Responsibility Of The Operator - Sigma 4-5KRL Manual

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3.3

Responsibility of the operator

Version 11/2017, Rev. 1.7.1 of 08/12/2022 • sb
Translation of the original operating manual,
The operator undertakes to authorise only trained, specialised personnel to
work on the centrifuge (see chapter 3.4 - "Requirements concerning the
personnel").
The areas of responsibility of the personnel concerning the operation,
maintenance, and care of the unit must be clearly defined.
The safety-conscious work of the personnel in compliance with the
operating manual and the relevant EC health and safety directives, and the
national laws concerning health and safety and the prevention of accidents
must be checked at regular intervals (e.g. every month).
Under the international rules for health and safety at work, the operator is
obliged to:
•
take measures in order to prevent danger to life or health during work.
•
ensure that the centrifuges are used properly and entirely as intended
(see chapter 1.2 - "Intended use").
•
take protective measures against fire and explosion when working with
hazardous substances.
•
take measures for the safe opening of the centrifuges.
The operator must perform a risk assessment concerning potential
accidents in connection with the centrifuge and take design-related
countermeasures, if necessary.
The operator must inform the users that any serious event which either
directly or indirectly had, could have had or could have one of the following
consequences must 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.
The centrifuge has to be maintained regularly (see chapter 8 -
"Maintenance and service").
Components that are not in a perfect state must be replaced immediately.
Refrigerated Centrifuge for Robot Use Sigma 4-5KRL
Refrigerated Centrifuge for Robot Use Sigma 4-5KRL IVD
3 Safety
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