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Hrudní Endovaskulární Graft Zenith Alpha™ Návod K Použití

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Hrudní Endovaskulární Graft Zenith Alpha™ Návod K Použití MEDICAL EN Zenith Alpha™ Thoracic Endovascular Graft 15 Instructions for Use CS Hrudní endovaskulární graft Zenith Alpha™ 22 Návod k použití DA Zenith Alpha™ torakal endovaskulær protese 29 Brugsanvisning DE Zenith Alpha™ thorakale endovaskuläre Prothese 36 Gebrauchsanweisung EL Θωρακικό ενδαγγειακό μόσχευμα Zenith Alpha™ 44 Οδηγίες χρήσης ES Endoprótesis vascular torácica Zenith Alpha™ 52 Instrucciones de uso FR Endoprothèse vasculaire thoracique Zenith Alpha™ 60 Mode d’emploi HU Zenith Alpha™ mellkasi endovaszkuláris graft 67 Használati utasítás IT Protesi endovascolare toracica Zenith Alpha™ 74 Istruzioni per l’uso NL Zenith Alpha™ thoracale endovasculaire prothese 81 Gebruiksaanwijzing NO Zenith Alpha™ torakalt endovaskulært implantat 88 Bruksanvisning PL Piersiowy stent-graft wewnątrznaczyniowy Zenith Alpha™ 95 Instrukcja użycia PT Prótese endovascular torácica Zenith Alpha™ 103 Instruções de utilização SV Zenith Alpha™ endovaskulärt graft för thorax 110 Bruksanvisning Patient I.D. Card Included I-ALPHA-TAA-1306-436-01 *436-01* ENGLISH ČESKY TABLE OF COntents OBSAH 1 DEVICE DESCRIPTION ....................................................................... 15 1 POPIS ZAŘÍZENÍ ....................................................................................... 22 1.1 Zenith Alpha Thoracic Endovascular Graft .........................................15 1.1 Hrudní endovaskulární graft Zenith Alpha .............................................. 22 1.2 Introduction System ...................................................................................15 1.2 Zaváděcí systém ................................................................................................. 22 1.3 Zenith Alpha Thoracic Endovascular Graft 1.3 Přídavné komponenty pro hrudní endovaskulární graft Ancillary Components ...............................................................................15 Zenith Alpha ......................................................................................................... 22 2 INTENDED USE ................................................................................... 15 2 URČENÉ POUŽITÍ ..................................................................................... 22 3 CONTRAINDICATIONS ...................................................................... 15 3 KONTRAINDIKACE ................................................................................... 22 4 WARNINGS AND PRECAUTIONS ..................................................... 15 4 VAROVÁNÍ A UPOZORNĚNÍ ................................................................... 22 4.1 General ............................................................................................................15 4.1 Obecně ................................................................................................................... 22 4.2 Patient Selection, Treatment and Follow-Up .....................................15 4.2 Výběr, léčba a následné kontroly pacienta .............................................. 22 4.3 Pre-Procedure Measurement Techniques and Imaging ................15 4.3 Měřicí techniky a zobrazování před výkonem ........................................ 22 4.4 Device Selection ...........................................................................................16 4.4 Volba zařízení ....................................................................................................... 23 4.5 Implant Procedure .......................................................................................16 4.5 Postup implantace ............................................................................................. 23 4.6 Molding Balloon Use — Optional ..........................................................16 4.6 Použití tvarovacího balónku - volitelné ..................................................... 23 4.7 MRI Information ............................................................................................16 4.7 Informace o vyšetření MRI .............................................................................. 23 5 POTENTIAL ADVERSE EVENTS ........................................................ 16 5 POTENCIÁLNÍ NEŽÁDOUCÍ PŘÍHODY ................................................. 23 6 PATIENT SELECTION AND TREATMENT ......................................... 17 6 VÝBĚR A LÉČBA PACIENTA ..................................................................... 24 6.1 Individualization of Treatment ................................................................17 6.1 Individualizace léčby ......................................................................................... 24 7 PATIENT COUNSELING INFORMATION .......................................... 17 7 PORADENSTVÍ PRO PACIENTY ............................................................. 24 8 HOW SUPPLIED .................................................................................. 17 8 STAV PŘI DODÁNÍ .................................................................................... 24 9 CLINICAL USE INFORMATION .......................................................... 17 9 INFORMACE O KLINICKÉM POUŽITÍ .................................................... 24 9.1 Physician Training ........................................................................................17 9.1 Školení lékařů ...................................................................................................... 24 Patient selection ..........................................................................................17 Výběr pacientů .................................................................................................... 24 9.2 Inspection Prior to Use ..............................................................................17 9.2 Kontrola před použitím ................................................................................... 24 9.3 Materials Required ......................................................................................17 9.3 Požadovaný materiál ........................................................................................ 24 9.4 Materials Recommended ..........................................................................17 9.4 Doporučený materiál ........................................................................................ 24 9.5 Device Diameter Sizing Guidelines .......................................................17 9.5 Pokyny k určení průměru zařízení ............................................................... 24 Table 1 — Main Body (P, D, PT) Graft Diameter Sizing Guide* ....18 Tabulka 1 — Návod k výběru velikosti průměru hlavního těla Table 2 — Distal Extension (DE) Graft Diameter Sizing Guide* ..18 (P, D, PT) graftu* ................................................................................................... 25 Tabulka 2 — Návod k výběru velikosti průměru distální 10 DIRECTIONS FOR USE ..................................................................... 18 extenze (DE) graftu* ........................................................................................... 25 Anatomical Requirements ........................................................................18 Proximal and Distal Component Overlap ...........................................18 10 POKYNY K POUŽITÍ ............................................................................... 25 General Use Information ...........................................................................19 Anatomické požadavky ................................................................................... 25 Pre-Implant Determinants .......................................................................19 Překrytí proximální a distální komponenty ............................................. 25 Patient Preparation .....................................................................................19 Obecné informace o použití .......................................................................... 26 10.1 The Zenith Alpha Thoracic Endovascular Graft Rozhodující činitele před implantací ......................................................... 26 Preparation/Flush – Proximal and Distal Components ..................19 Příprava pacienta ............................................................................................... 26 10.1.1 Placement of Proximal Component ........................................19 10.1 Příprava a propláchnutí hrudního endovaskulárního graftu 10.1.2 Placement of Distal Component ................................................19 Zenith Alpha – proximální a distální komponenty ............................... 26 10.1.3 Main Body Molding Balloon Insertion — Optional ...........19 10.1.1 Umístění proximální komponenty ................................................. 26 Final Angiogram ...........................................................................................19 10.1.2 Umístění distální komponenty ......................................................... 26 10.2 Ancillary Devices .........................................................................................19 10.1.3 Zavedení tvarovacího balónku hlavního těla - volitelné ....... 26 General Use Information ...........................................................................19 Finální angiogram .............................................................................................. 26 10.2.1 Distal Extensions .............................................................................19 10.2 Přídavná zařízení
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