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  • DEUTSCH, seite 18
TABLE OF CONTENTS
REUSE WARNING .............................................................................3
DEVICE DESCRIPTION ......................................................................3
Contents ......................................................................................3
Operating Principle .....................................................................3
Catheter Shaft ............................................................................3
Balloon/Radiopaque Marker .....................................................3
Contrast Injection ........................................................................3
User Information .........................................................................3
INTENDED USE / INDICATIONS FOR USE .........................................4
Clinical Benefit Statement ...........................................................4
CONTRAINDICATIONS ......................................................................4
WARNINGS .......................................................................................4
PRECAUTIONS ..................................................................................4
ADVERSE EVENTS ............................................................................4
HOW SUPPLIED ................................................................................5
Device Details..............................................................................5
Handling and Storage .................................................................5
OPERATIONAL INSTRUCTIONS ........................................................5
Inspection and Preparation ........................................................5
Procedure ....................................................................................5
Stone Retrieval ............................................................................5
Duct Occlusion ............................................................................6
Device Removal...........................................................................6
Disposal .....................................................................................6
Post-Procedure ...........................................................................6
PATIENT COUNSELING INFORMATION ............................................6
WARRANTY ......................................................................................6
SYMBOL DEFINITIONS .....................................................................6
Black (K) ∆E ≤5.0
2
MB Drawing 50573137
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