Össur GENU SLEEVE Instrucciones De Uso página 7

CE MARK AND COMPATIBILITY
This product is a medical device that has been tested to EC Directive 93/42/EEC. It bears the CE mark.
General provisions
This aid is recommended for use by only one patient. If it is used to treat more than one patient, the product
liability becomes void pursuant to Germany's medical Devices Law (MPG).
The Össur products' compatibility with third-party fittings is guaranteed if the following requirements are met:
The fittings are only used for their intended purpose (read instructions).
• If fittings with various maximum weight limits are used, the maximum load of the weakest fittings applies.
• The use of inspected individual components bearing the CE mark does not release the technicians from their
responsibility, within the scope of their possibilities, to inspect the combination of fittings for proper
functionality, proper assembly, and safety.
• If there is evidence that a combination of fittings does not provide the required degree of safety, then the
fittings may not be combined.
• The prosthesis must be constructed so as to meet the generally recognised professional rules followed by
orthopaedic technicians.
• If the patient's circumstances change (e.g. body weight, activities, etc.), the aid must be promptly inspected.
• If the aid was subjected to an unusually high load, such as a fall or drop, the aid must be promptly inspected by
a specialised workshop for possible damage.
• Safety-related regulations for individual fittings (e.g. maintenance intervals, see instructions) must be complied
with.
Combining various f ittings
• In addition to the aforementioned general provisions, the following shall also apply
• Only use fittings that comply with ISO 10328 requirements.
• Only use fittings that comply with MPG requirements.
• The fittings must be configured for the conventional pyramid or 30-mm system and fit together.
LIABILITY
In the event of damage: to process the complaint, Össur requires a copy of the delivery slip or Össur's bill along
with detailed reasons for returning the item(s).
Manufacturers can only be held liable for failures of their own manufactured fittings. A manufacturer's liability
extending beyond this scope is only possible if its fittings demonstrably caused the damage or functional failure of
fittings made by other manufacturers.
USEFUL LIFE
The maximum useful life (after date of delivery) of the Genu sleeve is three months.
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