Abbott Eterna 32400 User manual

Eterna™ Implantable Pulse Generator
Model 32400
Clinician's Manual

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
© 2022 Abbo. All Rights Reserved.

Contents
Prescripon and Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indicaon for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Clinical Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
MRI Safety Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Precauons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Adverse Eects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Product Descripon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Package Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Idenfying the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Direcons for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Creang a Generator Pocket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connecng a Lead or Extension to the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Implanng the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Replacing the Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposing of Explanted Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Checking the Status of the Generator Baery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Technical Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Appendix A: Product Specicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Storage and Excursion Temperature Specicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Product Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Generator Specicaons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Adapters and Extensions for Compability with Non-Abbo Leads. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Appendix B: System Components and Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Generator Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Charging System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Charging System Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Programmers and Controllers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Programmer and Controller Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Leads and Extensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Leads and Extensions Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Adapters and Extensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Appendix C: Generator Baery Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Appendix D: Regulatory Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Disposal Guidelines for Baery-Powered Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Statement of FCC Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Idencaon Informaon for Product Registraon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Wireless Technology Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Quality of Service for Wireless Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Appendix E: Symbols and Denions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
i

ii

Prescripon and Safety Informaon
Read this secon to gather important prescripon and safety informaon.
Intended Use
The Eterna™ Spinal Cord Smulaon (SCS) System is designed to deliver low-intensity electrical impulses to
nerve structures. The system is intended to be used with leads and associated extensions that are
compable with the system.
Indicaon for Use
The Eterna™ SCS System is indicated as an aid in the management of chronic, intractable pain of the trunk
and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery
syndrome and intractable low back and leg pain.
Contraindicaons
The Eterna™ SCS System is contraindicated for paents who are unable to operate the system or who have
failed to receive eecve pain relief during trial smulaon.
Clinical Studies
Clinical studies were conducted to assess the safety and eecveness of spinal cord smulaon (SCS)
systems. For informaon that supports the clinical use of neurosmulaon systems and the anatomical
placement of leads, refer to the clinical summaries manual for SCS.
MRI Safety Informaon
Some models of this system are Magnec Resonance (MR) Condional, and paents with these devices may
be scanned safely with magnec resonance imaging (MRI) when the condions for safe scanning are met.
For more informaon about MR Condional neurosmulaon components and systems, including
equipment sengs, scanning procedures, and a complete lisng of condionally approved components,
refer to the MRI procedures clinician's manual for neurosmulaon systems (available online at
medical.abbo/manuals). For more informaon about MR Condional products, visit the Abbo Medical
product informaon page at neuromodulaon.abbo/MRI-ready.
Warnings
The following warnings apply to this neurosmulaon system.
Poor surgical risks. Neurosmulaon should not be used on paents who are poor surgical candidates.
Neurosmulaon should not be used for paents with comorbidies that could prevent successful implant
or eecve therapy.
Magnec resonance imaging (MRI). Some paents may be implanted with the components that make up a
Magnec Resonance (MR) Condional system, which allows them to receive an MRI scan if all the
requirements for the implanted components and for scanning are met. A physician can help determine if a
paent is eligible to receive an MRI scan by following the requirements provided by Abbo Medical.
Physicians should also discuss any risks of MRI with paents.
Paents without an MR Condional neurosmulaon system should not be subjected to MRI because the
electromagnec eld generated by an MRI may damage the device electronics and induce voltage through
the lead that could jolt or shock the paent.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeuc ultrasound
diathermy (all now referred to as diathermy) on paents implanted with a neurosmulaon system. Energy
from diathermy can be transferred through the implanted system and cause ssue damage at the locaon
of the implanted electrodes, resulng in severe injury or death.
1

