Indications, Safety, and Warnings
This website provides excerpts from our user manuals. It is important to consult the full system manuals for the most updated information. The most current version of each manual is located on our Medtronic Manual Library website.
- Midas Rex Microsaws
- Triton Electric High-Torque Handpiece
- Triton Pneumatic Handpiece
- Midas Rex Legend EHS Stylus Surgical Drills
- Integrated Power Console
- Midas Rex MR7 High-Speed Pneumatic Drills
Midas Rex Microsaws
Use Midas Rex® Microsaws to remove hard tissue and bone during surgical procedures. The Midas Rex Microsaws are part of the Integrated Power Console (IPC® System).
IPC System: Indications, Safety, and Warnings
View the indications, safety, and warnings for the IPC System.
Triton Electric High-Torque Handpiece
The Triton® Electric High-Torque Handpiece is capable of removing hard and soft tissue, drilling pilot holes, and driving screws, wires, and pins during spinal, cranial, and small-bone surgical procedures performed in an operating-room environment by surgeons trained in its use.
The electric Triton High-Torque Handpiece is part of the Integrated Power Console (IPC® System).
IPC System: Indications, Safety, and Warnings
View the indications, safety, and warnings for the IPC System.
Triton Pneumatic Handpiece
View the indications, safety, and warnings for the Triton Pneumatic Handpieces.
Midas Rex Legend EHS Stylus Surgical Drills
The Midas Rex® Legend EHS Stylus® Surgical Drill and Midas Rex Legend EHS Stylus Touch Surgical Drill are part of the Midas Rex Legend EHS-Electric High Speed- System (Legend EHS System) and the Integrated Power Console (IPC® System).
Indications
Legend EHS System:
The Midas Rex Legend EHS–Electric High Speed System is intended for use in surgical procedures for the following medical applications:
- Neurosurgical
- Spine
- Orthopaedic surgery
- General surgery
- ENT
- Maxillofacial
- Craniofacial
Contraindications
Legend EHS System:
None.
Warnings
Legend EHS System:
DO NOT interchange components of the Legend EHS System with components from the Midas Rex Classic Motor System, the Midas Rex III Motor System or the Mednext® Bone Dissecting System and their associated attachments and dissecting tools.
DO NOT operate the Legend EHS System in a Magnetic Resonance Imaging Suite.
DO NOT use Legend EHS Motors or Legend Attachments before following proper cleaning and sterilization protocols.
DO NOT dissect bone without adequate irrigation to prevent thermal necrosis.
DO NOT operate the Legend EHS Motors without protective eyewear.
DO NOT attempt to run the Legend EHS motors immediately after autoclaving. Allow an adequate "cool down" period (Typically 1 hour).
DO NOT use the Legend EHS System in the presence of flammable anesthetics.
DO NOT use Legend EHS System components if damage is apparent or if components do not run properly. The Legend EHS System must be inspected for damage prior to each use.
- Conduct a visual inspection of the cables for cracks, tears or corrosion.
- Check attachments for proper appearance. Install attachment and dissecting tool, then briefly run motor.
- Check motor for overheating.
- Check attachment for overheating.
- Check dissecting tool for flail.
- Check for bent or missing pins in cable connectors
DO NOT attempt to use an overheating motor or attachment.
Consult the Legend Bone Mill product insert before use with the Legend EHS System.
For metal transection, observe the following safety precautions:
- Protective eyewear is essential.
- Irrigate copiously to cool the cutting surfaces.
- Protect the wound site from metal debris.
- Use a clamp or grasping device to control loose fragments during transection of any metal component.
Legend EHS Motors or Legend Attachments which fail due to extended use may as a result of such failing allow a component to detach and fall from the motor or attachment and may cause patient injury.
Electrical contacts must be properly dried prior to use.
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.
DO NOT use a Legend EHS System if the motor continues to run after releasing the foot pedal. If a Legend EHS System requires servicing or refurbishing, return system to Medtronic Powered Surgical Solutions.
DO NOT immerse the Legend EHS System Motor or Cables.
DO NOT place motor, attachment and dissecting tool on the patient or in an unsecured location during surgery.
