Bard Ventralight ST Gebrauchsanweisung Seite 3

INSTRUCTIONS FOR USE
Note on Transfascial Sutures: The Echo 2™ Positioning System eliminates the
need for transfascial orientation and positioning sutures. If transfascial sutures are
used for fixation, place sutures after removing the Echo 2™ Positioning System
from the body and after completing all other fixation.
Preparation
Ventralight™ ST Mesh with Echo 2™ Positioning System should be hydrated for no
more than 1-3 seconds and must be rolled immediately after hydration to maximize
the flexibility of the mesh. The safety and effectiveness of Ventralight™ ST Mesh
with Echo 2™ Positioning System in combination with solutions other than sterile
saline have not been tested.
Surface Orientation
It is extremely important that this product is oriented correctly to function as
intended. The visceral coated side of Ventralight™ ST Mesh (which contains the
Echo 2™ Positioning System frame) is designed to temporarily separate tissue
surfaces and minimize tissue attachment to the mesh. Place the bioresorbable,
coated side against those surfaces where minimal tissue attachment is desired, i.e.,
against bowel or other visceral structures. The uncoated polypropylene mesh side
must face the surface where tissue ingrowth is desired. The uncoated polypropylene
mesh side should never be placed against the bowel or other visceral structures.
Trocar Size Recommendations
Ventralight™ ST Mesh with Echo 2™ Positioning System should be hydrated for no
more than 1-3 seconds just prior to laparoscopic placement. The Ventralight™ ST
Mesh with Echo 2™ Positioning System must be rolled immediately after hydration.
Insert into the abdomen through the recommended minimum trocar or trocar
incision site. Never force the device through the trocar. If the device will not easily
deploy down the trocar, remove the trocar and insert through the next largest
available size trocar or through the trocar incision site and reinsert trocar. See
Table 1 in "Product Description" section for recommended minimum trocar size.
Inserting with Graspers
Note: This section is only applicable to REF 5990011G, REF 5991015G and
REF 5993035G, which do not include the Mesh Introducer.
1. Remove the Ventralight™ ST Mesh with Echo 2™
Positioning System from the sterile pouch.
2. Hydrate the device for no more than 1-3
seconds, in a sterile saline solution (Fig. 4).
3. Lay the device frame side up, on a flat, sterile
surface, as shown, with the long axis pointing
left to right, indicated by the black arrows in the
middle and outer edges of the frame. Lay the
center hoisting suture to the side so it is not in
the way (Fig. 5).
4. Start at the bottom and roll the device tightly
with the polypropylene side on the outside and
bioresorbable barrier and Echo 2™ Positioning
System frame on the inside (Fig. 6). Follow the
Nitinol frame outward as the mesh is rolled,
indicated by the arrows in Figure 6. Take care
not to let the hoisting suture become rolled up
with the mesh.
5. Hold the tightly rolled frame and grasp the
leading edge of the device with an atraumatic
grasper or grasping tool. Take care to grasp
both mesh and frame material at approximately
a 45-degree angle (Fig. 7). A black line
indicates the suggested location to grasp the mesh.
6. With the grasper, insert the leading edge of the rolled device into the trocar or
incision site. Do not let the rolled mesh bend as it is inserted into the trocar. In one
continuous movement, deploy the device into the abdomen (Fig. 8). Maintain
visualization of the device via laparoscope, as it is deployed into the abdomen.
Note: If the grasper slips from the device before it is
completely deployed through the trocar or incision
site, use a grasper from an opposing trocar location
to pull the device into the abdomen. Ensure that
the barrier is not damaged during insertion.
Inserting with the Mesh Introducer
Note: This section is only applicable to REF 5990015G, REF 5991520G,
REF 5991525G, REF 5991823G, REF 5990020G, REF 5992025G and
REF 5992533G, which include the Mesh Introducer.
1. Remove the Ventralight™ ST Mesh with Echo 2™ Positioning System from the
sterile pouch.
2. Hydrate the device for no more than 1-3 seconds, in a sterile saline solution (Fig. 4).
3. Lay the device frame side up, on a flat, sterile surface. Insert the device
between the tines of the Mesh Introducer, parallel to the long axis of the device.