Diathermy is further prohibited because it may also damage the neurosmulaon system components. This
damage could result in loss of therapy, requiring addional surgery for system implantaon and
replacement. Injury or damage can occur during diathermy treatment whether the neurosmulaon system
is turned on or o.
Electrosurgery. To avoid harming the paent or damaging the neurosmulaon system, do not use
monopolar electrosurgery devices on paents with implanted neurosmulaon systems. If use of
electrocautery is necessary, place the neurosmulator in Surgery mode using the clinician programmer app
or the paent controller app before using an electrosurgery device.
During the implant procedure, if an electrosurgery device must be used, take the following acons:
▪Use bipolar electrosurgery only.▪
▪Place the neurosmulator in Surgery mode before using an electrosurgery device.
▪
▪Set the electrosurgery device to the lowest possible energy seng. Output power below 80 W is▪
recommended for all acvaons.
▪Complete any electrosurgery before connecng the leads or extensions to the neurosmulator.▪
▪Keep the current paths from the electrosurgery device as far from the neurosmulaon system as ▪
possible.
▪Exit Surgery mode during intraoperave tesng and aer the procedure is completed. ▪
NOTE: During intraoperave tesng, Surgery mode must be turned o for the neurosmulaon system
to funcon correctly.
▪Conrm that the neurosmulaon system is funconing correctly during the implant procedure, before ▪
closing the neurosmulator pocket, and aer the implant procedure.
Aer any surgery, check the neurosmulaon system for the following:
▪Check the neurosmulator to ensure Surgery mode has been turned o, even if Surgery mode was not ▪
turned on at the beginning or during the procedure.
▪Conrm the neurosmulaon system is funconing. ▪
Implanted cardiac systems. Physicians need to be aware of the risk and possible interacon between a
neurosmulaon system and an implanted cardiac system, such as a pacemaker or debrillator. Electrical
pulses from a neurosmulaon system may interact with the sensing operaon of an implanted cardiac
system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac
system from sensing the output of the neurosmulaon system, (1) maximize the distance between the
implanted systems; (2) verify that the neurosmulaon system is not interfering with the funcons of the
implanted cardiac system; (3) avoid programming either device in a unipolar mode (using the device’s can as
an anode) or using neurosmulaon system sengs that interfere with the funcon of the implantable
cardiac system.
Other acve implanted devices. The neurosmulaon system may interfere with the normal operaon of
another acve implanted device, such as a pacemaker, debrillator, or another type of neurosmulator.
Conversely, the other acve implanted device may interfere with the operaon of the neurosmulaon
system.
Interference with other devices. Some of this system’s electronic equipment, such as the programmer and
controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including
other acve implanted devices. Avoid placing equipment components directly over other electronic devices.
To correct the eect of interference with other devices, turn o the equipment or increase the distance
between the equipment and the device being aected.
Operaon of machines, equipment, and vehicles. Paents using therapy that generates paresthesia should
turn o smulaon before operang motorized vehicles, such as automobiles, or potenally dangerous
machinery and equipment because sudden smulaon changes may distract them from properly operang
it. However, current data shows that most paents using BurstDR™ smulaon therapy do not experience
paresthesia. For paents who do not feel paresthesia, sudden smulaon changes are less likely to occur
and distract them while operang motorized vehicles, machinery, or equipment.
Explosive and ammable gases. Do not use a clinician programmer or paent controller 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.
2

Keep dry to avoid damage. Clinician programmers, paent controllers, and chargers are not waterproof.
Keep them dry to avoid damage. Advise paents to not use their devices when engaging in acvies that
might cause them to get wet, such as swimming or bathing.
Pediatric use. Safety and eecveness of neurosmulaon for pediatric use have not been established.
Pregnancy and nursing. Safety and eecveness of neurosmulaon for use during pregnancy and nursing
have not been established.
Device components. The use of components not approved for use by Abbo Medical with this system may
result in damage to the system and increased risk to the paent.
Device modicaon. This equipment is not serviceable by the customer. To prevent injury or damage to the
system, do not modify the equipment. If needed, return the equipment to Abbo Medical for service.
Applicaon modicaon. To prevent unintended smulaon, do not modify the generator soware in any
way. Only apply soware updates that are published directly by Abbo Medical.
Case damage. Do not handle the generator if the case is pierced or ruptured because severe burns could
result from exposure to baery chemicals.
Generator disposal. Return all explanted generators to Abbo Medical for safe disposal. generators contain
baeries as well as other potenally hazardous materials. Do not crush, puncture, or burn the generator
because explosion or re may result.
Product materials. Neurosmulaon systems have materials that come in contact or may come in contact
with ssue. A physician should determine whether or not a paent may have an allergic reacon to these
materials before the system is implanted.
Precauons
The following precauons apply to this neurosmulaon system.
General Precauons
Clinician training. Implanng physicians should be experienced in the diagnosis and treatment of chronic
pain syndromes and have undergone surgical and device implantaon training.
Paent selecon. It is extremely important to select paents appropriately for neurosmulaon. Thorough
psychiatric screening should be performed. Paents should not be dependent on drugs and should be able
to operate the neurosmulaon system.
Infecon. Follow proper infecon control procedures. Paents should avoid charging their generator over
an incision that has not completely healed. Infecons related to system implantaon might require that the
device be explanted.
Implantaon of two systems. If two systems are implanted, ensure that at least 20 cm (8 in.) separates the
implanted generators to minimize unintended interacon with other system components.
Implantaon of mulple leads. If mulple leads are implanted, leads and extensions should be routed in
close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnec energy that could
cause the paent unwanted smulaon.
Implant heang. While charging the generator, paents may perceive an increase in temperature at the
generator site. In paents who have areas of increased sensivity to heat, consider placing the implant
where the paent has normal sensaon.
High smulaon outputs. Smulaon at high outputs may cause unpleasant sensaons or motor
disturbances or render the paent incapable of controlling the generator. If unpleasant sensaons occur,
turn o smulaon immediately.
Electromagnec interference (EMI). Some equipment in home, work, medical, and public environments can
generate EMI that is strong enough to interfere with the operaon of a neurosmulaon system or damage
system components. Paents should avoid geng too close to these types of EMI sources, which include
the following examples: commercial electrical equipment (such as arc welders and inducon furnaces),
communicaon equipment (such as microwave transmiers and high-power amateur transmiers), high-
voltage power lines, radiofrequency idencaon (RFID) devices, and some medical procedures (such as
therapeuc radiaon and electromagnec lithotripsy).
Consumer goods and electronic devices. Magnec interference with consumer goods or electronic devices
that contain magnets, such as mobile phones and smart watches, may unintenonally cause the
neurosmulaon system to turn on or turn o or aect communicaon between the device and generator;
however, it will not change the prescribed programmed parameters. Paents should be advised to keep
3

