Medtronic XPS 3000 User manual
XPS® Model 3000 System
User’s Guide
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, FL 32216-0980 U.S.A.
Authorized Representative (for EC regulatory matters)
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel.: 011-31-45-566-8000
Fax: 011-31-45-566-8668
Rx Only
™
are trademarks and ® are registered marks of Medtronic Xomed, Inc.
Copyright© 2005 Medtronic Xomed, Inc.
Made in U.S.A.
The information contained in this document was accurate at time of publication. Medtronic Xomed reserves the right to
make changes in the product described in this manual without notice and without incorporating those changes in any
products already sold.
TABLE OF CONTENTS
Symbols ............................................................................................................................................ iii
When the System Arrives ................................................................................................................. iv
Warnings and Precautions ...........................................................................................................iv-vi
Customer Service............................................................................................................................. vii
Device Description............................................................................................................................ 1
System Description .................................................................................................................... 1
Indications ................................................................................................................................. 2
Contraindications .......................................................................................................................2
Parts List ..........................................................................................................................................3
®
XPS
3000 Console Description ...................................................................................................... 4
Front Console............................................................................................................................. 4
Rear Console .............................................................................................................................. 5
XPS® 3000 Set-Up and Use ...............................................................................................................6
Cable Connections ..................................................................................................................... 6
Console Set-Up ....................................................................................................................... 6-7
Language Selection ................................................................................................................ 6
XPS® Multifunction Footswitch, 1895400 ................................................................................ 10
XPS® Multifunction Footswitch, Single Pedal, 1895420 ........................................................... 10
XPS® Single Function Footswitch, 1895410 ............................................................................. 10
XPS® StraightShot® M4 and Magnum® II Microdebrider System Set-Up and Use........................ 11
Before Surgery ..................................................................................................................... 11-12
XPS® StraightShot® M4 and Magnum® II Handpiece Accessories ................................................ 13
Blade or Bur Installation........................................................................................................... 14
Tubing Attachment .................................................................................................................. 14
XPS® StraightShot® M4 and Magnum® II Surgical Precautions............................................... 1 4
After Surgery............................................................................................................................ 15
Blade or Bur Removal ........................................................................................................... 15
Visao™ and Xcalibur® Drill System Set-Up and Use ......................................................................16
Before Surgery ......................................................................................................................... 18
Visao™ and Xcalibur® Bur Installation and Tubing Attachment ............................................... 1 9
Bur Attachment..................................................................................................................... 19
Curved Bur Installation.........................................................................................................19
Tubing Attachment-Irrigation............................................................................................... 1 9
Tubing Attachment-Cooling................................................................................................. 20
Visao™ and Xcalibur® Surgical Precautions.............................................................................. 20
Powerforma® Drill System Set-Up and Use ....................................................................................21
Before Surgery ......................................................................................................................... 22
Powerforma® Bur Installation and Tubing Attachment ............................................................ 23
Bur Attachment..................................................................................................................... 23
Tubing Attachment-Irrigation............................................................................................... 2 3
Powerforma® Surgical Precautions ........................................................................................... 23
Skeeter® Ultra-Lite Oto-T ool System Set-Up and Use ...................................................................24
Before Surgery ......................................................................................................................... 26
i
Cleaning and Sterilization Guidelines ...........................................................................................27
Precaution ................................................................................................................................ 27
Warnings .................................................................................................................................. 27
