LaserSecure Instrumentation Instructions for Use

WARNING • Do not use with ANY SYSTEMS that are integrated with RF (radiofrequency). Due to the electrical current from the RF, metal will conduct and retain heat causing burns to the surface of the skin. • Do not use any device that is scratched or damaged. Any scratch on the non-reflective surface of the device renders it reflective and dangerous and may cause burns to the surface of the skin of the O.R. personnel. • Do not use any device that has been dropped accidentally without thorough examination of its condition. • Avoid direct light beam impact onto the metal pieces. Direct light beam impact will heat the metal and might reflect on the surroundings, including personnel. • Long-pulsed lasers will heat the metal Sutcliffe and may cause burns to the surface of the skin. The Sutcliffe should be cooled between pulses and also before moving to new areas. Never double pulse without cooling the Sutcliffe. • Lasers and other light sources should always be aimed away from the ocular globe and away from the metal device. Our LaserSecure® shields and instruments are made of high quality stainless steel with a non-reflective finish. Even though these devices are low maintenance, they must be handled with extreme care in order to maintain their quality and safety performances. To ensure protection of the patient and the O.R. personnel a yearly refurbishing is suggested, although the condition of the shield or instrument will give a better indication. DECONTAMINATION • Immerse the instruments in a decontaminating solution and follow the manufacturer’s instruction. • Avoid the use of chlorine that may corrode the stainless steel instruments. -2-

CLEANING PROCEDURE FOR THE DEVICES Devices must be cleaned before sterilization. Use procedures that have been previously established and validated for your institution or use the following recommendations. 1. Mild soap solution and soft bristled toothbrush 2. Ultrasonic procedure for at least 5 minutes 3. Using a washing machine 4. Dry instruments quickly and completely 5. Rinse extensively with distilled or demineralized water after cleaning. STERILIZATION RECOMMENDATIONS • Stainless steel instruments can be sterilized repeatedly by steam autoclave. • Do not sterilize stainless steel devices in bleach, as bleach will corrode them. • Treat the instruments made from different metals separately. • Do not mix instruments in good condition with instruments that are corroded or damaged. • Lubricate all instruments that have any "metal to metal" action. STEAM AUTOCLAVE Steam sterilize following a validated cycle according to your institution’s standards OR the following recommended parameters. Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the following recommended parameters. Cycle Type

Temperature

Exposure Time

Dry Time

UK Prevacuum

134°C (273°F)

3 minutes

30 minutes

Prevacuum

132°C (270°F)

4 minutes

30 minutes

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• If you cannot remove stains from your shields or instruments we may be able to restore the surface qualities by refurbishing the instruments for a minimal cost. • Please note that in severe cases of pitting or corrosion, refurbishing may not be possible. • We will evaluate your shields or instruments at no cost and inform you of our suggestions and/or cost evaluation. • Please do not return any shields or instruments without a return authorization number (Shipping and handling is the responsibility of the sender). Call or fax for an RA number and for further details. f INSTRUMENTATION LASERSECURE®

INSTRUCTIONS D’UTILISATION LIRE ATTENTIVEMENT LE MODE D’EMPLOI AVANT D’UTILISER CE PRODUIT.

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ATTENTION, consulter les documents joints. Ce produit est vendu non stérilisé. Obtenez nos instructions d'utilisation en visitant oculoplastik.com.

UTILISER UNIQUEMENT AVEC LES SYSTÈMES DE LASER PUR OU LUMIÈRE PULSÉE INTENSE PURE. NE PAS UTILISER AVEC LES SYSTÈMES INTÉGRÉS AVEC UN COURANT ÉLECTRIQUE.

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