Indications, Safety, and Warnings – Related Products

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

System Warnings
W1	It is important that the IPC® operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
W3	When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection.
W4	Disconnect power to the IPC™ before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC to hospital grade receptacles only.
W7	This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.
W8	Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide.
W9	Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
W10	Do not operate the IPC System in the presence of Magnetic Resonance Imaging devices.
W11	Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W12	The IPC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC™ System handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour).
W14	Consult the Legend® Bone Mill product insert before use with the Integrated Power Console.
W15	For metal transection, observe the following safety precautions:
	W15a Eye wear protection is essential. W15b Irrigate well to cool the cutting surfaces. W15c Protect the wound site from metal debris. W15d Use a clamp or grasping device to control loose fragments during transection of any metal component.
W16	Do not operate the IPC System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty.

Component Warnings
W19	Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W20	Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site.
W21	When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
W22	Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.
W23	Midas Rex® Variable Exposure attachments Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W24	Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury
W25	Electrical contacts must be dry prior to use.
W26	Heavy side loads and/or long operating periods may cause the device to overheat.
W27	Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W28	Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. Depending on the amount of irrigation used, the drill bits can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state.
W30	Do not immerse the system components.
W31	Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W32	A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in accordance with Medtronic specifications.
W33	Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment.
W34	Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far, may result in the attachment accidentally being unlocked.
W35	Midas Rex® Legend EHS® Motor and Midas Rex® Legend EHS Stylus® Motor should only be operated when the attachment is in the locked position.
W36	Smoke may be generated if attachment is not in the locked position
W37	The Legend EHS® motors will not run properly unless the attachment is in the locked position.
W38	DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W39	Remove Legend® Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.
W40	DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories
W41	The safe use of the Endo-Scrub® 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated.
W42	In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable.
W43	To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
W44	Keep NIM® Muting Probe cable away from IPC® system cables.

Disposable Warnings
W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
W46	Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-cutting powered tools induce bleeding and removal of significant tissue and bone.
W47	Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W48	Always keep the cutting tip of the tool away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
W49	Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
W50	Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W51	Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
W52	Bending or prying may break the accessory, causing harm to patient or staff.
W53	Do not use excessive force to pry or push bone with the attachment or tool during dissection.
W54	A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient.
W55	Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
W56	Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
W57	Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W58	CONSULT the cranial perforator device labeling for the recommended speed specifications.
W59	Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
W60	Tool flutes are sharp and may perforate surgical gloves. Tools may be grasped with a hemostat to aid in installation and removal.
W61	DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control.
W62	Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious tools with a new one prior to use.
W63	Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W64	Do not use metal-cutting tools on bone.
W65	Use only rotary tools specifically designed for use with this drill system.
W66	When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.
W67	The use of powered reciprocating instruments may result in vibration \ related injury.
W68	Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.
W69	Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once.
W70	Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
W71	Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
W72	Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
W73	Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase.
W74	T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly
W75	T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece.
W76	Always ensure that the drill is securely engaged into the handpiece prior to operating the system.
W77	Always examine operation of each tool in a handpiece before use.
W78	Powered burs and drills should be operated in the forward mode only.
W79	This system requires insulated connectors for the StraightShot® M4 Microdebrider, Straightshot® Magnum® II Microdebrider, Straightshot® III Microdebrider, Midas Rex® SC1, Visao®, or Skeeter® handpieces and the Multi Function Foot Control Unit.
W80	Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
W81	After each procedure, properly clean all reusable system components.
W82	Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider®, or Bone Mill consoles only.

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

System Warnings
W1	It is important that the IPC® operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
W3	When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection.
W4	Disconnect power to the IPC™ before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC to hospital grade receptacles only.
W7	This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.
W8	Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide.
W9	Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
W10	Do not operate the IPC System in the presence of Magnetic Resonance Imaging devices.
W11	Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W12	The IPC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC™ System handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour).
W14	Consult the Legend® Bone Mill product insert before use with the Integrated Power Console.
W15	For metal transection, observe the following safety precautions:
	W15a Eye wear protection is essential. W15b Irrigate well to cool the cutting surfaces. W15c Protect the wound site from metal debris. W15d Use a clamp or grasping device to control loose fragments during transection of any metal component.
W16	Do not operate the IPC System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty.

Component Warnings
W19	Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W20	Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site.
W21	When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
W22	Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.
W23	Midas Rex® Variable Exposure attachments Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W24	Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury.
W25	Electrical contacts must be dry prior to use.
W26	Heavy side loads and/or long operating periods may cause the device to overheat.
W27	Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W28	Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. Depending on the amount of irrigation used, the drill bits can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state.
W30	Do not immerse the system components.
W31	Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W32	A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in accordance with Medtronic specifications.
W33	Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment.
W34	Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far, may result in the attachment accidentally being unlocked.
W35	Midas Rex® Legend EHS® Motor and Midas Rex® Legend EHS Stylus® Motor should only be operated when the attachment is in the locked position.
W36	Smoke may be generated if attachment is not in the locked position.
W37	The Legend EHS® motors will not run properly unless the attachment is in the locked position.
W38	DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W39	Remove Legend® Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.
W40	DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories.
W41	The safe use of the Endo-Scrub® 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated.
W42	In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable.
W43	To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
W44	Keep NIM® Muting Probe cable away from IPC® system cables.

Disposable Warnings
W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
W46	Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-cutting powered tools induce bleeding and removal of significant tissue and bone.
W47	Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W48	Always keep the cutting tip of the tool away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
W49	Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
W50	Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W51	Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
W52	Bending or prying may break the accessory, causing harm to patient or staff.
W53	Do not use excessive force to pry or push bone with the attachment or tool during dissection.
W54	A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient.
W55	Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
W56	Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
W57	Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W58	CONSULT the cranial perforator device labeling for the recommended speed specifications.
W59	Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
W60	Tool flutes are sharp and may perforate surgical gloves. Tools may be grasped with a hemostat to aid in installation and removal.
W61	DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control.
W62	Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious tools with a new one prior to use.
W63	Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W64	Do not use metal-cutting tools on bone.
W65	Use only rotary tools specifically designed for use with this drill system.
W66	When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.
W67	The use of powered reciprocating instruments may result in vibration \ related injury.
W68	Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.
W69	Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once.
W70	Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
W71	Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
W72	Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
W73	Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase.
W74	T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly.
W75	T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece.
W76	Always ensure that the drill is securely engaged into the handpiece prior to operating the system.
W77	Always examine operation of each tool in a handpiece before use.
W78	Powered burs and drills should be operated in the forward mode only.
W79	This system requires insulated connectors for the StraightShot® M4 Microdebrider, Straightshot® Magnum® II Microdebrider, Straightshot® III Microdebrider, Midas Rex® SC1, Visao®, or Skeeter® handpieces and the Multi Function Foot Control Unit.
W80	Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
W81	After each procedure, properly clean all reusable system components.
W82	Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider®, or Bone Mill consoles only.

