ga naar manuals.medtronic.com voor een exemplaar van deze handleiding in uw taal. DA Du kan få en kopi af denne vejledning på dit sprog ved at kontakte den lokale Medtronic-repræsentant eller gå til manuals.medtronic.com. SV För att erhålla en kopia av denna handbok på ditt språk kontaktar du din lokala representant för Medtronic eller går till manuals.medtronic.com. FI Jos haluat tämän käyttöoppaan omalla kielelläsi, ota yhteyttä paikalliseen Medtronicin edustajaan tai siirry osoitteeseen manuals.medtronic.com. PT-PT Para obter uma cópia deste manual no seu idioma local, contacte o seu representante local Medtronic ou visite manuals.medtronic.com. EL Για να λάβετε αντίγραφο του παρόντος εγχειριδίου στην τοπική σας γλώσσα, επικοινωνήστε με τον τοπικό αντιπρόσωπο της Medtronic ή επισκεφθείτε την ιστοσελίδα manuals.medtronic.com. PL Aby uzyskać egzemplarz niniejszego podręcznika w wybranym języku, należy się skontaktować z lokalnym przedstawicielem firmy Medtronic lub odwiedzić stronę manuals.medtronic.com. CS Máte-li zájem o kopii této příručky v místním jazyce, kontaktujte místního zástupce společnosti Medtronic nebo navštivte webové stránky manuals.medtronic.com. HU Ha szeretne egy saját nyelvű példányt a jelen kézikönyvből, vegye fel a kapcsolatot a Medtronic helyi képviseletével, vagy látogasson el a manuals.medtronic.com weboldalra. TR Bu kılavuzun kendi dilinizde bir kopyasını almak için, bölgenizdeki Medtronic temsilcinize başvurun veya manuals.medtronic.com adresine gidin. NO Du kan få et eksemplar av denne håndboken på ditt språk ved å kontakte din lokale Medtronic-representant eller gå til manuals.medtronic.com. RU Для получения экземпляра этого руководства на вашем языке обратитесь к местному представителю Medtronic или посетите сайт manuals.medtronic.com. SR Da biste dobili kopiju ovog priručnika za korisnike na svom jeziku, kontaktirajte lokalno predstavništvo kompanije Medtronic ili posetite lokaciju manuals.medtronic.com. HR Da biste dobili kopiju ovog priručnika na svom jeziku, obratite se lokalnom predstavniku tvrtke Medtronic ili pak posjetite web-mjesto manuals.medtronic.com. PT-BR Para obter uma cópia deste manual em seu idioma local, entre em contato com o representante local da Medtronic ou acesse manuals.medtronic.com. 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/diffuser 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/diffuser cartridge (PA100-A)...5 Adapters...6 Attachments...6 Dissecting tools...6 Legend power source requirements...7 Legend pneumatic connections...7 Legend pneumatic motor technical specifications...8 Legend system assembly...8 Installing the lubricant/diffuser 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...11 Regulator hose...11 MR7 instrument case...11 Motor wrench...11 Lubricant/diffuser cartridge (PA700)...11 Adapters...12 Attachments...12 Dissecting tools...12 MR7 power source requirements...13 MR7 pneumatic connections...13 MR7 pneumatic motor technical specifications...14

MR7 system assembly...14 Installing the lubricant/diffuser 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 Defining 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 • Lumbar Stenosis Decompression • Posterior Lumbar Interbody Fusion (PLIF)

• Transforaminal Lumbar Interbody Fusion (TLIF) • Anterior Lumbar Interbody Fusion (ALIF) • 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 pneumatic control unit with regulator and various connectors • Legend attachments

• Legend dissecting tools - single use, disposable • Legend lubricant/diffuser - single use, disposable

The MR7 system is part of the Legend pneumatic high speed system and is comprised of the following: • MR7 or MR7 Touch motors • MR7 pneumatic control unit with regulator and various connectors

• MR7 TRITON adapter (optional) • MR7 lubricant/diffuser - 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 identified 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 staff may be involved. Disregarding this information could result in injury to the patient, operator, and/or operating room staff. Caution: These instructions point out special service procedures or precautions that must be followed to avoid damaging the instrument. A damaged instrument could result in injury to the patient, operator, and/or operating room staff. Note: This provides special information to make maintenance easier or important operating instructions more clear. Read and understand warnings before use of the Legend system.

