Colusi U31 User Manual

Via E.
Ellero , 15 – 33080 Cusano di Zoppola (PN) ITALY

N° 0434-979596 - N°0434-574080
info@icosimpianti.com - infocolussi@icosimpianti.com A Division of
ICOS Impianti Group S.p.A.
IMPIANTI GROUP
0051 0398
UNIVERSAL AUTOMATIC AUTOCLAVES
FOR HOSPITAL STERILIZATION
U 3 SERIES
INSTALLATION, USE AND MAINTENANCE MANUAL
READ CAREFULLY THE FOLLOWING INSTRUCTIONS
File Istru3nw11 Rev. 11 Data 27/04/11 pag. 1 of 87

CONTENTS
1 INTRODUCTION
1.1. PRODUCT PRESENTATION

1.2. AIM OF THE MANUAL
1.3. GENERAL WARNINGS
1.4. WARRANTY TERMS
2 GENERAL INFORMATION
2.1. APPLICATIONS
2.2. REFERENCE REGULATIONS
2.3. CONSTRUCTIVE FEATURES
2.4. TECHNICAL FEATURES
2.5. NOISE VOLUME/VIBRATIONS
2.6. APPARATUS THERMAL DISPERSION
2.7. OPERATING POSITION
2.8. WARNING LABELS
2.9. SYMBOLS USED
3 INSTALLATION
3.1. STORAGE AND CONSERVATION CONDITIONS

3.2. TRANSPORT AND POSITIONING
3.3. STARTING UP
3.4. ELECTRICAL CONNECTION
3.5. HYDRAULIC CONNECTION
4 INSTRUCTIONS FOR THE USE
4.1. STERILIZATION PROCEDURE

4.2. TREATMENT OF THE MATERIAL BEFORE STERILIZING
4.3. PREPARATION OF THE LOAD
4.4. CONTROL SYSTEM
4.5. PRINT MANAGEMENT
4.6. CYCLE DIAGRAMS
4.7. CARE OF THE STERILIZED MATERIAL
5 MAINTENANCE AND PERIDODICAL CLEANING
5.1. PERIODICAL CLEANING

5.2. ROUTINE MAINTENANCE / PERIODIC CONTROLS

CONTENTS
6 ALARMS - BREAKDOWNS
7 ENCLOSURES
CHANGING OF THE CUSTOMER’S PASSWORD

FLUIDS EXPECTED CHARACTERISTICS
EXPLODED
INSTALLATION DIAGRAM
POWER ELECTRICITY DIAGRAM
INLET/OUTLET ELECTRIC DIAGRAM
CONTROL PLC ELECTRIC DIAGRAM
RECORDING PLC ELECTRIC DIAGRAM
HYDRAULIC DIAGRAM

1 INTRODUCTION
Dear customer
We wish to thank You for choosing Icos Impianti Group Spa and we hope that you will be
completely satisfied with the characteristics of this product.
In the following pages You will find all instruction for the correct and safe use of the
appliance, and to take full advantage of its characteristics.
Important notice:
All the information contained in this manual can be modified without prior
notice.
Icos Impianti Group Spa accepts no liability for direct, indirect or incidental
damages relevant to the collection or use of these information.
This document can’t be reproduced, modified or transleted without a written

authorization by Icos Impianti Group Spa
1.1. PRODUCT PRESENTATION
COLUSSI “U 3” SERIES sterilizers are steam autoclaves characterized by an easy and

safe use and high functionality.
The great variety of models can satisfy every requirement.
These autoclaves was created to be easily set in the most various work context. The great
choice of accessories make every need be easily satisfied.
The type of appliance is indicated with the symbols U 3 followed by one number and two
letters:
- The number 1 indicates the smallest model of the series (2 sterilization units)
- The number 2 indicates the medium model (3 sterilization units)
The first letter refers to the number of doors. It can be:

- N if there is only one door (Normal autoclave)
- P if there are two doors, one opposite to the other (“Through type” autoclave)
The second letter indicates how the steam generator operates:

- E if the steam is produced by a steam generator (embodied) provided with electrical
resistances
- I if the steam is produced by warming the water contained in a heat exchanger
(embodied) through the steam coming from a power plant
- V if the steam comes from an external steam generator

1 INTRODUCTION
1.2. AIM OF THE MANUAL
This manual has been written to give instructions for:

- General knowledge of the product
- Correct instalation
- Sure and efficient use
- Material treatment before and after sterilization process
- Maintenance and cleaning
- Problems and alarms analysis and solutions
- Working drawings and diagrams
1.3. GENERAL WARNINGS
This product and its fittings must be used following the procedures explained in this
manual and only for the purposes which they were designed for.
Supply clauses
Referring to the instaIlation and the assembling carried out by other people, the
manufacturer accepts no liability, on any account, in case of :
a) uncorrect connections, according to “Rules for an efficient construction technique”, of:

- Pipes and accessories for the supply and the drainage of the working fluids
- Electrical connections
b) every operation or change on the machine and its accessories carried out without prior
authorization of the Manufactorer
c) additional stress (seismic, wind etc.) or dinamic l loads extraneous to the apparatus
d) stairs, metal structures, foundation, building works and protection structures for the
machine realized by a third party
e) removal of panels and electrical protections
f) inserting metal objects inside the machine
g) in case of a special type installation (eg. appliance installed in a pre-existing facilities,

built-in, or placed next to other machines) all internal parts must be protected so as to
avoid unqualified personnel having direct access (inspection doors with key-access or
another locking system to avoid direct access without using a tool). Chek installation
drawings and, if necessary, contact the manufacturer for further explanations.

