Indications, Safety, and Warnings
Indications for use
The Medtronic MR8™ drill system is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in neurosurgical (cranial and craniofacial including craniotomy), ear, nose and throat (ENT), and maxillofacial, orthopedic, arthroscopic, spinal, sternotomy, and general surgical procedures.
Additionally, the MR8™ drill system is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
Lumbar microdiscectomy
Lumbar stenosis decompression
Posterior lumbar interbody fusion (PLIF)
Transforaminal lumbar interbody fusion (TLIF)
Anterior lumbar interbody fusion (ALIF)
Direct lateral interbody fusion (DLIF)
MR8™ system description
MR8™ pneumatic motors
Pneumatic motors provide power to operate interchangeable, disposable surgical dissecting tools. These motors are designed to interface with a series of attachments and surgical dissecting tools using a standard quick-disconnect locking mechanism. Motors operate in the same manner whether controlled by a finger mechanism or PCU.
MR8™ attachments
Attachments are designed to align the surgical tools with the motor to provide support and stability during various surgical procedures. Attachment options include regular (straight, and angled), variable exposure (straight and angled), footed (craniotomies), and telescoping attachments and tubes. There are a variety of specialty attachments, such as the perforator, Jacobs chuck j-latch, and metal cutting that are also available. This allows flexibility with the length and style of attachment for surgeries.
MR8™ surgical dissecting tools
Surgical dissecting tools are designed and intended to resect, drill, or saw soft and hard tissue, bone, biomaterials, and metals during various surgical procedures. The surgical dissecting tools vary in length and the distal tips of the tools vary in shape and style. The tip designs include the following universal shapes: acorn, match head, ball or round, cylinder, oval, and tapered or side cutting. Specialized tools such as metal cutters, twist drills, hole-makers, hole saws, and reverse tapered tools are also available.
Residual risks
Residual risks related to the use of the Medtronic Midas Rex™ MR8™ Pneumatic System are: General Surgical Complications, Thermal Injury, Tissue or Bone Damage, Nervous System Injury, Cerebrospinal Fluid Leakage, Infection, and Hearing Damage.
Contraindications
None.
Special notices
The words warning, caution, and note have special meanings in this manual, and should be carefully reviewed:
Warning: A warning indicates that the personal safety of the patient or physician may be involved. Disregarding this information could result in injury to the patient or user.
Caution: A caution indicates that there is a risk of damaging equipment.
Note: A note is intended to provide additional information, which may be useful, but is not essential to complete the procedure.
Warnings
System
W1
The MR8™ system operator must be familiar with these instructions for use, its precautions, procedures, and safety issues.
W2
The MR8™ system and its associated equipment should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic surgery systems.
W3
Always inspect the components before and after use for any damage. If damage is observed, do not use the damaged component until it is repaired by Medtronic or replaced.
W4
Use adequate irrigation during dissection to prevent thermal necrosis.
W5
Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W6
Heavy side loads and/or long operating periods may cause the device to overheat.
W6a
Never place an overheated motor on the patient or draping during the surgery.
W6b
Discontinue use and rest the motor by using it intermittently or wrap the motor/attachment interface with a moist sterile towel.
W6c
If the motor is passed off, the receiver should grasp the motor by the proximal end close to the motor hose.
W7
Do not use excessive force to pry or push bone with the attachment or dissecting tool during surgery.
W8
Use only dissecting tools specifically designed for use with this drill system. Match the nomenclature and color code on the MR8 dissecting tool packaging to the same nomenclature and color band on the MR8 attachment.
W9
Do not use the MR8 system without proper cleaning and sterilization.
W10
Sterilize and dry the reusable device before storing. Decrease the likelihood of cross-contamination with timely sterilization. After each procedure, properly clean and sterilize all reusable system components.
W11
All service must be performed by Medtronic qualified personnel only.
The Midas Rex™ MR8™ pneumatic high-speed drill system
W12
Employ visualization, including the use of imaging techniques (for example, fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue the powered application if visualization to the surgical site is lost.
