Ossur OP2 KNEE Gebrauchsanweisung Seite 9

Each manufacturer can only be held liable for the failure of their own fit components. Any further liability on the
part of the manufacturer is only possible if it can be proven that his fit components were the cause of the damage
or malfunction of fit components from other manufacturers.
CE SYMBOL/COMPATIBILITY
All modular parts have been tested in accordance with EC Directive 93/42/EEC and bear the CE symbol.
General terms and conditions
This product is only intended for use with one patient. If it is used to treat more than one patient the product
liability in the intendment of the German medical products act will be forfeited.
Össur products are guaranteed to be compatible with other fit components if the following points are met:
• The fit components are used only for their intended purpose (pay attention to the relevant instructions for use).
• If fit components with different max. weight limits are used, the max. load of the weakest fit component
applies.
• The use of tested individual components with a CE symbol does not release the technician from his obligation
to check the combination of fit components within the scope of his possibilities with respect to their suitability,
correct assembly and safety.
• If there are any indications that a combination of fit components does not offer the necessary safety then these
fit components may not be combined.
• The prosthesis must be constructed in accordance with the generally accepted rules of the orthopaedic
technology trade.
• If the patient prerequisites change (e.g. body weight, mobility, etc.) the appliance must be checked immediately.
• If the appliance has been exposed to disproportionately high stress (e.g. fall) it has to be examined immediately
by a specialist workshop for any possible damage.
• Any regulations relating to individual fit components that are relevant for safety (see the relevant instructions
for use) must be observed.
Combination of different f it components
• In addition to the general terms and conditions listed above, the following also applies:
• only use fit components that satisfy the requirements of ISO 10328
• only use fit components that satisfy the requirements the MPGs
• the fit components must be designed for the common pyramid or 30 mm system and be matching.
USEFUL LIFE
The maximum useful life of the OP2 Knee is 36 months.
SPARE PARTS, ACCESSORIES
The following spare parts are available:
No. Material
4 Extension assist spring
5 Pylon clamp screw
6 Extension adjustment valve needle
7 Flexion adjustment valve needle
29 Bumper adjustment screw
30 Metal washer
31 Bumper
Only the listed articles are available as spare parts and accessories.
Please send the joint to be repaired to Össur for examination. We will provide a service joint for the duration of the
repair.
Article number
1.970.252
1.970.866
1.980.205
1.980.206
1.980.109
1.980.108
1.980.107
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