1 INTRODUCTION
Legal representatives of both public and private healthcare settings as well

as public and private healthcare providers, on the bases of their
observations made while performing their duties, are obliged to immediately
report to the Ministero della sanità (Ministry of Health), either directly or
through the healthcare settings which they belong to, any alteration in the
characteristics and in the performance of the apparatus, or any insufficiency
in the instructions for its use that could cause the death of a patient or
employee, or the aggravation of their condition.
The Ministry of Health communicates this to the manufacturer.
(extract of D. L. 24/02/97 no. 46, art. 9 e10; EEC 93/42)
The user is legally responsible for the installation and the use of the product.
Whether the product is not installed or used correctly, or an adequate
maintenance is not carried out, the Manufacturer can not be considered
liable for eventual brakes, wrong functioning, damages to people or things.
In order to avoid dangerous situations, with possible damages or injuries to people and/or
things, please observ the following precautions:
DO NOT pour water or other liquids on the appliance
DO NOT pour inflamable substances on the appliance
DO NOT use the machineif there are inflamable or explosive gases or steams
Before every maintenance or cleaning operation disconnect always

electricity supply.
Ensure that the electrical circuit is provided with an earth wirein compliance
with the regulations in force.
DO NOT remove any label or plate from the machine; if necessary ask for
new ones.
Use absolutely only original replacements.
The manufacturer has no liability in case of non-observance of these

warnings
1.4. WARRANTY TERMS

The warranty terms that we offer are:
- 12 months from the date of testing and starting up the machine;
- 18 months from the forwarding date;
Consumer materials and routine maintenance are excluded from the

guarantee.

2.1. APPLICATIONS
These universal steam autoclaves for hospital sterilization are suited to be used with
porous and rubber materials as well as with surgical instruments and prepackaged material
in bags, provided that these materials are able to resist both operating temperatures
(which vary from 100 to 134°C) and a maximum pressure of 2,5 bar.
The autoclave can be programmed for sterilizing liquids in open or (even hermetically)
sealed containers.
The addition of this function must be required to the manufacturer, and the programs
concerning liquid sterilization must be tested and calibrated on client specific
requirements.
It is better to avoid sterilizing materials using also additives and/or chemical solvents.
Sterilising autoclaves must be used by responsible personnel
Bowie & Dick test must be performed daily to estimate the efficiency of the
sterilizing process. Every few it is possible to perform the vacuum seal test
to estimate if there are any problems with the machine seal.
If the Bowie & Dick test turns out well, the machine can be used (however,
every cycle must be validated by a person in charge and, in any case, the
positive result of the Bowie & Dick test does not free the user from the
obligation of validating the entire sterilizing process according to the UNI EN
ISO 17665-1 technical regulation).
Attention: test documentation must be kept in conformity with the regulation
in force.
In case of improper use of the autoclaves the manufacturer has no more
liability
2.2. REFERENCE REGULATIONS
The autoclave is according to UNI EN 285:09, CEI EN 61010-1 e CEI EN 61010-2-040

technical rules and complies with EC marking for ECC 93/42, 2006/95/CE, 2008/108/CE
and 98/37/CE rules.
The autoclaves are constructed according to the following rules: CODAP 2000, UNI EN
287-1, UNI EN ISO 15609-1, CEI EN 61000-6-1, CEI EN 61000-6-3, CEI EN 60204-1, IEC
60417, UNI EN ISO 4126-1, IEC 60034-1, ISPESL VS. 262/94, IEC 60947-1, CEI EN
60947-1, CEI EN 60947-4-1, CEI EN 60947-5-1, CEI EN 60947-7-1, CEI EN 60947-7-2,
CEI EN 61558-1.

2.3. CONSTRUCTIVE FEATURES
- The bearing structure that support the sterilization chamber and all the components is
by AISI 304 stainless steel, and is shold up by 4 feet that can be regulated at different
heights so as to allow the appliance to start boiling, ensuring a perfect drainage;
- The sterilization chamber are by AISI 316 o AISI 316Ti stainless steel. The chamber is
6mm thick and the door is 15mm, both having a “Scotch Brite” finish and high
resistance to corrosion;
- The authomatical movement of the doors is provided with an “anti-crushing device”
according to CEI EN 61010-1 e CEI EN 61010-2-040 safety rules. This system protects
the health of the operator and grant the integrity of the sterilization loads in case of
incidental crush;
- The hydraulic circuit is copletely made by stainless steel (pipes, unions, valves) with
mechanically sealed unions;
- All the pipes for the steam flowing, the doors of the sterilization chamber, the steam
exchanger are covered by thermal insulation material. The temperatures of the
accessible and internal parts are under the limits established by CEI EN 61010-1 e
CEI EN 61010-2-040 safety rules and by UNI EN 285 product rule;
- the external pannelling are completely made by AISI 304 steel with “Scotch Brite”
finish;
- possibility to open the doors in case the control system stops and possibility to open
manually the doors in case of power missing;
- sleeves according to UNI EN 285 tecnical rule for the insertion of other probes (inside
the sterilization chamber or in the sump) and for the connection of instruments for the
phisic qualification as required by UNI EN ISO 17665-1 technical rule;
- the autoclave seal is obtained through a sylicon seal, that is set in a cavity realized
through precision works from a ring welded on the body, pushed against the door by
steam injection. Before opening the door the cavity containing the seal is drained so
that the seal is divided by the door before the door can be opened (to reduce
consumption);
- fractioned vacuum sterilization process according to EN 285 rules by high vacuum
liquid ring pump that can reach vacuum values lower than 70 absolute mbar;
- fluids control through pneumatic valves installed with mechanical seal unions;
- fitted with sterile filters with 99,999% filtering level according to D.O.P test.;
- fitted with the following indicator instruments: tubular spring manometer indicating the
cavity pressure (scale 0÷4 relative bar); tubular spring mano-vacuummeter monitoring
pressure in the chamber (scale -1÷3 relative bar);
- instruments measuring temperature and pressure both of the control system and of the
recording system as required by UNI EN 285 technical rule;
- provided with a safety pressure switch for the pressure in the chamber, a safety
pressure switch for the pressure in the generator, a service pressure switch for the
pressure in the seal, ratore, di un pressostato di servizio per la pressione nella
guarnizione; a monitoring pressure switch for water supply and a monitoring pressure
switch for compressed air supply;
- fitted with chamber emergency vessel drain tap;
- fitted with internal guides for eventual mobile loads structures (optional) that works as
grid-holdings (series grid);
- plan pressure of recipients with 3 relative bar + vacuum pressure value.

