Intended Use - Sunset Healthcare Sol Manual De Instrucciones

Intended use

The mask is a noninvasive accessory used for channeling airflow with or without supplemental
oxygen to a patient from a positive airway pressure (PAP) device such as a continuous positive
airway pressure (CPAP) or bi-level system. The mask is intended for single-patient use. The
mask is for users weighing over 66 pounds.
Contraindications
If the user has the following complications, the product may not be suitable for use. Special
attention should also be given when it must be used. In either case, it is up to the doctor to
decide whether or not to use the mask. These complications include:
• Recent eye surgery or dry eyes
• Glaucoma
• Hiatal hernia
• Impaired cardiac sphincter function, excessive reflux, impaired cough reflex
• Vomiting
• Bullous Lung Disease
• Pathologically Low Blood Pressure
• Bypassed Upper Airway
• Pneumothorax
• Diagnosis of acute sinusitis or otitis media
• Risk of aspiration of gastric contents
• Allergy or hypersensitivity to the mask materials, or inability to remove the mask
CAUTION:
In the United States, Federal law restricts the sale of this device by or on the order of a physician.