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DIRECTIONS To load blade on knife handle: 1. Using a Needle Holder, pick up the Weck Prep Blade (fig 1). Do not pick up by hand! 2. Hold Webster Skin Graft Handle firmly in opposite hand. 3. Align Weck Prep blade with distal end of Webster Skin Graft Handle (fig. 1). 4. Using the needle holder, smoothly slide Weck Prep Blade onto handle until firmly seated (fig. 2).
INSTRUCTIONS FOR USE: Webster Skin Graft Knife Handle, Goulian Guards, and the Goulian Skin Graft Knife Set (includes Weck Prep Blades). INSTRUMENT DESCRIPTION: The following instructions are for the Webster Skin Graft Knife Handle, Goulian Guards, and the Goulian Skin Graft Knife Set (including Weck Prep Blades): Description
Item Number
Webster Skin Graft Knife Handle
050230
Goulian Guard, 0.004”
050201
Goulian Guard, 0.006”
050202
Goulian Guard, 0.008”
050203
Goulian Guard, 0.010”
050204
Goulian Guard, 0.012”
050205
Goulian Guard, 0.014”
050206
Goulian Guard, 0.016”
050207
Goulian Guard, 0.018”
050208
Goulian Guard, 0.020”
050209
Goulian Skin Graft Knife Set (Item Number 050200) includes: Webster Skin Graft Knife Handle
050230
Goulian Guard (0.008”)
050203
Goulian Guard (0.010”)
050204
Goulian Guard (0.012”)
050205
Weck Prep Blades (5)
450205
Goulian Skin Graft Knife Set (Item Number 050200):
Fig 1
Fig 2
Fig 4
Fig 5
Fig 3
To load Goulian Guards on knife handle: 5. Carefully align the end of the Goulian Guard with the distal end of the Weck Prep Blade loaded Webster Skin Graft Handle (fig. 3). 6. Slide Goulian Guard smoothly onto handle until guard reaches stop (fig. 4). Note: Loading resistance of the guard onto the handle is normal and designed to prevent the guard from shifting once loaded. 7. If resistance is not felt during loading of guard, DO NOT USE. Replace guard. 8. Visually verify that the prep blade is fully “guarded” (fig. 5). Weck Prep Blade should be completely shielded (no exposed edges) by the Goulian Guard. 9. Using a downward motion of the wrist, verify that guard does not shift. 10. If guard shifts, exposing prep blade, DO NOT USE. Replace guard. PREPARATION AT POINT OF USE Directly after use, disassemble the knife handles, guards, and prep blades. Dispose of prep blades. Remove coarse contamination from the handles and guards and keep the instruments 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. TRANSPORTATION During the transportation of the instruments to the processing site, store contaminated instruments securely in a closed container to avoid damage to the instruments and/or contamination of the environment.
Weck Prep Blades (Item Number 450205):
PREPARATION FOR REPROCESSING Where applicable, instruments must be disassembled and/or opened for cleaning and sterilization. Failure to properly clean and sterilize instruments could lead to contaminated instruments being placed back into circulation. Note: Weck Prep Blades are disposable, one time use items and should never be reprocessed. CLEANING AND STERILIZATION INSTRUCTIONS: (For Weck Prep Blades (Item Number 450205) Only): Manual Processing Instructions (For Use with Enzymatic Detergent Only)
INDICATIONS FOR USE The Webster Skin Graft Knife Handle, Goulian Guards, and Goulian Skin Graft Knife Set (including Weck Prep Blades) are designed to resect tissue. The 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 selection and technique for the use of the instrument is the responsibility of the medical professional.
Pre-Cleaning • Weck Prep Blades have a razor blade edge – proper care should be taken when handling to avoid injury. • Remove cardboard sleeve from Weck Prep Blades. • Rinse the blades under warm water for a minimum time of two (2) minutes until all visible residues are removed. Cleaning • Place the blades in an ultrasound bath at 104°F (40°C) with a 0.5 % enzymatic detergent. • Sonicate for ten (10) minutes (minimum). • Remove the blades and rinse with distilled water for a minimum time of two (2) minutes. 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.
