Useful Life; Replacement Parts/Accessories - Össur BALANCE KNEE OM8 Instrucciones De Uso

• The use of tested individual components does not relieve the prosthetist from his duty to check by all possible
means the combination of fittings for their suitability, correct assembly and safety.
• If there are any indications that a certain combination of fittings does not guarantee the required level of safety,
then the fittings must not be combined.
• The prostheses must be built in accordance with the generally recognised professional rules of the orthopaedic
technical trade.
• If the patient's situation changes (e.g. body weight, degree of activity, etc.) the prosthesis must be checked
immediately.
• If the prosthesis has been subjected to disproportionately high stresses, e.g. during a fall, it must be inspected
for any possible damage immediately by a specialist workshop.
• Safety-relevant regulations for individual fittings (e.g. maintenance intervals, see Instructions for Use) must be
observed.
Combinations of different f ittings:
The above general conditions apply, in addition:
• Use only fittings that comply with the requirements of ISO 10328.
• Use only fittings that comply with the requirements of the Medical Devices Act.
• The fittings must be designed for use with standard pyramid or 30 mm systems, and must be compatible with
each other.

USEFUL LIFE

The applicable provisions of the latest Össur Product Catalogue apply. Maximum useful life of the Balance Knee
OM8 is 36 months.

REPLACEMENT PARTS/ACCESSORIES

Only the listed replacement parts and accessories are available.
No. Description
1 Adjusting screw
2 Spring
6 Clamp screw
15 Flexion screw
23 Extension stop
24 Washer
25 Thread Screw
To have a joint inspected please send the joint for repair to Össur. We will provide you with a service joint for the
duration of the repair.
Article no.
1.980.100
1.980.101
1.980.104
1.980.106
1.980.107
1.980.108
1.980.109
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