Otto Bock ActiGait - 4.4 Potential Risks;Side effects

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• The internal batteries in the Control Unit and Heel Switch are not replaceable. If
you open the Control Unit or Heel Switch, the seals will be broken and you will
compromise the ingress protection. The Control Unit battery has a life time of
5 years. When the capacity of the Control Unit battery is no longer sucient to
last for 1 day of use, the Control Unit should be discarded and replaced with a
new one. When the Heel Switch battery runs out of power, the whole Heel Switch
must be discarded and replaced with a new one.
• The ActiGait® should not be used while operating dangerous machines, which
require foot or leg operation with the aected leg, such as motor vehicles, air-
planes, industrial machinery etc., as failure of the ActiGait® may leave the patient
in a dangerous situation.
• The ActiGait® fullls all technical and legal requirements for use in the European
Community. The ActiGait® has not yet been formally investigated for use outside
this area. ActiGait® uses a wireless communication technology. Restrictions of
its use may exist in some countries outside the area mentioned above. Please
contact your local ActiGait® representative if in doubt whether the ActiGait® may
be used in a specic area outside the European Community.
• There is a risk of rupture of the skin if the sutures are removed earlier than 14
days post surgery.
• Preoperative use of antibiotics is recommended to reduce the risk of infection.
Infection is a potential hazard at any kind of surgery and the principle of preop-
erative use of antibiotics is therefore generally accepted.
• If the leg is not bandaged with elastic bandage or antithrombotic stocking up to
the groin after surgery, uid collections, such as oedema, may occur around the
Implant.
4.4 Potential Risks/Side effects
As with all surgical procedures, the implantation of a stimulation system involves
some risks. In addition to those normally associated with surgery, the implantation
and use of the ActiGait® carries the following risks:
• Infection
• Accidental damage of the nerve during surgery
• Subjects undergoing anticoagulation therapies may be at greater risk for post
operative complications such as hematomas
• Reoperation due to malfunction of the Implant