ProStar XL Manual Del Usuario página 4

5 . Place a 0 .038" (0 .97 mm) (or smaller) guide wire
through the introducer sheath . Remove the introducer
sheath while applying pressure on the groin to maintain
hemostasis .
6 . Carefully back-load the Prostar XL device over the guide
wire until the guide wire exit port is just above the skin
line . Remove the guide wire . Continue to advance the
Prostar XL device until the barrel is at skin level .
7 . Unlock the hub by depressing the interlocks with thumb
and forefinger . Once the hub is unlocked, rotate the hub
while gently advancing the barrel at a 45-degree angle,
or less .
8 . A steady, continuous drip of blood from the dedicated
marker lumen occurs when the Prostar XL device is
properly positioned (see figure 2) . Marking from the
lumen(s) containing suture(s) may occur but should
not be used as the indicator for proper positioning and
needle deployment .
Do not clamp the suture lumen with a hemostat
or other instrument. Doing so will prevent suture
deployment.
9 . Lock the hub back in place .
9 .1 . If a continuous drip of blood (luminal marking)
from the dedicated marker lumen is not apparent,
withdraw the device to expose the marker port .
Flush the marker lumen to verify patency, and
then continue to gently advance the Prostar XL
device while rotating the barrel .
9 .2 . If continuous marking is still not achieved, remove
the Prostar XL device and follow conventional
compression protocol, or replace the Prostar XL
device with an appropriately sized introducer
sheath .
9 .3 . Do not deploy needles until a continuous drip
of blood is evident from the dedicated marker
lumen .
needle Deployment
1 . Confirm that the interlocks are re-engaged and correctly
aligned with the locking indents in the hub (locked) .
2 . With the left hand, hold the hub of the device in position
at an angle of 45 degrees (or less) .
3 . With the right hand, rotate the handle counterclockwise,
to unlock the handle .
4 . Ensure blood marking is maintained .
5 . Pull the handle away from the hub to deploy the needles
(see figure 3) .
RELEASED
figure 2
6 . If resistance to rotating the handle is encountered,
do not attempt to deploy the needles . Significant
resistance is an indication that the hub is not properly
positioned . Refer to the tecHnIQue for neeDLe
BAcK-DoWn section to ensure proper hub positioning .
7 . Do not clamp the suture lumen with a hemostat
or other instrument. Doing so will prevent suture
deployment.
8 . Continue to pull the handle until the needle tips emerge
at the top of the barrel .
9 . While steadily holding the device in position, confirm that
all four needles are visible in the hub .
10 . If significant resistance is encountered prior to needle
tips emerging at the top of the barrel, or if all four of the
needles are not deployed, terminate deployment . Refer
to the tecHnIQue for neeDLe BAcK-DoWn section
to perform needle back-down procedure .
11 . Using a hemostat, remove the posterior needle(s)
followed by the anterior needle(s) using the funnel-
shaped hub as a fulcrum to facilitate needle removal
(see figure 4) .
suture Management
1 . Once needles have been removed from the hub, remove
slack in the suture(s) by pulling the suture ends to
evenly matched lengths and tensioning until resistance is
felt . Cut the suture ends close to the needles . Dispose
of needles in accordance with hospital policy .
2 . Withdraw the Prostar XL device while maintaining access
to the sutures exiting the hub during this step . Create
a "bow string" effect with the exposed suture(s) by
bending the Prostar XL device sheath away from the
operator and applying tension to the suture ends exiting
the hub (see figure 5) . This ensures that the sutures
are not tied around the sheath .
4
figure 3
figure 4
Fulcrum
Point
figure 5