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IFU, TENDYNE
TM
Mitral Valve System
Page 13 of 284
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.
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
TM
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.
Summary of Contents for Tendyne TENDV-LP-29L
Page 27: ...IFU TENDYNETM Mitral Valve System Page 27 of 284 APPENDIX A...
Page 50: ...Brugsanvisning TENDYNETM mitralklapsystem Side 50 af 284 BILAG A...
Page 129: ...TENDYNETM 129 284 EL MR Conformit Europ enne 93 42 2011 65 E Abbott Medical...
Page 135: ...TENDYNETM 135 284 8 0 10 5 4 2 CT Tendyne Tendyne SDS Abbott 10 3...
Page 137: ...TENDYNETM 137 284 MR 8 8 1 TendyneTM Tendyne Tendyne Tendyne Tendyne...
Page 149: ...TENDYNETM 149 284 5 6 7 a b D D c 8 9 tuohy 10 11 12 13 14 15 16 10 14 1 a 2 15...
Page 155: ...TENDYNETM 155 284 A...
Page 205: ...Bruksanvisning TENDYNETM mitralklaffsystem Side 205 av 284 VEDLEGG A...
Page 232: ...Instru es de utiliza o sistema de v lvula mitral TENDYNETM P gina 232 de 284 ANEXO A...
Page 282: ...Bruksanvisning TENDYNETM mitralisklaffsystem Page 282 of 284 BILAGA A...
Page 283: ...IFU TENDYNETM Mitral Valve System Page 283 of 284...