Referring to the drawing of Figure 1, the following constructive parts can be identified:
POS. DESCRIPTION
1 AUTOCLAVE BODY
2 AUTOCLAVE GENERATOR
3 RECOVER WATER TAP (OPTIONAL)
4 ELECTRIC PANEL
Figure 1

2.4. TECHNICAL FEATURES
U 31 VERSIONS
MODEL U 31 P E U 31 N E U 31 P V U 31 N V
Chamber Width mm. 440 440 440 440
Dimensions Height mm. 700 700 700 700
Dept mm. 850 850 850 850
Sterilisations units 2 2 2 2
Total volume (l) 237 245 237 245
Overall Width mm. 1000 1000 1000 1000
dimensions Height mm. 1800 1800 1800 1800
Dept mm. 1105 1080 1105 1080
Weights Net weight kg. 750 700 680 660
Gross weight kg. 830 780 760 740
Connections A- Main drain 1¼“ 1¼“ 1¼“ 1¼“
B- Safety-valve drain Ø 20mm Ø 20mm Ø 20mm Ø 20mm
C- Condensate drain ½“ ½“
D- Steam inlet ½“ ½“
E- Softened water inlet. ½“ ½“ ½“ ½“
F- compressed air 3/8” 3/8” 3/8” 3/8”
G- Electric cable output 3x400V~ +N+T 3x400V~ +N+T 3x400V~ +N+T 3x400V~ +N+T
50 Hz 50 Hz 50 Hz 50 Hz
frequency
Electrical power kW 20 20 2 2
Consumption (Ampere) 30.4 30.4 3 3
Steam consumption kg/h 50 50
MODEL U 31 P E/I U 31 N E/I U 31 P I U 31 N I

Dept mm. 850 850 850 850
Total volume (l) 237 245 237 245
Overall Width mm. 1000 1000 1000 1000
Dept mm. 1105 1080 1105 1080
C- Condensate drain ½“ ½“ ½“ ½“
D- Steam inlet ½“ ½“ ½“ ½“
F- compressed air 3/8” 3/8” 3/8” 3/8”
50 Hz 50 Hz 50 Hz 50 Hz
frequency
Consumption (Ampere) 30.4 30.4 3 3
Steam consumption kg/h 60 60 60 60

MODEL U 31 P EV U 31 N EV
Chamber Width mm. 440 440
Dimensions Height mm. 700 700
Dept mm. 850 850
Sterilisations units 2 2
Total volume (l) 237 245
Overall Width mm. 1000 1000
dimensions Height mm. 1800 1800
Dept mm. 1105 1080
Weights Net weight kg. 750 700
Gross weight kg. 830 780
Connections A- Main drain 1¼“ 1¼“
B- Safety-valve drain Ø 20mm Ø 20mm
E- Softened water inlet. ½“ ½“
F- compressed air 3/8” 3/8”
G- Electric cable output 3x400V~ +N+T 3x400V~ +N+T
50 Hz 50 Hz
frequency
Electrical power kW 20 20
Consumption (Ampere) 30.4 30.4
U 32 SERIES
MODEL U 32 P E U 32 N E U 32 P V U 32 N V
Dept mm. 1040 1040 1040 1040
Total volume (l) 295 302 295 302
Overall Width mm. 1000 1000 1000 1000
Dept mm. 1290 1265 1290 1265
F- compressed air 3/8” 3/8” 3/8” 3/8”
50 Hz 50 Hz 50 Hz 50 Hz
frequency
Consumption (Ampere) 40 40 3 3

MODEL U 32 P E/I U 32 N E/I U 32 P I U 32 N I

Dept mm. 1040 1040 1040 1040
Total volume (l) 295 302 295 302
Overall Width mm. 1000 1000 1000 1000
Dept mm. 1290 1265 1290 1265
C- Condensate drain ½“ ½“ ½“ ½“
D- Steam inlet ½“ ½“ ½“ ½“
F- compressed air 3/8” 3/8” 3/8” 3/8”
50 Hz 50 Hz 50 Hz 50 Hz
frequency
Consumption (Ampere) 40 40 3 3
Steam consumption kg/h 60 60 60 60
MODEL U 32 P E/V U 32 N E/V

Chamber Width mm. 440 440
Dimensions Height mm. 700 700
Dept mm. 1040 1040
Sterilisations units 3 3
Total volume (l) 295 302
Overall Width mm. 1000 1000
dimensions Height mm. 1800 1800
Dept mm. 1290 1265
Weights Net weight kg. 800 750
Gross weight kg. 880 830
Connections A- Main drain 1¼“ 1¼“
B- Safety-valve drain Ø 20mm Ø 20mm
E- Softened water inlet. ½“ ½“
F- compressed air 3/8” 3/8”
G- Electric cable output 3x400V~ +N+T 3x400V~ +N+T
50 Hz 50 Hz
frequency
Electrical power kW 26 26
Consumption (Ampere) 40 40

FOR ALL MODELS
Machine classification:( according to EN 61010-1 RULE)

Design pressure 3 bar + Vacuum
Operating temperature 144° C
Operating Pressure 3 bar + Vacuum
Overvoltage category II
Pollution level 2
Usage Internal
Altitude (max.) ≤ 2000 m
Relative humidity 5% a 85%
Temperature 5 a + 40 °C
Table 1: equipment features
NOTE: NOTE: The COLUSSI SERIES U 3 equipment can be provided (on request) with
supply voltage with frequency 60 Hz, in which case the frequency is indicated in the CE
label..

