Smartmonitor 2 Clinical Summary - Circadiance SmartMonitor2 Bedienungsanleitung

Additional Information

SmartMonitor 2 Clinical Summary

The SmartMonitor 2 was evaluated in a clinical study according to the most recent FDA recommendations. These
recommendations are available in the "Guidance for Apnea Monitor 510(k) Submission" released in 2002.
The study was completed with babies less than 1 year of age who were in need of an apnea monitor. The recorded
information was analyzed to identify the number of 10-second apnea events detected by the monitor. The same events were
then scored by a health care professional. SmartMonitor 2 sounded an alarm for 51 of 100 apnea events scored by the health
care professional and did not alarm for 49 scored apnea events. Out of every 100 alarms, 54 sounded when the baby was
breathing normally. Forty-six alarms actually indicated apnea. On average, the monitor sounded a false alarm once every 67
minutes.
With all apnea monitors you can expect a certain amount of false alarms. Often times these false alarms are caused by the
baby's movement and the amount of contact made by the electrodes on the baby's skin. In the home environment, your
baby's apnea monitor will be set to detect and alarm for apneas that are greater than 15 to 20 seconds rather than the 10
seconds used in the clinical study. When an apnea event occurs that is longer than 15 to 20 seconds, often the baby's heart
rate will slow down. As an added safety feature, SmartMonitor 2 also detects and alarms for this slow down in the baby's
heart rate.
If you would like additional clinical information about the function of the monitor prescribed for your baby, contact your health
care provider or your baby's doctor.
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