curvtek users manual
Contents
1. Lal zZ Z j B Lid z ee handpiece and hose cleaning maintenance Arthrotek Inc recommends that each handpiece be returned every six 6 months to the Arthrotek Inc facility for preventive maintenance Gloves should be worn when cleaning and handling contaminated instruments Also disconnect and properly dispose of the cartridge before cleaning the handpiece and hose Clean the handpiece and hose as soon as possible after use especially in and around the barrel of the handpiece Use the CurvTek Cleaning Brush to clean the two hex shaped tubes inside the barrel of the handpiece Remove all blood and debris from the surface of the handpiece with a soft bristle brush Note A damp cloth or brush soaked in mild non chlorine based detergent and water may be used to clean the handpiece and hose Connect the nitrogen hose to the handpiece to help protect the internal parts of the handpiece from water The hose should not be connected to a nitrogen source at this time Place the barrel of the handpiece downward while cleaning to help protect the internal parts from water Remove all debris by manipulating each moving part of the handpiece On Off switch trigger and toggle latch 12 Dry the surface with a soft cloth Disconnect the hose from the handpiece and place 2 drops of CurvTek Lubricant into the small air inlet tube of the handpiece located at the base of the h2. WALSAS INITIANNAL IJNOG A BIOMET COMPANY ARTAR IEK user s manual CurvTek is a registered trademark of Biolectron Inc A Biomet Company All other trademarks are not associated with Biomet table of contents niana a AE O bb rrr o2ogbxvjDn 2 The Tunnel Tie Down Technique 2 Chip Cycles ssssssssssseesseessessssessressresssessseesrressressressreess 2 Wound TOA GION essesi 2 Features of the CurvTek System 3 CurvTek System Components ccccsccessesesseeeeeseeeeneceeeseeeneeeees 4 CurvTek Hose Instructions Eeeereeereekeee 3 Hose to Regulator Connection 5 Hose to CurvTek Handpiece Connection 5 Nitrogen Pressure lnstructionS EL u eee 6 CurvTek Cartridge Insertion eseeeeeeree 7 Cartridge Insertion into Handpiece 7 Correct Cartridge Insertion 7 OAT E ce eeesceee eee mwaxaIJ J J y O_O u_n n_ A 8 Cartridge Removal from Handpiece j 8 CurvTek Handpiece InstrUctions eeeeeeeeee 9 Tunneling Operation ipeceaceesserereretercaseveaqarnenteacasioane 9 Cleaning and Maintenance c cecesseeseseceeteeseeeeteeaeeeeeeteneaeees 11 Handpiece and Hose Cleaning and Maintenanee 12 sa
3. Extra Long 7mm 3 per pack Extended Flat 7mm Sterilization Case 906771 Single Pack 906775 Single Pack 006796 operating instructions To ensure the successful operation of the CurvIek TSR System carefully read the following instructions prior to use in surgery CurvTek Hose Instructions Hose to Regulator Connection To connect the CurvIek hose push the male Schrader fitting of the hose into the female Schrader fitting of the nitrogen regulator Hose to CurvTek Handpiece Connection Rotate the handpiece s On Off switch to the Off position clockwise Disconnecting the Hose To disconnect the hose from the handpiece depress the Hall hose connector and twist it counter clockwise To disconnect the hose twist the collar on the regulator fitting clockwise Insert the Hall hose connector and twist it clockwise to the locked position Pull on the hose connector to verify that the hose has locked into position system user s manual Lad Fe N gt N S Z hal z Z Lu Z t nitrogen pressure instructions Set the nitrogen regulator to indicate 90 100 PSI Compensate for extension hoses by adding 2 PSI per foot of extension hose to the above pressure setting Hose Length Caution Over pressure may increase wear of the hose and may reduce the life of the handpiece Pressure less than 90 PSI may result in lower torque power being suppl
4. pulled the cutters engage the cortex and bone chips develop As the trigger is released the bone chips clear the tunnel Each pull and release of the trigger is a chip cycle To adequately create and clear the tunnel 12 15 chip cycles may be necessary for each tunnel Wound Irrigation In addition to chip cycles continuous wound irrigation is necessary to clear bone debris from the tunnel holes The irrigation method should be either continuous pulsed lavage or submerged Features of the CuruTek System Handpiece constructed of sturdy anodized aluminum Convenient drill cartridges available in various sizes for added flexibility in tunnel size Disposable cartridges reduce risk of contamination and ensure that the cutters are always sharp Pneumatic motor provides high torque for smooth tunneling system components CurvTek Handpiece CurvTek Lubricant 1 02 Nitrogen Hose 3 meters Long Hal a 7 and Schrader connectors 906740 906744 906743 CurvTek Cartridge CurvTek Cartridge CurvTek Cartridge Medium mm Large 12mm X Large 22mm 906750 Single Pack 906754 Single Pack 906000 Single Pack CurvTek Eye Needle CurvTek Eye Needle CurvTek Eye Needle 3 per pack Medium 7mm 3 per pack Large 12mm 3 per pack X Large 22mm 906760 Single Pack 906764 Single Pack 906768 Single Pack CurvTek Eye Needle CurvTek Eye Needle CurvTek 3 per pack