NOISE VOLUME/VIBRATIONS:
For the U 31 series:

The A-weighted average acoustic power level is less than or the same 71,1 dB(A).
The A-weighted maximum sound pressure level is is less than or the same 84,3 dB(A).
For the U 32 series:
The A-weighted average acoustic power level is less than or the same 72,4 dB(A).
The values declared have been measured and calculated in compliance with ISO 3746
standard.
The Person in charge of the sterilizer must ensure that its sound pressure level, once the
machine has been installed and settled, can not exceed the limit in which a danger can
occur.
If the machine has been correctly installed, there should be hardly any vibrations at all.
2.6 APPARATUS THERMAL DISPERSION:
The W-weighted sterilizer thermal dispersion has been measured by making the machine
working in not agitated air at room temperature (23±2°C), and it is lower than 4000 W .
The machine front thermal dispersion is lower than 900 W for the U 31 series models,
while is lower than 800 W for the U 32 series models. This has been measured with the
machine working in a room with a temperature of 23±2°C in the work area, and of 50°C in
the connection compartment with the loading doors closed.
2.6. OPERATING POSITION
The operator can stand near the machine, facing its front, only during the loading/start-up
and stop/unloading operations.
The most dangerous phases are loading (when the machine is hot) and, most of all,
unloading the sterilized objects. For the loading operations use heat-protection gloves as
to avoid danger of getting burnt. Even though the chamber is equipped with all of the
prescribed safety devices, make sure, before unloading, the relative pressure inside the
chamber has been set to zero.
In order to avoid dangers for people staying in the room where the machine is installed, a
danger area has been defined (indicated in Figure 2)
The size of this area is calculated from the machine front width (1300 mm) by a depth of
1000 mm.
Before opening the door to load or unload material, the authorized operator must be sure
that no other people are in this zone, because some parts of the machine, that can reach
temperature values higher than 50°C, become accessible.

ER
ANG A
D RE
A
Figure 2
Loading and unloading operations of the sterilized material must be carried

out only by assigned operators

2.8. WARNING LABELS:
Warning labels regarding remaining risks have been applied at the points sketched in
fig. 3.
POSITION DENOMINATION
1 Hot surface warning label
2 Protect hands warning label
3 CE label
4 Autoclave programmed for sterilizing liquids (for autoclaves with liquid
operation schedule)
5 Read instructions warning label
Figure 3
It is strictly prohibited to remove and/or damage the danger warning labels

placed on the machine.
Replace the labels whenever they become illegible.

2.9. SYMBOLS USED:
Number Symbol Description
1 HOT SURFACE
HOT SURFACE WARNING
2 PROTECT HANDS
EQUIPOTENZIALE
3
POTENTIALAUSGLEICH
EQUIPOTENTIEL
EQUIPOTENTIAL EQUIPOTENTIAL TERMINAL
4 WARNING RISK OF ELECTRIC SHOCK
5 START START MACHINE CYCLE
6 CIRCUIT BREAKER
7 I START-UP SWITCH
8 CE LABEL GRANTED BY RECOGNIZED

CERTIFYING BODY N° 0051 IMQ
0051
9 CE LABEL GRANTED BY RECOGNIZED

CERTIFYING BODY N°0398 CPM
0398
10 3N THREE PHASE ALTERNATIVE AND NEUTRAL CURRENT
11 EARTH TERMINAL
12 ATTENTION, CAREFULLY READ THE

USE AND MAINTENANCE MANUAL
legend of the symbols used on the apparatus

3 INSTALLATION
3.1. STORAGE AND CONSERVATION CONDITIONS
U 3 sterilizing autoclaves must be stored in closed rooms granting the following features
(Table 2):
Altitude (max.) ≤ 2000 m

Relative humidity 5% a 85%
Temperature -20 a +60 °C
Table 2
3.2. TRANSPORT AND POSITIONING
These sterilizers are packed and sent in wooden crates, on pallet. Therefore, they can be
moved through forklifts or transpallets.
The apparatus can be elevated through a crane, because the sterilizer is provided with
GOLFARI connections set on the upper part of the apparatus (Figure 4)
POSITION DENOMINATION
1 Small feet
2 Removable baseboard for transport with transpallet
3 Autoclave door key
4 Inspection opening key
5 Inspection opening
6 GOLFARI connections for lifting
Figure 4

3 INSTALLATION
To place the machine, follow this procedure:
1. place the machine on a transpallet or on a fork lift;

2. place the machine in its correct installation place;
3. remove the transpallet;
4. regulate the small feet of the machine;
5. reassemble the frontal baseboard fixing it with the screws
When positioning the machine in the installation place:

The machine must be set flushing
The base of the autoclave must be adherent to the floor
To carry out these operations the four feet in the lower part of the machine must be
regulated (Figure 4)
In order to ensure adequate maintenance there must be at least 1000 mm in the fronal
part of the machine and at least 500 mm on the side of the control panel, set on the right
or left side depending on the model (see enclosed installation diagram)
Placement of the N (normal one door) machine must be performed with the back of the
machine placed against the wall (distance not higher than 50 mm).
The sterilizers designed to be incorporated in pre-existing facilities or in expressly

designed areas must have a continuous junction with the adjacent surfaces. These
surfaces must comply with the tolerance limit shown in prospect 1and prospect 2.

