Teleflex Medical
Fiberoptic Cabel Guidelines, IFU
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Fiberoptic Cable Guidelines Device Description Fiberoptic cables are designed to deliver maximum light when coupled to a medical grade fiberoptic light source. The fiberoptic cables can be used with quartz halogen, metal halide, Xenalight™ 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. The cables are medical grade, high transmittance, peak efficiency.
Contraindications This device has no contraindications of which we have knowledge.
Warnings and Precautions
The light cables are provided non-sterile and must be sterilized before use. See instructions for cleaning and sterilization.
For use with Xenon lightsources, be sure lightsource is filtering at least 90% of infrared radiation (IR) to prevent high heat.
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 the cables as you would any fine optical device.
The user of this product should be thoroughly familiar and trained in use and care of the product.
Match the cable size to the endoscope. Using a larger cable (fiber bundle size) than the endoscope requires will result in overheating the endoscope’s proximal end.
Light loss and warmer than normal instrument temperatures may be encountered if using a light source fiber optic cable with a larger aperture or bundle diameter than the instruments receiving aperture or bundle diameter.
FIRE or INJURY HAZARD: Energy released by illuminators used with fiber optic light guides is retained in the cable and transmitted to a connected instrument through the cable end tip. The output of a connected instrument or end tip left in close proximity or contact with tissue or flammable materials presents a risk of injury or fire. Qualified personnel must determine a safe working distance and intensity setting for each application. The output should never be left on unattended.
Adverse Events We have no knowledge of any adverse events with this product.
Cleaning of Headlamp Cable Headlamp cable is not to be steam autoclaved. Autoclaving will cause damage to the non-sealed Proximal end of the cable which has a lens on it. The headlamp cable can be wiped cleaned with 70% Isopropyl alcohol or mild soap.
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. The following Steam Sterilization (Autoclave) guidelines are recommended:
Automated cleaning (full cycles) The device shall be run through a hospital grade full cycle. The minimum parameters for the full cycle are as follows: Motor Speed High [ USA Parameters] Phase
Recirculation Time [Minutes]
Temperature
Pre-Wash 1
02:00
Cold Tap Water
Enzyme Wash
03:00
Hot Tap Water
Detergent Type and Concentration NA Enzol®, 1 oz/gal
Rinse 1
00:15
Drying
06:00
Hot Tap Water
(Neutral pH 7.8-8.8) NA
60°C 90°C
NA
Steam Sterilization (Autoclave) The cycle selected is dependent on equipment and hospital protocol. General guidelines are: METHOD Steam (wrapped) Steam (wrapped) Steam (wrapped)
CYCLE Prevacuum
MINIMUM TEMPERATURE 270 deg. F (132 deg. C)
EXPOSURE TIME 4 minutes
Gravity
270 deg. F (132 deg. C)
10 minutes
Gravity
250 deg. F (121 deg. C)
45 minutes
The above sterilization parameters have been validated and are effective. Materials used in construction will withstand temperatures of 134C up to the times listed with no know adverse impact.
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 LevelDisinfection Sterilization
Sterilization
45 minutes @ 25 degrees C 77 degrees F 20 minutes @ 25 degrees C 77 degrees F
10 Hours NA
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, we will replace the product or component part without charge. Should your fiberoptic cable need servicing under this warranty, please contact 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. Chart of medical device symbols used Manufacturer
Caution, consult accompanying documents
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner
Consult Instructions for Use
Nonsterile
Do not use if package is damaged
Batch code / lot number Catalog, reorder or reference number
Manufactured for:
L02944 R01