Combination Possibilities; Conditions Of Use; Qualification Of The Prosthetist; Safety Instructions - Otto Bock Helix3D 7E10 Instructions For Use Manual

1.3 Combination possibilities

CAUTION
Failure to observe the manufacturer requirements regarding combination possibilities. Injuries, malfunc­
tions or product damage due to unallowable combination of prosthesis components
• Based on the instructions for use of all prosthetic components used, verify that they may be combined with
each other and are approved for the patient's field of application.
• Contact the manufacturer with questions.
INFORMATION
In a prosthesis, all prosthetic components have to meet the patient's requirements regarding the amputation
level, body weight, activity level, environmental conditions and field of application.
Recommended combinations
Prosthetic knee joints
Unallowable combinations
Prosthetic knee joints

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.
Helix
Kenevo 3C60, C­Leg 3C98­3, Genium 3B1, 3B1­2, 3B1­3, Ge­
nium X3 3B5­X3, 3B5­2, 3B5­3
Kenevo 3C60=ST, C­Leg 3C88­3, Genium 3B1=ST, 3B1­2=ST,
3B1­3=ST, Genium X3 3B5­X3=ST, 3B5­2=ST, 3B5­3=ST
Hip Joint System may only be carried out by prosthetists who have been authorised by
Hip Joint System is a medical product,
3D
Hip Joint System and result in risk of injuries
3D
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