Indications, Safety, and Warnings
- Spine Shaver and Nucleus Removal Blades
- Midas Rex Electric Bone Mill System
- Midas Rex Legend Bone Mill Attachment
Spine Shaver and Nucleus Removal Blades
The Spine Shaver and Nucleus Removal Blades are part of the Integrated Power Console (IPC® 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
Ear, Nose, and Throat:
None.
Neurologic Technologies:
The IPC System is contraindicated for arthroscopic microdiscectomy in individuals with the following:
- Severe/progressive neurological deficits
- Cauda equine syndrome
- Active infection
Arthroscopic microdiscectomy is not indicated for individuals with sequestered disc fragments, discogenic pain, internal disc destruction, or lumbago.
Warnings
Ear, Nose, and Throat and Neurologic Technologies:
Warnings
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: | ||||||||
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| 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. |
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.
Last updated: 26 Feb 2013