Use Instructions

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TABLE OF CONTENTS
EXPLANATION OF SYMBOLS ON LABELS .......................................................................................... I
1.0 THE OPTIMIZER SMART MINI SYSTEM ................................................................................... 1
1.1 Description of the OPTIMIZER Smart Mini System ......................................................... 1
1.2 OPTIMIZER Smart Mini IPG Implantable Leads Requirements ....................................... 1
1.3 OPTIMIZER Smart Mini IPG Lead Connectors ............................................................... 2
1.4 OPTIMIZER Smart Mini IPG Physical Characteristics ..................................................... 3
1.5 OPTIMIZER Smart Mini IPG Battery ............................................................................... 3
1.5.1 Battery Specifications ........................................................................................ 3
1.5.2 Battery Behavior ................................................................................................ 4
1.5.3 Battery Service Life ............................................................................................ 4
1.6 OPTIMIZER Smart Mini IPG Packaging .......................................................................... 4
1.7 OPTIMIZER Smart Mini IPG Storage .............................................................................. 4
2.0 USER PROFILE AND TRAINING ............................................................................................... 5
3.0 INDICATIONS OF USE .............................................................................................................. 5
4.0 CONTRAINDICATIONS AND PRECAUTIONS ........................................................................... 5
5.0 WARNINGS................................................................................................................................ 5
5.1 Potential Complications of Device Implantation ............................................................... 5
5.1.1 Atrial and Ventricular Arrhythmias Potentially Caused by Lead Implantation ....... 6
5.1.2 Ventricular Arrhythmias Potentially Caused by CCM therapy pulses ................... 6
5.1.3 Atrial Arrhythmias Potentially Caused by CCM Therapy Pulses .......................... 7
5.2 Electrocautery ................................................................................................................ 7
5.3 RF Ablation .................................................................................................................... 8
5.4 Diathermy (Medical “Short Wave” Induction Heating) ...................................................... 8
5.5 Defibrillation and Cardioversion ...................................................................................... 8
5.6 Therapeutic Ultrasound .................................................................................................. 9
5.7 Nuclear Magnetic Resonance (NMR), Magnetic Resonance Imaging (MRI) .................... 9
5.8 Radiation Therapy .......................................................................................................... 9
5.9 Lithotripsy ...................................................................................................................... 9
5.10 Handling ....................................................................................................................... 10
5.11 Resterilization and Reuse ............................................................................................. 10
5.12 Cremation .................................................................................................................... 10
6.0 CAUTIONS ............................................................................................................................... 10
6.1 Environmental Conditions ............................................................................................. 10
6.2 Transcutaneous Electrical Nerve Stimulation (TENS) ................................................... 10
6.3 Home Appliances ......................................................................................................... 11
6.4 Store Anti-Theft Systems/Airport Security Screening Systems ...................................... 11
6.5 Industrial Machinery ..................................................................................................... 11