Intended Use; Important; Warnings - Respironics REMstar User Manual

CAuTion: U. S. federal law restricts this device to sale by or on the order of a physician.

intended use

The Respironics REMstar Auto A-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. The system can deliver CPAP therapy or Auto-CPAP
therapy. For enhanced pressure relief in CPAP mode, the device can also deliver C-Flex or C-Flex+. For enhanced pressure relief in
Auto mode, the device can deliver C-Flex or A-Flex. Your home care provider will make the correct pressure settings according to
your health care professional's prescription.
When set in the Auto-CPAP therapy, the system will monitor your breathing as you sleep and automatically adjust the pressure to
meet your needs. When in CPAP therapy, the system will deliver a continuous, set pressure during the night.
Several accessories are available to make your OSA treatment with the REMstar Auto A-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.
• When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen.
• 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 after the oxygen
source. 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.
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