3 INSTALLATION
Prospect 1: Tolerances for the space which the sterilizer is installed in

Size in meters Tollerance in millimeters
Horizontal plane Vertical plane
Up to 3 ±12 ±16
above 3 and up to 6 ±16 ±16
Above 30 ±30 ±30
prospect 1
Prospect 2: Vertical and horizontal planarity tolerances:

Distance between reference Tolerance in millimeters
points in meters
Finished wall and ceiling Finished floor
surfaces (bearing surface)
0,1 3 2
1 5 4
4 10 10
10 20 12
15 25 15
prospect 2
Installation must be performed by skilled personnel authorized by Icos

Impianti Group Spa
A correct installation avoids possible problems in functioning and damages

to the machine, or eventual dangers for people and things
3.3. STARTING UP
The machine is delivered after having undergone an internal inspection and is set to
perform all the foreseen sterilizing operations. None setting up is therefore required.
However, during the connection to various feed sources, what follows must be considered:
This manual must always be available to the operator
The machine’s turn up key must be available to the operator and must be
taken off when the machine is not working
The access door inside the autoclave must be kept always closed. The keys
of said doors must be taken off and kept by person responsible for the
checking up of the apparatus.

3 INSTALLATION
3.4. ELECTRICAL CONNECTION
The electrical connection diagrams, supplied together with the apparatus, must be strictly
followed and the utmost attention must be paid to the grounding.
The earth terminal is located in the lower part of the electric control panel, next to
the machine power supply terminals.
The sterilizer is also provided with a terminal for equipotential bonding; the equipotential
terminal must be hooked up the apparatus base-plate, inside the machine side panels, and
it is tagged by an adhesive label with the word “EQUIPOTENTIAL”.
Connect the various pieces of the equipment one another by equipotential bonding.
Whenever the sterilizer is to be installed alone, the equipotential bonding must be
connected to its own earth terminal.
Furthermore, a differential four-pole thermal magnetic circuit breaker with a calibration

threshold of 30mA must be included in the apparatus supply line, in conformity with the
regulations in force and following what is written on Table 3.
Table 3: Safety Thermal Magnetic Circuit Breaker Characteristics

APPARATUS MOD. U 31 E U 32 E
SUPPLY VOLTAGE V 3x400V ~ +N+T 3x400V ~ +N+T
POWER kW 20 26
ABSORPTION A 30.4 40
THERMAL MAGNETIC FROM A 36 66
APPARATUS MOD. U 31 E/I U 32 E/I
POWER kW 20 26
APPARATUS MOD. U 31 I U 32 I
POWER kW 2 2
ABSORPTION A 3 3
APPARATUS MOD. U 31 EV U 32 EV
POWER kW 20 26
APPARATUS MOD. U 31 V U 32 V
POWER kW 2 2
ABSORPTION A 3 3
Table 3

3 INSTALLATION
The switch must be attached as close as possible to the machine and must be easily
accessible to the operator.
The switch must be labeled as “APPARATUS CIRCUIT BREAKER” and must exactly
identify the machine which is referred to.
The wire sections must be adequate to the power of the installed machine
(see CEI/IEC rules)
3.5. HYDRAULIC CONNECTION
The hydraulic/steam connection diagrams (indicating placement and connection type)

supplied together with the machine, must be strictly followed, even for the componentry,
paying the utmost attention to the diameter of the exhaust pipes, that must not be smaller
than the diameter of the corresponding connections.
The pipes must always be equipped with shut-off valves. The use of flexible pipes having
an appropriate length and being suitable for the fluid characteristics is recommended to
facilitate their installation.
The exhaust pipes (possibly made of galvanized steel ), must be resistant to temperatures
up to 140°C; it is recommended to realize a drain trap with a siphon, avoiding reverse
gradients and with an average drainage gradient of at least 2-3%, and an external outlet
for eventual steam vents.
Feedwater must grant a minimum water volume of 60 kg/h
Whether the machine is supplied with steam from external generator (I and V models) it is
necessary to install a condense separator on the upper side of the appliance, no more
than two meters from its own connection.
You can find here, two diagrams exemplifying the connection to an external steam
generator (prospect 3 and prospect 4).

3 INSTALLATION
PRESSURE REDUCTION
Many steam generators are made working at pressures significantly higher than those
required by the processes, both to optimize their operation and to have a greater thermal
inertia, that is a thermal reserve in case of an eventual increase in demand.
In this case we have a real pressure reduction power plant, usually located in the heating
power plant for a better supervision and maintenance.
This does not prevent the presence of further subsequent reducers from single users or
group of consumers, especially when the supply pressure must be maintained very exact
and constant.
For a safe and efficient operation

it is extremely important,
irregardless of the type of reducer
used (whether it is automatic or
servo-activated), that the
installation is rational and
complete with all the fittings as
shown in prospect 3.
For a centralized pressure

reducer, since its operation is of
primary importance for the correct
functioning of the entire plant,
prospect 3 which it more or less represents
the heart of, it is recommended to
install two reducers in parallel,
that is as a by-pass, one acting
as the reserve for the other
(prospect 3). If a reducer must be
stopped for maintenance or any
necessary repair, the machine
operation is 100% ensured by the
other.

