Autoclavable Endoscope Instructions for Use

ENGLISH/ INSTRUCTIONS FOR USE

Autoclavable Endoscope DESCRIPTION The ConMed Linvatec Autoclavable Endoscope is a rigid instrument that is inserted into body spaces and includes an optical system for conveying an image either directly to the user’s eye or to an accessory video system so that an image may be viewed upon a video monitor. Precaution: Prior to use, cleaning and sterilization, remove all protective packaging and disassemble all fiber optic post adapters (see illustration below). Components Your ConMed Linvatec endoscope comes complete with the following endoscope adapters: ACMI, WOLF DYONICS and LINVATEC/STORZ. Endoscopic Assembly: 1. Objective lens (distal lens) 1 2. Rod lens tubular shaft 3. Ocular lens (proximal lens) with eyepiece 4. Fiber optic post (ACMI style) 5. Fiber optic post adapter (WOLF, DYONICS style) 6. Fiber optic post adapter (LINVATEC/STORZ style)

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INTENDED USE The ConMed Linvatec Endoscope is indicated for use when access, illumination, and/or observation of body cavities, hollow organs, and/or canals is necessary during minimally invasive surgical procedures.

CONTRAINDICATIONS The ConMed Linvatec Endoscope is contraindicated in situations where endoscopic techniques and minimally invasive surgery are contraindicated.

WARNINGS

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1. It is important to read all instructions carefully. Failure to follow warnings and/or cautions may lead to improper use of the endoscope that can lead to severe patient injury and/or damage to the endoscope. 2. It is recommended that only individuals properly trained in surgical endoscopy use the endoscope and only in approved endoscopic surgical procedures. 3. To prevent possible burns to patient tissue, do not leave the endoscope distal tip in direct contact with patient tissue. 4. The fiber optic light post may become hot to touch during use. Avoid hand or tissue contact with the light post and/or reduce the light source brightness setting to avoid high temperatures.

PRECAUTIONS

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1. ConMed Linvatec endoscopes are not to be bent or flexed. This may cause damage or vastly reduce the endoscope’s life. Please follow the recommended steps outlined below. 2. Use extreme care when handling the endoscope. 3. Carefully clean the exposed lenses and fiber optic post with a cotton swab and isopropyl alcohol after each use. 4. Do not allow hard objects to come into contact with the objective or ocular lenses. 5. Do not use the endoscope for leverage during surgery.

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INSTRUCTIONS FOR USE 1. Sterilize endoscopes prior to use. 2. Always handle the endoscope by grasping the eyepiece. Handling by the shaft may damage the endoscope. 3. Prior to and after use, visually inspect the ocular lens (proximal end), objective lens (distal end) and the fiber optic post for damage or buildup of deposits (if deposits exist, please see “Removing Deposits” for cleaning instructions). 4. Avoid contact of the objective lens (distal end) with any instrumentation, especially resection systems. 5. Avoid touching the lenses. Debris and fingerprints obscure the view. 6. Upon insertion into the sheath or cannula, carefully align the endoscope with the appropriate instruments to avoid scratching the objective lens and bending the shaft.

