Warnings
Federal Law restricts this device to sale by or on the order of a licensed practitioner. Prescription use only. To
be used only for prescribed purposes.
Read all manuals and labels prior to use. Ensure the patient has received training prior to dispensing.
The device is not certified for continuous monitoring where failure to operate can cause injuries or death.
A Pulse Oximeter should not be used as an apnea monitor.
This device should not be prescribed for patients that are unable to understand and comply with instructions,
including removal of the Titration Trays unassisted.
The HCP (e.g. sleep technicians, dental office staff, sleep physicians and dentists) should consider the medical
history of the patient, including history of asthma, breathing, respiratory disorders, neurologic diseases or
other relevant health problems, and refer the patient to the appropriate HCP before prescribing the device.
Oral appliance prediction may not be accurate in cases of central sleep apnea (CSA) and severe respiratory
disorders.
Patients fitted with an oral appliance after their MATRx plus Study, as prescribed by the interpreting physician,
should be monitored and undergo further sleep testing with their therapeutic appliance in place to ensure
adequate treatment is achieved.
Use of the device during an OA Study may cause:
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User Profile
The device is used by the following individuals:
Healthcare Providers who are responsible for dispensing the device, instructing the patient, assessing suitability
and prescribing treatment
Patients who will be using the device for a home sleep study
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Contraindications
This device is not to be used as an apnea monitor or in a life supporting or life sustaining situation
This device is not to be used by patients under the age of 18
The MATRx plus device is MR unsafe
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In an OA Study mode, the device is not recommended for use in patients who:
Have loose teeth or advanced periodontal disease
Have full dentures or dental implants
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Temporary bite changes
Gum or tooth discomfort
Jaw discomfort
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Jaw joint discomfort
Increased salivation
Dry mouth
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