Instructions for Use | Introduction
1.
Introduction
The Trilogy Evo Universal ventilator is a medical device intended for use by qualified, trained personnel under the direction of a
physician according to its technical specifications.
Intended Use
The Trilogy Evo Universal ventilator provides invasive and non-invasive positive pressure ventilation for the care of patients
≥2.5 kg through adults. The ventilator can measure, display, record, and alarm
SpO
2
, FiO
2
, CO
2
, respiratory rate, and pulse rate
data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings
and non-emergency transport settings; for example, wheelchair, personal vehicle, or ambulance.
Environments of Use
The Trilogy Evo Universal ventilator is intended to be used:
•
In institutional environments.
•
While attached to a wheelchair, bedrail, gurney, roll stand, or sitting on a flat surface such as a table or nightstand.
•
While transporting patients within and between facilities such as automobile or commercial aircraft.
Contraindications
If the patient has any of the following conditions, consult the patient’s health care professional before using noninvasive
ventilation:
•
An inability to maintain a patent airway or adequately clear secretions
•
At risk to aspirate gastric contents
•
Acute sinusitis or otitis media
•
Epistaxis, causing pulmonary aspiration of blood
•
Hypotension