Operator's Manual

Operator Manual – Prodigy Sleep System
Revision: 04; CCRF-625
Effective Date: 30-Jan-19
Document Number: YST-UDoc-PR2-001-04
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1. Introduction
This manual contains information to instruct the user how to use the various components of the system.
Special skills and training are not required of the user, but it is imperative that all users have a full
understanding of the entire system and the associated safety precautions before using the device.
INTENDED USE
The Prodigy Sleep System is intended to provide means of obtaining information about sleep quality, as
well as other physiological signals from adult users. It is a physiological data recorder that acquires,
records, and transmits data. Signals include: Electroencephalogram (EEG), electrooculogram (EOG),
electrocardiogram (ECG), electromyogram (EMG) signals, airflow (nasal cannula), respiratory effort
(chest and effort), pulse rate and oxyhemoglobin saturation from the finger.
The Prodigy Sleep System is intended for use by users in a home setting, or for prescription use in a
healthcare facility.
INDICATIONS FOR USE
The Prodigy Sleep System acquires, records and transmits physiological signals to aid in sleep
management in adult patients in an unsupervised (home) environment, and under a physician’s care, to
aid in evaluation and diagnostic support of adult users in an unsupervised (home) or supervised
(hospital) environment.
• The signals include electromyogram (EMG), electroencephalogram (EEG), electrooculogram
(EOG), pulse oximetry (photoplethysmographic), electrocardiogram (ECG), airflow (nasal
cannula), respiratory effort (chest and abdomen), pulse rate, and oxyhemoglobin saturation.
Different configurations are available which collect data from different subsets of the signals
listed above.
WARNING
The Prodigy Sleep System is not indicated for real time monitoring of EEG activity during
resucitation.
CONTRAINDICATIONS
The following is a list of contraindications for this device:
• User is under the age of 18.
• Cognitive impairment (inability to follow simple instructions) resulting in inability to apply the
home sleep testing equipment when another individual is not available to assist with this task.
UNCONTROLLED COPY - SGS - 30-JAN-19