SURGICAL FIBEROPTIC CABLES INSTRUCTIONS FOR USE Rev J

PLEASE READ BEFORE USE Failure to follow these instructions could render the device unusable and void any warranty. Device Description CUDA® SURGICAL fiberoptic cables are designed to deliver maximum light when coupled to a medical grade fiberoptic light source. CUDA® SURGICAL fiberoptic cables can be used with quartz halogen, metal halide, or Xenon light sources. They are compatible with virtually all endoscopes, medical instruments, and microscopes. Intended Use This device is designed to illuminate a surgical site by relaying light from a fiberoptic light source onto the desired site. CUDA® SURGICAL cables are medical grade, high transmittance, peak efficiency. NOTE: The style of cable suitable for a given lightsource can be determined from the table below. Standard Cable X

Clad Rod Cable Lensed Cable

Fused Cable

Cuda 250W Halogen Other 250W X Halogen Focused Ceramic X X Xenon Other Xenon ≤ X X 300W Xenon >300W X Metal Halide ≤ 75W X • For use with Xenon lightsources, be sure lightsource is filtering at least 90% of infrared radiation (IR) to prevent high heat. Contraindications This device has no contraindications of which we have knowledge. Warnings and Precautions • • •

CUDA® SURGICAL light cables are provided non-sterile and must be sterilized before use. See instructions for cleaning and sterilization. Always inspect cables for any evidence of damage prior to use. Pay particular attention to optical surfaces looking for scratches or dings. Use caution to treat CUDA® SURGICAL cables as you would any fine optical device.

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• •

The user of this product should be thoroughly familiar and trained in use and care of the product. FIRE HAZARD: Never drape or cover the end of any fiberoptic cable with anything flammable.

Adverse Events We have no knowledge of any adverse events with this product. Cleaning and Sterilization of Fiberoptic Light Guides Cleaning Fiberoptic light guides for endoscopes, microscopes, and surgical instruments are high quality optical devices. They require similar care to that taken for any precision optical component. After each use, the light guide should be washed and cleaned of all debris. A soft brush and mild detergent should be used to clean the device. Pay particular attention to any crevices or seams. Avoid any harsh materials or detergents that can scratch or in any way damage the optical surfaces on each end of the light guide. ST Technologies recommends following the guidelines contained in ASTM F 1518-00 “Standard Practices for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera.” Although written specifically for endoscopes, much of it applies to light guides. Steam Sterilization (Autoclave) The cycle selected is dependent on equipment and hospital protocol. General guidelines are: METHOD

CYCLE

Steam (wrapped) Steam (wrapped) Steam (wrapped)

Prevacuum Gravity Gravity

MINIMUM TEMPERATURE 270 deg. F (132 deg. C) 270 deg. F (132 deg. C) 250 deg. F (121 deg. C)

EXPOSURE TIME 4 minutes 10 minutes 45 minutes

Chemical Disinfection It is recommended that the guidelines below published by Advanced Sterilization, a Johnson & Johnson company be followed. Product

Cidex Activated Dialdehyde Solution Cidex Plus 28 Day Solution

High Level Disinfection Sterilization 45 minutes @ 25 degrees C 77 degrees F 20 minutes @ 25 degrees C 77 degrees F

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Sterilization

10 Hours

NA

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Steris Sterilization Follow Steris Corporation Guidelines Sterrad Sterilization Follow Sterrad (a J&J Company) Guidelines Limited Warranty Your fiberoptic cable has a one (1) year warranty from the date of shipment on workmanship and all defects of material except for broken fiber. Should your product prove to have such defects within one (1) year of shipment, ST Technologies will repair or replace the product or component part without charge. Should your fiberoptic cable need servicing under this warranty, please contact your distributor or your customer support specialist for return authorization documentation. You should carefully pack the product in a sturdy carton, including a note describing the defects, your name, your company name, telephone number and a return address. Warranty does not cover equipment subject to misuse, accidental damage, and normal wear and tear. This warranty gives you specific legal rights, and you may also have other rights that vary from state to state. Post warranty repairs Please contact your distributor or your customer support specialist for return authorization documentation.

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CÂBLES A FIBRES OPTIQUES

ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

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FIBEROPTISCHE KABEL

ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

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CAVI IN FIBRA OTTICA

ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

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CABLES DE FIBRA ÓPTICA

ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

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CABOS DE FIBRA ÓPTICA INSTRUÇÕES

ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 Customer Service: 904 208 2291 Toll Free 877 814 2237 EC|REP RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

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