Boston Scientific Maverick2 MONORAIL Gebrauchsanweisung Seite 2

TABLE OF CONTENTS
REUSE WARNING STATEMENT ........................................................................................3
DEVICE DESCRIPTION .....................................................................................................3
Device Name ...............................................................................................................3
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 .....................................................................................................4
WARNINGS ......................................................................................................................4
PRECAUTIONS .................................................................................................................4
ADVERSE EVENTS ...........................................................................................................4
HOW SUPPLIED ...............................................................................................................4
Device Details .............................................................................................................4
Handling and Storage .................................................................................................4
OPERATIONAL INSTRUCTIONS .......................................................................................4
Additional Items for Safe Use .....................................................................................4
Preparation .................................................................................................................5
Procedure ...................................................................................................................5
Table 1. Typical Maverick 2 Monorail PTCA Dilatation Catheter Compliance ........... 6
Disposal ..................................................................................................................... 6
Post Procedure ........................................................................................................... 6
INFORMATION TO BRIEF THE PATIENT .......................................................................... 6
REFERENCES ................................................................................................................... 6
WARRANTY .................................................................................................................... 6
SYMBOL DEFINITIONS ................................................................................................... 6
Black (K) ∆E ≤5.0
2
MB Drawing 50573139 M