Instructions for Use
175037EN B
The Midas Rex™ Microsaw and Triton™ System
Microsaws and Triton Electric High-Torque Handpiece
Customer service
For further information regarding the use of this product or to report any problems, please contact Medtronic Customer Service or contact your local distributor:
Medtronic Powered Surgical Solutions
4620 North Beach Street
Fort Worth, Texas 76137 USA
US Help Line (800 468 9710)
www.medtronic.com
International Service: International Customers should contact their local Medtronic 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: Intelliow™ IPC™,
Legend™, Legend EHS™, Legend EHS Stylus™, Midas Rex™, Mednext™, Stylus Touch™, 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
Warnings ....................................................................................................................................................................................... 1
Precautions ...................................................................................................................................................................................2
Handpiece systems ....................................................................................................................................................................3
Attachment assembly ............................................................................................................................................................... 3
IPC set up ....................................................................................................................................................................................... 3
IPC touchscreen controls .........................................................................................................................................................4
Manual safe mode ...................................................................................................................................................................... 4
Multifunction foot pedal controls .........................................................................................................................................5
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ..............................................................5
Technical specications ............................................................................................................................................................ 5
Midas Rex microsaw blade and rasp nomenclature ......................................................................................................6
Installation and removal of the Midas Rex microsaw attachments .......................................................................... 7
Triton electric high-torque handpiece attachments ...................................................................................................... 8
Installing, activating, and removing an attachment in the Triton electric high-torque handpiece .............8
Installation and removal of cutting tools, wires, and pins in Triton electric high-torque attachments ......9
Cleaning and sterilization ......................................................................................................................................................11
The Midas Rex microsaws and Triton electric high-torque handpiece system Limited Warranty*
(U.S. customers only) ...............................................................................................................................................................14
Symbols ........................................................................................................................................................................................15
System warnings ...................................................................................................................................................................1
Component warnings .......................................................................................................................................................... 2
Tools and disposable components warnings .............................................................................................................. 2
Connect to the IPC ................................................................................................................................................................ 3
IPC pump detection ............................................................................................................................................................. 4
Speed ......................................................................................................................................................................................... 4
Irrigation ................................................................................................................................................................................... 4
Safe mode (SAFE) ..................................................................................................................................................................4
Mode select switch ............................................................................................................................................................... 4
Foot and nger-control ...................................................................................................................................................... 4
Reverse pedal ..........................................................................................................................................................................5
Microsaw reciprocating saw attachment ....................................................................................................................7
Microsaw sagittal saw attachment ................................................................................................................................7
Microsaw oscillating saw attachment ...........................................................................................................................7
Microsaw irrigation and tubing clips attachment .................................................................................................... 8
Triton sagital saw attachment .......................................................................................................................................... 9
Triton reciprocating saw attachment ............................................................................................................................. 9
Triton AO/Synthes Chuck and Trinkle Chuck attachment ...................................................................................... 9
Triton Jacobs Chuck attachment ..................................................................................................................................... 9
Triton Hudson Chuck and Zimmer Chuck attachment .......................................................................................... 10
Triton wire collet and pin collet attachment ...........................................................................................................10
Midas Rex microsaw reprocessing instructions ......................................................................................................11
Triton electric high-torque handpiece reprocessing instructions ....................................................................12
The Midas Rex Microsaw and Triton system
Glossary
The following words and acronyms may be used in this manual:
EHS Electric High-Speed
FCU Foot Control Unit
FWD Forward - Rotation is clockwise
IPC Integrated Power Console
REV Reverse - Rotation is counter-clockwise
Indications for use
The Electric Drill System is an electrically operated surgical instrument system. The electric 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 Electric Drill System is indicated for the incision/cutting, removal, drilling, and sawing 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 lnterbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar lnterbody Fusion (ALIF)
• Direct Lateral lnterbody Fusion (DLIF)
Device description
The Midas Rex microsaw is a powered saw system that is used to remove soft tissue, hard tissue, and bone during surgical procedures. The Triton electric high-torque
handpiece is a powered system that is used to drive screws, wires, and pins, drill pilot holes, and remove soft tissue, hard tissue, and bone during surgical procedures.
The devices are intended for use by physicians trained in the procedures described.
Contraindications
None
No latex policy
Medtronic Powered Surgical Solutions guarantees that all Legend equipment and products identied in this manual manufactured by and/or for Medtronic Powered
Surgical Solutions do not contain latex.
Medtronic Powered Surgical Solutions’ packaging materials, labels, pouches, package inserts, or similar items do not contain latex.
Warnings
System warnings
W1 The Midas Rex microsaw and Trition electric high-torque handpiece system operator must be familiar with this Instructions for Use, the IPC User’s Guide, their
precautions, procedures and safety issues.
W2 The Midas Rex microsaw and Trition electric high-torque handpiece system and its associated equipment should be used only by qualied medical
professionals who are thoroughly trained and experienced in performing surgery with Medtronic computer-assisted surgery systems.
