Reusable Bipolar Coagulation Accessories Directions for Use

DIRECTIONS FOR USE Reusable Bipolar Coagulation Accessories

Refer to the Driving Console Operator’s Manual (and Addendums) For Bipolar Coagulation Accessories Compatibility

CAUTION: The Bipolar Coagulation Accessory 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 Bipolar Coagulation Accessory is received in a defective condition, do not use and notify Alcon immediately: By Phone: (In USA) (800) 445-2389 or (713) 668-9100 By Mail: Alcon Ask for Consumer Affairs Attention: Consumer Affairs (International) contact local Alcon representative 9965 Buffalo Speedway Houston, TX 77054-1309. USA Each package is identified by a Lot Number which provides traceability and should be given to the Consumer Affairs Department when discussing the Bipolar Coagulation Accessory. 2. Alcon assumes no responsibility for complications that may arise as a result of the improper reuse or improper usage of the Bipolar Coagulation Accessories. 3. These accessories used in conjunction with an Alcon® ophthalmic surgical console constitute a complete surgical system. Use of accessories other than those of Alcon may affect system performance and create potential hazards. 4. Verify that all connections are thoroughly dry prior to use. Do not activate coagulation while holding forceps with an ungloved hand or while forceps are in contact with a metallic surface. Failure to do so may result in electrical shock. 5. Connect cables and instruments to the surgical console only while the coagulator mode is off (standby). Failure to do so may result in injury or electrical shock to the patient or operating room personnel. 6. Cables should always be positioned in such a way that contact with the patient is prevented. 7. Bipolar accessories should be checked before each use for tip damage (i.e. misalignment, burrs, bending or discoloration) or insulation damage (i.e. cracks, nicks, lacerations or abrasions); electrode cables should particularly be checked for possible damage to the insulation. Damaged instruments or cables should be discarded and replaced. Using forceps or cables which are damaged can be hazardous to both the patient and operating room personnel. 8. These bipolar coagulation accessories are limited to extraocular uses only. 9. Flammable agents or solvents should be allowed to fully evaporate before the application of high-frequency energy. 10. To reduce the risk of accidental burns, caution should always be taken when operating high-frequency surgical equipment. 11. Do not use the coagulation devices on patients with pacemakers. If electrosurgery is used on patients with implanted cardiac pacemakers or pacemaker electrodes, be aware that irreparable damage to the pacemaker and its function may occur and lead to ventricular fibrillation. 12. 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 non-sterile reusable bipolar coagulation forceps or cable. DIRECTIONS FOR USE: Setup: 1. Within the sterile field, the Scrub Nurse should attach the sterile forceps or brush to the sterile bipolar cable ensuring that instrument pins are fully in the cable receptacle. 2. The Scrub Nurse passes the other end of the cable to the Circulator and ensures that the instrument and sufficient cable remain in the sterile field. 3. After verifying that the coagulator mode is off (standby), the Circulator inserts the bipolar cable safety plugs into the surgical console bipolar coagulation (“COAG”) connectors. CLEANING AND STERILIZATION: Alcon recommends a maximum of twenty (20) uses of reusable bipolar coagulation accessories. Note: The following cleaning and sterilization instructions provide a method for effectively cleaning and sterilizing the Reusable Bipolar Coagulation Accessories 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 of the Reusable Bipolar Coagulation Accessories 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 the surgical facility’s standard procedure. 1. Thoroughly clean bipolar coagulation accessories before initial use and IMMEDIATELY after each subsequent use. Do not store or allow the accessories to dry after use until thoroughly cleaned. 2. Cleaning Procedure: Manual Perform the following steps to thoroughly clean the accessories: Step One: Unplug the bipolar cable from the console and disconnect the instrument from the cable. Step Two: Discard single use cables, brushes or forceps according to surgical facility guidelines. Step Three: Wipe off any residue with a soft, clean, lint free non-abrasive cloth and rinse the forceps and/or cable with room temperature sterile deionized water to remove any remaining debris. If necessary, hand wash the forceps and/or cable using a soft bristled brush. The use of abrasive cleaners or solvents is not recommended. Step Four: Thoroughly flush all surfaces with room temperature sterile deionized water until no visible debris remains. Step Five: Dry the forceps and/or cables with a soft, clean, lint free nonabrasive cloth. Step Six: Visually inspect to ensure the bipolar coagulation accessories are clean and dry. Repeat the process as needed. Step Seven: Place the cleaned bipolar coagulation accessories in an autoclavable tray to prevent damage to forceps (especially tips) and cables during storage and autoclaving or wrap to prevent damage in preparation for autoclaving. Loosely coil (10 - 15 cm diameter) the reusable bipolar cables. To prevent damaging the cable insulation or inner wire, avoid kinking, sharply bending or placing heavy objects on the cables. 3. Cleaning Procedure: Automatic In the event use of an automated process is required, perform all of the following steps to process the Bipolar Coagulation Accessories. 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 to the Bipolar Coagulation Accessories.

