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
CHAPTER 1
XPS MICRO SYSTEM
1.0 System Description
1.1 XPS Micro System
Consists of a power control console, foot control, power cord, handpiece and manual. The system is used to drive XPS accessories.
The XPS Micro System is designed to accommodate otorhinolaryngology including but not limited to the following procedures:
• Functional Endoscopic Sinus Surgery (Fess)
• Adenoidectomy
• Removal of Laryngeal and Vocal Cord Lesions
• Rhinoplasty
• Dermabrasion
1.1.1 XPS Micro Console
Provides power to the StraightShot Magnum II Handpiece and XPS StraightShot III Handpiece (for Japan Only).
1.2 Indications for Use/Intended Uses
1.2.1 XPS Micro System
Intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology and head and neck surgery. Sinus
indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus
trephination and irrigation, frontal sinus drill out, endoscopic DCR, and trans-sphenoidal procedures. Nasopharyngeal/laryngeal indications
include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, including the surgical management of
recurrent respiratory papillomatosis (RRP), and tonsillectomy/tonsillotomy. 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.
1.2.2 Operator Notice
The clinician is strongly recommended to have a thorough understanding of and experience with powered Microdebrider surgical equipment
prior to use. Medtronic Xomed provides surgical technique booklets relating to the application of the various cutting blades and accessories for
the XPS Micro System. The health care professional should seek out and review all other clinical reference materials as dictated by the individual
patient’s clinical condition.
1.3 Contraindications
None are known.
1.4 Components
When you unpack the XPS Micro System, save the cartons and packing material in which your system arrived. If the instrument is to be shipped
from one location to another, the custom designed shipping package will provide the best protection. When the box is unpacked, check o the
contents of the box against the items listed on the packing slip. If the contents are incomplete, or if there is damage, notify Medtronic Xomed.
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.
1.4.1 Ensure that the following components are present:
XPS Micro Console, Ref. 1894440
Pneumatic Foot Control, Ref. 3328200
One of the following handpieces:
StraightShot Magnum II Handpiece, Ref. 1897200
XPS StraightShot III Handpiece (Japan Only), Ref. 1897201
One of the following User’s Guides:
XPS Micro System User’s Guide and Service Manual (English Only), Ref. 1894445
XPS Micro System User’s Guide and Service Manual (Multi Lingual), Ref. 1894447
One of the following Power Cords:
Power Cord, North America, 115V, Ref. 1895820
Power Cord, United Kingdom/Ireland, 240V, Ref. 1895821
Power Cord, Europe, 230V, Ref. 1895822
Power Cord, Japan, 100V, Ref. 1895823
For a complete list of system components and accessories contact your local Medtronic Xomed representative or call Customer Service at 800874-5797 or 904-296-9600.
XPS Micro System 5
1.4.2 Pneumatic Foot Control
The Foot Control cable connects with the console by a push connector. Pedal: — The pedal provides control of handpiece speed. Handpiece
speed increases as the pedal is depressed.
1.4.3 StraightShot Magnum II Handpiece
The StraightShot Magnum II and StraightShot III Handpieces are intended for use with the XPS Micro Console, although they will also operate
with the XPS model 2000 and 3000 Consoles. When used with the XPS Micro Console, the StraightShot Magnum II and StraightShot III
Handpieces have a top operating speed of 3,000 rpm in oscillate mode and 6,000 rpm in forward mode. The handpiece features a convenient
locking mechanism and allows adjustability of blade or bur tip alignment. The lightweight design combines high power and precision
performance.
1.4.4 XPS Disposables
Disposable XPS blades, burs and tubing sets are available for use with this system.
6 XPS Micro System
CHAPTER 2
PREPARATION AND USE
2.0 GENERAL INFORMATION
Warning
• Do not operate the XPS Micro System in the presence of ammable anesthetics. Avoid potential ignition or explosion of gases.
• Achieve electrical grounding reliability with proper connections. Connect the XPS Micro Console to hospital grade receptacles only.
• 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.
• 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.
• Verify handpiece was sterilized prior to use. If not sterilized, do not use.
• 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.
Precautions
• 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.
