About This Guide; Prescription And Safety Information; Intended Use; Indication For Use - Abbott Eterna 16000 User Manual

Charging system spinal cord stimulation system
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About This Guide

This guide explains how to use the charging system (Model 16000 and charging system
accessories). Follow the information in this guide to correctly use your charging system.
If you have any questions about your system, contact Technical Support.

Prescription and Safety Information

Read this section to gather important prescription and safety information.

Intended Use

The charging system is intended to be used to charge the Eterna™ implantable pulse
generator (IPG), also referred to as a generator.

Indication for Use

Refer to the user's guide for the appropriate neurostimulation system.

Contraindications

Refer to the user's guide for the appropriate neurostimulation system.

Additional Prescription Information

Refer to the user's guide for your patient controller for instructions for use and other
important information, including indications for use, contraindications, warnings,
precautions, adverse effects, and the personal identification card related to your
neurostimulation system.

MRI Safety Information

Do not bring your charger into the scanner magnet room. It can be affected by the
magnetic resonance imaging (MRI) magnet, may present a projectile hazard, and is
considered MR Unsafe.

Warnings

The following warnings apply to this charging system.
Device inspection.
Before using the charging system, check the charger, charging cable,
and power adapter for visible damage or indication of prior disassembly. If any damage
or prior disassembly is observed, do not use the charging system and contact Technical
Support.
Device modification.
This charger is not serviceable by the customer. To prevent injury
to yourself or damage to the charging system, do not modify the charger. If needed,
return the charger to Abbott Medical for service.
Battery warning.
The charger contains a lithium‑ion battery and other potentially
hazardous materials. Do not crush, puncture, or burn the charger because explosion or
fire may result.
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