5900 Optical CourtSan Jose, CA 951381-800-624-4422

1000-400-371 Rev. C

TPS Small JointShaver Handpiece

(275-601-500)

0197

The CE mark of this product indicates conformity to93/42/EEC Medical Device Directive when used inconjunction, as a system, with other products bearingthe same mark.

Stryker European RepresentativeRA/QA Manager - Stryker EuropeZAC Satolas Green PusignanAv. De Satolas Green69881 MEYZIEU Cedex, France

SYMBOL DEFINITION

This symbol is used to alert the reader to important safety andprecautionary information. When displayed on the actual device, itrefers the user to accompanying documents.

PREFACE

WARNINGS, CAUTIONS, AND NOTES

Please read this manual completely and follow its instructions carefully. Thewords WARNING, CAUTION, and NOTE carry special meanings and should becarefully reviewed.

WARNING The personal safety of the patient and/or user may beinvolved. Disregarding this information could result in injuryto the patient and/or operating staff.

CAUTION These instructions point out special service procedures orprecautions that must be followed to avoid damaging theinstrument.

NOTE This provides special information to make maintenanceeasier or important instructions clearer.

GENERAL INFORMATION

Stryker Corporation accepts full responsibility for the effects on safety, reliability,and performance of this equipment only if:

• Assembly operations, extensions, re-adjustment, modifications, orrepairs are carried out by persons authorized by Stryker Corporation.

• The electrical installation of the relevant room complies with theapplicable IEC, CEC, and NEC requirements.

WARNING Federal law (U.S.A.) restricts this device for use by, or onthe order of, a physician.

NOTE Stryker Endoscopy reserves the right to makeimprovements in the product(s) described herein.Product(s) therefore may not agree in detail to the publisheddesign or specifications. All specifications are subject tochange without notice. Please contact the StrykerEndoscopy Customer Service Department for informationon changes and new products.

TABLE OF CONTENTS

System Description............................................................................................................1

TPS Small Joint Shaver Handpiece...............................................................................1

Set Up & Operating Instructions........................................................................................3

Cable Connection................................................................................................................3

Installing and Removing Cutter and Bur..........................................................................4

Handpiece Operation.............................................................................................................5

Cleaning & Maintenance.....................................................................................................7

Sterilization Recommendations......................................................................................9

Trouble Shooting..............................................................................................................11

Periodic Maintenance.......................................................................................................12

Specifications...................................................................................................................14

Description of Type BF Equipment................................................................................14

Instrument Repair and Loaner Program.......................................................................15

Limited Warranty...............................................................................................................16

Reorder Information.......................................................................................................17

Service Locations...............................................................................................................19

USER AND PATIENT SAFETY

Please note the following WARNINGS:

• DO NOT operate in an environment in the presence of a flammableanesthetic mixture with air, oxygen, or nitrous oxide.

• The TPS Small Joint Shaver handpiece is designed to be used by a person familiar with arthroscopic procedures. Misusing the TPS SmallJoint Shaver handpiece may cause damage to both the patient andsystem components. Prior to use, inspect system components for functionand damage. DO NOT use the equipment if damage is apparent.

• Avoid contacting cutters and burs with metal objects. Do not insertmetal objects in the shaver blade or bur window. If cutters or burscontact metal objects, it may cause the cutter or bur to break andleave pieces in the wound, which may be difficult to remove.

• Bending or prying with cutters or burs may cause the cutter or bur tobreak or shed metal and leave pieces in the wound, which may bedifficult to remove.

• Disposable cutters and burs are for SINGLE USE ONLY! Do notreuse cutters and burs.

CAUTIONS:

• To provide adequate cooling for the cutters, to prevent accumulationof unwanted materials in the surgical site, and to prevent abnormalwear of the cutting surfaces, be certain that the cutter tip is immersed inwater and that suction (at least 5 inHg vacuum) is flowing whenever theinstrument is running.

SYSTEM DESCRIPTION

TPS SMALL JOINT SHAVER HANDPIECE275-601-500

The Stryker TPS Small Joint Shaver handpiece is an electrically poweredinstrument specifically designed to accomplish soft tissue debridement andbone abrasion and removal. The TPS console powers the handpiece. The TPSfootswitch provides control of the handpiece. The handpiece features a quicklocking mechanism for cutter insertion and is designed to provide suctioncontrol at the handpiece for surgeon convenience. A variety of shaver bladesand burs is available to meet surgical needs.

