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X-RAY IDENTIFICATION
The radiopaque marker allows physicians to identify the manufacturer and model number under standard x-ray procedures. For the Axonics Neurostimulator, the designated code is AXA,
which appears as light characters on a black background
(Figure 2)
.
PROPOSED AXONICS FIGURE
Figure 2: The Axonics Neurostimulator radiopaque marker, “AXA”.
Figure 2:
The Axonics Neurostimulator radiopaque marker,“AXA.”
NEUROSTIMULATOR IMPLANT PROCEDURE
The following section describes the procedure for implanting the Axonics Neurostimulator. This procedure should be performed when an Axonics tined lead has already been implanted.
Procedure supplies
In addition to the general surgical tools required by the physician, the following supplies are needed for the preparation, implantation, programming, and Remote Control pairing of the
Neurostimulator:
• Axonics Neurostimulator (Model 1101)
• Axonics Charging System
• Axonics Clinician Programmer
• Axonics Remote Control
Caution:
The user should avoid damaging the Neurostimulator and be especially cautious using sharp instruments as damage to the Neurostimulator may require a surgical
replacement.
Neurostimulator Preparation
Use the Charger to activate the Neurostimulator. Before opening the sterile Neurostimulator package, the Clinician Programmer (CP) should be used to communicate with the
Neurostimulator to verify the ability to communicate and to check battery status. If the Neurostimulator battery is low, the device should be charged through the box before implantation
by using the Charger. Refer to the CP and Charging System Manuals for further instructions.
Creating the Neurostimulator pocket
1. The Neurostimulator will be placed in a subcutaneous pocket at the anterior surface of the muscle in the upper buttock area. Create a small incision, slightly larger than the smaller
dimension of the Neurostimulator, and then bluntly dissect a subcutaneous pocket.
Notes:
• The Neurostimulator should be placed no deeper than 3.0 cm (about 1 in) below the skin and should be parallel to the skin. If the Neurostimulator is too deep or is not parallel to
the skin, charging and/or programming the device may be unsuccessful.
• The Neurostimulator should be implanted horizontally
(Figure 3)
with the ceramic side farthest from the patient’s midline to facilitate charging and programming.
• For a patient with another neurostimulator already implanted, the neurostimulators should be placed as far away as practical and separated by a minimum of 20 cm (8 in).
Cautions:
• The Neurostimulator implant site should be irrigated with antibiotic solution, and it is recommended that IV antibiotics be administered perioperatively. Do not soak the
Neurostimulator in antibiotic solution as this may affect lead connections.
• The Neurostimulator has been sterilized. The Neurostimulator should not be placed on any non-sterile surface. The Neurostimulator should not be placed on skin. An infection
may require surgical removal of the implanted system.
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