Complications Associated With Device / Charger Operation; Following Implantation - Impulse Dynamics OPTIMIZER Lite System Patient Manual

For the treatment of moderate to severe heart failure
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4.2
Complications associated with device/charger operation include,
but are not limited to:
5.0

FOLLOWING IMPLANTATION

You must become actively involved in your own recovery by following your
doctor's instructions carefully, including:
Report any redness, swelling, or drainage from your incision to
your doctor.
Avoid lifting heavy objects until instructed by your doctor.
Walk, exercise, and bathe according to your doctor's instructions.
Be sure to contact your doctor if you develop a fever that persists
for more than two or three days.
Ask your doctor any questions you may have about your device,
heart rhythm, or medications. Be sure to take all medications as
directed by your doctor.
Do not wear tight clothing that could irritate the skin over the
device.
Avoid rubbing the device or the surrounding chest area.
If directed by your doctor, limit any arm movements that may
affect the implanted lead system.
Avoid rough contact that could result in blows to the implant site. If
you fall or are in an accident that results in an impact to the
implant site, contact your doctor.
Complications Associated with Device /
Charger Operation
An OPTIMIZER Lite IPG may not properly sense and
deliver CCM signals due to a software or hardware
problem, necessitating replacement.
An OPTIMIZER Lite IPG may detect environmental
interference and inappropriately deliver CCM therapy.
See Section 6.4.
A Vesta Charger may not function as designed due to a
software or hardware problem and not charge your
OPTIMIZER Lite IPG as intended. A replacement charger
will be required.
6

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