Helix Ottobock | 27
1.3 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
3D
Hip Joint System is a medical product,
which is designed exclusively for the tting on one patient. Use of the product by a further person is prohibited.
The Helix
3D
Hip Joint System has been designed for everyday life activities. It is not suitable for sports activities
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!
1.4 Qualication of the prosthetist
The tting with a Helix
3D
Hip Joint System may only be carried out by prosthetists who have been authorised by
Ottobock with a corresponding certication.
1.5 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
3D
Hip Joint System and result in risk of injuries
for the prosthesis wearer. Therefore, also advise the prosthesis wearer of the following rules.
1.5.1 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 certication course for the Helix
3D
Hip Joint System is obligatory before the rst t-
ting. Additional product training courses may become necessary to qualify for tting product updates.
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