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Intended Use; Important; Warnings - Philips REMstar Pro User Manual

C-flex+.
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CauTion: U. S. federal law restricts this device to sale by or on the order of a physician.

intended use

The Respironics REMstar Pro C-Flex+ system delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in
spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

important

The device is to be used only on the instruction of a licensed physician. 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 REMstar Pro C-Flex+ 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, 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.
• If you are using a full face mask (a mask covering both your mouth and your nose), the mask must be equipped with a safety (entrainment) valve.
• If you are using the optional Respironics 15 mm tubing, the device tubing type setting must be set to 15. If your device does not have the
tubing type setting, you must use the Respironics 22 mm tubing.
• When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.
• When using oxygen with this system, turn the device on before turning on the oxygen. Turn the oxygen off before turning the
device off. This will prevent oxygen accumulation in the device. 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 between the device
and the oxygen source. The pressure valve helps prevent the backflow of oxygen from the patient circuit into the device when the
unit is off. Failure to use the pressure valve could result in a fire hazard.
• Do not connect the device to an unregulated or high pressure oxygen source.
• 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.
• 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 35° C (95° F). If the device is used at room temperatures warmer
than 35° C (95° F), the temperature of the airflow may exceed 43° C (109° 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 water is spilled into the enclosure, or if the enclosure is broken, 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.
• Periodically inspect electrical cords and cables for damage or signs of wear. Discontinue use and replace if damaged.
• To avoid electrical shock, always unplug the power cord from the wall outlet before cleaning the device. DO NOT immerse the
device in any fluids.
• If the device is used by multiple persons (such as rental devices), a low-resistance, main flow bacteria filter should be installed in-
line between the device and the circuit tubing to prevent contamination.
• Be sure to route the power cord to the outlet in a way that will prevent the cord from being tripped over or interfered with by
chairs or other furniture.
• This device is activated when the power cord is connected.
• For safe operation when using a humidifier, the humidifier must always be positioned below the breathing circuit connection at
the mask and the air outlet on the device. The humidifier must be level for proper operation.
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User Manual

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Respironics remstar pro c-flex +

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