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Midas Rex Legend Pneumatic High-Speed System Instructions for Use
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Instructions for Use 175002MLLL H
Midas Rex™ Legend™ Pneumatic High-Speed System Legend Gold™, Legend Gold Touch™, Legend Platinum™, Midas Rex MR7™, and Midas Rex MR7 Touch™
Customer service For further information regarding the use of this product or to report any problems, contact your Medtronic Customer Service or contact your local distributor: Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, Texas 76137 USA US Help Line (800) 335-9557 or (800) 874-5797 RS.DFWrepairs@medtronic.com International Service: International Customers should contact their local Medtronic representative. 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.
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Contents
Glossary...1 General information...1 Midas Rex™ Legend™ and Midas Rex™ MR7™ systems description...1 Pneumatic motor systems...1 Attachments...1 Surgical dissecting tools...1 System accessories...1 Indications for use...1 Target patient population...1 Intended use...1 Clinical benefits...1 Contraindications...2 Special notices...2 Warnings...2 Precautions...3 Training requirements...4 Residual risks...4 Possible adverse events...4 Material composition...4 Legend™ system motors...4 Legend Gold™ motor...4 Legend Gold Touch™ motor...4 Legend Platinum™ motor...4 Legend™ accessories...5 PCU...5 Regulator...5 Regulator hose...5 Instrument case...5 Motor wrench...5 Lubricant/diffuser cartridge (PA100-A)...5 Adapters...6 Attachments...6 Dissecting tools...7 Legend™ power source requirements...7 Legend™ pneumatic connections...8 Legend™ pneumatic motor technical specifications and performance characteristics...8 Legend™ system assembly...9 Installing the lubricant/diffuser cartridge (PA100-A) and connecting the motor to the PCU...9 PCU activation...10 Midas Rex™ MR7™ system motors...11 MR7™ motor...11 MR7 Touch™ motor...11 MR7™ accessories...11 PCU...11 Regulator...11 Regulator hose...11 Instrument case...11 Motor wrench...11 Lubricant/diffuser cartridge (PA700)...12 Adapters...12 Attachments...13 Dissecting tools...13 MR7™ power source requirements...13 MR7™ pneumatic connections...14 MR7™ pneumatic motor technical specifications and performance characteristics...14
MR7™ system assembly...15 Installing the lubricant/diffuser cartridge (PA700) and connecting the motor to the PCU...15 PCU activation...16 Legend™ / MR7™ tools and attachments...18 Dissecting tool nomenclature...18 General guidelines for attachments and tool applications...19 Attachment assembly and disassembly...23 Straight attachment...23 Angled attachment...24 Fixed footed attachment...24 Rotating footed attachment...25 Contra-angle and right-angle attachments...25 Metal cutting attachment...26 Variable exposure straight and angled attachment...26 Telescoping tube and telescoping tube base attachment – straight (AT10) and angled (AT10A)...27 Telescoping curved bur and telescoping base attachment – straight (AT10) and angled (AT10A)...28 Perforator (AD01 & AD03) attachment...28 Jacobs chuck attachment...29 Angled double lock (DK) attachment...29 J-latch attachment...30 Bone mill attachment...30 Safety data sheet for lubricant...30 System set-up check...30 Legend™ / MR7™ system troubleshooting...31 Motors...31 Attachments or telescoping tubes...32 Dissecting tools...33 Disassembly of Legend™ equipment...34 Disassembly of MR7™ equipment...34 Sterility...35 Legend™ and MR7™ system reprocessing instructions...35 Cleaning brushes...35 Pneumatic motors reprocessing instructions...35 PCU, regulator and hose reprocessing instructions...36 Attachments/tubes reprocessing instructions ...37 Return policy for devices exposed to Transmissible Spongiform Encephalopathies (TSE)...38 Refurbishing or repairs...39 Planned maintenance...39 Scheduled maintenance intervals 1, 2, 3, 5, 6, 7, 9, 10, 11...40 Scheduled maintenance intervals 4, 12...42 Scheduled maintenance interval 8...42 Disposal...42 Midas Rex™ Legend™ / MR7™ Pneumatic High-Speed System limited warranty*...43 Symbols ...45
Midas Rex™ Legend™ Pneumatic High-Speed System
Glossary DK
Double Locking
PCU
Pneumatic Control Unit
PHYSICIAN NOTE: The physician must convey the indications, contraindications, warnings, and precautions given in this document to the patient.
