CLEANING & STERILIZATION INSTRUCTIONS Cutting …brasselerusamedical.com/wp-content/uploads/sites/8/20… ·  · 2016-10-14CLEANING & STERILIZATION INSTRUCTIONS ... , making sure

Cutting Accessories •Burs •SawBlades •K-Wires •SteinmannPins •TwistDrills

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

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,laserweldedorbrazedtwopiecesawblades.• 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: • Donotuseexcessiveforcetotwistorbendsawblades. • Cuttinginmetalguidesoraccidentalcontactwithmetalretractorsmaydamagethesawbladeandmaynecessitateitsreplacement. • Insertsawbladeintoalignmentguideorcuttingfixturepriortoactivatinghandpiece. • Sawbladesbecomehotfromfriction.Irrigationofsawbladesisrecommendedduringuseandisrequiredwhenusinganalignmentguideorcuttingfixture.

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

Note:TheeffectsoftheMagneticResonanceenvironmentontheK-WiresandSteinmannPinshavenotbeendetermined.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.

SawBlades,K-WiresandPins: 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 - RecommendedManualCleaningProcedure(RotaryInstruments): 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,laserweldedorbrazedtwopiecesawblades.

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PARAMETERS FOR STERILIZATION

SawBlades/K-Wires/SteinmannPins/TwistDrills

Burs–StainlessSteel,CarbideandDiamond

Note:Theseprocesseshavebeenvalidatedforaone-timesterilizationasbeingcapableofcleaningandsterilizingBurs/SawBlades/K-Wires/SteinmannPins/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® Surgical Power & Accessories 4837McGrathStreet Ventura,CA93003

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PRODUCT DISPOSAL

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

BrasselerU.S.A.Medical,LLCOneBrasselerBoulevard•Savannah,GA31419800.535.6638•912.921.7578(fax)BrasselerUSAMedical.com

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BM-3880-REV2-03.14-1M-XXX©2014BrasselerU.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.