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SECTION 1—GENERAL GUIDELINES
Invacare®Twilight™Full Face Mask 4 Part No 1130237
SECTION 1—GENERAL GUIDELINES
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WARNING
SECTION 1 - GENERAL GUIDELINES contains important information for
the safe operation and use of this product.
If oxygen is used in conjunction with a PAP machine and the full face mask,
the oxygen flow MUST be turned Off when the PAP machine is not
operating. If the oxygen flow is left On, oxygen may accumulate within the
tubing, machine enclosure, or the mask surroundings. Accumulated
oxygen in the tubing, machine enclosure, or the mask surroundings may
increase the risk of fire.
CAUTION
“Caution: Federal law restricts this device to sale or rental by or on order of a
physician, or any other practitioner licensed by the law of the state in which
he/she practices to use or order the use of this device.”
At low CPAP pressures the flow through the exhalation port may be inadequate
to clear all exhaled gas from the tubing. Some rebreathing may occur.
This Twilight Full Face Mask should be used only with PAP systems
recommended by your physician or respiratory therapist. A mask should not be
used unless the PAP system is turned On and operating properly.
This mask is a full face mask, which covers both the nose and the mouth.
NEVER block the vent hole or holes associated with the mask.
DO NOT use an electrically conductive breathing tube.
PAP systems are intended to be used with special masks which have vent holes
to allow continuous flow of air out of the mask. When the PAP machine is
turned On and functioning properly, new air from the PAP machine flushes the
exhaled air out through the mask exhalation vent holes. However, when the
PAP machine is not operating, not enough fresh air is 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 PAP systems.
The mask may not be suitable for those with risk of gastric regurgitation or
similar conditions.
For patients who are unable to remove the mask, it MUST be used under
qualified supervision.
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 systems.