Teleflex Medical
522227 With Strong Extension
Pilling Bronchoscopes, Esophagoscopes, Laryngoscopes, Mediastinoscopes and Subglottiscopes Instructions for Use
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INSTRUMENT DESCRIPTION The following instructions are for metal, reusable Pilling Bronchoscopes, Esophagoscopes, Laryngoscopes, Mediastinoscopes and Subglottiscopes:
PREPARATION FOR REPROCESSING Where applicable, the instrument must be disassembled and/or opened for cleaning and sterilization. Failure to properly clean and sterilize the instrument could lead to contaminated instruments being placed back into circulation. CLEANING, DISINFECTION AND DRYING INSTRUCTIONS
Bronchoscope
Esophagoscope
Laryngoscope
Mediastinoscope
Subglottiscope For additional information or guidance on Cleaning and Sterilization instructions, contact your Teleflex Sales Representative or Teleflex Customer Service. INDICATIONS FOR USE Instruments are for use by, or as directed by, a trained medical professional. Instruments should be used only for the purpose for which they are designed. The proper surgical technique for the use of the instrument is the responsibility of the medical professional. PREPARATION AT POINT OF USE Directly after use, remove coarse contamination from the instrument and keep the instrument moist for transit to the processing site. Prior to cleaning and sterilization do not use any fixing agents or hot water >104°F (>40°C) since this may lead to the fixation of residue and can have a negative influence on the cleaning process. TRANSPORTATION During the transportation of the instrument to the processing site, store contaminated instrument securely in a closed container to avoid damage to the instrument and/or contamination of the environment.
Automatic Processing Instructions For Use with Alkaline or Enzymatic Detergents ENZYMATIC PRE-CLEANING • If possible, disassemble the handles. • Disassemble light carriers and window plugs (if applicable) from scopes. • Soak the scopes, light carriers and window plugs (if applicable) in lukewarm tap water for a minimum time of 5 minutes. • Brush the scopes, light carriers, and window plugs (if applicable) under lukewarm tap water until no residuals are visible. • Care must be taken to reach all areas. The housing of the rigid optics is brushed using an adequate brush.
Manual Processing Instructions For Use with Enzymatic Detergents
CLEANING • If possible, disassemble the handles. • Disassemble light carriers and window plugs (if applicable) from scopes. • Soak the scopes, light carriers and window plugs (if applicable) in lukewarm tap water for a minimum time of 5 minutes. • Brush the scopes, light carriers, and window plugs (if applicable) under lukewarm tap water until no residuals are visible. • Care must be taken to reach all areas. The housing of the rigid optics is brushed using an adequate brush. • The scopes, light carriers and CLEANING window plugs (if applicable) are • Place the opened instrument in a then soaked in a bath with 0.8% perforated basket on the slide-in solution of enzymatic cleaner for a tray and start the cleaning process. minimum time of 10 minutes. • Pre-wash for 2 minutes with • After soaking, the scopes, light cold water. carriers and window plugs (if • Empty. applicable) are brushed again and • Wash for 5 minutes at 113°F (45°C) thoroughly rinsed under lukewarm with a 0.8% enzymatic detergent. tap water. • Empty. Note: The preparation of • Neutralize for 3 minutes with concentration, temperature and cold water. application time of the cleaning agent • Empty. must be according to the instructions • Rinse for 2 minutes with cold water. for use provided by the manufacturer. • Empty. Examples of detergents used during Note: The preparation of validations: Enzymatic Detergent: concentration, temperature and application time of the cleaning agent Cidezyme/Enzol. must be according to the instructions for use provided by the manufacturer. Examples of detergents used during validations: Enzymatic Detergent: Cidezyme/Enzol.
The following steam sterilization cycles may be used for Pilling Bronchoscopes, Esophagoscopes, Laryngoscopes, Mediastinoscopes and Subglottiscopes:
ALKALINE PRE-CLEANING • If possible, disassemble the handles. • Disassemble light carriers and window plugs (if applicable) from scopes. • Soak the scopes, light carriers and window plugs (if applicable) in lukewarm tap water for a minimum time of 5 minutes. • Brush the scopes, light carriers, and window plugs (if applicable) under lukewarm tap water until no residuals are visible. • Care must be taken to reach all areas. The housing of the rigid optics is brushed using an adequate brush.
