Otto Bock ActiGait - Page 7

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• Attending product training by OB personnel
• Observing or assisting in the implantation of an ActiGait® Implant by an
experienced surgeon
• Performing the rst surgery under supervision of a surgeon experienced in
the procedure
• The clinicians, who select the patients and set up the ActiGait® stimulation,
must be properly trained by someone experienced in patient selection and
programming of the ActiGait®. The trainer must be authorized by Otto Bock. Im-
proper selection of patients and programming of the ActiGait® may result in lack
of eect of stimulation or lack of improvement of gait. Improper selection and
programming may expose the patient to dangerous situations, discomfort or pain
and the risk of falling during walking.
• ActiGait® patients should not engage in any activity which leaves them in a dan-
gerous situation if the ActiGait® fails.
• The ActiGait® should not be exposed to therapeutic levels of ultrasound energy,
as the device may inadvertently concentrate the ultrasound eld and cause harm.
• Shortwave or microwave diathermy should not be used. Both the heating and
non-heating modes of operation pose a risk of tissue destruction. If given any
medical treatment in which an electrical current is passed through the body from
an external source, care should be taken to monitor the functioning of the Acti-
Gait® Implant during the initial stages of treatment.
• The electronic components of the ActiGait® Implant may be damaged by thera-
peutic ionizing radiation. This kind of damage may not be immediately detect-
able.
• Application of magnetic resonance imaging (MRI) or spectroscopy techniques to
a patient with the ActiGait® Implant involves a risk of potentially hazardous side
eects. Patients with an ActiGait® Implant should seek medical guidance before
entering environments with strong magnetic or electromagnetic elds, such as
magnetic resonance (MR) scanners or strong radio-transmitters or radars, includ-
ing areas protected by a warning notice preventing entry by patients tted with
a pacemaker, as strong electromagnetic elds may heat the device excessively or
result in uncontrolled pulses.
• Use of electrical stimulation in pregnancy involves a risk of potentially hazard-
ous side eects. For use during pregnancy qualied medical guidance should be
obtained.
• Extended periods of time with the legs in a xed position, e.g. during travelling,
should be avoided as this may cause uid retention in the leg.