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SECTION 1—GENERAL GUIDELINES
SECTION
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.
Invacare®Twilight™Full Face Mask | 4 | Part No 1130237 |