Indications, Safety, and Warnings
- Midas Rex MR7 High-Speed Pneumatic Drills
- Midas Rex Legend Tools and Attachments
- Curved Burs
- Midas Rex Electric Bone Mill System
- Midas Rex Legend Bone Mill Attachment
- Midas Rex Legend EHS Stylus Surgical Drill
- Visao High-Speed Otologic Drill
Midas Rex MR7 High-Speed Pneumatic Drills
Indications
The Medtronic Midas Rex® MR7 System is a pneumatically operated surgical instrument system. The pneumatic motors provide 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), orthopaedic and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Contraindications
None.
Warnings
Do not use the Midas Rex MR7 System before proper cleaning and sterilization.
Do not operate the Midas Rex MR7 System in the presence of Magnetic Resonance Imaging devices.
Do not use damaged, faulty, or modified Midas Rex MR7 System components. Inspect the Midas Rex MR7 System for damage prior to each use:
- Check the motor’s exhaust hose for cracks or tears.
- Visually inspect attachments and tools. Do not use bent or damaged tools.
- Install attachment and dissecting tool, then briefly run motor.
- Check motor for overheating and leaking lubricant.
- Check attachment for overheating.
- Check dissecting tool for flail.
Do not operate the Midas Rex MR7 System without eye protection.
Motors and attachments which fail due to extended use may allow a component to detach and fall from the motor or attachment, and may cause patient injury.
Heavy side loads and/or long operating periods may cause the device to overheat. If overheating occurs:
Never place an overheated motor on the patient or draping during surgery.
Discontinue use and rest the motor by using intermittently, or wrap the motor/attachment interface with a moist sterile towel.
If the motor is passed off, the receiver should grasp the motor by the proximal end close to the motor hose.
To avoid injury to the patient or user, do not place the handpiece on the patient or in an unsecured location, when not in use.
Midas Rex MR7 motors should only be operated when the attachment is in the locked position.
Use only Medtronic Midas Rex Legend® or MR7 devices with an MR7 motor. Use of other devices may cause injury or damage equipment, and will void the manufacturer’s warranty.
Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and are 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.
Do not attempt to remove a tool while the motor is running.
Do not attempt to remove a tool from an overheated motor or attachment.
Do not use the device if the package is opened or damaged.
Be sure to match the color code and nomenclature on the Legend Dissecting Tool packaging with the color band and nomenclature on the Legend Attachment. Failure to do so could result in injury to the patient or operating room staff.
Do not use the MR7 system with the Midas Rex in-line oiler. The MR7 motor is sufficiently lubricated by the lubricant/diffuser on the motor hose, and will be over-lubricated if the Midas Rex in-line oiler is used.
Failure to properly secure the lubricant/diffuser cartridge may cause injury to operator and/or operating room staff.
Do not attempt to remove the lubricant/diffuser cartridge while the system is pressurized.
Do not 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.
To avoid injury to the patient or user, do not use the pneumatic control unit to operate systems other than the MR7, Legend, and Triton systems.
To avoid injury when using the MR7 Touch motor, ensure the safety slide is in the “O” position before installing the attachment and tool.
Dissecting tool flutes are sharp and may perforate surgical gloves. Tools may be grasped with a hemostat to aid in installation and removal.
Do not use excessive force to pry or push bone with the attachment or tool during dissection. This could cause the tool to break and cause injury to the patient or operating room staff.
Use adequate irrigation during dissection, to prevent thermal necrosis.
MR7 motors should only be operated when the attachment is in the locked position.
Do not disassemble equipment before the gas is released from control unit.
Do not soak/submerge MR7 devices.
Do not use ultrasound to clean MR7 devices.
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.
Do not sterilize the MR7 pneumatic control unit, regulator hose, or Triton adapter.
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.
Remove Legend Footed Attachments cautiously and slowly per instructions to avoid injury to the operator.
For metal transection, observe the following safety guidelines:
- Wear eye protection.
- Irrigate well 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.
- Do not use metal cutting dissecting tools on bone.
Consult the cranial perforator device labeling for the recommended speed specifications.