For a complete list of system accessories refer to product brochures, availablefrom your Stryker representative or call Stryker Customer Service,1-800-624-4422.

NOTE The TPS Small Joint Shaver handpiece is onlycompatible with the Stryker TPS Console.

Read and understand the information in this manual.Familiarization with the TPS Small Joint Shaver Handpieceand TPS console prior to use is also important. For further

WARNING information, contact your Stryker representative.

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SET UP & OPERATING INSTRUCTIONS

Cable Connections

CAUTION These are PUSH/PULL connectors. DO NOT thread or twistfor insertion or removal.

To connect the cables:

1. Match the red dot on the cable with the red dot on the console.

2. Gently push connectors together. They will lock in place.

To disconnect cables:

1. Grasp the cable connector and pull back on the connector collar.DO NOT pull on the cable.

2. The connector will disconnect.

Handpiece

Installing and Removing Shaver Blades and BursTo insert a shaver blade or bur:1. Push down on the locking collar of the handpiece.

2. Gently insert the shaver blade or bur. A slight rotating motion will helpproperly seat the cutter or bur.

3. Release the locking collar.

4. Pull the installed shaver blade or bur slightly to ensure that it is engaged.

Disposable shaver blades and burs are for ONE USE ONLY!Do not attempt to sterilize disposable shaver blades or burs,as they are packaged sterile and are not intended for seconduse.

WARNING

Use only Stryker approved shaver blades and burs inconjunction with the TPS Small Joint Shaver Handpiece.

WARNING

To remove a shaver blade or bur:

1. Push down on the locking collar of the handpiece.

2. Lift the shaver blade or bur out of the handpiece.

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Handpiece Operation

1. Attach cutter or bur to handpiece as described above.2. Plug handpiece cable into console.3. Connect footswitch to console.4. Set the wall suction to the desired level.5. Plug the console into the wall and turn it on.6. Set the maximum handpiece speed and mode with the touch screen

on the console or footswitch.

Before using this system, read and understand theinformation in this manual and the instructions supplied witheach TPS component. Familiarization with the Total PerformanceSystem WARNING prior to use is important.

7. Activate the handpiece using the footswitch. Depending on userpreference, footswitch pedal may be assigned different functions usingthe TPS console.

8. Regulate the suction by rotating the lever on the top of the handpiece.The suction is fully on when the lever is rotated toward the front of thehandpiece. The suction is off when the lever is rotated aft.

Excessive pressure, such as bending or prying, may causecutters and burs to bend or break and may cause harm topatient and/or operating room staff.

WARNING

WARNING DO NOT modify accessory for use in handpiece.

WARNING DO NOT attempt to change accessory while handpiece isrunning.

CAUTION DO NOT stall instruments. This may damage system.

CAUTION DO NOT immerse handpiece when HOT.

Page 7 Page 8

CLEANING and MAINTENANCE

CAUTION DO NOT use solvents, lubricants or other chemicals, unlessspecified otherwise.

AFTER EACH SURGERY

1. Prior to cleaning, remove bur, blade, cutter, and instrument components.

2. Rinse units thoroughly under running tap water, flushing water through allpassages.

3. Lay the units in a horizontal position in a clean pan. Prepare an enzymaticdetergent solution as recommended by the manufacturer. Add a sufficientamount of the prepared solution to the pan to cover the units.

4. Leave the units to soak for the recommended amount of time. This willreduce blood, protein and mucus from the instrument.

5. After soaking, remove the units and rinse thoroughly under running tapwater.

6. Use a mild detergent to clean the units. Using a soft bristle brush, gentlyclean the device while immersed in the cleaning solution. Thoroughlybrush all passages of the unit.

7. Flush the units thoroughly under running water.

8. Shake the handpiece, with locking collar pointing downward, to removeany water.

NOTE Compressed air or nitrogen may be used to remove any additionalmoisture from handpiece.

9. Dry handpiece with lint-free towel. Pay special attention to the electricalconnection where the cable attaches to the handpiece.

10. Sterilize handpiece per Sterilization Recommendations.

WARNING System components should be operated and inspected for anydamage. DO NOT use if damage is apparent.

NOTE Clean handpieces prior to sterilization.

NOTE After sterilization, the electrical connector of the handpiece mustbe free of any moisture in the internal connection features.Damage could result to the instrument if it is operated withmoisture.

STERILIZATION RECOMMENDATIONS

CAUTION Sterilize handpiece prior to first use and every use thereafter.