their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any
smart device in a pocket near the generator. If a paent is concerned about a smart device interacng with
their neurosmulaon system, consider disabling magnet mode. For more informaon about seng the
magnet mode, refer to the clinician programmer manual or contact Technical Support.
Lead movement. Paents should be instructed to avoid bending, twisng, stretching, and liing objects
over 2 kg (5 lb) for six to eight weeks aer implantaon of a neurosmulaon system. Extension of the
upper torso or neck may cause lead movement and alter the smulaon eld (especially with leads in the
cervical area), resulng in oversmulaon or ineecve smulaon.
Paent training. Instruct paents to use their neurosmulaon system only aer an authorized clinician has
programmed the generator and has trained the paent on how to safely control smulaon and to charge
the system.
Programmer use. Allow only authorized use of the clinician programmer to avoid any programming changes
that may injure a paent.
Sterilizaon and Storage
Single-use, sterile device. The implanted components of this neurosmulaon system are intended for a
single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before
shipment and are supplied in sterile packaging to permit direct introducon into the sterile eld. Do not
resterilize or reimplant an explanted system for any reason.
Storage environment. Store components and their packaging where they will not come in contact with
liquids of any kind.
Handling and Implementaon
Expiraon date. An expiraon date (or “use-before” date) is printed on the packaging. Do not use the
system if the use-before date has expired.
Recharge-by date. A recharge-by date is printed on the packaging. If this date has been reached or has been
exceeded before the date of implantaon, the generator should be charged prior to implantaon.
Handle devices with care. The clinician programmer and paent controller are sensive electronic devices
that can be damaged by rough handling, such as dropping them on the ground.
Care and handling of components. Use extreme care when handling system components prior to
implantaon. Excessive heat, excessive tracon, excessive bending, excessive twisng, or the use of sharp
instruments may damage and cause failure of the components.
Package or component damage. Do not implant a device if the sterile package, the device, or any device
components show signs of damage, tampering, or if the sterile seal is ruptured, or contaminaon is
suspected for any reason. Return any suspect components to Abbo Medical for evaluaon.
Exposure to body uids or saline. Exposure of the metal contacts, such as those on the connecon end of a
lead or extension, to body uids or saline prior to connecon can lead to corrosion. If such exposure occurs,
clean the aected parts with sterile, deionized water or sterile water for irrigaon, and dry them completely
prior to lead connecon and implantaon.
System tesng. To ensure correct operaon, always test the system during the implant procedure, before
closing the neurosmulator pocket, and before the paent leaves the surgery suite.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic
lithotriptor, may damage the electronic circuitry of an implanted generator. If lithotripsy must be used, do
not focus the energy near the generator.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage
to an implanted neurosmulaon system if used directly over the implanted system.
External debrillators. Safety for use of external debrillator discharges on a paent receiving
neurosmulaon has not been established. External debrillaon can cause induced currents in the lead-
extension poron of the neurosmulaon system. Aer debrillaon, conrm the neurosmulaon system
is sll working.
Therapeuc radiaon. Therapeuc radiaon may damage the electronic circuitry of an implanted
neurosmulaon system, although no tesng has been done and no denite informaon on radiaon
eects is available. Sources of therapeuc radiaon include therapeuc X rays, cobalt machines, and linear
accelerators. If radiaon therapy is required, the area over the implanted generator should be shielded with
lead. Damage to the system may not be immediately detectable.
4

