XPS® Micro System
User’s Guide and Service Manual
The following are trademarks or registered trademarks of Medtronic, Inc. in the United States and other countries: Magnum®,
StraightShot®, and XPS®. All other trademarks, service marks, registered trademarks, or registered service marks are the property of
their respective owners in the United States and other countries.
TABLE OF CONTENTS
SYMBOLS ................................................................................................................................................................................................1
WARNINGS AND PRECAUTIONS ........................................................................................................................................................2
INTERNATIONAL CUSTOMER SERVICE .............................................................................................................................................3
THE XPS MICRO SYSTEM HELP LINE .................................................................................................................................................3
LIMITED WARRANTY ............................................................................................................................................................................4
CHAPTER 1 XPS MICRO SYSTEM ....................................................................................................................................... 5
1.0 System Description ........................................................................................................................................................................................5
1.1 XPS Micro System ............................................................................................................................................................................................5
1.1.1 XPS Micro Console .........................................................................................................................................................................................5
1.2 Indications for Use/Intended Uses ...........................................................................................................................................................5
1.2.1 XPS Micro System ...........................................................................................................................................................................................5
1.2.2 Operator Notice ..............................................................................................................................................................................................5
1.3 Contraindications ..........................................................................................................................................................................................5
1.4 Components .....................................................................................................................................................................................................5
1.4.1 Ensure that the following components are present: .........................................................................................................................5
1.4.2 Pneumatic Foot Control ................................................................................................................................................................................6
1.4.3 StraightShot Magnum II Handpiece ........................................................................................................................................................6
1.4.4 XPS Disposables ...............................................................................................................................................................................................6
CHAPTER 2 PREPARATION AND USE ................................................................................................................................ 7
2.0 General Information .......................................................................................................................................................................................7
2.1 Prepare Console, Handpiece and Accessories .....................................................................................................................................7
2.2 Install Blade or Bur .........................................................................................................................................................................................8
2.3 Attach Tubing ...................................................................................................................................................................................................8
2.4 Attach tubing clip ............................................................................................................................................................................................8
2.5 Perform Surgery ...............................................................................................................................................................................................9
2.6 Handle Emergencies ...................................................................................................................................................................................10
2.7 Disassemble System .................................................................................................................................................................................... 10
CHAPTER 3 CLEANING AND STERILIZATION GUIDELINES ...........................................................................................11
3.0 After Surgery .................................................................................................................................................................................................. 11
3.1 Cleaning ........................................................................................................................................................................................................... 11
3.2 Sterilization ................................................................................................................................................................................................... 11
3.2.1 XPS Micro Console and Power Cord ..................................................................................................................................................... 12
3.2.2 Foot Control ..................................................................................................................................................................................................12
3.2.3 StraightShot Magnum II and XPS StraightShot III Handpieces ................................................................................................... 12
3.3 Sterilization References .............................................................................................................................................................................. 12
CHAPTER 4 TECHNICAL SPECIFICATIONS .......................................................................................................................13
GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC IMMUNITY ........................................... 14
CHAPTER 5 TROUBLESHOOTING ....................................................................................................................................16
CHAPTER 6 ASSEMBLY/DISASSEMBLY ........................................................................................................................... 17
6.0 Introduction .................................................................................................................................................................................................. 17
6.1 System Block Diagram (Reference only) .............................................................................................................................................17
6.2 Console Assembly ....................................................................................................................................................................................... 18
6.3 Bottom Console Assembly ....................................................................................................................................................................... 18
6.4 Top Console Assembly ................................................................................................................................................................................19
6.5 Console Final Assembly ............................................................................................................................................................................19
SYMBOLS
C
SN
D
2
B
105345
STERILE EO
Caution
Catalog Number
Serial Number
Date Of Manufacture
Use By Date
Do Not Reuse
Sterilized Using Ethylene Oxide.
Lot Number
Power O / Power On
Forward
Oscillation
Foot Control
Type B Applied Part
Handpiece
Biohazard
RF Transmitter (Interference may occur)
Follow instructions for use
Conforms to ANSI/AAMI ES60601-1,
Certied to CAN/CSA-C22.2 No.60601-1,
IEC/EN 60601-1
XPS Micro System 1
WARNINGS AND PRECAUTIONS
It is important that the XPS Micro 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:
Warnings
Describes serious adverse reactions and potential safety hazards that can occur during the proper or improper use of a device.
Precautions
Any special care to be exercised by a practitioner or patient for the safe and eective use of the device.
Note
Identies special information allowing easier maintenance of equipment or to clarify or emphasize important instructions.
Warnings
• Do not operate the XPS Micro System in the presence of ammable anesthetics. Avoid potential ignition or explosion of gases.
• 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.
• Disconnect power to the XPS Micro Console before cleaning the unit to avoid electrical macro shock.
• Disposable blades, burs and irrigation tubing are for single-use only. Do not attempt to sterilize disposable blades, burs or irrigation tubing.
These disposables are packaged sterile and are not intended for repeated use. To prevent contamination use only once.
• Achieve electrical grounding reliability with proper connections. Connect the XPS Micro Console to hospital grade receptacles only.
• After each procedure, properly clean all reusable system components.
• 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 signicant 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
blades and burs. The use of powered reciprocating instruments may result in vibration-related injury. Use appropriate precautions.