The following steam sterilization cycles may be used for Webster Skin Graft Knife Handles, Goulian Guards, and Goulian Skin Graft Knife Sets (excluding Weck Prep Blades):
STERILIZATION INSTRUCTIONS Sterilization Method
Instrument Configuration
Temperature
Pre-vacuum
Wrapped
270°F (132°C)
Exposure Time (minimum) 4 minutes
Drying Time (minimum) 10 minutes
Sterilization Method
Instrument Configuration
Pre-vacuum Gravity Displacement
Wrapped Wrapped
Pre-vacuum Gravity Displacement
Wrapped Wrapped
Temperature (minimum)
Exposure Time (minimum)
Drying Time (minimum)
USA-Parameters 270°F (132°C) 250°F (121°C)
4 minutes 30 minutes
10 minutes 10 minutes
Outside-USA-Parameters 273°F (134°C) 270°F (132°C)
3 minutes 10 minutes
10 minutes 10 minutes
Note: Sterilized Weck Prep Blades (wrapped, peel pack) are validated for use within 48 hours after sterilization. Unused sterilized blades that exceed the 48 hour validation should be properly discarded.
NOTE: Flash sterilization is not recommended for use with these instruments.
Prep blades will rust if left in a moist environment. The blades are made of carbon steel (not stainless steel). Carbon steel is sharper and retains sharp edge better than stainless steel.
For additional information or guidance on Cleaning and Sterilization instructions, contact your Teleflex Sales Representative or Teleflex Customer Service.
Do not sterilize with the blade inside the handle. The blade will rust and be difficult to remove from the handle.
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’s site, during use in a previous procedure or during the cleaning or sterilization processes. Inspect after sterilization and prior to use in order to ensure proper function. Inspect instrument for rust, pitting, cracking or burrs, staining or discoloration, and worn or broken parts. Repair or replace any instrument found not to be acceptable.
CLEANING AND STERILIZATION INSTRUCTIONS: (For Webster Skin Graft Knife Handles, Goulian Guards, and Goulian Skin Graft Knife Sets (Item Number 050200) excluding Weck Prep Blades (Item Number 450205)). CLEANING INSTRUCTIONS Automatic Processing Instructions For Use with Alkaline or Enzymatic Manual Processing Instructions For Use with Enzymatic Detergents Detergents Pre-Cleaning • Soak the instrument in tap water for a minimum time of 5 minutes. • Disassemble the instrument (if applicable). • Brush under tap water with a soft brush until all visible residues are removed. Cleaning • Place the opened instrument in a wire basket on the slide-in tray and start the cleaning process. • Pre-rinse for 1 minute 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 0.5% enzymatic detergent. • Empty. • Neutralize for 3 minutes with warm water (>104°F (40°C)). • Empty. • Rinse for 2 minutes with warm water (>104°F (40°C)). • 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. 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 sterile lint-free cloth. Compressed, filtered air can be used for instruments with lumens. Disinfection Teleflex does not provide disinfection instructions due to the sterility instructions provided.
Pre-Cleaning • Soak the instrument in tap water for a minimum time of 5 minutes. • Disassemble the instrument (if applicable). • Brush under tap water with a soft-bristled brush until all visible residues are removed. Cleaning • Place the instrument in an ultrasound bath at 104°F (40°C) with a 0.5 % enzymatic detergent. • Sonicate for 15 minutes (minimum). • Remove the instrument and flush with de-ionized water for approximately 15 seconds while simultaneously brushing using a soft-bristled brush until all detergent residue has been removed. 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. Drying Dry instruments with a sterile lint-free cloth. Compressed, filtered air can be used for instruments with lumens. Disinfection Teleflex does not provide disinfection instructions due to the sterility instructions provided.
MAINTENANCE, HANDLING AND OPERATION OF SURGICAL INSTRUMENTS 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, functionally checked, and sterilized (where applicable) prior to each use. 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 After cleaning and inspection, place the instrument in packaging 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. 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 healthcare facility using appropriate validated laboratory methods. 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 authorizes 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
Sterilization Instructions Instrument should be arranged in a disassembled position. To avoid electrochemical reactions, separate instruments fabricated from different materials. © Copyright 2018 Teleflex
Pilling is a registered trademark of Teleflex Incorporated or its affiliates.
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