2.1 Prepare Console, Handpiece and Accessories
1. Inspect components for damage and determine if system is ready to use.
2. Check console is turned o.
Mode Control
Speed Control
OOn
3. Plug the power cord into the console and into the wall outlet.
4. Connect the handpiece to the console.
Note: When inserting handpiece cable into the console, conrm that the red
marks align.
Foot Control Connector
Handpiece Connector
5. Connect the Foot Control cable to the console.
Note: Connect Foot Control to console in operating room to capture actual atmospheric pressure, against which foot pressure is
compared.
• Insert cable until the latch snaps (click) into place.
• Tug on cable to ensure it is correctly latched.
• Place Foot Control under table.
6. Turn the console on by pressing the power switch on the back panel.
• See green light indicating power ON.
• Turn power OFF.
XPS Micro System 7
2.2 Install Blade or Bur
Warning
• Do not modify accessories used with the handpiece. Performance could be diminished with modied accessories.
• 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.
• 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.
• Do not use accessory if package is opened or damaged. Broken seal oers no protection against cross-contamination.
1. Verify handpiece was sterilized.
2. Inspect for clean appearance.
3. Pull back the locking collet (A) on the front of the handpiece.
4. Insert blade or bur with a slight rotating motion until blade or bur is seated.
5. Align blade or bur tip opening to desired position.
6. Release the locking collet.
7. Pull on the blade or bur to ensure engagement and visually check to make sure distal tip of inner blade is in contact with the distal tip of
the outer cannula.
A
C
B
2.3 Attach Tubing
1. Adjust the clamp on the irrigation tubing to the o position and spike the bag of irrigant.
2. Push the free end of the irrigation tubing onto the irrigation port on the blade (B) until tubing passes barb on the port and is secure.
3. Attach suction tubing securely to the suction port on the handpiece (C).
4. Clinic provided standard suction tubing:
a. Attach standard suction tubing to exhaust port of handpiece.
b. Attach suction tubing to clip.
c. Attach suction tubing to dedicated suction canister.
5. Irrigation tubing:
a. Attach irrigation tubing to handpiece.
b. Attach tubing to clip.
2.4 Attach tubing clip
1. Secure clip (D) to Strain Relief (E).
2. Secure the suction and irrigation tubing to the handpiece cable with clip (D).
8 XPS Micro System
D
E
2.5 Perform Surgery
Warning
• 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.
• 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.
• 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.
• Properly dispose of single-use devices removed from sterile packages. Devices lost sterility upon removal from packaging.
Surgical Warnings
• 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.
• 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.
• 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.
• Discontinue use of curved bur if tip begins to wobble and replace bur to prevent unintended tissue removal from patient.
Precautions
• Do not allow uids to drip onto the console, moisture inside console could cause damage.
• To prevent damage to curved blades and burs, disconnect suction tube prior to changing blade or bur during procedure.
• 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.
1. Inspect components for damage and determine if system is ready to use.
2. Select forward or oscillate mode by rotating mode knob on top of console.
3. Select handpiece speed by rotating speed control knob on top of console.
Handpiece operating ranges
Handpiece Rotation Mode Low Limit High Limit
StraightShot Magnum II FWD 500 rpm 6,000 rpm
StraightShot Magnum II OSCILLATE 500 rpm 3,000 rpm
XPS StraightShot III FWD 500 rpm 6,000 rpm
XPS StraightShot III OSCILLATE 500 rpm 3,000 rpm
4. Press power switch on back of console to on position.
5. Open tubing clamp to allow irrigation to ow to blade or bur.
6. With all system parts active, press footswitch to check performance.
Note: Achieve 500 RPM by turning speed control knob fully, counter clockwise, then pressing foot control lightly.
OOn
XPS Micro System 9
2.6 Handle Emergencies
In the event of any life-threatening emergency follow standard operating procedures at your site. In the event that power to the unit is
interrupted, immediately remove foot from footswitch.
2.7 Disassemble System
A. Remove Blade or Bur
BIOHAZARD
Warning
• 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.
• Remove and discard tubing, blades and burs following local regulations for proper disposal of contaminated materials.