General information Read and understand this manual before using the Midas Rex™ Legend™ Pneumatic High-Speed Drill System. The Midas Rex™ Legend™ system is designed for use by medical professionals familiar with powered surgical instrumentation. The surgeon is responsible for learning the proper techniques in the use of this system, as inappropriate use may potentially be harmful. It is strongly recommended that the surgeon and dedicated operating room personnel are knowledgeable with the use of this system by being trained in Medtronic Midas Rex™ Hands-On Workshops or by one of the local authorized representatives.
Midas Rex™ Legend™ and Midas Rex™ MR7™ systems description Pneumatic motor systems Pneumatic motors provide power to operate disposable surgical dissecting tools. These motors are designed to interface with a series of attachments and surgical dissecting tools using a standard quick-connect locking mechanism. Motors operate in the same manner whether controlled by a lever or PCU. The Legend system is comprised of the following: • Legend Gold, Legend Gold Touch, or Legend Platinum motors • Legend PCU 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 PCU 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.
Attachments Attachments are designed to align the surgical tools with the motor to provide support and stability during various surgical procedures. Attachment options, of various lengths, include regular (straight, and angled), variable exposure (straight and angled), footed (craniotomes), and telescoping attachments and tubes. There are a variety of specialty attachments, such as the perforator, Jacobs chuck, j-latch, and metal cutting that are also available. This allows flexibility with the length and style of attachment for surgeries.
Surgical dissecting tools Surgical dissecting tools are designed and intended to resect, drill, or saw soft and hard tissue, bone, biomaterial, and metal during various surgical procedures. The surgical dissecting tools vary in length and the distal tips of the tools vary in shape and style. The tip designs include the following universal shapes: acorn, match head, ball or round, cylinder, oval, and tapered or side-cutting. Specialized tools such as metal cutters, twist drills, hole-makers, hole saws, and reverse tapered tools are also available.
System accessories System accessories enable the Midas Rex™ Legend™ / MR7™ systems to carry out the intended use. Accessories include the motor wrench, cleaning brushes, instrument trays, PCU, lubricant/diffuser, pneumatic hoses, and tool rack. All of these are considered medical devices except for the tool rack.
Indications for use The Medtronic Midas Rex™ Legend™ Pneumatic High-Speed Systems are pneumatically operated surgical instrument systems. 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 pneumatic Legend™ Systems are 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)
Target patient population Candidates for surgical applications stated in the Indications for use.
Intended use The Medtronic Midas Rex™ Legend™ Pneumatic High-Speed Systems are intended to be used to perform the task of removing soft and hard tissue and bone as stated in the indications for use.
Clinical benefits Clinical Benefits of the Midas Rex™ Legend™ Pneumatic High-Speed Systems include optimized visibility and maneuverability in the surgical site, sufficient power to cut bone and biomaterials, ergonomic grip that allows precise control, sensory feedback while cutting, the ability to adjust/configure the system efficiently, and a portfolio of attachments and tools that meet different surgical needs.
1
Midas Rex™ Legend™ Pneumatic High-Speed System
Contraindications None.
Special notices
The words warning, precaution and note have special meanings in this manual, and should be carefully reviewed: Warning: A warning indicates that the personal safety of the patient or user may be involved. Disregarding this information could result in injury to the patient or user. Precaution: A precaution indicates that there is a risk of damaging equipment. Note: A note is intended to provide additional information, which may be useful, but is not essential to complete the procedure.