Midas Rex Legend Tools and Attachments
Midas Rex® Legend tools and attachments are accessories to the Midas Rex Legend EHS System.
Indications
The Midas Rex Legend EHS – Electric High Speed System is intended for use in the surgical procedures for the following medical applications:
- Neurosurgical
- Spine
- Orthopaedic surgery
- General surgery
- ENT
- Maxillofacial
- Craniofacial
Contraindications
None.
Warnings
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 he 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 pre-mature 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
IPC System:
| 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. |
Curved Burs
Indications
The XPS® Curved Bur is intended for use in an ear, nose, and throat electric or
pneumatic surgical drill for incising or removing bone in the ear, nose, or throat
area, and is an accessory to the XPS® 3000 and IPC® System.
Contraindications
None.
Warnings
- Use adequate irrigation from a separate user-provided irrigating source. The use of a bur without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
- Keep the cooling sleeve irrigated to minimize thermal injury to tissue.
- Excessive noise from the drill or eccentricity of the drill may cause hearing damage when drilling close to the cochlea or ossicular chain.
- During procedures near nerves, keep bur and bur cannula away from tissue to minimize the potential for thermal injury.
- For procedures near nerves, nerve monitoring should be used to alert the user of the potential for injury.
- Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS accessories.
- The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.
- Employ visualization when using rotating XPS accessories. Discontinue powered application in the event of lack of visualization of the surgical site.
- Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
- When not operating handpiece, ensure that handpiece rests on a non-conductive surface that provides containment for handpiece and blade/bur. Avoid unintended thermal injury by an uncontained handpiece
- When not operating handpiece, eliminate accidental foot control activation. Control energy to and through handpiece to prevent unintended tissue, bone or nerve resection.
- Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
- Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
- Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
- Bending or prying may break the blade or bur, causing harm to patient or staff.
- Excessive pressure applied to bur may cause bur fracture. Should a bur fracture during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.
- Test for bur wobble (eccentricity) at the desired speed prior to use. Select a new bur or reduce speed if wobble is observed. Eccentricity of the bur can cause bur vibration and may result in excessive tissue and bone destruction and hearing damage. Always examine the operation of each bur in the handpiece before each use. Operating certain burs at high speed can cause vibration of the bur.
- Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue removal from patient.
- Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.
- Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories.
- Do not attempt to resharpen used burs. Worn burs should be replaced with new ones frequently to ensure effective cutting and control of the drill.
- Do not use any parts other than Medtronic Xomed, Inc. system components as damage or substandard performance could result.
- Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination use only once.
- Do not use burs above the speed indicated on the bur label. Exceeding speed may cause the burs to break.
Midas Rex Electric Bone Mill System
Indications
The Midas Rex® Electric Bone Mill is intended to mill bone, producing bone particles 1 to 5 mm in size.
Contraindications
There are no known contraindications.
Warnings
- It is important that the Electric Bone Mill operator be familiar with this manual, its precautions, procedures and safety issues.
- 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.
- 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.
- Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
- Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
- 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.
- Always inspect the components before and after use for any damage. If damage is observed, do not use the damaged part until it is repaired or replaced.
- DO NOT operate the Midas Rex Electric Bone Mill base without the bowl and cap secured in place.
- Verify reusable device was sterilized prior to use. If not sterilized, do not use.
- Achieve electrical grounding reliability with proper connections. Connect the Bone Mill to hospital grade receptacles only.
- DO NOT operate the Midas Rex Electric Bone Mill in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
- Take care to process bone to the desired partical size. DO NOT over process bone.
- The Midas Rex Electric Bone Mill bowl, cap, and spatula are provided STERILE and are intended for SINGLE PATIENT USE ONLY. DO NOT RESTERILIZE THESE COMPONENTS. MEDTRONIC ASSUMES NO LIABILITY FOR PRODUCTS WHICH HAVE BEEN RESTERILIZED BY HEALTH CARE FACILITIES. In discarding the disposables, follow health-care facility guidelines on proper disposal of contaminated materials.
- Disconnect power to the Midas Rex Electric Bone Mill base before cleaning the unit to avoid electrical shock.