5. andle Reconnect handpiece and hose assembly to a nitrogen source Set the nitrogen regulator to indicate 90 100 PSI Run for 5 seconds with the trigger fully depressed 13 system user s manual had N gt 4 Lal z z Lid z fe Sterilization guide l Disconnect and properly dispose of used cartridges 2 Clean all instruments Do not sterilize dirty instruments 3 Disconnect the nitrogen hose from the handpiece 4 Properly place the handpiece and hose in the CurvTek Sterilization Container System Recommended Sterilization Times for Handpiece and Hose Enclosed in the CurvTek Sterilization Container System Type of Sterilizer and Condition of Case Aictual Steam Exposure Temperature Setting Time Gravity Discharge 250 Wrapped 60 minutes High Speed Pre Vacuum Wrapped 10 minutes 270 F Pre Vacuum Flash 275 Wrapped 4 minutes Note The term wrapped means the handpiece and hose are enclosed in the CurvTek Sterilization Container System without external hospital wrapping troubleshooting If the handpiece will not start 1 Check that the regulator valve is turned on and that the regulator is set at 90 100 PSI 2 Ensure that the handpiece is receiving nitrogen pressure and that the nitrogen supply tank has at least 500 PSI 3 Ensure that the nitrogen hose is properly attached to the handpiece and regulator and ensure that the handpiece s On Off switc
6. d N gt 4 Lal z z Lid z fe Cartridge Use wt idae yaaga a anida ox quite ve we 000 single e repel erat a oe av a vera CurvTek cartridges are Gamma radiated sterile packaged and designed for single patient use only When a cartridge is fully seated into the handpiece the cartridge handpiece assembly is ready for use The cartridge may be used to drill a maximum of 4 transosseous tunnels to provide maximum cutter head sharpness If more than 4 transosseous tunnels are required another sterile cartridge should be used Rotate the handpiece s On Off switch to the Off position clockwise whenever removing a cartridge Completely depress the toggle latch on the handpiece and pull firmly on the cartridge to remove it from the handpiece Properly dispose of the cartridge after single patient use Hold the cartridge with the thumb and forefinger of one hand and hold the handpiece with your free hand handpiece instructions Read the cartridge instructions before operating the cartridge handpiece assembly Ensure that the bone quality at the repair site is adequate for the integrity of the repair Also be certain that the repair site is free from soft tissue to prevent interference with the cutting performance of the cutter heads Tunneling Operation Before inserting the cartridge into the hand Rotate the On Off switch to the O
7. g and maintenance instructions Warning DO NOT disassemble the handpiece or attempt to repair it The handpiece can only be serviced at the Arthrotek Inc factory There are no user serviceable parts inside the handpiece DO NOT immerse the handpiece in fluid or place the handpiece under running water Water or any fluid may affect internal assemblies DO NOT use a bleach or chlorine based detergent to clean the handpiece The use of chlorine or bleach will cause corrosion to components DO NOT clean the handpiece in an ultrasonic cleaner Use of an ultrasonic cleaner may damage the special lubricant of the bearings and cause a freeze up of the handpiece during use DO NOT lubricate any part of the handpiece with anything other than the CurvTek Lubricant mentioned in the cleaning and maintenance section Lubricating with other oils or silicone may cause the handpiece to run hot and slow If you suspect that the handpiece was lubricated improperly return it immediately to Arthrotek Inc for inspection and cleaning DO NOT re sterilize cartridges Note In the event of accidental immersion in fluid remove the handpiece from the fluid wipe it dry and blow out with an air supply Connect the handpiece to a hose then to a nitrogen source and run it with the trigger fully advanced for 20 to 30 seconds Autoclave immediately and return to Arthrotek Inc for inspection 11 system user s manual had ra gt N z
