Abbott Eterna 16000 User manual

Charging System
Eterna™ Spinal Cord Smulaon 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 reproducve harm. For more
informaon, 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 respecve owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
Pat. hp://www.abbo.com/patents
© 2023 Abbo. All Rights Reserved.

Contents
About This Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Prescripon and Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indicaon for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Addional Prescripon Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
MRI Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Precauons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Adverse Eects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Product Descripon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Charger Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Using Your Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Pairing the Charger with the Paent Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
When to Charge Your Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Charging Your Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Seng 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
Troubleshoong. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Troubleshoong Charging Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Service and Ordering Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Appendix A: Regulatory Statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Disposal Guidelines for Baery-Powered Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Statement of FCC Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Product Classicaon Statement (CISPR 11, Class B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Idencaon Informaon for Product Registraon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Wireless Technology Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Quality of Service for Wireless Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Wireless Security Measures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Troubleshoong for Wireless, Coexistence, or Interference Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Appendix B: Product Specicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Appendix C: Technical Specicaons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Appendix D: Electromagnec Compability Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Appendix E: Symbols and Denions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
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About This Guide
This guide explains how to use the charging system (Model 16000 and charging system
accessories). Follow the informaon in this guide to correctly use your charging system.
If you have any quesons about your system, contact Technical Support.
Prescripon and Safety Informaon
Read this secon to gather important prescripon and safety informaon.
Intended Use
The charging system is intended to be used to charge the Eterna™ implantable pulse
generator (IPG), also referred to as a generator.
Indicaon for Use
Refer to the user's guide for the appropriate neurosmulaon system.
Contraindicaons
Refer to the user's guide for the appropriate neurosmulaon system.
Addional Prescripon Informaon
Refer to the user’s guide for your paent controller for instrucons for use and other
important informaon, including indicaons for use, contraindicaons, warnings,
precauons, adverse eects, and the personal idencaon card related to your
neurosmulaon system.
MRI Safety Informaon
Do not bring your charger into the scanner magnet room. It can be aected by the
magnec resonance imaging (MRI) magnet, may present a projecle hazard, and is
considered MR Unsafe.
Warnings
The following warnings apply to this charging system.
Device inspecon. Before using the charging system, check the charger, charging cable,
and power adapter for visible damage or indicaon of prior disassembly. If any damage
or prior disassembly is observed, do not use the charging system and contact Technical
Support.
Device modicaon. 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.
Baery warning. The charger contains a lithium‑ion baery and other potenally
hazardous materials. Do not crush, puncture, or burn the charger because explosion or
re may result.
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Baery care. Baeries should not come in contact with metal or be exposed to high
temperature or re. Baeries can explode, leak, or melt if disassembled, shorted (when
baery connecons contact metal), or exposed to high temperature or re.
Power adapter and charging cable compability. Use only power adapters and
charging cables that meet the rangs specied in the appendix for technical
specicaons. Use of accessories, transducers, and cables other than those specied or
provided by Abbo Medical could result in increased electromagnec emissions or
decreased electromagnec immunity and result in improper operaon of the system.
Power adapter handling. Do not posion the power adapter in such a way that it is
dicult to disconnect from an electrical outlet.
Explosive or ammable gases. Do not use your charger around explosive or ammable
gas fumes or vapors. This includes oxygen-enriched environments such as hyperbaric
chambers. Operang the device near gas fumes or vapors could cause them to catch
re. If gas fumes or vapors catch re, it could cause severe burns, injury, or death.
Strangulaon. The cords in this charging system pose a strangulaon risk. Keep cords
out of the reach of children.
Choking. Small parts in this charging system pose a choking risk. Keep small system
parts out of the reach of children.
Keep dry to avoid damage. Your charger is not waterproof. Keep it dry to avoid damage.
Never use the charger in or around water. If the charger becomes wet, allow it to dry
completely before use.
Precauons
The following precauons apply to this charging system.
Device components. The charging system is for use with the Eterna™ implantable pulse
generator only. You may use a commercially available power adapter and charging cable
as long as it meets the technical specicaons listed in the appendix.
Handle the device with care. The charger is a sensive electronic device that can be
damaged by rough handling, such as dropping it on the ground.
Review your user’s guide. Before using your charger, review the system informaon in
the applicable paent controller user’s guide.
Infecon. Follow proper infecon control procedures. Also avoid showering and
touching the bandages while your incisions are healing. If you need to charge your
generator before your incisions have healed completely, take care not to disturb the
bandages and follow your physician’s guidance on charging.
Home use. This product is intended for home use per clinician instrucon. To avoid
damage and other potenal hazards, keep this product away from children and pets.
Pain-relief patches. Avoid using pain-relief patches or topical anesthecs, such as
pain‑relieving creams or medicated balms, over your generator site before or during
charging. These pain-relief patches or topical anesthecs may reduce your ability to
perceive discomfort due to charging.
Alcohol consumpon. Avoid drinking alcoholic beverages before or during charging
because they may reduce your ability to perceive discomfort due to charging.
Charging system immunity. Wireless communicaon equipment, such as wireless home
network devices, mobile and cordless telephones, and walkie-talkies, can interfere with
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the charging system. To correct the eects of typical system interference, keep the
charging system at least 0.5 m (1.6 ) from these types of wireless communicaon
equipment. If you connue to have problems with interference, further increase the
distance between the equipment and your charging system.
Charge your charger. The charger should be fully charged aer every generator charging
session.
