14
Cautions:
• Avoid pulling the lead body taut when implanted.
• Do not attempt to insert the lead into the Neurostimulator if the setscrew is not sufficiently retracted as doing so may cause damage to the lead and/or cause the lead to not seat
fully into the connector block.
• Ensure that the setscrew tightens on the retention sleeve, not an electrode. Tightening the setscrew onto the contact could damage the contact, leading to lack of therapy.
5. Fully insert the torque wrench into the hole of the Neurostimulator connector block. Tighten the setscrew by turning the torque wrench clockwise until it clicks
(Figure 6)
.
PROPOSED AXONICS FIGURE
PROPOSED AXONICS FIGURE
Figure 5: Use the torque wrench to turn the
setscrew counterclockwise to remove
the Neurostimulator setscrew.
Figure 6: Secure the lead by tightening the
setscrew clockwise onto the retention sleeve.
Figure 6:
Secure the lead by tightening the setscrew clockwise onto the retention sleeve.
Cautions:
• Ensure that the torque wrench is fully inserted into the setscrew. Otherwise the setscrew may be damaged, which can result in intermittent or loss of stimulation.
• The torque wrench is designed for single use only and cannot be assured to work appropriately if used for multiple surgeries. Discard the torque wrench after use.
Implanting the Neurostimulator
1. Place the Neurostimulator into the subcutaneous pocket. Ensure that the ceramic side is placed away from the patient’s midline to ensure good communication with the Remote
Control and ease of recharging
(Figure 3)
. The etched writing can face either towards or away from the muscle tissue. Ensure that the lead curves gently away from the
Neurostimulator with no sharp bends.
Note:
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, telemetry and/or charging may be unsuccessful.
Caution:
Do not coil excess length in front of Neurostimulator. Wrap excess length around the perimeter of the Neurostimulator
(Figure 7)
or place under the Neurostimulator to
minimize interference with telemetry during programming.
PROPOSED AXONICS FIGURE
Figure 7: Wrap excess lead around or under, but not on top
of, the Neurostimulator.
Figure 7:
Wrap excess lead around or under, but not on top of, the Neurostimulator.
2. Use the Clinician Programmer to check the impedances and ensure good function and connectivity of the system.
Notes:
• The Neurostimulator should be in the subcutaneous pocket during system interrogation to ensure proper readings.
• Refer to the Clinician Programming Manual for detailed instruction on checking the system integrity and impedances.
3. Use the suture hole in the header to secure the Neurostimulator to the muscle fascia with non-absorbable silk.
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