DO NOT open or disassemble the console. There are no user serviceable parts inside. Refer all servicing to Medtronic Powered Surgical Solutions.
DO NOT immerse the console.
DO NOT sterilize.
DO NOT connect any cables or equipment to the console unless the cables and equipment are approved for use by Medtronic Powered Surgical Solutions as documented in the appropriate Instructions for Use and Classified by UL for use with this system.
DO NOT use a dissecting tool without the appropriate attachment as injury may occur to the patient and/or operator.
DO NOT use a Legend Attachment if any part of the attachment appears to be bent, loose, missing or damaged. If a Legend Attachment requires servicing or refurbishing, return attachment to Medtronic Powered Surgical Solutions.
DO NOT force or modify any attachment or dissecting tool to fit a Legend EHS or Stylus Motor.
Consult the Legend Bone Mill product insert before use with the Legend EHS System.
Heavy side loads and/or long operating periods may cause overheating of the attachment to the point where the attachment is uncomfortable to hold.
- Never place an overheated attachment on the patient or patient draping during surgery.
- Mitigate the overheating by discontinuing use and rest the attachment by using intermittently, or wrap the attachment interface with a moist sterile towel.
- If the attachment is passed off, the receiver of the attachment must handle the attachment cautiously.
Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.
DO NOT use a dissecting tool without the appropriate attachment as injury may occur to patient, operator and/or operating room staff.
DO NOT use excessive pressure, such as bending or prying, on attachments or dissecting tools. This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff.
DO NOT use an attachment and dissecting tool combination if flail or vibration occurs.
DO NOT use metal cutting dissecting tools on bone.
DO NOT use a twist drill or contra-angle dissecting tool at an operating speed over 62,000 rpm.
DO NOT use a dissecting tool if the sterile packaging is damaged.
If a dissecting tool package is opened, but the tool is not used or contaminated, the tool can be re-sterilized. Remove tool from original packaging and place into an approved autoclave package. Steam sterilize as follows:
- High Vacuum Steam 270°F (132°C) for 5 minutes
- Gravity Displacement 270°F (132°C) for 15 minutes
The re-sterilized tool must be used promptly following re-sterilization. If rust or corrosion is encountered after re-sterilization, do not use the re-sterilized tool.
Dissecting tool flutes are sharp and can perforate surgical gloves. Always handle with care. Do not spin, twist, or pull a tool by grasping the flutes. Gently pull on dissecting tool shaft to ensure that it is fully seated and properly installed in motor.
DO NOT use the Legend EHS foot control to operate any systems other than Legend EHS.
DO NOT open or disassemble the Foot Control. There are no user serviceable parts inside. Refer all servicing to Medtronic Powered Surgical Solutions.
DO NOT sterilize the Foot Control.
DO NOT use cables with cracks, tears or corrosion.
DO NOT use cables with bent or missing connector pins.
DO NOT kink EHS cables.
DO NOT use power cable with cracks, tears or corrosion.
DO NOT use power cable with bent or missing connector pins.
DO NOT use any other components except for Midas Rex Legend® Attachments, Legend Dissecting Tools, and Legend accessories in combination with Legend EHS Motors. Use of devices other than Legend EHS System or associated parts or components may cause injury to the patient, operator and/or operating room staff. Use of devices other than Legend EHS System or associated parts or components will damage the motor and attachments and will void manufacturer’s limited warranty.
DO NOT use any other components except for Midas Rex Legend® Attachments, Legend Dissecting Tools and Legend accessories in combination with a Legend EHS or Stylus Motor. Use of devices other than Legend EHS Systems or associated parts or components may cause injury to the patient, operator and/or operating room staff. Use of devices other than Legend EHS Systems or associated parts or components will damage the motor and attachments and will void manufacturer’s limited warranty.
DO NOT re-use or re-process a dissecting tool that has already been used. Using a dissecting tool that has already been used may cause injury to the patient, operator and/or operating room staff. Using a dissecting tool that has already been used may affect motor performance and will void manufacturer’s limited warranty.
DO NOT use an attachment and dissecting tool combination if flail or vibration occurs.
DO NOT use a twist drill or contra-angle dissecting tool at an operating speed over 62,000 rpm.
