ULTRAFlow II I/A Handpiece Directions for Use

I/A Handpiece DIRECTIONS FOR USE Refer to the driving console Operator’s Manual (and Addendums) for Handpiece compatibility. DESCRIPTION and CHARACTERISTICS of the DEVICE The UltraFlow™ II Irrigation/Aspiration (I/A) handpiece is designed for use with the I/A tips during cataract surgery. Each package contains one non-sterile UltraFlow II I/A handpiece (Figure 1) and one tip protector (Figure 2).

Figure 1

Figure 2

The UltraFlow II I/A handpiece is an accessory to the Infiniti™, Laureate™, Centurion™ and Constellation™ systems used to perform irrigation and aspiration functions for the removal of cortical material during ophthalmic surgery. The device weighs about 24 grams and its Patient Fluid Path components are made from Stainless steel, Titanium, and Brazing Alloy. The UltraFlow II I/A handpiece is non-sterile and must be cleaned and sterilized prior to the first use and after each subsequent use. INTENDED USE – INDICATIONS for USE The UltraFlow II I/A handpiece is intended for use in conjunction with a phacoemulsification system to perform cataract removal surgery. The UltraFlow II I/A handpiece is indicated for use in ophthalmic procedures that require simultaneous lens extraction, irrigation, and aspiration. The target patient population includes patients who require ophthalmic surgery consistent with the indications for use. The intended users are licensed ophthalmic surgeons and their trained operating room staff. CLINICAL BENEFITS The clinical benefits of the UltraFlow II I/A handpiece include facilitating phacoemulsification cataract surgery in ophthalmic anterior segment procedures. CONTRAINDICATIONS No contraindications for the device have been established. WARNINGS 1. This handpiece is provided as a non-sterile multi-use unit and must be cleaned and sterilized prior to use and subsequent use. The use of any unsterilized handpiece may result in infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. 2.

To prevent infection, destroy the handpiece if used on a patient with prion-related or other infectious disease.

3.

Maintenance/Limitations on Reprocessing: Inspect the handpiece for damages (e.g. nicks, crimps, dents) before each use. Immediately remove the handpiece from service if it is damaged. 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 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 device is received in a defective condition or has been unintentionally opened. Do not use any of the contents if the sterile package is damaged or the seal is broken in any way. In these cases, please contact:

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By Phone: In USA – (800) 757-9780

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

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 UltraFlow™ II I/A handpiece. 3.

The equipment used in conjunction with the handpiece 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. 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.

Maintenance/Limitations on Reprocessing: If weak or no irrigation/aspiration flow is observed during surgical setup per the console Operator’s Manual, remove the handpiece from the driving console and return it to Alcon for evaluation.

7.

Use of a tool other than the tip wrench supplied in the ALCON cassette pack may cause damage to the I/A tip and handpiece.

8.

All fluids extracted during surgery should be treated as biohazards. Take appropriate precautions when handling instruments and lines in contact with aspirated fluid.

9.

Immediately rinse/neutralize enzymatic cleaners, detergents or disinfectant solutions completely after use.

10. Do not immerse the handpiece in liquid after autoclaving; allow it to air cool for at least 15 minutes prior to use. DIRECTIONS FOR USE Keep this Directions for Use 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 UltraFlow II I/A 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/neutralized immediately after cleaning/processing per the surgical facility’s 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.

2.

Preparation for Point of Use Cleaning (Immediately after use)

3.

Step One:

Remove the irrigation and aspiration tubing from the handpiece.

Step Two:

Remove the infusion sleeve and tip from the handpiece and discard according to surgical facility guidelines.

Point of Use Cleaning (Immediately after use) Perform the following steps to thoroughly clean the handpiece: Step One:

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 Two:

Submerge the tip end of the handpiece in a container of room temperature sterile deionized water.

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4.

Step Three:

Using a syringe, push a minimum of 120cc of room temperature sterile deionized water through both the irrigation and aspiration paths. No other cleaning agent is required. Disinfection is not required nor recommended at this step.