- After each procedure, properly clean all reusable system components.
- Sterilizing and drying the Midas Rex Electric Bone Mill Base before storing decreases the likelihood of cross-contamination.
- All service must be performed by Medtronic-qualified personnel only.
- DO NOT operate the Midas Rex Electric Bone Mill before following proper cleaning and sterilization protocols.
- Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
- DO NOT come in contact with the interior of the disposable bowl or cap during the milling of bone.
- DO NOT operate the Midas Rex Electric Bone Mill in the presence of Magnetic Resonance Imaging Devices.
- DO NOT operate the Bone Mill without eye wear protection.
- DO NOT use any other components except for Medtronic Midas Rex Electric Bone Mill disposables.
- Do not use accessory if package is opened or damaged. A broken seal offers no protection against cross-contamination.
- DO NOT modify accessories. Performance could be diminished with modified accessories.
Precautions
- The addition of any liquid to the milling process should be administered in small volume to prevent leakage.
- Improper sterilization or overloading of the Midas Rex Electric Bone Mill can lead to permanent motor damage.
- The Midas Rex Electric Bone Mill must not be overloaded. DO NOT process more that 10 cc of bone at one time. The maximum starting size of the pieces should not exceed 1.5 cc. Additional bone graft may be processed in separate batches or loads.
- DO NOT use Midas Rex Electric Bone Mill Disposables to process more than 6 bone pieces approximately 1.5 cm 3 in size at one time.
- DO NOT use Midas Rex Electric Bone Mill Disposables to process more than a total of 40 cc of bone during any one surgical procedure.
- DO NOT immerse and/or soak the Bone Mill Base or Console.
- DO NOT use chlorine based or corrosive cleaning agents such as bleach, acetone, solutions containing glutaraldehyde, etc.
- The equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used.
- Take care when placing base unit on a surgical drape, that the base is in a stable position and that the cable is safely routed.
Federal Law (USA) restricts this device to sale by or on the order of a physician.
Midas Rex Legend Bone Mill Attachment
Indications
The Bone Mill Attachment is intended to mill bone into particles 1 to 5mm in size.
Warnings
Do not use the EM200 motor or EC100 console with the Bone Mill Attachment. Motor part numbers are etched on the motor and console part numbers are located on the back of the console.
Do not operate the Bone Mill Attachment before following proper cleaning and sterilization protocols.
Do not use any disposable if the sterile packaging is damaged.
Do not operate the Bone Mill Attachment without the bowl, and cap secured in place.
Do not come in contact with the interior of the disposable bowl and cap during bone milling.
Do not use the Bone Mill disposable components for more than one surgical procedure, as this may cause cross-contamination and affect patient safety.
Use only Medtronic Midas Rex Legend Motors and Legend Bone Mill disposables in combination with the Bone Mill Attachment. Use of other devices will void the manufacturer’s warranty.
Do not operate the Bone Mill Attachment in the presence of Magnetic Resonance Imaging devices.
Do not operate the Bone Mill Attachment without eye protection.
Cautions
The addition of any liquid to the milling process should be administered in small volumes to prevent leakage.
Do not use Bone Mill disposables to process more than 6 bone pieces approximately 1.5 cc in size at one time.
Do not use Bone Mill disposables to process more than a total of 40 cc of bone during any one surgical procedure.
Do not run the Legend Bone Mill Attachment with a pneumatic motor at an operating pressure below 80 psi (5.5 bar) or above 120 psi (8.3 bar).
If using an EHS motor, set the console or depress the foot pedal to achieve 70,000 RPM when using the Bone Mill Attachment.
Do not immerse and/or soak the Bone Mill base.
Do not use chlorine based or corrosive cleaning agents such as bleach, acetone, solutions containing gluteraldehyde, etc.
Federal Law (USA) restricts this device to sale by or on the order of a physician.
Midas Rex Legend EHS Stylus Surgical Drill
The Midas Rex® Legend EHS Stylus® Surgical Drill is 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. |
Visao High-Speed Otologic Drill
The Visao® High-Speed Otologic Drill is part of the IPC® System and XPS® 3000 System.