1. Remove the tubing.
2. Depress the locking collet of the handpiece and pull the blade or bur out.
3. Discard the tubing, blade and/or bur following local regulations.
B. To Disconnect the Cables from the Console
1. Grasp the cable connector and gently pull back on the collar of the connector. The connector will disconnect.
2. When removing Foot Control Cable
a. Press latch down.
b. Pull cable out.
10 XPS Micro System
CHAPTER 3
CLEANING AND STERILIZATION GUIDELINES
3.0 After Surgery
BIOHAZARD
Note: Discarding of biohazard and/or non-reusable materials should be done following local regulations for proper disposal of
contaminated materials.
Warnings
• After each procedure, properly clean all reusable system components.
1. Cleaning and sterilizations regulations and standard operating procedures must be followed.
2. Remove the tubing.
3. Depress the locking collet of the handpiece and pull the blade or bur out.
4. Discard the tubing, blade and/or bur following local regulations.
3.1 Cleaning
Warnings
• 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.
• 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.
Precautions
• 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 immerse or sterilize the console, foot control or power cord.
• Use only mild enzymatic detergent.
• Do not cold soak sterilize the handpiece in glutaraldehyde. This will void warranty.
1. Turn the power o and remove AC plug from wall outlet.
2. At the console, grasp the cable collar and gently pull back. The connector will disconnect.
3. Remove Foot Control Cable by pressing down on the latch and then pulling the cable out.
4. Remove power cord from back of console.
5. Wipe the console with disinfectant.
6. Dry console with a clean, non-abrasive cloth after cleaning. Moisture inside the console could cause damage.
7. Wipe power cord with disinfectant.
8. Wipe foot control and foot control cable with disinfectant or a mild detergent and water.
9. Wipe handpiece and cable with disinfectant.
10. Gently clean the handpiece with a moistened soft bristle brush or pipe cleaner. Ensure cleaning all passages. Use a mild enzymatic
detergent solution to loosen and remove collected tissues from the unit.
11. Hold handpiece with the front end pointed downward during rinsing.
12. Dry handpiece and cable with a lint-free towel. Make sure to dry o the electrical connection on the cable ends.
13. Apply a small amount of silicone spray into front-end collet and outside of handpiece. Wipe dry before storing.
14. Sterilize handpieces immediately after cleaning.
3.2 Sterilization
Warnings
• Sterilize and dry handpiece before storing the system. Decrease likelihood of cross-contamination with timely sterilization.
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. Heating above 149°C 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.
• Remove the handpiece from the sterilizer immediately after the sterilization cycle is complete.
• Do not cold soak sterilize the handpiece in glutaraldehyde. This will void warranty.
XPS Micro System 11
3.2.1 XPS Micro Console and Power Cord
Do not attempt to sterilize.
3.2.2 Foot Control
Do not attempt to sterilize.
3.2.3 StraightShot Magnum II and XPS StraightShot III Handpieces
The following cycles are compatible with the each handpiece as listed below; however, it is the responsibility of each health care facility to validate the
sterilization process with their particular equipment and procedures to assure sterility.
Sterilization
(Temperatures are
minimum required,
times are minimum
required)
The sterilization parameters given below should be used for devices that are fully disassembled when disassembly is possible. Use basic
aseptic technique during post-sterilization assembly to maintain the sterility of the instrument(s). All steam sterilization cycles have been
validated in the wrapped conguration and instruments can be sterilized wrapped or unwrapped.
Steam Sterilization
Cycle Gravity Pre -Vac Pre-Vac (FR/WHO) Pre-vac (UK)
Temperature 121C 132C 134C 134C
Time 40 minutes 4 minutes 18 minutes 3 minutes
Drying 8 minutes, or until visibly dry
STERRAD 100S Compatible
100% EtO Sterilization Parameters
Preconditioning 54±2°C, 60±5% relative humidity, 30 minutes
Sterilization Temperature 54-55C
Relative Humidity 60 +/- 5%
Ethylene oxide concentration 600 +/- 25 mg/L
Gas exposure time (full-cycle) 120 minutes
Aeration 48-52C, 8 hours
3.3 Sterilization References
• AAMI TIR12: Designing, testing and labeling reusable medical devices for reprocessing in health care facilities
• AAMI TIR28: Product Adoption and Process Equivalence for Ethylene Oxide Sterilization.
