Product information and instructions

CAUTION

Device description
Indications
Contraindications
Warnings
Surgical precautions

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Rx only

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Device description

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Indications

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

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Contraindications

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Warnings

• 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 ENT 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 (ecentricity) 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 ENT-qualified personnel only.
• 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.

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Surgical Precautions

• XPS® blades should be operated in oscillate mode only. Operating in the forward mode may cause damage to the blade. XPS burs should be operated in forward mode only.
• The handpiece should be evaluated prior to each use for suitable operating condition.
  • System components should be operated and inspected for damage prior to use. Do not use system if damage is apparent.
• It is recommended that a secondary handpiece be available to minimize any downtime and inconvenience to the surgical staff.
• The Straightshot® Magnum® II and StraightShot M4 Microdebriders are intended to operate at speeds greater than 6,000 rpm ONLY when used with the XPS high speed bur line.
• Always ensure that the bur is securely engaged into the handpiece prior to operating the system.
• When operating or testing the Poweforma®, Xcalibur® and Visao® drill handpieces, ensure the bur is properly inserted and locked into the handpiece. Running the drill with the collet unlocked can damage the locking mechanism.
• Improper priming of the Xcalibur and Visao high-speed Drills will result in excessive handpiece temperature.
• The Xcalibur and Visao high-speed Water-Cooled Drills work only with the XPS 3000. Use without water bag will damage the motor in the handpiece.
• Do not allow the console or footswitch to get wet. If liquid enters the console or footswitch, damage could occur.
• To prevent damage to curved blades and burs, disconnect suction tube prior to changing blade or bur during procedure.
• DO NOT clean handpieces in ultrasonic cleaner or allow them to be fully immersed in any soaking solution. These procedures may result in damaging the handpieces beyond repair.
• Do not sterilize the console or footswitch.
• Do not clean the handpiece in an ultrasonic cleaner or cold soak sterilize the handpiece in glutaraldehyde. Do not immerse handpieces, motors or handpiece cables in any solution, except as detailed in the cleaning section of this manual. These procedures void the warranty and may damage the handpiece beyond repair.
• Always handle handpieces with care to avoid damage.
• Do not use organic solvents such as acteone or isopropyl alcohol to clean the bur chuck. Use only an enzymatic detergent and distilled water for cleaning after every case or as required.
• Remove the bur from the handpiece before sterilization.
• Sterilize immediately after cleaning. Do not store unless a drying cycle has been performed.
• Always wrap the electrical cord carefully inside the sterilization tray during sterilization to prevent damage to the cord when closing the tray lid.
• Remove the handpiece from the sterilizer immediately after the sterilization cycle is complete.
• Temperatures higher than those stated may be used for handpiece sterilization when necessary to satisfy governmental or health care facility requirements so long as the temperature does not exceed 149°C (300ºF). Heating above 149°C (300ºF) may damage components and will void the warranty.
• Regardless of which type of steam sterilization is used, it is extremely important that the handpiece is rapidly and completely dried before it is stored. Do not operate or store the handpiece unless a drying cycle has been preformed. If a vacuum drying cycle is not used following steam sterilization, moisture may be trapped within the handpiece causing corrosion and residue deposits, resulting in premature wear and a reduction in the functional life expectancy of the handpiece. In addition, damage may result if the handpiece is operated with moisture in the electronic connections.
• Store system in a clean dry place.
• 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 ENT may result in increased emissions and decreased immunity of this unit.
• The XPS® 3000 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the XPS 3000 should be observed to verify normal operation in the configuration in which it will be used.

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Rx Only

IMPORTANT SAFETY INFORMATION!
THIS THERAPY IS NOT FOR EVERYONE. PLEASE CONSULT YOUR PHYSICIAN. A PRESCRIPTION IS REQUIRED.
FOR FURTHER INFORMATION, PLEASE CALL MEDTRONIC ENT AT 800-874-5797

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Version 2.1.0 This webpage was first published on September 08, 2005, and was last updated on September 25, 2006.
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