Personal Requirements - Elitech FreezePoint 6000 Series User Manual

Section 1: Safety

1.4 Personal requirements

WARNING!
Risk of injury due to inadequately qualified personnel!
Work performed on the device by unqualified personnel or the presence of unqualified personnel in the
hazard zone of the device creates risks that can result in serious injury and substantial property damage.
• Only have qualified personnel perform any kind of activity.
This manual specifies the following personnel qualifications for the different task areas:
User
Based on his or her expert medical and/or pharmaceutical training, knowledge, and experience, the user is
capable of safely executing the tasks assigned to him or her.
The user is not authorized to perform any start-up activities.
The user is capable of independently detecting, evaluating, and avoiding possible risks.
The user has the expert knowledge for the intended use of the device and observes all hygiene regulations
for rooms used for medical purposes and the use of medical products.
The user knows the contents of all applicable regulations, guidelines, and standards required by law for the
safe use of the device and is capable of meeting the requirements stipulated therein.
Lab supervisor
The lab supervisor coordinates and monitors the technical procedures at the installation site of the device.
Based on his or her professional training and many years of professional experience with medical devices,
the lab supervisor is capable of performing the start-up tasks delegated to him or her by the manufacturer.
Service technician
Based on his or her professional training in the area of mechanical and electrical engineering, the service
technician is capable of performing the tasks related to troubleshooting and servicing delegated to him or
her by the manufacturer.
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