The operating personnel must ensure that any serious event which either
directly or indirectly had, could have had or could have one of the following
consequences will be reported to the manufacturer or competent authority:
a) The death of a patient, user or other person,
b) the temporary or permanent degradation of the health of a patient, user
or other person,
c) a serious risk to public health.
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3.5 Informal safety instructions
• This operating manual is a part of the product.
• The operating manual must be kept at the location of use of the
centrifuge. Ensure that it is accessible at all times.
• The operating manual must be handed over to any subsequent owner
or operator of the centrifuge.
• Any changes, additions or updates received must be added to the
operating manual.
• In addition to the operating manual, the general and local rules and
regulations concerning the prevention of accidents and the protection of
the environment must also be supplied.
• Safety and danger indications on the centrifuge must be kept readable
at all times. If necessary, they must be replaced.
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