1885078HSE

Ear, Nose and Throat devices powered sinus surgical blades and burs product images.

Indications, Safety, and WarningsIndications for useBurs used with the Medtronic StraightShot™ microdebrider (compatible with the IPC™ system) are indicated for the incision, resection, and drilling of hard tissue and bone in ENT and sinus/rhinologic procedures, including: septoplasty, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinusotomy (medial, lateral, and posterior), maxillary antrostomy (including circumferential), choanal atresia repair, sphenoidectomy, endoscopic dacryocystorhinostomy (DCR), trans-sphenoidal procedures, maxillary sinus polypectomy, and inferior turbinate reduction.ContraindicationsNone known. Each medical professional must evaluate the appropriateness of use based on their own training and experience and the specific needs of the patient.Warnings

Do not use burs above the speed indicated on the bur label.

Improper use of high-speed burs can result in damage to the eye and/or orbit, vascular damage, nerve damage, and/or cerebral damage. Use appropriate caution when operating in the vicinity of critical anatomy.

Burs should be operated in Forward mode only.

Excessive noise from the bur when drilling close to the cochlea or ossicular chain may cause hearing damage.

Excessive pressure applied to the bur may cause fracture; if this occurs, all fragments must be retrieved and removed from the patient. Unremoved fragments may cause tissue damage.

Do not use excessive force to pry or push bone with the bur during dissection; bending or prying may break the tool.

Do not apply excessive side loading — this could cause angled attachments to unlock accidentally from the motor.

Test for excessive vibration or wobble at the desired speed before use; discontinue use and replace the bur if it begins to wobble.

Inspect the bur before and during use for wear, fragmentation, or other defects; replace damaged burs. Do not attempt to re-sharpen tools.

Insertion of metal objects in the bur tip may cause it to break, leaving fragments in the wound that may be difficult to remove.

Do not use the bur if the package is opened, damaged, or expired.

Do not change the bur with the microdebrider running, to prevent laceration of the user and cross-contamination through a compromised glove.

Operate the bur only after appropriate anatomical landmarks and the intended surgical site have been confirmed; ensure adequate visualization.

Burs are single-use only, sterilized by ethylene oxide; do not attempt to resterilize.

Precautions

StraightShot™ microdebriders are intended to operate at speeds greater than 6,000 rpm only when used with the high-speed bur line.

Disconnect the suction tube prior to changing the bur during the procedure.

Ensure the bur is fully engaged in the microdebrider before use.

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