Lay Operators; Service Personnel - Breas Vivo 45 LS User Manual

They are allowed to change the clinical settings of a ventilator and prescribe new settings.
They may also operate software applications for follow-up on patient's ventilator
treatment.
Training
The respiratory health care specialists shall be trained to a good knowledge of the
Vivo 45 LS, its capabilities and the settings that can be made. This training consists of
reading the Clinician's manual in full and it shall be conducted before operating the
Vivo 45 LS.
Related Documents
The Clinician's manual is intended for the respiratory health care specialists. It shall be
available for training of new personnel and as reference when operating the Vivo 45 LS.
1.6.2

Lay Operators

Day-to-day caregivers, patients, relatives and other non-professional users that operate
the Vivo 45 LS within the prescribed settings.
They are allowed to operate the Vivo 45 LS with the Home mode activated. The lay
operator may also perform basic maintenance that doesn't require special equipment or
a service environment.
In Home mode, the device is locked in order to limit settings accessibility and hide fea-
tures/controls.
The User Manual contains the information intended for patients and lay operators.
Training
The lay operator shall be trained to basic knowledge of the Vivo 45 LS and in the spe-
cific operations they are assigned to perform. The training shall be based on the user
manual and the responsible clinical personnel shall assess the level of training required
for each lay operator.
Related Documents
The User manual is intended for lay operator. It shall be available for the training and as
reference when operating the Vivo 45 LS.
1.6.3

Service Personnel

Certified service personnel with responsibility to maintain the equipment in proper
working order. They have a technical education and/or relevant experience of technical
work on electrical equipment. If local or national regulations requests additional author-
ization or competence, these shall be complied to.
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Introduction 15
User manual