Do not soak/submerge Legend devices.
Do not use ultrasound to clean Legend devices.
Do not use chlorine based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite/bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.
The use of a washer-disinfector for cleaning may cause a premature degradation in performance.
Allow an adequate cooling period after steam sterilization.
Do not steam or EO sterilize the Legend attachment cleaning nozzle.
Do not use Pana Spray on variable exposure attachments, as it may cause the attachment to overheat.
Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
Dissecting tool size and geometry may contribute to excessive vibration at certain speeds. Increase or decrease speed by adjusting the foot/finger control, or by changing the operating pressure or console speed setting. If necessary, use a different dissecting tool.
Do not use the Variable Exposure Attachment if the TUBE adjustment ring spins freely or fails to click into place with each adjustment, as the exposure may change without warning.
Do not use the end of the tube as a depth gauge or depth stop.
DO NOT use a Legend Attachment if any part of the attachment appears to be bent, loose, missing or damaged. Excessive pressure or improper handling, such as bending or prying, with the attachment or dissecting tool may cause injury to patient, operator and/or operating room staff. If a Legend Attachment requires servicing or refurbishing, return attachment to Medtronic Powered Surgical Solutions.
Remove Legend Footed Attachments cautiously and slowly to avoid injury to the operator.
DO NOT use metal cutting dissecting tools on bone.
For metal transection, observe the following Safety Precautions:
- Eyewear protection is essential.
- Irrigate copiously to cool the cutting surfaces.
- Protect the wound site from metal debris.
- Use clamp or grasping device to control loose fragments during transection of any metal component.
Dissecting tool flutes are sharp and may perforate surgical gloves. Dissecting tools for the Telescoping Attachment may be grasped with a hemostat to aid in installation and removal.
CONSULT the cranial perforator device labeling for the recommended speed specifications.
Indications
IPC System:
The IPC® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic, surgical procedures.
Contraindications
IPC System:
None.
Warnings
WARNINGS
| System Warnings | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| W1 | It is important that the IPC operator be familiar with the system User’s Guide, its precautions, procedures and safety issues. | ||||||||
| W2 | Do not use the IPC System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases | ||||||||
| W3 | When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection. | ||||||||
| W4 | Disconnect power to the IPC before cleaning the unit to avoid electrical macro shock. | ||||||||
| W5 | Do not attach unapproved components to the IPC to avoid electrical macro shock. | ||||||||
| W6 | To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC to hospital grade receptacles only. | ||||||||
| W7 | This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, 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. | ||||||||
| W8 | 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 Guide. | ||||||||
| W9 | Portable and mobile RF communications equipment can affect Medical Electrical Equipment. | ||||||||
| W10 | Do not operate the IPC System in the presence of Magnetic Resonance Imaging devices. | ||||||||
| W11 | Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit. | ||||||||
| W12 | The IPC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used. | ||||||||
| W13 | Do not attempt to run the IPC System handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour). | ||||||||
| W14 | Consult the Legend® Bone Mill product insert before use with the Integrated Power Console. | ||||||||
| W15 | For metal transection, observe the following safety precautions: | ||||||||
| |||||||||
| W16 | Do not operate the IPC System without eye protection. | ||||||||
| W17 | All service must be performed by Medtronic qualified personnel only | ||||||||
| W18 | Repair and/or modification to the IPC by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty. | ||||||||
| 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 part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site. |
| W21 | When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration. |
| W22 | Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.. |
| W23 | Midas Rex® Variable Exposure attachments Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure. |
| W24 | Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury. |
| W25 | Electrical contacts must be dry prior to use. |
| W26 | Heavy side loads and/or long operating periods may cause the device to overheat. |
| W27 | Do not use an overheated device, as it may cause thermal injury to the patient or operator. |
| W28 | 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. Depending on the amount of irrigation used, the drill bits can achieve temperatures in excess of 50° C. |
| 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. |
| W31 | Do not place motor, attachment and tool on the patient or in an unsecured location during surgery. |
| W32 | A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in accordance with Medtronic specifications. |
| W33 | Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment. |
| W34 | Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far, may result in the attachment accidentally being unlocked. |
| W35 | Midas Rex® Legend EHS® Motor and Midas Rex Legend EHS Stylus® Motor should only be operated when the attachment is in the locked position. |