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 cross-contamination.
• 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.

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.

Indications

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

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.

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 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.

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

System Warnings
W1	It is important that the IPC operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
W3	When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection.
W4	Disconnect power to the IPC before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC to hospital grade receptacles only.
W7	This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.
W8	Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide.
W9	Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
W10	Do not operate the IPC System in the presence of Magnetic Resonance Imaging devices.
W11	Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W12	The IPC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC System handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour).
W14	Consult the Legend® Bone Mill product insert before use with the Integrated Power Console.
W15	For metal transection, observe the following safety precautions:
	W15a Eye wear protection is essential. W15b Irrigate well to cool the cutting surfaces. W15c Protect the wound site from metal debris. W15d Use a clamp or grasping device to control loose fragments during transection of any metal component.
W16	Do not operate the IPC System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty.

Component Warnings
W19	Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W20	Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site.
W21	When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
W22	Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.
W23	Midas Rex® Variable Exposure attachments Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W24	Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury.
W25	Electrical contacts must be dry prior to use.
W26	Heavy side loads and/or long operating periods may cause the device to overheat.
W27	Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W28	Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. Depending on the amount of irrigation used, the drill bits can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state.
W30	Do not immerse the system components.
W31	Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W32	A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in accordance with Medtronic specifications.
W33	Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment.
W34	Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far, may result in the attachment accidentally being unlocked.
W35	Midas Rex® Legend EHS® Motor and Midas Rex Legend EHS Stylus® Motor should only be operated when the attachment is in the locked position.
W36	Smoke may be generated if attachment is not in the locked position.
W37	The Legend EHS motors will not run properly unless the attachment is in the locked position.
W38	DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W39	Remove Legend Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.
W40	DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories.
W41	The safe use of the Endo-Scrub® 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated.
W42	In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable.
W43	To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
W44	Keep NIM® Muting Probe cable away from IPC system cables.

Disposable Warnings
W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
W46	Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-cutting powered tools induce bleeding and removal of significant tissue and bone.
W47	Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W48	Always keep the cutting tip of the tool away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
W49	Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
W50	Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W51	Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
W52	Bending or prying may break the accessory, causing harm to patient or staff.
W53	Do not use excessive force to pry or push bone with the attachment or tool during dissection.
W54	A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient.
W55	Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
W56	Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
W57	Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W58	CONSULT the cranial perforator device labeling for the recommended speed specifications.
W59	Tools with "L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
W60	Tool flutes are sharp and may perforate surgical gloves. Tools may be grasped with a hemostat to aid in installation and removal.
W61	DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control.
W62	Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious tools with a new one prior to use.
W63	Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W64	Do not use metal-cutting tools on bone.
W65	Use only rotary tools specifically designed for use with this drill system.
W66	When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.
W67	The use of powered reciprocating instruments may result in vibration \ related injury.
W68	Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.
W69	Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once.
W70	Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
W71	Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
W72	Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
W73	Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase.
W74	T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly.
W75	T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece.
W76	Always ensure that the drill is securely engaged into the handpiece prior to operating the system.
W77	Always examine operation of each tool in a handpiece before use.
W78	Powered burs and drills should be operated in the forward mode only.
W79	This system requires insulated connectors for the Straightshot® M4 Microdebrider, Straightshot Magnum® II Microdebrider, Straightshot III Microdebrider, Midas Rex® SC1, Visao®, or Skeeter® handpieces and the Multi Function Foot Control Unit.
W80	Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
W81	After each procedure, properly clean all reusable system components.
W82	Auxiliary Power Outlet with protective cover is for use with the Hydrodebrider®, or Bone Mill consoles only.

 

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

System Warnings
W1	It is important that the IPC® operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
W3	When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection.
W4	Disconnect power to the IPC™ before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC to hospital grade receptacles only.
W7	This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.
W8	Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide.
W9	Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
W10	Do not operate the IPC System in the presence of Magnetic Resonance Imaging devices.
W11	Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W12	The IPC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC™ System handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour).
W14	Consult the Legend® Bone Mill product insert before use with the Integrated Power Console.
W15	For metal transection, observe the following safety precautions: W15a Eye wear protection is essential. W15b Irrigate well to cool the cutting surfaces. W15c Protect the wound site from metal debris. W15d Use a clamp or grasping device to control loose fragments during transection of any metal component.
W16	Do not operate the IPC System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty.

Component Warnings
W19	Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W20	Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site.
W21	When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
W22	Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.
W23	Midas Rex® Variable Exposure attachments Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W24	Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury.
W25	Electrical contacts must be dry prior to use.
W26	Heavy side loads and/or long operating periods may cause the device to overheat.
W27	Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W28	Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. Depending on the amount of irrigation used, the drill bits can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state.
W30	Do not immerse the system components.
W31	Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W32	A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in accordance with Medtronic specifications.
W33	Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment.
W34	Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far, may result in the attachment accidentally being unlocked.
W35	Midas Rex® Legend EHS® Motor and Midas Rex® Legend EHS Stylus® Motor should only be operated when the attachment is in the locked position.
W36	Smoke may be generated if attachment is not in the locked position.
W37	The Legend EHS® motors will not run properly unless the attachment is in the locked position.
W38	DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W39	Remove Legend® Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.
W40	DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories.
W41	The safe use of the Endo-Scrub® 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated.
W42	In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable.
W43	To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
W44	Keep NIM® Muting Probe cable away from IPC® system cables.

Disposable Warnings
W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
W46	Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-cutting powered tools induce bleeding and removal of significant tissue and bone.
W47	Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W48	Always keep the cutting tip of the tool away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
W49	Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
W50	Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W51	Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
W52	Bending or prying may break the accessory, causing harm to patient or staff.
W53	Do not use excessive force to pry or push bone with the attachment or tool during dissection.
W54	A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient.
W55	Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
W56	Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
W57	Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W58	CONSULT the cranial perforator device labeling for the recommended speed specifications.
W59	Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
W60	Tool flutes are sharp and may perforate surgical gloves. Tools may be grasped with a hemostat to aid in installation and removal.
W61	DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control.
W62	Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious tools with a new one prior to use.
W63	Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W64	Do not use metal-cutting tools on bone.
W65	Use only rotary tools specifically designed for use with this drill system.
W66	When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.
W67	The use of powered reciprocating instruments may result in vibration \ related injury.
W68	Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.
W69	Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once.
W70	Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
W71	Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
W72	Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
W73	Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase.
W74	T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly.
W75	T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece.
W76	Always ensure that the drill is securely engaged into the handpiece prior to operating the system.
W77	Always examine operation of each tool in a handpiece before use.
W78	Powered burs and drills should be operated in the forward mode only.
W79	This system requires insulated connectors for the StraightShot® M4 Microdebrider, Straightshot® Magnum® II Microdebrider, Straightshot® III Microdebrider, Midas Rex® SC1, Visao®, or Skeeter® handpieces and the Multi Function Foot Control Unit.
W80	Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
W81	After each procedure, properly clean all reusable system components.
W82	Auxiliary Power Outlet with protective cover is for use with the HydroDebrider®, or Bone Mill consoles only.

