TPS Small Joint Shaver Handpiece Instructions

PREFACE

SYMBOL DEFINITION

WARNINGS, CAUTIONS, AND NOTES Please read this manual completely and follow its instructions carefully. The words WARNING, CAUTION, and NOTE carry special meanings and should be carefully reviewed. WARNING

The personal safety of the patient and/or user may be involved. Disregarding this information could result in injury to the patient and/or operating staff.

CAUTION

These instructions point out special service procedures or precautions that must be followed to avoid damaging the instrument.

NOTE

This provides special information to make maintenance easier 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, or repairs are carried out by persons authorized by Stryker Corporation.

•

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

WARNING

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

NOTE

Stryker Endoscopy reserves the right to make improvements in the product(s) described herein. Product(s) therefore may not agree in detail to the published design or specifications. All specifications are subject to change without notice. Please contact the Stryker Endoscopy Customer Service Department for information on changes and new products.

This symbol is used to alert the reader to important safety and precautionary information. When displayed on the actual device, it refers the user to accompanying documents.

USER AND PATIENT SAFETY Please note the following WARNINGS:

TABLE OF CONTENTS System Description...1 TPS Small Joint Shaver Handpiece...1

•

•

•

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

Set Up & Operating Instructions...3

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

Installing and Removing Cutter and Bur...4

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

Trouble Shooting...11

Cable Connection...3

Handpiece Operation...5 Cleaning & Maintenance...7 Sterilization Recommendations...9

Periodic Maintenance...12 Specifications...14 Description of Type BF Equipment...14

•

•

Bending or prying with cutters or burs may cause the cutter or bur to break or shed metal and leave pieces in the wound, which may be difficult to remove. Disposable cutters and burs are for SINGLE USE ONLY! Do not reuse cutters and burs.

CAUTIONS: •

To provide adequate cooling for the cutters, to prevent accumulation of unwanted materials in the surgical site, and to prevent abnormal wear of the cutting surfaces, be certain that the cutter tip is immersed in water and that suction (at least 5 inHg vacuum) is flowing whenever the instrument is running.

Instrument Repair and Loaner Program...15 Limited Warranty...16 Reorder Information...17 Service Locations...19

SYSTEM DESCRIPTION NOTE

WARNING

TPS SMALL JOINT SHAVER HANDPIECE 275-601-500 The Stryker TPS Small Joint Shaver handpiece is an electrically powered instrument specifically designed to accomplish soft tissue debridement and bone abrasion and removal. The TPS console powers the handpiece. The TPS footswitch provides control of the handpiece. The handpiece features a quick locking mechanism for cutter insertion and is designed to provide suction control at the handpiece for surgeon convenience. A variety of shaver blades and burs is available to meet surgical needs. For a complete list of system accessories refer to product brochures, available from your Stryker representative or call Stryker Customer Service, 1-800-624-4422.

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The TPS Small Joint Shaver handpiece is only compatible with the Stryker TPS Console. Read and understand the information in this manual. Familiarization with the TPS Small Joint Shaver Handpiece and TPS console prior to use is also important. For further information, contact your Stryker representative.

SET UP & OPERATING INSTRUCTIONS

Handpiece

Cable Connections

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

These are PUSH/PULL connectors. DO NOT for insertion or removal.

thread or twist

2.

Gently insert the shaver blade or bur. A slight rotating motion will help properly seat the cutter or bur.

To connect the cables:

3.

Release the locking collar.

1.

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

4.

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

2.

Gently push connectors together. They will lock in place.

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 second use.

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.

WARNING Use only Stryker approved shaver blades and burs in conjunction with the TPS Small Joint Shaver Handpiece. WARNING To remove a shaver blade or bur:

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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. 2. 3. 4. 5. 6.

Attach cutter or bur to handpiece as described above. Plug handpiece cable into console. Connect footswitch to console. Set the wall suction to the desired level. Plug the console into the wall and turn it on. Set the maximum handpiece speed and mode with the touch screen on the console or footswitch. Before using this system, read and understand the information in this manual and the instructions supplied with each TPS component. Familiarization with the Total Performance System WARNING prior to use is important.

