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Medical Information
What the VPAP Malibu™ Is Intended For
The VPAP Malibu is indicated for the treatment of adult patients with obstructive
sleep apnea (OSA). It is intended for use in the hospital and home.
!
CAUTION (USA ONLY)
Federal law restricts this device to sale by or on the order of a physician.
Tell Your Doctor If...
You must tell your doctor if you have any of the following conditions, and CPAP
(continuous positive airway pressure) or bilevel therapy must not be used:
• pneumothorax or pneumomediastinum
• severe heart failure, low blood pressure, or dehydration
• surgery to the brain, middle or inner ear, pituitary gland, or sinuses
• respiratory distress syndrome
• middle ear infection or perforated ear drum
• severe nosebleed.
Warnings
CPAP or bilevel therapy should be used with caution if you have any of the
following conditions:
• respiratory failure
• cavities or cysts in the lung, or previous history of pneumothorax
• previous history of severe nosebleed
• sinus infection.
Tell your doctor if you have any of these conditions. Your doctor will advise you
whether the likely benefits of CPAP or bilevel therapy outweigh the expected
risks.
Special care should be exercised if you are dehydrated, or may become
dehydrated, for example as a result of fluid restriction or diuretic therapy
(including changes in therapy).
Discontinue therapy and seek medical advice if, during therapy or when you start
therapy each night, you feel faint or light-headed.
The following are general warnings that pertain to your use of a VPAP Malibu
unit. Specific warnings appear next to the relevant instructions in this guide.
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