Abbott Eterna 32400 - Appendix C: Generator Battery Information; Battery Life and Charging; BurstDR Nominal Settings; Appendix D: Regulatory Statements

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
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