Tabla De Contenido - COOK Medical Zenith TX2 Instrucciones De Uso

ENGLISH
TabLE of CoNTENTS
1 DEVICE DESCRIPTION ....................................................................... 13
1.1 Zenith TX2 Dissection Endovascular Graft with
Pro-Form and the Z-Trak Plus Introduction System ........................13
1.2 Thoracic Z-Trak Plus Introduction System ..........................................13
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 ............................................................................................14
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 ...........................................................................................15
A multidisciplinary team that has combined
procedural experience with......................................................................15
10.2 Inspection Prior to Use ..............................................................................15
10.3 Materials Required .....................................................................................15
10.4 Device Diameter Sizing Guidelines .......................................................15
Table 1 Straight Component and Tapered
Component Graft Diameter Sizing Guide ...........................................15
11 DIRECTIONS FOR USE ..................................................................... 15
General Use Information ...........................................................................15
Pre-Implant Determinants .......................................................................15
Patient Preparation ......................................................................................15
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 .....................................16
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 .................................................................................16
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 ...............................................17
13 REFERENCES ..................................................................................... 17
ČESky
obSaH
1 POPIS ZAŘÍZENÍ ........................................................................................ 18
1.1 Endovaskulární graft Zenith TX2 Dissection s prvkem
Pro-Form a se zaváděcím systémem Z-Trak Plus ................................... 18
1.2 Hrudní zaváděcí systém Z-Trak Plus ............................................................ 18
2 URČENÉ POUŽITÍ ...................................................................................... 18
3 KONTRAINDIKACE.................................................................................... 18
4 VAROVÁNÍ A UPOZORNĚNÍ .................................................................... 18
4.1 Obecně .................................................................................................................... 18
4.2 Výběr, léčba a následné kontroly pacienta ............................................... 18
4.3 Postup implantace .............................................................................................. 18
4.4 Použití tvarovacího balónku - volitelné ..................................................... 18
4.5 Informace o vyšetření MRI ............................................................................... 19
5 POTENCIÁLNÍ NEŽÁDOUCÍ PŘÍHODY .................................................. 19
6 MOŽNÁ RIZIKA A PŘÍNOSY .................................................................... 19
7 VÝBĚR A LÉČBA PACIENTA...................................................................... 19
7.1 Individualizace léčby .......................................................................................... 19
8 PORADENSTVÍ PRO PACIENTY .............................................................. 19
9 STAV PŘI DODÁNÍ ..................................................................................... 19
10 INFORMACE O KLINICKÉM POUŽITÍ ................................................... 20
10.1 Školení lékařů ....................................................................................................... 20
Výběr pacientů ..................................................................................................... 20
Souhrn operatérských zkušeností multidisciplinárního týmu .......... 20
10.2 Kontrola před použitím ..................................................................................... 20
10.3 Požadovaný materiál.......................................................................................... 20
10.4 Pokyny k určení průměru zařízení ................................................................ 20
Tabulka 1 Pokyny pro výběr průměru přímé komponenty
a kónické komponenty graftu ....................................................................... 20
11 POKYNY K POUŽITÍ ................................................................................ 20
Obecné informace o použití ........................................................................... 20
Rozhodující činitele před implantací ........................................................... 20
Příprava pacienta ................................................................................................ 20
11.1 Příprava a propláchnutí endovaskulárního graftu Zenith TX2
Dissection s prvkem Pro-Form a se zaváděcím systémem
Z-Trak Plus ............................................................................................................. 20
11.1.1 Umístění endovaskulárního graftu Zenith TX2
Dissection s prvkem Pro-Form a se zaváděcím systémem
Z-Trak Plus ............................................................................................................. 20
11.1.2 Zavedení tvarovacího balónku - volitelné .................................. 21
Finální angiogram ............................................................................................... 21
11.2 Dodatečná zařízení ............................................................................................ 21
12 POKYNY PRO SNÍMKOVÁNÍ A POOPERAČNÍ KONTROLU .............. 21
12.1 Obecně .................................................................................................................... 21
Tabulka 2 Doporučený plán zobrazovacích vyšetření
pro pacienty s endograftem ........................................................................... 21
12.2 Doporučení pro kontrastní a nekontrastní CT ......................................... 21
Tabulka 3 Přijatelné protokoly snímkování ............................................... 21
12.3 Rentgenové snímky zařízení v hrudníku .................................................... 22
12.4 Informace o vyšetření MRI ............................................................................... 22
12.5 Další sledování a léčba ...................................................................................... 22
13 REFERENCE .............................................................................................. 22
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