Warnings W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 W11 W12 W13 W14 W15 W16 W17 W18 W19 W20 W21 W22 W23 W24
W25 W26 W27 W28 W29 W30 W31 W32 W33 W34 W35 W36 W37 W38 W39 W40 W41 W42
2
The system user must be familiar with this Instructions for Use (IFU), their precautions, procedures, and safety issues. The system and its associated accessories should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic powered surgery systems. Always inspect the device before and after use for any damage. If damage is observed, do not use damaged device. Use adequate irrigation during dissection to prevent thermal necrosis. Do not use an overheated device, as it may cause thermal injury to the patient or user. Heavy side loads and/or long operating periods may cause the device to overheat. Never place an overheated motor on the patient or draping during the surgery. Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery. Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color code band on the attachment. Do not use reusable devices without proper cleaning and sterilization. Sterilize and dry reusable device before storing. After each procedure, properly clean and sterilize all reusable devices. All service must be performed by Medtronic qualified personnel only. Discontinue use of device if visualization to the surgical site is lost. Do not attempt to remove a dissecting tool or attachment while the motor is running to prevent laceration of user and/or cross-contamination through a compromised glove. Do not immerse the device, except when recommended by the cleaning instructions in this IFU. The motors should only be operated when the attachment/tool is in the fully locked position. Do not use the system if the motor continues to run after releasing the foot pedal or finger control lever. Do not place the device on the patient or in an unsecured location during surgery. Do not use an attachment and dissecting tool combination that results in tool flail or excessive vibration. Do not use the reusable device immediately after steam sterilization. Allow an adequate cooling period after steam sterilization. Do not operate the pneumatic motors in the presence of magnetic resonance imaging (MRI) equipment. Do not use metal-cutting attachment or metal-cutter tools to cut/resect bone. For metal transection, observe the following safety precautions: W24a Wear eye protection. W24b Irrigate well to cool cutting surfaces. W24c Protect wound site from metal debris. When using 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. Failure to follow prescribed maintenance schedule on motors and attachments may result in device(s) detaching and falling from the motor or attachment which may cause patient injury. To avoid this, motors and attachments should be serviced periodically at intervals recommended by Medtronic. When using non-DK 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. Remove footed attachments cautiously and slowly as per instructions to avoid injury to the user. Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor. Place Legend Gold Touch™ and MR7 Touch™ motors in Safe mode while not in use. Failure to properly secure lubricant/diffuser cartridge may cause injury to patient, user, and/or operating room staff. Do not use a motor that is leaking lubricant. Do not pinch, kink, obstruct, cut, tear, or step on the motor/exhaust hose. This may cause the hose to burst, potentially injuring the patient or user. Tool flutes are sharp and may perforate surgical gloves. Keep the cutting area of the tool away from fingers and loose clothing to prevent laceration of user and cross-contamination through compromised glove. A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease pressure supplied to the motor to prevent vibration. If vibration persists, change to a different tool size or geometry to prevent unintended tissue damage. Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage. Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent contamination, use only once. Excessive pressure applied to tool may cause tool fracture. Should a tool fracture in use, exercise extreme care to ensure all the fragments of the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. Do not use a dissecting tool if its packaging is damaged or opened outside the sterile field. Sterility is compromised if packaging is opened or damaged. Do not use dull tools. Use of dull tools can reduce cutting effectiveness and can cause the motor temperature to increase. Use of a dull tool may lead to heat at the cutting site. Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging.
Midas Rex™ Legend™ Pneumatic High-Speed System W43 When using a non-DK angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor. W44 The system user should ensure sensitive anatomy is protected during drilling and use of the system. Failure to do so could cause injury to the patient. W45 Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting with the Preparation for Cleaning step. W46 Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning. W47 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. W48 Do not use any parts other than Medtronic device as damage or substandard performance could result. W49 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. W50 Do no load more than one motor inside the instrument tray per sterilization cycle. W51 The system devices must be cleaned separate from the instrument trays. Do not load system devices into instrument tray until the devices are clean. W52 After each procedure, properly clean and sterilize all reusable devices.