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, damaged 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 cross contamination.
• 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.

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.

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

System Warnings
W1	After each procedure, properly clean and disinfect all reusable system components.
W2	To avoid the risk of fire or explosion, do not use the NIM® System in the presence of flammable anesthetics and/or oxygen rich environment.
W3	Disconnect power to the NIM-Neuro®/Response® 3.0 Console before cleaning the unit to avoid electrical macro shock.
W4	Achieve electrical grounding reliability with proper connections. Connect the NIM-Neuro/Response 3.0 Console to hospital grade receptacles only.
W5	DO NOT use any parts other than Medtronic Xomed, Inc. components as damage or substandard performance could result.
W6	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.
W7	It is important that the NIM-Neuro®/Response® 3.0 operator be familiar with this manual, its precautions, procedures and safety issues.
W8	To avoid electrical shock, do not attach unapproved components or accessories to the NIM System.
W9	All service must be performed by Medtronic qualified personnel only.
W10	To avoid patient burns: Do not activate the electrosurgical instruments while stimulator is in contact with tissue. Do not leave stimulating electrodes or probes in surgical field. Do not store stimulating electrodes or probes in electrosurgical instrument holder. Do not allow a second surgeon to use electrosurgical instruments while stimulator is in use.
W11	Direct stimulator contact may disrupt the operation of active implanted devices. Consult medical specialist before use.
W12	Electrocardiogram monitoring artifacts may be caused by NIM stimulus current delivery or EMG electrode impedance monitoring.
W13	Use of unapproved stimulators, stimulus probes, stimulus dissection instruments or electrodes may result in compromised NIM operation, such as, but not limited to decreased accuracy.
W14	Repair and/or modification to the NIM or any accessory by anyone other than qualified service personnel may significantly compromise the unit’s ability to monitor nerve activity and/or void the equipment warranty.
W15	The NIM does not prevent the surgical severing of nerves. If monitoring is compromised, the surgical practitioner must rely on alternate methods, or surgical skills, experience, and anatomical knowledge to prevent damage to nerves.
W16	If paralyzing anesthetic agents have been used, patient must regain muscle activity prior to use of the NIM-Neuro/Response 3.0 EMG Monitor.
W17	To avoid the risk of infection while using the NIM Stylus, the user must maintain good sterility practices.
W18	False negative responses (failure to locate nerve) may result from: Shorted EMG electrode or cabling (conductive parts of applied needle electrodes or cables contacting each other). Patient Interface fuse blown (32 mA, 250V. Xomed Part No.: 8250615). Patient Interface defective. Inadequate stimulus current. Inadequate current for stimulation of nerve through hardware, such as stimulus dissection instruments, may vary based on the physical size, shape characteristics, and design of the hardware and proximity to the nerve. Inadvertent simultaneous current delivery from both Stimulator (Patient Interface) probe outputs. This may result in current shunting, division between the stimulator probes. Shorted internal amplifier (characterized by baseline activity of < 3 μV p-p).
W19	Stimulator current may cause involuntary patient movement resulting in patient injury.
W20	Anesthetic agents used may have an effect on the EMG amplitude.
W21	Be careful not to damage vascular structures when preparing the nerve for the installation of the APS™ Electrode.
W22	EMG amplitude may be affected by anesthesia regimen used. Consult anesthesiologist if EMG changes are observed.
W23	Electrode integrity should be checked after electrode insertion and before electrode removal to give additional assurance that electrode continuity was maintained throughout the entire procedure. If electrode impedance is very high, discontinue use and replace.
W24	Remove APS™electrode from patient prior to using external defibrillator to prevent thermal injury to patient at APS™electrode site.
W25	Avoid trans-thoracic stimulation; when possible, maintain anode and cathode stimulating sites in close proximity.
W26	Operation in close proximity to a shortwave or microwave therapy equipment may produce instability in the electrical stimulator output.
W27	Safe stimulus levels are dependent on various conditions including but not limited to: type of excitable tissue, Charge Per Pulse, and Charge Per Unit Area. Waveform morphology, repetition rate, and stimulator effective surface area must be considered. Special operator attention is required for stimulus levels which exceed default settings or conditions resulting in levels higher than 2 mA RMS/cm2.

Indications

This device is intended for use in surgical procedures for patient-connected intraoperative nerve monitoring, ie, assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying cranial and peripheral motor nerves during surgery.

Contraindications

The use of paralyzing anesthetic agents will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation. Whenever nerve paralysis is suspected, consult an anesthesiologist.

Warnings

W1	The NIM-Neuro™ 2.0 does not prevent the surgical severing of nerves. If monitoring is compromised, the surgical practitioner must rely on alternate methods, or surgical skills, experience, and anatomical knowledge to prevent damage to nerves.
W2	To avoid patient burns: W2a Do not activate electrosurgical Instrument while the stimulator is in contact with tissue. W2b Do not leave stimulating electrodes or probes in surgical field. W2c Do not store stimulating electrodes or probes in electrosurgical Instrument holder. W2d Do not allow a second surgeon (ie, fat harvesting) to use electrosurgical instrument while stimulator is in use. W2e Special operator attention may be required for stimulus currents exceeding 2 mA RMS/cm2. The RMS value of current is generally lower than the stimulator current setting in mA. To calculate RMS current, waveform morphology, pulse width, repetition rate, and the stimulator current delivered must be considered.
W3	While Muting is activated, auditory and visual monitoring are disabled.
W4	To avoid false negative responses, verify stimulator current setting is high enough, and verify stimulus delivery by tone, voice, or display. Low stimulator current may cause a false negative response.
W5	High stimulator current may cause involuntary patient movement resulting in patient injury.
W6	High stimulator current activating of the fifth cranial nerve or Mastication muscles may cause tongue lacerations.
W7	False negative responses (failure to locate nerve) may result from: W7a Shorted EMG electrode or cabling (conductive parts of applied needle electrodes or cables contacting each other). W7b Patient Interface fuse blown (32 mA, 250V. Xomed Part No.: 8250615). W7c Patient Interface defective. W7d Inadequate stimulus current. W7e Inadequate current for stimulation of nerve through hardware, such as stimulus dissection instruments, may vary based on the physical size, shape characteristics, and design of the hardware and proximity to the nerve. W7f Neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli. W7g Inadvertent simultaneous current delivery from both Stimulator (Patient Interface) probe outputs. This may result in current shunting, division between the stimulator probes. W7h Shorted internal amplifier (characterized by baseline activity of < 3 μV p-p).
W8	Do not power-on the NIM-Neuro 2.0 when the stimulator is in the surgical field.
W9	To avoid eye injury during electrode placement, the electrode needles should be directed away from the globe and adequately secured with tape.
W10	To avoid the risk of fire or explosion, do not use the NIM-Neuro 2.0 in the presence of flammable anesthetics and/or oxygen rich environments.
W11	To avoid electrical shock, do not attach unapproved components or accessories to the NIM.
W12	To avoid the risk of infection while using the NIM-Neuro 2.0 touchscreen stylus, the user must maintain good sterility practices.
W13	Electrocardiogram monitoring artifacts may be caused by NIM-Neuro 2.0 stimulus current delivery or EMG electrode impedance monitoring.
W14	Direct stimulator contact may disrupt the operation of active implanted devices.
W15	While stimulating, it is recommended to use only approved EMG monitor(s) equipped with active audio and/or visual current delivered feedback systems to ensure delivery of current to intended tissues.
W16	Proper handling, insertion, and placement of electrodes and probes is critical for safe and accurate EMG monitoring: W16a Improperly placed or bent needles increase the risk of needle breaking off in the patient. W16b Do not attempt to straighten bent needles because this may cause stress and weaken device, causing needle to break off in patient. W16c Extreme care must be taken when handling instruments with sharp points or edges.
W17	The surgical practitioner must choose the appropriate size electrodes and probes based on the procedure to be performed and the stimulating current necessary for the application.
W18	Avoid trans-thoracic stimulation; when possible, maintain anode and cathode stimulating sites in close proximity.
W19	Reuse of single use electrodes and probes increase the risk of infection and may cause degraded or ineffective monitoring.

