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

Rx Only

CLEANING & STERILIZATION INSTRUCTIONS

SURGICAL POWER & ACCESSORIES

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EXPLANATION OF SYMBOLS

Batch code.

Catalog number.

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.

g

h

i

N

B

D

L

M

d

IK

H

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CLEANING RECOMMENDATIONS

CAUTIONS & WARNINGS:

• Donotre-useorreprocessusedcuttingaccessories.• Followtheinstructionsandwarningsissuedbythesuppliersofanycleaninganddisinfectionagentsandequipmentused.• Followuniversalprecautionsandprotectiveapparelwhenhandlingandcleaningcontaminatedcuttingaccessories.• Disposeofallcuttingaccessoriesproperlyaftereachuse.• 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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SawBlades: • Donotuseexcessiveforcetotwistorbendblades. • Cuttinginmetalguidesoraccidentalcontactwithmetalretractorsmaydamagethebladeandmaynecessitateitsreplacement. • Insertsawbladeintoalignmentguideorcuttingfixturepriortoactivatinghandpiece. • Sawbladesbecomehotfromfriction.Irrigationofbladesisrecommendedduringuseandisrequiredwhenusinganalignmentguideorcuttingfixture.

K-Wires and Pins: • Immobilizethepatient’sareaoffixationtopreventexcessiveforcesontheK-Wireorpin. • ExcessiveforcesontheK-Wireorpinmaycauselooseningormetalfatigueandsubsequentdevicefracture. • K-Wiresorpinshouldberemovedassoonasadequatehealinghasoccurred.

Note:TheeffectsoftheMagneticResonanceenvironmentontheK-wiresandSteinmanPinshavenotbeendetermined.Thesemedicaldeviceshavenotbeentestedformagneticfield/migration,artifactsorheatingintheMRIenvironment.

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CLEANING PROCEDURES:

• Itisalwaysrecommendedtouseunusedsterilecuttingaccessoriesineachprocedure.• Unusedcuttingaccessoryremovedfromoriginalnon-sterilepackage: 1. Sterilize as directed on the table on page 8.• Unusedcuttingaccessorycontaminatedduringsurgery: 1. Removecuttingaccessoriesfromhandpieceandorattachment. 2. Cleancuttingaccessoriesassoonaspossibletoavoiddryingofcontaminants.Disinfectingthecuttingaccessoriesmaybeneededtoprotectpersonnel

handlingtheinstrumentbeforecleaningandsterilization.Ifcleaningmustbedelayed,immersethecuttingaccessoryinaneutral-pHcleaningsolutiontopreventdryingofcontaminantsontheinstrument.

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

Ifproductneedstobereturned,thefollowingapplies:

Consumable/DisposableProduct: Anyunusedconsumable/disposableproductmaybereturnedforcreditwithinninety(90)daysofinvoicedateifitqualifiesforresale(unopenedandunmarked

package).Productsmaybesubjecttoarestockingfee.Creditwillnotbeissuedforproductsthatdonotqualifyforresale.

CapitalEquipment: Anyunusedcapitalequipmentmaybereturnedforcreditwithinthirty(30)daysofinvoicedateifitqualifiesforresale(unopenedandunmarkedpackage).

Productsmaybesubjecttoarestockingfee.Creditwillnotbeissuedforproductsthatdonotqualifyforresale.

Packaging and Shipping: Returneditemsshouldbepackagedinoriginalpackaging.Creditwillnotbeissuedforitemsdamagedinreturnshipmentduetopackaginginadequacy.

Note:Itisunlawfultoshipcontaminatednon-sterilizedproducts.

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ContactaCustomerServiceRepresentativeatBrasselerUSA®SurgicalPower&Accessoriesat800-535-6638toobtaina“ReturnMerchandiseAuthorization”(RMA)number.

Pleaseincludethefollowinginformationwiththereturnedproduct(s): •Catalognumber,serialnumberandlotnumber(ifapplicable)ofdevice. •ReturnMerchandiseAuthorization(RMA)numbernotedwiththereturn. •Originalinvoicenumberorcopyoforiginalinvoice. •Originalinvoicedate. •Customername,addressandaccountnumber. •Itemizedpackinglist. •Briefstatementdescribingreasonforproductreturn.

Returnto: Brasseler USA®SurgicalPower&Accessories 4837McGrathStreet Ventura,CA93003

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PRODUCT DISPOSAL

Disposeofproductorrecycleinaccordancewithlocallawsandregulations.

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

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BM-3880-REV1-08.13-XXM-XXX©2013BrasselerU.S.A.Medical,LLC•Allrightsreserved•PrintedintheU.S.A.

SURGICAL POWER & ACCESSORIES

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