Precautions P1 P2 P3 P4 P5 P6 P7 P8 P9 P10 P11 P12 P13 P14 P15 P16 P17 P18 P19 P20 P21 P22 P23 P24 P25 P26
Do not use a twist drill or contra-angle tool/attachment at an operating pressure over 552 kPa (80 psi). The use of a washer-disinfector for cleaning may cause a degradation in performance. 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. Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite, sodium hydroxide, formic acid, or solutions containing glutaraldehyde. Remove and discard accessories following local regulations for disposal of contaminated materials. Do not use ultrasonic cleaners for system devices. Use only nylon cleaning brushes. Non-nylon cleaning brushes leave residue that may prevent the tool from being secured properly in the motor. Do not expose these devices to sterilization temperatures greater than 137°C (279°F). Exposure to temperatures greater than 137°C (279°F) may impact the performance of the device and also the efficacy of the sterilization cycle. Because of the variability in cleaning efficiencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) should be validated by persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility. Do not modify device; performance could be diminished. When not operating the motor, eliminate accidental foot control activation. Do not operate the system without eye protection. Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. It is recommended that devices should be cleaned as soon as possible, preferably within 30 minutes, following use to limit fixation of contaminants. Do not use a pneumatic motor without a lubricant/diffuser or oiler cartridge installed. Do not use a lubricant/diffuser or oiler cartridge for more than one hour of drill time. Do not reuse or attempt to refill a lubricant/diffuser or oiler cartridge. It is a single-use product. Do not use a lubricant/diffuser or oiler cartridge if it appears to be damaged, or if the inner foil seal is punctured. Do not carry PCU by the N2 DISS pressure hose. Do not disassemble equipment before gas pressure is released from PCU and associated hoses. Do not use the PCU to operate systems other than the Midas Rex™ and TRITON™ pneumatic systems. 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. Do not soak or submerge system devices. Use the instrument tray for sterilizing the reusable devices only. Do not use the instrument tray for cleaning or disinfection of the reusable devices.
3
Midas Rex™ Legend™ Pneumatic High-Speed System
Training requirements This device is intended for use by physicians, or appropriate staff, trained in the procedures described in the indications for use.
Residual risks Residual risks related to the use of the Medtronic Midas Rex™ Legend™ Pneumatic System are: General Surgical Complications, Thermal Injury, Tissue or Bone Damage, Nervous System Injury, Cerebrospinal Fluid Leakage, Infection, and Hearing Damage.
Possible adverse events In the event that a serious incident has occurred related to device use, immediately report the event to Medtronic and the competent authorities.
Material composition Material contained in product that can cause an allergic reaction: nickel. Patients can be exposed to the following material in the dissecting tool with carbide ( Tool CFN with “C” in suffix), which are carcinogenic, mutagenic, and toxic for reproduction (CMR): Material
CAS number
Cobalt
7440-48-4.
For additional material of concern information such as REACH, CA Prop 65, or other product stewardship programs, go to www.medtronic.com/productstewardship.
Legend™ system motors Legend Gold™ motor High speed, high torque pneumatic motor (Figure 1-1) used to dissect bone and biomaterials.
Legend Gold Touch™ motor High speed, high torque pneumatic motor (Figure 1-2) with a variable speed finger control lever used to dissect bone and biomaterials. Instruction manual will use “
” symbol to indicate information on Legend Gold Touch™ motor.
Legend Platinum™ motor 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™ motors used to dissect bone and biomaterials. Warning: The system user must be familiar with this IFU, their precautions, procedures, and safety issues. 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
4
5.
Hose
Collet
3.
Swivel
2.
Motor case
4.
Fixed angle
Extension lever Collet
4. 3.
Legend Platinum™ motor
1.
1. 2.
5.
Hose
6
3
2
Finger control lever Motor case
5. 6.
Safety slide Convertible angle
7. 8.
Swivel Hose
Midas Rex™ Legend™ Pneumatic High-Speed System
Legend™ accessories PCU
The PCU (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: The PCU is provided with a certified supply pressure gauge. The PCU 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. Precautions: The PCU and pressure hose should not be sterilized.
Regulator
The regulator (Figure 2-3) controls the delivery pressure of compressed gas to the PCU. The pressure gauges indicate cylinder pressure (right gauge) and delivery pressure (left gauge). Note: Outlet pressure gauge accurate to +/-12 psi.
Regulator hose
The regulator connects the gas source to the PCU to deliver compressed gas.
Instrument case
The instrument case (Figure 2-4) is used to organize equipment and to secure instruments during sterilization and transport.
Motor wrench
Motor wrench is used to align arrows on motor collet flats prior to installation of an attachment (Figure 2-5).
