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Indications, Safety, and Warnings - Other Products

  

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 EHS Stylus High-Speed Surgical Drill

Indications

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).

Legend EHS System:

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

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:

a. Protective eyewear is essential.

b. Irrigate copiously to cool the cutting surfaces.

c. Protect the wound site from metal debris.

d. 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.

a. Never place an overheated attachment on the patient or patient draping during surgery.

b. Mitigate the overheating by discontinuing use and rest the attachment by using intermittently, or wrap the attachment interface with a moist sterile towel.

c. 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 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.

Do not 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:

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:
  W15a Eye wear protection is essential.
W15b Irrigate well to cool the cutting surfaces.
W15c Protect the wound site from metal debris.
W15d Use a clamp or grasping device to control loose fragments during transection of any metal component.
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.