Home and Occupaonal Environments
Security, anthe, and radiofrequency idencaon (RFID) devices. Some anthe devices, such as those
used at entrances or exits of department stores, libraries, and other public places, and airport security
screening devices may aect smulaon. Addionally, RFID devices, which are oen used to read
idencaon badges, as well as some tag deacvaon devices, such as those used at payment counters at
stores and loan desks at libraries, may also aect smulaon. Paents who are implanted with nonadjacent
mulple leads and paents who are sensive to low smulaon thresholds may experience a momentary
increase in their perceived smulaon, which some paents have described as uncomfortable or jolng.
Paents should cauously approach such devices and should request help to bypass them. If they must go
through a gate or doorway containing this type of device, paents should turn o their generator and
proceed with cauon, being sure to move through the device quickly.
Scuba diving or hyperbaric chambers. Before diving or using a hyperbaric chamber, paents should contact
their physician to discuss the eects of high pressure on their implanted system. Implanted systems with
non-Abbo leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Paents
with implanted Abbo leads should avoid scuba diving in more than 30 m (100 ) of water or entering
hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of me, as this may damage the
neurosmulaon system. For less than 30 m (100 ) of water or pressures below 4.0 ATA, duraons of less
than 60 minutes are recommended.
Wireless use restricons. In some environments, the use of wireless funcons (for example, Bluetooth®
wireless technology) may be restricted. Such restricons may apply aboard airplanes, near explosives, or in
hazardous locaons. If you are unsure of the policy that applies to the use of this device, please ask for
authorizaon to use it before turning it on.
Adverse Eects
In addion to those risks commonly associated with surgery, the following risks are associated with using
this neurosmulaon system:
▪Unpleasant sensaons or motor disturbances, including involuntary movement, caused by smulaon▪
at high outputs (If either occurs, turn o your generator immediately.)
▪Undesirable changes in smulaon, which may be related to cellular changes in ssue around the▪
electrodes, changes in electrode posion, loose electrical connecons, or lead failure
▪Smulaon in unwanted places (such as radicular smulaon of the chest wall) ▪
▪Lead migraon, causing changes in smulaon or reduced pain relief▪
▪Epidural hemorrhage, hematoma, infecon, spinal cord compression, or paralysis from placement of a▪
lead in the epidural space
▪Cerebrospinal uid (CSF) leakage▪
▪Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant▪
▪Persistent pain at the electrode or generator site ▪
▪Seroma (mass or swelling) at the generator site▪
▪Allergic or rejecon response to implant materials▪
▪Implant migraon or skin erosion around the implant ▪
▪Baery failure▪
System Overview
This neurosmulaon system is designed to deliver electrical smulaon to nerve structures. The
neurosmulaon system includes the following main components:
▪Generator and accessories▪
▪Charger and accessories▪
▪Leads▪
▪Clinician programmer applicaon on clinician programmer device ▪
▪Paent controller applicaon on paent controller device ▪
▪Paent magnet
▪
5

The implantable pulse generator (also referred to as an IPG or neurosmulator) delivers electrical pulses
through the leads to electrodes near selected nerve bers in order to provide therapeuc smulaon. The
paent magnet can turn the generator on and o if the physician enables this funconality.
Physicians use the clinician programmer to create and modify programs for a paent, view and email
program log les, and view generator and charger informaon. Paents use the paent controller to control
their prescribed programs, monitor generator baery status to maintain smulaon, monitor charging
status, and modify charger sengs. Paents use the charger to charge their generator.
NOTE: In this document, the term "clinician programmer" refers to the Abbo Medical Clinician Programmer
device, "paent controller" refers to the Abbo Medical Paent Controller device, "clinician programmer
app" refers to the Abbo Medical Clinician Programmer soware applicaon (app), and "paent controller
app" refers to the Abbo Medical Paent Controller app.
The following image shows how the major system components are intended to interact.
Figure 1. Interacon among main system components
1. Clinician programmer1.
2. Charger2.
3. Paent controller3.
4. Generator4.
5. Leads/Extensions/Adapters5.
6. Magnet6.
indicates devices communicate through
Bluetooth® wireless technology
NOTE: This manual provides instrucons for implanng the generator. For instrucons for using other
components or more informaon about the neurosmulaon system, see the applicable manuals for those
components.
Product Descripon
This implantable pulse generator is a rechargeable electronic device designed to be connected to one or
more extensions or leads with up to 16 electrodes total. It is powered by a hermecally sealed rechargeable
baery within a tanium case and uses microelectronic circuitry to generate constant-current electrical
smulaon. The generator can deliver smulaon with a single program or with mulple programs. Each
program can provide smulaon to a single anatomical area or to mulple areas. The generator
communicates wirelessly with the clinician programmer and the paent controller and receives radio
frequency energy from an external charger to charge the generator baery.
Addional funcons supported:
▪Upgradeability. Soware upgrades aer implantaon provide paents with addional features as▪
approved by the respecve regulatory agencies. To upgrade features on the generator, a clinician
programmer or paent controller is needed.
▪Compability. The generator header is designed to allow the generator to connect to an Abbo adapter ▪
so compable leads or extensions from another manufacturer can be used with the Eterna™ SCS
system. Refer to the compability guidelines in this manual (see “Adapters and Extensions for
Compability with Non-Abbo Leads” (page 12)).
6