| W36 | Smoke may be generated if attachment is not in the locked position. |
| W37 | The Legend EHS motors will not run properly unless the attachment is in the locked position. |
| W38 | DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove. |
| W39 | Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator. |
| W40 | DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories. |
| W41 | The safe use of the Endo-Scrub® 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated. |
| W42 | In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable |
| W43 | To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. |
| W44 | Keep NIM® Muting Probe cable away from IPC system cables. |
| Disposable Warnings | |
|---|---|
| W45 | Verify reusable device was sterilized prior to use. If not sterilized, do not use. |
| W46 | 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 significant tissue and bone. |
| W47 | Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery. |
| W48 | Always keep the cutting tip of the tool away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove. |
| W49 | Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed. |
| W50 | Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories. |
| W51 | Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site. |
| W52 | Bending or prying may break the accessory, causing harm to patient or staff. |
| W53 | Do not use excessive force to pry or push bone with the attachment or tool during dissection. |
| W54 | A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient. |
| W55 | 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. |
| W56 | Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage. |
| W57 | Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. |
| W58 | CONSULT the cranial perforator device labeling for the recommended speed specifications. |
| W59 | Tools with L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. |
| W60 | Tool flutes are sharp and may perforate surgical gloves. Tools may be grasped with a hemostat to aid in installation and removal. |
| W61 | DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control. |
| W62 | 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. |
| W63 | 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 retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. |
| W64 | Do not use metal-cutting tools on bone. |
| W65 | Use only rotary tools specifically designed for use with this drill system. |
| W66 | When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation. |
| W67 | The use of powered reciprocating instruments may result in vibration-related injury. |
| W68 | Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade. |
| W69 | Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once. |
| W70 | Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization. |
| W71 | Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination. |
| W72 | Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging. |
| W73 | Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase. |
| W74 | T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly. |
| W75 | T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece. |
| W76 | Always ensure that the drill is securely engaged into the handpiece prior to operating the system. |
| W77 | Always examine operation of each tool in a handpiece before use. |
| W78 | Powered burs and drills should be operated in the forward mode only. |
| W79 | This system requires insulated connectors for the Straightshot® M4 Microdebrider, Straightshot Magnum® II Microdebrider, Straightshot III Microdebrider, Midas Rex® SC1, Visao®, or Skeeter® handpieces and the Multi Function Foot Control Unit. |
| W80 | Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization. |
| W81 | After each procedure, properly clean all reusable system components. |
| W82 | Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider™, or Bone Mill consoles only. |
Integrated Power Console (IPC System)
Indications
The IPC System is indicated for the incision/ cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial) Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
Device Description
The IPC System is a powered microdebrider, drill, and saw system that will remove soft tissue, hard tissue, and bone during surgical procedures.
The system consists of a power control console, footpedal, connection cables and assorted handpieces to drive various burs, blades, drills, rasps, cannulae, and saws. It includes integrated irrigation pumps for irrigation of blades, burs, and for motor coolant.
In addition to the handpieces and pumps there is a connection for continuous stimulation of the Visao straight burs that enables nerve integrity monitoring during surgical procedures. The Nerve Integrity Monitor (NIM) is a separate device that stimulates and monitors the nerve. This system has connections that allow the NIM to be connected with the Visao handpiece and Stimulating Bur Guard, enabling the NIM to stimulate and monitor the nerve at the surgical site.
The system can be used to clear the end of a rigid rod endocscope in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site.
This device is intended for use by physicians trained in the procedures described.
Contraindications
The IPC system is contraindicated for arthroscopic microdiscectomy in individuals with the following:
- Severe/progressive neurological deficits
- Cauda equine syndrome
- Active infection
Arthroscopic microdiscectomy is not indicated for individuals with sequestered disc fragments, discogenic pain, internal disc destruction, or lumbago.