3 INSTALLATION
In case of highly variable flow rates, it

may be actually preferable to install
two reducers, both operating: one
active at the lower flow rates, the
other to be used to assist the first one
when its flow capacity has been
exceed. See prospect 4
A larger single reducer would have
difficulty in working with low rates of
flow and would be subject to
considerable wear because of the
leakage. In same cases even three or
more reducers in parallel may be
used.
Instead, with high but sufficiently
stable flow rates, a big centralized
reducer can be used. Servo-activated
pneumatic pressure reducers are
adequately able, with very high rates
of flow (as long as too extremely low
reductions do not frequently occur),
prospect 4 to cope with considerable variations
in flow.
If the plant, or any part of it served by
the pressure reducer, is not planned
to sustain the maximum upstream
pressure, even if incidentally, the
reducer must be supplied with a
suitable and reliable safety-valve.
Feed fluids (water and air) must respect the specifications of the “fluids
foreseen characteristics schedule” herewith enclosed

4.1. STERILIZATION PROCEDURE
The universal sterilizing autoclave steam-treatment process can be divided into three main
phases (see
Figure 5):
cent.bar
T°C
2.5 350 139
STERILIZATION
2.0 300
133.7
1.5 250
127.6
PRESSURE
1.0 200 120.4
0.5 150
111.6
0 100
time (MINUTS) 80
0 5 7.5 10 12.5 15 20
-0.5 -50
VACUUM
-1.0 0 HOMOGENIZATION DRYING
Figure 5
- HOMOGENIZATION
Through homogenization the air present in the chamber is removed and substituted by
steam, so as to create optimal conditions.
Any presence of air, beside favouring localized drops in temperature which end up by
influencing with a detriment the entire sterilizing process, also tends to act as an insulator
in some areas which, therefore, do not become homogeneous with the rest of the load. To
prevent this from happening, it is necessary to perform a precisely ordered series of
vacuum/pressure variations, which are, in any case, effectively capable of removing the air
present in the load and in the chamber, optimizing, at the same time, the humidity and
homogeneity of the load before the sterilization starts.
- STERILIZATION
During this phase the temperature inside the chamber is maintained between established
values for an established period (that change according to the temperature).
At the end of this phase the load is considered sterile, but, before downloading, it is
necessary to make pressure go back to atmospheric level and to reduce humidity inside
the chamber.
- DRYING
The drying phase serves to normalize the sterilized load by reducing its humidity and
temperature. To hit this target all loads (except liquids) are subjected to a hard vacuum
phasefor an established period of time, that varies depending on the load treated. At the
end of this phase it is possible to download the sterilized material.

4.2. TREATMENT OF THE MATERIAL BEFORE STERILIZING
Sterilization can be considerate efficacious, sure and repeatable only if the material is
adequately treated before beeing sterilized, and set in order and in the correct position
inside the sterilization chamber.
It is important to notice that organic residues or deposits of any substances used are
inevitably full of microorganisms and can obstacle the contact between the steam and the
walls of the instrument, so that the letal process, usually granted, is not working.
The uncorrect disposition of the load could provoke diffiiculties (and sometimes totally
prevene) in steam circulating and/or penetrating the material, with unthinkable
consequences. Also drying process can be influenced by this factor.
Handling and moving contamined material, it is better to folow these precautions:
- Wear adequately thick rubber gloves

- Clean the hands, after wearing gloves, with germicidal detergent
- Avoid transporting the instruments directly with the hands; use a tray
- Protect the hands form the contact with pointed or cutting parts, to avoid the risk of
dangerous infections
- Divide immediately evey component that can not or has not to be sterilized
- Wash accurately the hands, still wearing gloves, once stopped handling non-sterile
material
All materials and/or instruments that have got to be sterilized must be perfectly clean and
all residues removed (organic r inorganic deposits, paper fragments, cotton or gauze,
limestone etc.)
No cleaning or residues removal causes problems during the sterilization

process and can cause damages to the instruments and to the sterilizer
While cleaning the instruments, pay attention to:
- Divide metal instruments according to the type of the material (carbon steel, stainless
steel, brass, aluminium, chromium, etc.), to avoid electrolytic oxide-reduction;
- Use a neutral PH detergent;
- After washing, rinse accurately the instruments and verify the complete removal of the
residues; if necessary repeat the washing or clean by hand.
Avoid calcareous stains using deionized or distilled water for rinsing. In case
for this operation current water with high hardness grade is used, dry always
the instruments

Before the sterilization treatment wash accurately and then dry all textile material (or
porous material in general) like overalls, napkins, caps etc.
Consult the indications given by the producer of the instrument/material

which has to be sterilized before treating it in the autoclave, verifying
eventual incompatibilities. Follow strictly the indications for the use of
detergent or disinfectant products and the instructions for the use of
authomatic washing machineries.
Do not use detergents with high concentration of chlorine and/or

phosphates. These components can damage the autoclave and/or to the load
structure and the metal instruments which could be present in the
sterilization chamber.
4.3. PREPARATION OF THE LOAD
In order to obtain the highest efficacy from the sterilizing process and to save material as
long as possible, follow these indications:
- Place instruments from different metals (stainless steel, hardened steel, aluminium
etc.) in different baskets or in any case, one separate from the others;
- Instruments or containers that are not made from stainless steel must not be in contact
with the load structure of the autoclave;
- Place every container sufficiently far from the others, so that they can maintain their
position during the whole sterilization cycle;
- Ensure that all instruments are open when beeing sterilized;
- Place cutting instruments (scissors, lancets, etc.) so that they can not be in contact
during the cycle; if necessary, use a cotton or gauze cloth to isolate and protect them;
- Place containers (glasses, cups, test-tubes) on their side or turned upside down,
avoiding possible water stagnations;
- Do not overload the machine (about 24 kg for every sterilization unit and for
instruments and about 7 kg for fabrics);
- Place bags avoiding the air remains inside; this could obstruct correct steam
penetration and remotion;
notice for rubber and plastic tubes:
- Rinse always the tubes with water and no pyrogen before use; do not dry them
- Place the tubes so that their extremities are neither closed nor crushed;
- Do not cause foldings or windings; let the tubes be extended as straight as possible;

