Important safeguards

READ ALL INSTRUCTIONS BEFORE USE.

WARNINGS

To avoid the risk of electrocution, burns, fire or physical injury:

  • The device is only to be used while awake. It should not be used while sleeping.
  • Only the supplied products should be used together. Do not use attachments other than those recommended by the manufacturer.
  • Discontinue use if the product appears damaged in any way.
  • Never attach the Mouthpiece directly to a charging source other than the control unit provided.
  • This device should only be charged using the USB Cable provided.
  • Do not operate in close proximity (e,g. 3.4 feet) to a shortwave or microwave unit as other Electromagnetic equipment may produce instability in the simulator output.
  • Always keep the Control Unit away from water.
  • Unplug the Control Unit immediately if it falls into water.
  • Never use a damaged USB Cable to charge the Control Unit.
  • This product contains no user serviceable parts. Refer to “Warranty” and “Trouble Shooting” if appliance no longer works as expected.
  • The device is only to be used as specified in this document.

To avoid the risk of physical injury:

  • This device should not be used by persons:
    – children (under 18 years of age)
  • eXciteOSA should be kept away from children and pets (choking hazard and electrical hazard).
  • eXciteOSA to be used in a home or healthcare environment (or equivalent).
  • eXciteOSA’s durable controller unit can be repurposed for use by multiple successive patients
  • eXciteOSA’s disposable mouthpiece is for single patient use
  • Do not use eXciteOSA when driving a vehicle or operating machinery and other
    equipment.
  • When charging the device, keep away from all liquids.
  • No modification of this device is allowed. Do not try to alter, trim or change any components of the device.
  • The silicon on the Mouthpiece must be intact before use. If there is any breach of the silicon (including electrodes) – DO NOT USE THE MOUTHPIECE.

CONTRAINDICATIONS

Do not Use eXciteOSA if:

  • you are pregnant or maybe pregnant.
  • you have a pace maker or implanted electrodes.
  • you have dental braces or jewellery in your mouth.
  • you are suffering from mouth ulceration or recent dental work.
  • having or suspecting of having obstructive sleep apnoea with AHI greater than 15.

Safety and effectiveness in the above conditions have not been established.

PRECAUTIONS

Consult your Doctor/Dentist if:

  • you have gum disease or have bleeding from your gums or other oral conditions.
  • you experience pain, numbness or bleeding after using this product.
  • you have any nose, throat conditions and previous oral surgery
  • you have any medical conditions
    – Facial skeletal abnormalities
    – Obesity (BMI > 35)

This device should not be used:

  • while asleep (device only to be used when awake)
  • in contact with your head, neck, spine, chest, eyes, ears or any other parts of the body other than inside the mouth as instructed.

Adverse Reactions:

  • accumulation of saliva
  • tingling sensation on tongue