Non Invasive Interfaces; Mobility And Usage Environment; Continuous Operation; Service Life - Breas Vivo 3 Clinician Manual

1.2.1

Non Invasive Interfaces

The ventilator system can be used non-invasively with nasal mask, full/total face mask,
and nasal pillow interfaces.
1.2.2

Mobility and Usage Environment

The ventilator system is classified as transit-operable and is intended to be used in
homes, public spaces, institutions and hospitals.
The ventilator system is intended to be used together with portable applications such as
wheelchairs, personal family vehicles, ground ambulances and civil aircraft (not helicop-
ter). It is not intended for use during emergency transports.
1.2.3

Continuous Operation

The ventilator can be used for continuous operation up to 24 hours/day at least for 90
days without restarting.
1.2.4

Service Life

The expected service life of the Vivo 3 is 5 years or 20,000 hours.
1.3

Intended Use

Vivo 3 is intended to provide non-invasive or invasive ventilation for patients weighing
over 10 kg (22 lbs) who require long-term support or mechanical ventilation for respira-
tory insufficiency or respiratory failure, with or without obstructive sleep apnea.
Vivo 3 is intended for spontaneously breathing patients.
1.4

Intended Users

This section describes the intended users of the Vivo 3, 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 understanding 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.
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Introduction 11
Vivo 3 Clinician's Manual