Lay Operators; Service Personnel - Breas Vivo 3 Clinician Manual

Training
The respiratory health care specialists shall be trained to a good knowledge of the
Vivo 3, its capabilities and the settings that can be made. This training consists of read-
ing the Clinician's manual in complete and it shall be conducted before operating the
Vivo 3.
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 3.
1.4.2

Lay Operators

Day-to-day caregivers, patients, relatives and other non-professional users that operate
the Vivo 3 within the prescribed settings.
They are allowed to operate the Vivo 3 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 3 and in the specific
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 3.
1.4.3

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.
Certified service personnel may perform any repairs, upgrades or service operations
that they have been certified to perform, as long as they have the required equipment
and the operation is performed in an appropriate environment. They may also operate
software applications for follow-up on ventilators usage and for troubleshooting.
12 Introduction
Vivo 3 Clinician's Manual
Doc. 007232 Y-2