General System Owner's Responsibility
System Owner
The term System Owner refers to the person who himself operates the device for trade or commercial purposes, or who surrenders the device to a third party for use/application, and who bears the legal product liability for protecting the user, the personnel or third parties during the operation.
System Owner‘s Obligations
The device is used in the industrial sector, universities, and research laboratories. The System Owner of the device must therefore comply with statutory occupational safety requirements.
In addition to the safety instructions in this manual, the safety, accident prevention and environmental protection regulations governing the operating area of the device must be observed.
In this regard, the following requirements should be particularly observed:
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- The System Owner must obtain information about the applicable occupational safety regulations, and - in the context of a risk assessment - must determine any additional dangers resulting from the specific working conditions at the usage location of the device. The System Owner must then implement this information in a set of operating instructions governing operation of the device.
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- During the complete operating time of the device, the System Owner must assess whether the operating instructions issued comply with the current status of regulations, and must update the operating instructions if necessary.
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- The System Owner must lay down and specify responsibilities with respect to operation, maintenance, and cleaning.
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- The System Owner must specify, establish, and document the content and the execution of regular PET quality control test. Bruker Service needs to have access to these data for reference during Planned Maintenance.
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- The System Owner must ensure that all personnel dealing with the device have read and understood the Instructions for Use. In addition, the System Owner must warrant that the device is operated by trained and authorized personnel and provide personnel with training and hazards information at regular intervals. Especially when dealing with radioactive tracers, the corresponding workflows and safety measures are of utmost importance.
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- The System Owner must provide the personnel with the necessary protective equipment.
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- All personnel who work with, or in the close proximity of the device, need to be informed of all safety issues and emergency procedures.
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- The System Owner must ensure that new personnel are supervised by experienced personnel. It is highly recommended to implement a company training program for new personnel on all aspects of product safety and operation.
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- The System Owner must ensure that personnel are regularly informed of the potential hazards within the laboratory. This is all personnel that work in the area, but in particular laboratory personnel and external personnel such as cleaning and service personnel.
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- The System Owner is responsible for taking measures to avoid inherent risks in the handling of dangerous substances, preventing industrial disease, and providing medical first aid in emergencies.
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- The System Owner is responsible for providing facilities according to the local regulations for the prevention of industrial accidents and generally accepted safety regulations according to the rules of occupational medicine.
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- All substances needed for operating and cleaning the device samples, solvents, cleaning agents, gases, etc. have to be handled with care and disposed of appropriately. All hints and warnings on storage containers must be read and adhered to.
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- The System Owner must ensure that the work area is sufficiently illuminated to avoid reading errors and faulty operation.
