Section 3 Instructions For Implantation Of The Thoraflex™ Hybrid Device; Preparation Of The Thoraflex™ Hybrid Delivery System; Forming Of The Thoraflex™ Hybrid Delivery System - Vascutek Thoraflex THP2224X100B Instrucciones De Uso

SECTION 3 INSTRUCTIONS FOR IMPLANTATION OF THE THORAFLEX™ HYBRID DEVICE
SECTION 3.1 PREPARATION OF THE THORAFLEX™ HYBRID DELIVERY SYSTEM
Once in the sterile field, the entire Thoraflex™ Hybrid Delivery System must be thoroughly pre-soaked for at least
1 minute but no longer than 5 minutes in a saline solution to ensure adequate absorption.
Note: The delivery system and the device must not be allowed to dry out after soaking. Pre-soaking will reduce
the force necessary to unsheath the stented section of the device.
SECTION 3.2 FORMING OF THE THORAFLEX™ HYBRID DELIVERY SYSTEM
The stented section of the Thoraflex™ Hybrid Delivery System (Figure 6) can be shaped to resemble the anatomy
of the aorta in the area of the stent graft only.
CAUTION: DO NOT BEND THE STENTED SECTION WITHIN 10MM OF THE SPLITTER OR WHILE HOLDING
THE HANDLE OF THE SYSTEM.
CAUTION: IF THE SYSTEM IS FORMED INTO AN ANGLE OF GREATER THAN 50° A HIGHER FORCE WILL
BE NEEDED TO DEPLOY THE STENT.
Figure 6 – Shaping of the Stented Section of the System
If any major sheath kinking is evident after shaping the delivery system then local pressure should be applied to
the kinks in order to reduce the sheath folding and remove any sharp points (Figure 7).
Figure 7 – Removal of Kinks in the Sheath
11