Lubricant/diffuser cartridge (PA100-A)
Lubricant/diffuser cartridge provides lubrication to motors, diffuses spent air from motor, and filters oil from exhausted air. Note: Each motor has a lubricant/diffuser housing (Figure 2-6) at the end of the motor hose. 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™ PCU
2-2
Legend™ PCU 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 Precaution: Ensure the adapter is fully threaded onto the regulator hose and fully threaded/connected to the corresponding wall outlet before operating the pneumatic system.
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 N2 DISS to male Schrader adapter allows for the PCU’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 PCU’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 PCU’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 N2 DISS to air DISS adapter allows for the PCU’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 PCU’s N2 DISS pressure hose connection to be attached to a male Schrader in-house 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 PCU’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 N2 DISS to WF4 adapter allows for the PCU’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.
Triton pneumatic adapter The Triton adapter (Figure 3-8) allows the Triton motor to be driven by the PCU. It functions much the same way as the Triton port on the PCU, except that it is connected between the PCU and the gas source, rather than being integrated into the PCU. 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)
3-4
N2 DISS to air DISS adapter
3-7
N2 DISS to WF4 adapter
3-8
Triton pneumatic adapter
Attachments Attachments provide support and stability to the rotating dissecting tool. 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: Use adequate irrigation during dissection to prevent thermal necrosis 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.
6
Midas Rex™ Legend™ Pneumatic High-Speed System
Dissecting tools Dissecting tools’ intended use is for cutting bone and biomaterials. Dissecting tools are provided as sterile. Warnings: • Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color code band on the attachment. • Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent contamination, use only once. • Do not use an attachment and dissecting tool combination that results in tool flail or excessive vibration.
Legend™ power source requirements Table 1: LegendTM Power source requirements Device Legend Gold™ motor Legend Gold Touch™ motor Legend Platinum™ motor
Required operating (dynamic) pressure
Nominal operating (dynamic) pressure
Approximate flow rate required
80 psi to 120 psi
100 psi
12 cubic feet/min
552 kPa to 827 kPa
690 kPa
340 liters/min
80 psi to 120 psi
100 psi
12 cubic feet/min
552 kPa to 827 kPa
690 kPa
340 liters/min
80 psi to 120 psi
100 psi
12 cubic feet/min
552 kPa to 827 kPa
690 kPa
340 liters/min
Gas type Nitrogen or dry-filtered compressed air Nitrogen or dry-filtered compressed air Nitrogen or dry-filtered compressed air
Precaution: Do not run a motor at an operating pressure below or above the required operating pressure range. Operating pressure below 552 kPa (80 psi) may not provide proper lubrication to the motor. Operating pressure above 827 kPa (120 psi) may damage or reduce the life of the motor.
7
Midas Rex™ Legend™ Pneumatic High-Speed System
Legend™ pneumatic connections Warning: Do not disassemble equipment before gas pressure is released from PCU and associated hoses. Precaution: 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. Midas Rex™ safety valve 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. Legend™ regulator Operating (dynamic) pressure may be checked diagnostically at the Legend™ or MR7™ PCU 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™ PCU reads within a range of 552 kPa to 827 kPa (80 psi to 120 psi), as required. To ensure optimal motor performance, set nominal operating pressure to 690 kPa (100 psi). If the surgeon requests additional power during a procedure, compressed gas source may be turned up to an operating pressure of 827 kPa (120 psi). To decrease pressure, turn down the in-house compressed gas source or turn the pressure handle on the regulator counter-clockwise. Push down on the pressure relief at the PCU to exhaust excess pressure.
Legend™ pneumatic motor technical specifications and performance characteristics Table 2. Legend™ pneumatic motor technical specifications and performance characteristics Device
8
Weight (gm)
Size Length (cm)
Diameter (cm)
Legend Gold™ motor
140.6
11.2
1.8
Legend Gold Touch™ motor
190.5
12.2
1.7
Legend Platinum™ motor
136
10
1.6
Midas Rex™ Legend™ Pneumatic High-Speed System
Legend™ system assembly Installing the lubricant/diffuser cartridge (PA100-A) and connecting the motor to the PCU Warnings: • Do not disassemble equipment before gas pressure is released from PCU and associated hoses. • Do not use a pneumatic motor without a lubricant/diffuser or oiler cartridge installed. 1.
