30 | Ottobock
Helix
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
3D
Hip Joint System is obligatory before the first fit
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
Hip Joint except those described in this manual are permitted.
CAUTION
Malfunctions caused by using inappropriate prosthetic components.
The Helix
3D
hip joint system may only
be used with the CLeg, the Genium and the prosthetic feet intended for use with them.
CAUTION
Component failure caused by exceeding the safe service life.
This component has been tested according to
ISO 15032 standard for two million load cycles. Depending on the amputee’s activity level, this corresponds to
a usage duration of 2 to 3 years for a hip disarticulation or an amputee with hemipelvectomy.
Using the component beyond this period can result in component failure and cause the amputee to fall.
In general, we recommend annual safety checks.
1.6.2 Instructions for prosthesis wearers
INFORMATION
The prosthesis wearer must be advised of the appropriate handling of the Helix
3D
Hip Joint as well as of the
Instructions for Prosthesis Wearers mentioned below.
WARNING
Risk of accident when driving a motor vehicle.
The ability of prosthesis users to drive a vehicle is determined
on a case-by-case basis. Criteria include the type of fitting (amputation level, unilateral or bilateral, residual limb
conditions, design of the prosthesis) and the amputee’s individual abilities.
All persons are required to observe their country’s national and state driving laws when operating motor vehi
cles. For insurance purposes, drivers should have their driving ability examined and approved by an authorised
test centre.
For maximum safety and convenience, Ottobock recommend that, at the very least, a specialist evaluate the
need for any adaptations to the car (such as by installing a steering fork, automatic shift). Riskfree driving
should be ensured even when the prosthesis is not functioning.
Содержание Helix3D 7E10
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