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• Sterile rinsing bowls; sterile physiological saline solution; sterile
heparinized saline solution, and diluted radiopaque contrast medium
(15:85 medium to saline dilution)
• Sterile table for THV and device preparation
• 20 cc syringe or larger
• 50 cc syringe or larger
• High-pressure 3-way stopcock (x2)
7.2 Valve Handling and Preparation
Follow sterile technique during device preparation and implantation.
7.2.1 THV Rinsing Procedure
Before opening the valve jar, carefully examine for evidence of damage
(e.g. a cracked jar or lid, leakage, or broken or missing seals).
CAUTION: If the container is found to be damaged, leaking, without
adequate sterilant, or missing intact seals, the THV must not be
used for implantation, as sterility may be compromised.
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 THV.
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 THV as follows:
a) Place the THV in the first bowl of sterile, physiological
saline. Be sure the saline solution completely covers
the THV and holder.
b) With the valve and holder submerged, slowly agitate
(to gently swirl the valve and holder) back and forth
for a minimum of 1 minute.
c) Transfer the THV 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.
d) 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.
7.3 Valve Handling and Preparation
7.3.1 Prepare the System
Step
Procedure
1
Visually inspect all the components for damage. Ensure the
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 delivery system with heparinized saline through
the flush port.
3
Remove the distal balloon cover from the delivery system.
Remove the stylet from the distal end of the guidewire
lumen and set aside.
4
Flush the guidewire lumen with heparinized saline. Insert
the stylet back into the guidewire lumen.
Note: Failure to replace the stylet in the guidewire
lumen may result in damage to the lumen during
the THV crimping process.
5
Place the delivery system into the Default Position (end of
strain relief is aligned between the two white markers on
the balloon shaft) and make sure that the flex catheter tip
is covered by the proximal balloon cover.
6
Unscrew the loader cap from the loader and flush the
loader cap with heparinized saline.
7
Place the loader cap onto the delivery system with the
inside of the cap oriented towards the distal tip.
Fully advance the balloon catheter in the flex catheter.
Peel off the proximal balloon cover over the blue section of
the balloon shaft.
8
Attach a 3-way stopcock to the balloon inflation port. Fill a
50 cc or larger syringe with 15-20 ml of diluted contrast
medium and attach to the 3-way stopcock.
9
Fill the inflation device with excess volume of diluted
contrast medium relative to the indicated inflation volume.
Lock and attach to the 3-way stopcock. Close stopcock to
the inflation device.
10
Pull vacuum with the syringe to remove air. Slowly release
the plunger to ensure that the contrast medium enters the
lumen of the delivery system. Repeat until all air bubbles
are removed from the system. Leave zero-pressure in the
system.
WARNING: Ensure there is no residual fluid left in the
balloon to avoid potential difficulty with valve
alignment during the procedure.
Close stopcock to the delivery system.
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