After Surgery........................................................................................................................27-28
Cleaning ...............................................................................................................................28-30
Sterilization ...........................................................................................................................31-34
Warnings .............................................................................................................................. 31
Precautions ........................................................................................................................... 31
Sterilization References ............................................................................................................ 34
T roubleshooting .............................................................................................................................. 35
System Malfunctions ............................................................................................................... 35
Blade or Bur Malfunctions .......................................................................................................35
Drill and Handpiece Malfunctions ........................................................................................... 36
Footswitch Malfunctions .........................................................................................................36
Limited Warranty and Repair.........................................................................................................37
Technical Specifications.................................................................................................................38
Handpieces - XPS® StraightShot® M4 Microdebrider, StraightShot® Magnum® II,
LandmarX® Magnum® II, XPS® StraightShot® III (Japan only) ................................................ 38
Visao™ and Xcalibur® Drills ..................................................................................................38-39
MPS® Powerforma® Drill ........................................................................................................... 39
Skeeter® Ultra-Lite Oto-T ool ..................................................................................................... 39
Console .................................................................................................................................... 39
XPS® Multifunction Footswitch, 1895400 ................................................................................ 40
XPS® Multifunction Footswitch, Single Pedal, 1895420 ........................................................... 40
XPS® Single Function Footswitch, 1895410 ............................................................................. 40
Compliance ..................................................................................................................................... 40
Guidance and manufacturer’s declaration – electromagnetic immunity - Part I .......................... 41
Guidance and manufacturer’s declaration – electromagnetic emissions .....................................42
Recommended separation distances between portable and mobile RF communications
equipment and the XPS® 3000........................................................................................................42
Guidance and manufacturer's declaration - electromagnetic immunity - Part II..........................43
Recommended Environmental Conditions ...................................................................................... 43
LIST OF FIGURES
Figure 1 Front Console ................................................................................................................. 4
Figure 2 Rear Console................................................................................................................... 5
Figure 3-A Control Button Cluster-Standard Mode.......................................................................... 7
Figure 3-B Control Button Cluster-Procedure Mode ........................................................................ 7
Figure 4 Default Displays and Settings ........................................................................................ 8
Figure 5 Menu Flow Diangram...................................................................................................... 9
Figure 6-A XPS® Multifunction Footswitch, 1895400 ...................................................................... 10
Figure 6-B XPS® Multifunction Footswitch, Single Pedal, 1895420................................................. 10
Figure 7 XPS® Single Function Footswitch, 1895410 ................................................................... 10
Figure 8 XPS® StraightShot® M4 and Magnum® II Microdebrider System.................................. 12
Figure 9 Blade or Bur Installation ................................................................................................ 14
Figure 10 Tubing Attachment........................................................................................................ 14
Figure 11 Xcalibur® Hi-Torque Drill System................................................................................... 16
Figure 12 Visao™ High-Speed Otologic Drill or
Xcalibur® Hi-Speed Drill System .................................................................................... 17
Figure 13 Powerforma® Drill System .............................................................................................. 21
Figure 14 Skeeter® Ultra-Lite Oto-T ool System.............................................................................. 25
ii
SYMBOLS
A
C
N
D
U
2
E
R
B
A TTENTION, SEE INSTRUCTIONS FOR USE
CA T ALOG NUMBER
SERIAL NUMBER
DA TE OF MANUF ACTURE
USE BY DA TE
DO NOT REUSE
STERILIZED BY ETHYLENE OXIDE.
DO NOT USE IF P ACKAGE IS OPENED OR DAMAGED.
STERILIZED BY RADIA TION.
DO NOT USE IF P ACKAGE IS OPENED OR DAMAGED.
LOT NUMBER
ON (MAIN POWER)
OFF (MAIN POWER)
REVERSE
FOR WARD
ACC
OSCILLATION
FOOTSWITCH — V ARIABLE MODE
FOOTSWITCH — ST AR T/STOP
FOOTSWITCH
FOOTSWITCH DIRECTION - FOR W ARD
FOOTSWITCH DIRECTION - OSCILLA TE
FOOTSWITCH DIRECTION - REVERSE
TYPE B APPLIED P AR T
ACCESSOR Y CONNECTOR
MANUAL ST AR T/STOP
HANDPIECE
SKEETER® HANDPIECE
RF TRANSMITTER (INTERFERENCE MA Y OCCUR)
MENU
MENU
IRRIGANT
COOLANT
PUMP
LOCKED
UNLOCKED
CAUTION: PINCH HAZARD. KEEP FINGERS CLEAR OF ROLLERS.
iii
WHEN THE SYSTEM ARRIVES
UNPACKING AND INSPECTION
As the box is unpacked, check off the contents of the box against the items listed on the packing slip. If the contents
are incomplete or if there is damage, notify Customer Service. If the shipping container is damaged, or the cushioning
material shows signs of stress, notify the carrier as well.
