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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5. Re-Processing
The Prodigy Sleep System is a reusable medical device that is intended to be re-processed by cleaning
and disinfection between every use. Re-processing is to be done by authorized service personnel only in
a designated cleaning area.
WARNING
Unauthorized personnel shall not open the device in attempt to service or otherwise
modify the components of the device, as this may damage components or result in
electrical shock.
The components are supplied to users in a clean and disinfected condition, so there is no need for the
user to clean the device. Re-processing should also be performed promptly after use to prevent
microbial growth and organic contamination. For additional education on reusable devices see the
clinical guidelines of the CDC.
Electrodes are designed for single use only and shall be discarded after use. Do not attempt to reprocess
used electrodes.
Wrist Pulse Oximeter, Effort Belts, Effort Belt Cables and Snap Lead Cables are reusable medical devices
that are intended to be re-processed by cleaning and disinfections between every use. Re-processing is
to be done by authorized service personnel only in a designated clearing area. Do not reprocess the
device if it is damaged or soiled with blood.
WARNING
Do not re-process the device if it is damaged. If damaged, dispose of components in
accordance to local regulations. Handling damaged components may result in electrical
shock, fire hazards, and/or injury to the handler or others near the device.
CAUTION
Keep device in protective case when not in use. If the device comes in contact with
blood, it shall be discarded immediately and not reprocessed to avoid blood born
pathogens from spreading.
All cleaning personnel shall review safety instructions and Material Safety Data Sheets prior to
performing any cleaning procedures.
UNCONTROLLED COPY - SGS - 30-JAN-19