ORA SYSTEM 2000 with VerifEye+ Autoclavable Cover Directions for Use

ORA SYSTEM™ 2000 with VerifEye+™ Autoclavable Cover DIRECTIONS FOR USE DESCRIPTION and CHARACTERISTICS of the DEVICE

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The ORA SYSTEM™ 2000 with VerifEye+™ autoclavable cover is a non-sterile device designed to cover the ORA SYSTEM™ 2000 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™ 2000 with VerifEye+™ autoclavable cover is intended to maintain a sterile barrier for the ORA SYSTEM™ 2000 aberrometer during ophthalmic surgery. The ORA SYSTEM™ 2000 with VerifEye+™ 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.

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CONTRAINDICATIONS No contraindications for the device have been established.

CLINICAL BENEFITS

Sterilization Sterilization: Sterilize the covers using a steam sterilization. The sterilization provided 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. Alcon™ recommends the following stream (autoclave) program for sterilization1 • Sterilization temperature: 134 ºC • Sterilization exposure time: 4 minutes 1 Reference: EN ISO 17664: sterilization of medical devices - Information to be provided by the manufacturer for the processing of Resterilizable Medical Devices.

The clinical benefits of the ORA SYSTEM™ 2000 with VerifEye+™ autoclavable covers include the maintenance of a sterile barrier for the aberrometer during ophthalmic surgery.

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After sterilization, allow the components to cool before handling.

WARNINGS

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There are no specific limits for the time or conditions of storage.

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

INSTALLATION DIRECTIONS for AUTOCLAVABLE COVER:

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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.

1. Before installing, inspect cover for chips, cracks and other forms of material degradation. Do not use if there is evidence of damage to the product. 2. Slide the cover over the nose of the aberrometer. 3. Push cover into position until it snaps into position.

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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REMOVAL DIRECTIONS for AUTOCLAVABLE COVER:

By Phone:

By Website:

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

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

1. Grasp the cover on each side of the distal end. 2. While gently pulling each side away from the aberrometer pull towards the nose of the aberrometer to remove.

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.

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: Clean the Autoclavable Cover with DisCide Ultra Disinfection Towellette, liquid, or equivalent substance per the manufacturer’s instructions. Step Four: Dry the cover thoroughly before subsequent sterilization.

300038843 REV. A 191-1149-001 REV A

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PACKAGING AND STERILIZATION The ORA SYSTEM™ 2000 with VerifEye+™ autoclavable covers are provided bagged, in a non-sterile condition and are sterilized via autoclave prior to use. Please see instructions above for the cleaning and sterilization procedures.

SERIOUS INCIDENT REPORTING Any serious incident related to the use of this medical device should be reported to Alcon Laboratories Inc.: By Phone:

By Website:

In USA - (800) 757-9780 In EU/International: Contact the local country office or your Alcon distributor.

http://www.alcon.com/contact-us/ In EU, by email: [email protected]

These serious incidents should also be reported to the competent authority for medical devices of your Member State.

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DEFINITIONS Definitions for symbols that appear on product labels: CATALOG NUMBER

MANUFACTURER

SERIAL NUMBER

DATE OF MANUFACTURE YYYY-MM-DD

LOT NUMBER

CONSULT USERS MANUAL

MEDICAL DEVICE

DO NOT USE IF PACKAGE IS DAMAGE

CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN MAGNETIC RESONANCE ENVIRONMENT UNSAFE

DOES NOT CONTAIN LATEX OR DRY NATURAL RUBBER AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY CONSULT INSTRUCTIONS FOR USE OR CONSULT ELECTRONIC INSTRUCTIONS FOR USE

www.ifu.alcon.com

Alcon Laboratories Belgium Lichterveld 3 2870 Puurs-Sint-Amands Belgium

Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 USA Made in USA with Global Materials

191-1149-001 REV. A ISSUED DATE: 20-AUG-2020

©2020 Alcon Inc.

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Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 USA Made in USA with Global Materials 300038843 REV. A ISSUED: 03-DEC-2020