INDICATIONS FOR USE

The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.

INTENDED USE

The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases such as chronic bronchitis, emphysema, asthma, or lung cancer, those in the terminal stage of cancer, or any patient requiring supplemental oxygen. The device is portable, enabling patients who need an oxygen device to be treated at home according to a clinician’s prescription or direction. The Portable Oxygen Concentrator is a prescription-only device, is not intended for use in life-supporting or life-sustaining situations, and is provided non-sterile. It is designed to be used indoors or outdoors.

CONTRAINDICATIONS

The Portable Oxygen Concentrator is not intended to be used:

•in life-supporting or life-sustaining situations

•in an operating or surgical environment

•with a non-adult population

•in conjunction with flammable anesthetic or flammable materials

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