Introduction
2
Inclusion Criteria
Spontaneously breathing, newborn infant (≤ 12 months of age), either gender without
regard to ethnicity.
Appropriate candidate for cardio-respiratory monitoring including any one or more of the
following:
• Diagnosis of cardiac, respiratory or neurological disease
• Witnessed or suspected episodes of apnea or periodic breathing
• Gestational age less than or equal to 36 weeks
• History of sibling(s) experiencing ALTE’s or SIDS
• Patients requiring supplemental oxygen
Exclusion Criteria
Any candidate with one or more of the following was excluded from enrollment:
• Presence of an artificial airway
• Receiving mechanical ventilation
• Receiving continuous positive airway pressure (CPAP)
• Presence of a cardiac or diaphragmatic pacemaker
Each patient was connected to a data acquisition system that included the Respironics Inc.
SmartMonitor and SmartMonitor 2 and the Alice System. Respiration and heart rate signals were
recorded using infant electrocardiogram electrodes. The Alice system was used to gather
physiological signals and record signals for airflow, breathing effort, and movement.
All Alice System data were reviewed by a qualified, credentialed clinician, using an Alice
polysomnograph system. Waveforms were manually reviewed and scored on an electronic
medium. The beat/breath detection and alarm channels from the SmartMonitor and SmartMonitor
2 were hidden prior to scoring by the clinician. The clinician identified apnea, bradycardia, and
tachycardia events on the Alice System.
Events were identified as required by the Guidance for Infant/Child Apnea Monitor 510(k)
Submissions, released 2002.
Results
Summary of Results
Compared to the SmartMonitor, the new SmartMonitor 2 identified 6.8% more apneas. The
SmartMonitor 2 also had 12.3% fewer false alarms and missed 6.8% fewer central apneas than
the SmartMonitor. The results of this study demonstrate that the new SmartMonitor 2 is
substantially equivalent to the predicate SmartMonitor. A detailed breakdown of study results is
provided in the following sections.
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