Otto Bock ActiGait, Руководство пользователя

Страница: 6 / 69

5
• concomitant medical and psychological conditions, which would compromise
the safety of the patient in connection with the implantation and use of the Ac-
tiGait®, such as: severe cardiac disease, uncontrolled hypertension or history of
malignancy within the preceding five years
• other active implanted devices, such as demand pacemakers or implanted defi -
brillators, as mutual electromagnetic interference may distort the efficacy of both
devices and expose the patient to dangerous situations
4. Warnings and Precautions
4.1 Safety precautions
Neurodan A/S is solely responsible for the safety, reliability, and function of the
apparatus on the condition that repairs, adjustments, and alterations, incl. replace-
ment of batteries, have been carried out by an individual appointed by Neurodan
A/S and when the apparatus is used in accordance with the manual.
The ActiGait® and the ActiGait® Accessories contain radio circuits approved by the
relevant authorities. Changes or modifications to any part of the ActiGait® or the
ActiGait® Accessories could void your authority to operate the equipment.
Maintenance may only be carried out by trained personnel. It is the responsibility of
the physician to inform the patient about all potential risks, warnings and precau-
tions.
It is the responsibility of the clinician to instruct the patient in the correct use of the
ActiGait® and to inform the patient to contact the clinician about any discomfort
while using the ActiGait®.
4.2 Warnings
• The ActiGait® is a device for treatment of drop foot, and must be considered and
used accordingly. Stimulation of other nerves besides the peroneal nerve with the
ActiGait® involves a risk of potentially hazardous side effects. It is not meant as a
device that eliminates or cures any condition.
• Implanting the ActiGait® Implant requires experience in peripheral nerve opera -
tions and handling of active implantable medical devices. Training is performed
by self-study of the Surgeon Manual and the following steps: