User Manual for Fiber Optic Cables Rev F

TABLE OF CONTENTS Indication for Use

1

Symbols

1

General Warnings

2

Cable Care

3

Maintenance

3-4

Repair and Return Information

5

Limited Express Warranty

6

INDICATION FOR USE This fiber optic light guide is designed to deliver illumination from a high intensity light source to a surgical headlight or surgical instrument for surgical site illumination, either standard or minimally invasive. It is compatible for use with light sources made with the following: Xenon with lamp power rating of up to 300 Watts, Halogen with lamp power rating of up to 250 Watts, or Metal Halide with lamp power rating of up to 100 Watts. Any light source used with this cable should have a minimum of 90% IR filtering to prevent cable damage during use.

SYMBOLS Note: The symbols listed below identify those symbols that can be found on a medical grade light source and other illumination related equipment. Attention: Consult Accompanying Documents

Brightness

Type CF Equipment

Type BF Equipment

-1-

GENERAL WARNINGS • The user of this product should be thoroughly familiar and trained in the use and care of this product. • The user should carefully study this manual before making any attempt to use the product clinically. Instructions should be followed specifically, with special attention given to warnings and cleaning instructions. This manual should also be available to the surgical team during a procedure. • Follow the instructions in the operating manuals of other manufacturers’ equipment when they are used in conjunction with this product. • Before every procedure, carefully inspect the light guide cable to ensure it has been properly maintained, cleaned and sterilized (if compatible), and that it is fully functional. • Light sources use high intensity lamps, which produce heat as well as brilliant light. The high brightness produced by the light source and the light output of the light guide cable can cause burns. • Care should be taken to follow the maintenance and cleaning instructions. Excessive bending of the cable should be avoided. • Use care not to point the light guide directly at the eye while in operation. The brilliant light output can cause severe eye discomfort. • FIRE HAZARD: DO NOT DRAPE OR COVER THE LIGHT SOURCE OR THE LIGHT GUIDE WHILE IT IS OPERATING. DO NOT PLACE THE LIGHT GUIDE ON A DRAPE WHILE IT IS OPERATING. • SAFETY PRECAUTIONS MUST ALWAYS BE EXERCISED WHEN USING ELECTRICAL EQUIPMENT TO PREVENT OPERATOR/PATIENT SHOCK, FIRE HAZARD, OR EQUIPMENT DAMAGE.

-2-

CABLE CARE Fiber optic cables are fine, high quality optical instruments. You can prolong the useful life by following a few guidelines. • Avoid stretching your cable, forming configurations involving sharp angles or kinks, or contact with sharp or pointed objects. The internal light fibers are made of glass, a material that breaks under stress. Fiber breakage will result in diminished light output. • Utilize the gown clips (if provided) to keep the headlight cable secured to the surgeon's gown for greater comfort and maneuverability. (This does not apply to endoscopic use.) • Do not use your fiber optic cable with any alterations to its original design or fabrication. Bundle size (aperture) of the fiber optic cable should be matched to the aperture of the instrument to obtain maximum light output. • NOTE: A larger aperture fiber optic cable will not increase light output of a smaller aperture instrument. • Keep the optical faces from contacting the floor or other hard surfaces. The resulting scratches will diminish light output. Store the cables in sterilization trays for additional protection. • Any inadvertent cut or puncture to the silicone tube will render the cable unsafe. It should be taken out of service immediately.

MAINTENANCE Follow all applicable bloodborne pathogen procedures as indicated by OSHA and /or your hospital requirements when cleaning, disinfecting, and sterilizing instruments and accessories. Cleaning (other than Ultralite*): Lukewarm water with mild detergent is recommended to remove all blood and debris. (Do not use synthetic detergents or oil-based soap, as these chemicals may be absorbed into the cable and could subsequently leak out and cause tissue reactions.) Rinse thoroughly with distilled water, taking care to rinse the face of glass fiber at both ends of the cable. Cleaning (Ultralite*): Luxtec suggests the use of alcohol wipes to clean the Ultralite and Sweatband headlight cables.

* Ultralite and Sweatband cables can be identified by the curved lens at the lightsource end.