8. h is rotated to the On position 4 Attach another hose to the regulator and handpiece if necessary If the handpiece still fails to operate return it to Arthrotek Inc for inspection Il If the handpiece s trigger sticks while tunneling 1 Slowly push the trigger forward until it is in the fully released position Ill If the cutter heads fail to retract from the tunnel holes 1 DO NOT pull the handpiece away from the bone and DO NOT depress the handpiece trigger 2 Attempt to dislodge the cutter heads with a slight side to side handpiece motion 14 service and ordering To return the handpiece 1 Contact Arthrotek Customer Service for a Return Goods Authorization RGA number at 1 800 535 8692 2 Ship the handpiece via FedEx or UPS Air to Arthrotek Inc and be certain the RGA number is clearly marked on the outside of the box International customers may return goods by standard AirMail or Air Parcel Post with a Customs Declaration 3 Enclose a description of the problem you encountered such as Handpiece will not run Handpiece runs without depressing trigger Cartridge will not insert into the handpiece This information is very helpful in diagnosing the problem 4 If the instrument is out of warranty enclose a purchase order number for the repair If the handpiece is under warranty enclose a purchase order number for the shipping charges A CurvTek handpiece not under warran
9. ied to the cutter heads which could adversely affect the drilling performance Caution If a hose is cut or internally damaged the loose end of the hose may flail and whip If this occurs immediately shut off the valve on the nitrogen supply and disconnect the hose from the Schrader connection of the nitrogen regulator cartridge insertion Cartridge Insertion into Handpiece Be certain that the handpiece On Off switch Hold the cartridge between thumb and fore is in the Off position clockwise whenever finger of one hand inserting or removing a cartridge With the free hand grasp the barrel of the Carefully insert the back end of the cartridge handpiece and depress the toggle latch on the with the two male hex drives into the barrel handpiece with the thumb of the handpiece until the cartridge slips Caution Keep hands away from and do not into place push on the serrated front end of the cartridge during insertion since this could result in injury from the sharp cutter tips Incorrect Cartridge Insertion Note If one or both cutter heads advance from the cartridge while it is being inserted into the handpiece this indicates that the associated male and female hex drive s did not mate properly If this occurs remove the cartridge and rotate the non mating male hex drive s slightly Reinsert the cartridge into the handpiece Repeat until properly seated system user s manual ha
10. l be at its option to repair or replace the handpiece or to refund the amount paid for the handpiece The foregoing warranties apply only under normal use and do not cover 1 any damage or defect caused by accident misuse or abuse 2 any damage or defect caused by alteration tampering repair or attempted repair by anyone other than Arthrotek Inc and 3 any damage or defect caused by unauthorized attachments or accessories EXCEPT AS SPECIFICALLY REQUIRED BY APPLICABLE LAW THE FOREGOING WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED AND ARTHROTEK INC SPECIFICALLY DISCLAIMS ANY AND ALL WARRANTIES OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE UNDER NO CIRCUMSTANCE SHALL ARTHROTEK INC ITS AUTHORIZED REPRESENTATIVES OR ITS AFFILIATED OR SUBSIDIARY COMPANIES BE LIABLE FOR SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES The foregoing warranties are not assignable or transferable and may not be extended or moditied except in writing by an officer of Arthrotek Inc Consigned or loaned handpieces will be maintained at no charge unless damaged during use Inquiries and Ordering Information In the United States Phone 800 348 9500 Fax 219 372 1718 Write Arthrotek Inc PO Box 587 Warsaw IN 46581 0587 16 ARTHR IEK A BIOMET COMPANY PO Box 587 Warsaw IN 46581 0587 219 2676 6639 e 2000 Arthrotek Inc All Rights Reserved web site www arthrotek com Domestic eMail arthrotek ar
11. ll N GUIE J ya DX ss zz n jjj 14 Troubleshooting e esereke eke eee 14 Service an Oi del ll l a una yiy kane yan radkn ada aye k dan 15 Bal uan yy n o DMTMNnNnN oN iZJ J VZ M M MMMMI oD 16 system user s manual had N gt 4 Lal z z Lid z fe introduction The CurvIek System combines the benefits of preferred soft tissue reattachment with innovative pneumatic technology for creating curved transosseous tunnels The unique CurvTek handpiece and cartridge assembly machines curved bone tunnels creating a strong bony bridge for each suture tie down The Tunnel Tie Down Technique The Tunnel Tie Down Technique maxi mizes tissue to bone compression for optimum healing by creating a curved tunnel With the matching curved needle a suture can be easily passed through the curved tunnel and tied right to the bone The CurvTek System requires attention to bone chip removal to ensure successful results Unlike conventional straight drills that allow bone debris removal through flutes the Tunnel Tie Down Technique requires two simultaneous activities for bone debris removal Chip Cycles and continuous wound irriga tion Chip Cycles The trigger advance and release action is called a chip cycle Chip cycles are required to allow bone debris removal throughout the process of creating a tunnel As the trigger is