Warnings

System warnings W1 W2

The Legend pneumatic system operator must be familiar with this Instructions for Use, their precautions, procedures, and safety issues. The Legend pneumatic system and its associated equipment should be used only by qualified 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 specifically 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 qualified 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. 1

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 modified 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 staff. Use of devices other than Legend Systems or associated parts or components will damage the motor and attachments and will void manufacturer’s limited warranty. 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 finger 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 qualified 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, fluoroscopy, 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 effect 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 specifications. 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 staff. 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 modified 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 affect 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 W51 W52 W53 W54 W55 W56 W57 W58 W59 W60 W61 W62 W63 2

Keep the cutting area of the tool away from fingers and loose clothing to prevent laceration of user and cross-contamination through compromised glove. Operate the tool only after appropriate anatomical landmarks at the intended surgical site have been confirmed. Use care in application of the rotating cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories. Bending or prying may break the accessory, causing harm to patient or user. A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed of the motor to prevent vibration. 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. 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. Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. Do not re-sharpen used tools. Worn tools should be frequently replaced with new ones to ensure effective cutting and control. 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. Do not use metal-cutting tools to cut/resect bone. Use only rotary tools specifically designed for use with the Medtronic Midas Rex Legend drill system. 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 W65 W66 W67 W68

Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging. Do not use dull tools. Use of dull tools can reduce cutting effectiveness and can cause the motor temperature to increase. Always ensure that the tool is secured in the motor or attachment prior to operating the system. Exposure of tool packaging to light for extended periods of time may cause damage to packaging. Do not use or re-process a dissecting tool that has already been used. Using a dissecting tool that has already been used may cause injury to the patient, operator and/or operating room staff or contamination. Using a dissecting tool that has already been used may affect motor performance. W69 Do not use an attachment and dissecting tool combination if tool flail or excessive vibration occurs. W70 Dissecting tool flutes are sharp and may perforate surgical gloves.

Legend pneumatic control unit warnings W71 W72 W73 W74

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

Legend lubricant/diffuser cartridge warnings W75 W76 W77 W78

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

Cautions C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C11 C12 C13 C14 C15 C16 C17 C18 C19 C20 C21 C22 C23

When using an angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor. Do not use twist drill or contra-angle tool/attachment at an operating pressure over 80 psi (5.5 bar). Do not kink hoses. Inspect hoses for cracks, tears, or corrosion. The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance. 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. Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure. Remove and discard accessories following local regulations for disposal of contaminated materials. 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. Do not autoclave the pneumatic adapter. Legend pneumatic control unit and pressure hose should not be sterilized. Do not exceed 1 hour drill time per surgery for a Legend lubricant/diffuser. Use only Legend dissecting tools with a Legend pneumatic motor. Do not attempt to remove Legend lubricant/diffuser while the motor is in operation. Do not attempt to refill a used lubricant/diffuser cartridge. Do not sterilize the lubricant/diffuser cartridge. The lubricant/diffuser cartridge may melt into the lubricant/diffuser housing with potential damage to the motor. The lubricant/diffuser cartridge must be removed from the motor’s lubricant/diffuser housing prior to sterilization. When using angled attachments with the Legend Gold Touch, extend the lever on the Finger Control and hold by the attachment. If the motor has an uncomfortable temperature to touch/ hold following sterilization, allow an adequate “cool down” period. If the motor has an uncomfortable temperature to touch/ hold and an adequate “cool down” period was used, check that a new Legend lubricant/diffuser is properly attached to the motor’s lubricant/diffuser housing to help cool down motor. Run the motor briefly to assist in its cool down. The Legend Gold, Gold Touch, and Platinum lubricant/diffuser cartridge (PA100-A) is not interchangeable with the MR7 lubricant/diffuser cartridge (PA700). Ensure you select the appropriate lubricant/diffuser cartridge for the motor. During a lengthy surgical procedure with extended motor use, lubricant may drip from lubricant/diffuser cartridge. Do not re-use a lubricant/diffuser cartridge. It is a single-use product. Remove lubricant/diffuser cartridge from motor assembly prior to sterilizing it.

