HEALTHCARE PROFESSIONALS

Indications, Safety, and Warnings

Integrated Power Console, Handpieces, and Accessories

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™ system 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 To avoid the risk of electric shock, this equipment must only be connected
to a supply main with protective earth.
W4 To avoid the risk of electrical shock, achieve electrical grounding reliability
with proper connections. Connect the IPC™ system to hospital grade
receptacles only.
W5 Do not attach any system component or accessory other than Medtronic
approved components to the IPC™ system as this may result in electrical
shock, component damage, substandard performance, increased
emissions, or decreased immunity.
W6 Disconnect power to the IPC™ system before cleaning the unit to avoid
electrical shock.
System
Warnings
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 the anesthetized patient.
W8 Do not operate the IPC™ system in the presence of Magnetic Resonance
Imaging devices.
W9 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 User’s Guide.
W10 The IPC™ system should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the IPC™ system
should be observed to verify normal operation in the configuration in which
it will be used.
W11 Portable and mobile RF communications equipment can affect Medical
Electrical Equipment.
W12 Keep NIM™ Muting Probe cable away from IPC™ system cables to
prevent unintended EMG interference or muting.
W13 After each procedure, properly clean all reusable system components.
W14 All service must be performed by Medtronic qualified personnel only.
Repair and/or modification to the IPC™ system by anyone other than
qualified service personnel may significantly compromise the unit’s ability
to perform effectively and/or void the equipment warranty.
W15 Auxiliary Power Outlet with protective cover is for use with the
Hydrodebrider or Bone Mill only. Consult Hydrodebrider and Bone Mill
instructions prior to use.

Component
Warnings
W16 Always inspect the components before and after use for any damage or
malfunction. If damage or malfunction is observed, do not use damaged
part until it is repaired or replaced. Use of damaged or malfunctioning
parts can increase risk of injury.
W17 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.
W18 Do not use an overheated device as it may cause thermal injury. Smoke
and/or excessive heat may be caused by:

 Applying excessive force while cutting (e.g. side loading)

 Long operating periods (exceeding handpiece duty cycle)
 Attachment not fully locked in handpiece
 Inadequate or loss of irrigation
 Component failure or wear

W19 The handpieces will not run properly unless the attachment is in the
locked or secured position.
W20 Do not change accessory with handpiece running to prevent laceration
of user and cross-contamination through compromised glove.
W21 Do not place motor, attachment and tool on the patient or in an
Component
Warnings
unsecured location during surgery.
W22 Do not activate foot pedal without confirming the safe position and
handling of the handpiece. Accidental handpiece activation could result
in unintended tissue, bone, or nerve resection.
W23 Verify reusable device was cleaned and sterilized prior to use. If not
sterilized, do not use.
W24 For warnings & precautions related to reprocessing, refer to Cleaning
and sterilization instructions.
W25 This system requires insulated connectors for the StraightShot™ M4
Microdebrider, StraightShot™ Magnum™ II Microdebrider,
StraightShot™ III Microdebrider, Midas Rex™ Spine Shaver (SC1),
Visao™, or Skeeter™ handpieces and the multifunction foot pedal.
W26 When using StraightShot™ microdebrider handpieces with non-
rotatable tools, ensure rotation lock is engaged to prevent inadvertent
rotation. When using with optical Image Guided Surgery (IGS), engage
the rotation lock prior to calibration and verification of the tip.

Disposable
Warnings
W27 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.
W28 Do not use accessory if package is opened or damaged. Broken seal
offers no protection against cross-contamination.
W29 Operate the tool only after the appropriate anatomical landmarks and
the intended surgical site have been confirmed. Ensure adequate
visualization when using powered accessories. Discontinue powered
application in the event of lack of visualization of the surgical site.
W30 Use methods at the operative site to control bleeding that do not
compromise patient safety during at-risk surgery.
W31 Always keep the cutting area of the tool away from fingers and loose
clothing to prevent laceration of user and cross-contamination through
compromised glove.
W32 Excessive noise from the tool when drilling close to the cochlea or
ossicular chain may cause hearing damage.
W33 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 this device in the vicinity of critical
anatomy.
W34 Excessive pressure applied to tool may cause tool 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.
W35 Do not use excessive force to pry or push bone with the attachment, tool
or blade during dissection.
W36 Do not apply excessive side loading. Excessive side loading could
cause angled attachments to unlock accidentally from motor.
W37 Do not modify any system components or accessories. Use of modified
components or accessories may increase risk of injury or diminish
performance of the system.
Disposable
Warnings
W38 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.
W39 Bending or prying may break the accessory, causing harm to patient or
staff.
W40 Inspect tools prior to and during use for signs of wear, fragmentation,
eccentricities, or other defects. Replace and discard damaged tools. Do
not attempt to re-sharpen tools.
W41 Test attachments for excessive vibration at desired speed before use.
Vibration may be caused by eccentricity of the tool or worn components.
Replace tool, attachment, or handpiece, or change handpiece speed.
W42 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.
W43 Powered blades should be operated in the Oscillate mode only.
Operating in the Forward mode may cause damage to the blade.
W44 Do not use the burs above the speed indicated on the bur label.
W45 If an airway blade becomes clogged during use, 1-5 cc of irrigant could
be aspirated by the patient before detection by the user.
W46 Do not attempt to sterilize disposable devices. The disposables are
packed sterile and are intended for single use. Devices lose sterility
upon removal from packaging.

