Indications, Safety, and Warnings –
Other Products

Powered ENT Instruments

Integrated Power Console (IPC System)
Straightshot M4 Microdebrider
Straightshot M4 Blades and Burs

Integrated Power Console (IPC System)

Indications

The IPC^® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic, surgical procedures.

Contraindications

None.

Warnings

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.

 

Straightshot M4 Microdebrider

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

Indications

IPC System:

The IPC^® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, in Head & Neck / ENT (Otologic, Neurologic, Neurotologic, Sinus, Rhinologic, Nasopharyngeal / Laryngeal), Oral / Maxillofacial, and Plastic / Reconstructive / Aesthetic, surgical procedures.

Contraindications

IPC System:
None.

Warnings

IPC System:

WARNINGS

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.

 

Straightshot M4 Blades and Burs

Indications

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidectomy, and medial, lateral, and posterior frontal sinusotomy.

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

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.

Contraindications

None

Warnings

• Do not change accessory with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
• For Airway Blades: Should the blade become clogged during use, risk assessment has determined 1-5 cc of irrigant could be aspirated by the patient before detection by the user.
• Do not modify accessories used with the handpiece. Performance could be diminished with modified accessories.
• Do not use burs above the speed indicated on the bur label.
• For high speed drilling (greater than 6,000 rpm) ensure that an XPS High Speed Bur is used.
• Use adequate irrigation from a separate user-provided irrigating source. The use of an accessory without irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
• Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The disposables are packed sterile and not intended for repeat use. To prevent contamination, use only once.
• Insertion of metal objects in blade or bur tip may cause the blade or bur to break leaving fragments in the wound. The fragments may be difficult to remove, causing irritation, inflammation and foreign-body response at surgical site.
• Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent laceration of user and cross-contamination through compromised glove.
• Bending or prying may break the blade or bur, causing harm to patient or staff.
• Operate the blade or bur only after the appropriate anatomical landmarks and the intended surgical site have been confirmed.
• Blades, burs and irrigation tubing are disposable and intended for single-use only, UNLESS OTHERWISE MARKED.
• Test for wobble at desired speed prior to use. Discontinue use of accessory if tip begins to wobble and replace accessory to prevent unintended tissue removal from patient.
• Blade and bur accessories are available for resection of soft tissue and bone for surgical procedures. Use of accessories depends on the intended application and patient needs. Sharp-cutting powered accessories induce bleeding and removal of significant tissue and bone.
• Use care in application of the moving cutting end to only appropriate anatomical landmarks and the intended surgical site when using XPS accessories. The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use appropriate precautions.
• Employ visualization when using rotating XPS accessories, including use of image guided surgery system if needed. Discontinue powered application in the event of lack of visualization of the surgical site.
• Use methods at the operative site to control bleeding that do not compromise patient safety during at-risk surgery.
• Always inspect the components before and after use for any damage. If damage is observed, do not use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
• Do not use any parts other than Medtronic system components as damage or substandard performance could result.
• Remove and discard accessories following local regulations for proper disposal of contaminated materials.
• Do not use accessory if package is opened or damaged. Broken seal offers no protection against cross-contamination.
• Use lock on Straightshot M4 handpiece to prevent inadvertent rotation of blade or bur during use.
• It is important that the XPS 3000 operator be familiar with the system User’s Guide, its precautions, procedures, and safety issues.
• Properly dispose of single-use devices removed from sterile packages. Devices lose sterility upon removal from packaging.
• Excessive pressure applied to bur may cause bur fracture. Should a bur fracture occur during use, extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed from the patient. Unremoved bur fragments may cause tissue damage to the patient.

Vent Tubes

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.