Introduction; Indications For Use; Description; Warnings - Axium MN20600-02 Manual Del Usuario

Introduction

Your Axium Patient Programmer is used to program your Trial or Implantable Stimulator. This User
®
Manual gives detailed instructions on how to safely use your Programmer and your Stimulator. See your
doctor if you have any questions.

Indications for Use

The Spinal Modulation Neurostimulator System is indicated for the management of chronic intractable
pain.

Description

The Axium Patient Programmer is a portable, hand-
held device. It is used to communicate with your
Stimulator. Your Programmer contains information
about your Stimulator. You will use it to adjust your
stimulation settings or turn stimulation off. It can run
on its rechargeable battery. It can also be plugged into
a power outlet.
A Clinical Programmer is used by your doctor to
initially set up your Stimulator and make adjustments
later if needed. Only your doctor and/or Spinal
Modulation clinical personnel use the Clinical
Programmer.

Warnings

• Do not use your Programmer or the Stimulator until your doctor has trained you.
• Do not use your Programmer until your doctor has set up your Stimulator.
• Do not have any elective magnetic resonance imaging (MRI). If MRI is necessary, your doctor
should remove any leads and disconnect the TNS or INS device. Using MRI in the area of the
leads may move the leads. It can also damage the TNS or INS device. Using MRI may cause
uncomfortable ("jolting" or "shocking") levels of stimulation. MRI may cause heating at the
tip of the lead. Unintended stimulation could result in tissue damage.
• Before having a CT scan, tell your doctor that you have an implanted device. All stimulation
for your device should be turned OFF before the procedure. After the scan, your doctor
should turn it back on and make sure the system is working properly.
• Do not have any diathermy (high energy heat) procedures. Diathermy may cause injury to you
or damage your Stimulator.
• Do not remove your leads or Connector Cable by yourself. This may cause serious injury and
could cause an infection.
• Do not open or modify the Programmer or TNS. Keep them closed to protect them.
Modifications to the device may cause improper operation.
• Do not transport the Programmer outside of its carrying case. Operate it only in a moisture-
free environment. The Programmer may malfunction if it becomes wet.
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