• 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.
• 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.
• 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.
• Some users may experience skin redness, irritation, or discomfort. If this happens,
discontinue use and contact your healthcare professional.
• Consult a physician 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.
• This mask should not be used on patients who are uncooperative, obtunded,
unresponsive, or unable to remove the mask.
• This mask is not recommended if the patient is taking a prescription drug that may
cause vomiting.
• Consult a physician or dentist if you encounter tooth, gum, or jaw soreness. Use of a
mask may aggravate an existing dental condition.
• A minimum of 3cm H₂O (hPa) must be maintained when using this mask.
• Attaching an exhalation device requires therapy pressure level adjustment to
compensate for increased leak.
• Do not overtighten the headgear straps. Watch for signs of overtightening, such as
excessive redness, sores or bulging skin around the edges of the mask. Loosen the
headgear straps to alleviate symptoms.
• Do not block or seal the anti-asphyxia valve or exhalation ports.
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