Sterilization Instrument Method Configuration
Temperature (minimum)
Exposure Time (minimum)
Drying Time (minimum)
Pre-vacuum Gravity Displacement
Wrapped
USA Parameters 270°F (132°C)
4 minutes
10 minutes
Wrapped
250°F (121°C)
30 minutes
10 minutes
Pre-vacuum Gravity Displacement
Wrapped
Outside USA Parameters 273°F (134°C) 3 minutes
10 minutes
Wrapped
270°F (132°C)
10 minutes
10 minutes
Note: Flash sterilization is not recommended for use with these instruments. STORAGE Instrument must be stored in a dry, clean, chemical-free and dust-free environment. Instrument must remain wrapped in terminally sterilized packaging (as per ISO 11607) or within the sterilization container to maintain sterility.
CLEANING • Place the opened instrument in a perforated basket on the slide-in tray and start the cleaning process. • Pre-wash for 2 minutes with cold water. • Empty. • Wash for 5 minutes at 131°F (55°C) with a 0.5% alkaline detergent. • Empty. • Neutralize for 3 minutes with cold water. • Empty. • Rinse for 2 minutes with cold water. • Empty. Note: The preparation of concentration, temperature and application time of the cleaning agent must be according to the instructions for use provided by the manufacturer. Examples of detergents used in validation studies: Alkaline Detergent: Neodisher Mediclean.
ADDITIONAL INSTRUCTIONS Use of cleaning and sterilization methods other than those provided by Teleflex must be validated by the health care facility using appropriate validated laboratory methods. INSPECTION AND FUNCTIONAL CHECK Inspect the instrument after each sterilization cycle and prior to each use as it may be damaged during transit to the customer, during receiving at the customer site, during use in a previous procedure or during the cleaning or sterilization process. All moving parts, tips, box locks, ratchets, serrations and cutting edges, if applicable, must be inspected for wear and confirmed to be functional. Confirm smooth operation during opening and closing of a hinged instrument and that tips/blades align properly. Screws may become loose during normal operation of an instrument. Inspect before sterilization and prior to use in order to ensure proper function. Inspect the instrument for rust, pitting, cracking or burrs, staining or discoloration, readability of device markings as applicable, and worn or broken parts. Repair or replace any instrument found not to be acceptable.
DISINFECTION Teleflex does not provide disinfection instructions due to the sterility instructions provided.
DISINFECTION Teleflex does not provide disinfection instructions due to the sterility instructions provided.
DRYING Dry the outside of the instruments using the drying cycle of the cleaning/ disinfection device. If necessary, the instruments can additionally be dried by hand with a lint-free cloth. Compressed air can be used for instruments with lumen.
DRYING Dry the instruments with a lint-free cloth. Compressed air can be used for instruments with lumen.
PACKAGING After cleaning and inspection, place the instrument in terminally sterilizable packaging (as per ISO 11607) or a sterilization container which will protect the instrument from the environment as well as permit sterilization. After sterilization the instrument should remain in the packaging or sterilization container for protection from the environment and to maintain sterility. STERILIZATION Instrument should be arranged in a disassembled/open position, where applicable. It is recommended that the light carriers be removed from the scope channels before sterilization and put into the wide mouth of the scope during sterilization. This will protect the light carrier and easily identify it as belonging to that specific scope. To avoid electrochemical reactions, separate instruments manufactured from different materials.
WARNING Instruments which are used consciously on patients with a prion based disease (transmissible spongiform encephalopathy disease, CJD, BSE, etc.) or on patients suspected of having one of these diseases are not safe to be reused and must be disposed of as per approved hospital procedures. Do not clean and/or sterilize instruments suspected of prion-contamination prior to disposal, as introducing these instruments to the reprocessing facility may lead to contamination of other instruments and/or the reprocessing facility equipment. PRODUCT INFORMATION DISCLOSURE Teleflex excludes all warranties, except Teleflex’s applicable Standard Warranty whether expressed or implied, including but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Teleflex shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from use of this product except for the intended use specified. Teleflex does not assume nor authorize any person to assume for them any other or additional liability or responsibility in connection with these products. For additional information, go to: www.teleflex.com/ifu
Pilling is a registered trademark of Teleflex Incorporated or its affiliates. © 2022 Teleflex Incorporated. All rights reserved.
3015 Carrington Mill Blvd Morrisville, NC 27560 USA USA: (866) 246 6990 International: +1 919 544 8000 L000612 R00 (2022-03)