Healthcare Professionals
PEAK PlasmaBlade Device
Indications, Safety, and Warnings – Other Products
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MR7
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.