Intended Use ..................................................................................................................................................................... 1

Device Description ........................................................................................................................................................... 1

Radiopaque Identification Tag ...................................................................................................................................... 1

Package Contents ........................................................................................................................................................ 2

Specifications and Technical Data ............................................................................................................................... 2

Materials ...................................................................................................................................................................... 3

Compatible Implantable Components .......................................................................................................................... 4

Safety Information ............................................................................................................................................................ 5

Sterilization .................................................................................................................................................................. 5

Handling and Storage .................................................................................................................................................. 5

Technical Service ......................................................................................................................................................... 5

Rechargeable Stimulator Systems ................................................................................................................................. 6

IPG Battery Life ............................................................................................................................................................ 6

Non-Rechargeable Stimulator Systems ......................................................................................................................... 7

IPG Battery Life ............................................................................................................................................................ 7

Estimating Longevity .................................................................................................................................................... 8

Elective Replacement .................................................................................................................................................. 8

SCS Systems with ImageReady™ MRI Technology ...................................................................................................... 9

SCS Implant Conditions for Full Body MRI Eligibility ................................................................................................... 9

Instructions for Use ........................................................................................................................................................ 10

Preparation ................................................................................................................................................................ 10

Implanting the IPG ......................................................................................................................................................11

Connecting the Lead, Lead Extension, Splitter, or Connector to the 16 Contact IPG ................................................ 12

Connecting the Lead, Lead Extension, Splitter, or Connector to the 32 Contact IPG ................................................ 13

Connecting to the IPG ................................................................................................................................................ 14

Entering Pairing Mode Using a Pairing Magnet ......................................................................................................... 15

Device Removal .............................................................................................................................................................. 16

Device Disposal .............................................................................................................................................................. 17

Post-Procedure ............................................................................................................................................................... 18

Table of Contents

Implantable Pulse Generator

92959607-02

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