s User guide

INDICATIONS FOR USE
Surgical and dental instruments are designed to perform specific functions such as cuing, grasping, clamping, dissecting,
probing, retracting, draining, aspirating, suturing, or ligating. Surgical instruments may also be used to facilitate the insertion
of surgical implants.
CONTRAINDICATION
Instruments should not be used for anything other than their intended use.
WARNING
If any device is/was used in a patient with, or suspected of having Creutzfeld Jakob Disease (CJD), the device cannot be reused
and must be destroyed aer exposure as the instruments have not been validated to withstand the chemical and thermal
exposure recommended to eradicate prions.
Consult individual national infection control/prevention protocols for specific guidance regarding processing medical devices
with suspected exposure to CJD.
PRECAUTIONS
• IntegraMiltexinstrumentsaresuppliednon-sterile,unlessotherwisenotedandmustbecleaned,lubricatedand
sterilized prior to use according to hospital protocol and procedures outlined in this document.
• Inappropriateuseofinstrumentsmayresultinpatientinjury,damagedorbrokeninstruments.
• Propercleaning,handling,sterilizationandstandardroutinemaintenance(suchassharpening,ifapplicable)
will ensure that the instruments perform as intended and will extend their useful life.
• Delicatesurgical/dentalinstrumentsrequirespecialhandlingtopreventdamagingthetips.Usecaution
during cleaning and sterilization.
• Donotusedryheatsterilizationorexposetophenolsoriodophors.
• Donotapplyexcessivestressorstrainatjoints;misusewillresultinmisalignmentorcracksattheboxlocks
 orjaws.
• Rongeursandbonecuingforcepsshouldonlybeusedtocutbone,neverwireorpin.Donottwistorapply
excessive stress during use.
• Wearappropriateprotectivegloves,eyewearandclothingwhenhandlingbiologicallycontaminated
instruments.
• Instrumentsmanufacturedfromdierentmetalsorwithspecialcoating,shouldbeprocessedseparatelyto
 avoidelectrolyticactionbetweenthedierentmetals.
• Beforeuse,inspecttheinstrumentsforpossibledamage,wearornon-functioningparts.Carefullyinspect
 thecritical,inaccessibleareas,jointsandallmovableparts.
• Damagedordefectiveinstrumentsshouldnotbeusedorprocessed.
• Sutureneedlesaredesignedforsingle-useandshouldnotbereprocessed.Followsharpssafetyguidelinesforpointofusedisposable.
DECONTAMINATION AND STERILIZATION PROCEDURES
PersonnelshouldfollowacceptedguidelinesasrecommendedinANSI/AAMIST79-Comprehensiveguidetosteamsterilization
andsterilityassuranceinhealthcarefacilitiesandISO17664.ForEthyleneOxidesterilization,followtheANSI/AAMIST41Ethyl-
eneOxidesterilizationinhealthcarefacilities:safetyandeectiveness,4thedition.Sterilizationofmedicaldevicesinformation
to be provided by the manufacturer for the processing of resterilizable medical devices. Instruction for reprocessing reusable
surgicalinstrumentsisprovidedaccordingtoISO17664.Thedecontaminationproceduredoesnotsterilizetheinstruments.
RefertoandprocesstheinstrumentsasoutlinedintheSTERILIZATIONsection.
CARE AND HANDLING
1. PRECLEANING:
• Keepinstrumentsmoistanddonotallowbloodand/orbodilyuidstodryontheinstruments.
• Removegrosscontaminantswithsteadystreamoflukewarm/coolwater(below110°F/43°C).Rinseeach
instrument thoroughly. Do not use saline or chlorinated solutions.
• Openjawsofhingedinstrumentsforcleaning.Givespecialaentiontojointsandserrations.Instruments
having more than one part or piece must be disassembled to expose all surfaces to the cleaning process.
Retain all parts to facilitate reassembly.
• Separatesharpsanddelicatesurgicalinstruments.Avoidprocessinginstrumentsofdierentmetallic
composition together.
• Keepebonizedinstrumentsseparatefromotherstainlesssteelinstrumentstoavoidscratchestoand
removal of the ebonized coating.
2. RINSE: Rinse instruments thoroughly under warm distilled or demineralized water.
3. CLEANING:
CLEANING PRECAUTIONS:
• Ifappropriate,disassemblesurgicalinstrumentspriortocleaningandsterilization.
