Inogen TAV, Инструкция по эксплуатации, Страница: 5 / 36

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Intended Use
The Inogen Tidal Assist Ventilator (TAV), with
accessories, is a volume assist ventilator
intended to aid adult patients with
respiratory insufficiency. It is designed for
patients who are capable of spontaneously
breathing a minimum tidal volume of
3.5cc/kg of predicted body weight. The device
is designed for continuous applications such
as patient ambulation, physical therapy,
occupational therapy, respiratory therapy, and
other rehabilitation efforts in an institutional
or home care environment. The device is
intended for operation by trained personnel,
patients or caregivers under the direction of a
physician.
Contraindications
The TAV® System is not designed for patients
who cannot spontaneously breathe or who
are fully dependent on mechanical ventilation.
Adverse Effects
• As is common with other forms of
oxygen therapy, the following side
effect may arise during therapy with the
system:
º
Drying or irritation of nasal
passages
Cautions
• Please read the entire Instructions for
Use before using the TAV® system.
• Do not use the TAV® Ventilation System
in magnetic resonance imaging (MRI)
environments. MRI equipment may
cause electronic components in the
ventilator to malfunction.
• Do not expose the TAV® system to
excessive heat or moisture.
• Federal (USA) law restricts the sale of this
device on or by the order of a physician.
Warnings
• Not to be used for life support
applications.
• Not intended for use by patients who
breathe more than 40 breaths per
minute or patients who consistently fail
to trigger the device.
• The Tidal Assist flow setting 4 does not
support a breath rate higher than 25
bpm and Tidal Assist flow setting 5 does
not support a breath rate higher than
20 bpm.
• The use of the Tidal Assist ventilation
system requires moderate patient
participation; therefore, you must be
able to understand and comply with
instructions. If you take strong sedatives
or other medications that may inhibit
mental capacity, you should not use
the system without proper medical
supervision.
• Expert clinical judgment should be
exercised in the appropriate use and
selection of device settings for each
individual patient. Inappropriate patient
selection or selection of TAV® settings
may result in suboptimal delivery of
oxygen and/or breathing assistance to
the patient. Please consult with your
doctor before using the TAV® System.
• If the TAV® System malfunctions, you
may not receive the appropriate therapy.
A readily available alternate or backup
means of delivering your therapy should
always be available.
• The TAV® System is designed for use with
oxygen sources that comply with local
regulations for medical oxygen.
• Oxygen supports combustion. Oxygen
should not be used while smoking or in
the presence of an open flame.
• Turn off the oxygen source when not
using the TAV® System. Oxygen delivered
into the tubing may accumulate within
the TAV® device enclosure. Oxygen
which has accumulated within in the
device enclosure or tubing could pose a
risk of fire.
No Smoking
No Open Flame