Boston Scientific RHYTHMIA HDx IntellaNav StablePoint Mode D'emploi page 2

TABLE OF CONTENTS
DEVICE DESCRIPTION .............................................................................................................. 3
Contents .............................................................................................................................. 3
Operating Principle .............................................................................................................. 3
User Information.................................................................................................................. 3
INTENDED USE / INDICATIONS FOR USE ................................................................................. 3
Clinical Benefit Statement ................................................................................................... 3
CONTRAINDICATIONS .............................................................................................................. 3
PRECAUTIONS .......................................................................................................................... 3
General ................................................................................................................................ 3
Cables .................................................................................................................................. 3
Environmental ..................................................................................................................... 3
Cleaning and Disinfecting.................................................................................................... 3
Repair or Replacement ........................................................................................................ 3
ADVERSE EVENTS .................................................................................................................... 3
Arrhythmias ......................................................................................................................... 3
Misinterpretation of Data .................................................................................................... 4
Incorrect Force Measurements ............................................................................................. 4
Electrical Hazards ................................................................................................................. 4
CONFORMANCE TO STANDARDS ............................................................................................ 4
HOW SUPPLIED ........................................................................................................................ 4
Handling and Storage .......................................................................................................... 4
OPERATIONAL INSTRUCTIONS ................................................................................................ 4
CLEANING GUIDELINES............................................................................................................ 4
Routine Cleaning and Disinfecting ...................................................................................... 4
Decontaminating the Equipment Before Shipping ............................................................. 4
Disposal ............................................................................................................................... 4
SERVICE INFORMATION ........................................................................................................... 5
Equipment Service and Maintenance .................................................................................. 5
WARRANTY .............................................................................................................................. 5
CONTACTS ................................................................................................................................ 5
Black (K) ∆E ≤5.0
2