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your stimulator to fracture or migrate. This can result in a loss of stimulation,
intermittent stimulation, and additional medical procedures.
Scuba diving or hyperbaric chambers
– Do not dive below 13 meters (45 feet)
of water or enter hyperbaric chambers above 1.5 atmospheres absolute (ATA).
These conditions can damage the device. Before diving or using a hyperbaric
chamber, discuss the effects of high pressure with the clinician.
Skydiving, skiing, or hiking in the mountains
– High altitude should not affect
the System. However, take care to not put undue stress on the Stimulator.
During skydiving, the sudden jerking that occurs when the parachute opens can
dislodge or fracture the Stimulator. This can result in a loss of stimulation,
intermittent stimulation, and additional medical procedures.
Unexpected changes in stimulation
– Electromagnetic interference, changes in
posture, and other activities can cause a perceived increase in stimulation.
Some patients have described this as a jolting or shocking sensation. You
should reduce your amplitude to the lowest setting and turn OFF your System
before engaging in activities that could become unsafe. Discuss these activities
with your clinician.
Interference during programming
- If interference is suspected during
programming of the WAA Programmer, the clinician should confirm that the
Bluetooth® data transmission is operating properly. Bluetooth® data
communication is confirmed by the blue light indicator on the WAA
Programmer blinking. If during the programming session the light indicator is
not blinking then the clinician should do the following:
•
Terminate the current programming session and shut down the
WaveCrest Application.
•
Check for sources of Bluetooth® interference in the surrounding area.
•
Remove or turn off the source of interference.
•
Re-establish the Bluetooth® link with the WAA Programmer through
pairing.
•
Resume programming by opening the WaveCrest Application.
•
Confirm the light indicator is now blinking.
