LeMaitre XenoSure Instrucciones De Uso página 4

Directions For Use
Choose the required XenoSure Biologic Patch model as appropriate for the type of procedure
being performed. The XenoSure Biologic Patch can be cut to a size appropriate for a given
repair. XenoSure Biologic Patch is for SINGLE USE ONLY.
Patch Preparation
Surgical gloves must be thoroughly washed to remove all powder residues before handling
the XenoSure Biologic Patch.
Examine the information of the jar label to verify selection of the correct XenoSure Biologic
Patch size. Carefully inspect the entire container and tamper-evident seal for damage.
DO NOT USE THE XENOSURE BIOLOGIC PATCH IF THE JAR IS DAMAGED OR IF THE SEAL IS
BROKEN. Do not discard the product. Please contact your distributor for further instructions.
Rinse Procedure
Remove the tamper-evident outer plastic seal and unscrew the jar cap. The contents of the
jar are sterile and must be handled aseptically to prevent contamination. The outside of the
jar is not sterile and must not enter the sterile field.
From the jar, remove the XenoSure Biologic Patch by grasping its corners with sterile,
atraumatic forceps.
Once removed from the container, submerge the XenoSure Biologic Patch in the sterile sa-
line. Using the same forceps, gently agitate the XenoSure Biologic Patch in the basin. Allow
the XenoSure Biologic Patch to remain in the rinse basin until required by the surgeon.
Model Size (cm)
0.6BV8 0.6x8
0.8BV8 0.8x8
1BV6
1BV10 1x10
1.5BV10 1.5x10
1BV14 1x14
2BV9
4BV4
4BV6
6BV8
8BV14 8x14
10BV16 10x16
Alternate Patch Size Rinse Procedure
For any patch size not listed in the table, use the following rinse instructions.
Patch length (cm) x Patch width (cm) = Patch area (cm
If the patch has an area less than or equal to 24cm
minutes in 500ml of saline.
If the patch has an area greater than 24cm
requires a rinse time of 3 minutes in 1000ml of saline.
Note: The patch area is based on one side of the patch. This calculation has been formulated
intentionally. Please follow the instructions.
Implantation
Cut and/or trim the XenoSure Biologic Patch to the desired shape. Any excess XenoSure
Biologic Patch material should be treated as biological waste and discarded according to
hospital procedure.
During implantation, irrigate the XenoSure Biologic Patch tissue frequently with sterile
physiologic saline to prevent drying.
Rinse Procedure
1x6
500ml for 2
minutes
2x9
4x4
4x6
6x8
1000ml for 3
minutes
)
2
, the patch requires a rinse time of 2
2
and less than or equal to 160cm
2
, the patch
2