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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• Physical impairment resulting in inability to apply the home sleep testing equipment when
another individual is not available to assist with this task.
GENERAL SAFETY INFORMATION
• Magnetic and electrical fields are capable of interfering with the proper performance of the
Prodigy Sleep System. Make sure that all external devices operated in the vicinity of the unit
comply with the relevant EMC requirements.
• This device shall not be used for life support or critical applications. It may stop operating in the
event of a power interruption or system fault.
• Do not use in the vicinity of flammable liquids or gases (such as flammable anesthetics).
• Do not sterilize any component of the device. Cleaning and disinfection should only be done
according to instructions and by trained service personnel.
• Equipment needs to be set-up and put into service in accordance with the information provided
in the accompanying documents, including this operator manual.
• Do not use the Prodigy Sleep System if you are connected to a high-frequency surgical
instrument as this could cause skin irritation or burns under the electrodes.
• If any signs of skin irritation become present (e.g. itchiness, redness, swelling) while handling the
Prodigy Sleep System discontinue use immediately
• Do not use the Prodigy Sleep System when other electronic medical devics are also attached to
your body as this may cause improper operation.
• External defibrillation of a person wearing Prodigy Sleep System components can injure the
person with risk of burns under the electrode sites during defibrillation. To eliminate any risk,
remove all Prodigy Sleep System components before defibrillation paddles are applied.
• Interference from other RF wireless and mobile communication devices is possible. Refer to
Table 6 - Recommended separation distances between portable and mobile RF communications
equipment and the Prodigy Sleep Systemfor recommended distances between Prodigy Sleep
System components and other RF devices
• Handle the components with care and avoid dropping or otherwise rough handling of the
components.
• There are no user serviceable parts inside the device. The user shall not open the device and
make any adjustments or attempt to service the device.
• Avoid contact with liquids. Keep all liquids away from device components.
• Avoid placing components in direct sunlight or in close proximity to intense heat, including
household heaters or open flame.Keep Prodigy Sleep System components clean and do not
expose to lint, dust, or other particulate matter. The contamination of such material within
component openings or on electrode surfaces can negatively impact device performance.
• The presence of children, pets, and vermin does not normally affect the proper functioning of
the Prodigy Sleep System. However, it is advised to keep Prodigy Sleep System away from
UNCONTROLLED COPY - SGS - 30-JAN-19