OZiL Frag Handpiece Directions for Use Rev A

OZil Frag Handpiece Directions for Use 9. Be sure the handpiece connector is dry before connecting it to the console.

DESCRIPTION and CHARACTERISTICS of the DEVICE

10. Do not ultrasonically clean the handpiece. Ultrasonic cleaning of this handpiece will cause irreparable damage.

The OZil FRAG Handpiece is a reusable device used to perform a posterior segment lens fragmentation procedure.

11. Do not immerse the handpiece in liquid after autoclaving, allow it to air cool for at least 15 minutes.

The OZil FRAG handpiece consists of handpiece and cable assemblies. The handpiece is presented as a titanium shell containing an ultrasonic horn and stack assembly. When piezo-electric crystals within the handpiece are electrically excited, their mechanical vibrations are conducted to the ultrasonic horn, which amplifies and converts the vibrations to longitudinal motion. The titanium shell containing the horn and stack assembly is hermetically sealed to provide protection during autoclave sterilization.

PACKAGING The OZil FRAG Handpiece is packaged in a box, provided in a nonsterile condition, and must be cleaned and sterilized via autoclave prior to use.

DIRECTIONS FOR USE

The cable provides electrical energy to the handpiece and is equipped with electrically erasable programmable read-only memory (EEPROM) to gather and store information related to the handpiece.

Keep this Directions for Use document for reference when using this handpiece. The Directions for Use is intended to supplement the system Operator’s Manual. The manual includes in-depth information for familiarizing the operating room staff with the controls and functions of the instrument. The following cleaning and sterilization instructions provide a validated method for effectively cleaning and sterilizing the OZil FRAG Handpiece per ISO 17664. 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/neutralize immediately after cleaning/processing per the surgical facility’s standard procedure. Alcon has determined that the use of cleaners containing amines can lead to premature degradation and weakening of the handpiece cable jackets; therefore, Alcon advises against using these cleaners. 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 point of use /manual cleaning process and a cleaning process using an automated washer-disinfector are presented. 2. Preparation for Point of Use Cleaning (Immediately after use) Step 1 Remove the aspiration tubing from the handpiece. Step 2 Unplug the handpiece connector from the console and install the protective cap. Step 3 Remove the tip from the handpiece using a tip wrench and discard according to the surgical facility guidelines. 3. Point of Use Cleaning Procedure (Immediately after use) Perform the following steps to thoroughly clean the handpiece: Step 1 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. The cable exterior may be wiped with deionized water or 70% IPA. Step 2 Submerge the nosecone (front part) of the handpiece in a container of room temperature sterile deionized water. Step 3 Using a syringe, draw or push a minimum of 120cc of sterile deionized water through the aspiration path. No other cleaning agent is required. Disinfection is not required nor recommended at this step. Step 4 Using same syringe, flush port with a minimum of 60cc of air to void any residual water in the lumen. Suitably qualified, medical-grade compressed air can be used as alternate. Step may be repeated as needed until no additional residual water is removed. Step 5 Dry the exterior surfaces of the handpiece and cable with a soft, clean, lint-free non-abrasive cloth. Step 6 Visually inspect to ensure the handpiece is clean, dry and undamaged. Repeat the process as needed. 4. Manual Cleaning Procedure: Refer to Point of Use Cleaning Procedure. No additional cleaning necessary. Proceed directly to Automated Cleaning Procedure (section 5 below) or Inspection/Storage for Sterilization (section 6 below) per facility requirements. 5. Automated Cleaning Procedure Ensure first that the Point of Use Cleaning Procedure is completed and then, perform the following steps to process the handpiece. Note: a. Due to the potential for the accumulation of particulate and bioburden residues in the washer-disinfector 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. The automated cleaning 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.

INTENDED USE – INDICATIONS for USE The OZil FRAG Handpiece is intended to ultrasonically emulsify and remove the crystalline lens from the eye. The OZil FRAG Handpiece is indicated for lens removal by ultrasonic emulsification via the pars plana and fluidic aspiration. The device is indicated for patients undergoing posterior segment lens removal. The intended users are ophthalmic surgeons and their trained operating room staff.

CONTRAINDICATIONS No contraindications for the device have been established.

CLINICAL BENEFITS The intended clinical benefits of OZil FRAG Handpiece, in conjunction with its corresponding console and associated accessories, are expected to contribute to ophthalmic surgical interventions that improve or preserve vision.

WARNINGS 1.

2. 3.

During any phacoemulsification procedure, metal particles may result from inadvertent touching of the phacoemulsification tip with a second instrument, or from ultrasonic energy causing micro abrasions of the ultrasonic tip. To prevent infection, destroy the handpiece if used on a patient with prion-related or other infectious disease. Maintenance/Limitations on Reprocessing: Before each use, inspect the handpiece and power cord for damage (e.g. nick, 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.

PRECAUTIONS 1. Use of this product may require surgical setting adjustments. Ensure that appropriate system settings are used with the OZil FRAG Handpiece. Prior to initial use, contact Alcon for in service information. (Within the U.S., call 800-TO-ALCON, or 817-293-0450. Outside of the U.S., contact your local Alcon sales representative.) 2. Do not use if the handpiece is received in a defective condition. In this case, please contact: By Phone:

By Website:

In USA:

https://www.alcon.com/contact-us/

(800) 757-9780 In EU/International: Contact your local Alcon representative

Each handpiece is identified by a lot number which provides traceability and should be given to your local Alcon representative when discussing the handpiece. 3. The equipment used in conjunction with the FRAG Pak disposables constitutes a complete surgical system. Use of disposables other than those of Alcon may affect system performance and create potential hazards. 4. Use care in handling the handpiece, particularly when cleaning. Pay extra attention to protecting the nosecone area. 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 Operator’s Manual of the Alcon surgical system for a list of appropriate handpieces for that system. 6. Maintenance/Limitations on Reprocessing: The handpiece performs a check cycle whenever it is connected to the driving console. If the handpiece performs improperly and fails the check cycle, remove it from the driving console and return it to Alcon for evaluation. 7. All fluids extracted during surgery should be treated as biohazards. Take appropriate precautions when handling instruments and lines in contact with aspirated fluid. 8. 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 any questions, please contact Alcon. 812-4798-001 REV A

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ISSUED DATE: 17-AUG-2021