Notice for packets and baskets
- Put baskets close together, at the necessary distance one from another and absolutely
not in piles, avoiding their contact with the walls of the chamber;
- Special material to be sterilized can be wrapped up in specific porous envelops
(sterilizing paper or muslin cloths), closed with adhesive tape for autoclaves.
Do not use metallic clips, pins etc., because sterility would be no more
ensured;
Do not place a gasket on another
Only few significant instructions for the preparation of material to be

sterilized have been supplied up here. It is advisable, however, to refer to the
Regulation in force, as well as to the vast literature on the subject, to get the
best long-term results.

4.4 CONTROL SYSTEM
description of the main control buttons
the diagrams of (Figure 6) and of (Figure 7) show the main control buttons and pilot-lights
on theload side and on the sterile side of the machine:
colUssi
GENERATOR CHAMBER
SYSTEM
HELP
MENU'
START
STOP
O-I
Figure 6
• System button: allows to regulate touch screen display options (contrast, brilliance
etc.)
• Help button: displays help page
• Menù button: brings back to “main menù” (Figure 8)
• Start button: allows to start up again after an interruption caused by an alarm

Figure 7

Main menù page
By starting up the machine, after “COLUSSI “ label is shown, “MAIN MENÙ” page
appears.
Figure 8
This page allows several operations (starting up a sterilization cycle, going to maintanance
menù, etc.), as described in the following paragraph.
State of the sterilizer
The state conditions of the sterilizer are highlighted in every page of the display.
The upper frame on the left indicates the functioning state of the sterilizer: “ALLRIGHT”
writing lasts on the screen when there is no alarm state; in case of alarm state the blinking
“ALARM !!” writing appears and lasts still the problem has been solved and the system
reset. To recognize the alarm condition and reset it, click on the “ALARM !!” writing (in this
way the page with the list of all the present alarms can be reached) and push the “RESET”
button. If the sterilizer was in cycle and the cause of the alarm condition has been solved,
the system starts up again from the beginning of the phase interrupted by the alarm.
The upper frame in the centre contains the name of the current page.
The upper frame on the right indicates current date and time.
The frame in the second line on the left indicates the state of the machine: “OUT CYCLE”
indicates that the machine is on standby: “CICLE IN PROGRESS” indicates that the
sterilizer is carrying out a sterilizing cycle; “END CYCLE” indicates the sterilizer has
completed the sterilization cycle, but the load is still inside; “SUSPEN. CYCLE” indicates
that any alarm condition is present and the machine is waiting for an operator to recognize
the alarm and to decide if continuing the cycle or opening the door (in any case safety
conditions for the operator are granted).
The frame in the second line on the right indicates the state of the doors. The foreseen
states are: “OPEN DOOR”, “CLOSED DOOR”, “OPENING” and “CLOSING”.

Figure 9
Keyboards
The control system uses two types of keyboards: a keyboard to write texts and a numerical
keyboard to insert numbers.
To write a text, push the preferred sequence of buttons and push enter “↵”. The “BS”
button cancel the type before the cursor, the “DL” button cancel the type after the cursor.
At the end of the text push “END” to make the keyboard disappear.
Figure 10
To write a number push the preferred sequence of buttons, then push the “↵” button. If the
window in usage foresees the insertion of several data, it is possible to scroll the various
fields to be filled in using “>” (following field) and ”<” (previous field). At the end of the
insertion push the “END INPUT” button to make the keyboard disappear. The values
written on the band between the buttons and the display refer to the limit values accepted
in the field in which the number is beeing written.

“STERILIZATION” Menù
This menù allows to start each sterilization process.

To start a sterilization cycle follow these points:
1 – start up the machine using the key switch on the control board ( or push “MENU’”
button on the control panel if the machine is working).
Figure 11
2 – Push the “STERILIZATION” button
Figure 12
3 – push the field near the “OPERATOR” writing e insert the operator password (who must
be authorized– see Figure 47) using the virtual keyboard that appears and push its enter
button
4 – if the machine follows STERILCOLUSSI driving program and if the system is settled
so that the cycle can be set in local or through the driving system, pushing many times the
field next to the “WORK Selection” writing, it is possible to select the way of carrying out
the sterilization cycle. In case, by pushing the said field, the options do not modify, it
means that different options from the one previously selected are not available.
The “WORK Selection” field set on “OPERATOR” allows to start the sterilization cycle
selecting directly on the autoclave the program to be used. The “WORK Selection” field set

on “SYSTEM” allows to start the sterilization cycle by using the settings from the
STERILCOLUSSI driving program.
5 – push the field next to the “Working program” writing to select the work cycle and the
program in the “BASIC PROGRAM SELECTION” page or in the “USER PROGRAM
SELECTION” page.
To go from a page to another one push the button down on the left.
Figure 13
Figure 14
6 – after selecting the preferred program, push “CONFIRM” button to allow the system set
the order number, then push the “START” buton to start the sterilization cycle.
By pushing the “END” button in any moment during the process described, the system
goes back to the main menù.

