INSTRUCTIONS FOR USE:
I. RINSE PROCEDURE
1. Remove inner container from outer cardboard package. Do not place the
container in the sterile field.
2. Examine the freeze indicator. Do not use if activated.
3. Inspect container and package. Do not use if there is evidence of moisture
or leakage.
4. Open inner container. Use sterile, atraumatic forceps to grasp the edge of
the patch and remove from the container using aseptic technique. Rinse
surgical gloves to remove glove powder prior to touching the patch.
5. Immerse and agitate Peri-Guard, for a minimum of 3 minutes, in a
sterile basin containing 500 ml of sterile physiologic saline (0.9% NaCl).
Do not pour the storage solution into the sterile physiologic saline. At the
surgeon's discretion the 500 ml rinse solution may contain one of the
following antibiotic treatments: ampicillin & gentamicin, bacitracin,
cefazolin, cefotaxime, neomycin, and vancomycin. Testing has shown
that Peri-Guard is not adversely affected by treatment with the
antibiotics listed. The effects of other antibiotics on Peri-Guard have not
been tested. The long term effects of antibiotic treatments of Peri-Guard
have not been assessed. Do not use antibiotics contrary to the antibiotic
manufacturer's instructions.
6. Keep the patch immersed in sterile saline until ready to use.
THE PATCH MUST REMAIN MOIST AT ALL TIMES.
II. IMPLANT INSTRUCTIONS
1. The patch may be tailored during surgery to meet the surgeon's needs.
2. Visually examine both sides of the Peri-Guard patch. If one side
appears smoother, implant the smoother surface so that it faces the
blood flow surface.
3. Peri-Guard may be sutured, clipped, or stapled to the edge of the host
tissue or vessel.
4. When implanting by suture, suture bites should be taken 2 to 3 millimeters
from the edge of the graft.
5. The graft should be applied and fixed in place carefully to obtain best
results.
6. Discard any unused pieces of Peri-Guard. Peri-Guard cannot be
resterilized or reused.
STORAGE:
Do not freeze. Store at room temperature.
3