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b) This automated washing procedure provides a method per for effectively processing up to three (3) Bipolar Coagulation Accessories at a time. c) The temperatures and cycle parameters below will not cause damage to the product. d) Do not wash the Bipolar Coagulation Accessories with non-ophthalmic instruments. Step One: Manually clean the Bipolar Coagulation Accessories immediately after each surgical procedure per the manual cleaning procedure above before using an automated washer. Step Two: Prepare the washer 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 such as Miele* Labwasher model G7735 with injector model #0-177 with a wire basket is described 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. 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 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 mimimum of 5 minutes at 22 - 27° C then drain. • Final Rinse at 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. Step Five: Secure the Bipolar Coagulation Accessories in the wire basket. Step Six: Start the wash program. When the wash program is completed, visually inspect to ensure the bipolar coagulation accessories are clean and dry. Repeat the process as needed. Place the processed Bipolar Coagulation Accessories in an autoclavable tray to prevent damage during storage and autoclaving or wrap to prevent damage in preparation for autoclaving. 4. Sterilization Sterilize the Bipolar Coagulation Accessories using a steam sterilization cycle. The sterilization instructions provided in Table 1 below have been validated by Alcon Laboratories, Inc. as being CAPABLE of sterilizing the Bipolar Coagulation Accessories 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 instructions 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: Due to the potential for the accumulation of particulate and bioburden residues in the sterilizer water reservoirs, it is the surgical facility’s responsibility to properly maintain the equipment and their associated filters to ensure the introduction of steam into the bipolar coagulation accessories are contaminant free at levels acceptable per the surgical facility’s requirements. Table 1 - STERILIZATION TEMPERATURE AND TIME SETTINGS MINIMUM MINIMUM EXPOSURE STERILIZER TYPE PULSES CONFIGURATION TIME (MINUTES) TEMPERATURE Gravity Displacement Wrapped 132° C (270° F) N/A 15 Gravity Displacement Pulsing Prevacuum Pulsing Prevacuum Pulsing Prevacuum

(four negative and four positive pules)

N/A 4 4

Unwrapped Unwrapped Wrapped

132° C (270° F) 132° C (270° F) 134° C (273° F)

10 4 5

4

Wrapped

134-137° C (273-279° F)

3

Note: This product has been validated to perform reliably after steam sterilization at 134°C (273°F) for 18 minutes (prevacuum, wrapped). 5. For maximum life and optimum performance, allow forceps to cool after steam sterilization. Note: There are no specific limits for the time or conditions of storage. 6. References: ¹EN ISO 17664: Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. Definition for symbols that may appear on product labeling:

LOT

SEE DIRECTIONS FOR USE DOES NOT CONTAIN LATEX OR DRY NATURAL RUBBER AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

BATCH CODE

REF / REF CATALOG NUMBER MANUFACTURER

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

Alcon Laboratories (U.K.) Ltd. Frimley Business Park Frimley, Camberley Surrey, GU16 7SR, United Kingdom

*Registered trademark of Miele & Cie. KG © 2007, 2009-2010, 2012-2013 Novartis

for REF 8065128402 (class I) per 93/42/EEC

ALCON LABORATORIES, INC. 6 2 0 1 S O U T H F R E E W AY FORT WORTH, TX 76134-2099 USA a Novartis company MADE IN USA 328-1002-001 REV. M

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