Ethicon Biopatch Protective Disk with CHG

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• Instructions for Use:
  - Prepare the skin surrounding the percutaneous device according to hospital protocol.
  - Remove the BIOPATCH Dressing from the sterile package using aseptic technique.
  - Place the BIOPATCH Dressing around the catheter, making sure the BLUE side is facing upward. The smooth WHITE foam side should be next to the patients skin.
  - In order to ensure easy removal when used with a film dressing, place the BIOPATCH Dressing around the catheter/pin site in such a way that the catheter rests upon the slit portion of the BIOPATCH Dressing. The edges of the radial slit must approximate one another to assure efficacy.
  - Secure the catheter and BIOPATCH Dressing to the skin with BIOCLUSIVE Transparent Dressing. Assure complete contact between skin and the BIOPATCH Dressing.
  - Change the patch as necessary. In accordance with facility protocol, dressing changes should occur at a minimum of every 7 days. Dressing changes will be needed more frequently with highly exudative wounds.
  - To remove the BIOCLUSIVE Dressing, pick up the corner of the dressing and stretch the dressing away from the catheter, holding the catheter in the place. (Dressing will partially lift.) Peel back until resistance is felt. Repeatedly stretch and peel as necessary until the dressing is removed.
  - The BIOPATCH Dressing will remain attached to the BIOCLUSIVE Dressing, so removal will be simultaneous.
• Precaution:
  - BIOPATCH Dressing should not be placed over infected wounds. It is not intended to be used as a treatment of percutaneous device-related infections.
• Warning:
  - Do not use biopatch dressing on premature infants. Use of this product on premature infants has resulted in hypersensitivity reactions and necrosis of the skin.
  - For external use only.
  - Do not allow this product to contact the eyes, ears, mouth, or mucous membranes.
  - The safety and effectiveness of biopatch antimicrobial dressing has not been established in children under 16 years of age.
  - Do not use biopatch dressing on patients with a known sensitivity to chlorhexidine-gluconate. Adverse reactions to chlorhexidine gluconate such as dermatitis, hypersensitivity, and generalized allergic reactions are very rare, but if any such reactions occur, discontinue use of the dressing immediately. Hypersensitivity reactions associated with the topical use of chlorhexidine gluconate have been reported in several countries. The most serious reactions [including anaphylaxis] have occurred in patients treated with lubricants containing chlorhexidine gluconate, which were used during urinary tract procedures.

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