Steris SYSTEM 1E, Руководство по обслуживанию

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3.1 SYSTEM 1E™ LIQUID CHEMICAL
STERILANT PROCESSING SYSTEM
DESCRIPTION
The SYSTEM 1E Liquid Chemical Sterilant Processing
System is made up of the System 1E Processor, the
Water Preparation unit and the UV Water Treatment
unit. The three units function together as a system and
cannot be altered. The Water Preparation unit includes
the A and B pre-filters, housings and water pressure
regulator. The water pressure regulator is factory set
to 50 psig. The UV Water Treatment unit includes a
stainless steel chamber with quartz sleeve, an ultra-
violent lamp and a UV intensity monitor.
The SYSTEM 1E Liquid Chemical Sterilant Processing
System runs only two cycles: a Liquid Chemical
Sterilization Cycle and a Diagnostic Cycle. There are
no user or service adjustments that can be made to alter
either cycle sequence or parameter set points. The
Liquid Chemical Sterilization Cycle is used for the
processing of medical equipment, while the Diagnostic
Cycle is a daily test cycle that verifies the operation of
the unit components.
Accessories such as processing trays and Quick
Connects are not addressed in this manual.
3.2 OVERVIEW OF THE SYSTEM
The SYSTEM 1E Liquid Chemical Sterilant Processing
System is intended for the liquid chemical sterilization
of manually cleaned immersible, reusable, critical and
semi-critical heat-sensitive medical devices, including
endoscopes and their accessories. Devices processed
in the SYSTEM 1E Liquid Chemical Sterilant
Processing System have been chemically sterilized
using S40™ Sterilant Concentrate, a peracetic acid
liquid chemical sterilant, and rinsed with extensively
treated, potable water.
The SYSTEM 1E Processor treats potable water using
a three stage process: pre-filtration, UV irradiation,
and 0.1 micron filtration.
• The pre-filtration stage reduces particulates present
in the potable water.
• The UV irradiation stage reduces waterborne
pathogenic viruses in the unlikely event that they
are present in potable water.
• The dual membrane, 0.1 micron pharmaceutical
sterilizing-grade filter effectively removes bacteria,
fungi and protozoa from the rinse water.
After completion of the cycle for the SYSTEM 1E
Processor (which includes liquid chemical sterilization
and rinse phases), the load is ready for immediate use.
Once removed from the SYSTEM 1E Processor the
devices are wet. Critical devices
1
and some semi-
critical devices are processed within containers. The
containers are closed with transparent lids; the
containers are not designed for sterile storage and
medical devices should not be stored after processing
in SYSTEM 1E Processor. Processed medical devices
should be used immediately to minimize the risk of
environmental contamination.
SYSTEM 1E Processors are to be used only by trained
personnel who are fully familiar with, and strictly
comply with, the operating instructions and
conditions detailed in the Operator Manual, as well as
any applicable Quick Connect Processing Instructions.
The warranty pertaining to equipment or products
sold by STERIS is contained in STERIS’s Terms and
Conditions of Sale.
Important: Liquid chemical sterilization of a surgical
or diagnostic device by the SYSTEM 1E Processor
requires that the liquid sterilant make contact with all
exterior and interior surfaces of the device. In the case
of a device having internal channels or other interior
surfaces, the device manufacturer’s instructions
should be reviewed to determine the manufacturer’s
recommendations for the preparation of the device for
liquid chemical sterilization or disinfection. STERIS is
not responsible for the adequacy of the device
manufacturer’s instructions or the design of the device
which fails to permit liquid to contact the surfaces of
all internal channels and components of the devices.
The device will not be liquid chemically sterilized if
the sterilant does not contact all interior and exterior
surfaces of the device.
3.3 COMPONENT DESCRIPTION
Refer to Figure 3-1 for this section. This figure shows
the general components used in the SYSTEM 1E Liquid
Chemical Sterilant Processing System. The unit can be
broken down into the following subsections:
1. Fluid Pathway
2. Housing of Water Filter
3. Air Manifold
3.3.1 Fluid Pathway Description of SYSTEM 1E
Processor
1. Due to their size, a limited number of critical devices are processed in a processing tray. Go to www.steris.com
to determine how a specific device is processed.
Section 3: Principles of Operation