Tabla De Contenido - Vascutek Thoraflex THP2224X100B Instrucciones De Uso

Vascutek Ltd. Thoraflex™ Hybrid Device
Instructions for Use
CONTENTS
SECTION 1 INSTRUCTIONS FOR USE
1.1
1.2
1.3
1.4
1.5
SECTION 2 SIZING
SECTION 3 INSTRUCTIONS FOR IMPLANTATION OF THE THORAFLEX™ HYBRID DEVICE
3.1
3.2
3.3
3.4
3.5
3.6
SECTION 4 ADDITIONAL INFORMATION
4.1
4.2
4.3
4.4
4.5
4.6
4.7
SECTION 5 TROUBLESHOOTING GUIDE
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
4
Components and Description
Indications
Contraindications
Cautions
Magnetic Resonance Imaging (MRI) Safety
Preparation of the Thoraflex™ Hybrid Delivery System
Forming of the Thoraflex™ Hybrid Delivery System
Introduction of the Thoraflex™ Hybrid Delivery System Using a Guidewire
Positioning the Thoraflex™ Hybrid Delivery System
Deployment Sequence for the Thoraflex™ Hybrid Device
Thoraflex™ Hybrid Device Anastomoses
Use of the Thoraflex™ Hybrid Device Perfusion Side Branch
Origin of Gelatin
Sterilisation
Packaging
Additional Labels
Disposal of the Thoraflex™ Hybrid Delivery System
Returning a Thoraflex™ Hybrid Delivery System or Device
Difficulty Advancing the Delivery System to the Intended Deployment Site
Sheath Retraction - A High Force is Required to Retract the Sheath and Deploy the
Device
Sheath Retraction - The Strap becomes Detached from the Delivery Sheath
Sheath Retraction - The Strap Handle Breaks in Two
The Splitter is Detached During / Prior to Deployment
The Handle Release Clip is not Attached to the Delivery System Handle
Difficulty Removing the Guidewire
Difficulty Removing the Release Wire from the Delivery System
Difficulty Removing the Delivery System - High Angulation
Difficulty Removing the Delivery System- Release Wire and Guidewire
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