Package Contents
In addion to the product documentaon, the generator kit contains the following items:
▪1 generator (Model 32400) ▪
▪1 pocket sizer (Model 12720) ▪
▪1 torque wrench (Model 1101) ▪
▪2 port plugs (Model 12710)
▪
Idenfying the Generator
You can idenfy the generator in the following ways:
▪The model number and barcode are engraved on the generator.
▪
▪The generator has a radiopaque idencaon tag in the lower right corner that can be viewed with▪
standard X-ray procedures. On the tag, ABT idenes Abbo Medical as the manufacturer, and the
leer and a number combinaon A2 idenes the model family. Addionally, the header port plug is
radiopaque and, if used, is visible with standard x‑ray procedures (see the following gure).
▪The clinician programmer app when connected to the generator indicates the model number and allows▪
you to view other generator informaon. See the clinician programmer manual for instrucons.
Figure 2. Locaon of the generator code on the Eterna™ implantable pulse generator
Direcons for Use
Read this secon carefully for suggested direcons for use related to the Eterna™ implantable pulse
generator. For direcons for use for other system components such as the clinician programmer, see the
clinician’s manual for the clinician programmer.
NOTE: Before the surgical procedure, set up communicaon between the clinician programmer and the
generator while the generator is in its sterile packaging to ensure that it is funconal and fully charged. If
the generator has never established communicaon with a programmer, you must rst acvate the
generator for communicaon by holding the magnet over the generator for 8 to 25 seconds.
NOTE: Ensure the generator is fully charged before implantaon. The generator can be charged through its
sterile packaging.
Creang a Generator Pocket
The following steps outline the suggested procedure to create an generator pocket:
1. Determine the site for the generator, ensuring that the lead is long enough to reach the pocket and 1.
provide a strain relief loop.
NOTE: Common sites for generator implantaon are along the midaxillary line, in the upper buock
along the posterior axillary line (taking care to avoid the belt line), and in the area over the abdomen
just below the lowermost rib. To ensure a at area is selected, you can mark a at area prior to the
surgical procedure while the paent is in a sing posion.
CAUTION: Do not place the generator deeper than 2.5 cm (0.98 in.) because the clinician
programmer, generator charger, and paent magnet may not communicate eecvely with the
generator.
CAUTION: Ensure the generator is set to Surgery mode using the clinician programmer.
7

2. Create the pocket so that the generator is parallel to the skin surface. Ensure the pocket is at least2.
0.5 cm (0.20 in.) below the surface of the skin but does not exceed a depth of 2.5 cm (0.98 in.).
3. Insert and remove the pocket sizer to ensure that the pocket is large enough to accommodate the3.
generator, allowing enough extra room for a strain relief loop for each lead or extension.
Connecng a Lead or Extension to the Generator
The following steps outline the suggested guidelines to connect a lead or extension to the generator:
WARNING: To avoid harming the paent or damaging the neurosmulaon system, ensure that any
electrosurgery procedures are completed before connecng the leads or extensions to the generator.
CAUTION: Do not connect a lead or extension with body uid or saline residue on its contacts because
corrosion can occur and cause failure of the system.
1. If any of the lead or extension contacts are exposed to body uid or saline, thoroughly clean the1.
contacts with sterile deionized water or sterile water for irrigaon and dry them completely.
2. To help ensure that the lead or extension can be fully inserted into the generator header, insert the
2.
torque wrench through the septum on the generator header, turn the torque wrench clockwise to
ghten the setscrew unl the torque wrench clicks, and then loosen the setscrew again by turning the
wrench counterclockwise about 2.5 mes.
CAUTION: Use only the torque wrench included in the extension, generator, or torque wrench kit. If
you need to loosen the setscrew, turn the setscrew (in quarter turns counterclockwise) just enough
to insert or remove the lead or extension from the generator header. Retracng the setscrew too
far may cause it to come loose and fail to secure the lead or extension to the generator.
CAUTION: To avoid sharply bending and damaging the lead or extension when performing the
following step, insert the lead or extension parallel with the header port. Addionally, try grasping
the lead or extension about 5 mm at a me from the opening of the header port while inserng.
3. Using clean gloves, carefully slide the proximal end of the lead or extension into the generator header 3.
unl it stops. Conrm that the lead or extension is correctly inserted by following these visual indicators
and referring to the following gure:
–The rst contact band (at the p) of the lead or extension extends slightly past the rst header –
contact and is visible, the windows between each of the header contacts are clear, and the ninth
contact band of the lead or extension is not visible.
Figure 3. Correct versus incorrect inseron of the lead or extension
Fully inserted
1. First contact band (p) is visible past the rst1. header contact
2. Window between each header contact is clear2.
3. Ninth contact band is not visible3.
Not fully inserted
4. First contact band (p) is not visible past the rst4. header contact
5. Window between each header contact is5. parally blocked by contact band
6. Ninth contact band is visible6.
4. Use the clinician programmer app to communicate with the generator and test the impedance to4.
ensure that the lead or extension is fully inserted. See the clinician's manual for the clinician
programmer app for instrucons.
NOTE: To test the system integrity turn o Surgery mode. Aer system integrity has been veried, set
the generator back into Surgery mode before closing the pocket.
NOTE: If the system integrity check fails, disconnect the lead or extension and reconnect to the
generator. Repeat the system integrity check.
8
–

