Otto Bock ActiGait - 1. Introduction; 2. Intended Use; 2.1 Medical Purpose; 2.2 Application

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1. Introduction
This manual describes the use of the ActiGait® and is directed towards individuals
with an ActiGait® Implant. The manual is to be used as an information resource and
an instruction manual. The term “User” denes individuals who have an ActiGait®
Implant and thereby are users of the ActiGait®.
For clinicians the Clinician Manual (647G805=GB) is available
2. Intended Use
2.1 Medical Purpose
The ActiGait® is solely to be used as treatment in patients having a drop foot follow-
ing an upper motor neuron lesion.
2.2 Application
The ActiGait® system is a partially implantable medical device for treatment of drop
foot which activates the muscles of the lower leg during walking. The system is
intended for use by persons suering from paralysis of the ankle dorsiexor muscles
caused by damage to the central nervous system. The largest group of potential users
are persons with hemiplegia as a consequence of stroke. The system will not function
for people with drop foot caused by peripheral nerve damage.
2.3 QualicationofClinician
The selection of users for ActiGait®, setup and adjustment are done by clinicians such
as medical doctors, physiotherapists or equivalent. To be able to program and adjust
the ActiGait®, the clinician must have obtained a certicate on usage of the Clinical
Station software following training by Otto Bock
2.4 Follow up Schedule
It is recommended that the ActiGait® is activated 1-3 weeks after implantation, as the
wound healing must be nished rst. The user should thereafter be followed closely
with 2-3 follow-ups during the rst 6 months for ne-tuning of the settings and gen-
eral guidance. Subsequently, the user should be seen in the clinic on request.