IFU, TENDYNE
TM
Mitral Valve System
Page 8 of 284
Figure 2.
Tendyne
TM
Loading System
1.
Closed Cap
2.
Centering Cap Assembly (Centering Cap, Centering Rod,
Centering Cone, and Thumb Screw)
3.
Loading Funnel
4.
Loading Tube
5.
Loading Handle
6.
Tether Clip (not shown)
1.2.2.
Tendyne
TM
Delivery System
The Tendyne Delivery System (Figure 3) introduces the
sheath tip through the ventricular myocardium to the
mitral annulus to facilitate deployment of the valve. If
necessary, the Delivery System can partially recapture
and reposition the valve after full deployment. The
Delivery System handle includes a Delivery Sheath,
Loading Tube (part of the Loading System), Delivery
Handle, Collapsible Dilator, and Introducer Needle.
Figure 3.
Tendyne
TM
Delivery System
1.
Delivery Sheath
2.
Loading Tube (Part of Loading System)
3.
Delivery Handle
4.
Collapsible Dilator
5.
Introducer Needle
1.2.3.
Tendyne
TM
Pad Positioning System
The Tendyne Pad Positioning System (Figure 4) fastens
the Apical Pad to the braided tether at the epicardial
surface. It employs a Tether Load System (TLS) that
holds the tether securely with a pin while tension load is
applied.
Figure 4.
Tendyne
TM
Pad Positioning System
1.
Positioning Handle
2.
Pad Arms
3.
Pad Release Knob
4.
Lock Wheel
5.
Travel Indicator and Indicator Window
6.
Lead Screw Release Knob and Button
7.
Tether Load System (TLS)
8.
Extension Tube
9.
Pin
1.2.4.
Non-Sterile Reusable Components
The Tendyne Stand and Tendyne Weight are provided
non-sterile and are reusable. They must be cleaned and
sterilized prior to each use. Follow the cleaning and
sterilization instructions provided in Section 10.14.
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...