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Technical Service; End Of Programmed Service; Ipg Battery Life - Boston Scientific Precision Montage MRI Informacion Para Medicos

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Information for Prescribers

Technical Service

There are no user serviceable parts. If you have a specific question or issue, please contact
your Boston Scientific representative.

End of Programmed Service

The Precision Montage MRI System IPG software is programmed to end service after 12 years.
As the IPG nears the end of the programmed period, the Remote Control and Clinician
Programmer provide the following indicators to inform the user that the end of the programmed
period is approaching:
• Remote Control - Approximately six months before the end of programmed period, the
Remote Control displays a weekly message indicating the number of service days
remaining. Approximately one month before the end of the programmed period, the
message displays daily.
• Clinician Programmer - When less than six months of service remain, an indicator displays
on the Connect screen of the Clinician Programmer. When end of the programmed period
has been reached, a message displays when connecting to the Stimulator to indicate that
end of the programmed period has been reached and programming is not allowed.
Patients should contact their health care provider upon first receiving a message regarding the
number of service days remaining.

IPG Battery Life

The rechargeable battery in the Precision Montage MRI System IPG should provide at least
five years and up to 25 years or more of service.
is at least 30 days.
Over time, the IPG battery will need more frequent recharges. Like all
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rechargeable batteries, use over time and repeated recharge cycles reduce the maximum
charge capacity of the IPG battery.
The expected years of battery operation are defined as the longer of either:
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A. Typical case: the time at which therapy cannot be maintained with daily charging.
OR
B. High energy case: when the maximum recharge interval has decreased by more than 50 % from the initial recharge
interval.
This estimated recharge interval is based on the following assumptions:
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• The Precision Montage MRI IPG is newly implanted and at the beginning of its charging life.
• The IPG has been programmed to the following settings: Current amplitude: 4 mA; Pulse Width: 300 μs; Pulse Rate:
50 Hz and Impedance: 750 Ohms.
NOTE: Your actual settings may vary, thus varying the number of days for your recharge interval.
Precision Montage™ MRI System Information for Prescribers
91053246-04
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The IPG recharge interval at typical settings
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