8
Step Procedure
1
Set up two (2) sterile bowls with at least 500 mL of sterile physiological saline to thoroughly rinse the
glutaraldehyde sterilant from the valve.
2
Carefully remove the valve/holder assembly from the jar without touching the tissue. Verify the valve
serial identification number with the number on the jar lid and record in the patient information
documents. Inspect the valve for any signs of damage to the frame or tissue.
3
Rinse the valve as follows: Place the valve in the first bowl of sterile, physiological saline. Be sure
the saline solution completely covers the valve and holder. With the valve and holder submerged,
slowly agitate (to gently swirl the valve and holder) back and forth for a minimum of 1 minute.
Transfer the valve and holder to the second rinsing bowl of sterile physiological saline and gently
agitate for at least one more minute. Ensure the rinse solution in the first bowl is not used. The
valve should be left in the final rinse solution until needed to prevent the tissue from drying.
CAUTION: Do not allow the valve to come into contact with the bottom or sides of the rinse bowl
during agitation or swirling in the rinse solution. Direct contact between the identification tag and
valve is also to be avoided during the rinse procedure. No other objects should be placed in the
rinse bowls. The valve should be kept hydrated to prevent the tissue from drying.
7.2.2 Prepare the Components
Refer to the Edwards eSheath Introducer Set, Edwards Crimper and Edwards Balloon Catheter
instructions for use for device preparation.
Step Procedure
1
Visually inspect all components for damage. Ensure the Edwards Commander delivery system is fully
unflexed and the balloon catheter is fully advanced in the flex catheter.
WARNING: To prevent possible damage to the balloon shaft, ensure that the proximal end of the
balloon shaft is not subjected to bending.
2 Flush the flex catheter.
3 Carefully remove the distal balloon cover from the delivery system.
4
Remove the stylet from the distal end of the guidewire lumen and set aside. Flush the guidewire
lumen with heparinized saline and insert the stylet back into the distal end of the guidewire lumen.
Note: Failure to insert the stylet back into the guidewire lumen may result in damage to the lumen
during crimping process.
5
Place the delivery system into the default position and make sure that the flex catheter tip is covered
by the proximal balloon cover. Unscrew the loader cap from the loader tube and flush the loader cap.
Place the loader cap over the proximal balloon cover and onto the flex catheter with the inside of the
cap oriented towards the distal tip.
6
Fully advance the balloon catheter in the flex catheter.
Peel off the proximal balloon cover over the blue section of the balloon shaft.
7
Attach a 3-way stopcock to the balloon inflation port. Partially fill a 50 cc or larger syringe with
15-20 mL diluted contrast medium and attach to the 3-way stopcock.
8
Fill the inflation device provided by Edwards Lifesciences with excess volume relative to the indicated
inflation volume. Lock the inflation device and attach to the 3-way stopcock.
9
Close the 3-way stopcock to the Inflation device provided by Edwards Lifesciences and de-air the
system using the 50 cc or larger syringe. Slowly release the plunger and leave zero-pressure in the
system.
10
Close the stopcock to the delivery system. By rotating the knob of the inflation device provided by
Edwards Lifesciences, transfer the contrast medium into the syringe to achieve the appropriate
volume required to deploy the valve.
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