Quick Lock Connector Reusable Handles Instructions

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INSTRUCTIONS FOR USE NÁVOD K POUŽITÍ BRUGSANVISNING GEBRUIKSAANWIJZING KASUTUSJUHISED INSTRUCTIONS D’UTILISATION GEBRAUCHSANWEISUNG ΟΔΗΓΊΕΣ ΧΡΉΣΗΣ HASZNÁLATI ÚTMUTATÓ ISTRUZIONI PER L’USO LIETOŠANAS INSTRUKCIJA

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LITHUANIAN NORWEGIAN POLISH PORTUGUESE ROMANIAN RUSSIAN SLOVAK SPANISH SWEDISH TURKISH UKRAINIAN

NAUDOJIMO INSTRUKCIJA BRUKSANVISNING INSTRUKCJE UŻYCIA INSTRUÇÕES DE UTILIZAÇÃO INSTRUCŢIUNI DE UTILIZARE ИНСТРУКЦИИ ПО ПРИМЕНЕНИЮ NÁVOD NA POUŽITIE INSTRUCCIONES DE USO BRUKSANVISNING KULLANMA KILAVUZU ІНСТРУКЦІЇ З ВИКОРИСТАННЯ

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1. Product description and intended use The Quick Lock Connector Reusable Handles is a family of handheld instruments intended to be used in vitreoretinal surgery for manual actuation of the GRIESHABER™ Advanced DSP Tips, available in various forceps and scissors shapes. The Quick Lock Connector Reusable Handles come in various models, featuring different actuation mechanisms. The instruments are provided non-sterile and are suitable for reprocessing and reuse. 2. Indications for use and intended user The Quick Lock Connector Reusable Handles in combination with the GRIESHABER™ Advanced DSP Tips are indicated to be used in vitreoretinal surgery where grasping and cutting is needed to treat pathologies such as macular holes, epiretinal membranes, diabetic retinopathy, membrane proliferations, retinopathy of prematurity and others. The device is intended to be used by ophthalmic surgeons.

Quick Lock Connector Reusable Handles

3. Contraindications and undesirable side-effects No contraindications and no undesirable side-effects are known when used as intended. 4. Clinical benefits The clinical benefits of the Quick Lock Connector Reusable Handles include use in vitreoretinal surgery for manual actuation of the GRIESHABER™ Advanced DSP Tips for grasping and cutting. 5. Precautions and warnings • The instrument is provided as an unsterile unit and must be processed in accordance with the provided instructions prior to first use and reprocessed after each reuse (see section 7 for details). • If a patient with a prion-related disease undergoes a procedure which, in the medical opinion of the physician, poses a high risk of instrument contamination, the instrument should be destroyed or processed according to local requirements.

Quick Lock Connector Reusable Handles

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• The instrument tip must be properly attached to the handle: Check that the dot on the tip aligns with the mark on the handle and that the tip fits tightly. • After attaching the instrument tip to the handle and prior to each use, the instrument must be properly inspected for correct function and possible damage (see section 6 for details). The end of product life is recognized by appearance of damage or loss of instrument function. The instrument should then be immediately removed from service. • Most of the Quick Lock Connector Reusable Handles may also be used with the former GRIESHABER Reusable Microinstrument Tips (20 gauge 712.xx.00 and 23 gauge 713.xx.00). However, the RENAISSANCE Advanced Handle is not recommended to be used with the 20 gauge reusable tips (712.xx.00), as some of the instrument tips may not close completely. • Avoid touching hard surfaces with the instrument as this can lead to damage. • Do not use or repair damaged or defective instruments.

