Transcend 365 miniCPAP User Manual page 7

Transcend 365 miniCPAP User Manual
Do not block or otherwise obstruct the exhalation ports of the mask. Follow the
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manufacturer's instructions included with your mask.
This equipment is not suitable for use with oxygen or in the presence of a
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flammable anesthetic mixture with air or oxygen, or with nitrous oxide. Sources of
oxygen must be located more than 1 m from the equipment to avoid the risk of fire
and burns.
The Transcend 365 miniCPAP is only to be used with the supplied or recommended
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accessories. Use of accessories not recommended may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the PAP
system and may be potentially unsafe.
The Transcend 365 miniCPAP is not defibrillation proof.
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• Do not attempt to sterilize Transcend 365 miniCPAP.
The device is only compatible with appropriately marketed FDA cleared masks and
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hoses. A mask should not be used unless the device is turned on and is properly
delivering Ramp or therapy pressure. The proper placement and positioning of the
mask on the face is critical to the consistent operation of this equipment. The
exhalation port(s) associated with the mask should never be blocked. Explanation
of the Warning: The device is intended to be used with masks or connectors
specifically designed to have exhalation ports to allow continuous flow of air out of
the mask. When the device is turned on and functioning properly air flow from the
device flushes the exhaled air out through the mask exhalation port. When the
device is not operating, however, fresh air will not be provided through the mask
and exhaled air may be rebreathed.
Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or
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permits spontaneous breathing can cause asphyxiation.
Strangulation hazard from power cord and air tube. These can become wrapped
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around a neck and strangle.
Keep power cord and air tube more than 3 feet from a baby's crib and out of a
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baby's reach. Keep cord and tube out of children's reach.
Small parts are unlikely to be expelled from the Transcend 365 miniCPAP enclosure,
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but in case of severe damage internal components may fragment and create a
swallowing or choking hazard if they get out of the enclosure.
• Do not position the equipment in bed. Covering breathing tubes with a blanket or
heating them can affect the quality of therapy or injure the user.
To prevent disconnection of the tubing during use, only tubes in compliance with
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ISO 5367 or ISO 80601-2-74 should be used.
Do not use the Transcend 365 miniCPAP at an altitude above 8000 ft. (2438 m)
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unless in an airplane, or outside a temperature of 41-95F (5-35 C). Using the
device outside of this temperature range or above this altitude can affect the
quality of the therapy or injure the user.
Do not add any attachments or accessories to the humidifier or CPAP that are not
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approved for use by this instruction. Unapproved accessories may lead to improper
functioning of the device and affect the quality of the therapy or injure the user.
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