Step Four:

Using the same syringe, flush both ports with a minimum of 60cc of air. Suitably qualified, medical-grade compressed air may be used as an alternate. This step may be repeated as needed until no additional residual water is removed.

Step Five:

Dry the exterior surfaces of the handpiece with a soft, clean, lint free non-abrasive cloth.

Step Six:

Visually inspect to ensure the handpiece is clean, dry, and undamaged. Repeat the process as needed.

Step Seven:

Install the UltraFlow™ II tip protector by pushing it straight onto the handpiece body.

Manual Cleaning Procedure Refer to Point of Use Cleaning Procedure. No additional cleaning necessary. Proceed directly to Automated Cleaning Procedure (section 5) or Inspection/Storage for Sterilization (section 6) 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 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) This 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.

Step One:

Prepare the washer-disinfector with multi-purpose injector per Operator’s Manual. Use an ISO 15883 compliant washer-disinfector. The use of a typical automated washer-disinfector and wire basket is depicted below. Note: Use de-ionized water only. Required materials: • Detergent with pH range of 8.5 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 Two:

Set detergent and neutralizer dispensers as recommended by detergent and washer-disinfector manufacturer.

Step Three:

Program washer-disinfector to have the following automated cycle: • Main wash at a minimum of 55° C for 10 minutes (dispense detergent as recommended by detergent and washer-disinfector manufacturer). • Neutralizer for a minimum of 1.5 minutes (dispense neutralizer as recommended by detergent and washer-disinfector 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.

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• Final Rinse at a minimum of 70° C for 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. Rinsing duration or temperature may be increased up to 95° C if desired to achieve thermal disinfection in accordance with local facility procedures. Step Four: Using the Auto Wash Kit, secure the handpiece to the wire mesh basket using the small gauge wire and connect the handpiece with the “Y” adapter assembly as shown. Step Five: Place wire basket with handpiece in multi-purpose injector rack and connect the “Y” adapter assembly to the injector nozzle as shown.

Step Six: Plug off any unused injector nozzle with silicone tubing. Pictured: Miele* Labwasher, Model G7735 with injector Model #0-177.

Step Seven:

Start the Wash Program. When the wash program is completed, visually inspect to ensure the handpiece is clean, dry, and undamaged. Repeat cleaning as needed. Use a clean, dry syringe to flush both ports with a minimum of 60cc of air to void any residual water in the lumens. Suitably qualified, medical-grade compressed air may be used as an alternate. Repeat as needed until no additional residual water is removed from the lumens. Dry the exterior surfaces of the handpiece and cable with a soft, clean, lint-free non-abrasive cloth.

6.

Inspection/Storage Prior to Sterilization: Visually inspect to ensure the device is clean, dry, and undamaged. Place the processed handpiece with tip protector in an autoclavable tray or wrap to prevent damage to handpiece during storage and autoclaving. Storage conditions (temperature, humidity, altitude) are not restricted.

7.

Sterilization Sterilize the handpiece as soon as practical using a steam sterilization cycle. The sterilization instructions provided in Table 1 have been validated by Alcon Laboratories, Inc. as being capable of sterilizing the handpiece for reuse. The sterilization instructions in Table 2 are intended for USA users and have been validated by Alcon Laboratories, Inc. in accordance with FDA guidance as being capable of sterilizing the handpiece for reuse. It remains the responsibility of the processor to ensure that the processing as actually performed using equipment,

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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 ISO 17665-1 and nationally recognized standards, or to the surgical 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 handpiece is contaminant free at levels acceptable per the surgical facility’s requirements. Table 1 - STERILIZATION TEMPERATURES AND TIME SETTINGS¹ CONFIGURATION MINIMUM MINIMUM PULSES (ISO 11607-1 EXPOSURE TIME TEMPERATURE3 compliant wrap2) (MINUTES)

STERILIZER TYPE

Gravity Displacement Gravity Displacement Pulsing Prevacuum Pulsing Prevacuum Pulsing Prevacuum Pulsing Prevacuum