Clean handpiece before sterilization (see Cleaning and Maintenance). Use thefollowing information to sterilize handpieces when using one of the followingmethods.

HANDPIECE

“Flash” Autoclave• Gravity displacement sterilizer• 270-272°F (132-134°C)• Unwrapped instrument tray• 10 minute minimum exposureHi-Vac• Pre-vacuumed sterilizer• 270-272°F (132-134°C)• Wrapped or unwrapped• 4 minute minimum exposure time• 8 minute minimum dry time270 F Gravity• Gravity displacement sterilizer• 270-272°F(132-134°C)• Wrapped in an instrument tray or fully perforated

sterilization box• 35 minute exposure time• 8 minute dry time250 F Gravity• Gravity displacement sterilizer• 250-254°F(121-123°C)• Wrapped in an instrument tray or fully perforated

sterilization box• 45 minute exposure time• 8 minute dry timeEtO/Oxyfume 2002• Wrapped in an instrument tray or fully perforated

sterilization box• Preconditioning Parameters

Temperature: 54 ±2°CRelative Humidity: 70% ± 5%Precondition Time: 1 hr

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Sterilization ParametersEthylene Oxide Carrier: Oxyfume 2002Temperature: 54± 2°CRelative Humidity: 70% ± 5%Pressure (PSIG Start): 14 ± 1 PSIGEto Concentration: 600 ± 25 mg/LGas Exposure Time: 4 hours

• 12 hours aeration time @ 55°C100% EtO• Wrapped in an instrument tray or fully perforated

sterilization box• Preconditioning Parameters

Temperature: 54± 2°CRelative Humidity: 70% ± 5%Precondition Time: 1 hr

Sterilization ParametersTemperature: 54 ± 2°CRelative Humidity: 70% ± 5%Eto concentration 600±25mg/LGas Exposure Time: 4 hours

• 12 hours aeration time @ 55°C

After sterilization the electrical connector of the handpiece mustbe free of any moisture in the internal connection features.Damage could result to the instrument if it is operated with

CAUTION moisture.

CAUTION Cool by wrapping in a sterilized damp sponge or cloth.DO NOT IMMERSE TO COOL.

CAUTION DO NOT leave the handpieces in a steam sterilizer. Remove thehandpiece from the sterilizer immediately after sterilization.

CAUTION Be sure the suction valve on the handpiece is open during thesterilization and disinfection process.

TROUBLESHOOTING

ProblemShaver blade or bur does not turn.

CauseShaver blade or bur not seated properly.

SolutionPull back locking collar and reseat shaver blade or bur.

ProblemHandpiece will not run.

CauseHandpiece plug is not firmly seated in console.

SolutionEnsure handpiece cord is firmly plugged into console.

ProblemHandpiece will not run.

CauseThe cord is malfunctioning.

SolutionSend in handpiece for repair.

ProblemHandpiece will not run.

CauseFootswitch cord is not firmly seated in console.

SolutionEnsure footswitch cord is firmly plugged into console.

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PERIODIC MAINTENANCE SCHEDULE

The following table shows maintenance activities, time intervals, and the toolsand equipment.

ActivityRun handpiece for 1 minute to determine temperature. If the distal tip and bodyof the handpiece are uncomfortably hot to the touch (approximately 110°F),return the instrument for service.

Interval3 Months

Tools & Equipment RequiredN/A

ActivityCheck leakage current.

Interval12 Months

Tools & Equipment RequiredTrue RMS digital multimeterand safety analyzer (See Specifications)

Page 13

SPECIFICATIONS

REF: 275-601-500TPS SMALL JOINT SHAVER HANDPIECESpeed: 3000 RPMSize: 6.20"L x 1.125"H x .900"W(15cm x 3cm x 2cm)Weight: 7.1 oz. (200 g)

Classification:

Type BF Applied part.Duty cycle: Continuous operation.IPX0 Ordinary Equipment

NOTE See TPS Console/TPS Irrigation Console Users Manual foradditional TPS electrical safety specifications.

NOTE Follow current regulations to dispose of waste products, accessories,and equipment.

Page 14

Additional periodic maintenance procedures include the following:

Inspect each handpiece to be sure that it is in proper working order and thatthere are no loose or missing components. Check that all parts move freely.

Test each handpiece by assembling the system and running each handpiece.Attach the power source, assemble the accessories and operate. Note anyunusual sounds or vibrations, and note operating speeds.

