Initial placement 20FR Guidewire PEG kit REORDER NO: 00710802 INSTRUCTIONS FOR USE 1 of 5
These products have been manufactured not to include latex. Intended Use: The Initial placement 20FR Guidewire PEG kit is an initial placement percutaneous endoscopic gastrostomy kit designed for enteral feeding. Contents: Product Number 00710802 20FR, 60cm silicone gastrostomy feeding tube with insertion 5cc ampule lidocaine marked catheter and 76cm pull guidewire dilating tip Silicone external bolster, one piece Triple pack povidone-iodine swabs 20FR silicone dual port feeding adaptor Prep Razor 260cm teflon coated guidewire Four 4" x 4" gauze pads Grasping snare Two ointments (10% povidone-iodine) 24" x 36" fenestrated drape Lubricating jelly No. 11 scalpel Curved hemostat 5cc syringe Stainless steel scissors Filter cannula Cotton tip applicators 19 gauge x 1½" needle Triple patient label 25 gauge x 5/8" needle Four 2" x 2" drainage gauze 18 gauge cannula Bite Block 48 FR Warnings and Precautions: Read all instructions prior to use. lnspect contents of PEG kit for damage. If damage is evident, do not use kit. PEG procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques. Consult the medical literature relative to techniques, complications and hazards prior to the performance of an endoscopic procedure. Always keep the stomach insufflated until the external bolster has been finally positioned on the PEG tube. lf excessive resistance is met as the PEG dilating tip is exiting the abdominal wall, the incision and subcutaneous tissue may require expansion or enlargement. Following the completion of the PEG placement, wait 24 hours before feeding the patient. Traction removal may cause trauma or other complications in some patients. US Endoscopy did not design this device to be reprocessed or reused, and therefore cannot verify that reprocessing can clean and/or sterilize or maintain the structural integrity of the device to ensure patient and/or user safety. This disposable medical device is not intended for reuse. Any institution, practitioner, or third party who reprocesses, refurbishes, remanufactures, resterilizes, and/or reuses this disposable medical device must bear full responsibility for their safety and effectiveness. Contraindications: Esophageal obstructions will require a medical evaluation to determine if endoscopy and the passage of a PEG are advisable. PEG placement should not be performed if abdominal transillumination is not achieved. Directions for Use: Following suggested medical techniques, prep the patient for PEG placement. 1. Prep the abdomen. 2. Perform endoscopy; insufflate stomach to ensure that abdominal and gastric walls are in contact. 3. Transilluminate abdominal wall to choose correct location of the incision. 4. Apply finger pressure to abdomen and endoscopically observe indentation. 5. Pass the snare or forceps through the scope channel to the anticipated exiting area of the Introducer Cannula. One method of retrieving the guidewire is to advance the opened snare loop under the target site to entrap the Introducer Cannula after it enters the stomach. 2 of 5
6. Using local anesthesia, anesthetize the incision site. 7. Using the scalpel, make a 1cm incision at the anesthetized site. Performing a smaller incision may cause unwanted resistance as the PEG dilating tip exits the abdominal wall. 8. Separate the incision site and subcutaneous tissue. 9. Under endoscopic observation, insert the Introducer Cannula through the abdominal incision into the stomach. 10. Pass the floppy tip end of the guidewire through the Introducer. Under endoscopic observation, use the retrieval snare or forceps to securely grasp the guidewire and extubate the scope/snare assembly. Pull the guidewire through the mouth until there is approximately 40-50cm of guidewire remaining outside the abdomen. 11. Straighten the tapered PEG dilating catheter and slide the tapered end over the guidewire. Push the guidewire completely through the PEG assembly until it exits the dome end of the PEG. 12. Using the lubricant, lubricate the outside of the PEG tube assembly. 13. Grasp the guidewire near the abdomen, and grasp the guidewire near the dome end of the PEG tube. Gentle tension on both ends of guidewire is needed to traverse catheter through esophagus. 14. Once the dilating catheter and silicone tube have started to exit, carefully pull the guidewire out of the PEG tube assembly. 15. Carefully pull the dome safely through the oral pharynx and into the stomach cavity. Reintubate the endoscope and observe the dome meeting the gastric mucosa. Excess tension should be avoided as undue pressure may cause complications. 16. Wipe down the PEG tube. Clean the abdominal incision site, and if desired, apply Povidone-Iodine ointment. 17. External Bolster Placement: Use hemostat to dilate the hole in the bolster. Slide the bolster onto PEG tube until it meets the skin. The bolster collar should be facing away from the patient. Excess tension should be avoided as undue pressure may cause complications. Obstreperous patients may need the bolster sutured in place. If the bolster is not sutured, it can be frequently rotated for site cleaning. If sutured, site cleaning must be accomplished without bolster rotation. 18. Leave approximately 12 inches of the PEG tube extending from the abdomen and cut off the balance. 19. Securely install the dual port feeding adapter into the open end of the PEG tube. Close both ports to prevent leakage. PEG Removal Methods: Consult the medical literature about PEG tube removal and the need for endoscopic observation. Caution: Federal law (U.S.A.) restricts sale of this device to or on the order of a physician. 3 of 5
Product Disposal: After use, these products may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations. Issued Date: December 2013 Warning: An issued or revision date for these instructions is included for the user s information. In the event that two years have elapsed between this date and product use, the user should contact US Endoscopy to determine if additional information is available. Listening and delivering solutions, the US Endoscopy listening and delivering solutions design, and all marks denoted with or are registered with the U.S. Patent and Trademark Office, or trademarks owned by US Endoscopy. Teflon is a registered trademark of E.I. Dupont de Nemours and Co., Inc. US Endoscopy, a wholly owned subsidiary of STERIS Corporation. Made in the U.S. 4 of 5
Explanation of symbols used on Labels and Instructions for Use Use By Sterilized by Ethylene Oxide Contents Non-Sterile Reference Single Use Only Lot Do Not Re-Sterilize Date of Manufacture Latex Free Length Read instructions prior to using this product Authorized Representative in the European Community For use with Olympus active cord Store at controlled room temperature For use with Microvasive active cord I.D. O.D. Discard within 24 hours after opening package Product contains Phthalates Do not use if packaging or product damage is evident. For sterile products only, contents are sterile if package is unopened and undamaged. Federal law (U.S.A.) restricts this device to sale, distribution and use by or on the order of a physician. Rx Only (U.S.A.) 5 of 5