Abbott Tendyne Gebrauchsanweisung Seite 20

10.2. Removing the Valve from the Storage Container
The valve package or container should not be opened
until the valve sizing is confirmed.
WARNING: Do not use the valve if the tamper-evident
seal is damaged, broken, or missing, or if fluid is
leaking from the jar.
1. Assure that the labeling on the valve container
indicates the proper valve model selected for
the case.
2. Using blunt-nosed sterile forceps, carefully
remove the valve holder from the jar. Use the
designated tab on the valve holder.
CAUTION: Do not place the non-sterile exterior
of the jar containing the valve in the sterile
field.
3. Carefully cut the stay suture and grasp the
valve at the cuff. Remove the valve from the
holder.
CAUTION: Manage tether and leader to assure
they remain sterile.
4. Drain the valve completely.
5. Carefully inspect the valve.
CAUTION: Do not use the valve if there is any
sign of damage or deterioration.
10.3. Rinsing the Valve
Follow sterile technique during valve preparation and
implantation.
1. On a table within the sterile field, prepare
three (3) sterile basins for rinsing the valve,
each with 600 – 800 mL of sterile heparinized
saline (1000 units/L).
CAUTION: Do not add any other solutions,
drugs, chemicals, or antibiotics to the rinse
solution, as irreparable damage to the leaflet
tissue, which may not be apparent under visual
inspection, may result.
2. Fully immerse the valve in the heparinized
saline solution in the first basin and rinse the
valve for two (2) minutes.
3. Use a 20-35 mL syringe to perform a 20 mL
flush of each of the three (3) leaflet pockets to
remove residual glutaraldehyde.
TM
IFU, TENDYNE Mitral Valve System
CAUTION: Do not touch the leaflets or squeeze
the valve during rinsing.
4. Transfer the valve to the second basin and
rinse the valve for a second time for two (2)
minutes.
5. Perform another 20 mL flush of each of the
three (3) leaflet pockets.
6. Transfer the valve to the third basin and rinse
the valve for a third time for two (2) minutes.
7. Perform another 20 mL flush of each of the
three (3) leaflet pockets.
8. Flush the braided tether thoroughly to remove
residual glutaraldehyde.
9. Insert the tether leader into the Tuohy-Borst
valve on the tether flushing assembly until the
end abuts the valve stem. Close the Tuohy-
Borst valve.
10. Attach a 20-35 mL syringe to the Y-connector
and aspirate the air from the tether.
11. Perform a forward and backward flush of the
tether three (3) times or until no air bubbles
are identified exiting the tether flushing
assembly. Loosen Tuohy-Borst valve and
remove the tether and leader from the tether
flushing assembly.
12. After rinsing, leave the valve fully immersed in
the third basin until it is ready to be loaded.
CAUTION: The valve should be kept hydrated
throughout the rest of the preparation
procedure to prevent the tissue from drying.
WARNING: Throughout preparation of the
components, remove air using syringes, stopcocks, and
flushing with positive pressure saline as needed. It is
imperative that all components be purged of air to
prevent introducing air emboli into the heart.
10.4. Preparing the Pad Positioning System
1. Place sterile weight on table. Inspect for
evidence of damage or corrosion. If damage or
corrosion is detected, do not use.
2. Assure that the labeling on the pouch indicates
the Apical Pad model that is selected for the
case. Remove jar containing Apical Pad from
sterile pouch. Open jar and inspect Apical Pad.
Do not use if damage is detected.
3. Remove sterile tray from Tendyne™ Pad
Positioning System package. Assemble
components on sterile table.
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