Refer calibration and operating difficulties not detailed in this manual to yourStryker representative, distributor or Stryker Customer Service or the nearestsubsidiary.

To ensure the longevity, performance and safety of this equipment, package inoriginal packaging materials when storing or transporting.

INSTRUMENT REPAIR/LOANER

This service is available in the USA only.

The Stryker TPS Small Joint Shaver handpiece is not field repairable. In case ofoperating difficulties, all Stryker products must be returned to StrykerEndoscopy for maintenance. On request, Stryker will provide a loaner unit whilerepairs are being made to your TPS Small Joint Shaver handpiece.

To obtain repairs for any inoperative Stryker product:

1. Return the inoperative unit to the attention of Stryker Endoscopy,5900 Optical Court, San Jose, CA 95138.

CAUTION To ensure that the equipment is not damaged during shipping,package the equipment in its original packing material.

2. Include a purchase order number of authorization for repair. The ordershould explain the nature of the difficulty.

3. Include a name and address for shipping of the loaner instruments andthe repaired instruments.

4. If requested, every effort will be made to send a loaner unit immediately.Contact Stryker Customer Service at 1-800-624-4422 to request aloaner. Repair turnaround time does not exceed two weeks under mostconditions.

5. The repaired unit will be shipped back along with the invoice for therepair charges. If a loaner unit is provided, a memo billing for the unit willalso be included.

6. Return the loaner unit to the Stryker Endoscopy Repair Department assoon as a new unit is received. The memo billing for the loaner will becredited upon receipt of the loaner at Stryker.

For more information, call Stryker Customer Service at 1-800-624-4422.

Outside of the U.S.A., contact your Stryker sales representative or your Strykersubsidiary. A list of subsidiaries is on page 19.

Page 15 Page 16

LIMITED WARRANTY

Stryker Endoscopy warrants the TPS Small Joint Shaver handpiece againstdefects in both materials and workmanship to the registered owner at the time ofpurchase. All components are covered by the warranty for a period of one yearfrom the date of shipment. This warranty extends to all purchasers and is limitedto the repair or replacement of the product without charge when returned toStryker Endoscopy, 5900 Optical Court, San Jose, CA 95138. Stryker cannotaccept responsibility for returns or replacements which have not been autho-rized. Contact Stryker Customer Service at 800-624-4422 for return authoriza-tion.

This warranty does not apply to any unit which has been subject to misuse,abuse, neglect, improper installation or operation or that has been altered,adjusted or tampered with by any person other than Stryker Endoscopyauthorized service personnel.

If upon examination by authorized service personnel it is determined that themalfunction is due to misuse or abuse, warranty provisions will not apply. Anestimate of the cost of repair work will be given to the customer prior to servicingand repairing the unit.

The customer is responsible for returning the defective equipment to the factoryat his or her own expense. Stryker Endoscopy or its representative will servicethe unit, repair or replace any defective parts thereof, and return the unit.

If, upon examination, it is determined that the fault has been caused by misuseor abnormal conditions of operation, the repairs will be billed to the customer inthe same manner as out-of warranty repair.

Instruments repaired by Stryker Endoscopy will be issued a 30 day warrantyagainst defects in both materials and workmanship, provided the originalwarranty period has passed. Instruments submitted due to defects in materialsand workmanship during the warranty period will be repaired at no charge tothe customer.

The warranty as set forth herein is exclusive and in lieu of all other warranties,remedies, obligations, and liabilities of Stryker Endoscopy, expressed orimplied, including the lightning bolt within a triangle intended to alert servicepersonnel of the presence of high voltage, which may cause injury or fatalelectric shock.

REORDER INFORMATION

275-601-500 TPS Small Joint Shaver handpiece

WARNING Use only Stryker approved accessories. A complete list ofaccessories is available from your Stryker representative, orcall Stryker customer service at 1-800-624-4422.

