Edwards Lifesciences SAPIEN 3 Instrucciones De Uso página 6

Step Procedure
11 Rotate the knob of the inflation device to remove the
contrast medium into the syringe and achieve the
appropriate volume required to deploy the THV.
Close the stopcock to the syringe and remove syringe.
12 Verify that the inflation volume in the inflation device is
correct.
CAUTION: Maintain the inflation device in the locked
position until THV deployment to minimize the risk
of premature balloon inflation and subsequent
improper THV deployment.
7.3.2 Mount and Crimp the THV on the Delivery System
Step Procedure
1 Completely submerge the Qualcrimp crimping accessory in
a bowl of 100 ml physiological saline. Gently compress until
fully saturated. Swirl for a minimum of 1 minute. Repeat
this process in a second bowl.
2 Remove the THV from the holder and remove the ID tag.
3 Rotate the crimper handle until the aperture is fully open.
Attach the 2-piece Crimp Stopper to the base of the crimper
and click into place.
4 If necessary, partially crimp the THV in the crimper until it
snugly fits inside the Qualcrimp crimping accessory.
Note: Partial crimping is not necessary for the
20 mm valve.
5 Place the Qualcrimp crimping accessory over the THV
aligning the edge of the Qualcrimp crimping accessory
with the outflow of the THV.
Step Procedure
6 Place the THV and Qualcrimp crimping accessory in crimper
aperture. Insert the delivery system coaxially within the
THV 2 - 3 mm distal to the blue balloon shaft (in the Valve
Crimp Section) of the delivery system with the orientation
of the valve on the delivery system as described below:
Antegrade approach:
Inflow (outer skirt end) of the valve towards the proximal
end of the delivery system.
Retrograde approach:
Inflow (outer skirt end) of the valve towards the distal
end of the delivery system.
7 Center the balloon shaft coaxially within the THV. Crimp the
THV until it reaches the Qualcrimp stop.
8 Remove the Qualcrimp crimping accessory from the THV
and Qualcrimp stop from the Crimp Stopper, leaving the
Final Stop in place.
9 Center the THV within the crimper aperture. Fully crimp the
THV until it reaches the Final Stop and hold for 5 seconds.
Repeat this crimp step two (2) more times for a total of
3 crimps.
Note: Ensure that the Valve Crimp Section is coaxial
within the THV.
10 Pull the balloon shaft and engage the Balloon Lock so the
delivery system is in Default Position.
11 Flush the loader with heparinized saline. Immediately
advance the THV into the loader until the tapered tip of the
delivery system is exposed.
CAUTION: The THV should not remain fully crimped
and/or in the loader for over 15 minutes, as leaflet
damage may result and impact valve functionality.
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