Keep the shipping materials for carrier inspection.
After unpacking your new XPS® Model 3000 System, save the cartons and packing material. If the instrument is to
be shipped from one location to another, the carefully designed shipping package will provide proper protection.
WARNINGS AND PRECAUTIONS
It is important that the XPS® Model 3000 operator be familiar with this manual: its precautions, procedures and
safety issues. Three labels are used in this manual to identify important concerns, conditions, or procedures:
“WARNING”
Identifies conditions or practices that present a risk of injury to the patient and/or user.
"PRECAUTION / CAUTION"
Identifies conditions or practices that could result in damage to the equipment.
"NOTE"
Identifies special information allowing easier maintenance of equipment or to clarify or emphasize important
instructions.
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 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.
• T est 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.
• T est 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 .
iv
WARNINGS (continued)
• 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 staf f.
• 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 crosscontamination.
• 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.
PRECAUTIONS
• 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.
• 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.
v
PRECAUTIONS (continued)
• 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 ONL Y 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™ Hi-Speed Drills will result in excessive handpiece temperature.
• The Xcalibur® and V isao™ High-Speed W ater-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 Xomed 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.
NOTICE
It is important that you read this entire manual
before you use the XPS
use these devices before you have read and are
thoroughly familiar with this document.
vi
®
Systems. It is unsafe to
CUSTOMER SERVICE
U.S. CUSTOMER SERVICE
General customer service and technical support are available toll-free:
800-874-5797 or 904-296-9600
Monday-Friday
8:00 AM - 6:00 PM E.S.T .
www.xomed.com
MICROELECTRONICS REPAIR
T echnical Support:
800-872-9877
904-296-6448 (F AX)
Monday - Friday
8:00 AM - 5:00 PM E.S.T .
Return Address:
Medtronic Xomed, Inc.
4102 Southpoint Blvd.
Jacksonville, FL 32216-0980 U.S.A.
Attention: Repair Department
CUSTOMER SERVICE INFORMATION
For further information regarding the use of this product or to report any problems, please contact Medtronic
Xomed using the appropriate information provided on the blue and white contact information card packaged with
each device; or contact your local distributor.
MEDTRONIC XOMED, INC. HELPLINE
Should you need immediate help with a technical question or guidance through the appropriate protocol, just call
the Medtronic Xomed Help Line at 1-800-874-5797.
NOTE:
When contacting our Customer Service and Technical Support, please have the appropriate product number,
product serial number, date of purchase, and nature of inquiry available.
Product Number
Serial Number
Date of Purchase
vii
DEVICE DESCRIPTION
SYSTEM DESCRIPTION
The XPS® 3000 System consists of a power control console, footswitches, connection cables, and assorted
handpieces to drive various burs, blades, drills, rasps, and cannulae.
XPS® 3000 CONSOLE — Provides power to the selected handpiece. In addition to the StraightShot® M4
Microdebrider and V isao™ High-Speed Otologic Drill, the system console also powers the StraightShot® Magnum
and Magnum® II handpiece, Powerforma® (High Speed Drill), Xcalibur® Hi-Torque and Hi-Speed Drills, and Skeeter
(microdrill) handpieces. It includes an integrated irrigation pump for irrigation of blades and burs and a second
pump (optional) for motor coolant of the V isao™ High-Speed and Xcalibur® Hi-Speed Otologic Drills.