N/A

Wrapped

132° C (270° F)

15

N/A

Unwrapped4

132° C (270° F)

10

4

Unwrapped

132° C (270° F)

4

4

Wrapped

132° C (270° F)

4

4

Wrapped

135° C (275° F)

3

4

Wrapped

134° C (273° F)

3

4

NOTES: This product has been validated to perform reliably after steam sterilization at 134° C (273° F) for 18 minutes (prevacuum, wrapped). 2 “Wrapped” refers to use of central processing sterilization wrap material, compliant to ISO 11607-1 requirements, and appropriately secured to ensure sterility is maintained. Single or double wrapping techniques are both acceptable; each technique does not impact the effectiveness of the sterilization cycle. 3 Facilities targeting specific minimum lumen temperatures at sterilization inception may find temperature will rise more rapidly by vertically orienting handpieces. 4 Intended to support urgent clinical needs only. Please refer to regional standards or local facility procedures for additional guidance. 1

Table 2 - STERILIZATION TEMPERATURES AND TIME SETTINGS (USA) MINIMUM MINIMUM CYCLE MINIMUM EXPOSURE DRYING PULSES CONFIGURATION TYPE TEMPERATURE TIME TIME (MINUTES) (MINUTES) Gravity N/A Wrapped 132° C (270° F) 15 15 Gravity N/A Unwrapped5 132° C (270° F) 10 N/A Pulsing 4 Unwrapped5 132° C (270° F) 4 N/A Prevacuum Pulsing Prevacuum Pulsing Prevacuum

4

Wrapped

132° C (270° F)

4

20

4

Wrapped

135° C (275° F)

3

16

NOTES: 5

Immediate use sterilization cycles intended to support urgent clinical needs only. Please refer to AAMI ST79 for additional guidance.

8.

Sterilization Wrap: Sterilization wrap used must provide sterile barrier as per ISO 11607-1 and be secured as needed to ensure sterility is maintained when moving product about facility.

9.

Console setup: After transport to the driving console for the next use, refer to the driving console Operator’s Manual for proper surgical setup.

10. Tip setup: Refer to Alcon’s pack/tip Directions for Use for proper assembly of the tip to the handpiece.

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11. Limitations for Reprocessing: Reuse is limited by physical damage (see warning #3) and observation of inadequate irrigation or aspiration flow prior to surgery (see precaution #6). When the handpiece is used properly per this Directions for Use, 400 re-uses have been verified. 12. Storage: Storage conditions (temperature, humidity, altitude) are not restricted. See warning #3 for indicators of device end of life. REFERENCES Standards: ISO 17664, ISO 17665-1, ISO 11607-1, ISO 15883-1/-2, AAMI ST79 Other Guidance: Robert Koch Institute (RKI) Guidelines, DGHK/DGSV/AKI Guidelines (current Zentral Steril Supplement) PACKAGING The UltraFlow™ II I/A handpiece is packaged in a box, provided in a non-sterile condition, and must be cleaned and sterilized via autoclave prior to use. SERIOUS INCIDENT REPORTING Any serious incident related to the use of this medical device should be reported to Alcon Laboratories Inc.: By Phone:

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

Website:

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 State. DEFINITIONS Definitions for symbols that appear on product labels:

CC

CONSULT INSTRUCTIONS FOR USE OR CONSULT ELECTRONIC INSTRUCTIONS FOR USE

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

BATCH CODE

CATALOG NUMBER

NON STERILE

MEDICAL DEVICE

MANUFACTURER

DATE OF MANUFACTURE: YYYY-MM-DD

COUNTRY OF MANUFACTURE

DOES NOT CONTAIN LATEX OR DRY NATURAL RUBBER

CAUTION: U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN *Registered trademark of Miele & CIE KG

www.ifu.alcon.com

© 2021 Alcon Inc.

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

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

300051077 REV. B ISSUED: 18-MAY-2022