• Donotsoakinstrumentsinhotwater,alcohol,disinfectantsorantisepticstoavoidcoagulationofmucus,
 bloodorotherbodyuids.Donotexceedtwohourssoakinginanysolution.
• Donotusesteelwool,wirebrushes,pipecleanersorabrasivedetergentstoremovesoilasthesewill
damage the instrument and lead to corrosion.
• Microsurgical,platedanddelicateinstrumentsshouldbecleanedmanuallyandshouldnotbeprocessedin
an ultrasonic cleaner. Carefully protect the tips of delicate microsurgical instruments throughout the entire
cleaning and sterilization process.
• Topreservethesurfacecoatingofebonizedinstruments,keepebonizedinstrumentsseparatefromother
instruments and avoid mechanical cleaning and abrasive cleaners as these processes can scratch the
surface and remove the surface coating.
• Coloranodizedaluminuminstrumentsmaylosetheircolorthroughtheuseofconventional,mechanical
treatment processes.
A. MANUAL CLEANING:Topreventformationofbiolm,cleaningshouldoccurassoonaspossibleaer
instrumentation is used.
• Chooseacleaningsolutionappropriateforsurgical/dentalinstrumentsandfollowmanufacturer’s
instructions for use.
• TheuseofneutralpHdetergentsisrecommendedtoavoidcorrosion,piingandbreakage.
• Usingasmall,cleanhand-heldbrush,removesoilfromallsurfacesofinstrumentwhilefullyimmersedin
solution.
B. ULTRASONIC AND MECHANICAL CLEANING
• Forultrasoniccleaning,followmanufacturer’sspecicationsforwaterlevel,concentrationlevelsofcleaning
agent and temperature.
• Useanultrasoniccleanertoremovesoilfromhardtoreachsurfacessuchasgrooves,crevicesandmoving
parts aer gross soil has been removed.
• Openordisassembleinstrumentsasappropriate.
• Whenusingmechanicalwasher,makesureallinstrumentsstayproperlyinplaceanddonottouchoroverlap
each other.
• Donotallowebonizedinstrumentstocomeincontactwitheachotherorotherinstruments.
• Alwaysfollowthemanufacturer’sspecicationsforautomaticwasher-sterilizersanduseafree-rinsing,
 low-sudsingdetergentwithaneutralpH(6.0-8.5).Duetovariationsinwaterquality,thetypeofdetergent
 anditsconcentrationmayrequireadjustmentforoptimalcleaning.
4. RINSE AND DRY:Rinseallinstrumentsthoroughlywithdistilled,pyrogen-freewatertoremovealltracesofdebrisandcleans-
ingagents.Makesureallinternallumensandratchetsarethoroughlyrinsed.
Instrumentsmustbethoroughlydriedandallresidualmoisturemustberemovedbeforetheyarestored.Useaso,absorbent
towel/cloth to dry external surfaces. Compressed air may be used to aid the drying process.
5. LUBRICATE:Theuseofawatersolubleinstrumentlubricantthatiscompatiblewiththemethodof
sterilization to be used is recommended before instruments are sterilized.
• Aerthoroughlycleaninginstruments,properapplicationoflubricantstoalljointsandmovablemating
surfaces will keep them moving freely and aid in protecting surface from mineral deposits.
• Properlubricationisrequiredforallinstruments,regardlessofsurfacecoatings.
• Notethatultrasoniccleanersremovealllubrication;therefore,thismaintenanceprocedureshouldbedone
routinely aer ultrasonic cleaning and before sterilization.
• Iffollowingthelubricatingprocedure,donotrinseaerthisstep.
6. STERILIZATION:
Aer following decontamination recommendations, reusable instruments are ready for sterilization.
• SeeANSI/AAMIST79.
• AAMIstandardsrecommendthatsterilizermanufacturer’swrieninstructionsforcycleparametersshould
 alsobefollowed.Medicaldevicemanufacturer’sexposuretimestosterilizationtemperaturemayneedtobe
longer than minimum indicated by sterilizer manufacturer but must never be shorter. It is the responsibility of
the user to establish whether sterilizer meets these minimum recommendations.
• Instrumentsmaybepackagedinrigidcontainers,orpackagingclearedforuseinsterilization.Packaging
should ensure sterility of instruments until opened for use at the sterile field and permit removal of contents
without contamination.
• RecommendedsteamsterilizationparametertoachieveSterilityAssuranceLevel(SAL)of10
-6
:
Independentlaboratorytesting,referencingFDA(21CFRPart58)GoodLaboratoryPracticeRegulationshasvalidatedthe
following parameters.
