Teleflex Medical
ADSON FCPS 5", INSULATED, 1.0MM STR TIP
Weck Reusable Bipolar Forceps Instructions for Use and Care
2 Pages
![WECK INSTRUCTIONS FOR USE AND CARE REUSABLE BIPOLAR FORCEPS This forceps is reusable and is supplied NON-STERILE. Process the forceps through cleaning and sterilization prior to initial use, following guidance as outlined in this IFU. For questions or additional information on our complete line of forceps, please contact Teleflex Medical at +1 919 544 8000, or toll free at (866) 246 6990, or on the web at www.teleflex.com. For irrigating forceps, also flush irrigating lumen with a minimum of 1 mL (with the prepared enzymatic detergent using a syringe. Repeat this stage 2 (two) additional times, for a total of 3 (three) flushes. Caution: Avoid use of abrasive cleaners or solvents. INTENDED USE: These reusable forceps are electrosurgical devices designed to be used in soft tissue surgical procedures. WARNING: Any use of this forceps for tasks other than for which it is indicated will usually result in a damaged or broken forceps. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. EXTENDING FORCEPS LIFE These forceps have been validated for twenty-five uses. However, the number of uses obtained from the forceps depends upon the degree of care taken in processing and handling, and the surgical procedures and techniques in which the forceps is used. To achieve maximum life the following is recommended: Not allowing gross organic contaminates to dry on the forceps (e.g., blood, mucus, and tissue), by initiating forceps decontamination immediately after completion of the surgical procedure. Do not allow forceps tips to touch each other while ESU is active or activated. Completely drying forceps before storage. Protecting forceps from inadvertent damage while in storage, by wrapping them and avoiding extremes in temperature and humidity. Avoiding STERRAD®100S on gold-plated forceps. NOTE: Spotting or discoloration may result from inadequate cleaning prior to sterilization or may be due to mineral deposits in water used to autoclave. INSPECTION OF FORCEPS It is recommended that a procedural review be established,, by which the forceps are inspected frequently (before and after each use) for damage such as: Tip misalignment. Tip damage e.g., burrs, bending, or discoloration. For insulated instruments: cracks, nicks, lacerations, or abrasions in insulation. Cracks or nicks in the base of the instrument, where the tines are seated. It is recommended that a procedural review be established (before and after each use) by which the forceps showing such damage or wear are either sent for refurbishing, discarded and/or replaced. CAUTION: Using forceps which are damaged or worn can be hazardous to both the patient and operating room personnel. REPROCESSING AND STERILIZATION (i.e., cleaning & sterilization) Institutional device sterilization and reprocessing should occur in facilities that are adequately designed, equipped, monitored, and staffed by trained personnel. Sterilize and clean per your institution’s validated procedures and cycle parameters. The following parameters for cleaning and the most commonly utilized methods of sterilization are recommended as guidelines for validation. NOTE: Reprocessing this device dictates that it undergo a thorough cleaning prior to sterilization. WARNING: Clean and sterilize after each use. MANUAL CLEANING Rinse Forceps thoroughly for a minimum of 30 seconds with purified/ deionized water and until visibly clean of accumulated debris. Prepare a neutral pH enzymatic cleaner [e.g. Steris® Prolystica® 2X Concentrate Enzymatic Presoak and Cleaner] per manufacturer’s instructions. Wash the surface of the forceps using a soft bristled cleaning brush and prepared enzymatic cleaner for a minimum of one (1) minute and until visibly clean. Thoroughly rinse forceps by immersing it in a large volume of critical (purified) water for a minimum of 1 (one) minute. Remove the forceps and discard the rinse water. Do not reuse the water. Always use fresh volumes of water for each rinse. Repeat this stage 2 (two) additional times, for a total of 3 (three) rinses. For irrigating forceps, also flush irrigating lumen with a minimum of 1 mL with critical (purified) water using a syringe until no visible detergent remains. Always use fresh volumes of water for each flush. Repeat this stage 2 (two) additional times, for a total of 3 (three) flushes. Once the forceps are free of cleaning solution and debris, thoroughly dry the outside surfaces with a lint free wipe and the lumen using filtered compressed air. Visually inspect the forceps, in a well-lit area to ensure all surfaces are clean. For irrigating forceps, inspect the lumen AUTOMATED PRE-CLEANING INSTRUCTIONS Rinse the instruments under warm running tap water until visibly clean. Use a soft bristle brush (plastic brush) as needed for hard to remove soil. Hard to reach areas such as, internal spaces should be flushed with a water pistol/syringe. Irrigating forceps are provided with a stylet to clean the lumen during rinsing. CLEANING AND DISINFECTION Place the forceps in a bath with a tested cleansing and disinfectant agent such as Renu-Klenz™ (Steris) (1/4 oz/gal) prepared according manufacturer’s recommendations using lukewarm tap water. The forceps must be completely covered with the solution. NOTE: The application times, temperatures, and concentration stated by the manufacturer of the cleansing/disinfectant agent must always be observed. The lumen of irrigating forceps must then be flushed with the prepared detergent. The forceps (particularly irrigating forceps) are then immersed in the detergent solution and allowed to sonicate for ten minutes. Repeat the cleansing process if visible contamination is still present on the instrument. Fresh solutions must be prepared daily. In case of severe soiling, the solution must be changed sooner. A high contamination load in the ultrasonic bath impairs the cleansing action and promotes the risk of corrosion. The cleansing solution must be renewed regularly according to the conditions of use. The criterion is visibly apparent soiling. In any case, a frequent change of bath is necessary, at least once a day. National guidelines must be observed. AUTOMATED MACHINE CLEANING INSTRUCTIONS The forceps are then to be transferred via a suitable container (e.g., wire mesh basket) into the automated washer. The following cycle is recommended with these parameters programmed; set to high. Phase Recirculation Time Water Temperature (minutes) Detergent Type and Concentration Pre-wash 1 02:00 Cold Tap water N/A Enzyme Wash 02:00 Hot Tap Water Klenzyme™, 1 oz/gallon Wash 1 02:00 65.0˚C (Set Point) Renu-Klenz™, ¼ oz/gallon Rinse 1 01:00 Hot Tap Water N/A Drying 07:00 90˚C N/A The device(s) should then be dried using a clean, soft cloth and visually examined using the naked eye under normal lighting condition to determine that all adherent visible soil (e.g., blood, protein substances and other debris) had been removed from all surfaces, lumens, crevices and serrations. Klenzyme and Renu-Klenz are trademarks of Steris. STERILIZATION NOTE: Remove stylet if supplied Page: 1 of 2 IFU-WECKRF-5, Rev.: A (04-2018) L02615 R00 TELEFLEX MEDICAL 3015 CARRINGTON MILL BLVD, MORRISVILLE, NC 27560 USA](https://images.bioclinicalservices.com.au/d56nx7efrgktqew7wx4ruj2rx8sn/320w/Teleflex%20Medical%20-%20WECK%20Medical%20-%20L02615%20-%20Weck%20Reusable%20Bipolar%20Forceps%20Instructions%20for%20Use%20and%20Care%20-%202020-04%20-%20Rev%20A.png)
Preview
Page 1
WECK INSTRUCTIONS FOR USE AND CARE REUSABLE BIPOLAR FORCEPS This forceps is reusable and is supplied NON-STERILE. Process the forceps through cleaning and sterilization prior to initial use, following guidance as outlined in this IFU. For questions or additional information on our complete line of forceps, please contact Teleflex Medical at +1 919 544 8000, or toll free at (866) 246 6990, or on the web at www.teleflex.com.
For irrigating forceps, also flush irrigating lumen with a minimum of 1 mL (with the prepared enzymatic detergent using a syringe. Repeat this stage 2 (two) additional times, for a total of 3 (three) flushes.
