Respironics SmartMonitor2, Operator'S Manual, Page: 7 / 80

Introduction
1
Introduction
Unpacking and Inspection
When you receive the SmartMonitor® 2, unpack the shipping case and:
Carefully examine the contents.
Save the shipping carton.
Make sure you have all the necessary items and that they are not damaged.
Report anything missing or damaged to Respironics.
About this Manual
This manual provides all the information you need to set up and operate the Respironics SmartMonitor 2
and explains how to use it to monitor the baby's vital functions. Carefully read and understand this manual
before using the system. Words that appear in
Bolded Italics are defined in the Glossary in the back of
this manual.
Indications for Use
The SmartMonitor 2 is intended for use in continuous monitoring of heart rate and respiration of infant
patients in a home, hospital or portable environment. Its primary function is detection of
central apnea .
Its secondary function is measurement of heart rate.
What is the Purpose of the SmartMonitor 2?
SmartMonitor 2 is an apnea monitor designed to monitor and record the baby's breathing ( respiration )
and heart (cardiac) activity. The monitor alerts you if either of these activities exceeds the limits
prescribed by the physician.
Patient alarm limits are set by the health care professional before the SmartMonitor 2 monitor is delivered
to the patient. During monitoring, when the baby's breathing effort and heart activity are not within these
set boundaries, an indicator light comes on and an alarm sounds. This manual explains how to set up the
SmartMonitor 2, how to monitor the baby, and how to transfer information.
Other devices may be used with the SmartMonitor 2. Refer to the section Using Auxiliary Equipment for
further information.
Summary of Clinical Performance Evaluation
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.
Study Design
This was a multi-center, prospective, non-randomized study carried out at six clinical sites in the
United States. Infants in nurseries and other settings appropriate for attended monitoring, who
were considered to be appropriate candidates for cardio-respiratory monitoring, were recruited
and enrolled into the study.
Methods
Enrollment was competitive and each site was instructed to continue patient enrollment until a
sample size of at least 100 qualified central apneas was obtained.