Unplug the cable carefully. To avoid damaging the charging cable, do not pull on cable
when unplugging it from the charger or power adapter. Grasp the connector and pull
carefully.
Paent training. Paents should use their neurosmulaon system only aer an
authorized clinician has programmed their generator and has trained them on how to
safely control smulaon and to charge the system.
Adverse Eects
The following adverse eects are associated with using this charging system. Refer to
the paent controller user’s guide for a complete list of adverse eects related to the
use of the Eterna™ SCS system.
▪Heang or discomfort at the pocket while charging. If you feel discomfort at the▪
implant site while charging your generator, stop using the charger. Use your paent
controller to change the charging mode or contact your physician.
▪Heang or discomfort at surgical staples while charging. Charging should not be▪
carried out while surgical staples are in place.
▪Interference with another implanted medical device. This equipment generates,
▪
uses, and can radiate radiofrequency (RF) energy that may interfere with other
electronic devices, including other implanted medical devices. To try to correct the
eect of any interference with other devices, turn o the charging equipment or
increase the distance between the charging equipment and the device being
aected.
Product Descripon
The charging system consists of a charger, a charging cable, a power adapter, charging
apparel, and a travel case for storing the charging system. The charger is used to charge
the Eterna™ implantable pulse generator wirelessly. The charger interfaces with the
paent controller applicaon wirelessly through Bluetooth® wireless technology. The
paent controller applicaon allows you to modify charger sengs, view the baery
level of your charger and generator, and view the charging status of your charger and
generator.
Charger
The charger is used to wirelessly charge
your Eterna™ implantable pulse generator.
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Power adapter
The power adapter connects with an
electrical outlet and with the charging cable
to charge the charger baery.
Charging cable
The charging cable connects with the
power adapter and with the charger to
charge the charger baery.
Charging apparel – lumbar
Charging apparel is used to posion and
stabilize the charger over your generator
and charge the generator without having to
manually hold the charger in place. The
lumbar apparel is worn like a belt around
your waist.
Charging apparel – pectoral
Charging apparel is used to posion and
stabilize the charger over your generator
and charge the generator without having to
manually hold the charger in place. The
pectoral apparel can be worn in mulple
conguraons using the double strap or the
counterweight.
Charger travel case
The travel case is used to store the parts of
the charging system.
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Charger Indicators
The charger has a power icon, a baery icon, and a paent controller alert icon as
shown in the gure below. The charger provides indicator lights and sounds that show
the charger status and the acon being performed.
▪PC Alert icon. The PC alert icon illuminates when the charger has encountered an▪
error. You may view more informaon about the error on your paent controller.
▪Power icon. The power icon illuminates when the charger is turned on. When the ▪
charger is charging the generator, the power icon blinks slowly. When the charger is
in pairing mode, the power icon blinks quickly.
▪Baery icon. The baery icon illuminates in segments to indicate the charger ▪
baery level. While the charger is being charged, a segment of the baery icon
blinks.
NOTE: The indicator lights on the charger may be dicult to see if under direct
sunlight.
Figure 1. Charger icons
1. PC Alert icon1.
2. Power icon2.
3. Baery icon3.
Table 1. Charger sounds
Event Charger sound
Power on 1 beep
Volume on 1 beep
Power o 2 beeps
Error 3 beeps every 5 seconds
Low baery 3 beeps every 5 minutes
Generator found Short, repeang beeps
Generator charging started 2 beeps
low tone then high tone
Generator charging stopped
(not aligned)
2 beeps
high tone then low tone
Generator charging complete
(fully charged)
3 beeps
low tone, high tone, then low tone
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Using Your Charger
The instrucons in this secon explain how to use your charging system to charge your
generator baery and charger baery, how to use the charging apparel, and how to care
for and travel with your charging system.
NOTE: Each me before using the system, inspect the device and its accessories for
damage. Avoid using a damaged device or accessory. If your device is damaged,
contact Technical Support.
Pairing the Charger with the Paent Controller
Before you use your charger for the rst me, you may want to pair the charger with
your paent controller. Pairing refers to seng up communicaon between the charger
and the paent controller. When these devices are paired, you can use your paent
controller to monitor charging sessions, adjust charger sengs, such as volume control,
and perform charger soware updates. Refer to your paent controller user guide for
more informaon.
NOTE: Your charger and paent controller do not need to be paired or connected to
Bluetooth® wireless technology in order to charge your generator.
To prepare the charger for pairing, do the following:
1. Ensure that your paent controller and charger are charged.1.
2. Place the paent controller near the charger.2.
3. Turn on the charger.3.
4. Press and hold the power icon on the charger for 5 seconds, and then release the4.
buon. The power icon and the baery icon blink once. Then the power icon blinks
quickly, indicang the charger is in the pairing state.
5. On the paent controller, select the charger you are pairing. Refer to your paent5.
controller manual for more informaon.
NOTE: If the pairing does not occur within 5 minutes, the charger exits pairing
mode and then automacally turns o aer 90 seconds of inacvity.
When to Charge Your Generator
Your clinician will help you plan a charging schedule that will work best for you to
maintain eecve therapy. For example, you may establish a charging roune of once per
week.
The following are addional consideraons to help you decide when to charge your
generator:
▪Prior to an MRI ▪
▪Prior to an upcoming surgery ▪
▪In ancipaon of travel ▪
▪When the next charging opportunity is uncertain ▪
▪When the paent controller applicaon displays a low baery nocaon for your ▪
generator
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