Table Des Matières - Boston Scientific AMS Ambicor Mode D'emploi

TABLE OF CONTENTS
WARNING ......................................................................................................................................3
DEVICE DESCRIPTION .................................................................................................................3
User Information ......................................................................................................................3
Contents ....................................................................................................................................3
Material of Animal Origin .......................................................................................................3
INTENDED USE..............................................................................................................................3
INDICATIONS FOR USE ................................................................................................................3
CONTRAINDICATIONS .................................................................................................................4
WARNINGS ....................................................................................................................................4
PRECAUTIONS...............................................................................................................................4
PATIENT COUNSELING INFORMATION ....................................................................................4
SILICONE INFORMATION ............................................................................................................4
MAGNETIC RESONANCE IMAGING (MRI) ...............................................................................4
MRI-Related Heating ...............................................................................................................4
Artifact Information .................................................................................................................4
ADVERSE EVENTS ........................................................................................................................5
CLINICAL STUDIES .......................................................................................................................6
HOW SUPPLIED.............................................................................................................................6
Handling and Storage .............................................................................................................6
OPERATIONAL INSTRUCTIONS..................................................................................................6
Pre-procedural Instructions .................................................................................................6
Procedural Instructions .........................................................................................................6
Post-procedure Information ..................................................................................................9
PRODUCT REPLACEMENT INFORMATION ............................................................................10
WARRANTY .................................................................................................................................10
Black (K) ∆E ≤5.0
2
A