Instructions For Prosthesis Wearers - Ottobock 7E10 Helix3D Gebrauchsanweisung

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.
CAUTION
Risk of injury as a result of excessive strain. The Ottobock prosthetic components described here have been
developed for activities of daily living and must not be used for unusual activities such as extreme sports (free
climbing, paragliding etc.).
Careful handling of the prosthesis and its components not only increases their service life but, above all, ensures
the patient's safety!
Should prosthetic components be subjected to unusual stresses (such as a fall), immediately contact your pros­
thetist and have the components inspected for any damage. If necessary, the responsible prosthetist will pass
the prosthesis on to the Ottobock Service.
CAUTION
Risk of injury when continuing to use the product after noticeable functional changes have occurred. To re­
duce the risk for the prosthesis wearer, the Helix
functional changes occur. Noticeable functional changes may include poor response, incomplete extension,
diminished swing phase control or stance phase stability, abnormal noises etc.
Should such a change occur, the hip joint must be inspected by a prosthetist and possibly be returned to Ot­
tobock for repair.
CAUTION
Risk of falling when climbing stairs. On stairs, the prosthesis wearer always has to use the handrail.
28 | Ottobock
Hip Joint System must no longer be used when noticeable
3D
Hip Joint as well as of the
3D
Helix