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NOTE: General user advice. Not following these instructions may result
in physical injury, damage to the product or damage to the environment!
A notice to the user and/or patient that any serious incident that has
occurred in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user
and/or patient is established.
All identified risks have appropriate risk mitigation or rationales in place.
It is agreed that risk has been lowered as far as possible and residual
risk has been deemed acceptable.
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