Precautions

P1	Special care must be exercised to distinguish between the high-pitched beep of the Event Tones (EMG activity over threshold), and the Stimulus Warble Tone (indicates the set current is being delivered).
P2	When the “Bleedle Alarm” (BLEE-dle-DEET) sounds, the cause must be identified and eliminated immediately.
P3	To avoid loud, extraneous monitoring noise during electrosurgical unit activation, ensure the Muting Probe is properly attached to the active electrosurgical lead.
P4	Inadequate stimulus current flow may be caused by non-flush contact between the stimulating electrode or probe and the nerve, inadequate stimulator probe electrical contact surface area, or high impedance.
P5	Inability to deliver stimulus current flow may be caused by: P5a Stimulator return electrode not connected, or other incomplete electrical connection between the NIM-Neuro 2.0, monitoring electrode and stimulator probe. P5b STIM 1 (EMG) Patient Interface fuse blown (32 mA, 250 V, REF 8250615). P5c Stimulus set to 0.00 mA. P5d Defective stimulating electrode or probe.
P6	To avoid false positive EMG events (stimulus artifacts): P6a Ensure the recording electrodes and the stimulator (+) or (-) cabling are routed separately and not tangled. P6b Ensure EMG ground (green wire) is physically placed between the stimulator return electrode (white wire with red plug) and the EMG channel input electrodes.
P7	Proper placement and setup of the electrosurgical unit away from the NIM-Neuro 2.0 will reduce or minimize unnecessary muting, interference, and offsets.
P8	Use of unapproved stimulators, stimulus probes, stimulus-dissection instruments or electrodes may result in compromised NIM-Neuro 2.0 operation, such as, but not limited to, decreased accuracy.
P9	Electrode integrity should be checked (on the “electrodes” screen) after electrode insertion and before electrode removal to give additional assurance that electrode continuity was maintained throughout the entire procedure. If electrode impedance is very high, discontinue use and replace.
P10	The Patient Interface cable, and Muting Probe cable should be secured to the floor with tape or other nontrip device.
P11	Excessive or insufficient muting may result from improper muting gain. For excessive muting, move the Muting Probe to a Lower jack number. For insufficient muting, move the Muting Probe to Higher jack number. Standard position is number 3.
P12	To avoid excessive muting: P12a Do not place the NIM-Neuro 2.0 in close proximity to the electrosurgical unit. P12b Do not place Patient Interface or electrode wires in close proximity to the electrosurgical unit or electrosurgical unit wires. P12c Avoid high-power electrosurgical unit monopolar settings. Note that muting caused by electrode charging may last several seconds after electrosurgical Instrument use. P12d Be aware of external sources that may induce muting including cellular phones, diathermy, electrocautery used in adjacent operating rooms, or other sources of electromagnetic interference.
P13	Avoid accidental contact between connected but unapplied electrodes and other conductive parts.
P14	Contaminated single use electrodes and probes must be disposed of in an appropriate sharps biohazard container in accordance with hospital or other user facilities policy.
P15	For extra-ocular monitoring, it is recommended that electrode placement be done under the direction of a neurologist or ophthalmologist.
P16	The Patient Interface safety fuse used in all NIM Patient Interfaces Boxes for the Stimulator Output are specifically tested for ECU protection. Use Xomed 11270048 Fuse, 5 x20mm, 32mA, 250 V. Order 8250615 Fuse Kit for replacements.

Additional Precautions

AP1	To avoid system damage, do not connect any device other than NIM-Neuro 2.0 Muting Probes into any of the four muting probe inputs on the rear panel of the NIM-Neuro 2.0.
AP2	Disconnect the power of the NIM-Neuro 2.0 or a connected printer before cleaning. To prevent cleaning solutions from seeping into the electronic portions of the instrument, spray cleaner lightly on a cotton cloth, then wipe the instrument with the cloth. Be especially careful around the controls, connectors and panel edges. Do not use abrasive cleaners (especially on the touch screen).
AP3	Repair and/or modification to the NIM-Neuro 2.0, or any accessory by anyone other than qualified service personnel may significantly compromise the units ability to monitor nerve activity and/or void the equipment warranty. For best performance, it is recommended that all service be performed by Medtronic Xomed service personnel. The Manufacturing Test is not intended for end users and is to be used only under the direct supervision of Medtronic Xomed Personnel (see section 7.13).
AP4	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.
AP5	Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
AP6	Use of accessories and cables other than those specified and sold by Medtronic Xomed may result in increased emissions and decreased immunity of this unit.
AP7	The NIM-Neuro 2.0 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the NIM-Neuro 2.0 should be observed to verify normal operation in the configuration in which it will be used.

Indications

The NIM^® EMG Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor.

The EMG Tube is indicated for use where continuous monitoring of the nerves supplying the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

Contraindications

None.