FOOTSWITCH — The Single Function footswitch controls speed; the Multifunction footswitch controls
handpiece speed, rotation mode, and footswitch mode.
XPS® STRAIGHTSHOT® M4 MICRODEBRIDER — Features a finger wheel that allows the user to rotate the
cutting tip of specially designed straight and curved rotatable blades. It is also compatible with non-rotating blades
and burs. It includes a locking mechanism to prevent inadvertent rotation of non-rotating blades. The lightweight
design combines high power and precision performance and can operate in forward mode of 12,000 rpm for bur
operation and 5,000 rpm in oscillate for blade operation. The StraightShot® M4 also provides irrigation tubing
management grooves to keep tubing out of the surgeon’s way during a procedure.
STRAIGHTSHOT® MAGNUM® II MICRODEBRIDER HANDPIECE — Features a locking mechanism and allows
adjustability of blade or bur tip alignment. The lightweight design combines high power and precision performance
and can operate in forward mode of 12,000 rpm for bur operation and 5,000 rpm oscillate for blade operation.
STRAIGHTSHOT® MAGNUM® HANDPIECE — Features a locking mechanism and allows adjustability of blade
or bur tip alignment. The lightweight design combines high power and precision performance.
VISAO™ HIGH-SPEED OTOLOGIC DRILL — The lightweight design is used in otologic bone drilling operations.
It may be used with either standard burs or with V isao™ High-Speed Curved Burs.
®
®
XCALIBUR® HI-TORQUE AND HI-SPEED (W A TER-COOLED) OTOLOGIC DRILLS — Has two motor
assemblies, one hi-torque and one hi-speed (Water-Cooled); and one straight and one angled handpiece attachment. It is used in otologic bone drilling operations.
SKEETER® UL TRA-LITE OTO-TOOL — A slender , lightweight drill handpiece and burs specifically used in
middle ear surgical procedures, including stapes footplate procedures. The Skeeter® may be powered from the XPS
3000 console, XPS® 2000 console, or from a battery powered variable speed foot control.
POWERFORMA® OTOLOGIC DRILL — Straight and angled drill handpieces for otologic bone drilling. The
Powerforma® connects, via an adapter plug, to the XPS® 3000 and XPS® 2000 consoles.
®
1
INDICATIONS
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 sur gery . An integral pump is provided for irrigation and a second integral
pump may be provided for handpiece cooling.
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, exostosis 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, transsphenoidal 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, 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.
The XPS
and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures.
®
3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft
CONTRAINDICATIONS
None are known.
2
PARTS LIST
Part # Description
1897101 ................................ XPS
1897102 ................................ XPS
1898200T ............................. XPS
1897200 ................................ StraightShot
1897200T ............................. LandmarX
1897201 ................................ XPS
1895400 ................................ XPS
1895410 ................................ XPS
1895420 ................................ XPS
1895505 ................................ XPS
®
Model 3000 Console With Irrigation (one pump)
®
Model 3000 Console With Coolant and Irrigation (two pumps)
®
StraightShot® M4 Microdebrider
®
Magnum® II Handpiece
®
Magnum® II Handpiece
®
StraightShot® III Handpiece (Japan only)
®
Multifunction Footswitch
®
Single Function Footswitch
®
Multifunction Footswitch, Single Pedal
®
Accessory Cable, Short
1895820 ................................ Power Cord, North American, 115V
1895821 ................................ Power Cord, United Kingdom/Ireland, 240V
1895822 ................................ Power Cord, Continental Europe, 230V
1895823 ................................ Power Cord, Japan, 100V
1897821 ................................ Power Cord, 6 Meter, IEC320, 115V
3334800 ................................ Visao