Warnings
| System Warnings | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| W1 | It is important that the IPC operator be familiar with the system User’s Guide, its precautions, procedures and safety issues. | ||||||||
| W2 | Do not use the IPC POWEREASE System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases. | ||||||||
| W3 | When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection. | ||||||||
| W4 | Disconnect power to the IPC system before cleaning the unit to avoid electrical macro shock. | ||||||||
| W5 | Do not attach unapproved components to the IPC system to avoid electrical macro shock. | ||||||||
| W6 | To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC system to hospital-grade receptacles only. | ||||||||
| W7 | This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, 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. | ||||||||
| W8 | 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 Guide. | ||||||||
| W9 | Portable and mobile RF communications equipment can affect Medical Electrical Equipment. | ||||||||
| W10 | Do not operate the IPC POWEREASE System in the presence of Magnetic Resonance Imaging devices. | ||||||||
| W11 | Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit. | ||||||||
| W12 | The IPC system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC system should be observed to verify normal operation in the configuration in which it will be used. | ||||||||
| W13 | Do not attempt to run the IPC POWEREASE system handpiece immediately after autoclaving. Allow an adequate “cool down” period (typically 1 hour). | ||||||||
| W14 | Consult the Legend® Bone Mill product insert before use with the Integrated Power Console system. | ||||||||
| W15 | For metal transection, observe the following safety precautions: | ||||||||
| |||||||||
| W16 | Do not operate the IPC POWEREASE system without eye protection. | ||||||||
| W17 | All service must be performed by Medtronic qualified personnel only | ||||||||
| W18 | Repair and/or modification to the IPC system by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty. | ||||||||
| 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 part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site. |
| W21 | When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image-Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration. |
| W22 | Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image-guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site. |
| W23 | Midas Rex® Variable Exposure attachments. Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure. |
| W24 | Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury. |
| W25 | Electrical contacts must be dry prior to use. |
| W26 | Heavy side loads and/or long operating periods may cause the device to overheat. |
| W27 | Do not use an overheated device, as it may cause thermal injury to the patient or operator. |
| W28 | 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. Depending on the amount of irrigation used, the drill bits and blades can achieve temperatures in excess of 50° C. |
| W29 | Do not attempt to change a dissecting tool, saw blade, 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 | Do not place motor, attachment and tool on the patient or in an unsecured location during surgery. |
| W32 | A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in accordance with Medtronic specifications. |
| W33 | Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the attachment. |
| W34 | Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far may result in the attachment accidentally being unlocked. |
| W35 | Midas Rex® Legend EHS® Motor and Midas Rex Legend EHS Stylus® Motor should only be operated when the attachment is in the locked position. |
| W36 | 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 surgeon or staff. |
| W37 | The Indigo® and Legend EHS motors will not run properly unless the attachment is in the locked position. |
| W38 | DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove. |
| W39 | Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator. |
| W40 | DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories. |
| W41 | The safe use of the Endo-Scrub® 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated. |
| W42 | In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable |
| W43 | To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. |
| W44 | Keep NIM® Muting Probe cable away from IPC system cables. |
| W45 | Verify reusable device was sterilized prior to use. If not sterilized, do not use. |
| Disposable Warnings | |
|---|---|
| W46 | 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 significant tissue and bone. |
| W47 | Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery. |
| W48 | Always keep the cutting tip of the tool/saw blade away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove. |
| W49 | Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed. |
| W50 | Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories. |
| W51 | Insertion of metal objects in accessory tip may cause the accessory to break, leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site. |
| W52 | Bending or prying may break the accessory, causing harm to patient or staff. |
| W53 | Do not use excessive force to pry or push bone with the attachment, tool, or blade during dissection. |
| W54 | A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient. |
| W55 | 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. |
| W56 | Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage. |
