Cutting Accessories • Burs • Blades • K-Wires • Steinman Pins • Twist Drills

CLEANING & STERILIZATION INSTRUCTIONS

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EXPLANATION OF SYMBOLS

Authorized representative in the European community.

Batch code.

Catalog number.

Conforms with the essential requirements of the European community directives.

Consult instructions for use.

Date of manufacture.

Do not re-sterilize.

Do not reuse.

Do not use if package is damaged.

Manufacturer.

Non-sterile.

Sterilized using irradiation.

Use by.

PghCiNBDLMd

IK H

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CLEANING RECOMMENDATIONS

CAUTIONS & WARNINGS:

• Donotre-useorreprocessusedcuttingaccessories.• Followtheinstructionsandwarningsissuedbythesuppliersofanycleaninganddisinfectionagentsandequipmentused.• Followuniversalprecautionsandprotectiveapparelwhenhandlingandcleaningcontaminatedcuttingaccessories.• Disposeofallcuttingaccessoriesproperlyaftereachuse.• Undercertainclassificationsofrisk, theWorldHealthOrganization(WHO),or localregulatoryauthoritiesrecommendspecialCJD(Creutzfeldt-JakobDisease)inactivationprocessingprocedures.ConsultWHOandlocalregulationsforfurtherinformation.

• Donotcleanorre-sterilizecannulateddrills,toolsteel,440steel,laserweldedorbrazedtwopieceblades.• Donotprocessaccessoriesinautomatedwasher-sterilizer.

General to all Cutting Accessories: • Onlyusewithappropriatepowersystem.Seeapplicablepowersysteminstructionsforuse. • Donotusecuttingaccessoryatspeedsexceedingthehandpiecemanufacturer’sspecifications. • Disposeofproductorrecycleinaccordancewithlocallawsandregulations. Burs,RaspsandTwistDrills: • Avoidapplicationsofexcessivelateralforce. • Useproperburguardwithburperthehandpiecemanufacturer’sspecifications. • Donotusecarbidebursfortwistingorbendingcuts,breakagemayoccur.

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Saw Blades: • Donotuseexcessiveforcetotwistorbendblades. • Cuttinginmetalguidesoraccidentalcontactwithmetalretractorsmaydamagethebladeandmaynecessitateitsreplacement. • Insertsawbladeintoalignmentguideorcuttingfixturepriortoactivatinghandpiece. • Sawbladesbecomehotfromfriction.Irrigationofbladesisrecommendedduringuseandisrequiredwhenusinganalignmentguideorcuttingfixture.

K-WiresandPins: • Immobilizethepatient’sareaoffixationtopreventexcessiveforcesontheK-Wireorpin. • ExcessiveforcesontheK-Wireorpinmaycauselooseningormetalfatigueandsubsequentdevicefracture. • K-Wiresorpinshouldberemovedassoonasadequatehealinghasoccurred.

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CLEANING PROCEDURES:

• Itisalwaysrecommendedtouseunusedsterilecuttingaccessoriesineachprocedure.• Unusedcuttingaccessoryremovedfromoriginalnon-sterilepackage: 1. Sterilize as directed on the table on page 8.• Unusedcuttingaccessorycontaminatedduringsurgery: 1. Removecuttingaccessoriesfromhandpieceandorattachment. 2. Clean cutting accessories as soon as possible to avoid drying of contaminants. Disinfecting the cutting accessories may be needed to protect personnel

handlingtheinstrumentbeforecleaningandsterilization.Ifcleaningmustbedelayed,immersethecuttingaccessoryinaneutral-pHcleaningsolutiontoprevent drying of contaminants on the instrument.

SawBladesandK-Wires: 1. Rinsesoiledcuttingaccessorythoroughlywithalargeamountoflukewarm(targetlowerendofthe72-110°F/22-43°Ctemperaturerange)runningtap

waterforaminimumofone(1)minute. 2. MakeanenzymaticcleaningsolutionsuchasSTERIS®Prolystica™2xConcentrateEnzymaticPresoakandCleaner[1/8ounceperone(1)gallonofwarm

tapwater](targetlowerendofthe91-109°F/33-43°Ctemperaturerange). 3. Soakthecuttingaccessoryintheenzymaticcleaningsolutionfortwo(2)minutes,makingsurethecuttingaccessoryiscompletelyimmersedtoprevent

aerosolization of contaminants. 4. Manuallycleanthecuttingaccessoryusingasoft-bristledbrushforone(1)minutetoremovesoilanddebris. 5. Rinsesoiledcuttingaccessorybyimmersingthecuttingaccessoryinasufficientvolume(enoughtocoverthedevice)oflukewarm,tapwater(targetlower

endofthe72-110°F/22-43°Ctemperaturerange)forone(1)minute. 6. RepeatStep5two(2)moretimesforatotalofthree(3)rinses.Visuallyinspectcuttingaccessoriesforthepresenceorabsenceofresidualsoiland/orcleaner. 7. Dryimmediatelywithacleanlint-freesoftcloth. 8. Inspectfordamageandreplacewithnewcuttingaccessoryifdamaged. 9. Sterilizeasdirectedonthetableonpage8.

