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Intended Use; Warnings - Respironics SleepEasy User Manual

Sleepeasy with c-flex
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CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician.
Read all instructions before using the SleepEasy with C-Flex device with integrated humidifier.

Intended Use

The Respironics SleepEasy with C-Flex device delivers continuous positive airway pressure (CPAP) therapy for the treatment of
Obstructive Sleep Apnea in spontaneously breathing patients weighing >66 lbs. It is intended for use in the home or hospital environment.
IMPORTANT: Your home care provider will make the correct pressure settings according to your health care professional's
prescription. Several accessories are available to make your OSA treatment with the SleepEasy system as convenient and
comfortable as possible. To ensure that you receive the safe, effective therapy prescribed for you, use only Respironics
accessories.

Warnings

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.
• This device is not intended for life support.
• 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, not enough fresh air will 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.
• Do not use this device without the water chamber installed.
• This device contains small parts which could present a choking hazard.
• Do not use extension cords with this device.
• If oxygen is used with the device, turn on the device before you turn on the oxygen flow. Turn the oxygen off before turning the
device off. Also, 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 on, oxygen delivered into the tubing may accumulate within the device's
enclosure. Oxygen accumulated in the device enclosure will create a risk of fire.
• When using oxygen with this system, a Respironics Pressure Valve must be placed in-line with the patient circuit after the oxygen
source. Failure to use the pressure valve could result in a fire hazard.
• Do not use the device in the presence of a flammable anaesthetic mixture in combination with oxygen or air, or in the presence
of nitrous oxide.
• When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen.
• Oxygen accelerates fires. Keep the device and the oxygen container away from heat, open flames, any oily substance, or other
sources of ignition. Do not smoke in the area near the device or the oxygen.
• If administering fixed-flow supplemental oxygen, the oxygen concentration may not be constant. The inspired oxygen
concentration will vary, depending on the CPAP setting, patient breathing pattern, and leak rate. Substantial leaks around the
mask may reduce the inspired oxygen concentration to less than the expected concentrations. Appropriate patient monitoring
should be implemented.
• Do not connect the device to an unregulated or high pressure oxygen source.
• Do not use the device near a source of toxic or harmful vapors.
• Do not use this device if the room temperature is warmer than 95° F. If the device is used at room temperatures warmer than
95° F, the temperature of the airflow may exceed 106° F. This could cause irritation or injury to your airway.
• Do not operate the device in direct sunlight or near a heating appliance because these conditions can increase the temperature of
the air coming out of the device.
• Contact your health care professional if symptoms of sleep apnea recur.
• If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been
dropped or mishandled, if the enclosure is broken, or if water has entered the enclosure, disconnect the power cord and
discontinue use. Contact your home care provider.
• Repairs and adjustments must be performed by Respironics-authorized service personnel only. Unauthorized service could cause
injury, invalidate the warranty, or result in costly damage.
• Inspect the power cord often for any signs of damage. Discontinue use and replace if damaged.
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