3334800T ............................. Visao
3333700 ................................ Xcalibur
3333705 ................................ Xcalibur
3333750 ................................ Xcalibur
3333755 ................................ Xcalibur
3333840 ................................ Xcalibur
3333850 ................................ Xcalibur
Accessories
1895520 ................................ Powerforma
1895522 ................................ StraightShot
1896840 ................................ StraightShot
1897510 ................................ XPS
1897851 ................................ XPS
1897852 ................................ XPS
1898400 ................................ XPS
1994025 ................................ Adapter for Powerforma
3055601 ................................ Skeeter
3318501 ................................ Powerforma
3318502 ................................ Powerforma
™
High-Speed Otologic Drill
™
High-Speed Otologic Drill, IGS Trackable
®
Straight Hi-T orque Handpiece Attachment
®
Straight Hi-Speed Handpiece Attachment
®
Angled Hi-Torque Handpiece Attachment
®
Angled Hi-Speed Handpiece Attachment
®
Hi-Speed Motor Assembly, Water-Cooled
®
Motor Assembly (Hi-Torque)
®
to XPS® Irrigator Tubing
®
to XPS® Irrigation Tubing, 5/Box
®
®
®
®
®
Magnum® Sterilization Tray
IV Pole Basket for Footswitch
Model 3000 System User’s Guide
Model 3000 System Repair Manual
StraightShot® M4 Sterilization Tray
®
Ultra-Lite Oto-Tool
®
Irrigation Tubing, Non-Sterile
®
Irrigation Tubing, Sterile, 5/bx
®
Handpiece
3318503 ................................ Irrigation Tubing Set, Sterile, 4/bx
3318506 ................................ Hi-Speed Drill Coolant Tubing Set, 2/bx
3318510 ................................ Handpiece Cable Cap, Small
3318515 ................................ Handpiece Cable Cap, Large
3318600 ................................ Clips for MPS
3319001 ................................ MPS
®
3319005 ................................ Case, Bur Rack, MPS
3327700 ................................ MPS® Powerforma® Straight Handpiece
3327750 ................................ MPS
®
3333610 ................................ Xcalibur
3333620 ................................ Xcalibur
3333625 ................................ Xcalibur
3333630 ................................ Xcalibur
3333635 ................................ Xcalibur
3333645 ................................ Xcalibur
3333655 ................................ Xcalibur
3333890 ................................ Xcalibur
3333895 ................................ Xcalibur
3334610 ................................ Visao
™
3334625 ................................ Visao
3334635 ................................ Visao
3334895 ................................ Visao
®
/Powerforma®/Xcalibur® Handpiece Cable/Tubing
Powerforma® Sterilization Tray
Powerforma® Angled Handpiece
®
Irrigation Sleeve Assembly
®
Hi-T orque Extended Bur Guard, Without Irrigation
®
Hi-Speed Extended 75 mm Bur Guard, Without Irrigation
®
Hi-T orque Extended Bur Guard, W ith Irrigation
®
Hi-Speed Extended 75 mm Bur Guard, With Irrigation
®
Hi-Speed Extended 64 mm Bur Guard, Without Irrigation
®
Hi-Speed Extended 64 mm Bur Guard, With Irrigation
®
Sterilization Tray
®
Hi-Speed Drill Sterilization Tray
Irrigation Sleeve
™
Extended Bur Guard, Without Irrigation
™
Extended Bur Guard, With Irrigation
™
Sterilization Tray
®
For a complete list of system components and accessories
contact your local Medtronic Xomed representative
or call Customer Service at 1-800-874-5797 or 1-904-296-9600.
3
XPS® 3000 CONSOLE DESCRIPTION
FRONT CONSOLE
1. SPEED DISPLA Y – When the system is running, the actual operating speed of the handpiece displays. When
inactive, the display shows the top speed set by the operator.
2. ROTATION INDICA TOR – Displays rotation mode (forward, reverse, or oscillate). Lights indicate selected
rotation. Rotation may be selected at either the multi-function footswitch or with the center control button in the
normal mode.
