Изделия для сердечно-сосудистого протезирования: гибридный стент-графт для протезирования грудной аорты Thoraflex Hybrid Plexus на системе доставки

Ülke: Beyaz Rusya

Dil: Rusça

Kaynak: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Mevcut itibaren:

Vascutek Limited, ВЕЛИКОБРИТАНИЯ

Sınıf:

изделия медицинского назначения

Tarafından üretildi:

Vascutek Limited

Yetkilendirme tarihi:

2020-06-25

Ürün özellikleri

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