Warnings

Warnings – EMG Tubes

• Avoid insertion of a suction tube or stylet in a tube that has been distorted by biting or other forces. This may further damage the tube and block the airway.
• Do not use local anesthetic gels or creams to lubricate the tube or apply topical anesthetic sprays on the vocal cords. The use of paralyzing anesthetic agents or neuromuscular blockers will significantly reduce, if not completely eliminate, EMG responses to direct or passive neural stimulation. Whenever nerve paralysis is suspected, consult anesthesiologist.
• Do not use an EMG tube with a high electrode impedance. This may be due to inadequate electrode continuity. Replace with another EMG tube.
• Do not use the EMG tube in surgical procedures with flammable gases or high temperature generating devices, such as surgical lasers or cauteries, to avoid combustion.
• Do not perform Magnetic Resonance Imaging (MRI) on a patient with an intubated EMG tube. The effect of MRI on the steel reinforcing coiled wire in the EMG tubes is unknown.
• Do not over inflate the cuff. Over inflation may cause cuff deflation or rupture resulting in tube blockage and/ or tracheal damage.
• Do not attempt to remove an inflated cuff from the trachea, which may result in injury of the larynx or vocal cords. If resistance is encountered during removal, ensure that the cuff is fully deflated.
• Do not attempt to re-sterilize or reuse single use disposable devices. Re-sterilization or reuse may result in device damage and patient injury.
• Do not use if sterile package has been opened or is damaged.  
• Avoid false negative responses (failure to locate nerve), which may be caused by:
• Neuromuscular fatigue from prolonged or repeated exposure to electrical stimuli.
• Deep anesthesia, which may suppress neuroelectrical activity of the recurrent laryngeal nerve.
• Insufficient contact between the electrodes and vocal cords due to misplacement or using a tube size that is too small.
• Displacement during the procedure when rotating the patient’s head and neck.
• Avoid disrupted air supply due to inadequate oxygenation by confirming, monitoring, and maintaining anesthesia gas delivery systems and connections at all times.
• Avoid inadequate oxygenation from placement in the right main bronchus by confirming the correct positioning after intubation.
• Avoid inadequate oxygenation due to a collapsed or blocked tube after performing a test inflation, by inspecting the inner diameter of tube for patency after test inflation.
• Avoid injury by disposing of the devices in an appropriate sharps biohazard container.  

Warnings – EMG Monitors

• Do not activate electrosurgical instruments while the stimulator is in contact with tissue or in the surgical field in order to avoid patient burns.
• Do not attempt to straighten bent needles, which may weaken the metal. Improperly placed, weak or bent needles increase the risk of the needle breaking off in the patient.
• Do not excessively bend or flex the electrodes or the electrical integrity may be compromised. Check electrode integrity after insertion.
• Do not connect electrode leads to any other types of equipment or connections than EMG recording/monitoring equipment or electrical shock to the patient or user may occur.
• Avoid injury by using extreme care when handling and cleaning instruments with sharp points or edges.
• Avoid damage to the trachea, larynx or vocal cords during insertion by inspecting the tube, cuff, and monitoring connections for damage, which may occur if the cuff is over inflated during set-up testing.
• Avoid delivery of current to unintended tissues by using an EMG monitor equipped with active audio and/or visual feedback systems for stimulating.
• Failure to use a NIM™ Stimulator Probe may result in not identifying the location or detecting injury to neuromuscular tissue. During EMG monitoring only, (passive monitoring), neuromuscular tissue may not elicit a response from sharp dissection or all types of manipulation. Use the stimulator probe to confirm location of the neuromuscular tissue.

Recommendations

• It is strongly recommended that the clinician(s) have a thorough understanding of and experience with intraoperative EMG Monitoring prior to using the EMG Endotracheal Tube in a surgical procedure. This device is not intended to replace the surgeon’s medical judgment or knowledge of neural anatomy and physiology. It is intended to provide the surgeon with an additional tool with which to make better-informed decisions regarding the surgical procedure.
• It is strongly recommended that the surgeon consult with the attending licensed medical practitioner who will be administering anesthesia prior to the use of EMG monitoring to review EMG monitoring techniques, goals and the effects of the administration of anesthesia on neuromuscular activity.
• A patient with an implanted electronic device should not be subjected to electrical stimulation unless specialist medical opinion has first been evaluated.
• Proper sizing, intubation and extubation should be in accordance with accepted medical techniques and expert clinical judgment. A tube that is one size larger than standard selection is recommended whenever possible to improve electrode contact with vocal cords. The proper size tube for the patient should be determined prior to intubation by the anesthesia provider and/or surgeon.
• A spare EMG Endotracheal tube of the correct size should be kept readily available. There is a greater risk of damaging the tube under extreme operating conditions, such as excessive bending, prolonged procedures, and repeated manipulation.
• A bite block is recommended for use with the EMG Endotracheal Tube to prevent damage to the tube.  
• For safe and accurate EMG monitoring, proper handling, insertion and placement of electrodes and probes is critical. Review the appropriate user’s guide for the monitor being used for the procedure.

Indications

The Stim Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.

Contraindications

None.

Warnings

It is important that the Stim Bur Guard operator be familiar with this manual, the NIM^® 2.0 or 3.0 system manual, the bur manual, the XPS^® 3000 BF manual / IPC^® manual, their warnings, precautions, procedures and safety issues.

Four labels are used in this manual to identify important concerns, conditions, or procedures:

Warnings: Describes serious adverse reactions and potential safety hazards that can occur during the proper or improper use of a device.
Precautions: Any special care to be exercised by a practitioner or patient for the safe and effective use of the device.
Additional Precautions: Identifies conditions or practices that could result in damage to the equipment.
Note: Identifies special information or to clarify/emphasize important instructions.

Warning

This device may cause brief ECG interference. If experiencing unacceptable interference, use a NIM^® 2.0 console with software version 2.86 or higher to reduce the occurrence of interference.

Use only Medtronic NIM^® 2.0 or 3.0 with the Stim Bur Guard to ensure delivery of current to intended tissues and adequate audio/visual monitoring.

If using the Stim Bur Guard for nerve mapping, use extreme caution to prevent inadvertent nerve damage.

The clinician(s) must have a thorough understanding of and experience with intraoperative EMG Monitoring prior to using the Stim Bur Guard in a surgical procedure. This device is not intended to replace the surgeon’s medical judgment or knowledge of neural anatomy and physiology. It is intended to provide the surgeon with an additional tool with which to make better-informed decisions regarding the surgical procedure.

The use of paralyzing anesthetic agents will significantly reduce, if not completely eliminate, EMG responses to direct or passive neural stimulation. Whenever nerve paralysis is suspected, consult anesthesiologist.

Avoid inadvertent activation of the handpiece while in close proximity to nerves.

Minimize guard contact with the patient during prolonged drill on-time to avoid thermal damage to surrounding tissue. The nose section of the Stim Bur Guard may become hot during prolonged on-time.

