Abbott Eterna 32400, Руководство для клиницистов

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Appendix C: Generator Battery Information
The Eterna™ implantable pulse generator contains a rechargeable lithium ion battery. This battery should
provide at least 10 years of service before replacement is recommended. If the patient does not charge the
generator battery, stimulation will eventually stop. At nominal stimulation settings, 1 hour of charging
should be sufficient to support 3 weeks or more of stimulation therapy.
When a program requires a patient to charge more than once a day, an elective replacement indicator (ERI)
message may display in the patient controller indicating that the generator is approaching its end of service
and to consult the physician to determine if generator replacement is needed.
Battery longevity and the time it takes to recharge a battery depend on multiple factors, including but not
limited to the following:
▪ Program stimulation settings, such as frequency, pulse width, amplitude, and number of active ▪
electrodes
▪ Program dosage ▪
▪
Program impedance
▪
▪
Daily usage time
▪
▪
Age of the generator battery ▪
▪
Length of time since the last charge
▪
▪
Shelf life of the device between the dates of manufacture and implant
▪
▪
Duration of communication sessions between the generator and the patient controller or clinician ▪
programmer
▪ If the generator was stored outside of recommended storage temperatures ▪
Nominal stimulation settings for BurstDR™ programs are as follows:
▪ 2 leads ▪
▪
1 area
▪
▪
BurstDR™ stimulation
▪
▪
5 pulses per Burst
▪
▪
Amplitude: 0.6 mA ▪
▪
Pulse width: 1000 µs ▪
▪
Burst frequency: 40 Hz
▪
▪
Intra-burst rate: 500 Hz ▪
▪
Intermittent dosage with 30 seconds On Time and 90 seconds Off Time ▪
▪
Therapy on 24 hours a day
▪
▪
Program impedance: 525 Ω ▪
Appendix D: Regulatory Statements
This section contains regulatory statements about your product.
Disposal Guidelines for Battery-Powered Devices
This device contains a battery and a label is affixed to the device in accordance with European Council
directives 2002/96/EC and 2006/66/EC. These directives call for separate collection and disposal of electrical
and electronic equipment and batteries. Sorting such waste and removing it from other forms of waste
lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger
ecosystem. Return the device to Abbott Medical at the end of its operating 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 protection against harmful
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