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Residual risk
Some of the products contains software based components. LINAK has made
various possible efforts to assure that the software is free of errors and that
the software has been developed according to the rules of IEC 60601-1-4
(software in Medical products). That involves Risk Analysis which shows a small
residual risk for unwanted/unintended movement of actuators under specifi c
conditions.
According to the above rules it must be informed and if necessary considered
in the Risk analysis of the fi nal application - More details to residual risk can be
provided by LINAK if necessary.
Warning!
The plastic parts in the system cannot tolerate cutting oil.
Warning!
LINAK’s actuators and electronics are not constructed for use within the
following fi elds:
• Planes and other aircrafts
• Explosive environments
• Nuclear power generation
Warning!
If faults are observed, the products must be replaced.
Warning!
Never spray directly on the products with a high-pressure cleaner.
Warning!
Always insure that the patient is accessible in case of emergency.
Warning!
Cables must be secured safely so that persons cannot get trapped in it.
Warning!
Always use locking mechanism and O-ring
Warning!
Sockets not used must be fi tted with blind plugs to ensure IP degree
The LINAK products cannot tolerate the infl uence of strong solvents, basic or
alkaline liquids.
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