3. PROCEDURE AND CURRENT OPERATIONS DISPLA Y – In operating mode, displays procedure-blade/bur
setting and irrigation pump rate. In procedure selection/menu mode, it displays a choice of procedures, allowing
the user to choose suggested operational settings for the current procedure.
4. CONTROL BUTTON CLUSTER – Operates in two modes, Normal and Procedure. In Normal operation, center
button controls direction (forward and oscillate), top and bottom buttons control speed (increase and decrease),
and left and right button control rate of irrigation (decrease and increase). Depressing the menu button activates
the Procedure Mode. Arrow buttons control the cursor and the center button is the Select button. Operation of
the speed and procedure functions is described below.
5. HANDPIECE CONNEC-
TORS – Connect the appropriate handpiece to the
console here. (Large connector for all handpieces
except for Skeeter® handpiece.)
6. FOOTSWITCH CON-
NECTOR – Connect the
footswitch to the console
here. During standard operation the footswitch
must be connected to operate the active handpiece.
7. HANDPIECE IRRIGA-
TION PUMP – Pumps
fluid through a tubing set
to the blade or bur.
8. XCALIBUR® HI-SPEED
WATER COOLANT
PUMP –
Pumps cooling fluid for
the W ater -Cooled drill
motor assembly (available only on REF#
1897102).
Figure 1 Front Console
4
REAR CONSOLE
1. MANUAL ST AR T STOP BUTTON – In the case of footswitch failure intraoperatively , button allows
circulating nurse to manually turn handpiece operation on and off.
2. ENDO-SCRUB® CABLE CONNECTOR – Accepts accessory cable which powers the Endo-Scrub® 2.
3. FUSE ACCESS – REPLACE ONL Y WITH 250V, 4.0A, T ype F , 5 x 20mm fuses.
4. POWER SWITCH – Press the power switch to the “|” position to turn on the system. Press the switch to the
“O” position to turn the system off.
5. POWER CORD CONNECTOR – Hospital grade power cord connects here.
6. DB-9 CONNECTOR – Connector for future data exchange.
Figure 2 Rear Console
5
XPS® 3000 SET-UP AND USE
CAUTION
Inspect components for damage before use. Do not operate if components are damaged.
CABLE CONNECTIONS
To connect the cables to the console:
1. Insert the cable connectors by aligning the red dot on the cable connector with the red dot on the console
connector.
2. Push connectors together. They should lock in place.
To disconnect the cables from the console:
1. Grasp the cable connector and gently pull back on the collar of the connector.
2 . The connector will disconnect.
CAUTION
Grasp the cable connector; do not pull on the cable.
CONSOLE SET-UP
LANGUAGE SELECTION
The system is provided with a one pump console (1897101) or two pump console (1897102) defaulted to the
customer’s preferred language. Each console is capable of displaying six (6) languages as indicated below:
One Pump - 1897101
English
French
Italian
German
Spanish
Dutch
One Pump - 1897101
English
Spanish
Danish
Finnish
Swedish
Portuguese
T wo Pumps - 1897102
English
French
Italian
German
Spanish
Dutch
T wo Pumps - 1897102
English
Spanish
Danish
Finnish
Swedish
Portuguese
To change the language selection, simultaneously press the left and right arrow key on the control button cluster.
Next, a menu will appear on the display showing the language choices. Use the arrow keys to move the cursor to the
desired language and press the center key to select.
PRECAUTIONS
• System components should be operated and inspected for damage prior to use. DO NOT USE SYSTEM IF
DAMAGE IS APPARENT .
• Do not allow the console to get wet. If liquid enters the console, damage could occur.
WARNING
• Only connect the console to hospital grade receptacles to ensure electrical grounding reliability.
1. Plug the power cord into the console and into the wall outlet.
2. Connect the handpiece (s) to the appropriate console connector (s).
3. Connect the footswitch cable to the console. See next section for instructions on footswitch operation.
4. Turn the console on by pressing the power switch on the back panel. The console will display default
settings for the handpiece speed, direction of cutter rotation, and type of surgical procedure.
