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1.4
Intended Users
This section describes the intended users of the Vivo 2, their qualifications and their
related documents.
1.4.1
Respiratory Health Care Specialists
Health care professionals such as physicians and respiratory therapists, assigned to form
the clinical authority when it comes to operating mechanical ventilators.
They have a good understanding of the human respiratory system and a general under-
standing of mechanical ventilators.
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 2,
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 2.
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 2.
1.4.2
Lay Operators
Day-to-day caregivers, patients, relatives and other non-professional users that operate
the Vivo 2 within the prescribed settings.
They are allowed to operate the Vivo 2 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 2 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.
12
Introduction
User manual
Doc. 007229 D-3
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