• ISO 11135-1: Sterilization of health care products – Ethylene Oxide – Part 1: Requirements for development, validation, and routine control of
a sterilization process for medical devices
• ISO 11135-2: Sterilization of health care products – Ethylene Oxide – Part 2: Guidance on the application of ISO 11135-1
• ISO 10993-7: Biological evaluation of medical devices. Part 7: Ethylene oxide sterilization residuals
• AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
• ISO 17664: Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical
devices.
• ISO 14937: Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development,
validation and routine control of a sterilization process for medical devices.
• HTM 2010 Health Technical Memorandum 2010 Part3: Validation and Verication – Sterilization
12 XPS Micro System
CHAPTER 4
TECHNICAL SPECIFICATIONS
XPS Micro Console
Part No. 1894440
Electrical Input Power 100-240 VAC, 50-60 Hz, 100W Max
Size 16 cm Width x 12 cm Height x 21 cm Depth
Weight 1.3 kg
Class Class I Medical Device per EN 60601-1
Ingress Protection IP42
The product is protected against ingress of
particles and liquid to the level IP42. A 4mm
probe can not enter the enclosure and contact
live parts and the product is protected against
splashing and dripping liquid.
StraightShot Magnum II Handpiece/XPS StraightShot III Handpiece
Part No. 1897200 or 1897201
Speed 500-3,000 rpm oscillate
500-6,000 rpm forward
Size 17 cm length x 1.6 cm diameter
Weight 0.45 kg
Duty Cycle Maximum On Time 55 seconds
Minimum O Time 30 seconds for 30 minutes of duty cycle
Minimum 1 hour rest before restarting duty cycle.
Foot Control
Part No. 3328200
Size 11.5 cm Length x 8.9 cm Width x 5.6 cm Height
Weight 0.8 kg
Ingress Protection IPX8
The product is protected against ingress of liquids and against the
eects of constant submersion in water.
Recommended Environmental Conditions
Operating Temperature 10 - 33°C
Humidity 30 - 75% RH
Pressure 700 – 1060 hPa
Storage Temperature -40 - 70°C
Humidity Up to 95% RH at 35°C for maximum 3 days
Pressure 500 – 1060 hPa
Preventive Maintenance
After each use: Spray silicone into handpiece collet assembly
Weekly Inspection: Footswitch cable O-ring.
To maintain the system in good working order, follow “Cleaning &
Sterilization Guidelines”.
Compliance
IEC/EN 60601-1: 2nd and 3rd edition
CAN/CSA-C22.2 No. 60601-1
IEC/EN 60601-1-2: 2nd and 3rd edition
XPS Micro System 13
GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC IMMUNITY
Guidance and manufacturer’s declaration – electromagnetic immunity - Part I
The XPS Micro System is intended for use in the electromagnetic environment specied below. The customer or the user of the XPS Micro System should assure
that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply lines
IEC 61000-4-11
Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV dierential mode
±2 kV common mode
<5 % UT for 0.5 cycle S
40 % UT for 5 cycles
70 % UT for 25 cycles
<5 % UT for 5 sec
3 A/m 3 A/m Power frequency magnetic elds should be at
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV dierential mode
±2 kV common mode
<5 % UT for 0.5 cycles
40 % UT for 5 cycles
70 % UT for 25 cycles
<5 % UT for 5 sec
Floors should be wood, concrete, or ceramic
tile. If oors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the XPS Micro System requires
continuous operation during power mains
interruptions, it is recommended that the
XPS Micro System be powered from an
uninterruptible power supply or a battery.
levels characteristic of a typical location in a
typical commercial or hospital environment.
Guidance and manufacturer’s declaration – electromagnetic emissions
The XPS Micro System is intended for use in the electromagnetic environment specied below. The customer or the user of the XPS Micro System should assure
that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage uctuations
IEC 61000-3-3
Group 1 The XPS Micro System uses RF energy only for its internal function. Therefore, its
Class B The XPS Micro System is suitable for use in all establishments, including domestic
Class A
Complies
RF emissions are very low and are not likely to cause any interference in nearby
electronic equipment
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings for domestic purpose.
14 XPS Micro System
Recommended separation distances between portable and mobile RF communications equipment and the XPS Micro System
The XPS Micro System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of
the XPS Micro System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the XPS Micro System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
power of transmitter
W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and
people.
