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Intended Use; Warnings; Cautions - Philips BiPAP autoSV advanced system One User Manual

Non-invasive ventilatory support to treat adult patient.
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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 BiPAP autoSV Advanced System One is intended to provide non-invasive ventilatory support to treat adult patients (>30 kg/66 lbs)
with Obstructive Sleep Apnea and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. This device
may be used in the hospital or home.

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) or entrainment valve 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 or entrainment valve. 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, 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.
• 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.
• Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.
• When using oxygen with this system, the oxygen supply must comply with local regulations for medical oxygen.
• 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 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.
• 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.
• 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.
• The BiPAP autoSV Advanced System One device can deliver pressures up to 25 cm H
conditions, pressures of up to 35 cm H
• The data obtained when using an Oximetry module accessory is not considered to be diagnostic and is not to be used in the
diagnosis of a patient's condition.
note: Please see the "Limited Warranty" section of this manual for information on warranty coverage.

Cautions

A Caution indicates the possibility of damage to the device.
• Pins of connectors should not be touched. Connections should not be made to these connectors unless ESD precautionary
procedures are used. Precautionary procedures include methods to prevent build-up of electrostatic charge (e.g., air conditioning,
humidification, conductive floor coverings, non-synthetic clothing), discharging one's body to the frame of the equipment or
system or to earth or a large metal object, and bonding oneself by means of a wrist strap to the equipment or system or to earth.
2
O are possible.
2
O. In the unlikely event of certain fault
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User Manual

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