Set system non-running (static) pressure between 552 kPa to 827 kPa (80 psi to 120 psi) 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. Remove cover from lubricant/diffuser (Figure 5-1). Note: 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 motor oiler housing at the end of the hose to the port on the PCU (Figure 5-5). Warning: • Always inspect the device before and after use for any damage. If damage is observed, do not use damaged device. • Do not disassemble equipment before gas pressure is released from the PCU and associated hoses. Notes: • If using the Legend Gold Touch™, slide the finger/foot control on the Legend™ PCU 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™ PCU.
5-3
Insert lubricant/diffuser
5-4
5-5
Connect the motor hose
5-6 Lock the finger/foot control
Rotate lubricant/diffuser
9
Midas Rex™ Legend™ Pneumatic High-Speed System
PCU activation Warning: Do not carry PCU by the N2 DISS pressure hose.
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 PCU (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™ PCU 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 lever and pull the Safety Slide to the “ | ” position. Depressing the finger ccontrol lever 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 (Figure 6-3).
Note: When using longer attachments with the Legend Gold Touch™, the extension lever on the finger control lever may be extended to provide better digital control (Figure 6-4). 3. Operating (dynamic) pressure may be checked diagnostically at the Legend™ PCU 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™ PCUreads within a range of 552 kPa to 827 kPa (80 psi to120 psi) as required. To ensure optimal motor performance, set nominal operating pressure to 690 kPa (100 psi). If the surgeon requests additional power during a procedure, compressed gas source may be adjusted to an operating pressure of 827 kPa (120 psi). To decrease pressure, turn down the in-house compressed gas source or turn the pressure handle on the regulator counter-clockwise. Push down on the pressure relief at the PCU to exhaust excess pressure in the hoses. Then re-adjust pressure as needed. 6-1
10
Depress the foot pedal
6-2 Install and lock attachment
6-3
Allow motor to run
6-4
Extend the finger control lever
Midas Rex™ Legend™ Pneumatic High-Speed System
Midas Rex™ MR7™ system motors MR7™ motor High-speed, high-torque pneumatic motor (Figure 7-1) used to dissect bone and biomaterials.
MR7 Touch™ motor High-speed, high-torque pneumatic motor (Figure 7-2) with a variable speed finger control lever. This motor is used to dissect bone and biomaterials. Instruction manual will use the “ ” symbol to indicate information on MR7 Touch™ motor. Warning: The system user must be familiar with this IFU, their precautions, procedures, and safety issues. 7-1
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
5.
Hose
3
1.
Finger control lever
3.
Motor case
5.
Swivel
2.
Collet
4.
Safety slide
6.
Hose
MR7™ accessories PCU The PCU (Figure 8-1) provides variable speed motor control through a foot pedal. It also allows the user to switch between finger control lever and foot control of the motor (if applicable).
Regulator The regulator (Figure 8-2) controls the delivery pressure of compressed gas to the PCU. The pressure gauges indicate cylinder pressure (right gauge) and delivery pressure (left gauge). Note: Outlet pressure gauge accurate to +/-12 psi.
Regulator hose The regulator hose connects the gas source to the PCU to deliver compressed gas.
Instrument case The instrument case (Figure 8-3) is used to organize equipment and to secure instruments during sterilization and transport.
Motor wrench The motor wrench is used to align arrows on motor collet flats prior to installation of an attachment (Figure 8-4).
11
Midas Rex™ Legend™ Pneumatic High-Speed System
Lubricant/diffuser cartridge (PA700) The lubricant/diffuser cartridge (Figure 8-5) provides lubrication to the motor and filters oil from exhausted air. Precaution: The LegendTM lubricant/diffuser cartridge and the MR7TM lubricant/diffuser cartridge are not interchangeable. 8-1
8-2
MR7™ PCU
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
Adapters Precaution: Ensure the adapter is fully threaded onto the regulator hose and fully threaded/connected to the corresponding wall outlet before operating the pneumatic system.
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
N2 DISS to male Schrader adapter allows for the PCU’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 PCU’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 9-3) allows for the PCU’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
N2 DISS to air DISS adapter allows for the PCU’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 PCU’s N2 DISS pressure hose connection to be attached to a male Schrader in-house 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 PCU’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
N2 DISS to WF4 adapter allows for the PCU’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.
