Boston Scientific Stingray LP Instrucciones De Uso página 2

TABLE OF CONTENTS
REUSE WARNING STATEMENT ........................................................................................3
DEVICE DESCRIPTION .....................................................................................................3
Contents .....................................................................................................................3
Operating Principle .....................................................................................................3
Materials .....................................................................................................................3
Non-Pyrogenic ............................................................................................................3
User Information.........................................................................................................3
INTENDED USE / INDICATIONS FOR USE ........................................................................3
CLINICAL BENEFIT STATEMENT .......................................................................................3
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE.................................................3
CONTRAINDICATIONS .....................................................................................................3
WARNINGS ......................................................................................................................3
PRECAUTIONS .................................................................................................................3
ADVERSE EVENTS ...........................................................................................................4
HOW SUPPLIED ...............................................................................................................4
Device Details .............................................................................................................4
Handling and Storage .................................................................................................4
OPERATIONAL INSTRUCTIONS .......................................................................................4
Additional Items for Safe Use .....................................................................................4
Product Preparation ....................................................................................................4
Product Operation ......................................................................................................4
Guidewire Trapping Technique ..................................................................................5
Disposal ......................................................................................................................5
Post-Procedure ...........................................................................................................5
INFORMATION TO BRIEF THE PATIENT ...........................................................................5
WARRANTY .....................................................................................................................5
Black (K) ∆E ≤5.0
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