Exsurco Medical Amalgatome SD, User Manual

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A
MALGATOME
®
SD U
SER
G
UIDE
PN#: X101456, Rev. C Page 23 of 56
Cleaning and Sterilization Instructions
This section describes the Amalgatome SD System cleaning and sterilization requirements.
The Amalgatome SD is reusable and requires cleaning and sterilization prior to reuse. Manual cleaning and
Automated Cleaning have both been validated for use with the system. It is important to exercise care when
handling the components to protect them from physical damage. Only remove the components as instructed in the
following procedures. Any further disassembly of the system can cause damage and/or loss of calibration and will
void the warranty. The system contains no user-serviceable parts and must be returned to Exsurco Medical for
repair and maintenance.
As with any decontamination procedure, follow the accepted guidelines for hand washing, use of personal
protective equipment (PPE), etc., as recommended by the Association for the Advancement of Medical
Instrumentation (AAMI) Standards and Recommended practice,
Safe Handling and Biological Decontamination
of Medical Devices in Health Care Facilities and in Non-Clinical Settings, current version of ANSI/AAMI ST35 .
CAUTIONS:
•
Do not allow blood, tissue, or disinfectants to dry on any part of the Amalgatome SD System.
•
Do not use cleaning agents with chlorine or chloride (e.g., saline or bleach) as the active ingredient as they are
corrosive to stainless steel and can result in physical damage to the system, including rust and corrosion.
•
Do not use saline as it has a corrosive effect on stainless steel and can result in physical damage to the system.
•
Always use cleaning agents that are safe for surgical instruments and stainless steel.
•
Never place the pneumatic hose in any kind of automated washing system.
•
Always inspect instruments and devices for rust and corrosion per AORN and hospital protocols.