8 Supplement | Area Control Unit
Safety-related information
3 Safety-related information
3.1 Intended use
The distribution system for medical gases and vacuum (Medical Distribution
System) is used for distributing and monitoring gases and vacuum for medical
applications.
3.1.1 Component description
As a component of the distribution system for medical gases and vacuum, the area
control unit is used for the continuous monitoring of pressures and volume flows of
medical gases and vacuum.
3.2 Environment of use
Do not operate the area control unit in an environment that is subject to explosion
hazard.
Set up the area control units indoors only.
3.3 User group requirements
The term "user group" describes the personnel responsible who have been
assigned by the operating organization to perform a particular task on a product.
3.3.1 Duties of the operating organization
The operating organization must ensure the following:
– Every user group has the required qualifications (e.g., has undergone specialist
training or acquired specialist knowledge through experience).
– Every user group has been trained to perform the task.
– Every user group has read and understood the relevant chapters in this
document.
3.3.2 User groups
Clinical users
This user group operates the product in accordance with the intended use.
Users have medical specialist knowledge in the application of the product.
Reprocessing personnel
This user group carries out the necessary activities to reprocess the product.
Reprocessing personnel has specialist knowledge in the reprocessing of medical
devices.
Service personnel
This user group installs the product and performs the service activities.
Service personnel has specialist knowledge in electrical and mechanical
engineering and experience in the servicing of medical devices.
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