Impulse Dymanics OPTIMIZER Smart System - Default Chapter; Table of Contents

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TABLE OF CONTENTS

EXPLANATION OF SYMBOLS ON LABELS ....................................................................................................... I

1. THE OPTIMIZER SMART SYSTEM: AN OVERVIEW ............................................................................. 1

1.1 Description of the OPTIMIZER Smart IPG .............................................................................................. 1

1.2 OPTIMIZER Smart IPG Lead Connectors ................................................................................................ 2

1.3 OPTIMIZER Smart IPG Physical Characteristics ..................................................................................... 2

1.4 OPTIMIZER Smart IPG Battery ............................................................................................................... 3

1.5 OPTIMIZER Smart IPG Rechargeable Battery Behavior ......................................................................... 3

1.6 Extrapolated Battery Life .......................................................................................................................... 4

1.7 Extrapolated Battery Charge Longevity .................................................................................................... 4

1.8 User Profile and Training .......................................................................................................................... 5

1.9 Scientific Background About Heart Failure and CCM .............................................................................. 6

2. INDICATIONS .................................................................................................................................................. 7

3. CONTRAINDICATIONS AND PRECAUTIONS .......................................................................................... 8

4. WARNINGS ....................................................................................................................................................... 8

4.1 Prohibited Use ........................................................................................................................................... 8

4.2 Potential Complications of Device Implantation ....................................................................................... 8

4.2.1 Atrial and Ventricular Arrhythmias Potentially Caused by Lead Implantation ............................. 8

4.2.2 Ventricular Arrhythmias Potentially Caused by CCM Signals ...................................................... 9

4.2.3 Atrial Arrhythmias Potentially Caused by CCM Signals ............................................................... 9

4.3 Handling .................................................................................................................................................. 10

4.4 Storage and Handling .............................................................................................................................. 10

4.5 Packaging Information ............................................................................................................................ 10

4.6 Resterilization and Reuse ........................................................................................................................ 11

4.7 Cremation ................................................................................................................................................ 11

5. CAUTIONS ...................................................................................................................................................... 11

5.1 Environmental Conditions ....................................................................................................................... 11

5.2 Electrocautery .......................................................................................................................................... 11

5.3 RF Ablation ............................................................................................................................................. 12

5.4 Diathermy (Medical “Short Wave” Induction Heating) .......................................................................... 12

5.5 Defibrillation and Cardioversion ............................................................................................................. 12

5.6 Radiation Therapy ................................................................................................................................... 13

5.7 Nuclear Magnetic Resonance (NMR), Magnetic Resonance Imaging (MRI) ......................................... 13

5.8 Lithotripsy ............................................................................................................................................... 14

5.9 Therapeutic Ultrasound ........................................................................................................................... 14

5.10 Transcutaneous Electrical Nerve Stimulation (TENS) ............................................................................ 14

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