1.4 Intended Environment
The Vivo 45 is intended to be used in clinical settings (e.g. hospitals, sub-acute care insti-
tutions), public spaces and home environments as well as during portable applications
such as wheelchairs, personal family vehicles, ground ambulances and civil aircraft,
excluding helicopters.
It is not intended for use during emergency transportation.
1.5 Intended Users
This section describes the intended users of the Vivo 45, their qualifications and their
related documents.
1.5.1 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 set-
tings. 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, its capabilities and the settings that can be made. This training consists of read-
ing the Clinician’s manual in full and it shall be conducted before operating the Vivo 45.
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.
1.5.2 Lay Operators
Day-to-day caregivers, patients, relatives and other non-professional users that operate
the Vivo 45 within the prescribed settings.
They are allowed to operate the Vivo 45 with the Home mode activated. The lay opera-
tor 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.
12 Introduction
Vivo 45 User manual
Doc. 006149 D-3
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