Cerebra Medical Label

This report was generated by:

Prodigy DSA (Prodigy Digital Sleep Analysis)

Manufacturer:

Cerebra Medical
1470 Willson Place Unit B
Winnipeg, Manitoba R3T 3N9
Canada
Tel: 1-888-942-6774
Title: Report Label - Prodigy DSA
Document Number: M2-Label-001-04
Revision: 04; CCRF-668
Effective Date: 18-Jul-19

Intended Use:

The Prodigy DSA is a collection of software applications intended for use as an aid for the evaluation of sleep and the diagnosis of sleep disorders.

The Prodigy DSA is intended to be used for scoring, viewing, and editing digital data collected from adult, human subjects during sleep, and generating graphs and variables for viewable reports typically used to evaluate sleep and sleep disorders.

The device is to be used by a physician and/or qualified PSG Technologist. Use is restricted to files obtained from patients greater than 18 years of age.

Warnings and Cautions:

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

The scoring provided by the Prodigy DSA must be reviewed, edited as necessary, and approved before the report is generated.

The first epoch of REM sleep and of non-REM sleep require special attention as brief periods of either kind may occasionally be missed or mistakenly scored resulting in large errors in sleep latency or REM latency.

Arousals may be underreported in cases where arousal frequency is very high.

Modification to any component of the Prodigy DSA may result in erroneous results or failure of the software to operate. Users should consult the User Manual.

Note - Identifiers of particular software versions are displayed within user interfaces and results files