Page 17 Page 18

Page 19 Page 20

SERVICE LOCATIONSFor service in the U.S.A., call your Stryker Endoscopy representative or StrykerEndoscopy Customer Service at 1-800-624-4422. Outside of the U.S.A., please contactyour Stryker Endoscopy distributor at one of the following locations:

Stryker Corporation2725 Fairfield RoadKalamazoo, MI 49002USAPhone: 1-269-385-2600Telex: 224464 STRYKER KMZFax: 1-616-385-1996

Stryker Canada45 Innovation DriveHamilton, Ontario, CanadaL9H 7L8Phone: 905-690-5700(800) 668-8323 (toll free)Fax: +1(905) 690-5698

Stryker Deutschland GmbHGewerbeallee 18, D-45478Mulheim an der RuhrGERMANYPhone: 49-208-999060Fax: 49-208-9990666

Stryker Taiwan16F, No. 59, Sec. 2, Dunhua S. RoadTaipai 106, TAIWANPhone: 886-2-2701-1081, ext. 26Fax: 886-2-2701-1082

Stryker U.K. Ltd.Hambridge RoadNewburyBerkshire RG14 5 EGUKPhone: 44-1635-262400Fax: 44-1635-262464

Stryker B.V.Marinus Van Meelweg 17P.O. Box 87475657 LS EindhovenTHE NETHERLANDSPhone: 31-40-2922522Fax: 31-40-2922555

Stryker Europe Rep-RA/QA ManagerZAC Satolas Green PusignanAv. De Satolas Green69881 MEYZIEU Cedex, FRANCEPhone: 33-1-48175000Fax: 33-1-48632175

Stryker Korea11F, Dongsung Bldg, 158-24Samsung-dong, Kangnam-gu,Seoul 135-090, KOREAPhone: 82-2-565-7303Fax: 82-2-552-4456

Stryker AustraliaNo. 50 Broughton RoadArtarmon, NSW 2064AUSTRALIAPhone: 61-2-9415-5100Fax: 61-29-429-4127

Stryker Pacific HeadquartersSuite 2501, Citibank TowerCitibank Plaza3 Garden Road, CentralHONG KONGPhone: 852-2-9415-5100Fax: 61-29-429-4127

Stryker Singapore PTE/LTD70 Bendemeer Road#03-32 Hiap Huat HouseSINGAPORE 339940Phone: 65-293-0119Fax: 65-293-7028

Stryker Osteonics, SA5, Chemin des Aulx 51228 Plan-les-OuatesCase Postale 7151212 Grand-Lancy 1Geneve, SWITZERLANDPhone: 41-22-884-0111Fax: 41-22-884-0199

Stryker India Private LimitedFirst FloorC-5, SDA Commercial ComplexNew Delhi 110 017INDIAPhone: 91-11-686-6740Fax: 91-11-696-6020

Stryker JapanDai Tokyo Kasai Shinjuku Bldg.3-25-3, YoyogiShibuya-ku, Tokyo 151-0053JAPANPhone: 813-535-29106Fax: 813-535-21789

Stryker China10th Sungib Industrial Center53 Wong Chnk Hang RoadAberdeenHONG KONGPhone: 852-2814-7463Fax: 852-2873-0210

Stryker Europe HeadquartersCite-Centre, Grand Rue 92Ch-1820 MontreuxSWITZERLANDPhone: 41-21-966-1201Fax: 41-21-966-1200

Stryker Latin AmericaPlaza Royale Suite 30415600 NW 67th Ave.Miami Lakes, Florida 88014USAPhone: 1-305-821-1888Fax: 1-305-826-0067

Stryker Middle East / AfricaHamdan St.1404 Al Masoud Bldg.Abu DhabiU:A:EPhone: 9712-312145Fax: 9712-313698

Stryker Mexico, S.A. de C.V.Montecito No. 38Piso 12, Oficina 31Colonia NapolesMEXICO 03810Phone: 525-488-0890Fax: 525-488-0891

NV Stryker SA (Belgium)DoornveldIndustrie Asse nr. 11, Bus 451731 ZelikBELGIUMPhone: 32-246-3148Fax: 32-246-31321

Stryker ChileAvenida Nueva Tajamer 481Oficina 805 Piso 8Torre Norte, SantiagoCHILEPhone: 562-244-3600Fax: 562-244-3696

Stryker SpainPuentecesures, 1 bajo28029 MadridSPAINPhone: 34-1-323-1731Fax: 34-1-315-2782

Stryker ABAminogatan 34s-43153 MolndalSWEDENPhone 46 31 70 60 690Fax: 46 31 70 60 622

Stryker A/SStamholmen 193DDK 2650 HuidovreDENMARKPhone: 45 3677 9966Fax: 45 3677 8666

Stryker FinlandVemissakatu 8F03100 VantaaFINLANDPhone: 358 9 857 1400Fax: 358 9 857 1466

MANUFACTURER:

Stryker Endoscopy Inc.5900 Optical CourtSan Jose, CA 95138USAPhone: 1-408-754-2000Fax: 1-408-754-2505