3

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 finger 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

1-2

Legend Gold motor

4

2

1

Legend Gold Touch motor

4

1

5

5

7 8

3 1.

Collet

3.

Swivel

2.

Motor case

4.

Convertible angle

1-3

5.

Hose

Legend Platinum motor

1

2

4

3

4

1. 2.

1.

Collet

3.

Swivel

2.

Motor case

4.

Fixed angle

5.

Hose

5

Extension lever Collet

6

3

2 4. 3.

Finger control Motor case

5. 6.

Safety slide Convertible angle

7. 8.

Swivel 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 finger/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 certified Supply Pressure gauge. Legend pneumatic control unit has a handle (Figure 2-2) for ease of re-positioning unit while on floor 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/diffuser cartridge (PA100-A)

Provides lubrication to Legend motors, diffuses spent air from motor, and filters oil from exhausted air. Note: Each Legend Motor has a lubricant/diffuser 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/diffuser cartridge (PA100-A) is not interchangeable with the MR7 lubricant/diffuser cartridge (PA700). Ensure you select the appropriate lubricant/diffuser cartridge for the motor. 2-1

Legend pneumatic control unit

2-2

Legend pneumatic control unit handle

2-3

Regulator

1

1.

Delivery pressure gauge

2.

Cylinder pressure gauge

2

2-4

Instrument case

2-5

Motor wrench

2-6

Lubricant/diffuser

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 3-1) allows for the regulator hose to connect to AUS-SIS wall fittings 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

3-2

3-5

3-6

N2 DISS to female Schrader adapter

N2 DISS to male Schrader adapter

N2 DISS to surgical tool air male SIS adapter

3-3

N2 DISS to male Schrader adapter (UK)

3-7

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 prefix 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.

6

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend power source requirements Table 1: Power source requirements Motors

Required operating (dynamic) pressure

Nominal operating (dynamic) pressure

Approximate flow rate required

Legend Gold Legend Gold Touch Legend Platinum

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

Gas type Nitrogen or dry-filtered compressed air Nitrogen or dry-filtered compressed air Nitrogen or dry-filtered compressed air

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

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. 4

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. 7

Midas Rex™ Legend™ Pneumatic High-Speed System

Legend pneumatic motor technical specifications Table 2. Legend pneumatic motor technical specifications Product

Size

Weight (gm)

Legend Gold

143

Length (cm)

Diameter (cm)

14.2

1.8

Legend Gold Touch

167

15.5

1.8

Lengend Platinum

100

12.3

1.6

Legend system assembly Installing the lubricant/diffuser 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/diffuser (Figure 5-1). b. Do not remove inner foil seal of lubricant/diffuser (Figure 5-2). 3. Insert lubricant/diffuser into lubricant/diffuser housing located at base of motor hose (Figure 5-3). 4. Rotate lubricant/diffuser 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 diffuser housing. If the cartridge has been pressurized for longer than 4 hours, it should be replaced. 5-1

5.

Lubricant/diffuser cover

5-2

Inner foil (Do not remove)

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 finger/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.

8

5-3

Insert lubricant/diffuser

5-4

5-5

Connect the motor hose

5-6 Lock the finger/foot control

Rotate lubricant/diffuser

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. 2.

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

6-2 Install and lock attachment

6-3

Allow motor to run

6-4

Extend the finger control lever

9

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 finger control. This motor is used to dissect bone and biomaterials. Instruction manual will use the “ Warning: Refer to Warnings W1. 7-1

” symbol to indicate information on MR7 Touch.