An appropriate amount of irrigation creates a moist contact point forming a meniscus about the bur head without covering more than 1/2 of the bur head. This moist contact point creates a low resistance connection to the patient while preventing thermal injury to the tissue. Excessive irrigation may prevent adequate current delivery to the tissue due to current shunting.
 

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.

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

Disposable Warnings
W51	Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
W52	Bending or prying may break the accessory, causing harm to patient or staff.
W69	Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once.
W71	Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
W72	Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.

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

WARNINGS

System Warnings
W1	It is important that the IPC® operator be familiar with the system User’s Guide, its precautions, procedures and safety issues.
W2	Do not use the IPC System in the presence of flammable anesthetics. Avoid potential ignition or explosion of gases.
W3	When not operating handpiece, eliminate accidental foot control activation. Control energy to and through the handpiece to prevent unintended tissue, bone, or nerve resection.
W4	Disconnect power to the IPC™ before cleaning the unit to avoid electrical macro shock.
W5	Do not attach unapproved components to the IPC to avoid electrical macro shock.
W6	To avoid the risk of electrical shock, achieve electrical grounding reliability with proper connections. Connect the IPC to hospital grade receptacles only.
W7	This medical device complies with EN60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient.
W8	Medical Electrical Equipment needs special Precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide.
W9	Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
W10	Do not operate the IPC System in the presence of Magnetic Resonance Imaging devices.
W11	Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this unit.
W12	The IPC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the IPC should be observed to verify normal operation in the configuration in which it will be used.
W13	Do not attempt to run the IPC™ System handpiece immediately after autoclaving. Allow an adequate “cool down” period (Typically 1 hour).
W14	Consult the Legend® Bone Mill product insert before use with the Integrated Power Console.
W15	For metal transection, observe the following safety precautions: W15a Eye wear protection is essential. W15b Irrigate well to cool the cutting surfaces. W15c Protect the wound site from metal debris. W15d Use a clamp or grasping device to control loose fragments during transection of any metal component.
W16	Do not operate the IPC System without eye protection.
W17	All service must be performed by Medtronic qualified personnel only.
W18	Repair and/or modification to the IPC by anyone other than qualified service personnel may significantly compromise the unit’s ability to perform effectively and/or void the equipment warranty.

Component Warnings
W19	Do not use any parts other than Medtronic system components as damage or substandard performance could result.
W20	Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is repaired or replaced. Damaged parts may deposit metal shavings on surgical site.
W21	When precise location of blade tip is required, engage the rotation lock on the handpiece, then calibrate and verify the blade tip on Image Guided Surgery (IGS) system. Always lock M4 handpiece when driving non-rotatable blades to maintain their IGS calibration.
W22	Employ visualization, including use of imaging techniques (e.g., fluoroscopy, image guided surgery) when using rotating powered accessories. Discontinue powered application in the event of lack of visualization of surgical site.
W23	Midas Rex® Variable Exposure attachments Surgeons should familiarize themselves with the performance of dissecting tools before use, and should explore the effect of various levels of tool exposure on dissection stability. If the tool exhibits excessive chatter, vibration, or movement, decrease the tool exposure.
W24	Motors and attachments may fail due to extended use and allow a component to detach and fall from the motor or attachment, causing patient injury.
W25	Electrical contacts must be dry prior to use.
W26	Heavy side loads and/or long operating periods may cause the device to overheat.
W27	Do not use an overheated device, as it may cause thermal injury to the patient or operator.
W28	Use adequate irrigation. The use of a tool without irrigation may cause an inordinate amount of heat buildup resulting in a thermal injury to tissue. Depending on the amount of irrigation used, the drill bits can achieve temperatures in excess of 50° C.
W29	Do not attempt to change a dissecting tool or attachment while the motor is running, or when the motor or attachment is in an overheated state.
W30	Do not immerse the system components.
W31	Do not place motor, attachment and tool on the patient or in an unsecured location during surgery.
W32	A system that is not functioning properly should not be used until all necessary repairs have been made and the unit is tested to ensure that it is functioning in accordance with Medtronic specifications.
W33	Match the nomenclature and color code on the tool packaging to the same nomenclature and color code on the Attachment.
W34	Make sure that the attachment is still in the locked position after each adjustment of the tool exposure, as attempting to increase the tool exposure too far, may result in the attachment accidentally being unlocked.
W35	Midas Rex® Legend EHS® Motor and Midas Rex® Legend EHS Stylus® Motor should only be operated when the attachment is in the locked position.
W36	Smoke may be generated if attachment is not in the locked position.
W37	The Legend EHS® motors will not run properly unless the attachment is in the locked position.
W38	DO NOT change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
W39	Remove Legend® Footed Attachments cautiously and slowly as per instructions to avoid injury to the operator.
W40	DO NOT modify accessories used with the handpiece. Performance could be diminished with modified accessories.
W41	The safe use of the Endo-Scrub® 2 System in procedures where surgical lasers are also employed has not been clinically demonstrated.
W42	In order to ensure compliance with requirements of IEC 60601-1, use a Medtronic approved power cable.
W43	To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.
W44	Keep NIM® Muting Probe cable away from IPC® system cables.

