Table Des Matières - Boston Scientific WATCHMAN FLX Serie Mode D'emploi

TABLE OF CONTENTS
REUSE WARNING ..................................................................................................................... 3
DEVICE DESCRIPTION .............................................................................................................. 3
Contents .............................................................................................................................. 3
Materials .............................................................................................................................. 3
Table 1. Closure Device Materials .................................................................................... 3
User Information.................................................................................................................. 3
INTENDED USE ......................................................................................................................... 3
INDICATIONS FOR USE ............................................................................................................. 3
Clinical Benefit Statement ................................................................................................... 3
Summary of Safety and Clinical Performance ...................................................................... 3
CONTRAINDICATIONS .............................................................................................................. 3
WARNINGS ............................................................................................................................... 3
MAGNETIC RESONANCE IMAGING .......................................................................................... 4
3.0 Tesla Temperature Information ..................................................................................... 4
1.5 Tesla Temperature Information ...................................................................................... 4
Image Artifact Information .................................................................................................. 4
PRECAUTIONS .......................................................................................................................... 4
ADVERSE EVENTS .................................................................................................................... 4
HOW SUPPLIED ........................................................................................................................ 4
Device Details ...................................................................................................................... 5
Handling and Storage .......................................................................................................... 5
OPERATIONAL INSTRUCTIONS ................................................................................................ 5
Preparation .......................................................................................................................... 5
Procedure ............................................................................................................................ 5
Figure 1. WATCHMAN FLX Delivery System (Delivery Catheter and Closure Device) ....... 5
Implantation Procedure ....................................................................................................... 5
Table 2. WATCHMAN FLX Device Selection ...................................................................... 6
Figure 2. Initial deployment of the WATCHMAN FLX Device showing the proper
configuration of the device and Implant shoulder reference for positioning the
Closure Device within the LAA. ....................................................................................... 6
Figure 3. WATCHMAN FLX Device Position and Size ........................................................ 6
Disposal ............................................................................................................................... 7
Post-Procedure .................................................................................................................... 7
Implantable Device Patient Information .............................................................................. 7
INFORMATION TO BRIEF THE PATIENT .................................................................................... 7
WARRANTY .............................................................................................................................. 7
Black (K) ∆E ≤5.0
2
MB Drawing 50573138 M