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.

Quality Management System

Younes Medical Technologies operates a Quality Management System that complies with the requirements of the ISO 13485:2003 standard and holds Certificate Number FM 551942 issued by the British Standards Institute (BSI). This certification includes the Standards Council of Canada (SCC) endorsement under the Canadian Medical Device Conformity Assessment System (CMDCAS) scheme.

Under the supervision of BSI, a Notified Body (0086), Younes Medical Technologies is also in conformance with the provisions of Annex V/Annex VII and of the Essential Requirements of Annex I of the European Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC. As well, Younes Medical Technologies’ Quality Management System incorporates all requirements of the US FDA Quality System Regulations, as per Part 820 of Title 21 of the Code of Federal Regulations (CFR).

Certification

In addition to the ISO 13485:2003, Younes Medical Technologies is in compliance with the following medical device standards:

  • ISO 14971:2007 – Medical devices – Application of risk management to medical devices
  • IEC 62304:2006 – Medical device software – Software life cycle processes
  • IEC 62366:2007 – Medical devices – Application of usability engineering to medical devices

Younes Medical Technologies is committed to continual improvement of its product and Quality Management System.

The Michele Sleep Scoring system has received market clearance in Canada, the European Union and the United States of America.

The Michele Sleep Scoring system holds the following certificates:

  • ISO: BSI ISO 13485:2003 Certificate # FM 551942

                 

  • Canada: MICHELE Sleep Scoring System Health Canada Medical Device Licence # 83643
  • Europe: BSI CE Certificate # CE 552637

To obtain further information on Younes Medical Technologies’s Quality Management System, please contact Brittany Gibson, Director of Quality Assurance for Younes Medical Technologies.

P 204 949 3200
E brittany.gibson@younessleeptechnologies.com

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.