INSTRUCTIONS FOR USE
@2023 ASR Systems, Inc. Alll rights reserved. US and foreign patents pending Titan CSR® Retractor and ASR Systems are trademarks of ASR Systems, Inc.
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Description
TheTITANCSR™self-retainingretractorsystemis a latex-free, reusable system designed to provide access and exposure for surgical procedures.
IntendedUse
The TITAN CSR self-retaining retractor is intended for use during surgical procedures in order to provide surgicalaccessandexposure.
PartNumbers
Inspection,Warningsand Precautions,&Contraindications
ASRSystems’InstructionsforUseareprovidedtohelp supportthesafeandeffectivereprocessingoftheTITAN CSR™byhealthcareprofessionalsinahealthcarefacility.
ASRSystems’TITANCSRisdeliveredtothehealthcarefacilityas anon-sterileitemthatmustbeinspected,cleaned,and sterilizedpriortouse ASRSystemshasvalidatedthecleaning andsterilizationproceduresdemonstratingtheTITANCSRcan besafelyusedasintended.Theseinstructionsarebasedonthe validationtestingconductedbyanaccreditedGLPmicrobiology lab.Healthcareprofessionalsmusttakecareandresponsibility toensureappropriateequipment&materialsareusedto reprocesstheTITANCSR.Healthcareprofessionalsmustprovide adequatetrainingtostaffusingorreprocessingtheTITANCSR If ahealthcareprofessionaldeviatesfromASRSystems’ instructions,itisthehealthcarefacility’sresponsibilitytoverify effectivenessofthereprocessingprocedure.
Inspection: InspecttheTITANCSRpartsbeforeandaftereachusetodetect wear, tear, or imperfections. Set aside any damaged or deformed parts, do not use, and contact ASR Systems for further instructions Should you have concerns regarding the operation of the TITAN CSR proper function, please contactASRSystemstodiscuss.
Warnings And Precautions: The TITAN CSR self-retaining surgical retractor system and accessories are supplied non-sterile. All instruments must be inspected, cleaned, and sterilized prior to each use, including the initial use. The TITAN CSR modular frame, blades, and blade clamps may have sharp edges and require careful handling while inspecting, wiping, cleaning, and packaging. Personal Protective Equipment (PPE): PPE should be worn, per individualfacilityprotocol,whenhandlingorworkingwithacontaminatedor potentially contaminated TITAN CSR. Creutzfeldt-Jakob Disease (CJD): DiscardordestroyinstrumentsincontactorexposedtopatientswithCJD,or those suspected of CJD. Cross-Contamination Issues: Care should be taken inaccordancewithfacilityprotocolforanycrosscontaminationissues