Medisafe SI PCF, Руководство пользователя

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Introduction SI PCF User Manual
Ref: DOC03148 Issue 1 Friday, 06 January 2017
Page 18 of 81
Intended Use
The Medisafe Sonic Irrigator PCF is a High-
Pressure, Ultrasonic, Flushing Washer
Disinfector for the medical market. It is
intended to provide cleaning and low-level
thermal disinfection of surgical instruments,
including complex lumen/cannulated devices,
such as robotic surgical instruments.
This is achieved through a combination of
ultrasonics and a flushing action to remove
debris from both the outside and inside (hollow
instruments only) of items placed within the
wash tank.
Note:
The SI PCF Washer has been validated for
the cleaning and low-level thermal disinfection of
surgical instruments and devices, including complex
lumen/cannulated surgical instruments and devices
such as robotic surgical instruments. Testing to
validate cleaning and disinfection efficacy for a
specific instrument is the responsibility of the
instrument manufacturer. Consult the instrument
manufacturer’s instructions regarding cleaning and
disinfection.
Note : If the equipment is used in a manner not
specified by the manufacturer, the effectiveness
and protection provided by the equipment may be
impaired.
Performance
Washing is achieved using a unique, specially
formulated and clinically validated
decontamination fluid (EDA+ or 3E-Zyme®),
which is introduced into the machine during
the cycle.
This machine has a class AB weir incorporated
into the tank design to comply with most water
authority regulations.
A stringent quality control program ensures
that every unit is manufactured and tested
under controlled conditions to ensure that all
units perform identically.
Cycle Record
During the cycle, parameters are reported at
key stages of the process as an ASCII serial
data steam via the RS232 port. This can then
be logged either on a printer (see section 2-6-2
and 2-10) or on a PC (see section 2-11).
The on-board cycle log can be download via a
USB flash drive (see section 3-14).
Cycle Failure
The SI PCF is designed to perform within strict
and carefully controlled tolerances. If an
unexpected condition occurs during a wash
cycle, the system will abort the cycle and
report an error, see section 3-12 for more
details.
Concept Summary
The SI PCF has the ability to wash up to
twenty instruments.
There are six pre-defined user selectable
programs with Pre -w ash, Wash, Rinse and
Disinfection stages tailored to clean a
multitude of different loads.
The program parameters can also be changed
within specified limits by an engineer during
installation or service.
The SI PCF has an interlock system that
prevents a cycle being started with the lid up.
Load Instruments
The user loads the instruments into the basket,
places it into the machine and presses the
touch screen to lock the lid.
Prewash
The cycle begins with a cold-water fill to the
mid-level; the spray and irrigation valves are
opened alternately with the pump running for
the specified time. The water is then drained.
Wash
At the main wash stage, the tank is filled to the
top level with a cold and hot water mix to attain
a set temperature. Detergent is also added at
this point. The pump is pulsed on and off, to
even out the temperature, fill all cavities, and
to mix the chemical thoroughly. Once the tank
is full the ultrasonics degas the tank by pulsing
on and off to remove any dissolved air. A
period of irrigation follows in order to flush any
material from inside the instruments. The
ultrasonics then alternate with irrigation for the
set period of time. The water is then drained.
Rinse
The tank is filled to the mid-level; and heated
to the set point. The machine then alternates
between the spray and irrigation for the pre-
defined time. The water is then drained.
For some programs this stage is repeated.
Disinfection
If disinfection is required, the machine is then
filled to the minimum level with hot water and
heated up to the pre-set temperature (
91°C /
196°F ) for 3 minutes. The water is then
drained.
Cooling
To disperse the vapour in the chamber, the
machine opens the drain valve and fills with
cold water for several minutes.
Unload
The user touches the screen to acknowledge
the end of the cycle, which unlocks the lid and
allows the basket to be removed.