Bard Composix L/P, Инструкция по эксплуатации

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4) Directions for Using Composix™ L/P Mesh with Echo PS™ Positioning System
To activate and in fl ate the device:
1. Once the C
OMPOSIX
™ L/P Mesh with E
CHO
PS™ Positioning System (the device) is inserted into the abdo-
men, use a grasper to locate the blue retrieval loop on the in fl ation tube, ensuring that the blue in fl ation tube
is not wrapped around the mesh and is clearly visible (Fig. 9).
2. Pass a suture passer device through healthy skin at the center of the hernia defect (avoid going directly
through the umbilicus). Grasp the blue retrieval loop and pull the retrieval loop and in fl ation tube out of
the abdominal cavity (Fig. 10).
3. Place an atraumatic clamp or hemostat on the in fl ation tube at the level of the skin to temporarily hold the
device in place (Fig 11a). Cut the in fl ation tube 1-2 cm below the retrieval loop with surgical scissors to
ensure the tube is unobstructed. Discard the retrieval loop (Fig. 11b).
4. Remove the in fl ation assembly from the sterile pouch and screw the in fl ation adapter tightly to the syringe
(Fig. 12). Connect the in fl ation tube and in fl ation assembly as follows (Fig. 13):
a. Ensure the clear cap of the adapter is pushed downward to open the in fl ation tube channel
b. Insert the in fl ation tube at least 5 cm into the cap opening
c. Push the clear cap of the adapter upward to lock in place
5. To in fl ate the device, release the clamp or hemostat and pull the in fl ation tube upward to lift the mesh
off the viscera (Fig 14). Always grab and pull the tube directly. Do not lift up using the in fl ation adapter/
assembly. In fl ate the device by pumping the syringe until the balloon is fully in fl ated (Fig. 15). One to
three pumps will be required to fully in fl ate the device depending on the size of the mesh. A slight high
pitch sound may occur; this is normal and indicates the in fl ation assembly is working properly. If desired,
remove the syringe once in fl ated by unscrewing from the adapter then set aside (Fig. 16).
Note: The mesh should now be unrolled, opened and ready to be properly positioned.
Fig. 9 Fig. 10 Fig. 11 Fig. 12
Fig. 13 Fig. 14 Fig. 15 Fig. 16
To properly position and fi xate the mesh:
6. Raise the in fl ation tube to properly adjust the mesh to the desired position then clamp the in fl ation tube
to hold the device in place (Fig. 17).
7. Use a grasper to orient the C
OMPOSIX
™ L/P Mesh in relation to the defect (Fig. 18). The B
ARD
®
logo and
dark shaded areas on the device represent the long axis. The two shaded points at both ends of the long
axis indicate the midline of the C
OMPOSIX
™ L/P Mesh.
8. Once the device has been properly positioned and before the E
CHO
PS™ Positioning System is de fl ated,
ensure that no tissue is entrapped between the device and abdominal wall and fi xate around the entire
patch perimeter of C
OMPOSIX
™ L/P Mesh with fasteners placed 1-2 cm apart and at least ½ cm inside
the outermost row of stitches (Fig. 24). Ensure that no fasteners are placed through the E
CHO
PS™
Positioning System (Fig. 19).
Fig. 17 Fig. 18 Fig. 19
To de fl ate and remove the E
CHO
PS™ Positioning System:
9. To de fl ate the E
CHO
PS™ Positioning System, release the clamp on the in fl ation tube, cut the tube as
close to the skin as possible, and then discard (Fig. 20).
10. Begin removal of the E
CHO
PS™ Positioning System by grasping one of the two removal points marked by
the dark arrows adjacent to the B
ARD
® logo and pulling the positioning system off the mesh in one smooth
motion (Fig. 21).
11. Continue to grasp the E
CHO
PS™ Positioning System, pulling it up to the tip of the trocar (Fig. 22). Re-
move both the E
CHO
PS™ Positioning System and trocar simultaneously (Fig. 23). Verify that the device
is fully intact after removal, and discard the E
CHO
PS™ Positioning System appropriately.
12. Reinsert the trocar, place any additional fi xation as desired, and complete the procedure. Care should
be taken to ensure that the patch is adequately fi xated to the abdominal wall. If necessary, additional
fasteners and/or sutures should be placed.
Fig. 20 Fig. 21 Fig. 22 Fig. 23
Fixation
B
ARD
® fi xation devices or nonabsorbable mono fi lament sutures are recommended to properly secure
C
OMPOSIX
™ L/P Mesh. If other fi xation devices are used, they must be indicated for use in hernia repair. If
transfascial sutures are to be used for fi xation, place sutures after removing the E
CHO
PS™ Positioning System
from the body and after completing all mechanical fi xation. Care should be taken to ensure that the mesh is
adequately fi xated to the abdominal wall. If necessary, additional fasteners and/or sutures should be placed.
Adverse Reactions
Possible complications include seroma, adhesions, hematomas, in fl ammation, extrusion, fi stula formation and
recurrence of the hernia or soft tissue defect.
Traceability
Traceability labels which identify the type, size, and lot number of the device are attached to every package.
A label should be af
fi xed to the patient’s permanent medical record to clearly identify the device which was
implanted.
If you experience a product failure, please contact Davol Inc. at 1-800-556-6275 for instructions on returning
the product.
Storage
C
OMPOSIX
™ L/P Mesh with E
CHO
PS™ Positioning System should be stored in a clean, dry area at ambient
room temperature until ready for use.
Bard, Composix, Davol, and Echo PS are trademarks and/or registered trademarks of C. R. Bard, Inc.
or an af
fi liate.
Copyright © 2010, 2011 C. R. Bard, Inc. All Rights Reserved.
a
c
b
a
b
Fig. 24
Reference Step #8 above.
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