5. Insert the torque wrench through the septum and ghten the setscrew, turning it clockwise unl the5.
torque wrench clicks.
NOTE: Aer removing the torque wrench, check the septum to ensure it has closed. If the septum did
not close, gently reseat the septum aps.
Figure 4. Tighten the setscrew clockwise
6. If implanng two leads, repeat the previous steps. If implanng a single lead only, insert the header port
6.
plug into the unused port, and use the torque wrench to ghten the setscrew unl the torque wrench
clicks.
Figure 5. Insert the port plug
Implanng the Generator
The following steps outline the suggested procedure to implant the generator:
CAUTION: Do not implant the IPG face down. Implant it with the label facing toward the skin, or it may
not communicate or recharge.
1. Place the generator into the generator pocket. The depth of the generator pocket from the surface of 1.
the generator to the surface of the skin should be at least 0.5 cm (0.20 in.) and not exceeding
2.5 cm (0.98 in.).
2. Carefully coil any excess lead or extension behind the generator in loops no smaller than 2.
2.5 cm (0.98 in.) in diameter to provide strain relief for the lead or extension and generator connecon.
CAUTION: Do not bring the suture needle in contact with a generator, lead, or extension, or the
component may be damaged.
3. To stabilize the generator within the pocket, pass suture through the hole at the top of the generator3.
header and through the hole on the side of the generator header, and secure these to connecve ssue.
4. Check the enre system by uoroscopy before closing to ensure proper posioning of the lead or leads 4.
and that the lead or leads are straight, with no sharp bends or kinks.
5. Use the clinician programmer app to communicate with the generator and perform intraoperave5.
tesng to conrm that the system is operaonal. See the clinician's manual of the clinician programmer
app for instrucons.
NOTE: Generator output may not be idencal to that of the trial smulator at the same sengs.
NOTE: Ensure the generator is set to Surgery mode.
6. Ensure that the generator is away from the pocket incision suture line, close the pocket incision, and6.
apply the appropriate dressings.
NOTE: When the surgical procedure is completed, ensure Surgery mode has been turned o.
9

Replacing the Generator
The following steps outline the suggested procedure to replace an generator:
1. Turn o smulaon or verify that it is turned o.1.
CAUTION: Exercise care when using sharp instruments or electrocautery around leads or
extensions, or they may be damaged.
2. Open the generator implant site per normal surgical procedure.2.
3. Insert the torque wrench through the septum of the generator header and loosen the setscrew by3.
turning it counterclockwise.
CAUTION: When performing the following step, do not bend the lead or extension sharply; or it
may be damaged.
4. Gently remove the lead or extension from the generator header; then clean and dry all connecons,4.
ensuring they are free of uid and ssue.
5. To complete the generator replacement procedure, see the following secons: “Connecng a Lead or
5.
Extension to the Generator” (page 8) and “Implanng the Generator” (page 9).
Disposing of Explanted Components
Explanted Abbo Medical components should be returned to Abbo Medical for proper disposal. To return
an explanted component, place it in a container or bag marked with a biohazard label and coordinate the
return with your Abbo Medical representave or Technical Support.
Checking the Status of the Generator Baery
The generator contains a rechargeable baery. The amount of me that the baery will provide acve
smulaon depends on the paent’s smulaon sengs and daily usage me. To check the status of the
generator baery, use the clinician programmer app or paent controller app.
NOTE: Generator baery status is available upon inial connecon to the clinician programmer app and the
paent controller app.
The following list provides addional informaon about the baery status:
▪Smulaon will automacally stop when the baery cannot support smulaon.▪
▪Alert messages will appear on the clinician programmer app and the paent controller app when the▪
generator baery is low or depleted and when charging is required to maintain uninterrupted
smulaon therapy.
▪An elecve replacement indicator (ERI) message will appear on the clinician programmer app and▪
paent controller app stang the generator may need to be replaced due to the generator baery
approaching its end of service.
NOTE: With rechargeable baeries, intervals between charging may become more frequent with use
over me.
Technical Support
For technical quesons and support for your product, use the following informaon:
▪[phone] (toll-free within North America)▪
▪[phone]▪
For addional assistance, call your local Abbo Medical representave.
10