| W57 | Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage. |
| W58 | CONSULT the cranial perforator device labeling for the recommended speed specifications. |
| W59 | Tools with "L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability. |
| W60 | Tool flutes and blade teeth are sharp and may perforate surgical gloves. Tools/blades may be grasped with a hemostat to aid in installation and removal. |
| W61 | DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control. |
| W62 | 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. |
| W63 | 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 retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient. |
| W64 | Do not use metal-cutting tools on bone. |
| W65 | Use only rotary tools specifically designed for use with this drill system. |
| W66 | When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation. |
| W67 | The use of powered reciprocating instruments may result in vibration/related injury. |
| W68 | Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade. |
| W69 | Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once. |
| W70 | Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization. |
| W71 | Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination. |
| W72 | Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging. |
| W73 | Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase. |
| W74 | T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly. |
| W75 | T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece. |
| W76 | Always ensure that the drill is securely engaged into the handpiece prior to operating the system. |
| W77 | Always examine operation of each tool in a handpiece before use. |
| W78 | Powered burs and drills should be operated in the forward mode only. |
| W79 | This system requires insulated connectors for the Straightshot® M4 Microdebrider, Straightshot Magnum® II Microdebrider, Straightshot III Microdebrider, Midas Rex® SC1, Visao®, or Skeeter® handpieces and the Multi Function Foot Control Unit. |
| W80 | Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization. |
| W81 | After each procedure, properly clean all reusable system components. |
| W82 | Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider or Bone Mill consoles only. |
| W83 | Place Stylus Touch in safe mode while not in use. |
| W84 | Do not place Stylus Touch handpiece in the proximity of magnetic field, such as magnetic drape and MRI equipment, to avoid inadvertent handpiece activation. |
| W85 | Do not apply excessive side loading. Excessive side loading could cause angled attachments to unlock accidentally from motor. |
| Precautions | |
|---|---|
| P1 | PRIME/FLUSH Priming is a feature designed to purge air out of the tubing set(s) during setup. The first time a Prime or Flush button is pressed it will turn on pump 1 and/or 2 long enough to purge air out of the tubing set(s).Turning power Off and On resets the PRIME feature. Once pressed all Prime buttons will change to Flush buttons. |
| P2 | To prevent damage to curved tools, disconnect suction tube prior to changing tool during procedure. |
| P3 | When using an angled attachment, hold the handpiece assembly by the attachment so that the attachment does not inadvertently loosen from the handpiece. |
| P4 | For Legend tools only: If a tool package is opened, but the tool is not used or contaminated, the tool can be re-sterilized. Remove tool from original packaging and place into an approved autoclave package. Steam sterilize as follows: High-Vacuum Steam 132°C for 5 minutes Gravity Displacement 132°C for 15 minutes The re-sterilized tool must be used promptly following re-sterilization. If rustor corrosion is encountered after re-sterilization, do not use the re-sterilized tool. |
| P5 | DO NOT run the 16-MF attachment with operating speed above 62,000 rpm. This may cause over heating and damage to internal gears of attachment. |
| P6 | DO NOT use twist drill or Contra-Angle tool at an operating speed over 62,000 rpm. |
| P7 | Do not attempt to disconnect the cable from the Midas Rex Legend EHS Stylus Motor. |
| P8 | Do not kink cables. Inspect cables and pins for cracks, tears or corrosion. |
| P9 | Do not use anti-fog on scope or sheath, as weeping or leaking may result. |
| P10 | Disconnect cable from Midas Rex Legend EHS motor prior to sterilization. |
| P11 | The use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance. |
| P12 | Remove devices from instrument case before placing into washer disinfector and allow devices to drain. |
| P13 | Orient devices in the washer-disinfector by following manufacturer recommendations. |
| P14 | DO NOT use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions. |
| P15 | DO NOT use low-temperature liquid peracetic acid sterilization due to immersion procedure. |
| P16 | DO NOT steam or EO sterilize the Legend Attachment Cleaning Nozzle. |
| P17 | Remove and discard accessories following local regulations for proper disposal of contaminated materials. |
| P18 | Disposable devices are for single-use only. |
| P19 | Clean the motor and cable while still connected together. This will help to reduce ingress of debris. |
| P20 | Use ONLY recommended cleaning agents. |
| P21 | Do not use excessive force to insert the endoscope into the Endo-Scrub 2 sheath. This will damage the endoscope as well as the Endo-Scrub 2 sheath. |
| P22 | If the endoscope tip can be seen extending beyond the tip of the Endo-Scrub 2 sheath, then the sheath has been damaged. Damaged product must be immediately discarded. |
Midas Rex MR7 High-Speed Pneumatic Drills
