Össur 4SEAL TF Technical Manual página 9

NOTES REGARDING SAFETY
• Before applying care using a silicone liner, the user's situation must be carefully examined and documented
(see the Contraindications and Mobility class sections). Furthermore, concomitant illnesses and medications
should be considered. For example, diseases of the kidneys and the medications administered for them can
lead to fluctuations in the residual limb because water retention is reduced. As a result, the silicone liner can
become too big.
• Selecting the correct size is imperative.
• The Liner must be carefully washed 2-3 times before first use.
• The shaft must be prepared carefully.
• The trim of the liner must be free of sharp edges, corners or folds. These can lead to skin problems for the user.
• The method for putting on the liner must be carefully explained to the user and should be practiced several
times.
• Check if there are any air pockets. If air pockets exist, please massage them out.
• Please describe the care of the Össur Liner and of the user's skin in detail. Experience has shown that improper
care can lead to the most common cases of skin irritation.
• Give the user the Instructions for Users. Tell the user extensively and carefully about the products listed there
and practice the use of the Össur Liner with the user.
• The Liner must NOT be pulled up with sharp objects or fingernails.
• The Liner must not be washed in the washing machine.
All information consists of recommendations and must be adapted to the user's needs.
Servicing
Servicing depends on the degree to which the liner is used. The more active the user is and the longer that they
wear the liner during the day, the higher the degree of use. Then the liner and the silicone adhesive shaft should be
checked more often. The maintenance of the Össur Liner system is also critical for the servicing interval.
However, the entire prosthesis must be examined no later than every six months.
During servicing, the following must be checked and replaced if necessary:
• the construction
• the screwed connections
• the conditions for care (mobility class, weight)
• damage to the liner and the sealing lips
• liner size and fit
• general contamination.
CE MARK, COMPATIBILITY
All modular parts have been tested in accordance with EC Directive 93/42/EEC and have the CE mark.
General provisions:
This aid is recommended for use on only one patient. If it is used for the treatment of more than one patient, the
product warranty becomes invalid according to the German medical Devices Act. The compatibility of Össur
products with fittings of other manufacturers is ensured if the following points are fulfilled:
• The fittings are used only in accordance with their intended purpose (observe the instructions for use).
• If fittings with different max. weight limits are used, the max. weight of the weakest fitting applies.
• The use of certified components with a CE mark does not relieve the technician from the obligation to check
the combination of fittings as far as possible for their appropriateness, proper installation and safety.
• If there is evidence that a combination of fittings does not meet the necessary safety requirements, the fittings
must not be combined.
• Prostheses must be constructed in accordance with generally accepted professional rules of the orthopedic
trade.
• In the case that there is a change of patient conditions (e.g. body weight, activity, etc.), the aid must be
examined immediately.
• If the aid has been subjected to a disproportionately large strain (e.g. a fall), the aid must be examined
immediately by a specialist workshop for possible damage.
• Safety-relevant regulations for individual fittings (e.g. maintenance intervals; see the instructions for use) must
be observed.
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