W13
Do not attempt to remove a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state to prevent laceration of the user and/or cross contamination through a compromised glove.
W14
Do not immerse the system components, except when recommended by the cleaning instructions in this Instructions for Use.
W15
The MR8 motors should only be operated when the attachment is in the fully locked position.
W16
Do not modify any components of the system; performance could be diminished.
W17
Do not use the MR8 system if the motor continues to run after releasing the foot pedal or finger lever.
W18
Do not place the motor, attachment, or dissecting tool on the patient or in an unsecured location during surgery.
W19
Do not use an attachment and dissecting tool combination that results in tool flail or excessive vibration.
W20
Do not attempt to run the MR8 motors immediately after autoclaving. Allow an adequate cooling period after steam sterilization.
W21
Verify functionality prior to reuse:
W21a
Conduct a visual inspection of the hose for cracks, tears, or corrosion.
W21b
Check attachments for proper appearance. Install the attachment and dissecting tool, then briefly the run motor.
W21c
Check motor for overheating.
W21d
Check attachment for overheating.
W213
Check dissecting tool for flail.
W21f
Check motor for leaking lubricant.
W22
Do not place MR8 motor in the proximity of a magnetic field, such as magnetic drape or Magnetic Resonance Imaging (MRI) equipment to avoid inadvertent motor activation.
W23
Do not use metal-cutting attachment or tools to cut/resect bone.
W24
For metal transection, observe the following safety guidelines:
W24a
Wear eye protection.
W24b
Irrigate well to cool the cutting surfaces.
W24c
Protect the wound site from metal debris.
W24d
Use a clamp or grasping device to control loose fragments during transection of any metal component.
W25
Do not use any parts other than Medtronic system components, as damage or substandard performance could result.
W26
When using MR8 variable exposure attachments, surgeons should become familiar with the performance of dissecting tools before use and should explore the effect of various levels of tool exposure on tool stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W27
Motors and attachments may fail due to extended use resulting in component(s) detaching and falling from the motor or attachment and may cause patient injury.
W28
When using the MR8 non-DK variable exposure attachments, ensure that the attachment is still in the locked position after each adjustment of the tool exposure. Attempting to increase the tool exposure too far may result in the attachment accidentally being unlocked.
W29
Remove MR8 footed attachments cautiously and slowly, as per instructions to avoid injury to the operator.
W30
Excessive side loading could cause non-DK angled attachments to unlock accidentally from motor.
W31
Place MR8 pneumatic finger-controlled motor in Safe mode (“0”) while not in use.
W32
When not operating the motor, eliminate accidental foot control activation.
W33
Do not use the MR8 system in the presence of flammable anesthetics to avoid potential ignition or explosion of gases.
W34
Do not operate the MR8 system without eye protection.
W35
Failure to properly secure the lubricant/diffuser or oil cartridge may cause injury to operator and/or operating room staff.
W36
Do not use the pneumatic control unit to operate systems other than the Midas Rex devices.
W37
You must ensure the adapter is fully threaded onto the regulator hose and that the adapter is fully threaded/connected to the corresponding wall outlet before operating the pneumatic system.
W38
Do not attempt to use a motor that is leaking lubricant. MR8 motors which fail due to extended use and/or lubricant seal failure may allow foreign matter to migrate or emit from the tool collet end of the motor. Non-sterile fluid may leak into the surgical site. As a result, measures may be required to protect the patient from infection, per the physician’s discretion.
W39
Do not load more than one MR8 motor inside the instrument tray per sterilization cycle.
W40
Do not wrap the rigid sterilization container.
W41
The MR8 system operator should take appropriate measures in ensuring that sensitive anatomy is protected during drilling and use of the MR8 system.
W42
Use the MR8 instrument tray and the rigid sterilization container for sterilizing the re-usable MR8 devices only.
W43
Do not use the instrument tray and rigid sterilization container for cleaning or disinfection of the re-usable devices.
W44
Do not use alkaline cleaning for the instrument tray or the rigid sterilization container.
