Philips RESPIRONICS TrueBlue Mode D'emploi

TrueBlue
Instructions for Use
Intended Use
The TrueBlue Nasal Mask is intended to provide an interface for application of CPAP or bi-
level therapy to patients. The mask is for single patient use in the home or multi-patient use
in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg)
for whom CPAP or bi-level therapy has been prescribed.
Notes:
• An exhalation port is built into this mask so a separate exhalation port is not required.
• This mask is not made with natural rubber latex or DEHP.
Caution
U.S. Federal law restricts this device to sale by or on the order of a physician.
Symbols
Warning or Caution
Consult Instructions for
Use
Warnings
• This mask is not suitable for providing life support ventilation.
• This mask is designed for use with CPAP or bi-level systems recommended by your health care
professional or respiratory therapist. Do not wear this mask unless the CPAP or bi-level system is
turned on and operating properly. Do not block or try to seal the exhalation port. Explanation of
the Warning: CPAP systems are intended to be used with special masks with connectors which have
vent holes to allow continuous flow of air out of the mask. When the CPAP machine is turned on
and functioning properly, new air from the CPAP machine flushes the exhaled air out through the
attached mask exhalation port. However, when the CPAP machine is not operating, enough fresh air
will not be provided through the mask, and exhaled air may be rebreathed. This warning applies to
most models of CPAP systems. Rebreathing of exhaled air for longer than several minutes can, in some
circumstances, lead to suffocation.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is not operating.
Explanation of the Warning: When the device is not in operation, and the oxygen flow is left on,
oxygen delivered into the ventilator tubing may accumulate within the device enclosure. Oxygen
accumulated in the device enclosure will create a risk of fire.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an
open flame.
• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending
on the pressure settings, patient breathing pattern, mask selection, and the leak rate. This warning
applies to most types of CPAP and bi-level machines.
• Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue use and
contact your healthcare professional.
• At low CPAP or EPAP pressures, the flow through the exhalation port may be inadequate to clear all
exhaled gas from the tubing. Some rebreathing may occur.
Note
Not Made With Natural
Rubber Latex
1
Tip
System One Resistance
Control