Suspension Arm Systems Independant
Revision 1
35
5
Commissioning
5.1
Initial Commissioning and Handover
Initial commissioning
The entire suspension arm system and the M6 service head have to be correctly commissioned
after installation has been completed.
Functional check
The suspension arm system and the M6 service head must not be used on the patient before
the operator or a person authorized by the operator has performed a function check at the
operating site, and the persons assigned by the operator have been instructed.
This is deemed fulfilled if:
•
the functional safety of the suspension arm system and the M6 service head has been
ensured;
•
the maximum loading capacity (payload) has been reliably determined and posted on the
M6 service head in the form of a sticker;
•
the flawless function was confirmed by the operator during initial commissioning and
documented in a declaration of handover.
Handover
The following items must be complied with for the handover to the operator:
•
The suspension arm system and the M6 service head must be handed over to the operator
in their inspected state.
•
The handover must be done in writing and confirmed by the operator.
•
The operator must be instructed in the function and operation of the maximum loading
capacity (payload) upon handover.
•
As part of the handover, the operator must be made familiar with the function, operation,
cleaning and disinfection of the suspension arm system and the M6 service head.
•
As part of the handover, the operator must also be instructed in the approved adjustment
work according to the supplied Instructions for Use.
•
Upon completion of the instruction, it must be documented in an instruction report that the
operator/user has understood the special actions required for proper use.
