8 Instructions of Users
The
ECOM
ix can only be used by authorized personnel that has been formally instructed.
8.1 Authorization for Instructions
The instructions must only be performed through authorized personnel. These consist of:
• Service technicians of Intermedt
• Further authorized personnel of Intermedt: e.g Head of Service, Head of Development, Product
manager
• Service technicians of cooperating partners who are trained for the installation and maintenance
of the
ECOM
ix system
• Dialysis personnel who are authorized to instruct others (see section 8.4).
8.2 Execution of an instruction
The instructions will be performed at the end of an installation and when needed. The ideal group
contains 5 people at maximum. The instructions should not be interrupted by breaks or other tasks.
The system must be empty and in the main menu.
ECOC
arts must be available as all future
operators must connect an
ECOC
art to the
ECOM
ix during the training. All of the topics in the
forms must be discussed, and the participants must get the chance to ask questions.
The topics to be taught can be found in the form “Form user training
ECOM
ix Original”.
8.3 Documentation
The successful completion of thus training course must be documented through the signature of the
participant and the instructor in the designated form. The discussed topics on the form must be
ticked off. The form remains in the device book of the system.
The training is considered “successful”, if the participants took part in the whole training and the
instructor does not have reasonable doubts that parts have not been understood. In case of doubts
he/she should pose questions or discuss these parts again to remove any doubts.
8.4 Authorisation of future instructors
The instructions can performed in a way that the participant may instruct further operators. The
differences to a “basic training course” are:
State: April 2021
59
4.9.1., I Manual ECOMix Original (EN), 7, F: M. Lorek, 06.04.2021