GORE CARDIOFORM Instructions For Use Manual page 9

c. Attach the syringe to a stopcock and the Flush Port.
d. Flush the device until air no longer exits the tip of the Delivery
Catheter.
e. When the initial flushing is completed, begin loading the Occluder
by pushing the Slider up and then to the right until the Slider stops
(Figure 4a).
f. Complete Occluder loading by pushing the Slider down and then to
the right until it stops (Figure 4b).
g. Flush the device again until air no longer exits the tip of the Delivery
Catheter.
h. If additional air removal is desired, it is recommended to deploy the
Occluder (refer to Section E "Occluder Deployment") and repeat steps
d - g above.
The Occluder Lock should not be moved before or during Occluder loading
or deployment. Partial or complete Occluder locking may prevent Occluder
loading and deployment.
FIGURE 4a: Initial Occluder Loading
FIGURE 4b: Completion of Occluder Loading
D. Occluder Delivery
1. If applicable, load the Delivery Catheter onto the guidewire by threading
the guidewire into the lumen of the Delivery Catheter from the tip and out
the Guidewire Slot (Figure 5).
2. While flushing the device, load the Delivery Catheter into the appropriately
sized introducer sheath. Close the stopcock and remove the flushing
syringe from the stopcock.
E. Occluder Deployment
1. Advance the Delivery Catheter across the atrial septum until the tip is
positioned within the left atrium.
2. If a guidewire was utilized, remove the guidewire before attempting to
deploy the Occluder.
3. Begin deploying the Occluder left disc by pushing the Slider to the left until
it stops (Figure 6a).
4. Complete Occluder left disc deployment by pushing the Slider up and
then to the left until a flat left disc has formed (Figure 6b). This step may
be performed while simultaneously retracting the Delivery System to
minimize advancement of the Occluder within the left atrial chamber.
FIGURE 3: Packaging Insert Removal
FIGURE 4: Occluder Loading
FIGURE 5
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