Abbott Eterna 16000 User manual
Charging System
Eterna™ Spinal Cord Smulaon System
Model 16000
User's Guide
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to
the State of California to cause cancer and birth defects or other reproducve harm. For more
informaon, go to www.P65Warnings.ca.gov.
™ Indicates a trademark of the Abbo group of companies.
‡ Indicates a third-party trademark, which is property of its respecve owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
Pat. hp://www.abbo.com/patents
© 2023 Abbo. All Rights Reserved.
Contents
About This Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Prescripon and Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indicaon for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Addional Prescripon Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
MRI Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Precauons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Adverse Eects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Product Descripon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Charger Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Using Your Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Pairing the Charger with the Paent Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
When to Charge Your Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Charging Your Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Seng Up the Charging Apparel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Charging Your Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Caring for and Maintaining Your Charger and Charging Apparel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Traveling with Your Charging System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Troubleshoong. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Troubleshoong Charging Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Service and Ordering Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Appendix A: Regulatory Statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Disposal Guidelines for Baery-Powered Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Statement of FCC Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Product Classicaon Statement (CISPR 11, Class B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Idencaon Informaon for Product Registraon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Wireless Technology Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Quality of Service for Wireless Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Wireless Security Measures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Troubleshoong for Wireless, Coexistence, or Interference Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Appendix B: Product Specicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Appendix C: Technical Specicaons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Appendix D: Electromagnec Compability Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Appendix E: Symbols and Denions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
i
ii
About This Guide
This guide explains how to use the charging system (Model 16000 and charging system
accessories). Follow the informaon in this guide to correctly use your charging system.
If you have any quesons about your system, contact Technical Support.
Prescripon and Safety Informaon
Read this secon to gather important prescripon and safety informaon.
Intended Use
The charging system is intended to be used to charge the Eterna™ implantable pulse
generator (IPG), also referred to as a generator.
Indicaon for Use
Refer to the user's guide for the appropriate neurosmulaon system.
Contraindicaons
Refer to the user's guide for the appropriate neurosmulaon system.
Addional Prescripon Informaon
Refer to the user’s guide for your paent controller for instrucons for use and other
important informaon, including indicaons for use, contraindicaons, warnings,
precauons, adverse eects, and the personal idencaon card related to your
neurosmulaon system.
MRI Safety Informaon
Do not bring your charger into the scanner magnet room. It can be aected by the
magnec resonance imaging (MRI) magnet, may present a projecle hazard, and is
considered MR Unsafe.
Warnings
The following warnings apply to this charging system.
Device inspecon. Before using the charging system, check the charger, charging cable,
and power adapter for visible damage or indicaon of prior disassembly. If any damage
or prior disassembly is observed, do not use the charging system and contact Technical
Support.
Device modicaon. 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 Abbo Medical for service.
Baery warning. The charger contains a lithium‑ion baery and other potenally
hazardous materials. Do not crush, puncture, or burn the charger because explosion or
re may result.
1
Table of contents