Ensure the tines are positioned 2 cm past the edge of the mesh and are on to
the edge of the frame, as shown (Fig. 9). To secure the tines together, place the
white "T" cap on the distal end of the Mesh Introducer (Fig 10).
Fig. 9
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 10
4. Begin rolling by rotating the handle of the Mesh Introducer towards the center of
the mesh (Fig. 11). Ensure the hoisting suture is facing the proximal end of the
Mesh Introducer so it does not get wrapped in the mesh. Place opposing hand
under the mesh, to aid in rolling. Continue rolling until the entire device is
wrapped around the Mesh Introducer (Fig. 12).
Fig. 11
5. Remove the white "T" cap from the end of
the Mesh Introducer and take care not to let
the mesh unroll. Ensure the device is
positioned such that the distal end of the
Mesh Introducer extends at least ½ cm
beyond the mesh edge (Fig. 13).
6. Insert the distal end of the Mesh Introducer
into the trocar, while simultaneously rotating
the handle of the Mesh Introducer in the
direction that the device was rolled (Fig. 11),
and deliver the device through the trocar.
The rotating motion of the device will help
keep it rolled around the tines, facilitating
insertion. Continue this motion until the
handle of the Mesh Introducer is near the
cap of the trocar. The mesh may not be
completely in the abdomen at this point (Fig. 14).
Note: Deliver the device through the trocar under sufficient visualization of the
device and the surrounding anatomy.
7. When the handle reaches the cap of the
trocar, rotate the handle ½ turn in the opposite
direction from which it was rolled (Fig. 15) and
gently pull the Mesh Introducer handle back
approximately 15 cm (6 inches) from the cap
of the trocar (Fig. 16). This motion will release
the tines of the Mesh Introducer from the
mesh so it can be inserted completely into the
abdomen. Do not completely remove the tines
from the device until it has passed through the
trocar entirely.
Note: If the Mesh Introducer is removed from the device before it is completely
deployed through the trocar, use an atraumatic grasper or grasping tool to push
the mesh through the trocar, or pull the device into the abdomen from an
opposing trocar location.
8. To complete deployment, rotate the handle
in the original direction it was rolled in
Step 4 of the section "Inserting with Mesh
Introducer" (Fig. 11). Continue to
simultaneously rotate the handle of the
Mesh Introducer and deploy the mesh
through the trocar until it is all the way in the
abdomen (Fig. 17).
Note: Deliver the device through the trocar under sufficient visualization of the
device and the surrounding anatomy.
9. After the mesh is deployed into the abdomen, remove and appropriately discard
the Mesh Introducer.
Hoisting, Positioning, Fixating and Removal of Device
1. Once the Echo 2™ Positioning System is
deployed into the abdomen, locate the center
hoisting suture. With a suture passer,
retrieve the hoisting suture through the
center of the hernia defect (Fig. 18). Avoid
going through the umbilicus. To prevent
potential contamination, ensure the suture
does not slip back into the abdominal cavity.
2. Raise the center hoisting suture to hoist the
device to the desired position, and then place
an atraumatic clamp or hemostat on the
center hoisting suture at the level of the skin
to temporarily hold the device in place (Fig. 19).
3. Use the visual markings on the frame (Fig. 1)
to identify the long and short axes of the mesh. Intraabdominally, use an
atraumatic grasper to orient and position the Echo 2™ Positioning System
appropriately, in relation to the defect.
4. Once properly positioned, ensure that no
bowel or any other tissue is entrapped
between the device and the abdominal wall.
Fixate around the entire perimeter of
Ventralight™ ST Mesh with fasteners
placed 1-2 cm apart (Fig. 20). Ensure that
no fasteners are placed through the
Echo 2™ Positioning System frame.
Removal of Echo 2™ Positioning System Frame
1. Remove the atraumatic clamp or hemostat
from the hoisting suture and, external to the
patient, cut the center hoisting suture close
to the patient's skin (Fig. 21).
Fig. 12
Fig. 13
Fig. 14
Fig. 15
Fig. 16
Fig. 17
Fig. 18
Fig. 19
Fig. 20
Fig. 21
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