12
Midas Rex™ Legend™ Pneumatic High-Speed System
TRITON™ pneumatic adapter
The TRITON™ adapter (Figure 9-8) allows the TRITON™ handpiece to be driven by the MR7™ PCU. It functions much the same way as the TRITON™ port on the Legend™ PCU, except that it is connected between the PCU and the gas source, rather than being integrated into the PCU. 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 Provide 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: Use adequate irrigation during dissection to prevent thermal necrosis 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 (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: • Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the dissecting tool packaging to the same nomenclature and color code band on the attachment. • Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent contamination, use only once. • Do not use an attachment and dissecting tool combination that results in tool flail or excessive vibration.
MR7™ power source requirements Table 3: Power source requirements Device MR7™ motor MR7 Touch™ motor
Required Operating (Dynamic) Pressure
Nominal Operating (Dynamic) Pressure
Approximate Flow Rate Required
80 psi to 120 psi
100 psi
12 cubic feet/min
552 kPa to 827 kPa
690 kPa
340 liters/min
80 psi to 120 psi
100 psi
12 cubic feet/min
552 kPa to 827 kPa
690 kPa
340 liters/min
Gas Type Nitrogen or Dry-Filtered Compressed Air Nitrogen or Dry-Filtered Compressed Air
Precaution: Do not run the motor at an operating pressure above or below the required operating pressure range. Operating pressure below 552 kPa (80 psi) may not provide proper lubrication to the motor. Operating pressure above 827 kPa (120 psi) may damage or reduce the life of the motor.
13
Midas Rex™ Legend™ Pneumatic High-Speed System
MR7™ pneumatic connections Warning: Do not disassemble equipment before gas pressure is released from PCU and associated hoses. Precaution: 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. Midas Rex™ safety valve 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. Legend™ regulator Operating (dynamic) pressure may be checked diagnostically at the Legend™ or MR7™ PCU 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™ PCU reads within a range of 552 kPa to 827 kPa (80 psi to 120 psi), as required. To ensure optimal motor performance, set nominal operating pressure to 690 kPa (100 psi). If the surgeon requests additional power during a procedure, compressed gas source may be turned up to an operating pressure of 827 kPa (120 psi). To decrease pressure, turn down the in-house compressed gas source or turn the pressure handle on the regulator counter-clockwise. Push down on the pressure relief at the PCU to exhaust excess pressure.
MR7™ pneumatic motor technical specifications and performance characteristics Table 4. MR7™ pneumatic motor technical specifications and performance characteristics Device
Weight (gm)
Size Length (cm)
Diameter (cm)
MR7™ motor
124.28
14.06
1.81
MR7 Touch™ motor
137.89
15.20
1.81
14
Midas Rex™ Legend™ Pneumatic High-Speed System
MR7™ system assembly Installing the lubricant/diffuser cartridge (PA700) and connecting the motor to the PCU 1. 2. 3. 4.
Set the non-running (static) pressure to 552 kPa to 827 kPa (80 psi to 120 psi) 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: • Do not disassemble equipment before gas pressure is released from PCU and associated hoses. • Do not use a pneumatic motor without a lubricant/diffuser or oiler cartridge installed. Precaution: Do not use a 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 PCU, by swinging the port cover to the side and pressing the end of the hose into the port (Figure 11-4).
Precuation: Do not use the PCU to operate systems other than the Midas Rex™ and TRITON™ pneumatic systems. Notes: • If using the MR7 Touch™ motor, slide the control slide on the PCU 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 Medtronic Customer Service. Warning: Place Legend Gold Touch™ and MR7 Touch™ motors in Safe mode while not in use. Prior to installation of an 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.
15
Midas Rex™ Legend™ Pneumatic High-Speed System
PCU activation Note: In order to activate the MR7 Touch™ motor, the safety slide on the finger control lever switch must be in the “ | ” position, and the control slide on the foot control must be in the “On” (finger control lever) position. The control slide will not lock in the “On” (finger control lever) position unless a motor is connected to the motor port.
To activate the 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 PCU reads within a range of 552 kPa to 827 kPa (80 psi to 120 psi) 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 turn the pressure handle on the regulator counter-clockwise. Push down on the pressure relief at the PCU 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
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
16
Motor will operate
12-2
Motor will not operate