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/diuser 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/diuser cartridge (PA100-A) ........................................................................................................................................5
Adapters ..................................................................................................................................................................................................6
Attachments ..........................................................................................................................................................................................6
Dissecting tools ....................................................................................................................................................................................6
Legend power source requirements ......................................................................................................................................................7
Legend pneumatic connections ..............................................................................................................................................................7
Legend pneumatic motor technical specications ...........................................................................................................................8
Legend system assembly ............................................................................................................................................................................8
Installing the lubricant/diuser 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/diuser cartridge (PA700) ............................................................................................................................................11
Adapters ..................................................................................................................................................................................................12
Attachments ..........................................................................................................................................................................................12
Dissecting tools ....................................................................................................................................................................................12
MR7 power source requirements ............................................................................................................................................................13
MR7 pneumatic connections ....................................................................................................................................................................13
MR7 pneumatic motor technical specications .................................................................................................................................14
MR7 system assembly ..................................................................................................................................................................................14
Installing the lubricant/diuser 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
Dening 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/diuser — 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/diuser — 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 identied 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 qualied 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 specically 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 qualied 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.
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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 modied 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
qualied 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 eect 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 specications.
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 modied 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 aect 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 conrmed.
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” identication are longer tools intended for light bone dissection. The increased tool head/stem conguration may aect dissection stability.
W59 Do not re-sharpen used tools. Worn tools should be frequently replaced with new ones to ensure eective 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 specically 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.
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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 eectiveness 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 aect 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/diuser cartridge warnings
W75 Failure to properly secure Legend lubricant/diuser cartridge may cause injury to operator and/or operating room sta.
W76 Do not attempt to remove the lubricant/diuser cartridge while the system is pressurized.
W77 Do not use a Legend pneumatic motor without a lubricant/diuser installed.
W78 Do not use a lubricant/diuser 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/diuser.
C13 Use only Legend dissecting tools with a Legend pneumatic motor.
C14 Do not attempt to remove Legend lubricant/diuser while the motor is in operation.
C15 Do not attempt to rell a used lubricant/diuser cartridge.
C16 Do not sterilize the lubricant/diuser cartridge. The lubricant/diuser cartridge may melt into the lubricant/diuser housing with potential damage to the
motor. The lubricant/diuser cartridge must be removed from the motor’s lubricant/diuser 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/diuser is
properly attached to the motor’s lubricant/diuser housing to help cool down motor. Run the motor briey to assist in its cool down.
C20 The Legend Gold, Gold Touch, and Platinum lubricant/diuser cartridge (PA100-A) is not interchangeable with the MR7 lubricant/diuser cartridge (PA700).
Ensure you select the appropriate lubricant/diuser cartridge for the motor.
C21 During a lengthy surgical procedure with extended motor use, lubricant may drip from lubricant/diuser cartridge.
C22 Do not re-use a lubricant/diuser cartridge. It is a single-use product.
C23 Remove lubricant/diuser cartridge from motor assembly prior to sterilizing it.
3
Midas Rex™ Legend™ Pneumatic High-Speed System
1
2
3
4
5
1
2
3
4
5
7
6
8
1
2
3
4
5
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
4
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 certied 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/diuser cartridge (PA100-A)
Provides lubrication to Legend motors, diuses spent air from motor, and lters oil from exhausted air.
Note: Each Legend Motor has a lubricant/diuser 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/diuser cartridge (PA100-A) is not interchangeable with the MR7 lubricant/diuser cartridge (PA700). Ensure you
select the appropriate lubricant/diuser cartridge for the motor.
2-1
2-4
Legend pneumatic control unit Legend pneumatic control unit handle Regulator
2-2
2-3
1
2
Instrument case Motor wrench Lubricant/diuser
2-5
2-6
1. Delivery
pressure
gauge
2. Cylinder
pressure
gauge
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 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 prex14
(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
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
Nitrogen or dry-ltered
compressed air
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.
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 specications
Table 2. Legend pneumatic motor technical specications
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/diuser cartridge (PA100-A) and connecting the Legend motor to thecontrol 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/diuser (Figure 5-1).
b. Do not remove inner foil seal of lubricant/diuser (Figure 5-2).
3. Insert lubricant/diuser into lubricant/diuser housing located at base of motor hose (Figure 5-3).
4. Rotate lubricant/diuser 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 diuser housing. If the cartridge has
been pressurized for longer than 4 hours, it should be replaced.
5-1
Lubricant/diuser cover Inner foil (Do not remove) Insert lubricant/diuser Rotate lubricant/diuser
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
8
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
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 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
1
2 3
MR7 motor MR7 Touch motor
4
7-2
1
5
3
3. Motor case
4. Safety slide
3. Motor case
4. Swivel
2
5. Hose 1. Finger control lever
2. Collet
4
5
6
5. Swivel
6. Hose
10
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