• Employ visualization when using rotating XPS blades and burs. Discontinue powered application in the event of lack of visualization of the
surgical site.
• Use methods at the operative site (airway, throat, head, neck or sinus cavity) 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 repaired or
replaced. Damaged parts may deposit metal shavings on surgical site.
• Do not use any parts other than Medtronic Xomed, Inc. components as damage or substandard performance could result.
• Do not attach unapproved components to the XPS Micro Console to avoid electrical macro shock.
• Remove and discard tubing, blades and burs following local regulations for proper disposal of contaminated materials.
• 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.
• All service must be performed by Medtronic Xomed-qualied personnel only.
• Do not modify accessories used with the handpiece. Performance could be diminished with modied 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
dicult to remove, causing irritation, inammation and foreign-body response at surgical site.
• Always keep the cutting tip of the blade or bur away from ngers and loose clothing. Prevent laceration of user and cross-contamination
through compromised glove.
• Properly dispose of single-use devices removed from sterile packages. Devices lost sterility upon removal from packaging.
• Sterilize and dry handpiece before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
• Verify handpiece was sterilized prior to use. If not sterilized, do not use.
• Bending or prying may break the blade or bur, causing harm to patient or sta.
• Do not change blades or burs with handpiece running to prevent laceration of user and cross-contamination through compromised glove.
• Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue removal from patient.
• Do not use accessory if package is opened or damaged. Broken seal oers no protection against cross-contamination.
2 XPS Micro System
Precautions
• 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.
• 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.
• DO NOT immerse or sterilize the console, foot control or power cord.
• DO NOT allow uids to drip onto the console, moisture inside console could cause damage.
• 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.
• The handpiece should be evaluated prior to each use for suitable operating condition.
• It is recommended that a secondary handpiece be available to minimize any downtime and inconvenience to the surgical sta.
• 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.
• Remove the handpiece from the sterilizer immediately after the sterilization cycle is complete.
• Use only mild alkaline, low sudsing detergent (Medtronic Xomed Drill System Cleaning solution is recommended).
• DO NOT cold soak sterilize the handpiece in glutaraldehyde. This will void warranty.
• 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 aect Medical Electrical Equipment.
• Use of accessories and cables other than those specied and sold by Medtronic Xomed may result in increased emissions and decreased
immunity of this unit.
• The XPS Micro System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the XPS Micro
System should be observed to verify normal operation in the conguration in which it will be used.
INTERNATIONAL CUSTOMER SERVICE
International customers should contact their local Medtronic Xomed oce or distributor.
THE XPS MICRO SYSTEM HELP LINE
Should you need immediate help with a technical question or guidance through the appropriate protocol, just call the XPS Micro System Help
Line at 1-904-296-9600.
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 (s)
Serial Number (s)
Date of Purchase
XPS Micro System 3
LIMITED WARRANTY
A. This LIMITED WARRANTY provides assurance for the customer who purchases a XPS Micro (hereinafter the “Product”) that should the Product
fail to function to Medtronic Xomed’s published specications during the term of this LIMITED WARRANTY (one year from the date of shipment
for new Product, 90 days from date of shipment for refurbished or used Product), Medtronic Xomed will either replace, repair, or issue a credit
(adjusted to reect the age of the Product) for the Product or any portion thereof. This LIMITED WARRANTY is extended only to the buyer
purchasing the Product directly from Medtronic Xomed or from its aliate or its authorized distributor or representative.
B. To qualify for this LIMITED WARRANTY, the following conditions must be met:
(1) The Product must be used on or before its “Use By” or “Use Before” date, if applicable.
(2) The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper
handling.
(3) Medtronic Xomed must be notied in writing within thirty (30) days following discovery of a defect.
(4) The Product must be returned to Medtronic Xomed within thirty (30) days of Medtronic Xomed receiving notice as provided for in (3) above
(5) Upon examination of the Product by Medtronic Xomed, Medtronic Xomed shall have determined that: (i) the Product was not repaired or
altered by anyone other than Medtronic Xomed or its authorized representative, (ii) the Product was not operated under conditions other
than normal use, and (iii) the prescribed periodic maintenance and services have been performed on the Product.
C. This LIMITED WARRANTY is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR
IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. In no event shall Medtronic Xomed be liable for any consequential, incidental, prospective or other similar damage resulting from a
defect, failure, or malfunction of the Product, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.
D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions
of applicable law. Users may benet from statutory warranty rights under legislation governing the sale of consumer goods. If any part or
term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conict with applicable law,
the validity of the remaining portion of the LIMITED WARRANTY shall not be aected, and all rights and obligations shall be construed and
enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.
Caution
Applicable law may restrict the sale, distribution or use of this device to, by or on the order of a licensed medical practitioner.
Returns and/or Repairs
Contact Medtronic Xomed Customer Service at (904-296-9600) to obtain a Return Goods Authorization number (RGA#) prior to shipping the
Product to Medtronic Xomed. Please have the original invoice number or purchase order number available to assist in verifying warranty
information. The RGA# should be prominently displayed on the box and included on all paperwork enclosed with the return and/or repair. All
Product returned to Medtronic Xomed should be safely packed in protective wrapping. Customer must supply the Purchase Order number; the
correct shipping and billing address; and either a completed Repair Order Form or a statement of the problem or reason for return.
4 XPS Micro System
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