Abbott IFU Gebrauchsanweisung Seite 8

Figure 2. Tendyne Loading System
TM
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 Delivery System
TM
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.
IFU, TENDYNE Mitral Valve System
TM
Figure 4. Tendyne Pad Positioning System
TM
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.
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