PRECAUTIONS

P1 Do not kink cables. Inspect cables and pins for cracks, tears or corrosion.
P2 When using a Y-Splitter, only one multifunction foot pedal shall be active at a time.
P3 Do not connect multiple Y-Splitters.
P4 StraightShot™ handpieces are intended to operate at speeds greater than 6,000
rpm only when used with the high speed bur line.
P5 Do not use anti-fog on scope or sheath, as weeping or leaking may result.
P6 Do not use excessive force to insert the endoscope into the Endo-Scrub™ 2
sheath. this will damage the endoscope as well as the Endo-Scrub™ 2 sheath.
P7 If the endoscope tip can be seen extending beyond the tip of the Endo-Scrub™ 2
sheath, then the sheath has been damaged. Damaged product must be
immediately discarded.
P8 Remove and discard accessories following local regulations for proper disposal of
contaminated materials.
P9 When using an angled attachment, hold the handpiece assembly by the
attachment so that the attachment does not inadvertently loosen from the
handpiece.
P10Always examine operation of each tool in a handpiece before use.
P11Powered burs and drills should be operated in the Forward mode only.
P12To prevent damage to tools, disconnect suction tube prior to changing tool during
procedure.
P13Ensure the blade or bur is fully engaged in the microdebrider. For blades, verify the
tip is fully engaged with the outer cannula prior to use.
P14T&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.
P15T&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.

STRAIGHTSHOT BLADES AND BURS

DEVICE DESCRIPTION

The Straightshot® Microdebrider is designed to accommodate a number of otorhinolaryngology

procedures, including functional endoscopic sinus surgery (FESS), adenoidectomy, removal of
laryngeal and vocal cord lesions, rhinoplasty, dermabrasion, and submental lipectomy. A variety of
disposable blades and burs are available for this purpose.

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 are known.

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 and M5 handpieces 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.

SURGICAL PRECAUTIONS

 The Straightshot Magnum® II and Straightshot M4 and M5 High-Speed Microdebriders are intended
to operate at speeds greater than 6,000 rpm ONLY when used with the XPS high-speed bur line.
 XPS Blades should be operated in the oscillate mode only. Operating in the forward mode may
cause damage to the blade. XPS burs should be operated in the forward mode only.
 To prevent damage to curved blades and burs, disconnect suction tube prior to changing blade or
bur during procedure.
 Be sure the blade is fully engaged in the microdebrider and verify the tip is fully engaged with the
outer cannula prior to use.

CURVED BURS
INDICATIONS

The XPS® Curved Bur is intended for use in an ear, nose, and throat electric or
pneumatic surgical drill for incising or removing bone in the ear, nose, or throat
area, and is an accessory to the XPS® 3000 and IPC® System.
CONTRAINDICATIONS

None are known.

WARNINGS

 Use adequate irrigation from a separate user-provided irrigating source. The use of a bur without
irrigation may cause an inordinate amount of heat buildup resulting in thermal injury to tissue.
 Keep the cooling sleeve irrigated to minimize thermal injury to tissue.
 Excessive noise from the drill or eccentricity of the drill may cause hearing damage when drilling
close to the cochlea or ossicular chain.
 During procedures near nerves, keep bur and bur cannula away from tissue to minimize the
potential for thermal injury.
 For procedures near nerves, nerve monitoring should be used to alert the user of the potential for
injury.
 Use care in application of the moving cutting end to only appropriate anatomical landmarks and the
intended surgical site when using XPS accessories.
 The use of powered reciprocating/rotating instruments may result in vibration-related injury. Use
appropriate precautions.
 Employ visualization when using rotating XPS accessories. Discontinue powered application in the
event of lack of visualization of the surgical site.
 Always inspect the components before and after use for any damage. If damage is observed, do not
use damaged part until it is replaced. Damaged parts may deposit metal shavings on surgical site.
 When not operating handpiece, ensure that handpiece rests on a non-conductive surface that
provides containment for handpiece and blade/bur. Avoid unintended thermal injury by an
uncontained handpiece.
 When not operating handpiece, eliminate accidental foot control activation. Control energy to and
through handpiece to prevent unintended tissue, bone or nerve resection.
 Always keep the cutting tip of the accessory away from fingers and loose clothing. Prevent
laceration of user and cross-contamination through compromised glove.
 Do not change accessory with handpiece running to prevent laceration of user and cross-
contamination through compromised glove.
 Do not use accessory if package is opened or damaged. Broken seal offers no protection against
cross-contamination.
 Bending or prying may break the blade or bur, causing harm to patient or staff.
 Excessive pressure applied to bur may cause bur fracture. Should a bur fracture during use,
extreme care must be exercised to ensure that all fragments of the bur are retrieved and removed
from the patient. Unremoved bur fragments may cause tissue damage to the patient.
 Test for bur wobble (eccentricity) at the desired speed prior to use. Select a new bur or reduce
speed if wobble is observed. Eccentricity of the bur can cause bur vibration and may result in
excessive tissue and bone destruction and hearing damage. Always examine the operation of each
bur in the handpiece before each use. Operating certain burs at high speed can cause vibration of
the bur.
 Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue
removal from patient.
 Blade and bur accessories are available for resection of soft tissue and bone for surgical
procedures. Use of accessories depends on the intended application and patient needs. Sharp-
cutting powered accessories induce bleeding and removal of significant tissue and bone.
 Do not modify accessories used with the handpiece. Performance could be diminished with
modified accessories.
 Do not attempt to resharpen used burs. Worn burs should be replaced with new ones frequently to
ensure effective cutting and control of the drill.
 Do not use any parts other than Medtronic Xomed, Inc. system components as damage or
substandard performance could result.
 Disposable devices are for single-use only. Do not attempt to sterilize disposable devices. The
disposables are packed sterile and not intended for repeat use. To prevent contamination use only
once.
 Do not use burs above the speed indicated on the bur label. Exceeding speed may cause the burs
to break.
SURGICAL PRECAUTIONS

 Ensure the bur is properly secured in the handpiece prior to activation.

 When operating or testing the handpiece, ensure the bur is properly inserted and locked into the bur
collet.