Abbott Tendyne Gebrauchsanweisung Seite 19

8.3. Storage
Store the Tendyne valve in a cool, dry environment. Do
not expose the bioprosthesis to extreme low or extreme
high temperature (<5°C [<41°F] or >47°C [>116°F]).
CAUTION: Check the temperature indicator
prior to use. Do not use if the temperature
indicator identifies exposure to a high or low
temperature.
Appropriate inventory control should be maintained so
that Tendyne valves, Apical Pads, Delivery Systems and
system components with earlier 'USE BY' dates are used
preferentially.
9. Required Equipment (Not Provided)
• Standard cardiac catheterization lab equipment
Transesophageal and transthoracic
•
echocardiographic equipment
• Three (3) 1-Liter sterile rinsing basins
• Two (2) Liters heparinized saline
Two (2) 1000 mL sterile saline bags with
•
pressure infusion bag and IV pole
• 20 – 35cc Luer-lock syringes
• 0.035" (0.89 mm) guidewire
• 8F introducer sheath, short length
• 7F or 8F single lumen balloon tip catheter
compatible with 0.035" (0.89 mm) guidewire
• Hemodynamic system interface cable
Long sterile probe cover
•
• 30 cc Balloon inflation device
10. Operator's Instructions
10.1. Setup Loading Stand and Stand Components
Before use, clean and sterilize stand, posts and weight
per Section 10.14. Ensure that the Stand Base and Stand
Posts are free of damage or corrosion. If damage or
corrosion is detected, do not use.
1. Assemble the stand by threading the Left Stand
Post into the left post hole in the Stand Base
and the Right Stand post into the right post
hole.
TM
IFU, TENDYNE Mitral Valve System
2. Ensure that the Stand Posts are fully threaded
into the post holes.
3. Remove sterile tray from Stand Components
Package. Inspect components and remove
from tray.
Figure 7. Tendyne™ Stand Components sterile tray
component layout.
1. Bottom Loading Clip - Clip 2
2. Angled Clip - Clip 3
3. De-air tube
4. Tether Flushing Assembly
5. Thumbscrews
6. Rotating Clip - Clip 1
7. Rotating Clip Head
8. Verification Tether
4. Attach the Rotating Clip - Clip 1 to the Rotating
Clip Head using a thumb screw.
5. Attach remaining thumb screws to the Rotating
Clip – Clip 1, Bottom Loading Clip – Clip 2 and
the Angled Clip – Clip 3.
6. Attach Bottom Loading Clip - Clip 2 to the Right
Stand Post and align with the lower groove
marked 2. Attach the Rotating Clip – Clip 3
assembly to the Right Stand Post at the upper
groove marked 1. Attach the Angled Clip –
Clip 3 to the Left Stand Post at the groove
marked 3.
NOTE: Install the clips with the numbers and
tether grooves facing upward.
7. Line the clips up with the respective numbering
and circumferential grooves on the stand
posts.
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