Indications, Safety, and Warnings

Midas Rex Legend EHS Stylus High-Speed Surgical Drill

Integrated Power Console (IPC System)

Indications

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

None.

Warnings

WARNINGS

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 surgical procedures for the following medical applications:

• Neurological
• 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 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.

CONSULT the cranial perforator device labeling for the recommended speed specifications.

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

1. It is important that the Electric Bone Mill operator be familiar with this manual, its precautions, procedures and safety issues.
2. 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.
3. 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.
4. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
5. Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
6. 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.
7. 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.
8. DO NOT operate the Midas Rex Electric Bone Mill base without the bowl and cap secured in place.
9. Verify reusable device was sterilized prior to use. If not sterilized, do not use.
10. Achieve electrical grounding reliability with proper connections. Connect the Bone Mill to hospital grade receptacles only.
11. DO NOT operate the Midas Rex Electric Bone Mill in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
12. Take care to process bone to the desired partical size. DO NOT over process bone.
13. 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.
14. Disconnect power to the Midas Rex Electric Bone Mill base before cleaning the unit to avoid electrical shock.
15. After each procedure, properly clean all reusable system components.
16. Sterilizing and drying the Midas Rex Electric Bone Mill Base before storing decreases the likelihood of cross-contamination.
17. All service must be performed by Medtronic-qualified personnel only.
18. DO NOT operate the Midas Rex Electric Bone Mill before following proper cleaning and sterilization protocols.
19. Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
20. DO NOT come in contact with the interior of the disposable bowl or cap during the milling of bone.
21. DO NOT operate the Midas Rex Electric Bone Mill in the presence of Magnetic Resonance Imaging Devices.
22. DO NOT operate the Bone Mill without eye wear protection.
23. DO NOT use any other components except for Medtronic Midas Rex Electric Bone Mill disposables.
24. Do not use accessory if package is opened or damaged. A broken seal offers no protection against cross-contamination.
25. DO NOT modify accessories. Performance could be diminished with modified accessories.

Precautions

1. The addition of any liquid to the milling process should be administered in small volume to prevent leakage.
2. Improper sterilization or overloading of the Midas Rex Electric Bone Mill can lead to permanent motor damage.
3. 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.
4. 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.
5. 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.
6. DO NOT immerse and/or soak the Bone Mill Base or Console.
7. DO NOT use chlorine based or corrosive cleaning agents such as bleach, acetone, solutions containing glutaraldehyde, etc.
8. 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.
9. 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.

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

IPC System:
None.

Warnings

IPC System:

WARNINGS

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

XPS 3000:
None.

Warnings

XPS 3000:

• 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.

NIM 3.0 Nerve Monitors

Indications

The NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots. The APS™electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.

Indications for NIM 3.0 EMG Monitoring Procedures include:
Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities

Contraindications

The NIM 3.0 is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.

Warnings

WARNINGS

Fusion ENT Navigation System

Indications

Your Medtronic computer-assisted surgery system and its associated applications are intended as an aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to diagnostic images of the anatomy.

Contraindications

Medical conditions which contraindicate the use of a Medtronic computer-assisted surgery system and its associated applications include any medical conditions which may contraindicate the medical procedure itself.

Warnings and Precautions

• The system and its associated applications should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Medtronic computer-assisted surgery systems.
• The system and its associated applications should be used only as an adjunct for surgical guidance. They are not a replacement for the surgeon’s knowledge, expertise, or judgement.
• If system navigation seems inaccurate and recommended steps to restore accuracy are not successful, abort use of the system.