Appendix A: Product Specicaons
Storage and Excursion Temperature Specicaons
Store the components in this kit according to the following recommended condions.
Table 1. Recommended storage and excursion condions for components
Long Term Storage Temperature Store at 23°C or 73°F
Temperature Excursions Excursions below 15°C (59°F) or above 30°C (86°F)
should be <24 hours in duraon
Excursion Temperature Limits -20°C (-4°F) to 60°C to (140°F)
Product Materials
The following materials are intended to come into contact with ssue.
Table 2. Product materials for generator kit
Component Material
Generator Titanium, silicone rubber, epoxy resin
Pocket sizer Polybutylene terephthalate
Port plug Polyether ether ketone (PEEK) with barium sulfate
NOTE: These components are not made with natural rubber latex.
Generator Specicaons
The Eterna™ implantable pulse generator has the following physical specicaons.
Table 3. Generator specicaons
Specicaons Model 32400
MR Condional Yes
Upgradeable features Yes
BurstDR™ smulaon capable Yes
Height 3.87 cm (1.52 in.)
Length 4.81 cm (1.89 in.)
Thickness 0.90 cm (0.36 in.)
Weight 26.4 g (0.93 oz)
Volume 13.79 cm3 (0.84 in.3)
Power source Rechargeable lithium ion cell baery
Connector specicaons Two 8‑channel connectors
In‑line, 2.54 mm (0.1 in.) spacing
Connector strength: 5N
Program storage capacity 16 programs with 8 sm sets each
11

The generator has the following operang parameters.
Table 4. Operang parameters for the generator
Parameter Tonic Range Tonic Steps Burst Range* Burst Steps*
Pulse width 20–1000 µs 10 µs
(20–500 µs range)
50 µs
(500–1000 µs range)
50–1000 µs 50 µs
Frequency 2–200 Hz 2 Hz — —
200–500 Hz 10 Hz — —
500–1200 Hz 20 Hz — —
Burst frequency — — 10–60 Hz 10 Hz
Intra-burst rate — — 250–500 Hz 10 Hz
500–1000 Hz 20 Hz
Amplitude 0–25.5 mA 0.1–1.0 mA
0–12.75 mA 0.05–0.50 mA
0–12.75 mA 0.05–0.50 mA
NOTE: Columns with * represent operang parameters for BurstDR™ smulaon programs on generators
capable of BurstDR smulaon mode.
NOTE: For each tonic program, you have the opon to select the amplitude range. For informaon on
seng the amplitude range, see the clinician's programming manual for this system.
NOTE: The number of sm sets in use for a tonic program governs the maximum frequency (1200/
number of sm sets).
NOTE: The maximum current depends on the impedance, frequency, and pulse width sengs.
Adapters and Extensions for Compability with Non-Abbo Leads
The Eterna™ implantable pulse generator is compable with select Medtronic leads and extensions.
However, a compable adapter or extension must be used to connect the Eterna™ implantable pulse
generator to Medtronic leads. Compable adapter and extension models are listed in the following table.
Refer to the clinician manuals of the A127™ extension and the 8‑channel adapter for the list of compable
Medtronic leads and extensions.
Table 5. Compable Abbo Adapters
Device Model
A127™ Extension 2341, 2342, 2343, 2346
8‑Channel Adapter 2311, 2316
WARNING: Always use a compable adapter to connect the Eterna™ implantable pulse generator to
compable Medtronic leads and extensions. Do not insert a Medtronic lead or extension directly into
the Eterna generator header as this may damage the header.
12

Appendix B: System Components and Accessories
The Eterna™ SCS system includes the following components.
NOTE: Not all models are available in all countries. Contact your local representave for more informaon.
NOTE: Refer to the terms and condions for repair or replacement of Abbo Medical neurosmulaon
system components as stated in the Limited Warranty card included in your product documentaon.
Generator
Model Descripon
32400 Eterna™ implantable pulse generator
Generator Accessories
Model Descripon
1101 Torque wrench
12710 Port plug
Charging System
Model Descripon
16000 Charger
Charging System Accessories
Model Descripon
14700 Adhesive
16730 Travel case
16740 Charging cable and power adapter kit
16750 Charging apparel kit – lumbar
16760 Charging apparel kit – pectoral
36000 Charger kit – lumbar
66000 Charger kit – pectoral
Programmers and Controllers
Model Descripon
55500 Paent controller app
55600 Clinician programmer app
Programmer and Controller Accessories
Model Descripon
1210 Magnet kit
13

