15 Pages
Preview
Page 1
en
INSTRUMENT DESCRIPTION (ENGINEERING)
PREPARATION AT POINT OF USE
The following instructions are for the Pilling IMA Retractor (341136).
Directly after use, remove coarse contamination from the instruments 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 interfere with the cleaning process.
INDICATIONS FOR USE
The Pilling IMA Retractor (341136) is a re-useable surgical instrument used to retract and hold soft tissue and connected bone during internal mammary artery surgical procedures.
TRANSPORTATION
During the transportation of the instruments to the processing site, store contaminated instruments securely in a closed container or instrument case to avoid damage to the instruments and/or contamination of the environment.
CLEANING, DISINFECTION AND DRYING INSTRUCTIONS
The Pilling IMA Retractor (341136) should be cleaned independently according to the instructions listed below.
INSTRUCTIONS FOR USE
1. Prior to placement of the retractor in the patient, join the two blades together (lightly touching) and the reinforcing T-screw (A) in fully extended position with no tilt (illustration 1).
1 A
2. After a median sternotomy, place the Pilling IMA Retractor (341136) in the patient with the lifting blade on the side of the patient to be raised for IMA takedown. 3. Turn the handle (B) to open the sternum (illustration 2).
2 A
B
C
4. When sufficiently opened, slowly turn the reinforcing screw (A) to allow the tilt of the retractor and lift of one half of the sternum to increase exposure. Do not over-tighten the reinforcing screw to avoid potential damage to the ribs. 5. After completing the IMA dissection, reverse the order of placement for removal.
Automatic Processing Instructions For Use with Alkaline or Enzymatic Detergents
Manual Processing Instructions For Use with Enzymatic Detergents
PRE-CLEANING • Soak the instrument in lukewarm tap water for a minimum time of 5 minutes. • Disassemble the instrument (if applicable) under lukewarm tap water. • Brush under lukewarm tap water with a soft brush until all visible residues are removed.
PRE-CLEANING • Soak the instrument in lukewarm tap water for a minimum time of 5 minutes. • Disassemble the instrument (if applicable) under lukewarm tap water. • Brush under lukewarm tap water with a soft-bristled brush until all visible residues are removed.
CLEANING • Place the opened instrument in a wire basket and start the cleaning process. • Pre-rinse for 2 minutes with cold water. • Empty. • Pre-rinse for 3 minutes with cold water. • Empty. • Wash for 5 minutes at 131°F (55°C) with a 0.5% alkaline detergent or at 113°F (45°C) with a 0.8% enzymatic 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 detergent manufacturer. Detergents must be approved for use with metal reusable general surgical instruments. Examples of detergents used in validation studies: Enzymatic Detergent: Cidezyme/Enzol; Alkaline Detergent: Neodisher Mediclean.
CLEANING • Place the instrument in an ultrasound bath at 104°F (40°C) with a 0.5% enzymatic detergent. • Sonicate for 10 minutes (minimum). • Remove the instrument and flush with lukewarm tap water for approximately 15 seconds while simultaneously brushing with a soft-bristled brush. Note: The preparation of concentration, temperature and application time of the cleaning agent must be according to the instructions for use provided by the detergent manufacturer. Detergents must be approved for use with metal reusable general surgical instruments. Examples of detergents used in validation studies: Enzymatic Detergent: Cidezyme/Enzol.
DRYING Dry the outside of the instruments using the drying cycle of the cleaning equipment. If necessary, instruments can be dried by hand with a lint-free cloth.
DRYING Dry instruments with a lint-free cloth.
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.
INSPECTION AND FUNCTIONAL CHECK
Inspect instruments after each sterilization cycle and prior to each use as they 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 processes. All moving parts must be inspected for wear and confirmed to be functional. Confirm smooth operation during opening and closing of instrument handle and reinforcing screw. Inspect instruments 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.
MAINTENANCE, HANDLING AND OPERATION OF SURGICAL INSTRUMENTS
WARNINGS • 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
The assembly and disassembly of the instrument must only be performed by personnel trained to the institution’s training requirements. The instrument must be cleaned, lubricated, functionally checked and sterilized prior to each use. Use a non-silicone, water-based lubricant prior to sterilization. Do not use mineral oil, petroleum or silicon-based lubrication products. Do not use an instrument with broken, cracked, or worn parts. Only use the instrument for its intended use. Misuse or improper handling may result in damage, potentially resulting in user or patient injury. If repair is required, return clean and sterile instruments to Teleflex.
PACKAGING
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 or guidance on Cleaning and Sterilization instructions, contact your Teleflex Sales Representative or Teleflex Customer Service at (866) 246 6990 or +1 919 544 8000.
After cleaning and inspection, place the instrument in a sterilization container or in terminally sterilized packaging (as per ISO 11607) which will protect the instrument from the environment as well as permit sterilization. After sterilization the instrument should remain in the sterilization container or packaging for protection from the environment and to maintain sterility.
STERILIZATION
Instruments should be sterilized in the disassembled/open position, where applicable. Engaged ratchets can result in damage to the instrument. To avoid electrochemical reactions, separate instruments fabricated from different materials. The following steam sterilization cycles may be used for instrument:
Sterilization Instrument Method Configuration Pre-vacuum
Wrapped
Pre-vacuum
Wrapped
Pre-vacuum Gravity Displacement
Wrapped Wrapped
Temperature 270°F (132°C) 273°F (134°C) to 279°F (137°C) 275°F (135°C) 270°F (132°C) to 275°F (135°C)
Exposure Drying Time Time (minimum) (minimum) 4 minutes
10 minutes
3 minutes
10 minutes
3 minutes
10 minutes
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 or within the sterilization container to maintain sterility.
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.
© Copyright 2018 Teleflex
Pilling is a registered trademark of Teleflex Incorporated or its affiliates.
L02412 R01