Land: Hviterussland
Språk: russisk
Kilde: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Vascutek Limited, ВЕЛИКОБРИТАНИЯ
изделия медицинского назначения
Vascutek Limited
2020-06-25
THORAFLEX™ HYBRID DEVICE INSTRUCTIONS FOR USE 3 English Français Deutsch Nederlands Italiano Español Português Dansk Norsk Česky Slovensky Русский Instructions for Use ………................................. 4 Mode d’emploi ………....................................... 24 Gebrauchsanweisung ....................................... 44 Gebruiksaanwijzing .......................................... 64 Istruzioni per l’uso ........................................... 84 Instrucciones de uso ....................................... 104 Instruções de Utilização .................................. 124 Brugervejledning ............................................ 144 Bruksanvisning ............................................... 164 Návod k použití .............................................. 184 Návod na použitie ………................................ 204 Инструкция по эксплуатации ………............. 224 4 ENGLISH VASCUTEK LTD. THORAFLEX™ HYBRID DEVICE INSTRUCTIONS FOR USE CONTENTS SECTION 1 INSTRUCTIONS FOR USE 1.1 Components and Description 1.2 Indications 1.3 Contraindications 1.4 Cautions 1.5 Magnetic Resonance Imaging (MRI) Safety SECTION 2 SIZING SECTION 3 INSTRUCTIONS FOR IMPLANTATION OF THE THORAFLEX™ HYBRID DEVICE 3.1 Preparation of the Thoraflex™ Hybrid Delivery System 3.2 Forming of the Thoraflex™ Hybrid Delivery System 3.3 Introduction of the Thoraflex™ Hybrid Delivery System Using a Guidewire 3.4 Positioning the Thoraflex™ Hybrid Delivery System 3.5 Deployment Sequence for the Thoraflex™ Hybrid Device 3.6 Thoraflex™ Hybrid Device Anastomoses SECTION 4 ADDITIONAL INFORMATION 4.1 Clinical Experience Summary 4.2 Use of the Thoraflex™ Hybrid Device Perfusion Side Branch 4.3 Origin of Gelatin 4.4 Sterilisation 4.5 Packaging 4.6 Additional Labels 4.7 Disposal of the Thoraflex™ Hybrid Delivery System 4.8 Returning a Thoraflex™ Hybrid Delivery System or Device SECTION 5 TROUBLESHOOTING GUIDE 5.1 Difficulty Advancing the Delivery Syste Les hele dokumentet