Integra Luxtec Operation manual

OPERATION AND SERVICE MANUAL
Integra® Luxtec® Fiber Optic Headlight Cables
For use with high power surgical light sources
Integra®Luxtec®
Fiber Optic Headlight Cables
EN

2
Integra® Luxtec®
Fiber Optic Headlight Cables
Table of Contents
Indications for Use .............................................................................................................................................................................................. 3
Symbols .................................................................................................................................................................................................................4
General Warnings .................................................................................................................................................................................................5
Precautions ...........................................................................................................................................................................................................5
Cable Care..............................................................................................................................................................................................................5
Maintenance .........................................................................................................................................................................................................6
Repair and Return Information........................................................................................................................................................................... 7
Limited Express Warranty.................................................................................................................................................................................... 7

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CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
Indications for use
This fiber optic headlight cable is designed to deliver illumination from a high intensity light source to a surgical headlight
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. This device is intended to be used by professional users.
Fiber optic headlight cables should never be used in ocular surgery or in a surgical procedure requiring direct
illumination of the eye.
See instructions for use for light source being used to ensure compatibility.
This device is CE marked in accordance with the Medical Devices Directive 93/42/EEC.

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Integra® Luxtec®
Fiber Optic Headlight Cables
Symbols
Found on a medical grade light source, other illumination related equipment, fiber optic cables and corresponding packaging.
Fuse
Type CF Equipment
Type BF Equipment
Motor
Fan
Certified by CSA
Consult Instructions for Use
Part Number
Batch Code
Serial Number
Manufacturer
Date of Manufacture
This device meets CE requirements
Caution: High Voltage
Equipotentiality
Protective Earth
On / Off
Stand-by
System Status Display
System
Do Not Dispose
Humidity Limitation
Alternating Current
Temperature Limitation
Atmospheric Pressure Limitation
Push
Hours
Over Temperature
Intensity
Lamp
Keep dry
REF
LOT
0123
Refer to Instruction Manual
Attention: Consult Accompanying Documents
High Temperature

5
• 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fiberoptic
cable to ensure it has been properly cleaned and maintained.
• 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cabledirectlyattheeyewhile
in operation. The brilliant light output can cause severe
eye discomfort.
• Lightsourcesusehighintensitylamps,whichproduceheat
as well as brilliant light. The high brightness and the light
output of the fiber optic cable can cause burns.
General Warnings
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.
Precautions
• Takeprecautionstoverifythatthefiberopticcableis
appropriately suited for the light source. Xenon and other
high illumination light sources require premium fiber optic
cables in order to achieve optimal performance and prevent
damage to the fibers, thereby diminishing the quality of the
light output or the useful life of a fiber optic cable.
• Takeprecautionsnottotouchordisconnectthecableend
fitting from the turret until the light source has been “shut
down” for a period of time and allowed to cool. The cable
end fitting will remain hot immediately following shut down,
which can cause burns.
• Takeprecautionstonotplaceandrestahotcableendfitting
and/or head light on a patient or allow the system to come in
contact with un-protected hands or tissue. The entire system
should be allowed to cool following use. Failure to do so can
cause burns and/or tissue damage.
FIRE HAZARD: DO NOT DRAPE OR COVER THE LIGHT SOURCE OR THE FIBER OPTIC CABLE WHILE IT IS OPERATING.
DO NOT PLACE THE CABLE END FITTING ON A DRAPE WHILE IT IS OPERATING.
•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thatareprovidedtokeepthe
headlight cable secured to the surgeon’s gown for
greater comfort and maneuverability.
Cable Care
Fiber optic headlight cables are fine, high quality optical instruments. You can prolong the useful life by following a few guidelines:
• Donotuseyourfiberopticcablewithanyalterationsto
its original design or fabrication.
• Keeptheopticalfacesfromcontactingthefloororotherhard
surfaces. The resulting scratches will diminish light output.
• Anyinadvertentcutorpuncturetotheoutersheathwill
render the cable unsafe. It should be taken out of
service immediately.

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Integra® Luxtec®
Fiber Optic Headlight Cables
Follow all applicable bloodborne pathogen procedures as indicated by OSHA and /or your hospital requirements when cleaning,
disinfecting, and sterilizing instruments and accessories.
Cleaning (UltraLite® headlight cables*):
Wipe the fiber optic cable sheathing with a water dampened paper towel, cloth, or gauze before using 70 % Alcohol as
the disinfectant.
Disinfecting (UltraLite headlight cables*):
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 lens.
Sterilization (UltraLite headlight cables*):
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.
Maintenance
* UltraLite and Sweatband headlight cables can be identified by the curved lens at the light source end.

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Repair and Return Information
Indications for replacement:
1. When a fiber optic headlight cable shows 30% loss of light
transmission of its fibers, the cable should 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 FIBER OPTIC CABLE 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 Integra representative to order replacement
cables or call Integra customer Service Department at
1-800-431-1123 (USA & Canada) or at [phone].
ATTENTION: OPERATING ROOM PERSONNEL
We require that you clean 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.
Limited Express Warranty
Integra warrants that the fiber optic headlight 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 Integra,
excluding fiber breakage. Integra Premium UltraLite headlight
cables feature a lifetime warranty against browning.
Integra’s sole and exclusive liability under this warranty
shall be, at Integra’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 Integra in writing,
(2) if requested by Integra, customer returns equipment to
Integra with shipping charges pre-paid and
(3) upon inspection, Integra 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 Integra, subjected
to unusual physical stress, or damaged during shipment. This
warranty is nontransferable unless authorized in writing by
Integra.
If Integra is unable to remedy any defect in the cable as
required by the foregoing warranties, Integra’s liability shall
not in any event exceed the purchase price received hereunder
by Integra for the equipment.
THE WARRANTIES SET FORTH HEREIN ARE IN LIEU OF ANY
OTHER REPRESENTATIONS OR WARRANTIES. INTEGRA
DISCLAIMS AND CUSTOMER WAIVES ALL OTHER EXPRESS
OR IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED
TO, ALL IMPLIED WARRANTIES OF MERCHANTABILITY FOR
A PARTICULAR PURPOSE. IN NO EVENT SHALL INTEGRA
BE LIABLE TO ANY PARTY FOR INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, WHETHER RELATED TO THIS OR
ANY OTHER CLAIM, REGARDLESS OF ANY KNOWLEDGE OF
INTEGRA OF SUCH POTENTIAL DAMAGES.
Disposal of the product, packaging material and accessories;
For disposal, observe the relevant regulations and laws valid in
your country. For further information, please contact Integra.

Integra® Luxtec®
Fiber Optic Cables
Integra, the Integra logo, Luxtec and UltraLite are registered trademarks of Integra LifeSciences Corporation or its subsidiaries
in the United States and/or other countries. ©2020 Integra LifeSciences Corporation. All rights reserved. Printed in the U.S.A.
60906075 Rev A 02/20 1480589-1
0123
Manufactured by:
Integra LifeSciences (Ireland) Limited
IDA Business and Technology Park
Sragh, Tullamore
County Offaly, Ireland
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