Caution: Avoid use of abrasive cleaners or solvents. INTENDED USE: These reusable forceps are electrosurgical devices designed to be used in soft tissue surgical procedures. WARNING: Any use of this forceps for tasks other than for which it is indicated will usually result in a damaged or broken forceps. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. EXTENDING FORCEPS LIFE These forceps have been validated for twenty-five uses. However, the number of uses obtained from the forceps depends upon the degree of care taken in processing and handling, and the surgical procedures and techniques in which the forceps is used. To achieve maximum life the following is recommended: Not allowing gross organic contaminates to dry on the forceps (e.g., blood, mucus, and tissue), by initiating forceps decontamination immediately after completion of the surgical procedure. Do not allow forceps tips to touch each other while ESU is active or activated. Completely drying forceps before storage. Protecting forceps from inadvertent damage while in storage, by wrapping them and avoiding extremes in temperature and humidity. Avoiding STERRAD®100S on gold-plated forceps. NOTE: Spotting or discoloration may result from inadequate cleaning prior to sterilization or may be due to mineral deposits in water used to autoclave. INSPECTION OF FORCEPS It is recommended that a procedural review be established,, by which the forceps are inspected frequently (before and after each use) for damage such as: Tip misalignment. Tip damage e.g., burrs, bending, or discoloration. For insulated instruments: cracks, nicks, lacerations, or abrasions in insulation. Cracks or nicks in the base of the instrument, where the tines are seated. It is recommended that a procedural review be established (before and after each use) by which the forceps showing such damage or wear are either sent for refurbishing, discarded and/or replaced. CAUTION: Using forceps which are damaged or worn can be hazardous to both the patient and operating room personnel. REPROCESSING AND STERILIZATION (i.e., cleaning & sterilization) Institutional device sterilization and reprocessing should occur in facilities that are adequately designed, equipped, monitored, and staffed by trained personnel. Sterilize and clean per your institution’s validated procedures and cycle parameters. The following parameters for cleaning and the most commonly utilized methods of sterilization are recommended as guidelines for validation. NOTE: Reprocessing this device dictates that it undergo a thorough cleaning prior to sterilization. WARNING: Clean and sterilize after each use. MANUAL CLEANING Rinse Forceps thoroughly for a minimum of 30 seconds with purified/ deionized water and until visibly clean of accumulated debris. Prepare a neutral pH enzymatic cleaner [e.g. Steris® Prolystica® 2X Concentrate Enzymatic Presoak and Cleaner] per manufacturer’s instructions. Wash the surface of the forceps using a soft bristled cleaning brush and prepared enzymatic cleaner for a minimum of one (1) minute and until visibly clean.
Thoroughly rinse forceps by immersing it in a large volume of critical (purified) water for a minimum of 1 (one) minute. Remove the forceps and discard the rinse water. Do not reuse the water. Always use fresh volumes of water for each rinse. Repeat this stage 2 (two) additional times, for a total of 3 (three) rinses. For irrigating forceps, also flush irrigating lumen with a minimum of 1 mL with critical (purified) water using a syringe until no visible detergent remains. Always use fresh volumes of water for each flush. Repeat this stage 2 (two) additional times, for a total of 3 (three) flushes. Once the forceps are free of cleaning solution and debris, thoroughly dry the outside surfaces with a lint free wipe and the lumen using filtered compressed air. Visually inspect the forceps, in a well-lit area to ensure all surfaces are clean. For irrigating forceps, inspect the lumen AUTOMATED PRE-CLEANING INSTRUCTIONS Rinse the instruments under warm running tap water until visibly clean. Use a soft bristle brush (plastic brush) as needed for hard to remove soil. Hard to reach areas such as, internal spaces should be flushed with a water pistol/syringe. Irrigating forceps are provided with a stylet to clean the lumen during rinsing. CLEANING AND DISINFECTION Place the forceps in a bath with a tested cleansing and disinfectant agent such as Renu-Klenz™ (Steris) (1/4 oz/gal) prepared according manufacturer’s recommendations using lukewarm tap water. The forceps must be completely covered with the solution. NOTE: The application times, temperatures, and concentration stated by the manufacturer of the cleansing/disinfectant agent must always be observed. The lumen of irrigating forceps must then be flushed with the prepared detergent. The forceps (particularly irrigating forceps) are then immersed in the detergent solution and allowed to sonicate for ten minutes. Repeat the cleansing process if visible contamination is still present on the instrument. Fresh solutions must be prepared daily. In case of severe soiling, the solution must be changed sooner. A high contamination load in the ultrasonic bath impairs the cleansing action and promotes the risk of corrosion. The cleansing solution must be renewed regularly according to the conditions of use. The criterion is visibly apparent soiling. In any case, a frequent change of bath is necessary, at least once a day. National guidelines must be observed. AUTOMATED MACHINE CLEANING INSTRUCTIONS The forceps are then to be transferred via a suitable container (e.g., wire mesh basket) into the automated washer. The following cycle is recommended with these parameters programmed; set to high. Phase
