Indications, Safety, and Warnings

Fusion ENT Navigation System

Indications

Your Medtronic Navigation^® 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

Warnings

• Do not modify the Fusion™ system.
• The system and its associated applications should be used only by qualified medical professionals who are trained on, and familiar with the proper operation of, Medtronic Navigation 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 judgment.
• If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system.
• To avoid risk of electrical shock, the Fusion system must only be connected to a supply mains with protective earth.
• To avoid risk of electrical shock, do not touch the Fusion system Input/Output (I/O) panel and the patient at the same time.
• Accessory equipment connected to the analog and digital interfaces of the Medtronic Navigation computer-assisted surgery system must be certified according to the applicable IEC standards (e.g., IEC 60601-1 for medical equipment, UL60601-1, and CSA C22.2 No. 601-1-M90). Furthermore all configurations shall comply with the system standard IEC 60601-1-1 or the system requirements of Clause 16  IEC 60601-1: 3rd Edition. Any person who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 60601-1-1 or the system requirements of Clause 16 IEC 60601-1: 3rd Edition. If in doubt, contact technical support or your local Medtronic Navigation representative.
• The system is not suitable for use in the presence of a flammable, anesthetic mixture with air or oxygen or nitrous oxide. Position the system at least 25 cm from any source of flammable gas.
• Some system components may contain batteries. Do not recharge or disassemble batteries. Do not dispose of batteries in fire. Observe local regulations concerning battery disposal.
• Discard before use any pre-sterilized component whose sterile packaging appears to be compromised or whose expiration date has passed. 
• Do not re-process, re-sterilize, or re-use any single-use device. Attempts to re-process or re-sterilize a single-use device may be ineffective and may compromise its structural integrity. Any re-use creates a risk of contamination which could result in patient injury, illness, or death. 
• There is currently no effective sterilization method for components that are tainted with the infectious agent that causes Creutzfeld-Jakob Disease (CJD). Therefore, you must discard immediately after surgery any components that come into contact with biologic material from patients who carry or are suspected to carry this infectious agent. As a precaution, drape all non-disposable components that could otherwise come into contact with such material. 
• The system has been tested for compatibility with Medtronic implantable cardiac device families. Interference testing indicates that the system does not adversely affect the function of these devices and does not constitute a patient hazard. 
• Use of the system may interfere with implantable device communication. Do not use the system while programming or interrogating any implantable device. 
• Use of the system may interfere with patient monitoring equipment. Position the Fusion™ system cart and Mobile Emitter as far as possible from any such equipment, and use interference filtering if possible. If you continue to experience interference, abort use of the system and call technical support.

Precautions

• Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
• This system is not sterilizable. Properly clean the system following the protocol in the Universal Cleaning and Sterilization instructions (9733025).
• The Fusion™ system and its associated applications contain no user-repairable parts. For repair or replacement of any part of the system, contact your technical support representative.
• Verify that all necessary instrumentation has been properly cleaned and sterilized before surgery. Refer to the Equipment Cleaning and Sterilization sheet (9730713) for cleaning and sterilization instructions. For non-sterilizable components, refer to the Non-Sterilizable Equipment Cleaning sheet (9733205).
• The system does not contain an uninterruptible power supply (UPS). The system must remain connected to an external source of power.
• Do not exceed the recommended electrical ratings for the system. Exceeding the ratings could damage the system.
• System components, including the Mobile Emitter, are fragile. Use care when handling system components.
• Do not drop or mishandle the system components in such a manner as to cause physical damage to the components. This may impair device function. Even if the component works immediately after being dropped, operational damage may have occurred that may not be observed until some future time. 
• Maximum load 600 VA. Do not apply loads in excess of 600 VA. Current exceeding 600 VA will overload the isolation transformer. The outlets inside the Fusion™ system are intended to power only Medtronic qualified subsystems. 
• Metallic objects in or near the navigation field can degrade navigational accuracy. If metallic distortion causes excessive error, navigation will be disabled. To restore navigation, remove metallic objects from the navigation field.
• Electrical noise in or near the navigation field can degrade navigational accuracy. If electrical noise introduces excessive error, the system will automatically disable navigation. To restore navigation, remove devices that produce electrical noise (such as electro-cautery equipment and electric drills) from the navigation field.
• The system cart, mouse, keyboard, Mobile Emitter, Emitter Holder, and Emitter Holder Clamp are not designed for sterilization and may be damaged if sterilization is attempted.

Fusion Standard Instruments and Fusion Supplemental Instruments

Device Description

Fusion™ Standard Instruments and Fusion Supplemental Instruments are electromagnetic (EM) ENT instruments intended for use with the Fusion software on a Medtronic computer-assisted surgery system. Each EM ENT Instrument is intended to have an EM ENT Instrument Tracker mounted on it. The system's mobile emitter generates a low-energy magnetic field to locate the tracker mounted on the instrument. Then, the software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings. EM ENT Instrument Trackers are sold separately.

