CAE Air1, Руководство пользователя, Страница: 38 / 158

©2020 CAE 905K710052 v.1.1 31
Intended Use and Indication for Use
I
NTENDED
U
SE AND
I
NDICATION FOR
U
SE
The CAE Air1 is intended as a continuous mechanical ventilator for invasive applications with the
provision of an adjustable percentage of oxygen in the breathing gas.
The ventilator is indicated for use on adult patients in healthcare facilities under the supervision of a
physician.
Purpose and Function of Device
The CAE Air1 is intended for continuous use to provide respiratory support for ventilation and
oxygenation of a patient. The device provides mandatory breaths and also supports spontaneous
efforts of the patient through the following modes of operation:
• Pressure Control with assist mode (pressure assist / pressure control mode) which allows
and assists patient-initiated breaths.
• Volume Control with assist mode (volume assist / volume control mode).
• Pressure Support mode with inspiratory termination flow and backup ventilator initiated
breaths in the case of apnea.
All three modes of operation allow for precise adjustment of ventilation parameters. The parameters
are viewable and adjustable through the user interface displayed on the ventilator touchscreen.
The breathing gases provided to the patient are a mixture sourced from surrounding room air and
oxygen from a common pressurized O
2
source, in a proportion than can be adjusted by the operator.
The ventilator function is supported by low, medium and high priority alarm conditions with visible
and audible alarm indications.
Intended Population
This device is intended to treat adult patients who are experiencing respiratory impairment, including
those diagnosed with COVID-19, and who require support through mechanical ventilation.
Intended Environment of Use
The ventilator is to be used only by trained healthcare providers under the direction of a physician.
The intended environment is traditional healthcare-type facilities that are equipped to provide
respiratory support with ambient air and a medical grade pressurized oxygen source.
The ventilator design and safety standards are suitable for installation in its intended environment of
use including an
The ventilator software includes cybersecurity features for protection of the device and patients.