7.

8.

Activate the handpiece using the footswitch. Depending on user preference, footswitch pedal may be assigned different functions using the TPS console. 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 the handpiece. The suction is off when the lever is rotated aft.

WARNING

DO NOT modify accessory for use in handpiece.

WARNING

DO NOT attempt to change accessory while handpiece is running.

CAUTION

DO NOT stall instruments. This may damage system.

CAUTION

DO NOT immerse handpiece when HOT.

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

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CLEANING and MAINTENANCE

CAUTION

DO NOT use solvents, lubricants or other chemicals, unless specified otherwise.

WARNING

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

AFTER EACH SURGERY

NOTE

Clean handpieces prior to sterilization.

1.

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

NOTE

2.

Rinse units thoroughly under running tap water, flushing water through all passages.

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

3.

Lay the units in a horizontal position in a clean pan. Prepare an enzymatic detergent solution as recommended by the manufacturer. Add a sufficient amount of the prepared solution to the pan to cover the units.

4.

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

5.

After soaking, remove the units and rinse thoroughly under running tap water.

6.

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

7.

Flush the units thoroughly under running water.

8.

Shake the handpiece, with locking collar pointing downward, to remove any water.

NOTE

9.

Compressed air or nitrogen may be used to remove any additional moisture from handpiece.

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

10. Sterilize handpiece per Sterilization Recommendations.

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STERILIZATION RECOMMENDATIONS

CAUTION

Sterilize handpiece prior to first use and every use thereafter.

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

HANDPIECE “Flash” Autoclave • Gravity displacement sterilizer • 270-272°F (132-134°C) • Unwrapped instrument tray • 10 minute minimum exposure Hi-Vac • Pre-vacuumed sterilizer • 270-272°F (132-134°C) • Wrapped or unwrapped • 4 minute minimum exposure time • 8 minute minimum dry time 270 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 time 250 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 time EtO/Oxyfume 2002 • Wrapped in an instrument tray or fully perforated sterilization box • Preconditioning Parameters Temperature: 54 ±2°C Relative Humidity: 70% ± 5% Precondition Time: 1 hr

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Sterilization Parameters Ethylene Oxide Carrier: Oxyfume 2002 Temperature: 54± 2°C Relative Humidity: 70% ± 5% Pressure (PSIG Start): 14 ± 1 PSIG Eto Concentration: 600 ± 25 mg/L Gas Exposure Time: 4 hours • 12 hours aeration time @ 55°C 100% EtO • Wrapped in an instrument tray or fully perforated sterilization box • Preconditioning Parameters Temperature: 54± 2°C Relative Humidity: 70% ± 5% Precondition Time: 1 hr Sterilization Parameters Temperature: 54 ± 2°C Relative Humidity: 70% ± 5% Eto concentration 600±25mg/L Gas Exposure Time: 4 hours • 12 hours aeration time @ 55°C

CAUTION

After sterilization the electrical connector of the handpiece must be free of any moisture in the internal connection features. Damage could result to the instrument if it is operated with 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 the handpiece from the sterilizer immediately after sterilization.

CAUTION

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

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TROUBLESHOOTING

PERIODIC MAINTENANCE SCHEDULE

Problem Shaver blade or bur does not turn.

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

Cause Shaver blade or bur not seated properly.

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

Solution Pull back locking collar and reseat shaver blade or bur. Problem Handpiece will not run. Cause Handpiece plug is not firmly seated in console. Solution Ensure handpiece cord is firmly plugged into console. Problem Handpiece will not run. Cause The cord is malfunctioning.

Interval 3 Months Tools & Equipment Required N/A Activity Check leakage current. Interval 12 Months Tools & Equipment Required True RMS digital multimeter and safety analyzer (See Specifications)

Solution Send in handpiece for repair. Problem Handpiece will not run. Cause Footswitch cord is not firmly seated in console. Solution Ensure footswitch cord is firmly plugged into console.

