Fibreoptic Cables Maintenance and Sterilization Guide Rev G April 2006

WARRANTY STATEMENT This Stryker Endoscopy product is warranted to the original purchaser for a period of 90 days from the date of purchase to be free from defects in material and workmanship. This warranty extends to all purchases and is limited to the repair or replacement of the product without charge when returned to Stryker Endoscopy, 5900 Optical Court, San Jose, California 95138.

Fiberoptic Cables

Stryker cannot accept responsibility for returns or replacements which have not been authorized. This warranty does not cover damages caused by misuse or by failure to follow procedures outlined in this manual or as demonstrated by Stryker Endoscopy representatives.

Maintenance and Sterilization

There are no other expressed warranties. IMPORTANT File in your maintenance record

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA +1-408-754-2000, +1-800-624-4422 www.stryker.com

Stryker European Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. de Satolas Green 69881 MEYZIEU Cedex, France 233-065-077 Rev. G

Conformance to: 93/42/EEC Medical Device Directive

CLEANING a.

Clean thoroughly with a soft-bristled brush in a lukewarm watersoap solution to remove possible contaminants. Use a non-oil cleaner or mild soap.

b.

CAUTION: DO NOT use synthetic detergents or oil-based soaps. These soaps may be absorbed and may subsequently leach out to cause a tissue reaction. c. d.

Rinse thoroughly in lukewarm water and then with distilled water. Resterilize the fiberoptic cables.

Prevent any scratching on the face of the end-fitting as scratches may result in light transmission loss.

ETO • • • • •

100% ETO 54°C ± 2°C Instruments wrapped in an instrument tray or fully perforated sterilization box 1 hour 45 minute exposure time 12-hour minimum aeration time

STERRAD™: • Use the manufacturer’s instructions for operation. • Do not sterilize in sterilization pouches. Doing so may result in damage to the device. STERIS® Sterilization: The fiberoptic cables can be sterilized using Steris System 1 in the Flexible Processing Tray. Arrange the cable as shown in the figure below.

STERILIZATION NOTE: Make sure the maximum temperature of the autoclave is accurate. CAUTION: DO NOT use a HIVAC sterilizer. It will cause the silicone tubing to bubble excessively. IMPORTANT POINTS CAUTION: Remove the fiberoptic cable and let it slowly cool (approximately 3-5 minutes) to room temperature. DO NOT immerse or rinse fiberoptic cables in cold water or any other fluid. This could cause glass fiber breakage which decreases light transmission capabilities.

WARNINGS: When the fiberoptic cable is plugged in to a functioning light source and not assembled to an attachment, the distal end of the cable radiates heat. To avoid risk of burns, DO NOT allow the distal end of the fiberoptic cable to come in contact with or rest near drapes, cloth, or papers. The surface temperature near the scope adapter and at the end of the light cable may exceed 41° C if the unit is operated at maximum brightness for extended periods of time. This may cause burns.

GRAVITY DISPLACEMENT: 134° C • • • •

Gravity displacement sterilizer, 134°C Instruments wrapped in an instrument tray or fully perforated sterilization box 6-minute exposure time Average dry time 15-20 minutes

DO NOT ABUSE, PULL, STRETCH, KINK, PUNCTURE OR OTHERWISE ALTER THE FIBEROPTIC CABLES. Any of the above damage will cause irreversible damage to glass optical fibers which will impair light transmission through the cable. Match the size of the fiber bundle with the instrument being used to obtain maximum efficiency in light transmission.