ORA SYSTEM 2000 with VerifEye Lynk Autoclavable Cover Directions for Use

ORA SYSTEM™ with VerifEye™ Lynk Autoclavable Cover DIRECTIONS FOR USE DESCRIPTION and CHARACTERISTICS of the DEVICE

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The ORA SYSTEM™ with VerifEye™ Lynk autoclavable cover is a non-sterile device designed to cover the ORA SYSTEM™aberrometer. It is intended to maintain a sterile barrier in the event of inadvertent contact between the aberrometer and sterile instruments or gloves. Each package contains three individually bagged covers.

INTENDED USE – INDICATIONS for USE The ORA SYSTEM™ with VerifEye™ Lynk autoclavable cover is intended to maintain a sterile barrier for the ORA SYSTEM™ aberrometer during ophthalmic surgery. The ORA SYSTEM™ with VerifEye™ Lynk autoclavable cover is indicated for use with the ORA SYSTEM™ aberrometer during ophthalmic surgery. There is no intended patient population for this device. The device is not used on patients. The intended users of these devices are licensed ophthalmic surgeons and their operating room staff.

CONTRAINDICATIONS No contraindications for the device have been established.

CLINICAL BENEFITS The clinical benefits of the ORA SYSTEM™ with VerifEye™ Lynk autoclavable cover include the maintenance of a sterile barrier for the aberrometer during ophthalmic surgery.

WARNINGS

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This cover is provided nonsterile and must be cleaned and sterilized prior to each use.

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Alcon has verified the recommended instructions for preparation and reuse of this product. The reprocessing of this product and achieving the desired result in the reuse of the device is the sole responsibility of the user. Any deviation from the recommended instruction must be examined carefully to ensure effectiveness of cleaning/sterilization processes and that cover integrity/fit are maintained.

PRECAUTIONS

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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.

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If the cover is received in a defective condition, do not use and notify Alcon immediately:

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By Phone:

By Website:

In USA – (800) 757-9780 In EU/International: Contact your local Alcon Representative

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

Automated Washer Procedure In the event use of an automated process is required, perform all of the following steps to process the covers. NOTE: a) To avoid accumulation of particulate and bioburden residues in the washer water reservoirs, the surgical facility must properly maintain the equipment and their associated filters to ensure the introduction of contaminant-free solutions. b) This automated washing procedure provides a method for effectively processing covers. c) The temperatures and cycle parameters below will not cause damage to the product. d) Do not wash the covers with non-ophthalmic instruments solutions or materials. Step One: Manually clean covers immediately after each surgical procedure per the manual cleaning procedure before using an automated washer. Step Two: Prepare the washer per the operator’s manual. The circulation rate of the automated washer should be at least 106 gallons (401 liters) of water per minute. Orientation suitable for a typical automated washer and wire basket is depicted below. NOTE: Use de-ionized water only for final rinse. Required materials: • Detergent with pH range of 8.5 to 10.8 • Organic acid neutralizer with pH range of 3.0 – 2.6 Step Three: Set detergent and neutralizer dispensers as recommended by detergent and washer manufacturer. Step Four: Program washer to have the following automated cycle: • Main wash at a minimum of 55ºC for at least 10 minutes (dispense detergent as recommended by detergent and washer manufacturer). • Neutralizer for a minimum of 1.5 minutes (dispense neutralizer as recommended by detergent and washer manufacturer). • Rinse for a minimum of 5 minutes at 22-27ºC then drain. • Repeat rinse for a minimum of 5 minutes at 22-27ºC then drain. • Final Rinse at a minimum of 70 ºC for 1.5 minutes then drain. • Dry at 100 ºC until dry (typically 15 minutes, time may be extended as needed). NOTE: Additional rinsing steps will not alter the effectiveness of the validated cycle.

Be sure the cover is dry prior to installing on the aberrometer. Before each use, inspect the cover for cracks or other damage. If the cover is damaged, it should be immediately removed from service. Step Five: Load washer disinfector racks with open end of cover facing downwards

DIRECTIONS FOR USE CLEANING AND STERILIZATION DIRECTIONS: The following cleaning and sterilization instructions provide a method for effectively cleaning and sterilizing the cover per EN 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, ensure the enzymatic chemicals, detergents or disinfectant solutions are completely rinsed/neutralized immediately after cleaning/ processing per your surgical facility’s standard procedure. 1.

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Thoroughly clean the cover before initial use and IMMEDIATELY after each subsequent use. Both a required manual cleaning process and a supplemental automated cleaning process are provided. Cleaning Procedure: Manual Perform the following steps to thoroughly clean the covers. Alcon does not recommend use of disinfectants on this surface, however, if used, it is the user’s responsibility to thoroughly rinse treated areas to ensure all potentially irritating residues have been removed. Step One: Remove cover and rinse any surface contamination off the cover using water (temperature <40ºC). Step Two: Dry off with a lint-free disposable wipe. Step Three: Using 60-70% isopropyl alcohol and lint-free wipes, thoroughly clean exterior surfaces. Step Four: Dry the cover thoroughly using absorbent lint-free wipes. Step Five: Visually inspect to ensure the cover is clean and dry prior to sterilization. Repeat the process as needed. Step Six: Wrap covers for sterilization or prepare for automated wash.

300036879 REV. A 191-1150-001 REV A

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Step Six: Start the wash program. After the drying step is completed, promptly remove and dry residual moisture from covers with absorbent clean lint-free wipes. Step Seven: Visually inspect to ensure covers are clean and dry. Repeat the process as needed. Sterilization Sterilization: Sterilize the covers using a steam sterilization cycle. The sterilization instruction provided in Table 1 below have been verified by Alcon as being CAPABLE of sterilizing the covers for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, materials and personnel in the facility achieve the desired result. This requires verification and routine monitoring of the process. Likewise any deviation by the processor from the instruction provided should be properly evaluated for effectiveness and potential adverse consequences. Please refer to nationally recognized standards, or to your facility’s standard procedures. NOTE: To avoid accumulation of particulate and bioburden residues in the washer water reservoirs, the surgical facility must properly maintain the equipment and their associated filters to ensure the introduction of steam to the covers is contaminant-free at levels acceptable per the surgical facility’s requirements.

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