Intended Use: The OralFitnessCheck visualizes the patient’s oral hygiene behavior as a communication aid to support patient education on the importance of oral hygiene and to improve understanding and willingness to adhere to dental recommendations. The patients’ results are only to be used to educate/advise on the patients’ dental hygiene practices and are not for the diagnosis, prevention, or treatment of disease or the assessment of health.

The OralFitnessCheck test is performed with an ORALyzer and the OralFitnessCheck test kit. The kit contains:

• • • A small vial of sterile solution.
    • A plastic cup is used for the patient to expectorate the sample.
    • A syringe to draw up the sample.
    • A filter that you attach to the syringe to filter the salivary sample.
    • A test cassette.

The ORALyzer Reader (machine that analyzes the result) and the label printer convert the results on the test cassette to an accurate numerical value.

PROCEDURE

It is recommended that the patient not brush their teeth for at least 30 minutes before testing. The patient may take a sip of plain water to remove food debris from the mouth. Then, they rinse for 30 seconds with the enclosed sterile water, which is expectorated into the enclosed cup. The fluid is drawn into the included syringe, and a filter is attached.  Three (3) drops are expressed from the syringe into the reservoir of the test cassette. The test cassette is then placed in the drawer of the ORALyzer machine.

 The ORALyzer reads the result from the cassette and then gives a reading in 5 minutes.