Disclaimer

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Disclosure: Refer to product labeling for specific information and directions regarding product purpose, use, warnings and cautions.

Intended Use

The MICHELE Sleep Scoring System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders.

The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarizing, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.

Warnings and Cautions

The Michele Sleep Scoring system does not analyze data that are different from those analyzed by human scorers. The report generated by the Michele Sleep Scoring system contains numerical and graphical data typical of those generated following manual scoring of polysomnograms. It does not contain any interpretation, diagnosis, or recommendations for treatment. These decisions are to be made by the treating physician.

The scoring provided by the Michele Sleep Scoring system must be reviewed, edited as necessary and approved before the report is generated.

Special attention should be paid to confirm the first epoch of REM sleep and of non-REM sleep since, occasionally, brief periods of either kind can be missed or mistakenly scored resulting in large errors in sleep latency or REM latency. Arousals may be under reported in cases where arousal frequency is very high.

Any modification to any component of the Michele Sleep Scoring system may result in erroneous results or failure of the software to operate.

If data files are sent to Younes Medical Technologies for processing or troubleshooting, failure to remove confidential patient information from the file may result in breach of patient privacy if files are lost in transit or accessed by unauthorized personnel.

Caution: US Federal law restricts this device to sale by or on the order of a physician.

Labeling Disclaimer

Instructions for use will be translated into the required language of an EU country prior to distribution to a user within that country.