Instructions for Use
PerformaTrak Full Face Mask
Intended Use
The PerformaTrak Full Face Mask is intended to provide an interface for application of
CPAP or bi-level therapy to patients. The mask is for single 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.
Note: An exhalation port is not built into the PerformaTrak Full Face Mask. A separate
exhalation device must be used with this mask.
Note: This mask is not made with natural rubber latex or DEHP.
Caution: US Federal law restricts this device to sale by or on the order of a physician.
Symbols
Warning or
Caution
Do Not Reuse
Warnings:
• This mask is not suitable for providing life support ventilation.
• This mask requires a separate exhalation device.
• 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. Rebreathing of exhaled
air for longer than several minutes can in some circumstances lead to suffocation. This
warning applies to most models of CPAP systems.
• 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.
• Monitor or intervene if the patient experiences skin redness, irritation, or discomfort.
• Monitor or intervene if any of the following symptoms occur: Unusual chest discomfort,
shortness of breath, stomach distension, belching, severe headache, blurred vision, drying
of the eyes, eye pain or eye infections.
Note
Not Made with
Natural Rubber
Latex
1
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Leak Symbol and
Value