INFINITI OZil AND U/S HANDPIECE Directions for Use

INFINITI ® OZil ® AND U/S HANDPIECE DIRECTIONS FOR USE

Refer to the driving console Operator’s Manual (and Addendums) for handpiece compatibility.

CAUTION: The Handpiece Directions-for-Use are not intended to substitute for the necessity of reading and understanding the driving console Operator’s Manual. The Operator’s Manual, which is provided with the console, includes in-depth material intended to familiarize the Operating Room Staff with the controls and functions of the console. CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician. WARNINGS: 1. If the handpiece is received in a defective condition, do not use and notify Alcon immediately: By Phone: Technical Services By Mail: Alcon (In USA) (800) 832-7827 Technical Services (International) (800) 832-7827 or 15800 Alton Parkway contact local Alcon representative Irvine, CA 92618 USA Each handpiece is identified by a Serial Number which provides traceability and should be given to Technical Services when discussing the handpiece. 2. Before each use, the handpiece and power cord should be inspected for damages (e.g. nicks, crimps, dents exposed wires). If the handpiece is damaged it should be immediately removed from service. Use of damaged Handpiece may result in serious permanent patient injury. 3. Each time the Handpiece is connected to the driving console, it performs a check cycle. If the Handpiece performs improperly and fails the check cycle, remove it from the driving console and return it to Alcon for evaluation. 4. Use care in handling the handpiece, particularly when cleaning. Extra attention to protecting the nosecone area should be taken. Always clean the handpiece over a surface cushioned with a pad or rubber mat. 5. This handpiece is to be used only with approved Alcon surgical systems. See the particular Operator’s Manual of the surgical system for a list of appropriate handpieces for that system. 6. In the event of any difference between this document and the driving console Operator’s Manual, please use the information in this Directions-For-Use. If you have questions, please contact Alcon. 7. Be sure the handpiece connector is dry before connecting it to the console. 8. Do not ultrasonically clean the handpiece. Ultrasonic cleaning of this handpiece will cause irreparable damage. 9. Never immerse the handpiece in liquid after autoclaving; allow it to air cool for at least 15 minutes. 10. During any phacoemulsification procedure, metal particles may result from inadvertent touching of the phacoemulsification tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasions of the ultrasonic tip. 11. If in the medical opinion of the physician a patient with a prion related disease undergoes a high risk procedure, the instrument should be destroyed or be processed according to local requirements. DESCRIPTION: Each package contains one ultrasonic handpiece. DIRECTION FOR USE: The following cleaning and sterilization instructions provide a method for effectively cleaning and sterilizing the Infiniti ® Ozil ® and U/S Handpieces per EN ISO 17664¹. Due to the potential for Toxic Anterior Segment Syndrome (TASS), Alcon does not recommend the use of enzymatic cleaners, detergents, or disinfectant solutions. If however, local jurisdictions mandate their use relative to ophthalmic instruments, the materials of construction are compatible with both, up to a pH of 11.3, when the enzymatic chemicals, detergents or disinfectant solutions are completely rinsed/neutralized immediately after cleaning/processing, per your facility’s standard procedure. 1. Thoroughly clean the handpiece before initial use and IMMEDIATELY after each subsequent use. Do not store or allow the handpiece to dry after use until thoroughly cleaned. Both a manual cleaning process and a cleaning process using an automated washer are presented. 2. Cleaning Procedure: Manual Perform the following steps to thoroughly clean the handpiece. Step One: Remove the irrigation and aspiration tubing from the handpiece. Step Two: Unplug the handpiece connector from the console and install the protective cap. Step Three: Remove the infusion sleeve and tip from the handpiece using the tip wrench and discard according to surgical facility guidelines. Step Four: Wipe any residue from the handpiece with a soft, clean, lint free non-abrasive cloth and rinse the handpiece with room temperature sterile deionized water to remove any remaining debris. If necessary, wash the exterior of the handpiece using a soft bristled cleaning brush. Step Five: Submerge the nosecone (front part) of the handpiece in a container of room temperature sterile deionized water. Step Six: Using a syringe, draw or push a minimum of 120cc of sterile deionized water through both the irrigation and aspiration paths. Step Seven: Using the same syringe, flush both ports with a minimum of 60cc of air. Step Eight: Dry the exterior surfaces of the handpiece and cable with a soft clean, lint free non-abrasive cloth. Step Nine: Visually inspect to ensure the Handpiece is clean and dry. Repeat the process as needed. Step Ten: Place the cleaned handpiece and cable in an autoclavable tray to prevent damage to connector and handpiece during storage and autoclaving or wrap to prevent damage in preparation for autoclaving. 3. Automated Washer Procedure In the event use of an automated process is required, perform all of the following steps to process the handpiece. Note: a) Due to the potential for the accumulation of particulate and bioburden residues in the washer water reservoirs, it is the surgical facility’s responsibility to properly maintain the equipment and their associated filters to ensure the introduction of contaminant- free solutions into the handpieces. b) This automated washing procedure provides a method for effectively processing up to three (3) handpieces at a time. c) The temperatures and cycle parameters below will not cause damage to the product. d) Do not wash the handpieces with non-ophthalmic instruments. Step One: Manually clean the handpiece immediately after each surgical procedure per the manual cleaning procedure above before using an automated washer. Step Two: Prepare the washer with multi-purpose injector per Operator’s Manual. The circulation rate of the automated washer should be at least 106 gallons (401 liters) of water per minute. The use of a typical automated washer and wire basket is depicted below. Note: Use de-ionized water only. Required materials: • Detergent with pH range of 8.5 up to 9.5. • Organic acid neutralizer with pH range of 3.0-2.6. • Adaptors and silicone tubing, e.g. Customized Auto Wash Kit: Alcon REF 8065750456. Step Three: Set detergent and neutralizer dispensers as recommended by detergent and washer manufacturer. Step Four: Program washer a minimum of to have the following automated cycle: • Main wash at a minimum of 55° C for at least 10 minutes (dispense detergent as recommended by detergent and washer manufacturer) • Neutralize for a minimum of 1.5 minutes (dispense neutralizer as recommended by detergent and washer manufacturer) • Rinse for a minimum of 5 minutes at 22 - 27° C then drain • Repeat rinse for a minimum of 5 minutes at 22 - 27° C then drain • Final Rinse a minimum of 70° C for at least 1.5 minutes then drain • Dry at a minimum of 100° C for at least 5 minutes Note: Additional rinsing steps will not alter the effectiveness of the validated cycle.

-1-