Impulse Dynamics OPTIMIZER Integra CCM-D - Guardio Charger

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TABLE OF CONTENTS
IMPORTANT MEDICAL NOTICE ........................................................................... i
1.0 INTRODUCTION .......................................................................................... 1
2.0 THE OPTIMIZER INTEGRA CCM-D SYSTEM ............................................ 1
2.1 OPTIMIZER Integra CCM-D Implantable Pulse Generator ................ 1
2.2 Guardio Charger ................................................................................ 3
3.0 INDICATIONS OF USE ................................................................................ 4
4.0 POTENTIAL COMPLICATIONS .................................................................. 4
4.1 Complications Associated with Implantation ...................................... 4
4.2 Complications Associated with Device / Charger Operation .............. 6
5.0 FOLLOWING IMPLANTATION ................................................................... 6
6.0 LIVING WITH YOUR OPTIMIZER INTEGRA CCM-D IPG .......................... 7
6.1 General Expectations ......................................................................... 7
6.2 Effect on Your Activities ..................................................................... 7
6.3 Medications ........................................................................................ 7
6.4 How Other Devices May Affect Your OPTIMIZER Integra CCM-D IPG
........................................................................................................... 8
6.5 The Importance of Your Implanted Medical Device Identification Card
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7.0 GUARDIO CHARGER ............................................................................... 11
7.1 System Components ........................................................................ 11
7.2 Features ........................................................................................... 12
7.3 Description ....................................................................................... 13
7.4 Charging Method .............................................................................. 13
7.5 Removal and Installation of the Plug Adapter .................................. 14
7.5.1 Removal of the Plug Adapter ................................................ 14
7.5.2 Installation of the Plug Adapter ............................................. 15
7.6 Charging Your Guardio Charger ...................................................... 16
7.7 Charging Your OPTIMIZER Integra CCM-D IPG ............................. 19
7.8 Termination of the Charging Session ............................................... 24
7.8.1 Early Termination of Charging Session................................. 24