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Precision Spinal Cord System

Precision Spinal Cord Stimulator System Clinician Manual Rev A

Clinician Manual

74 Pages

  Table of Contents Manual Overview ... 1 Device and Product Description ... 2 Implantable Pulse Generator ...2 Leads ...2 Lead Extension ...2 Lead Splitter...3  Indications for Use ... 4  Precision System Clinical Summary ...4  Contraindications ... 8 Safety Information... 9 Instructions for the Patient...9 Warnings ...9 Precautions ...9 Adverse Effects ... 11 Instructions for the Physician ... 11  Package Contents ... 13  IPG Kit ...13 Percutaneous Permanent Lead Kit ...13 Percutaneous Trial Lead Kit...13 Lead Extension Kit ...13 2x4 Splitter Kit...14 Surgical Paddle Lead Kit ...14 Infinion™ 16 Lead Kit...14 Infinion 16 Trial Lead Kit...14 Infinion CX Lead Kit...15 Infinion CX Lead Trial Lead Kit...15 Splitter 2x8 Kit...15 Infinion™ 16 Trial Configuration Kit...15 Infinion™ 16 Configuration Kit...15  Sterilization, Handling, and Storage ... 16  Sterilization ...16 IPG Handling and Storage ...16 Lead, Lead Extension, and Splitter Handling and Storage...17  Pre-Op Instructions ... 18 Percutaneous Lead Placement in the Epidural Space ... 19 Infinion CX Lead Placement in the Epidural Space with Entrada™ Needle...20 Lead Connection to Splitter...25  Surgical Paddle Lead Placement in the Epidural Space ... 28 Connecting the OR Cable Assembly ... 29 Intraoperative Stimulation Testing ... 30 Securing the Trial Lead ... 31 Securing the Infinion CX Trial Lead ... 32 Permanent Lead Anchoring and Tunneling... 33  Anchoring the Lead ...34 Tunneling the Lead or Lead Extension ...35 Clinician Manual 91083273-01 Rev A iii of iv
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File Name: precision_spinal_cord_stimulator_system_clinician_m.pdf

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