Guidance and manufacturer’s declaration – electromagnetic immunity - Part II
The XPS Micro System is intended for use in the electromagnetic environment specied below. The customer or the user of the XPS Micro System should assure
that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
Separation distance according to frequency of transmitter (meters)
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz
d = 1.2 √P
800 MHz to 2.5 GHz
d = 2.3 √P
guidance
Portable and mobile RF communications
equipment should be used no
closer to any part of the XPS Micro
System, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and
people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters,
an electromagnetic site survey should be considered. If the measured eld strength in the location in which the XPS Micro System is used exceeds the
applicable RF compliance level above, the XPS Micro System should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the XPS Micro System.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
3 Vrms
50 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m). Field strengths from xed
RF transmitters, as determined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range.b Interference
may occur in the vicinity of equipment
marked with the following symbol:
XPS Micro System 15
CHAPTER 5
TROUBLESHOOTING
• All service must be performed by Medtronic Xomed-qualied personnel only.
• The appliance inlet or the attachment plug is the means of disconnection from the supply mains.
• The XPS Micro shall be so positioned that it is not dicult to access and remove the attachment plug from the electrical supply.
Blade/Bur Malfunctions
Symptom Cause Solution
Damaged blade or bur. Upon inspection, blade or bur appears to be
Blade/bur doesn’t rotate. Blade or bur is not rmly seated. Pull back locking collet and reseat the blade or bur.
Blade not cutting eectively. Blade opening is obstructed. Remove blade from surgical site and submerse the
Blade or bur is leaking irrigant. Blade/bur not locked in collet correctly.
Handpiece
Symptom Cause Solution
Green LED on but Handpiece does Not rotate
when Foot Control is pressed.
Handpiece operates at high heat levels, stalls or
operates intermittently, or operates in a noisy
condition.
Foot Control
Symptom Cause Solution
Connector will not plug into console. Latch in “Up” position. Press Latch down and insert cable.
Console
Symptom Cause Solution
No Green LED. No Power. Check AC Cord is fully seated into AC Outlet and
Failed performance check. 1. Remove foot from foot control.
If second performance check were to reveal
continued problems.
damaged or defective.
Blade clogged.
Suction line has a leak or poor connection at
handpiece canister.
Suction line clogged.
Blade or bur continues to malfunction.
Wrong Handpiece.
Poor Connection.
Handpiece malfunction. The handpiece should be returned to Medtronic
Remove and replace defective blade or bur.
blade tip in sterile water with suction connected to
the handpiece to evacuate the obstruction, or use
stylet to clear blade.
The suction tube may be removed from the
handpiece and inserted over the end of the blade
and blade activated to evacuate the obstruction
from the tip of the blade.
Check for proper blade/bur insertion by pulling
back locking collar, and reseating blade/bur.
Check blade for obstruction. If visible, evacuate
obstruction.
Inspect suction connection on handpiece and
at suction canister, and if suction tubing is not
connected, then reconnect it.
Remove and inspect suction tubing, and if
obstructed, remove obstruction.
Remove and replace blade or bur.
Call Customer Service.
Use only StraightShot Magnum II or XPS
Straightshot III Handpiece.
1. Disconnect and reconnect handpiece.
2. Dry handpiece.
Xomed for service or repair.
back of Console.
Check Power Switch is on.
Check Fuse in back of Console.
2. Cycle console power OFF then ON again.
3. Repeat performance check.
1. Remove foot from foot control.
2. Turn console power o.
3. Re-check.
16 XPS Micro System
CHAPTER 6
Handpiece
Console
Power
Supply
Power Entry
Module
Circuit
Board
Indicator
Light
Mode
Maximum
Speed
Handpiece
cable
Pressure
Buffer &
Voltage to
Speed Signal
Forward/Reverse
Motor Start
ENABLE
+5 V & +12 V
Maximum
Switch
Mode Switch
Handpiece Connection
Magnum II (StraightShot III)
Switching Power Supply
Foot
Power
Pressure Line
12-pin Lemo
Receptacle
Connector, 48 VDC
Console
Power Cord
Motor Controller Circuit Board
Tubing
ASSEMBLY/DISASSEMBLY
6.0 Introduction
• All service must be performed by Medtronic Xomed-qualied personnel only.
