Conditions Of Use; Qualification Of The Prosthetist; Safety Instructions; General Safety Instructions - Ottobock 7E10 Helix3D Gebrauchsanweisung

1.4 Conditions of use

INFORMATION
Advise your patients of the information in this section.
CAUTION
Risk of injury when using the product on several patients. The Helix
which is designed exclusively for the fitting on one patient. Use of the product by a further person is prohibited.
The Helix Hip Joint System has been designed for everyday life activities. It is not suitable for sports activities
3D
and especially not for activities such as jogging, jumping, free climbing, parachute jumping, paragliding etc. For
the necessary environmental conditions, please see Section 5.2 "Technical information".
Careful handling of the prosthesis and its components not only increases their service life but, above all, ensures
the safety of the prosthesis wearer!

1.5 Qualification of the prosthetist

The fitting with a Helix
3D
Ottobock with a corresponding certification.

1.6 Safety instructions

CAUTION
Risk of injury in case of failure to follow the safety instructions. Failure to follow the safety instructions men­
tioned below can lead to faulty control or malfunction of the Helix
for the prosthesis wearer. Therefore, also advise the prosthesis wearer of the following rules.

1.6.1 General safety instructions

CAUTION
Danger caused by alignment and adjustment errors. During alignment and adjustment of the prosthesis,
errors can occur resulting in malfunction of the joint up to loss of function due to structural failure. This can
cause the patient to fall.
CAUTION
Participation in an Ottobock certification course for the Helix
ting. Additional product training courses may become necessary to qualify for fitting product updates.
CAUTION
Risk of injury caused by manipulations on system components. Any changes or modifications you make to
system components on your own initiative can lead to malfunction of the joint up to loss of function due to struc­
tural failure. This can cause the patient to fall.
• Any changes or modifications to the system may limit its use.
• The joint may only be opened and repaired by authorised Ottobock technicians. No adjustments or modifica­
tions on the Helix
3D
CAUTION
Malfunctions caused by using inappropriate prosthetic components. The Helix
be used with the C­Leg, the Genium and the prosthetic feet intended for use with them.
Helix
Hip Joint System may only be carried out by prosthetists who have been authorised by
Hip Joint except those described in this manual are permitted.
Hip Joint System is a medical product,
3D
Hip Joint System and result in risk of injuries
3D
Hip Joint System is obligatory before the first fit­
3D
3D
hip joint system may only
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