COOK Medical Zenith TX2 Instrukcja obsługi - Strona 2

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I-ZDEG-EU-1312-394-03

ENGLISH

Tab LE of CoNTENTS

1 DEVICE DESCRIPTION .......................................................................13

1.1 Zenith TX2 Dissection Endovascular Graft with

Pro-Form and the Z-Trak Plus Introduction System ........................13

Thoracic Z-Trak Plus Introduction System

1.2

2 INTENDED USE ...................................................................................13

3 CONTRAINDICATIONS ...................................................................... 13

4 WARNINGS AND PRECAUTIONS ..................................................... 13

4.1

General ............................................................................................................13

4.2

Patient Selection, Treatment and Follow-Up ..................................... 13

4.3

Implant Procedure ....................................................................................... 13

4.4

Molding Balloon Use - Optional .............................................................13

4.5

MRI Information

............................................................................................

5 POTENTIAL ADVERSE EVENTS ........................................................14

6 POTENTIAL RISKS AND BENEFITS ................................................... 14

7 PATIENT SELECTION AND TREATMENT ..........................................14

7.1

Individualization of Treatment ................................................................14

8 PATIENT COUNSELING INFORMATION ..........................................14

9 HOW SUPPLIED .................................................................................. 14

10 CLINICAL USE INFORMATION .......................................................15

10.1 Physician Training ........................................................................................ 15

Patient Selection

...........................................................................................

A multidisciplinary team that has combined

procedural experience with

10.2 Inspection Prior to Use ..............................................................................15

10.3 Materials Required .....................................................................................15

10.4 Device Diameter Sizing Guidelines

Table 1 Straight Component and Tapered

Component Graft Diameter Sizing Guide

11 DIRECTIONS FOR USE

.....................................................................

General Use Information ...........................................................................15

Pre-Implant Determinants .......................................................................15

Patient Preparation

......................................................................................

11.1 The Zenith TX2 Dissection Endovascular Graft

with Pro-Form and the Z-Trak Plus Intro duction

System Preparation/Flush ......................................................................... 15

11.1.1 Placement of The Zenith TX2 Dissection

Endovascular Graft with Pro-Form and the

Z-Trak Plus Introduction System ............................................................15

11.1.2 Molding Balloon Insertion - Optional

Final Angiogram ...........................................................................................16

11.2 Additional Devices ......................................................................................16

12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP ....16

12.1 General ............................................................................................................16

Table 2 Recommended Imaging Schedule

for Endograft Patients

.................................................................................

12.2 Contrast and Non-Contrast CT Recommendations ........................16

Table 3 Acceptable Imaging Protocols .................................................16

12.3 Thoracic Device Radiographs .................................................................. 17

12.4 MRI Information ............................................................................................17

12.5 Additional Surveillance and Treatment

13 REFERENCES .....................................................................................17

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