General Conditions; Useful Life; Safety Warnings - Össur 625.400 Instrucciones De Uso

GENERAL CONDITIONS:

This product is recommended for use by one patient only. Product liability pursuant to the Medical Devices Act
becomes null and void if it is used for treating more than one patient.
The compatibility of Össur products with fittings from other manufacturers is guaranteed as long as the following
points are satisfied:
• The fittings are only used in compliance with their intended purpose (see Instructions for Use).
• If fittings with different max. weight limits are used, the maximum loading corresponds to that of the weakest
fitting.
• 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 FITTINGS:
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.
ISO - P -
*) Body mass limit not to be exceeded!
For speci c conditions and limitations of use
see manufacturer's written instructions on
intended use!

USEFUL LIFE

The maximum useful life of the Össur adapter is 36 months.

SAFETY WARNINGS

You must observe the alignment guidelines and instructions for use.
You must observe the maintenance and care guidelines.
This medical aid is for use by one patient only.
kg *)
4