Useful Life - Össur MONOLOCK KNEE Instrucciones De Uso

CE MARK/COMPATIBILITY
All modular parts have been tested in compliance with EC Directive 93/42/EEC and bear the CE mark.
General Conditions
This product is only intended for use on one patient. If it is used to treat more than one patient, product liability as
specified in the medical Devices Act is forfeited.
The compatibility of Össur products with fitting parts made by others is ensured if the following conditions have
been met:
• The fitting parts are only used for their intended purpose (following the instruction manuals for the individual
parts).
• If fitting parts with different max. weight limits are used, the limit to observe is the max. permissible load of the
weakest fitting part.
• The use of tested of individual components with the CE mark does not release the technician from his
obligation to ensure to his best ability that hey are suitable, properly fitted and safe.
• If there are indications that a combination of fitting parts will not meet the required level of safety, they must
not be combined.
• The prosthesis must be built following the best practices generally recognized in the field of orthopedic
prosthetic construction.
• In case of a change in the patient's situation (e.g. body weight, mobility, etc.) the prosthesis must be inspected
without delay.
• If the prosthesis was exposed to a disproportionately strong load (e.g. a fall), the prosthesis must be inspected
for damage without delay in a specialist workshop.
• Safety-relevant rules for the individual fitting parts must be followed (see the relevant individual instruction
manual).
Combining different f itting parts
Applicable here are the already mentioned general guidelines and, in addition:
• Only use fitting parts which meet the specifications contained in ISO 10328
• Only use fitting parts which meet the requirements contained in the MPGs
• The fitting parts must be dimensioned for standard pyramid or 30 mm systems, and must fit each other.

USEFUL LIFE

The maximum useful life of the Monolock Kneejoint is 36 months.
REPLACEMENT AND SUPPLEMENTARY PARTS
The following replacement parts are available to you:
No. Part
1 Screw of the tube receiver
4 Stretch limit stop
7 Fastening screw for release lever
10 Rubber stops
14 Functional lever
Only the articles listed are available as replacement and supplementary parts.
For an inspection of the joint, please send the joint requiring repair to Össur. For the duration of the repair we will
provide you with a service joint.
Article Number
1.970.822
1.970.880
1.970.867
1.970.881
1.970.849
7