Boston Scientific Multi-Point 1.5 Thermal Sensor Gebrauchsanweisung Seite 2

TABLE OF CONTENTS
REUSE WARNING ............................................................................................................3
DEVICE DESCRIPTION .....................................................................................................3
Contents .....................................................................................................................3
Operating Principle .....................................................................................................3
Figure 1. MTS Shaft Marks ......................................................................................3
Figure 2. MTS Features ...........................................................................................3
Figure 3. MTS Sensor Locations .............................................................................3
Materials .....................................................................................................................4
User Information.........................................................................................................4
INTENDED USE ................................................................................................................4
Patient Groups ............................................................................................................4
INDICATIONS FOR USE ....................................................................................................4
Clinical Benefit Statement ..........................................................................................4
CONTRAINDICATIONS .....................................................................................................4
WARNINGS ......................................................................................................................4
PRECAUTIONS .................................................................................................................5
General .......................................................................................................................5
Handling .....................................................................................................................5
Procedural ...................................................................................................................5
ADVERSE EVENTS ...........................................................................................................5
CONFORMANCE TO STANDARDS .................................................................................. 6
HOW SUPPLIED .............................................................................................................. 6
Device Details ............................................................................................................ 6
Handling and Storage ................................................................................................ 6
OPERATIONAL INSTRUCTIONS ...................................................................................... 6
Preparation ................................................................................................................ 6
MTS Preparation ........................................................................................................ 6
Procedure .................................................................................................................. 6
Disposal ..................................................................................................................... 6
Post-Procedure ...........................................................................................................7
INFORMATION TO BRIEF THE PATIENT ...........................................................................7
WARRANTY .....................................................................................................................7
SYMBOL DEFINITIONS ....................................................................................................7
Black (K) ∆E ≤5.0
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MB Drawing 50573139 M