CLEANING & STERILIZATION INSTRUCTIONS Cutting...
-
Upload
nguyendang -
Category
Documents
-
view
215 -
download
0
Transcript of CLEANING & STERILIZATION INSTRUCTIONS Cutting...
Cutting Accessories •Burs •SawBlades •K-Wires •SteinmannPins •TwistDrills
Rx Only
CLEANING & STERILIZATION INSTRUCTIONS
SURGICAL POWER & ACCESSORIES
2
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
3
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.
4
Saw Blades: • Donotuseexcessiveforcetotwistorbendsawblades. • Cuttinginmetalguidesoraccidentalcontactwithmetalretractorsmaydamagethesawbladeandmaynecessitateitsreplacement. • Insertsawbladeintoalignmentguideorcuttingfixturepriortoactivatinghandpiece. • Sawbladesbecomehotfromfriction.Irrigationofsawbladesisrecommendedduringuseandisrequiredwhenusinganalignmentguideorcuttingfixture.
K-Wires and Pins: • Immobilizethepatient’sareaoffixationtopreventexcessiveforcesontheK-Wireorpin. • ExcessiveforcesontheK-Wireorpinmaycauselooseningormetalfatigueandsubsequentdevicefracture. • K-Wiresorpinsshouldberemovedassoonasadequatehealinghasoccurred.
Note:TheeffectsoftheMagneticResonanceenvironmentontheK-WiresandSteinmannPinshavenotbeendetermined.Thesemedicaldeviceshavenotbeentestedformagneticfield/migration,artifactsorheatingintheMRIenvironment.
5
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.
6
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.
7
STERILIZATION RECOMMENDATIONS
WARNINGS:
• Theuseofdisinfectingsolutionsforanexteriorinstrumentwipewillnotsterilizethecuttingaccessory.• Inspectsterilizedcuttingaccessories.Ifdiscolorationorrustisvisibledonotuse.
CAUTIONS:
• Donotprocessinautomatedwasher-sterilizer.• Donotre-useorreprocessusedcuttingaccessories.• Donotusecoldsterilizationsolutionsasthesecontainoxidizingagentswhichmaycausedamagetothedevice.• Donotsterilizewhileconnectedtohandpieceandorattachment.• WraptheinstrumentsperAAMIrecognizedguidelines.• Followthesterilizermanufacturer’swritteninstructionsforcycleparameters,loadconfigurationandAAMIguidelinesforsteamsterilization.• Donotcleanorre-sterilizecannulateddrills,toolsteel,440steel,laserweldedorbrazedtwopiecesawblades.
8
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
9
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.
10
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
BrasselerU.S.A.Medical,LLCOneBrasselerBoulevard•Savannah,GA31419800.535.6638•912.921.7578(fax)BrasselerUSAMedical.com
M
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.