CLEANING and STERILIZATION Pre-Rinsing: 1. Disassemble all components from the endoscope including fiber optic post adapters. 2. Soak for 3 minutes in warm water and a neutral pH enzymatic pre-wash solution to soften and remove biological debris (prolonged soaking may be detrimental to components). 3. Use a tray designed for endoscopes. Avoid contact with dissimilar equipment to avoid damage to optical surfaces. Washing: 1. Instruments should be submerged in warm water with an appropriate neutral pH detergent. 2. Carefully clean with a soft bristled brush or sponge only. Take care not to damage optical surfaces. 3. Do not place endoscopes in an ultrasonic cleaner or washer-sterilizer. Rinsing: 1. Rinse all equipment in clean, clear, non-saline water to remove all cleansing residue. 2. Carefully dry endoscope with soft cloth to ensure clean lenses. Removing Deposits: Due to insufficient cleaning or foreign matter in steam during the autoclave process, deposits may develop on the objective lens (distal end), ocular lens (proximal lens), and/or the fiber optic post. To remove the deposits, please follow the recommended steps outlined below: 1. Moisten a cotton-tipped swap with water. Dip the moistened swab in the aluminum oxide powder (described below). 2. Gently press the swab onto the optical surface to be cleaned and scrub the window in a circular motion. 3. Rinse the optical surfaces with distilled water to remove any remaining powder. 4. If stains are still present, carefully clean the lenses or fiber optic post with a cotton swab and isopropyl alcohol. NOTE: The aluminum oxide powder can be ordered separately under catalog T0001, “Endoscope Cleaning Kit.”

Steam Sterilization Precaution: Prior to sterilization, disassemble all fiber optic post adapters (see illustration).

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1. Autoclavable endoscopes have “AUTOCLAV” clearly marked on the body of the endoscope. Only endoscopes marked “AUTOCLAV” are suitable for steam sterilization. 2. After the recommended cleaning procedure is completed, sterilize using the following parameters.

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Method

Cycle

Minimum Temperature

Exposure Time

Dry Time

Steam (wrapped/ unwrapped)

Pre-vacuum

270°F (132°C)

4 minutes

10 minutes

Steam (wrapped/ unwrapped)

Gravity

250°F (121°C)

10 minutes

15 minutes

3. Prepare endoscopes such that all surfaces have direct contact with steam. 4. Do not suddenly expose hot endoscopes to cold after autoclaving. Let all components cool before use. NOTE: Endoscopes have been tested for survivability at 273°F (134°C) for 18 minutes. NOTE: In the practice of Immediate Use Steam Sterilization (IUSS), wrapped or unwrapped without a Dry Cycle, the time and temperature parameters of exposure, as stated above for wrapped devices, assure sterilization in chamber. Post-cycle sterility maintenance for a device processed by IUSS wrapped or unwrapped is dependent on handling and aseptic delivery to the sterile field.

Sterrad Sterilization The endoscopes have been reviewed for material, functional, and sterilization compatibility with STERRAD NX, 100S, and 100NX. Please refer to STERRAD sterilizer manufacturer instructions for appropriate STERRAD cycle parameters.

STORAGE of the INSTRUMENTS The endoscope should be stored in either its original shipping box or in an instrument storage tray to prevent damage.

WARRANTY ConMed Linvatec will repair or replace any endoscope found to have manufacturing or material defects within the first year after purchase by the initial purchaser. ConMed Linvatec will repair or replace, at our discretion, endoscopes which fail during normal use for a period of one year following purchase. The warranty does not apply to altered products, products previously repaired by unauthorized entities (entities other than ConMed Linvatec) and products damaged through customer misuse. ConMed Linvatec will only accept for repair or replacement, products that are clean and safe to handle. The warranty expires if the following parameters are not kept: pressure 3040 psi (2-2.75 bar), temperature 266° - 284°F (130° - 140° C). Never carry out an autoclavable treatment with other parameters than mentioned. An integrated temperature sensor indicates trespassing of the allowed temperature.

PACKING AND LABELING 1. Product should be accepted only if the original packaging and labeling arrive intact. 2. If packaging has been opened or altered, contact your local ConMed Linvatec sales representative, or in the U.S. contact the Customer Service Department.

CONTACT INFORMATION For more information or a product demonstration, contact your local ConMed Linvatec sales representative, or call 1-800-237-0169 in the U.S.

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EC REP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

ConMed Corporation 525 French Road Utica, NY 13502-5994 USA Phone: (727) 392-6464 Customer Service: 1-800-237-0169 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: [email protected] www.conmed.com ©2012, 2013 ConMed Corporation. All rights reserved. P000023343

Rev A

12/2020