Instructions For Use; Charging The Neurostimulator Battery; Verifying Neurostimulator Operation - Medtronic Activa RC Installationsanleitung

Instructions for use

Implanting physicians should be experienced in stereotactic and functional neurosurgery
and have expertise with functional stereotactic neurosurgical treatment of movement
disorders and should be thoroughly familiar with all product labeling.
Warning: DO NOT use the recharger on an unhealed wound. The recharging system
is not sterile, and contact with the wound can cause an infection.
Warning: Do not use saline or other ionic fluids at connections, which could result in
a short circuit.
Caution: Advise patients to charge the neurostimulator on a regular basis, taking into
consideration the therapeutic parameters and battery usage of the patient, to prevent
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
because battery capacity has been reduced.
▪
Battery function is not restored and the neurostimulator must be surgically
replaced. Battery function is not restored when:
–
the neurostimulator battery is permanently damaged.
–
the neurostimulator battery has been overdischarged and restored twice
before. The third time the battery is overdischarged, the neurostimulator will
reach end of service. Surgery is required to replace the neurostimulator.
Caution: When using sharp instruments near the neurostimulator, be extremely
careful to avoid nicking or damaging the case or the connector block. Damaging the
neurostimulator may require surgical replacement.

Charging the neurostimulator battery

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.)
Caution: Do not implant a neurostimulator if it was dropped onto a hard surface from
a height of 30 cm (12 in) or more, because the neurostimulator may be damaged and
fail to operate properly.
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