SmartMonitor 2 PS Parents’ Guide
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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 physician. SmartMonitor 2 sounded an alarm for 51 of 100 apnea events
scored by the physician 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 slowdown 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 home care provider or your physician.