W3 Do not place the Midas Rex microsaw and Trition electric high-torque handpiece systems in the proximity of a magnetic eld, such as magnetic drape or
Magnetic Resonance Imaging (MRI) equipment to avoid inadvertent handpiece activation.
W4 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 or replaced.
W5 Heavy side loads and/or long operating periods may cause the device to overheat.
W6 The Midas Rex microsaw and Trition electric high-torque handpiece systems are precision surgical instruments. With precision instruments, excessive force,
beyond the design strength of the instruments, can be caused by even simple manual overloading.
W7 Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery.
W8 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.
W9 Use only dissecting tools specically designed for use with the Midas Rex microsaw and Trition electric high-torque handpiece systems. Match the
nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment.
W10 Do not use the Midas Rex microsaw and Trition electric high-torque handpiece systems without proper cleaning and sterilization.
W11 Refer to the IPC Instructions for Use for additional instructions, warnings, and cautions.
W12 Refer IPC User’s Guide for warnings related to IPC.
W13 The Midas Rex microsaw and Trition electric high-torque handpiece system complies with EN60601-1-2 safety standard for electromagnetic compatibility
(EMC), requirements, and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive
equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference.
Diminished performance may lengthen operating time for anesthetized patient.
W14 Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information
provided in this Instructions for Use.
W15 Portable and mobile radio frequency (RF) communications equipment can aect medical electrical equipment.
W16 Do not operate the Midas Rex microsaw and Trition electric high-torque handpiece systems in the presence of (MRI) devices.
W17 Use of accessories and cables other than those specied and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W18 All service must be performed by Medtronic qualied personnel only.
1
The Midas Rex Microsaw and Triton system
Component warnings
W19 Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W20 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.
W21 Employ visualization, including use of imaging techniques (e.g., uoroscopy, image guided surgery) when using rotating powered accessories. Discontinue
powered application in the event of lack of visualization of surgical site.
W22 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.
W23 Electrical contacts must be dry prior to use.
W24 Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W25 Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue.
W26 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.
W27 Do not immerse the system components, except as noted.
W28 Do not place the Midas Rex microsaw, Triton electric high-torque handpiece, attachment or tool on the patient or in an unsecured location during surgery.
W29 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.
W30 Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment.
W31 Do not change an accessory with the handpiece running to prevent laceration of user and/or cross-contamination through compromised glove.
W32 Do not modify accessories used with the handpiece. Performance could be diminished with modied accessories.
W33 Verify reusable device was sterilized prior to use. If not sterilized, do not use.
W34 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.
W35 Place the nger-control of the Midas Rex microsaws in Safe Mode while not in use.
W36 Any device that has not been used in a four year period should be serviced by Medtronic to ensure its performance.
Tools and disposable components warnings
W37 Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-
cutting powered tools induce bleeding and removal of signicant tissue and bone.
W38 Use methods at the operative site to control bleeding that do not compromise patient safety during surgery.
W39 Keep the cutting area of the tool away from ngers and loose clothing to prevent laceration of user and cross-contamination through compromised glove.
W40 Operate the tool only after appropriate anatomical landmarks at the intended surgical site have been conrmed.
W41 Use care in application of the rotating cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W42 Bending or prying may break the accessory, causing harm to patient or user.
W43 Do not use excessive force to pry or push bone with the attachment or tool during dissection.
W44 A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed of the motor to prevent vibration. Change to a new tool
to prevent unintended tissue removal from patient.
W45 Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal
from patient.
W46 Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
W47 Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W48 Cutting edges of the tool utes or blades are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal.
W49 Do not re-sharpen used tools. Worn tools should be replaced with new ones frequently to ensure eective cutting and control.
W50 Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious
tools with a new one prior to use.
W51 Excessive pressure applied to the tool 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. Unremoved tool fragments may cause tissue damage to the patient.
W52 Use only tools specically designed for use with the Midas Rex microsaw and Triton electric high-torque handpiece systems.
W53 Do not sterilize disposable devices. They are terminally sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once.
W54 Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
W55 Do not use an accessory if its packaging is opened or damaged. A broken seal oers no protection against cross-contamination.
W56 Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
W57 Do not use dull, damaged, or bent tools. Use of dull tools can reduce cutting eectiveness and can cause the handpiece temperature to increase.
W58 Always ensure that the attachment is securely engaged into the handpiece prior to operating the system. Always examine operation of each tool in a
handpiece prior to use.
W59 Powered burs and drills should be operated in the forward mode only.
W60 Exposure of tool packaging to light for extended periods of time may cause damage to packaging.
Precautions
P1 Do not attempt to disconnect the cable from the Midas Rex microsaw. Do not kink cables. Inspect cables and pins for cracks, tears, or corrosion.
P2 The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.
P3 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.
P4 Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions.
P5 Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure.
P6 Remove and discard accessories following local regulations for disposal of contaminated materials.
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