Impulse Dymanics OPTIMIZER Smart System - Extrapolated Battery Life; Extrapolated Battery Charge Longevity

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1.6 Extrapolated Battery Life
The expected life of the Optimizer Smart IPG is limited by the expected service life of its
rechargeable battery. The rechargeable battery inside the Optimizer Smart IPG should
provide at least six years of service. Over time and with repeated charging, the battery in
the Optimizer Smart IPG will lose its ability to recover its full capacity.
Once the implant reaches its sixth year of service, it will have entered its elective
replacement period. The Optimizer Smart IPG will need replacement when stimulation
can no longer be maintained for a full week with routine weekly charging. In the sixth
year of service, it is thus important that the patient will be instructed to fully charge the
Optimizer Smart IPG seven days prior to routine checkup visits so that the physician may
determine if the Optimizer Smart IPG is still able to deliver a full week of CCM therapy
when recharged weekly.
The Optimizer Smart IPG is estimated to reach the end of its useful service at seven years
after implant, and replacement of the Optimizer Smart IPG is recommended at this point.
1.7 Extrapolated Battery Charge Longevity
Battery charge longevity can be estimated from the following tables. This is a
conservative estimate of charge longevity for OPTIMIZER Smart IPG at 5 and 7 V.
For CCM delivery of 7 hours per day as a function of parallel lead impedance:
Channels
impedance (OHM)
Stimulation
amplitude (V)
Charge longevity
(days)
220
5
20
220
7
11
300
5
26
300
7
15
600
5
46
600
7
28
900
5
60
900
7
38
1200
5
65
1200
7
44
This is the same but at 5 hours per day:
Channels
impedance (OHM)
Stimulation
amplitude (V)
Charge longevity
(days)
220
5
28
220
7
15
300
5
36
300
7
21
600
5
65
600
7
39
900
5
84
900
7
53
1200
5
90
1200
7
62