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Thompson Retractor Xenon Illumination Products IFU

IMPORTANT INFORMATION FOR USE OF THOMPSON RETRACTOR XENON ILLUMINATION PRODUCTS (LITE WAND XE, RETRACTOR LITE XE, LITE CLIP, AND LITE WAND INSTRUMENT CASE) ONLY

This IFU is intended to assist health care personnel in safe handling practices, effective reprocessing, and maintenance of Thompson Surgical Instruments, Inc.’s xenon illumination products.

Xenon Lights will survive a maximum of 100 cycles of steam autoclave sterilization.* All Thompson Retractor products and accessories are latex-free.

Thompson Surgical Instruments, Inc.

10341 East Cherry Bend Road

Traverse City, Michigan 49684

*Indicate (RMA #) on return shipments*

Rev A

061419

xenonifu

phone:

fax:

(800) 227-7543 (IN USA)

+1 (231) 922-0177 (OUTSIDE USA)

+1 (231) 922-0174

IMPORTANT INFORMATION FOR USE OF THOMPSON LITE WAND XE, RETRACTOR LITE XE, AND ACCESSORY LITE CLIP *

PLEASE READ BEFORE USE

FAILURE TO FOLLOW THESE INSTRUCTIONS MAY RENDER DEVICE UNUSABLE AND MAY VOID

WARRANTY OR SERVICE AGREEMENTS.

INDICATIONS FOR USE:

The Thompson Lite Wand Xe / Retractor Lite Xe ( hereafter referred to jointly as “Xenon Light” ) is

intended as a task light for surgical procedures. It is designed to be used in conjunction with a

retractor system which it can attach to through the use of a Cam Joint and/or single use Lite Clip. The

Xenon Light is designed to provide visible illumination of the surgical field or the patient through a

xenon light source only. The Xenon Light is designed to be used by surgeons and other medical care

practitioners in a surgical setting to provide visible illumination of the surgical field or the patient.

Thompson Surgical products are supplied non-sterile.

This IFU is intended to assist health care personnel in safe use and handling practices, effective

reprocessing, and maintenance of all Thompson Surgical Instruments, Inc.’s xenon illumination

products.

ALL INSTRUMENTS MUST BE INSPECTED, CLEANED, AND STERILIZED PRIOR TO EACH USE.

SCOPE:

This IFU provides recommended information for the cleaning and sterilization of xenon illumination

products that are manufactured and/or distributed by Thompson Surgical Instruments, Inc.

Always reference our website, www.thompsonsurgical.com, for the most current revision

of this IFU.

LIMITATIONS ON REPROCESSING:

Xenon Light will survive a maximum of 100 cycles of steam autoclave sterilization. * Accessory Lite

Clip is a single use product and will survive a maximum of 1 cycle of steam autoclave sterilization.

WARNINGS AND PRECAUTIONS:

PPE (Personal Protective Equipment): Should be worn, per individual hospital protocol,

when handling or working with contaminated (or potentially contaminated) instruments.

CJD (Creutzfeldt-Jakob Disease): Discard or destroy instruments in contact or exposed

to patients with CJD, or those suspected of CJD.

(Thompson Surgical does not advocate nor provide any validated instructions to eliminate

risk of cross-contamination.)

1. Do not use xenon illumination products if damaged.

2. Do not operate Xenon Light while hot. Allow Xenon Light to cool to avoid breakage.

3. Do not allow Xenon Light to contact any sharp edges or pointed objects. Extensive fiber

breakage could occur.

4. Do not leave end-fitting face unprotected; scratches can degrade performance.

5. Do not abuse, kink, pull, or stretch Xenon Light. Damage to enclosed glass optical fibers will

result in light transmittal losses.

6. Do not attempt to slide Lite Clip off distal end of Xenon Light. Instead, push Lite Clip off the

side of the Xenon Light with fingers.

7. Do not lever off of Xenon Light or Lite Clip when attached to retractor blade with other

instrumentation.

8. Do not soak Xenon Light in Cidex. Employ only the sterilization measures stipulated in this insert.

9. Do not drape or cover any end of fiber optic cable with any flammable material or item.

10. Product contains silicone.

11. Do not use Lite Clip on lipped blades or blades thicker than 2mm. May cause Lite Clip to

weaken or break.

