Potential Complications; Required Materials - Cook Medical Biodesign Gebrauchsanweisung

• Avoid excessive manipulation of tissue with a stapler loaded with the
Staple Line Reinforcement.
• To prevent loss of adhesive, avoid dipping the Staple Line Reinforcement
in water/saline. Dip the stapler jaws instead.
*The average total nominal thickness (anvil+cartridge side including adhesive) of
the Staple Line Reinforcement is indicated on the label as dimension "C".

POTENTIAL COMPLICATIONS

• Infection
• Acute or chronic inflammation (Initial application of graft materials may be
associated with transient, mild, localized inflammation)
• Allergic Reaction
STORAGE
This Staple Line Reinforcement should be stored in a clean, dry location at
room temperature.
STERILIZATION
The Staple Line Reinforcement has been sterilized using E-beam radiation.
INSTRUCTIONS FOR USE
These recommendations are designed to serve only as a general guideline.
They are not intended to supersede institutional protocols or professional
clinical judgment concerning patient care.

REQUIRED MATERIALS

• Compatible surgical stapler
• Warm sterile water or saline
• Sterile scissors
• Sterile basin
• Sterile gauze or sponge
NOTE: Always handle the Staple Line Reinforcement using aseptic
technique, minimizing contact with latex gloves.
1. Aseptically remove the tray from inside the pouch using sterile gloved
hands and place into the sterile field.
2. Wet the jaws of the surgical stapler or re-load
by compressing the jaws across a piece of
gauze (or a sponge) that has been soaked
with sterile water or saline.
NOTE: Liquid can be warmed up to 38°C
(100°F) to enhance adhesion.
An alternate wetting method is to quickly dip the jaws of the surgical
stapler or re-load in sterile water or saline and allow any excess water to
drip off.
3. Pull the Staple Line Reinforcement out of the tray by the finger grips on
wings of the foam applicator. Do Not Pull out of the Tray by the Tail.
4. Place the applicator inside the wet jaws of the surgical stapler. Visually
or palpably align the parallel edges of the applicator with the edges of
the stapler jaws. Gently insert the applicator to the back of the stapler
jaws until the applicator can not go any further. Notches in the applicator
provide for a stopping point to indicate how far back the applicator
should be positioned in the stapler jaws.
Step 4
4