Werbung
Instructions for Use
FitLife Total Face Mask
Intended Use
The FitLife Total Face Mask is intended to provide an interface for application of CPAP or bi-level
therapy to patients. This mask is for single patient use in the home or multi-patient use in the
hospital/institutional environment. The small size mask is to be used on patients 7 years or older
(>20 kg) for whom CPAP or bi-level therapy has been prescribed. The large and extra large
size masks are to be used on patients (>30 kg) for whom CPAP or bi-level therapy has been
prescribed.
Note:
An exhalation port is built into the FitLife Total Face Mask elbow so a separate
exhalation port is not required.
Note:
This mask is not made with natural rubber latex or DEHP.
Symbols
Warning or
Caution
Not made with
LATEX
natural rubber latex
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.
port. Explanation of the Warning:
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.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is not
Explanation of the Warning:
operating.
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.
• The patient's physician should be contacted if the patient experiences the following symptoms
while using the mask or after removing it: Unusual chest discomfort, shortness of breath,
stomach distension, belching, or severe headache; drying of the eyes, eye pain, or eye
infections; blurred vision. (Consult an ophthalmologist if symptoms persist.)
• 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.
• A minimum of 3cm H
• This mask should not be used for patients who are uncooperative, obtunded, unresponsive, or
unable to remove the mask by themselves.
• This mask is not recommended for patients who are taking a prescription drug that may
cause vomiting.
Tip
Note
CPAP systems are intended to be used with special
O must be maintained when using this mask.
2
Consult instructions
for use
System One Resistance
Control Setting
Do not block or try to seal the exhalation
When the device is not in operation, and the oxygen
E N G L I S H
1
Werbung
