TABLE OF CONTENTS
WARNING ......................................................................................................................................3
DEVICE DESCRIPTION .................................................................................................................3
User Information ......................................................................................................................4
Contents ....................................................................................................................................5
INTENDED USE..............................................................................................................................5
INDICATIONS FOR USE ................................................................................................................5
CONTRAINDICATIONS .................................................................................................................5
WARNINGS ....................................................................................................................................5
PRECAUTIONS...............................................................................................................................5
ADVERSE EVENTS ........................................................................................................................6
CLINICAL STUDIES .......................................................................................................................7
HOW SUPPLIED.............................................................................................................................9
Handling and Storage .............................................................................................................9
OPERATIONAL INSTRUCTIONS................................................................................................10
Procedural Instructions ........................................................................................................11
Connect Tubing ......................................................................................................................14
TROUBLESHOOTING ..................................................................................................................16
REFERENCES................................................................................................................................17
WARRANTY .................................................................................................................................18
Black (K) ∆E ≤5.0
2
A