-3-

MAINTENANCE Disinfecting (other than Ultralite*): Cables may be soaked briefly in disinfecting solutions without damage. Refer to the manufacturer's time specifications; however, avoid soaking cables for more than 10 minutes. Disinfecting (Ultralite*): Soaking the Ultralite and Sweatband headlight cables in any sterilizing disinfectant should be avoided. There is a lens assembly at the light source end, which is not sealed and could allow moisture to penetrate behind the lensing. Sterilization (other than Ultralite*): Your fiber optic cable has been specifically designed to withstand repeated sterilization in the following types of sterilizers: • Steam autoclave (pre-vacuum) 132°C for 4 minute cycle with a 20 minute dry time • Ethylene Oxide (EtO) Sterilization (Ultralite*): The Ultralite fiber optic cable has not been specifically designed to withstand sterilization. There is a lens assembly at the light source end, which is not sealed, and could allow moisture to penetrate behind the lensing.

Meticulous care should be taken to avoid cable contact with sharp or pointed objects. Ensure your autoclave is operating correctly for effective sterilization. Consult your autoclave manual for specific instructions, conditions and exposure periods. The pressure differential, which occurs during steam autoclaving, may cause small bubbles in the tubing. These bubbles will not affect the fiber optic cable and will dissipate in time. Following sterilization of your fiber optic cable, allow it to cool very slowly to room temperature. DO NOT immerse or rinse in a cold liquid, as this will cause fiber breakage and extensive light transmitting losses.

* Ultralite and Sweatband cables can be identified by the curved lens at the lightsource end.

-4-

REPAIR AND RETURN INFORMATION Indications for replacement: 1. When a fiber optic cable shows 30% loss of light transmission of its fibers, the cable needs to be replaced. This can be determined while holding both ends of the cable: point one cable end toward a light while looking at the other end. DO NOT PERFORM THIS CHECK WHILE THE LIGHT GUIDE IS ATTACHED TO AN OPERATING LIGHT SOURCE. The brilliant light output can cause severe eye discomfort. 2. When there is separation of the cable components that can be seen with a visual inspection, such as strain relief and sheath or endfittings. 3. When a cable has been excessively stretched or cut.

Contact your local LUXTEC distributor to order replacement cables or call Luxtec customer Service Department at 1-800-325-8966 (USA & Canada) or at +1-508-835-9700.

ATTENTION: OPERATING ROOM PERSONNEL We require that you clean and sterilize (if compatible) all equipment before returning for repair. If equipment is received in an unsanitary condition, an additional cleaning fee will be charged, including those pieces repaired under our warranty. Please note on shipping packaging if contents have not, or cannot be sterilized.

-5-

LIMITED EXPRESS WARRANTY LUXTEC Corporation warrants that the cable furnished hereunder shall be free from defects in material and workmanship under normal use and service for a period of eighteen (18) months from the date of shipment from LUXTEC, excluding fiber breakage LUXTEC’s sole and exclusive liability under this warranty shall be, at LUXTEC’s option, either to repair or replace any component of the cable which fails during the warranty period due to any defect in workmanship or material F.O.B. factory if: ·

(1) customer promptly reports such defect to LUXTEC in writing,

· (2) if requested by LUXTEC, customer returns equipment to LUXTEC with shipping charges pre-paid and ·

(3) upon inspection, LUXTEC finds the cable to be defective.

This warranty is contingent upon normal and proper use of the cable and does not cover fiber breakage or a cable which has been modified without written approval of LUXTEC, subjected to unusual physical stress, or damaged during shipment. This warranty is nontransferable unless authorized in writing by LUXTEC. If LUXTEC is unable to remedy any defect in the cable as required by the foregoing warranties, LUXTEC’s liability shall not in any event exceed the purchase price received hereunder by LUXTEC for the equipment. THE WARRANTIES SET FORTH HEREIN ARE IN LIEU OF ANY OTHER REPRESENTATIONS OR WARRANTIES. LUXTEC DISCLAIMS AND CUSTOMER WAIVES ALL OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO, ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND LUXTECNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL LUXTEC BE LIABLE TO ANY PARTY FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER RELATED TO THIS OR ANY OTHER CLAIM, REGARDLESS OF ANY KNOWLEDGE OF LUXTEC OF SUCH POTENTIAL DAMAGES.

99 Hartwell Street • West Boylston • MA, 01583 • USA Telephone: (800) 325-8966 (USA & Canada) or +1-508-835-9700 • Fax: +1-508-835-9976 • email: [email protected] www.integra-surgical.com

P/N 850165 Rev. F