Recirculation Time Water Temperature (minutes)
Detergent Type and Concentration
Pre-wash 1
02:00
Cold Tap water
N/A
Enzyme Wash
02:00
Hot Tap Water
Klenzyme™, 1 oz/gallon
Wash 1
02:00
65.0˚C (Set Point)
Renu-Klenz™, ¼ oz/gallon
Rinse 1
01:00
Hot Tap Water
N/A
Drying
07:00
90˚C
N/A
The device(s) should then be dried using a clean, soft cloth and visually examined using the naked eye under normal lighting condition to determine that all adherent visible soil (e.g., blood, protein substances and other debris) had been removed from all surfaces, lumens, crevices and serrations. Klenzyme and Renu-Klenz are trademarks of Steris. STERILIZATION NOTE: Remove stylet if supplied
Page: 1 of 2 IFU-WECKRF-5, Rev.: A (04-2018) L02615 R00
TELEFLEX MEDICAL 3015 CARRINGTON MILL BLVD, MORRISVILLE, NC 27560 USA
NOTE: When sterilizing forceps, avoid contact between cords, plug connectors, and any metal object, such as, another instrument or tray. STEAM/GRAVITY DISPLACEMENT: Place forceps in a single-pouch configuration (i.e., legally approved pouch to maintain sterility) and position it (single layer) in a production type, steam sterilization vessel. Process at 132°C (270°F) for a 15 minute cycle. Dry for 20 minutes. STEAM/PRE-VACUUM: Place forceps in a single-pouch configuration (i.e., legally approved pouch to maintain sterility) and position it (single layer) in a production type, steam sterilization vessel. Process at 132° C (270°F) using prevacuum conditions for a 4 minute cycle. Dry for 20 minutes. CHEMICAL STERILIZATION: Totally immerse the forceps in CIDEX® activated dialdehyde solution, (Johnson & Johnson Medical, Inc.), or equivalent. Expose the forceps to the CIDEX® for 10 hours at 25°C (77°F). Following chemical exposure, rinse and flush the forceps with copious amounts of sterile water for a minimum of one minute three separate times. STERRAD®100S: DOUBLE WRAP forceps with Spunguard® Heavy Duty Sterilization Wrap (Kimberly-Clark), or equivalent. Process a total exposure time of 50 minutes diffusion and 15 minutes plasma. Manufacturer
Date of manufacture
NOTE: STERRAD®100S will discolor gold-plated forceps use another sterilization method to avoid. CAUTION: When sterilizing irrigating forceps a STERRAD®100S booster must be fitted to the irrigating lumen.
Warning, Cautions, and Precautions Batch Code
SETUP AND USE Attach the sterile forceps to the sterile cord ensuring that the forceps pins are fully seated in the cord’s receptacles. This condition ensures that the connection is splash proof. CAUTION: The cord to the surgical electrodes should be positioned in such a way that contact with the PATIENT or other leads is avoided. Temporarily unused ACTIVE ELECTRODES should be stored isolated from the patient. For irrigating forceps, it is recommended that a gravity fed irrigation with appropriate solution be used. A stylet is provided for clearance of the irrigating lumen, as needed.
Not made with natural rubber latex
CAUTION: Federal (USA) law restricts the device to sale by or on the order of a physician. Catalog No. (IPN Internal Product No.)
Non-Sterile Product
Made in USA
Consult Instructions for use
CAUTION: Because of the variability of output voltages and modes from generator to generator, DO NOT USE this forceps with generator setting having a bipolar output voltage exceeding 1200Vp-p. Refer to the appropriate electrosurgical generator manual for indications and instructions on voltage output characteristics to ensure that all safety precautions are followed. If no RF output is delivered to the accessory handpiece when the generator’s activating switch is pressed, check the cord connection with the device and with the generator. If proper function is still not achieved and the accessory handpiece and generator function are confirmed as sound, replace the cord and refer the questionable cord to qualified personnel for further evaluation. WARNING: Connect Bipolar accessories to the Bipolar receptacle only, and Monopolar accessories to the Monopolar receptacle. Improper connection of accessories may result in inadvertent accessory activation or other potentially hazardous conditions. Power setting guidelines may vary due to differences in surgical techniques, patients, electrodes and surgical set-up. Start at the lowest power setting and increase as necessary to achieve the desired clinical effect. 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.
REUSABLE BIPOLAR FORCEPS Page: 2 of 2 IFU-WECKRF-5, Rev.: A (04-2018) L02615 R00
TELEFLEX MEDICAL 3015 CARRINGTON MILL BLVD, MORRISVILLE, NC 27560 USA