Document Reference: ENG-UMAN-000731
Revision: 5.00
Page 8 of 61
5.
Check the functioning of the Evoke System after the procedure and contact Saluda
Medical if any problems are apparent.
6.
For electrocautery, use bipolar mode if available.
Operating equipment
Patients may be distracted from operation of equipment if there are sudden
stimulation changes.
Patients should turn stimulation off before operating automobiles, other vehicles,
or potentially dangerous equipment.
Post-operative patient instructions
After implant of the Evoke System, patients should take care to allow adequate healing and
ensure that the leads and CLS do not move.
For six to eight weeks after surgery, patients should avoid:
o
lifting more than 2.2 kg (5 lbs);
o
physical activities requiring stretching, bending or twisting;
o
raising their arms above their head.
Patients may experience temporary pain at the implant site as the incisions heal
after the surgery.
Patients may experience redness or irritation at the implant site, in which case they
should contact their physician to check the wound for infection or adverse reaction
to the implanted materials.
Stimulator manipulation
Patients should avoid manipulating the Evoke System through the skin as it may
cause damage, lead or CLS movement, pain, irritation, or skin erosion.
If the CLS is “flipped” over inside the skin pocket it may no longer be able to be
charged.
Scuba diving
Patients should always obtain advice from their clinician prior to any diving
activities.
Patients should not dive below 5 m (16 ft.) or use hyperbaric chambers above 150
kPa (1.5 atm).
The CLS may be damaged at greater depths or pressures.
Implant failure
It is possible for the stimulator to stop working due to failure of a component or
battery, or a broken wire.
Patients should be advised to charge their stimulator fully and, if it still fails to work,
contact the Clinician.
Sterilization and storage
All surgical and implantable components of the Evoke System are supplied sterile.
The sterilized components of the Evoke System are sterilized using ethylene oxide.
