Intended Use; Warnings, Cautions, And Contraindications; Warnings - Respironics BiPAP Plus User Manual

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ntended
The Respironics BiPAP® Plus with Bi-Flex® M Series system delivers positive airway pressure
therapy for the treatment of Obstructive Sleep Apnea (OSA) only in spontaneously breathing
patients weighing >66 lbs (30 kg).
The device is to be used only on the instruction of a licensed physician. The system can deliver
Bi-level therapy with and without Bi-Flex. Your home care provider will make the correct pressure
settings according to your health care professional's prescription.
When set in the Bi-level therapy mode, the system will deliver a continuous, set pressure during
the night.
Several accessories are available to make your OSA treatment with the BiPAP Plus with Bi-Flex
M Series system as convenient and comfortable as possible. To ensure that you receive the safe,
effective therapy prescribed for you, use only Respironics accessories.
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arnIngs
Caution: U. S. federal law restricts this device to sale by or on the order of a physician.
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arnIngs
A warning indicates the possibility of injury to the user or the operator.
• This manual serves as a reference. The instructions in this manual are not intended to
supersede the health care professional's instructions regarding the use of the device.
• The operator should read and understand this entire manual before using the device.
• The device should be used only with masks and connectors recommended by Respironics
or with those recommended by the health care professional or respiratory therapist. A mask
should not be used unless the device is turned on and operating properly. The exhalation
port(s) associated with the mask should never be blocked.
Explanation of the Warning: The device is intended to be used with special masks or
connectors that have exhalation ports to allow continuous flow of air out of the mask. When
the device is turned on and functioning properly, new air from the device flushes the exhaled air
out through the mask exhalation port. However, when the device is not operating, enough fresh
air will not be 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.
• Use only the breathing circuit provided by your home care provider.
• When using a breathing circuit that contains a mask with an integrated exhalation port
or a circuit with a separate exhalation device, do not tape, seal, or otherwise block the vent
openings. Doing so could result in suffocation.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is not in use.
Explanation of the Warning: When the device is not in operation and the oxygen flow is left
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