Intended Use

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or 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, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon’s knowledge, expertise, or judgment.

Contraindications

None known.

Warnings and Precautions

Warnings

Exercise care during handling, storage, and cleaning to prevent both physical injury and deformation of the instrument tip.

Local burning of patient, physician, or other personnel may result from current paths through conductive elements like metal instruments. Contacting conductive elements with an active cautery may cause undesired tissue heating and burns.

Bending, prying, excessive force or misuse may result in breakage, failure of the instrument or localization errors, resulting in possible harm to patient or user.

Precautions

Visually inspect the EM ENT Instruments for damage. If you suspect that damage has occurred during use, inspect the instruments before proceeding. Do not attempt to use any instrument that appears to be bent or otherwise damaged.

Do not modify instruments.
 

Straightshot Automated EM Tracking Blades

The Straightshot^® Automated EM Tracking Blade is a sterile blade that is a single-use accessory component of the Straightshot M4 handpiece, which is an integral part of the  XPS^® System. The M4 tracked blades are intended for attachment to the handpiece and for use in conjunction with the Fusion™ ENT Navigation System software on a Medtronic computer-assisted surgery system.

Intended Use

The XPS^® System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or 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, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon’s knowledge, expertise, or judgment.

Contraindications

None known.

Warnings

Surgeons shall view endoscopic monitor while dissecting. Do not dissect with the M4 handpiece while actively tracking the instrument in the navigation software.

The M4 tracked blades are compatible with only the Straightshot^® M4 handpiece

Prior to use, examine the product packaging and the product itself for damage, deterioration, and expired shelf life. If found, discard the product.

Prior to use, inspect the cable for damage, nicks, or exposed wire. If found, discard the product.

The M4 tracked blades are provided in a sterile condition and are single-use only. Do not re-sterilize or reuse.

Do not modify the M4 tracked blades.

If you believe a blade has been bent during use, visually inspect it and discontinue use if the blade is bent or damaged.

The tracker (hub of the M4 blade) is not intended to be submerged in fluids and will be damaged if it is submerged.

Local burning of the patient, physician, or other personnel may result from current paths through conductive elements like metal instruments. Contacting conductive elements with an active cautery may cause undesired tissue heating and burns.

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.

Employ visualization when using rotating XPS accessories, including use of image guided surgery system if needed. Discontinue powered application in the event of lack of visualization of the surgical site.
 

Cranial Dynamic Reference Frame (DRF)

The Cranial Dynamic Reference Frame is an accessory to the Fusion ENT Navigation System. View Indications, Safety, and Warnings information for the Fusion ENT Navigation System.

Stealthmerge ENT Software

StealthMerge^® ENT Software is an optional software module for the Fusion™ ENT Navigation System. View Indications, Safety, and Warnings for the Fusion ENT Navigation System.

DICOM Q/R Software

DICOM Query/Retrieve (Q/R) Software is an optional software module for the Fusion™ ENT Navigation System. View Indications, Safety, and Warnings for the Fusion ENT Navigation System.

StealthStation Navigation System

View the indications, safety, and warnings for the StealthStation Navigation System.

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

Straightshot M4 Microdebrider

The Straightshot M4 Microdebrider is part of the IPC® System and XPS® 3000 System.

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

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.
   

Straightshot® Blades and Burs

Indications

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, sphenoidectomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal/laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy, tonsillotomy for obstructive tonsillar disease, removal of endobronchial lesions and surgical management of recurrent respiratory papillomatosis (RRP).

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.

Contraindications

None

Warnings

• DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
• For Airway Blades: Should the blade become clogged during use, risk assessment has determined 1-5 cc of irrigant could be aspirated by the patient before detection by the user.
• DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories.
• DO NOT use burs above the speed indicated on the bur label.
• For high speed drilling (greater than 6,000 rpm) ensure that an XPS High Speed Bur is used.
• Use adequate irrigation from a separate user-provided irrigating source. The use of an accessory without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
• 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.
• 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.
• Always keep the cutting tip of the accessory away from fingers and loose clothing. 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.
• Operate the blade or bur only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
• Blades, burs and irrigation tubing are disposable and intended for single-use only, UNLESS OTHERWISE MARKED.
• 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.
• 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.
• 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, including use of image guided surgery system if needed. 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.
• 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 use any parts other than Medtronic system components as damage or substandard performance could result.
• Remove and discard accessories following local regulations for proper disposal of contaminated materials.
• Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
• Use lock on Straightshot M4 handpiece to prevent inadvertent rotation of blade or bur during use
• It is important that the XPS 3000 operator be familiar with the system User’s Guide, its precautions, procedures, and safety issues.
• Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
• Excessive pressure applied to bur may cause bur fracture. Should a bur fracture occur 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.
   