Disposable Warnings
W45	Verify reusable device was sterilized prior to use. If not sterilized, do not use.
W46	Tools are available for resection of soft tissue and bone for surgical procedures. Use of tools depends on the intended application and patient needs. Sharp-cutting powered tools induce bleeding and removal of significant tissue and bone.
W47	Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
W48	Always keep the cutting tip of the tool away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
W49	Operate the tool only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
W50	Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using powered accessories.
W51	Insertion of metal objects in accessory tip may cause the accessory to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
W52	Bending or prying may break the accessory, causing harm to patient or staff.
W53	Do not use excessive force to pry or push bone with the attachment or tool during dissection.
W54	A tool’s size and geometry may create excessive vibration at certain speeds. Increase or decrease speed on console. Change to a new tool to prevent unintended tissue removal from patient.
W55	Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
W56	Eccentricity of the tool can cause tool vibration and may result in excess tissue and bone destruction and hearing damage.
W57	Excessive noise from the tool when drilling close to the cochlea or ossicular chain may cause hearing damage.
W58	CONSULT the cranial perforator device labeling for the recommended speed specifications.
W59	Tools with “L” identification are longer tools intended for light bone dissection. The increased tool head/stem configuration may affect dissection stability.
W60	Tool flutes are sharp and may perforate surgical gloves. Tools may be grasped with a hemostat to aid in installation and removal.
W61	DO NOT attempt to resharpen used tools. Worn tools should be replaced with new ones frequently to ensure effective cutting and control.
W62	Carefully inspect tool both prior to and following each use for signs of excessive wear, fragmentation, eccentricities or other defects. Replace any suspicious tools with a new one prior to use.
W63	Excessive pressure applied to bur may cause bur fracture. Should a tool fracture in use, extreme care must be exercised to ensure that all fragments of the tool are retrieved and removed from the patient. Unremoved tool fragments may cause tissue damage to the patient.
W64	Do not use metal-cutting tools on bone.
W65	Use only rotary tools specifically designed for use with this drill system.
W66	When using non-rotatable tools, ensure rotation lock is engaged to prevent inadvertent rotation.
W67	The use of powered reciprocating instruments may result in vibration \ related injury.
W68	Powered blades should be operated in the oscillate mode only. Operating in the forward mode may cause damage to the blade.
W69	Do not attempt to sterilize disposable devices. The disposables are packed sterile and are not intended for repeat use. To prevent contamination, use only once.
W70	Any tubing or other tip protectors used during shipping must be removed prior to cleaning and sterilization.
W71	Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
W72	Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
W73	Do not use dull, damaged or bent tools. Use of dull tools can reduce handpiece effectiveness and cause the handpiece temperature to increase.
W74	T&A Blades: Gently remove the inner tube from the outer tube. The inner tube may elongate upon removal from the outer tube. If this occurs, the inner tube may not lock properly into the handpiece or the blade may not work properly.
W75	T&A Blades: Rotate the inner tube when removing and inserting it in the outer tubes to prevent damage to the internal seal. If the seal is damaged, the blade will leak at the handpiece.
W76	Always ensure that the drill is securely engaged into the handpiece prior to operating the system.
W77	Always examine operation of each tool in a handpiece before use.
W78	Powered burs and drills should be operated in the forward mode only.
W79	This system requires insulated connectors for the StraightShot® M4 Microdebrider, Straightshot® Magnum® II Microdebrider, Straightshot® III Microdebrider, Midas Rex® SC1, Visao®, or Skeeter® handpieces and the Multi Function Foot Control Unit.
W80	Sterilize and dry reusable device before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
W81	After each procedure, properly clean all reusable system components.
W82	Auxiliary Power Outlet with protective cover is for use with the HydroDebrider®, or Bone Mill consoles only.

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).

Indications

MeroGel^® Injectable Bioresorbable Stent is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and nasal adhesions during the post operative period.

Contraindications

MeroGel^® Injectable is contraindicated in patients with a known hypersensitivity to hyaluronan or its derivatives.

Warnings and Precautions

In rare instances, the physiochemical condition associated with sinus surgery, both with and without sinus packing, may present a risk of toxic shock syndrome (T55). Warning signs of TSS include: sudden fever, vomiting, diarrhea, dizziness, fainting (or near fainting when standing up). and/or a rash that looks like a sunburn. MeraGel^® Injectable exhibits no antimicrobial properties; it is not bacteriostatic toward pre-existing infections, nor does it prevent the occurrence of new infections.

Do not inject intravascularly.

Foreign body reaction may occur as with most surgical adjuvant treatments. MeroGel^® Injectable must be used according to the instructions for use. Read instructions prior to use.
 

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.

Medtronic Xomed MeroGel^® Otologic Packing is a biomaterial composed of HYAFF^®, an ester of hyaluronic acid, a naturally occurring constituent of the extracellular matrix. Due to its absorption properties, MeroGel may be used to help control minimal bleeding. In contact with body fluids, it changes into a viscous and transparent gel (approximately 48 hours), conforming to mucosal surfaces, and eventually dissolves (approximately 6 weeks) or may be irrigated from the cavity.

Intended Use

MeroGel Otologic Packing is a space-occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding, and act as an adjunct to aid in the natural healing process.

Indications for Use

MeroGel Otologic Packing is indicated for us 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

• Avoid packing external canal with adherent dressings or applying excessive pressure,/li>
• It is recommended that MeroGel be used immediately after the opening of the pouch; discard any unused portion of the device

Precaution

Store in a cool, dry place (T<40°C).

Medtronic Xomed EpiFilm^® Otologic Lamina is a biomaterial composed of HYAFF^®, an ester of hyaluronic acid, a naturally occurring constituent of the extracellular matrix. The transparent lamina has micro-perforations to allow permeability, facilitating drainage of exudate at the surgical site.

Intended Use

The Medtronic Xomed EpiFilm Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.

Indications for Use

Medtronic Xomed EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures.

Contraindications

EpiFilm is contraindicated in patients with hypersensitivity to the product.

Warnings

Avoid packing external canal with adherent dressings or applying excessive pressure

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

Precaution

Store in a cool, dry place (T<40°C).

Intended Use

The Medtronic Xomed EpiDisc Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.

Indications for Use

Medtronic Xomed EpiDisc Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures.

Contraindications

EpiDisc is contraindicated in patients with hypersensitivity to the product.

Intended Use

Medtronic Xomed ossicular prostheses, when surgically implanted in the middle ear as individual replacements for the incus, malleus or stapes or for the entire ossicular chain, facilitate the mechanical transfer of sound energy from the tympanic membrane to the oval window of the cochlea. The mechanism of sound energy transfer performed by ossicular prostheses is analogous to that of the natural ossicles of the middle ear.

Device Description

Medtronic Xomed ossicular prostheses are available in numerous designs and sizes, emulating the bones of the middle ear to satisfy individual patient needs and surgical techniques in the functional reconstruction of all or part of the ossicular chain. A variety of biocompatible materials are used in the manufacture of Medtronic Xomed ossicular prostheses including: POLYCEL^® UHMWPE (ASTM F648), Fluoroplastic (ASTM D1710), platinum, stainless steel (ASTM F138), titanium (ASTM F67, F136), Hydroxylapatite and FLEX H/A^® Hydroxylapatite Composite.

Indications for Use

The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. The physician must exercise medical judgement and consider the patient’s complete medical history. Medtronic Xomed ossicular prostheses are indicated for the functional restoration of sound energy conduction in the middle ear as reconstructive devices or artificial replacement for the natural ossicles of the middle ear. Reconstruction or replacement of all or part of the ossicular chain may be necessary to correct structural damage of the middle ear ossicles or conductive hearing loss resulting from a number of pathologic conditions, including but not limited to:

• Chronic middle ear disease
• Otosclerosis
• Congenital fixation of the stapes
• Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery
• Surgically correctable injury to the middle ear from trauma

Contraindications

Certain conditions may preclude the selection of ossicular prostheses implants as a means of restoring conductive hearing loss including:

• The presence of middle ear infection which could result in displacement of the implant (s)
• Conductive hearing loss which may be restored by non-invasive methods
• The operative ear is the better or only hearing ear. Reduced hearing or total deafness is at risk in such cases.

Possible Adverse Effects

Surgery of the middle ear involves manipulation of fragile temporal bones and exposes inner ear structures to the risk of surgical trauma and infections. Serious complications may arise either during or after surgery which may result in irreparable damage to these otologic structures and their functions causing irreversible partial or total loss of hearing. Subsequent surgical procedures may be required to correct these conditions if possible.

