Össur TALUX TLXoxxyz Instrucciones De Uso página 8

1. Apply Loctite to bolts and fit adapter, finger tight.
2. Loosen up 1/4 turn to free up the hanger
3. Apply tension on strap by pushing the hanger towards top of foot
module (Figure 6)
4. Secure bolts with a wrench to keep hanger in place
5. Check tension on strap.
c. No slack should be on the strap when foot is neutral (Figure 7), check
tension by trying to run a piece of paper between strap and tensioner
plate, resistance should be felt.
d. A too tight strap results in the uppermost carbon plate to lift from the
second plate (Figure 8)
6. Torque to specifications, starting with the upper bolt.
7. Place plastic cap on bolts.
In the case of an achilles strap replacement, the following needs to be
carried out:
1. Undo attachment from foot module
2. Using a sharp knife, remove sole material around foot plate bolts to
make room for socket
3. Undo foot plate screws with an 8mm socket wrench
4. Clean surfaces if needed with a mild abrasive and/or acetone
5. Put Loctite on foot plate screws and torque the new strap in place with a
torque wrench (5 Nm)
6. Follow the instructions above to correctly set strap tension
LIABILITY
The manufacturer recommends using the device only under the specified
conditions and for the intended purposes. The device must be
maintained according to the instructions for use. The manufacturer is
not liable for damage caused by component combinations that were not
authorized by the manufacturer.
CE CONFORMITY
This device meets the requirements of the 93/42/EEC guidelines for
medical devices. This device has been classified as a class I device
according to the classification criteria outlined in appendix IX of the
guideline.
COMPLIANCE
This component has been tested according to ISO 10328 standard to two
million load cycles. Depending on the amputee's activity this
corresponds to a duration of use of two to three years. We recommend
carrying out regular yearly safety checks
ISO - "P" - "m"kg *)
*) Body mass limit not to be exceed!
For speci c conditions and limitations of use see
manufacturer's written instructions on intended use!
have been adapted adequately on the basis of the specified load level.
In the standard mentioned, test levels
(P) are assigned to a certain maximal
body masses (m in kg). In some cases,
which are marked with, no test level is
assigned to the product related maximal
body mass. In these cases, the test loads
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