W45
Do not sterilize and supply for surgical use any device that is not visibly clean and free of particulates. If particulates are present, repeat reprocessing, starting with the Preparation for Cleaning step.
W46
Use the instrument tray and the rigid sterilization container for sterilization only. The MR8 system devices must be cleaned separate from the trays.
W47
Devices cannot be sterilized to an adequate Sterility Assurance Level (SAL) without prior cleaning and decontamination.
System hoses
W48
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.
Tools and disposable components
W49
Tool flutes are sharp and may perforate surgical gloves. Tool stems may be grasped with a hemostat to aid in installation and removal. Use methods at the operative site to control bleeding that do not compromise patient safety during surgery.
W50
Keep the cutting area of the tool away from fingers and loose clothing to prevent laceration of the user and cross-contamination through a compromised glove.
W51
A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease the speed of the motor to prevent vibration. Change to a new tool to prevent unintended tissue damage.
W52
Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause patient hearing damage.
W53
Consult the cranial perforator manufacturer device labeling for the recommended speed specifications.
W54
Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
W55
Dissecting tools are for single-use only. Do not attempt to sterilize them. The dissecting tools are packed sterile and not intended for repeat use. To prevent contamination, use only once.
W56
Excessive pressure applied to a tool may cause tool fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all the fragments of the tool are removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W57
Do not sterilize disposable devices. They are sterilized at the factory and are not intended for repeat use. To prevent contamination, use only once.
W58
Do not use an accessory if its packaging is damaged or opened outside the sterile field. Sterility may be compromised if packaging is opened or damaged.
W59
Do not use dull tools. Use of dull tools can reduce cutting effectiveness and can cause the motor temperature to increase.
W60
Fluted tools are designed to be used in forward mode. Diamond tools may be used in forward or reverse modes.
W61
Exposure of tool packaging to ambient light for extended periods of time may cause damage to packaging.
Pneumatic control unit
W62
Do not carry pneumatic control unit by the N2 DISS pressure hose.
W63
Do not disassemble equipment before gas pressure is released from the pneumatic control unit and associated hoses.
Cautions
C1
When using a non-DK angled attachment, hold the motor assembly by the attachment so that the attachment does not inadvertently loosen from the motor.
C2
Do not use a twist drill dissecting tool at an operating pressure over 80 psi (5.5 bar).
C3
Use of a washer-disinfector for cleaning may cause a pre-mature degradation in performance.
C4
Remove devices from instrument tray before placing into washer-disinfector and allow devices to drain. Orient devices in the washer-disinfector by following manufacturer recommendations.
C5
Do not use low-temperature hydrogen peroxide gas plasma sterilization due to the lumen internal diameter and length restrictions.
C6
Do not use low-temperature liquid peracetic acid sterilization due to immersion procedure.
C7
Remove and discard accessories following local regulations for disposal of contaminated materials.
C8
Do not use an MR8 motor without a lubricant/diffuser or oiler cartridge installed.
C9
Do not use chlorine-based or corrosive cleaning agents such as bleach, lye, acetone, sodium hypochlorite or bleach, sodium hydroxide, formic acid, or solutions containing glutaraldehyde.
C10
Do not use a lubricant/diffuser or oiler cartridge for more than one hour of drill time.
C11
Do not reuse or attempt to refill a lubricant/diffuser or oiler cartridge. It is a single-use product.
C12
Do not use a lubricant/diffuser or oiler cartridge if it appears to be damaged or if the inner foil seal is punctured.
C13
Devices should be cleaned within 30 minutes (30:00) of use to limit fixation of contaminants.
C14
Do not use ultrasonic cleaner. Review the washer-disinfector cautions before using this cleaning method.
C15
Do not expose these devices to sterilization temperatures greater than 137 C (279 F). Exposure to temperatures greater than 137 C (279 F) may impact the performance of the device and also the efficacy of the sterilization cycle.
C16
Because of the variability in cleaning efficiencies and sterilizer operating parameters, all given parameters (temperature, time, etcetera) should be validated by persons who have training and expertise in sterilization processes. Deviation from the recommended sterilization processes is at the risk of the user facility.
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