High Vacuum Steam (Pre-vacuum)
Unwrapped in containers
Perforated stacked/unstacked
Solid unstacked
270ºF(132ºC) 4minutes
minimum
20minutes
Gravity Steam
Unwrapped in containers
Perforated unstacked
250ºF(121ºC) 45minutes 20minutes
Gravity Steam
Wrapped in cassees 250ºF(121ºC) 30minutes 20minutes
Ethylene Oxide (EtO)
Unwrapped in containers
Perforated unstacked
Solid unstacked
131ºF(55ºC) 60minutes(minimum)
Concentration:725mg/l
Humidity:70%
Aerationtime:8hoursminimum
IndependentlaboratorytestingconductedaccordingtoISO17664,hasvalidatedthefollowing
sterilization parameters.
Sterilization Method Temperature Exposure Time Dry Time
High Vacuum Steam (Pre-vacuum)
Wrapped 270ºF(132ºC) 3minutesminimum N/A
RETURNED GOODS POLICY
Productsmustbereturnedinunopenedpackageswithmanufacturer’ssealsintacttobeacceptedfor
replacement or credit unless returned due to a complaint of product defect. Determination of a product defect will be made by Integra
Miltex.Productswillnotbeacceptedforreplacementiftheyhavebeeninthepossessionofthecustomerformorethan90days.
REPAIRS AND MAINTENANCE
Improper,ineectiveandinsucientmaintenancecanreducethelifeofaninstrumentandwillinvalidatetheinstrument’swarranty.
Shouldinstrumentsrequirerepairormaintenance,contactIntegraMiltexforreturnauthorizationandaddress.
InstrumentsreturnedtoIntegraMiltexforrepairmusthaveastatementtestifyingthateachinstrumenthasbeen
thoroughlycleanedandsterilized.Failuretosupplyevidenceofcleaninganddisinfectionwillresultina
cleaning charge and delayed processing of your instrument repair.
PRODUCTINFORMATIONDISCLOSURE
INTEGRAANDITSSUBSIDIARIES(“INTEGRA”)ANDMANUFACTUREREXCLUDEALLWARRANTIES,EXCEPTINTEGRA’S
APPLICABLESTANDARDWARRANTYWHETHEREXPRESSEDORIMPLIED,INCLUDINGBUTNOTLIMITEDTO,ANYIMPLIEDWARRANTIES
OFMERCHANTABILITYORFITNESSFORAPARTICULARPURPOSE.NEITHERINTEGRANORMANUFACTURERSHALLBELIABLEFORANY
INCIDENTALORCONSEQUENTIALLOSS,DAMAGE,OREXPENSE,DIRECTLYORINDIRECTLY
ARISINGFROMUSEOFTHISPRODUCT.NEITHERINTEGRANORMANUFACTURERASSUMENORAUTHORIZEANYPERSON
TOASSUMEFORTHEMANYOTHERORADDITIONALLIABILITYOR
RESPONSIBILITYINCONNECTIONWITHTHESEPRODUCTS.
SYMBOLS USED ON LABELING
Manufacturer
1
European Authorized Representative
Catalog Number
LotNumber
Caution:SeeWarningsandPrecautions
ConsultInstructionsforUse
ComplieswithMDD93/42/EEC
EC REP
LOT
Federal(USA)lawrestrictsthisdevicetosaleby
or on the order of a physician or practitioner

Integra
®
Miltex
®
Care and Handling of Surgical and
Dental Instruments
DirectionsforUse/English
Integra,theIntegralogo,andMiltexareregisteredtrademarksofIntegraLifeSciences
CorporationoritssubsidiariesintheUnitedStatesand/orothercountries.
©2012IntegraLifeSciencesCorporation.AllRightsReserved. STANDARDIFURev. E 06/13
1
Company responsible for a device marketed under its own name regardless of whether
“manufacturedfor”or“manufacturedby”thecompany.
ComplieswithMDD93/42/EEC
IntegraYorkPA,Inc.
589DaviesDr.
York,PA17402USA
866-854-8300
717-840-9335
www.integralife.com/integra-miltex
EC REP
IntegraLifeSciencesServices(France)SASImmeubleSequoia2
97alléeAlexandreBorodine
ParcTechnologiquedelaPortedesAlpes
69800SaintPriest–France
Telephone:33(0)437475910
Fax:33(0)437475929
2
Do not reuse