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Burs - Recommended Manual Cleaning Procedure (Rotary Instruments): 1. Rinsethebursinrunningcooltapwaterforone(1)minute. 2. Prepareafreshneutral-pH,enzymaticcleaningsolution(suchasEnzol)perManufacturer’sworst-caseinstructionsbyusingone(1)ouncepergallonof

warm(86-109°F/30-43°C)tapwater. 3. Immersethebursinthecleaningsolutionandsoakinthepreparedsolutionforten(10)minutes. 4. Usingastiff-bristledbrush,cleaneachburindividuallyforaminimumofone(1)minutetoremovecontaminants.Careshouldbetakentocleancrevices

and other hard to reach areas thoroughly. 5. Thoroughlyrinsethebursunderrunningwarmtapwater(temperaturetonotexceed113°F/45°C)foraminimumofone(1)minuteanduntilvisiblyclean. 6. PrepareafreshneutralpHenzymaticsolution(seeStep3)inasonicatorbath.Completelysubmergethebursinthesolutionandsonicateforfifteen(15)

minutes. Separate burs from contacting and damaging each other. 7. Rinsedeviceusingrunningtapwater(temperaturetonotexceed113°F/45°C)foraminimumofone(1)minute. 8. Visuallyinspectdevicesforresidualsoil. 9. Dryimmediatelywithacleanlint-freesoftcloth. 10. Inspectfordamageandreplacewithnewcuttingaccessoryifdamaged. 11. Sterilize as directed on the table on page 8.

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STERILIZATION RECOMMENDATIONS

WARNINGS:

• Theuseofdisinfectingsolutionsforanexteriorinstrumentwipewillnotsterilizethecuttingaccessory.• Inspectsterilizedcuttingaccessories.Ifdiscolorationorrustisvisibledonotuse.

CAUTIONS:

• Donotprocessinautomatedwasher-sterilizer.• Donotre-useorreprocessusedcuttingaccessories.• Donotusecoldsterilizationsolutionsasthesecontainoxidizingagentswhichmaycausedamagetothedevice.• Donotsterilizewhileconnectedtohandpieceandorattachment.• WraptheinstrumentsperAAMIrecognizedguidelines.• Followthesterilizermanufacturer’swritteninstructionsforcycleparameters,loadconfigurationandAAMIguidelinesforsteamsterilization.• Donotcleanorre-sterilizecannulateddrills,toolsteel,440steel,laserweldedorbrazedtwopieceblades.

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PARAMETERS FOR STERILIZATION

Blades/K-Wires/SteinmanPins/TwistDrills

Burs–StainlessSteel,CarbideandDiamond

Note:Theseprocesseshavebeenvalidatedforaone-timesterilizationasbeingcapableofcleaningandsterilizingBurs/Blades/K-Wires/SteinmanPins/TwistDrills.

SteamSterilizationType MinimumTemperature MinimumExposureTime MinimumDryTimePre-Vacuum(Wrapped) 270°F(132°C) 4minutes 30minutesGravity(Wrapped) 270°F(132°C) 15 minutes 30minutes

SteamSterilizationType MinimumTemperature MinimumExposureTime MinimumDryTimePre-Vacuum(Pouch) 273°F(134°C) 3minutes 30minutesGravity(Pouch) 275°F(135°C) 10minutes 30minutes

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RETURN GOODS POLICY

Contact your distributor regarding returned goods policy.

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PRODUCT DISPOSAL

Dispose of product or recycle in accordance with local laws and regulations.

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BrasselerU.S.A.Medical,LLCOneBrasselerBoulevard•Savannah,GA31419800-535-6638Ext.7050•912-921-7578(fax)BUSAMedical.com

Emergo EuropeMolenstraat 15

2513BH,TheHagueTheNetherlands

Tel:+31(0)70-345-8570Fax:+31(0)70-346-7299

MP

T-3881-REV1-08.13-XXM-XXX©2013BrasselerU.S.A.Medical,LLC•Allrightsreserved•PrintedintheU.S.A.

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BrasselerU.S.A.Medical,LLC,hasimplementedaqualitymanagementsystemthatiscertifiedunderISO13485:2003.STERIS®andProlystica™aretrademarksofSTERISCorporation.BrasselerU.S.A.Medical,LLC,isnotaffiliatedwiththeaboveandmakesnoclaimtocopyrightsortrademarkswhicharethepropertyofthiscompany.BUSA®isatrademarkofPeterBrasselerHoldings,LLC,oritsaffiliates.Allothertrademarksaretrademarksoftheirrespectiveownersorholders.Colors,specificationsandproductavailabilitysubjecttochange.BUSA®SurgicalPower&AccessoriesproductsaresoldbyBrasselerU.S.A.Medical,LLC,OneBrasselerBoulevard,Savannah,Georgia31419,UnitedStates.