Medisafe PCF Pro, Руководство пользователя

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PCF Pro User Manual
DOC01851 Page 17 of 74
Intended Use
The Medisafe Sonic Irrigator PCF Pro 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 : 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 2-6-1
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 3-15).
Cycle Failure
The PCF Pro 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 3-9-10 for more
details.
Concept Summary
The PCF Pro has been designed as a stand-
alone high pressure sonic irrigation washer
disinfector, with the ability to wash up to sixty
instruments and offer the option of a
disinfection stage at the end of the wash.
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.
Load Instruments
The user loads the instruments into the basket
using the foot switch to raise and then lower
the electrically actuated Carrier Lift in an
automated sequence.
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. To even out the temperature, fill all
cavities, and to mix the chemical thoroughly
the pump is pulsed on and off. 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 with water to the mid-level;
the machine will then alternate between the
spray and irrigation for the pre-defined period
of 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 runs cold
water down the back wall of the tank.
Drying
To clear the excess water from the irrigation
and spray channels, compressed air is
alternately injected at regular intervals.
Unload
The user presses the foot switch to open the
Carrier Lift and unload one level at a time in an
automated sequence.