Inhaltsverzeichnis - Boston Scientific Hurricane Rx Gebrauchsanweisung

TABLE OF CONTENTS
REUSE WARNING .............................................................................3
DEVICE DESCRIPTION ......................................................................3
Contents ......................................................................................3
Operating Principle and Device Detail ........................................3
Balloon Construction ...................................................................3
Catheter Construction .................................................................3
Materials .....................................................................................4
User Information ........................................................................4
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
Catheter Insertion .......................................................................5
Balloon Inflation .........................................................................6
Catheter Withdrawal ...................................................................6
Disposal ......................................................................................7
Post-Procedure ...........................................................................7
PATIENT COUNSELING INFORMATION ............................................7
WARRANTY ......................................................................................7
SYMBOL DEFINITIONS .....................................................................7
Table 1. Symbol Definitions ...................................................7
Black (K) ∆E ≤5.0
2
MB Drawing 50573137