Midas Rex Legend EHS Stylus High-Speed Surgical Drill

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).

Indications

Legend EHS System:

The Midas Rex Legend EHS – Electric High Speed System is intended for use in 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:

1. Protective eyewear is essential.
2. Irrigate copiously to cool the cutting surfaces.
3. Protect the wound site from metal debris.
4. 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.

1. Never place an overheated attachment on the patient or patient draping during surgery.
2. Mitigate the overheating by discontinuing use and rest the attachment by using intermittently, or wrap the attachment interface with a moist sterile towel.
3. 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 he 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, orsolutions 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 pecifications.

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

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.

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.
 

Hydrodebrider Endoscopic Sinus Irrigation System

Indications

The Xomed^® Hydrodebrider™ System is indicated for use whenever irrigation of the paranasal sinuses is desired including post Endoscopic Sinus Surgery and office based irrigation.The Xomed Hydrodebrider is intended to treat such conditions and disorders as rhinitis and acute or chronic sinusitis.

Contraindications

There are no known contraindications.

Warnings

1. This medical device complies with EN 60601-1-2 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.
2. Disconnect power from the entire system before cleaning to avoid electrical shock.
3. While using the Xomed Hydrodebrider System with electromechanical devices, maintain BF conditions (insulated, earth-free) to prevent electrical shock.
4. Verify suction line is working properly to minimize ingestion of irrigation fluid during the procedure.
5. In cases where the lamina papyrecea has been compromised during the surgical procedure, care should be taken not to direct the flow of irrigant through the fistula and into the orbit.
6. Ensure irrigation tubing clamp is closed when the system is not in use to avoid inadvertent spray.
7. Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.

Endo-Scrub 2 Lens Cleaning Sheaths

Indications

The Endo-Scrub^® is intended to clear the end of a rigid rod endoscope, in order to maintain good visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery with standard mechanical instruments and lasers.

Contraindications

None.

Warnings

Indications

Integrated Power Console (IPC^® System): 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.

Contraindications

None

Warnings

MeroGel Nasal Packing

Indications

Medtronic Xomed MeroGel^® Nasal Dressing/Sinus Stent is indicated for use following nasal/sinus surgery. Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery.

Contraindications

MeroGel is contraindicated in patients with hypersensitivity to the product.

Warnings and Precautions

In rare instances the physiochemical condition associated with nasal surgery, both with and without nasal packings, may present a risk of toxic shock syndrome (TSS). Warning signs of TSS include: sudden fever (usually 39°C or more), vomiting, diarrhea, dizziness, fainting (or near fainting when standing up) and/or a rash that looks like a sunburn. MeroGel nasal dressings exhibit no antimicrobial properties: they are not bacteriostatic toward pre-existing infections; nor do they prevent the occurrence of new infections. In the case of pre-existing infections it is recommended that appropriate treatment be instituted.

• Avoid packing external ear canal with adherent dressings or applying excessive pressure.

• It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device.

• Store in a cool, dry place (T<40°C).

MeroPack

Indications

Medtronic Xomed MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent is intended for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and to help prevent lateralization of the middle turbinate during the postoperative period.

Contraindications

MeroPack is contraindicated in patients with known hypersensitivity to formaldehyde, hyaluronan, bovine collagen or their derivatives.

Warnings and Precautions

• In rare instances the physiochemical condition associated with nasal surgery, both with and without nasal packings, may present a risk of toxic shock syndrome (TSS). Warning signs of TSS include: sudden fever (usually 39°C or more), vomiting, diarrhea, dizziness, fainting (or near fainting when standing up) and /or a rash that looks like a sunburn. MeroPack™ Bioresorbable Nasal Dressing and Sinus Stents exhibit no antimicrobial properties; they are not bacteriostatic toward pre-existing infections; nor do they prevent the occurrence of new infections. In the case of pre-existing infections it is recommended that appropriate treatment be instituted.
• It is recommended that MeroPack be used immediately after opening of the pouch; discard any unused portion of the device.
• Foreign body reaction may occur as with most surgical adjuvant treatments
• MeroPack must be used according to the instruction for use. Read instructions prior to use.
• MeroPack must be thoroughly hydrated with sterile saline when placed in the nasal cavity to ensure proper resorption in under 14 days. Inadequate hydration can lengthen absorption time.
• Inspect the packaging to be sure that it is intact and undamaged prior to use. Do not use the product if the pouch is opened or damaged. Do not reuse.