7-2

MR7 motor

1

MR7 Touch motor

1

4

4

5 6

5 2

3

2

1.

Collet

3.

Motor case

2.

Collet flats

4.

Swivel

10

5.

Hose

3

1.

Finger control lever

3.

Motor case

5.

Swivel

2.

Collet

4.

Safety slide

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 finger 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/diffuser cartridge (PA700) The lubricant/diffuser cartridge (Figure 8-5) provides lubrication to the motor and filters oil from exhausted air. Caution: The Legend lubricant/diffuser cartridge and the MR7 lubricant/diffuser cartridge are not interchangeable. 8-1

MR7 pneumatic control unit

8-2

8-3

Regulator

1

1.

Delivery pressure gauge

2.

Cylinder pressure gauge

MR7 instrument case (PA700)

2

8-4

Motor wrench

8-5 Lubricant/diffuser cartridge

11

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 fittings 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

9-2

9-5

9-6

N2 DISS to female Schrader adapter

N2 DISS to male Schrader adapter

N2 DISS to surgical tool air male SIS adapter

9-3

N2 DISS to male Schrader adapter (UK)

9-4

9-7

N2 DISS to WF4 adapter

9-8 TRITON pneumatic adapter

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 AS14/14-AM angled attachments are 14 cm long and have a green color band. All dissecting tools with the prefix 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.

12

Midas Rex™ Legend™ Pneumatic High-Speed System

MR7 power source requirements Table 3: Power source requirements Motors

Required Operating (Dynamic) Pressure

Nominal Operating (Dynamic) Pressure

Approximate Flow Rate Required

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

MR7 MR7 Touch

Gas Type Nitrogen or Dry-Filtered Compressed Air Nitrogen or Dry-Filtered Compressed Air

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.

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. 10

Pneumatic adapter diagram: Gas connection options

4 5 3

6

2

7

1

8

9

10 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.

13

Midas Rex™ Legend™ Pneumatic High-Speed System

MR7 pneumatic motor technical specifications Table 4. MR7 pneumatic motor technical specifications Product

Weight (gm)

Size Length (cm)

Diameter (cm)

MR7

121

14.0

1.8

MR7 Touch

145

15.9

1.8

MR7 system assembly Installing the lubricant/diffuser cartridge (PA700) and connecting the MR7 motor to the control unit 1. 2. 3. 4.

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. Hold the lubricant/diffuser cartridge perpendicular to the housing (Figure 11-1), and press the cartridge’s circular fitting onto the housing’s circular receptacle (Figure 11-2), breaking the foil seal. Rotate the cartridge down until it clicks into place. 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/diffuser installed. 11-1

5.

Aligning the lubricant/diffuser cartridge with the housing

11-2

Pressing the cartridge onto the housing

11-3

Correctly installed lubricant/diffuser cartridge

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 film on the external surface from pressure and/or temperature differentials 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 flats are aligned (Figure 11-6). If the arrows are not aligned, use the motor wrench to turn the collet flat closest to the motor case until its arrow is aligned with the arrow on the other collet flat.

14

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 finger control switch must be in the “ | ” position, and the control slide on the foot control must be in the “On” (finger control) position. The control slide will not lock in the “On” (finger control) position unless a motor is connected to the motor port.

To activate the MR7 or MR7 Touch motors 1. 2.

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

11-5 Finger/foot control slide

11-6

Aligning the collet flat

15

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

12-2

Motor will not operate

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 “ 12-3

Legend Gold Touch motor will operate

12-5

MR7 Touch motor will operate

12-4

” position.

Legend Gold Touch motor will not operate

12-6 MR7 Touch motor will not operate

In addition, the Legend Gold Touch and the MR7 Touch will not operate if the finger/foot control on the pneumatic control unit is in the “ foot pedal is activated also. 12-7

16

Legend Gold Touch motor will not operate.

12-8

MR7 Touch motor will not operate.

” position, unless the