12. n position piece ensure the barrel of the handpiece is unobstructed and that the female hex components inside the handpiece are unob structed Insert the cartridge into the handpiece Hold the handpiece in one hand with index Stabilize the instrument perpendicular to the and middle fingers on the trigger bone by holding the cartridge between the thumb and forefinger of the free hand Caution Do not aggressively advance the cutter heads into the bone or attempt to create a complete tunnel with one continuous trigger motion This will damage the cutter heads flexible shafts and drill guides This action may also cause the cutter heads to overheat and thus prevent them from retracting from the prepared tunnel properly system user s manual had ra gt N z Lal zZ Z j B Lid z ee Continuous irrigation or immersion during the tunneling procedure is necessary to ensure bone chip clearance from the tunnel holes and to ensure adequate cooling of the cutter heads Depress the trigger to advance the cutter heads approximately one 1 millimeter into the bone Then release the trigger allowing the cutter heads to retract and clear the bone chips This trigger action is known as chip cycle Note If the CurvTek trigger sticks during the tunneling procedure slowly push the trigger forward until it is in the fully released position A smooth release of the trigger all
13. ows the cutter heads to clear the bone chips from the curved transosseous tunnels Caution If the cutter heads fail to retract from the tunnel holes DO NOT pull the handpiece away from the bone Reference Troubleshooting section When the cutter heads clear the tunnel holes smoothly depress the trigger again to advance the cutter heads approximately Continue to depress and release the trigger chip cycle as many times as necessary until the transosseous tunnel is complete another millimeter into the bone Note The number of chip cycles needed to create a transosseous tunnel is dependent on the density and quality of the bone At least 12 15 chip cycles is recommended Denser bone may require more chip cycles Caution Before creating another transosseous tunnel turn the handpiece off and be certain that the cutter heads are intact and clean of debris Creating subsequent transosseous tunnels with clean cutter heads will contribute to better tunneling performance In the event that a cutter head and or flexible shaft breaks while operating retrieve it and properly dispose of it and the damaged cartridge from which it came Open and insert a new cartridge to continue with the operation The transosseous tunnel is complete when the trigger is fully depressed 10 cleaning and maintenance To maintain the CurvIek TSR System components in proper operating condition please observe the following general cleanin
14. throtek com International eMail arthrotekeurope arthrotek com Form No Y BMT 692 113000 K
15. ty that is sent to Arthrotek Inc for repair is subject to a minimum charge of 50 00 to cover cleaning inspection testing and processing Repairs estimated to cost less than 25 percent of the handpiece s current list price will be initiated immediately Repairs estimated to exceed 25 percent of the handpiece s current list price will not be performed without customer authorization Arthrotek Inc will repair the handpiece within fifteen days from the time it is received The handpiece will be returned to you via FedEx Standard Overnight unless you specify otherwise in writing with the return All shipping charges are pre paid and added to the invoice amount if any 15 system user s manual had ra gt N z Lal zZ Z j Lal z co limited warranty Arthrotek Inc warrants to the first purchaser user that each new handpiece shall be free from defects in material and workmanship for a period of one 1 year from the date of shipment from Arthrotek Inc Arthrotek Inc warrants to the first purchaser user that any handpiece service or repair work performed by Arthrotek Inc shall be free from defects in material and workmanship for a period of six 6 months from the date of shipment from Arthrotek Inc This warranty only applies to the actual work performed by Arthrotek Inc Arthrotek Inc s sole obligation in the event of a defect in material or workmanship during the warranty period shal
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