Indications
Integrated Power Console (IPC® System):
Ear, Nose, and Throat:
The IPC® 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.
Neurologic Technologies:
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.
Contraindications
None.
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 main 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. |
Indications
XPS 3000:
The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.
Otology/neurotology indications include aural atresia, cholesteatoma, cochleostomy, development of a suture tunnel for cochlear implant fixation, drainage of petrous apex cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression, mastoidectomy, mastoidotomy, ossicular chain reconstruction (OCR), otosclerosis, removal of ear tumors including acoustic neuroma, tympanoplasty, and vestibular neurectomy.
Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.
Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillornatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions.
Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.
Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.
The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.
The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.
The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures.
Contraindications
None.
Warnings
- Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
- Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories.
- Insertion of metal objects in blade or bur tip may cause the blade or bur to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
- Do not use any parts other than Medtronic Xomed, Inc. system components as damage or substandard performance could result.
- Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.
- Do not attach unapproved components to the XPS® 3000 Console to avoid electrical macro shock.
- Carefully inspect burs prior to and following each use for excessive wear, fragmentation, eccentricities or other defects. Do not use dull, damanged or bent burs. Use of dull burs can reduce the handpiece effectiveness and cause the handpiece temperature to increase.
- Do not attempt to resharpen used burs. Worn burs should be replaced with new ones frequently to ensure effective cutting and control of the drill.
- Excessive pressure applied to bur may cause bur fracture. Should a bur fracture during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur
fragments may cause tissue damage to the patient. - Test for bur wobble (eccentricity) at desired speed prior to use. Use a bur guard (Xcalibur only) if needed. Select a new bur or reduce speed if wobble is observed.
- Test for bur wobble (eccentricity) at the desired speed prior to use. Select a new bur or reduce speed if wobble is observed. Eccentricity of the bur can cause bur vibration and may result in excessive tissue and bone destruction and hearing damage. Always examine the operation of each bur in the handpiece before each use. Operating certain burs at high speed can cause vibration of the bur.
- Keep the cooling sleeve irrigated to prevent thermal injury to tissue.
- During procedures near nerves, keep bur and bur cannula away from tissue to minimize the potential for thermal injury.
- For procedures near nerves, nerve monitoring should be used to alert the user of the potential for injury.
- Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS® accessories. The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.
- Employ visualization when using rotating XPS® accessories. Discontinue powered application in the event of lack of visualization of the surgical site.
- Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
- Use lock on StraightShot® M4 handpiece to prevent inadvertant rotation of blade or bur during use.
- When precise location of the blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on the Image Guided Surgery (IGS) system. Always lock the StraightShot® M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
- Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
- Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
- Bending or prying may break the blade or bur, causing harm to patient or staff.
- Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue removal from patient.
- Do not use burs above the speed indicated on the bur label. Exceeding speed may cause the burs to break.
- Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination use only once.
- Disconnect power to the XPS® 3000 Console before cleaning the unit to avoid electrical macro shock.
- After each procedure, properly clean all reusable system components.
- Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
- Remove and discard accessories following local regulations for proper disposal of contaminated materials.
- Properly dispose of single-use devices removed from sterile packages. Devices lost sterility upon removal from packaging.
- All service must be performed by Medtronic Xomed-qualified personnel only.
WARNINGS BEFORE SURGERY
- Verify reusable device was sterilized prior to use. If not sterilized, do not use.
- Do not use accessory if package is opened or damaged. Broken seal offers no protection against crosscontamination.
- Do not operate the XPS® 3000 System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
- Achieve electrical grounding reliability with proper connections. Connect the XPS® 3000 Console to hospital grade receptacles only.
- Use adequate irrigation from a separate user-provided irrigating source. The use of a bur without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
- When not operating handpiece, ensure that handpiece rests on a non-conductive surface that provides containment for handpiece and blade/bur. Avoid unintended thermal injury by an uncontained handpiece.
- When not operating handpiece, eliminate accidental foot control activation. Control energy to and through handpiece to prevent unintended tissue, bone or nerve resection.
- 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.