Infiniti and OZil Handpieces Directions for Use

and

Directions For Use

Handpieces

DESCRIPTION and CHARACTERISTICS of the DEVICE

DIRECTIONS FOR USE

Each package contains one ultrasonic handpiece. The Infiniti™ Ultrasonic (U/S) (8065750121) and OZil™ (8065750469) Handpieces are accessories to the Infiniti™ cataract extraction system. The Infiniti U/S and OZil handpieces each consist of handpiece and cable assemblies. Each 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 (both U/S and OZil) and torsional motion (OZil only). The titanium shell containing the horn and stack assembly is hermetically sealed to provide protection during autoclave sterilization. The cable assembly provides the electrical energy to the handpiece and is also equipped with Electrically Erasable Programmable Read-Only Memory (EEPROM) to gather and store information relating to the handpiece.

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 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 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 irrigation and aspiration tubing from the handpiece. Step 2 Unplug the handpiece connector from the console and install the protective cap. Step 3 Remove the infusion sleeve and tip from the handpiece using the tip wrench and discard according to 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 both the irrigation and aspiration paths. No other cleaning agent is required. Disinfection is not required nor recommended at this step. Step 4 Using the same syringe, flush both ports with a minimum of 60cc of air to void any residual water in the lumens. Suitably qualified, medical-grade compressed air can be used as an alternate. This 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. Step 1 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 up to 9.5. • Organic acid neutralizer with pH range of 3.0 – 2.6. • Adaptors and silicone tubing, e.g. Customized Auto Wash Kit REF 8065750456. Step 2 Set detergent and neutralizer dispensers as recommended by the detergent and washer-disinfector manufacturer. Step 3 Program washer-disinfector to have the following automated cycle: • Main wash at a minimum of 55°C for at least 10 minutes (dispense detergent as recommended by the detergent and washer-disinfector manufacturer). • Neutralize for a minimum of 1.5 minutes (dispense neutralizer as recommended by the 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. • Final Rinse 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. Rinsing duration or temperature may be increased up to 95°C if desired to achieve thermal disinfection in accordance with local facility procedures.

INTENDED USE – INDICATIONS for USE The Infiniti U/S and OZil Handpieces are intended to remove cataractous lens tissue by ultrasonic (U/S) disintegration and fluidic aspiration of tissue from the eye. The Infiniti U/S and OZil Handpieces are indicated for use with Infiniti cataract extraction system for emulsification, separation, and removal of cataracts, residual cortical material and lens epithelial cells in the eye during anterior segment ophthalmic surgery. The intended patient population for the Infiniti U/S and OZil handpieces involves patients undergoing cataract removal procedures. The intended users are ophthalmic surgeons and their trained operating room staff.

CONTRAINDICATIONS No contraindications for the device have been established.

CLINICAL BENEFITS The clinical benefits of the Infiniti U/S and OZil handpieces include facilitating the removal of cataractous lens tissue by ultrasonic (U/S) disintegration and fluidic aspiration of tissue in ophthalmic surgical interventions that improve or preserve vision.

WARNINGS 1.

2.

3. 4.

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 inflection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. 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: Inspect the handpiece and power cord for damages (e.g. nicks, crimps, dents and exposed wires) 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.

2.

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.) Do not use if the handpiece is received in a defective condition. In this case, please contact: By Phone:

By Website:

In USA: (800) 757-9780

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

In EU/International: Contact your local Alcon Representative Each handpiece is identified by a serial number which provides traceability and should be given to your local Alcon representative when discussing the handpiece. 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. 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. Be sure the handpiece connector is dry before connecting it to the console. 9. Do not ultrasonically clean the handpiece. Ultrasonic cleaning of this handpiece will cause irreparable damage. 10. Immediately rinse/neutralize enzymatic cleaners, detergents or disinfectant solutions completely after use. 11. Do not immerse the handpiece in liquid after autoclaving; allow it to air cool for at least 15 minutes prior to use. 3.

PACKAGING The Infiniti U/S and OZil Handpieces are each packaged in a box, provided in a nonsterile condition, and must be cleaned and sterilized via autoclave prior to use.

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Table 1 - STERILIZATION TEMPERATURES AND TIME SETTINGS1 STERILIZER TYPE

PULSES

CONFIGURATION (ISO 11607-1 compliant wrap2)

MINIMUM TEMPERATURE3

MINIMUM EXPOSURE TIME (MINUTES)

Gravity Displacement

N/A

Wrapped

132°C (270°F)

15

Gravity Displacement

N/A

Unwrapped4

132°C (270°F)

8

Pulsing Prevacuum

4

Wrapped

132°C (270°F)

4

Pulsing Prevacuum

4

Unwrapped4

132°C (270°F)

4

Pulsing Prevacuum

4

Wrapped

134°C (273°F)

3

Pulsing Prevacuum

4

Wrapped

135°C (275°F)

3

Step 4 Using the Auto Wash Kit, secure the handpiece to the wire mesh basket using the small gauge wire provided in the Auto Wash Kit and connect the handpiece with the “Y” adapter assembly as shown.

Notes: ¹This product has been validated to perform reliably after steam sterilization at 134°C (273°F) for 18 minutes (pre-vacuum, 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. USA users, 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. 11. Limitations for Reprocessing: Reuse is limited by physical damage (see warning #4) and failure of pre-surgical check cycle (see precaution #6). Due to chemicals used during reprocessing, the handpiece connector may experience discoloration. When the handpiece is used properly per this Directions for Use, 300 re-uses have been verified. 12. Storage: Storage conditions (temperature, humidity, altitude) are not restricted. See warning #4 for indicators of device end of life.

Step 5 Place wire basket with handpiece in multi-purpose injector rack and connect the “Y” adapter assembly to the 4 mm diameter injector nozzle as shown.

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)

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

Step 6 Plug off any unused injector nozzle with silicone tubing.

6.

7.

Pictured: Miele* Labwasher, Model G7735 with injector Model # 0-177. Step 7 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 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 can be used as an alternate. Repeated 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. Inspection/Storage Prior to Sterilization: Visually inspect to ensure device is clean, dry, and undamaged. Place the processed handpiece and cable in an autoclavable tray to prevent damage to connector and handpiece during storage and autoclaving or wrap to prevent damage in preparation for autoclaving. Storage conditions (temperature, humidity, altitude) are not restricted. 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 handpieces for reuse. 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 ISO 17665-1 and nationally recognized standards, or to the surgical facility’s standard procedures.

By Phone:

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

By Website:

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

By Email:

[email protected]

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

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.

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DEFINITIONS Definitions for symbols that appear on product labels: CONSULT INSTRUCTIONS FOR USE OR CONSULT ELECTRONIC INSTRUCTIONS FOR USE

NON-STERILE

DOES NOT CONTAIN LATEX OR DRY NATURAL RUBBER

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

SERIAL NUMBER

MANUFACTURER

CATALOG NUMBER

DATE OF MANUFACTURE

MEDICAL DEVICE

COUNTRY OF MANUFACTURE

CC

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

www.ifu.alcon.com

* Registered trademark of Miele & Cie. KG

300051142 REV. A 210-3383-001 REV A

© 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

[EN] ISSUED DATE: 25-JUN-2021

INTENTIONALLY LEFT BLANK

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Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 USA Made in USA with Global Materials 300051142 REV. A ISSUED: 10-NOV-2021