Otto Bock ActiGait, Руководство пользователя

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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” defines 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 suffering from paralysis of the ankle dorsiflexor 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 Qualification 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 certificate 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 finished first. The user should thereafter be followed closely
with 2-3 follow-ups during the first 6 months for fine-tuning of the settings and gen -
eral guidance. Subsequently, the user should be seen in the clinic on request.