5 . Figures 4 and 5 shows the default settings in Normal and Procedure Mode.
6
Increase Speed
Select Menu Mode
Increase Irrigation
and Prime
Select
Scroll Up Return to
Standard Mode
Scroll
Right
Decrease Irrigation
Decrease Speed
Figure 3-A Control Button Cluster-
Standard Mode
Direction Change
Scroll Left Scroll Down
Figure 3-B Control Button Cluster-
Procedure Mode
6. The control button cluster can control speed, direction, irrigation rate, and, in Procedure Mode (depress
menu button), give the operator suggested operating speeds for different procedures.
7 . Speeds may be adjusted by pressing top and bottom buttons to increase and decrease speed. Pump flow rate
may be adjusted by pressing right (increase) and left (decrease) buttons; press and hold right button for
prime. Direction (forward, reverse, oscillate) can be changed by pressing the center button.
Default speeds are listed below (* Not applicable).
HANDPIECE OSCILLA TE FORWARD REVERSE DEFAULT MODE
®
StraightShot
Visao
StraightShot
StraightShot
Powerforma
Xcalibur
Skeeter
Xcalibur
M4 5,000 rpm 6,000 rpm N/A* OSCILLATE
™
High-Speed Otologic Drill N/A* 60,000 rpm 60,000 rpm FWD
®
Magnum® II 5,000 rpm 6,000 rpm N/A* OSCILLATE
®
Magnum
®
®
Hi-Torque Motor N/A* 43,000 rpm 43,000 rpm FWD
®
®
Hi-Speed Motor N/A* 60,000 rpm 60,000 rpm FWD
®
3,000 rpm 6,000 rpm N/A* OSCILLATE
N/A* 43,000 rpm 43,000 rpm FWD
N/A* 12,000 rpm N/A* FWD
Handpiece operating ranges are listed below.
HANDPIECE ROTATION MODE LOW LIMIT HIGH LIMIT
StraightShot® M4 FWD 500 rpm 12,000 rpm
StraightShot® M4 OSCILLATE 500 rpm 5,000 rpm
Visao™ High-Speed Otologic Drill FWD or REV 10,000 rpm 80,000 rpm
StraightShot® Magnum® II FWD 500 rpm 12,000 rpm
StraightShot® Magnum® II OSCILLA TE 500 rpm 5,000 rpm
StraightShot® Magnum
StraightShot® Magnum
Powerforma
Skeeter
®
®
®
®
FWD 300 rpm 6,000 rpm
OSCILLATE 300 rpm 3,000 rpm
FWD or REV 10,000 rpm 52,000 rpm
FWD 6,000 rpm 12,000 rpm
Xcalibur® Hi-Torque FWD or REV 10,000 rpm 52,000 rpm
Xcalibur® Hi-Speed FWD or REV 10,000 rpm 80,000 rpm
8. ROTA TION MODE — Changed either by pressing the Rotation Control button (in the center of the control
button cluster) on the console or, if the multifunction footswitch is used, depressing and releasing the left
pedal.
7
0
Figure 4 Default Displays and Settings
rpm
MIDDLE EAR
1200
SKEETER
FORWARD
IRRIGATION OFF
No
Yes
HA NDPIECE
INSERT HANDPIECE
DETE CTE D ?
WHI C H
HA NDPIECE?
SKEETER
DRILL
HI-SPD
MAGNUM
DRILL
& M4
M AGNUM II
rpm
MASTOID
43000
rpm
MASTOID
60000
rpm
SINUS
BUR
FORWARD
IRRIGATION 40%
BUR
FORWARD
IRRIGATION 40%
5000
BLADE
OSCILLATE
IRRIGATION 40%
rpm
SINUS
3000
BLADE
OSCILLATE
Defaul t
Settings
Displays and
8
IRRIGATION 40%
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