Boston Scientific Encore 26 Mode D'emploi page 2

TABLE OF CONTENTS
REUSE WARNING .............................................................................3
DEVICE DESCRIPTION ......................................................................3
Contents ......................................................................................3
Operating Principle .....................................................................3
User Information .........................................................................3
INDICATIONS FOR USE/INTENDED USE ..........................................3
Target Patient Population ...........................................................3
Clinical Benefit Statement ...........................................................3
CONTRAINDICATIONS ......................................................................3
WARNINGS .......................................................................................4
ADVERSE EVENTS ............................................................................4
HOW SUPPLIED ................................................................................4
Device Details..............................................................................4
Handling and Storage .................................................................4
OPERATIONAL INSTRUCTIONS ........................................................4
Preparation ................................................................................4
Figure 1. Encore device unlocking mechanism ......................4
Figure 2. Encore device locking mechanism ..........................4
Procedure ....................................................................................4
Disposal ......................................................................................5
Post-Procedure ...........................................................................5
PATIENT COUNSELING INFORMATION ............................................5
WARRANTY ......................................................................................5
SYMBOL DEFINITIONS ....................................................................5
Black (K) ∆E ≤5.0
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MB Drawing 50573137