Complications which may occur include, but are not limited to:

• Sensorineural deafness due to trauma during surgery
• Granuloma and perilymph fistula
• Post surgery displacement of the implant due to the development of scar tissue
• Recurrence of oval window fixation
• Vertigo
• Incus necrosis
• Round window closure
• Labyrinthitis
• Otitis media

Precautions/Intraoperative:

A high degree of surgical skill is required for the proper implantation of any ossicular prostheses. Surgeons performing middle ear surgery should have received specific training in the reconstruction and replacement of the middle ear ossicles prior to attempting implantation of Medtronic Xomed ossicular prostheses. Extreme caution must be exercised by the surgeon during surgery to safeguard against undesirable results and postoperative complications.

At a minimum, the following precautions must be taken:

1. To avoid postoperative vertigo and/or loss of inner ear functions, the surgeon should carefully assess the length of the implant in relation to the depth of the middle ear vestibule. The implant should be trimmed (or a shorter implant selected) if it is too long for the vestibule to avoid any contact with sensitive inner ear structures.
2. To safeguard against postoperative sensorineural hearing loss, extreme care must be taken to avoid traumatizing the inner ear structures by unnecessarily contacting the inner ear structures with surgical instruments or the implant (s) or through the removal of perilymph from the vestibule.
3. As a precaution against implant extrusion through the tympanum, tissue grafts should be used as an interface between the implant and the tympanum. Similarly, a tissue graft should be employed over the stapes footplate, or alternatively, over the oval window in stapedectomy procedures to help prevent perilymph fistula or leakage of perilymph.
4. To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement.

Precautions/Postoperative

Following surgery, both surgeon and patient must be alert to any sign of adverse effects from surgery and the patient should be advised of the proper care of the operative ear. The following postoperative precautionary measures are recommended:

1. If there is any suspicion of oval window granuloma or fistula during the postoperative recovery period, an emergency exploratory tympanotomy and correction of the condition should be performed immediately.
2. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. Specific instructions on how to maintain proper hygiene of the operative ear should be given to the patient.
3. Magnetic Resonance Imaging (MRI) PRECAUTIONS: For ossicular prostheses with metal components:

Medtronic Xomed manufactures metal ossicular prostheses only from non-ferromagnetic metals and Austenitic medical grade stainless steel; however, slight magnetism can be characteristic of Austenitic stainless steel. While there are no known reports of MRI-related adverse effects to a patient due to any Medtronic Xomed ossicular prostheses, caution is advised when administering MRI procedures. Caution is particularly advised when magnetic fields above 1.5 Tesla are used, as the effects at such levels have not been thoroughly studied. Additionally, image artifact can occur due to the material composition of the prosthesis. Because of the potential for such artifact, alternative imaging techniques, such as CT scanning, should be considered.

Additional Information

Hydroxylapatite is the basic inorganic constituent of living bone tissue. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. In the event that minor modifications of a dense H/A head or shaft are required, it is advisable to perform all trimming or contouring with a diamond burr using copious amounts of irrigation. Smooth, even brushing strokes should prevent inadvertent breakage. Results, based on almost ten years of clinical experience using dense hydroxylapatite in the middle ear, suggest that implants can be placed in direct contact with the tympanic membrane without the added risk of extrusion.

However, the use of cartilage or other suitable autogenous tissue as an interface between the implant and the tympanic membrane should be left to the surgeon’s experiences and preferences.

FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxyl- apatite and silicone. The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain.

Sterility

Medtronic Xomed ossicular prostheses are provided STERILE. Medtronic Xomed ossicular prostheses are terminally sterilized in a highly controlled environment by ethylene oxide (ETO) gas . Sterility is confirmed through biological testing. The package should be carefully inspected for punctures, tears, security of the seal or any other evidence of the sealed pouch having been compromised prior to placement of the contents in the sterile field. The product is sterile in an undamaged, unopened package.

Although Medtronic Xomed ossicular prostheses are manufactured from materials which may be resterilized by various methods, MEDTRONIC XOMED DOES NOT RECOMMEND RESTERILIZATION OF ITS OSSICULAR PROSTHESES. MEDTRONIC XOMED ASSUMES NO LIABILITY FOR PRODUCTS WHICH HAVE BEEN RESTERILIZED BY HEALTH CARE FACILITIES.

Magnetic Properties of Medtronic ENT Otology Implant Devices

Effects of magnetic resonance imaging (MRI) scans on Medtronic ENT otology implants

Indications

The surgeon must use medical judgment and consider the patient’s medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but are not limited to:

• Chronic otitis media with effusion characterized as serous, mucoid, or purulent.
• Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
• A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.
• Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction.

Contraindications

Some conditions for which ventilation tubes may not be the therapy of choice include:

• Cases of otitis media which respond favorably to drug therapy alone.
• Cases involving chronic otitis media with effusion should not be treated by insertion of membrane style tubes.
• Cases of otitis media in which, in the medical judgment of the surgeon, a myringotomy alone or tympanocentesis will suffice as treatment for the condition.

Warnings

The surgeon is encouraged to carefully choose a tube size, style and material to meet the needs of each specific clinical situation, while minimizing adverse effects.

Larger tube diameters and increasing flange size may increase the chances of prolonged tube retention and/or residual perforation.

MAGNETIC RESONANCE IMAGING (MRI): (For metal ventilation tubes:)

Medtronic Xomed manufactures metal ventilation tubes only from titanium alloys and Austenitic medical grade stainless steel; however, slight magnetism can be characteristic of Austenitic stainless steel. While there are no known reports of MRI-related adverse effects to a patient due to any Medtronic Xomed ventilation tubes, caution is advised when administering MRI procedures. Caution is particularly advised when magnetic fields above 1.5 Tesla are used, as the effects at such levels have not been thoroughly studied. Additionally, image artifact can occur due to the material composition of the tube. Because of the potential for such artifact, alternative imaging techniques, such as CT scanning, should be considered.

Indications

The Meniett Low-Pressure Pulse Generator is indicated for the symptomatic treatment of Ménière’s Disease. The therapeutic effect of the Meniett device is achieved by application of low frequency, low amplitude pressure pulses to the middle ear whereby inner ear endolymphatic fluid is assumed to be evacuated from the inner ear and thus the patient is relieved of the symptoms associated with the disease.

Precautions

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide.

Portable and mobile RF communications equipment can affect Medical Electrical Equipment. Use of accessories and cables other than those specified and sold by Medtronic Xomed may result in increased emissions and decreased immunity of this unit.

The Meniett^® should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Meniett should be observed to verify normal operation in the configuration in which it will be used.