Model Descripon
35500 SCS paent controller kit
Leads and Extensions
Model Descripon
3100-series Percutaneous leads
3200-series Paddle leads
3300-series Extensions
Leads and Extensions Accessories
Model Descripon
1100-series Stylets
1102 Guidewire for percutaneous leads
1103 Introde-AK™ lead introducer
1105 Lead anchor, buery
1106 Lead anchor, long
1109 Strain relief
1112 Tunneling tool, 12 in.
1114 Epidural needle, 14 gauge, 4 in. (10 cm)
1116 Epidural needle, 14 gauge, 6 in. (15 cm)
1120 Tunneling tool, 20 in.
1192 Swi-Lock™ anchor
1194 Cinch™ anchor
1701 SCS accessory kit
Adapters and Extensions
Model Descripon
2311 8-channel adapter, M, 10 cm
2316 8-channel adapter, M, 60 cm
2341 A127™ extension, 15 cm
2342 A127™ extension, 40 cm
2343 A127™ extension, 60 cm
2346 A127™ extension, 90 cm
14

Appendix C: Generator Baery Informaon
The Eterna™ implantable pulse generator contains a rechargeable lithium ion baery. This baery should
provide at least 10 years of service before replacement is recommended. If the paent does not charge the
generator baery, smulaon will eventually stop. At nominal smulaon sengs, 1 hour of charging
should be sucient to support 3 weeks or more of smulaon therapy.
When a program requires a paent to charge more than once a day, an elecve replacement indicator (ERI)
message may display in the paent controller indicang that the generator is approaching its end of service
and to consult the physician to determine if generator replacement is needed.
Baery longevity and the me it takes to recharge a baery depend on mulple factors, including but not
limited to the following:
▪Program smulaon sengs, such as frequency, pulse width, amplitude, and number of acve
▪
electrodes
▪Program dosage
▪
▪Program impedance ▪
▪Daily usage me ▪
▪Age of the generator baery▪
▪Length of me since the last charge ▪
▪Shelf life of the device between the dates of manufacture and implant▪
▪Duraon of communicaon sessions between the generator and the paent controller or clinician ▪
programmer
▪If the generator was stored outside of recommended storage temperatures ▪
Nominal smulaon sengs for BurstDR™ programs are as follows:
▪2 leads▪
▪1 area▪
▪BurstDR™ smulaon▪
▪5 pulses per Burst▪
▪Amplitude: 0.6 mA▪
▪Pulse width: 1000 µs▪
▪Burst frequency: 40 Hz▪
▪Intra-burst rate: 500 Hz▪
▪Intermient dosage with 30 seconds On Time and 90 seconds O Time▪
▪Therapy on 24 hours a day▪
▪Program impedance: 525 Ω▪
Appendix D: Regulatory Statements
This secon contains regulatory statements about your product.
Disposal Guidelines for Baery-Powered Devices
This device contains a baery and a label is axed to the device in accordance with European Council
direcves 2002/96/EC and 2006/66/EC. These direcves call for separate collecon and disposal of electrical
and electronic equipment and baeries. Sorng such waste and removing it from other forms of waste
lessens the contribuon of potenally toxic substances into municipal disposal systems and into the larger
ecosystem. Return the device to Abbo Medical at the end of its operang life.
Statement of FCC Compliance
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to
part 15 of the FCC rules. These limits are designed to provide reasonable protecon against harmful
15

interference in a residenal installaon. This equipment generates, uses, and can radiate radiofrequency
energy and, if not installed and used in accordance with the instrucons, may cause harmful interference to
radio communicaons. However, there is no guarantee that interference will not occur in a parcular
installaon. If this equipment does cause harmful interference to radio or television recepon, which can be
determined by turning the equipment o and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
▪Reorient or relocate the receiving antenna.▪
▪Increase the separaon between the equipment and receiver. ▪
▪Connect the equipment into an outlet on a circuit dierent from that to which the receiver is
▪
connected.
▪Consult the dealer or an experienced radio/TV technician for help.
▪
Operaon is subject to the following two condions:
▪This device may not cause harmful interference.
▪
▪This device must accept any interference received, including interference that may cause undesired▪
operaon.
Modicaons not expressly approved by the manufacturer could void the user’s authority to operate the
equipment under FCC rules.
Idencaon Informaon for Product Registraon
This device has a label that contains, among other informaon, a product idener in the following format:
Table 6. Registraon idencaon informaon
Idener Type Registraon Idener
FCC registraon number PX2-GMIPG1
Wireless Technology Informaon
The following table summarizes the technical details of the Bluetooth® Low Energy as it is implemented in
the device.
Table 7. Bluetooth® Low Energy informaon
Antenna type Modied monopole
Antenna dimensions 10.7 mm x 4.3 mm x 3.0 mm
Modulaon GFSK
Output power (EIRP*) 2 mW (+3 dBm) typical
Duty cycle 14.1% or less over 6 min period
Range Up to 2 m typical
Center frequency 2.44 GHz
Channel frequency range 2.402 GHz to 2.480 GHz
Channel 40 logical channels using AFH
Bandwidth per channel 2 MHz
Data ow Bi-direconal
Protocol Bluetooth® Low Energy
Semi-duplex capability Yes
*EIRP = Equivalent isotropically radiated power (not duty cycle adjusted)
16