• Send XPS Micro components to authorized Medtronic Xomed repair center.
• Use instructions below as guidance to eld service.
• The following drawings and instructions are subject to change without notice.
• For reference only. Note: Inappropriate service will void warranty.
6.1 System Block Diagram (Reference only)
A A
Foot
Control
Handpiece
Speed
Slope
Generator
& Brake Signal
Generator
Entry
Module
Generator
Regulators and
Indicator Light
Frequency
Converter
Limiter
Motor
Controller
Logic
Transducer
Receptacle
Control
Circuit Board Functional Blocks
XPS Micro System 17
6.2 Console Assembly
Console consists of four basic parts:
• Top Enclosure
• Bottom Enclosure
• Rear Plate
• Power Supply and Mounting Plate
6.3 Bottom Console Assembly
Note: Apply VibraTite (20) about ½ hour prior to assembly
to the exposed threads of the Handpiece Cable (2)
connector and Footswitch Receptacle “Coupling” (1).
1. Apply Loctite (21) to screws (10).
2. Orient Power Supply (5) to Mounting Plate (8).
3. Install two screws (10) and set aside.
4. Install Footswitch Receptacle (1) into Bottom
Enclosure (8).
a. Remove nut from Footswitch Receptacle.
b. Insert receptacle through hole from outside to
inside.
c. Orient release tab of Footswitch Receptacle to
the top.
d. Replace nut and tighten.
5. Install Handpiece Connector Cable (2) to Bottom
Enclosure (8).
a. Remove cosmetic nut.
b. Insert connector through hole from inside to outside.
c. Screw on the Cosmetic Nut until:
• The ats on the Cosmetic Nut are vertical.
• The red dot on the connector is centered on top.
• The connector face is ush with the face of the cosmetic nut.
d. Tighten inside nut (Take care not to damage the Decal and ground ring).
6. Attach Mounting Plate (8) with Power Supply to Bottom Enclosure (8) with
screws (9).
7. Insert Power Entry Module (3) through Rear Plate (8) and press in until it clips
lock.
8. Slide Rear Cover (8) down into slots on Bottom Console (8).
9. Connect Power Entry Cable (3) to Power Supply (5).
10. Attach Ground from Power Entry Module (3) to Ground Stud on Power Supply
(5) with Starwasher (15) and Nut (12).
11. Attach Ground from Handpiece Connector Cable (2) to Ground Stud on Power
Supply (5) with Starwasher (15) and Nut (12).
12. Connect Tubing (22) to Footswitch Receptacle (1).
13. Connect Cable (4) to Power Supply (5).
18 XPS Micro System
6.4 Top Console Assembly
1. Align PWA XPS Micro Console (19) to standos.
a. Verify that LED mounted on PWA is positioned at the window at top decal
on enclosure.
b. Insert screws (11) with washers (16) and tighten.
2. Install Washer (14) and Nut (13) on rotary Switches and tighten.
3. Attach Knobs (7) to Switches by aligning Setscrew (supplied with Knobs) with
at on switch and tighten.
6.5 Console Final Assembly
1. Place Top Console (8) and Bottom Console (8) next to each other and connect
cables and tubing as follows:
a. Cable (4) from Power Supply to PWA (19).
b. Handpiece Cable (2) to PWA (19).
c. Tubing (22) from Footswitch Receptacle (1) onto the Pressure Switch
mounted on PWA (19).
• Verify each end of tubing is pressed on as far as possible.
2. Align Rear Cover (8) to slots in Top Console (8) and slide together ensuring
Cables and Tubing remain neat and are not pinched.
3. Place four Screws through Bottom Enclosure and tighten.
4. Snap in Screw Boss Covers.
Note: Disassembly is the REVERSE of assembly.
The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to
the product described in this manual. Refer to manuals.medtronic.com for the current version.
XPS Micro System 19
REF 1894445
EC REP
68E3777 F
2015-05
© 2015 Medtronic, Inc.
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, Florida USA 32216
800.874.5797
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
011.31.45.566.8000
medtronicENT.com
manuals.medtronic.com
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