Use Instructions

4
1.5.2 Battery Behavior
The battery voltage of the OPTIMIZER Smart Mini IPG, when its battery is fully charged,
is approximately 4.1 V.
When battery voltage of the OPTIMIZER Smart Mini IPG drops to 3.5 V, the IPG places
itself in OOO mode (Standby mode) and stops performing any functions except telemetric
communication with the Intelio Programmer and Vesta Charger. The IPG will return to
normal behavior whenever, during the battery recharging process, its battery voltage
rises above 3.6 V.
If the battery voltage of the OPTIMIZER Smart Mini IPG drops below 3.2 V, the IPG
disconnects its circuitry from the battery and stops performing any functions, including
telemetric communication with the Intelio Programmer and Vesta Charger. The IPG will
return to normal behavior whenever the battery is recharged.
It is therefore recommended that the patient be instructed to charge the OPTIMIZER
Smart Mini IPG at least once a week. Immediate recharging is also recommended if the
battery level of the OPTIMIZER Smart Mini IPG, after interrogation with the Intelio
Programmer, is noted to be at or below 3.6 V.
1.5.3 Battery Service Life
The expected life of the OPTIMIZER Smart Mini IPG is limited by the expected service
life of its rechargeable battery. The rechargeable battery inside the OPTIMIZER Smart
Mini IPG should provide at least 20 years of service under normal use.
Over time the rechargeable battery in the OPTIMIZER Smart Mini IPG, being subjected
to repeated charge and discharge cycles, will lose its ability to maintain its expected
charge capacity.
Once the OPTIMIZER Smart Mini IPG reaches its 20th year of service, it should be
evaluated for elective replacement. The OPTIMIZER Smart Mini IPG will need to be
replaced when its battery, after being fully recharged, can no longer maintain enough
charge to deliver CCM therapy for a full week without becoming severely depleted.
In order to evaluate the OPTIMIZER Smart Mini IPG for elective replacement, it is
important that the patient be instructed to fully charge their OPTIMIZER Smart Mini IPG 7
days prior to their scheduled routine checkup visit so that the physician may perform an
evaluation of the battery charge capacity of their OPTIMIZER Smart Mini IPG.
1.6 OPTIMIZER Smart Mini IPG Packaging
The OPTIMIZER Smart Mini IPG is packaged in a sterile TYVEK/PETG blister package and
placed inside a shelf box that also contains the following items:
• Peel-off labels for use with implantation documents
• Literature pack (includes a printed copy of this document, a patient ID Card, and other
important information)
The TYVEK/PETG blister package has been sterilized with ethylene oxide gas and is comprised
of an inner TYVEK/PETG blister pack contained within an outer TYVEK/PETG blister package.
The inner blister pack contains the following items:
• One (1) OPTIMIZER Smart Mini IPG
• One (1) Allen #2 torque wrench (77.68 mNm = 11 oz-in)
• One (1) IS-1 Port Plug
1.7 OPTIMIZER Smart Mini IPG Storage
The recommended storage conditions for the OPTIMIZER Smart Mini IPG are as follows:
• Ambient temperature: 32°F to 104°F
• Atmospheric pressure: 14.81 inHg to 90.02 inHg