General Safety Instructions; Instructions For Prosthesis Wearers - Otto Bock Helix3D 7E10 Instructions For Use Manual

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.
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
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.
30 | Ottobock
Hip Joint except those described in this manual are permitted.
Hip Joint System is obligatory before the first fit­
3D
3D
3D
hip joint system may only
Hip Joint as well as of the
Helix