PROCESSING / REPROCESSING INSTRUCTIONS

HOSPITAL MUST ENSURE OPERATIONS ARE PERFORMED USING THE APPROPRIATE EQUIPMENT,

MATERIALS, AND TRAINED PERSONNEL. ANY DEVIATIONS FROM THIS IFU SHOULD BE EVALUATED

FOR EFFECTIVENESS TO AVOID POTENTIAL ADVERSE CONSEQUENCES.

CLEANING

Xenon illumination products must be manually cleaned prior to Sterilization. Use caution when

handling Xenon Lights after use. The proximal end could be hot; allow instrument to cool to avoid

breakage. Keep instruments moist and covered / wrapped until transported to Point of Use. DO NOT

allow saline, blood, or other organic debris to dry on instruments.

Manual Cleaning:

1. With the distal end pointing at a downward angle, use a soft bristled brush to gently scrub the

instrument under warm running tap water, for a minimum of one minute.

2. Rinse and actuate the Xenon Light to ensure all areas are accessed by the running water.

3. Prepare a warm water soap solution, using non-oily cleaner or mild detergent.

4. Dip the soft bristled brush into the detergent and use it to gently scrub the Retractor Lite until all

visible soil is removed.

5. Rinse the instrument under warm, gently running tap water, distal end pointing down.

6. Repeat Steps 1 – 5.

7. Dry the Xenon Light using a clean, soft, lint-free cloth. Visually inspect the cloth to ensure no visible

soil remains.**

** If visible or residual soil is found, entire Manual Cleaning process must be repeated

DO NOT immerse or rinse in cold water or other fluid, to avoid glass fiber breakage. Extensive breakage

will result in light transmitting losses.

STERILIZATION

The Lite Wand Xe, Retractor Lite Xe, Lite Clips and Lite Wand instrument case may be sterilized

according to the recommendations below.

( Wrap instruments or instrument tray in 2 layers of 1-ply polypropylene wrap, using sequential

wrapping techniques. )

Steam Autoclave Sterilization ( Wrapped )

Sterilizer Type

Preconditioning Pulses

Temperature

Full Cycle Time

Dry Time

Prevacuum

3

132ºC (270ºF)

3 Minutes

30 Minutes*

INSPECTION, LUBRICATION, AND TESTING

1. Carefully inspect instruments to ensure all visible contamination removed. Reassemble instruments,

as necessary, to test instrument function.

2. Lubricate all moving mechanisms on instruments with a steam penetrable, water-soluble product

after every cleaning cycle.

3. Test action of movable parts to ensure smooth operation / uninhibited movement.

· Do not use any instruments that appear damaged or broken (cracked, deformed, nonfunctional,

or altered).

· Lubricate articulated instruments after every cleaning cycle.

STORAGE AND USE

If package integrity is compromised or suspect, repeat Processing / Reprocessing Instructions.

STORAGE: Store sterile, packaged instruments in a limited access area that is well-ventilated,

protected from contaminants, and dry.

USE: Carefully examine sterile instrument packaging prior to use, ensuring package integrity is maintained.

PROPER CARE AND MAINTENANCE

Xenon illumination products should be utilized without alteration to their original design or fabrication. Treat the glass surfaces at each end of the Xenon Light as you would any fine optical device. The

apertures (bundle sizes) of the Xenon Light must be matched to obtain maximum efficiency in light transmission. The Lite Wand Xe and Retractor Lite Xe work with 300W and lower xenon light sources

meeting IEC 60601 or equivalent national standards only. Replace Xenon Light when fiber bundle light transmission output decreases by approximately 30%.

PRODUCT WARRANTY

Thompson Surgical Instruments, Inc. warrants all Xenon Lights free from defects in material or workmanship under normal operating use for 60 days from the date of delivery. Fibers are not warranted against

breakage. Please be cautious when handling and avoid stepping on or kicking the fiber optic cable to prevent damage. Suitability for use of the Retractor Lite for any surgical procedure shall be determined by the

user. Thompson Surgical shall not be liable for incidental or consequential damages of any kind. Warranty is void if the Xenon Light is used with xenon light sources over 300W. Warranty void if product failure

resulted from normal wear and tear from instrument use, accident, abuse, misapplication, negligence, or if the product has been damaged, altered, or repaired outside of Thompson Surgical’s facility. Warranty void

if purchased from a non-authorized supplier/distributor.

SYMBOL LEGEND:

Manufacturer

Warnings / Precautions

Biological Risks

DO NOT Reuse

Non-Sterile

Keep Dry / Protect from Moisture

DO NOT USE if Package Damaged / Compromised