Instructions For Use; Charging The Neurostimulator Battery; Verifying Neurostimulator Operation - Medtronic RESTOREADVANCED 37713 Manuel D'implantation

37713_ch.fm 12/5/07 10:05 am
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)

Instructions for use

Implanting physicians should be experienced in epidural-access procedures and should be
thoroughly familiar with all product labeling.
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Warning: DO NOT use the recharger on an unhealed wound. The recharger, antenna
and belt are not sterile, and contact with the wound may cause an infection.
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Caution: Advise patients to charge the neurostimulator when a low battery (
screen is displayed on the patient programmer or recharger; this prevents the battery from
overdischarging. If the neurostimulator battery is allowed to overdischarge, the patient
cannot charge the neurostimulator; however, the clinician may be able to restore the
battery function using the Physician Recharge Mode on the recharger (refer to the
troubleshooting section of the software manual).
Allowing the neurostimulator battery to overdischarge will permanently affect the
neurostimulator in one of the following ways:
Battery function is restored; however, charging sessions may be more frequent
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because battery capacity has been reduced.
Battery function is not restored and the neurostimulator must be surgically replaced.
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Battery function is not restored when:
The neurostimulator battery is permanently damaged.
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The neurostimulator battery has been overdischarged and restored twice before.
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The third time the battery is overdischarged, the neurostimulator will reach end of
service. Surgery is required to replace the neurostimulator.
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Cautions:
When using sharp instruments near the neurostimulator, be extremely careful to
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avoid nicking or damaging the case, the insulation, or the connector block. Damaging
the neurostimulator may require surgical replacement.
Do not use saline or other ionic fluids at connections, which could result in a short
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circuit.

Charging the neurostimulator battery

If desired, charge the neurostimulator battery before opening the package. For charging
instructions, refer to the charging system user manual.

Verifying neurostimulator operation

Before opening the sterile neurostimulator package, verify that the neurostimulator is operable
by using the clinician programmer to interrogate the neurostimulator and read the
neurostimulator battery charge level. (Refer to the software manual for instructions on how to
read the battery charge level.)
MA16387A004 Rev A
Medtronic Confidential
NeuroImplant_R01
)
37713 2007-12 English 9