Instructions For Use; Verifying Neurostimulator Operation; Connecting The Extension To The Neurostimulator - Medtronic Itrel 4 Implantationsanleitung

Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)

Instructions for use

Implanting physicians should be experienced in epidural-access procedures, as well as
thoroughly familiar with all product labeling.
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Cautions:
▪
When using sharp instruments near the neurostimulator, be extremely careful to
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
circuit.

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 service life. (Refer to the software manual for instructions on how to
read the battery service life.)
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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.
Note: The neurostimulator pocket may be flushed with an antibiotic solution; do not submerge
the neurostimulator in fluid.

Connecting the extension to the neurostimulator

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Caution: Before connecting components, wipe off any body fluids and dry all
connections. Fluids in the connection may result in stimulation at the connection site,
intermittent stimulation, or loss of stimulation.
1. Wipe the extension connector pins with sterile gauze. If necessary, use sterile (United
States Pharmacopeia [USP]) water or a nonionic antibiotic solution.
2. Make sure the connector block receptacles are dry and clean.
3. Insert the appropriate extension connector pins into the appropriate neurostimulator
socket until they are seated fully within the connector block (Figure 1). If resistance is
felt while inserting the connector pins, use the torque wrench (packaged with the
neurostimulator) to retract the setscrews.
Note: To retract the setscrews, insert the torque wrench into the self-sealing grommet
and rotate the setscrews counterclockwise; however, do not remove the setscrews from
the connector block.
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Cautions:
▪
Do not insert the extension connector into the connector block if the setscrews
are not sufficiently retracted. If the setscrews are not retracted, the extension
M948681A002
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