TABLE OF CONTENTS
WARNING ......................................................................................................................................3
DEVICE DESCRIPTION .................................................................................................................3
System Description .................................................................................................................3
User Information ......................................................................................................................5
Contents ....................................................................................................................................5
INTENDED USE..............................................................................................................................5
INDICATIONS FOR USE ................................................................................................................5
CONTRAINDICATIONS .................................................................................................................5
WARNINGS ....................................................................................................................................5
PRECAUTIONS...............................................................................................................................5
SILICONE INFORMATION ............................................................................................................6
MRI-Related Heating ...............................................................................................................6
Artifact Information .................................................................................................................6
ADVERSE EVENTS ........................................................................................................................7
CLINICAL STUDIES .......................................................................................................................8
HOW SUPPLIED...........................................................................................................................10
Handling and Storage ...........................................................................................................10
OPERATIONAL INSTRUCTIONS................................................................................................10
Procedural Instructions .......................................................................................................10
TROUBLE SHOOTING .................................................................................................................18
WARRANTY .................................................................................................................................19
Black (K) ∆E ≤5.0
2