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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WARNING
Cleaning must be performed prior to disinfection. If a device is not cleaned soil can
prevent the proper action of disinfection from occurring, as soil can protect
microorganisms. Consequently, a soiled device can become a source for transmission of
microorganisms.
Wear protective disposable gloves and a mask during the cleaning procedure. Moisten a soft cloth with
warm water and mild detergent and thoroughly wipe the HMU, CMU, and power supply outside
surfaces. Also wipe down the packaging case surfaces, handle, and any other accessible surfaces that
may have been soiled. Thoroughly wipe the components with a soft cloth moistened with clean fresh
water to remove all traces of cleaning solution. Avoid getting fluid into the openings of the Prodigy TTU
(e.g. power input, USB connector) and the additional openings on the HMU & CMU (e.g. EEG electrode
connectors and snap EEG electrode connectors) during cleaning. Fluid ingress can be avoided by not
wringing out the cloth on the device, and using a moist cloth rather than a wet one. Additionally, wipe
the outside of the components only.
Once all traces of cleaning solution are removed, dry the components with a dry cloth and let stand for 6
hours or until all moisture is gone.
CAUTION
Let the components air dry. Do not dry the components with heat or by any other
means which may result in equipment damage.
DISINFECTING
Disinfection is a process that involves killing pathogens and other microorganisms via physical or
chemical means. Germicidal cloths can be used for low level disinfection; these cloths contain isopropyl
alcohol or hydrogen peroxide. Germicidal cloths must meet CDC and OSHA guidelines, are bactericidal,
tuberculocidal, virucidal, and fungicidal. Examples include Accel TB Wipes (www.virox.com) with
product number ACCWIP1-TB and Sani-Cloth plus (www.pdipdi.com) with store keeping unit Q89072.
For in-hospital studies, use cleaners/disinfectants approved for use by the hospital infection control
service for non-critical reusable equipment and items for users in-hospital.
Wear protective disposable gloves and a mask during the disinfecting procedure. Wipe the HMU, CMU,
TTU, and power supply outside surfaces and any surface on the packaging case that may have been
soiled with germicidal cloths and allow to remain wet as per the instructions of the manufacturer of the
germicidal cloth. After the time designated by the manufacturer has elapsed, wipe dry and let stand for
6 hours or until all moisture is gone.
UNCONTROLLED COPY - SGS - 30-JAN-19