Document Reference: ENG-UMAN-000730
Revision: 6.00
Page 9 of 40
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.
•
All Evoke™ sterilized components are single use only and should not be re-sterilized
or reused, because of the risk of infection and device malfunction.
•
Please observe the storage conditions printed on the labels of each component –
particularly storage and transport temperature, which varies between components –
as inadequate storage could have a negative impact on shelf-life and sterility.
•
Please observe the expiration dates printed on the labels and return any expired
product to Saluda Medical because of the risk of infection.