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• Please notify Alcon if any instrument is received damaged or in a defective condition. • Adhere to national regulations when disposing the product, its components or packaging. • Federal (USA) law restricts this device to sale by or on the order of a physician. SERIOUS INCIDENT REPORTING: Any serious incident related to the use of this medical device should be reported to Alcon Laboratories, Inc.: EU – Contact the local country office or your Alcon distributor Email: [email protected] Website: https://www.alcon.com/contact-us

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Serious incidents should also be reported to the competent authority for medical devices of your Member State. 6. Directions for use Set-up, prior to surgery • Attach tip to handle: Align dot on the tip with the groove in the handle. Slide the tip longitudinally onto the handle. While doing so, do not compress the activation mechanism; hold the RENAISSANCE™ Handle NG/Advanced Handle and the Revolution™ Handle at their rear part or the Sutherland Handle NG at the distal metal collar. • Twist tip clockwise until the dot of the tip aligns with the marking on the handle. While doing this, two clicks will be noticeable. • Check tip for tight fit. Inspect instrument for correct function (proper closing and opening of the attached tip), wear and damage (e.g. nicks, dents, corrosion and loss of instrument integrity). • Also, refer to Directions for Use of the instrument tips.

Quick Lock Connector Reusable Handles

7. Cleaning, Disinfection and Sterilization 7.1. General Information • Immediately clean instrument after each use. Do not store or allow the instrument to dry after use until thoroughly cleaned. Any dried remnants, especially saline solution, left on the instruments could trigger irreversible corrosion or other damage. • Refer to the safety instructions of cleaning, neutralizing, disinfecting etc. solutions and the equipment used, as well as to the facility’s hygienic instructions. • The periodic use of an instrument lubrication will increase the lifetime and function of the instrument. • Protect the instrument during ultrasonic cleaning and during processing in the washer by use of appropriate instrument trays and holders. No customized equipment required. • Do not clean the instruments with non-ophthalmic devices.

Quick Lock Connector Reusable Handles

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• All applied reprocessing procedures must be compatible with stainless steel and polyetheretherketone, as well as polyphenylsulfone (applicable only to the RENAISSANCE Advanced Handle) and fluoroelastomer (applicable only to the Sutherland Handle). • The instrument should not be exposed to oxidative or low pH cleaning solutions and especially not to NaOCl. Irreparable damage will result. • The instrument should not be exposed to temperature higher than 140°C (284°F). • The hot instrument should not be chilled in water or other liquid. Allow the instrument to cool by air. • Unless otherwise indicated, the cleaning and disinfecting steps should be performed at ambient temperature. • It remains the responsibility of the processor to ensure that processing achieves the desired result as performed with the particular equipment, materials and personnel in the facility. This requires verification and routine monitoring of the process. Likewise any deviation by the processor from

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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. • Due to the potential for the accumulation of particulate and bioburden residues in the equipment’s water reservoirs, the facility must properly maintain the equipment and associated filters to ensure that the introduction of water or steam is contaminant-free. • All provided reprocessing instructions have been validated by Alcon and provide methods for effectively cleaning, disinfecting and sterilizing the Quick Lock Connector Reusable Handles per ISO 17664 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices.

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7.2. Cleaning Procedure: Manual The following cleaning procedure has been validated by Alcon with 0.8% CIDEZYME† solution (8 ml per liter of water) using an ultrasonic cleaning unit with 35 kHz. Step 1: C  lean in ultrasonic bath filled with the cleaning solution for a minimum of 5 minutes. Step 2: F  lush with running tap water for a minimum of 1 minute. Step 3: Clean in ultrasonic bath filled with sterile deionized water for a minimum of 1 minute. Step 4: V  isually inspect to ensure instrument is clean. Repeat step 1 to 4 as needed. Step 5: P  roceed with disinfection. Note: If disinfection is not performed immediately, dry the instrument with sterile air until visually dry.

Quick Lock Connector Reusable Handles

7.3. Disinfection Procedure: Manual The following disinfection procedure has been validated by Alcon with 0.3% CIDEX† OPA solution (3 ml per liter of water) using an ultrasonic cleaning unit with 35 kHz. Step 1: Disinfect in ultrasonic bath filled with fresh disinfectant solution for a minimum of 5 minutes. Step 2: Rinse in ultrasonic bath filled with fresh sterile deionized water for a minimum of 1 minute. Step 3: Repeat step 2 two (2) additional times for a total of three (3) rinses after disinfection. Step 4: Dry the instrument thoroughly with sterile air. Step 5: Visually inspect to ensure the instrument is dry. Step 6: Place the instrument in a packaging suitable for sterilization and protection during storage. Proceed with sterilization.

