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ORIGINAL
Page 41
19.
Marking
On the top inside of each system side you find a label, containing information about:
Type
Serial number
Production date
Producer
Example of label:
20.
Risk Assessment and Safety
20.1
Risk Assessment
Upon delivery, TurnAid T4 is equipped with safety functions according to the Medical Device
Directive applying for the area to which the system is supplied. In case of resale of the system
either domestically or across borders please be advised that you as the responsible owner/user
of the system are also responsible for the equipment being equipped and mounted/assembled
according to the rules for your working place.
TurnAid T4 is designed so there is NO imminent danger of wrong operation with harmful
consequences for the patient or the nursing staff.
TurnAid T4 should only be used, maintained, assembled/dismounted competent persons.
•
In no way try to circumvent the built-in safety functions of the system.
•
ALWAYS read and understand the instruction manual prior to taking the system into use.
•
If the system is used other than intended, please contact TurnAid ApS.
•
TurnAid T4 CANNOT operate unless it has been connected to the power supply and it has
been powered on.
•
TurnAid T4 has no electric back up function so unintended use of the system cannot
happen if it has been disconnected from the power supply.