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Additional periodic maintenance procedures include the following: Inspect each handpiece to be sure that it is in proper working order and that there are no loose or missing components. Check that all parts move freely.

SPECIFICATIONS REF:

Test each handpiece by assembling the system and running each handpiece. Attach the power source, assemble the accessories and operate. Note any unusual sounds or vibrations, and note operating speeds. Refer calibration and operating difficulties not detailed in this manual to your Stryker representative, distributor or Stryker Customer Service or the nearest subsidiary. To ensure the longevity, performance and safety of this equipment, package in original packaging materials when storing or transporting.

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275-601-500 TPS SMALL JOINT SHAVER HANDPIECE Speed: 3000 RPM Size: 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 for additional TPS electrical safety specifications.

NOTE

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

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INSTRUMENT REPAIR/LOANER This service is available in the USA only. The Stryker TPS Small Joint Shaver handpiece is not field repairable. In case of operating difficulties, all Stryker products must be returned to Stryker Endoscopy for maintenance. On request, Stryker will provide a loaner unit while repairs 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.

LIMITED WARRANTY Stryker Endoscopy warrants the TPS Small Joint Shaver handpiece against defects in both materials and workmanship to the registered owner at the time of purchase. All components are covered by the warranty for a period of one year from the date of shipment. This warranty extends to all purchasers and is limited to the repair or replacement of the product without charge when returned to Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138. Stryker cannot accept responsibility for returns or replacements which have not been authorized. Contact Stryker Customer Service at 800-624-4422 for return authorization. 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 Endoscopy authorized service personnel. If upon examination by authorized service personnel it is determined that the malfunction is due to misuse or abuse, warranty provisions will not apply. An estimate of the cost of repair work will be given to the customer prior to servicing and repairing the unit.

2.

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

3.

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

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

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 a loaner. Repair turnaround time does not exceed two weeks under most conditions.

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

5.

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

6.

Return the loaner unit to the Stryker Endoscopy Repair Department as soon as a new unit is received. The memo billing for the loaner will be credited 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 Stryker subsidiary. A list of subsidiaries is on page 19.

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Instruments repaired by Stryker Endoscopy will be issued a 30 day warranty against defects in both materials and workmanship, provided the original warranty period has passed. Instruments submitted due to defects in materials and workmanship during the warranty period will be repaired at no charge to the customer. The warranty as set forth herein is exclusive and in lieu of all other warranties, remedies, obligations, and liabilities of Stryker Endoscopy, expressed or implied, including the lightning bolt within a triangle intended to alert service personnel of the presence of high voltage, which may cause injury or fatal electric shock.

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REORDER INFORMATION 275-601-500

TPS Small Joint Shaver handpiece

WARNING

Use only Stryker approved accessories. A complete list of accessories is available from your Stryker representative, or call Stryker customer service at 1-800-624-4422.

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SERVICE LOCATIONS For service in the U.S.A., call your Stryker Endoscopy representative or Stryker Endoscopy Customer Service at 1-800-624-4422. Outside of the U.S.A., please contact your Stryker Endoscopy distributor at one of the following locations: Stryker Corporation 2725 Fairfield Road Kalamazoo, MI 49002 USA Phone: 1-269-385-2600 Telex: 224464 STRYKER KMZ Fax: 1-616-385-1996 Stryker Canada 45 Innovation Drive Hamilton, Ontario, Canada L9H 7L8 Phone: 905-690-5700 (800) 668-8323 (toll free) Fax: +1(905) 690-5698 Stryker Deutschland GmbH Gewerbeallee 18, D-45478 Mulheim an der Ruhr GERMANY Phone: 49-208-999060 Fax: 49-208-9990666 Stryker Taiwan 16F, No. 59, Sec. 2, Dunhua S. Road Taipai 106, TAIWAN Phone: 886-2-2701-1081, ext. 26 Fax: 886-2-2701-1082 Stryker U.K. Ltd. Hambridge Road Newbury Berkshire RG14 5 EG UK Phone: 44-1635-262400 Fax: 44-1635-262464 Stryker B.V. Marinus Van Meelweg 17 P.O. Box 8747 5657 LS Eindhoven THE NETHERLANDS Phone: 31-40-2922522 Fax: 31-40-2922555