Quick Lock Connector Reusable Handles

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7.4. Cleaning and Disinfection Procedure: Automated Washer The following cleaning procedure has been validated by Alcon: • For the manual pre-cleaning step with 0.8% CIDEZYME solution (8 ml per liter of water) using an ultrasonic cleaning unit with 35 kHz. • For the automated cleaning step with detergent NEODISHER† MediClean (0.6%, dispensing rate 6 ml per liter of water) and the neutralizer NEODISHER Z (0.1%, dispensing rate 1 ml per liter of water). Manual Pre-Cleaning Step 1: C  lean in ultrasonic bath filled with the cleaning solution for a minimum of 5 minutes. Step 2: F  lush with running tap water for a minimum of 1 minute. Step 3: C  lean in ultrasonic bath filled with sterile deionized water for a minimum of 1 minute. Step 4: V  isually inspect to ensure instrument is clean. Repeat step 1 to 4 as needed.

After manual pre-cleaning proceed with automated cleaning and disinfection. Automated Cleaning and Disinfection Step 5: Program the washer to have the following automated cycle. • Wash with detergent at a minimum of 55°C (131°F) for at least 10 minutes. • Neutralize for a minimum of 1.5 minutes. • Rinse with water for a minimum of 5 minutes at 22–27°C (72°F–81°F) then drain. • Repeat rinse for a minimum of 5 minutes at 22–27°C (72°F–81°F) then drain. • Thermally disinfect at a minimum of 90°C (194°F) for at least 5 minutes. • Dry at a minimum of 100°C (212°F) for at least 5 minutes. Step 6: V  isually inspect to ensure the instrument is dry. If required, dry the instrument with sterile air.

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Quick Lock Connector Reusable Handles

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Step 7: P  lace the instrument in a packaging suitable for sterilization and protection during storage. Proceed with sterilization. Note: For the automated process use deionized water only. 7.5. Sterilization Procedure Sterilize the instrument directly after cleaning/disinfection using a steam sterilization cycle validated for these devices by your facility. If any kind of packaging is used during sterilization, it must be suitable for steam sterilization. See table 1 for recommended minimum sterilization parameters that have been validated by Alcon to provide a 10-6 sterility assurance level.

Table 1 – Recommended sterilization cycles Sterilizer Type

Sample Configuration

Minimum Temperature

Minimum Exposure Time (minutes)

Minimum Drying Time (minutes)

Gravity displacement

Wrapped Unwrapped Wrapped Unwrapped

132°C (270°F) 132°C (270°F) 132°C (270°F) 132°C (270°F)

18 10 4 4

15 NA 16 NA

Wrapped

134°C (273°F)

32)

16

Prevacuum pulsing1)

1) Prevacuum pulsing is based on cycles with 3 pulses. 2) Several European national health authorities recommend a minimal

sterilization time of 18 minutes at 134°C (273°F).

Quick Lock Connector Reusable Handles

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8. Definitions of symbols Consult instructions for use or consult electronic instructions for use Catalogue number Batch code Manufacturer

Keep dry Not made with natural rubber latex Caution, Federal law (USA) restricts this device to sale by or on the order of a physician Medical Device

Date of manufacture REUSABLE

Distributor

Reusable Non-sterile Caution Keep away from sunlight

EC

REP

Authorized representative in the European Community

† Trademark is the property of its respective owner

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Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 USA www.ifu.alcon.com

Quick Lock Connector Reusable Handles

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Alcon Nordic A/S Edvard Thomsens Vej 14 2300 København S Tlf: 3636 4320 www.ifu.alcon.com

Quick Lock Connector Reusable Handles

Quick Lock Connector Reusable Handles

Alcon Nordic A/S Edvard Thomsens Vej 14 2300 Köpenhamn S Danmark Tel: (0) 8634 4010 www.ifu.alcon.com

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Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 USA

© 2020 Alcon Inc.

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2020-03-24