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Stryker Europe Rep-RA/QA Manager ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, FRANCE Phone: 33-1-48175000 Fax: 33-1-48632175 Stryker Korea 11F, Dongsung Bldg, 158-24 Samsung-dong, Kangnam-gu, Seoul 135-090, KOREA Phone: 82-2-565-7303 Fax: 82-2-552-4456 Stryker Australia No. 50 Broughton Road Artarmon, NSW 2064 AUSTRALIA Phone: 61-2-9415-5100 Fax: 61-29-429-4127 Stryker Pacific Headquarters Suite 2501, Citibank Tower Citibank Plaza 3 Garden Road, Central HONG KONG Phone: 852-2-9415-5100 Fax: 61-29-429-4127 Stryker Singapore PTE/LTD 70 Bendemeer Road #03-32 Hiap Huat House SINGAPORE 339940 Phone: 65-293-0119 Fax: 65-293-7028 Stryker Osteonics, SA 5, Chemin des Aulx 5 1228 Plan-les-Ouates Case Postale 715 1212 Grand-Lancy 1 Geneve, SWITZERLAND Phone: 41-22-884-0111 Fax: 41-22-884-0199

Stryker India Private Limited First Floor C-5, SDA Commercial Complex New Delhi 110 017 INDIA Phone: 91-11-686-6740 Fax: 91-11-696-6020

NV Stryker SA (Belgium) Doornveld Industrie Asse nr. 11, Bus 45 1731 Zelik BELGIUM Phone: 32-246-3148 Fax: 32-246-31321

Stryker Japan Dai Tokyo Kasai Shinjuku Bldg. 3-25-3, Yoyogi Shibuya-ku, Tokyo 151-0053 JAPAN Phone: 813-535-29106 Fax: 813-535-21789

Stryker Chile Avenida Nueva Tajamer 481 Oficina 805 Piso 8 Torre Norte, Santiago CHILE Phone: 562-244-3600 Fax: 562-244-3696

Stryker China 10th Sungib Industrial Center 53 Wong Chnk Hang Road Aberdeen HONG KONG Phone: 852-2814-7463 Fax: 852-2873-0210

Stryker Spain Puentecesures, 1 bajo 28029 Madrid SPAIN Phone: 34-1-323-1731 Fax: 34-1-315-2782

Stryker Europe Headquarters Cite-Centre, Grand Rue 92 Ch-1820 Montreux SWITZERLAND Phone: 41-21-966-1201 Fax: 41-21-966-1200 Stryker Latin America Plaza Royale Suite 304 15600 NW 67th Ave. Miami Lakes, Florida 88014 USA Phone: 1-305-821-1888 Fax: 1-305-826-0067 Stryker Middle East / Africa Hamdan St. 1404 Al Masoud Bldg. Abu Dhabi U:A:E Phone: 9712-312145 Fax: 9712-313698 Stryker Mexico, S.A. de C.V. Montecito No. 38 Piso 12, Oficina 31 Colonia Napoles MEXICO 03810 Phone: 525-488-0890 Fax: 525-488-0891 Page 20

Stryker AB Aminogatan 34 s-43153 Molndal SWEDEN Phone 46 31 70 60 690 Fax: 46 31 70 60 622 Stryker A/S Stamholmen 193D DK 2650 Huidovre DENMARK Phone: 45 3677 9966 Fax: 45 3677 8666 Stryker Finland Vemissakatu 8F 03100 Vantaa FINLAND Phone: 358 9 857 1400 Fax: 358 9 857 1466

MANUFACTURER: Stryker Endoscopy Inc. 5900 Optical Court San Jose, CA 95138 USA Phone: 1-408-754-2000 Fax: 1-408-754-2505