During the whole cycle the machine goes authomatically on the “WORK STATE” page.
Figure 15
The main page contains, in lexicographic order, the following information:

- the five fields describing the state of the system: see Figure 15
- the working program (in this example “VACUUM TEST”);
- the power source used to generate steam (in this example ”ELECT. heating). The
possible values are:
o ELECTRIC: the generator works through electrical resistances;
o STEAM: the steam is directly taken from a line system;
o INDIRECT: the steam is produced in an exchanger that uses steam taken from
a line system;
- Indication of the phase or step in progress (in this example “awaiting right temp. for
gaskets). The possible phases are:
o SEAL CONTROL;
o HOMOGENIZATION;
o STERILIZATION;
o AERATION;
o VACUUM TEST;
o HEATING;
o COOLING;
- Value of the F0 sterilization parameter calculated on the base of the parameters read
by the control system and of data read by the recording system (value into round
brackets);
- Temperature of the cavity read by the control system (CONTR.) and the objective value
that the machine is trying to reach or maintain (PROGR.);
- Temperature of the sterilization chamber read by the control system (CONTR.), by the
recording system (RECORD) and the objective value that the machine is trying to
reach or maintain (PROGR.);
- Pressure of the chamber read by the control system (CONTR.) by the recording system
(RECORD) and the objective value that the machine is trying to reach or maintain
(PROGR.);
- The time passed (ATT), the time programmed (PROGR) and the remaining time
(MISS) of the phase in progress.
By pushing “PROGR.” The page describing the sterilization program in progress can be
reached.

Figure 16
In this page, in lexicographic order, it is possible to display the following information:

- The name of the program in progress;
- The execution characteristics of the sterilization cycle. The possible options are:
o AUTHOMATIC: the sequence of the phases is pre-set and followed with a strict
sequence:
o SEMIAUTHOMATIC: the sequence of the phases is established by the operator
during the sterilization cycle;
- The number of the order of the sterilization cycle (a number that identifies only the
productive lot);
- Name and surname of the operator who launched the cycle (or of the operator that in a
specific moment is liable for the sterilizer);
- The sequence of the phases characterizing the cycle in progress (the phase in
progress is indicated by thr blinking number on the left). The information written in
every line, from the left to the right, are the following:
o Progressive number;
o Name of the phase;
o Main characteristic data.
Push the “GRAPH” button, to reach the page indicating with a diagram the state of the
inlet and outlet devices of the control PLC.
Figure 17

Push the “TREND” button to display with a diagram the data recorded by the control
system and by the recording system.
By using the arrows under the diagram, it is possible to move the cursor inside the
diagram.
It is possible to display temperature and pressure phisical parameters present in the
chamber (data down on the left), relevant to the point selected with the cursor. Push the
button indicated by a rectangle (down on the right) to go back to the recording mode.
Figure 18
At the end of the sterilizing process the autoclave goes back to the window from which it is
possible to start a new sterilization cycle. The state of the sterilizer is set on “FINISHED
CYCLE” still one of the autoclave’s door has not been opened; then it sets on “OUT OF
CYCLE”.
Figure 19
Whether during the cycle electric power is interrupted, in the moment it starts again the
system sets on the following mask:

Figure 20
Pushing the “END” button the sterilizer reach the door opening conditions, pushing the
“START” button the cycle start again from the beginning of the phase stopped by the
interruption of electric power. In both of these cases the result of the sterilizing process is
identified as “CYCLE SUSPEN.”.
If during the sterilization cycle an alarm condition is generated the control system stops the
cycle and sets on the following page:
Figure 21
Push the “”ALARM !!” blinking writing to reach the page with the description of the alarm
conditions.

Figure 22
Two alarm pages are foreseen: use the arrows down on the left to move from one page to
another. Once the active alarm conditions have been analysed, and the causes of the
alarms eliminated, it is possible to restore the system by pushing the “RESET” button.
Figure 23
Pushing the “RESET” button the sterilizer starts up again. In every case the result of the
sterilizing process is identified as “CYCLE SUSPEN.”.
“LAST CYCLE” Menù
To reach the “LAST CYCLE” menù push its button in the main menù.
This menù allows to display and to print the information relevant to the latest cycle carried
out.

Figure 24
The available options are:

- SAMPLINGS: allows to print the samplings of the latest cycle establishing also the
sampling interval;
- EVENTS: allows to print the events relevant to the latest cycle carried out ;
- TREND: allows to dysplay with a diagram the data recorded by the control system and
by the recording system. Use the arrows under the diagram to move the cursor on it.. It
is possible to display temperature and pressure phisical parameters present in the
chamber (data down on the left), relevant to the point selected with the cursor. Push
the button indicated by a rectangle (down on the right) to go back to the recording
mode.
- REPRINT CYCLE: allows to reprint the latest cycle carried out recorded by the conyrol
system or by the recording system. It is also possible to reprint the diagram with data
about pressure and temperature;
Figure 25

“UTILITY” Menù
Per enter the “UTILITY” menù, push its button in the “MAIN MENÙ”.
This menu allows to display and print the information relevant to the sterilizer and to its
state, and allows to do some useful operation for the use of the printers.
Figure 26
The available options are:
- MACHINE DATA: allows to display the data identifying the sterilizer.

The visualized data are, in order:
o sterilizer model;
o manufacture number of the sterilizer (and identification number of the container
in pressure that corresponds to the body of the autoclave);
o manufacture number of the generator;
o date of the sterilizer starting up;
o version of the software installed on the PLC;
o version of the software installed on the Touch-screen terminal;
Figure 27
- MAINTEN. STATE: allows to display the data relevant to the latest maintenance
operation.

Among the data contained in the report, the following ones can be visualized:
o Total number of the cycles carried out;
o The date of the latest maintenance operation carried out;
o The number of the cycles done in the moment of the maintenance intervention;
o The description of the works carried out;
o The name of the technician who did the maintenance;
o The date or the number of the cycles according to which the next programmed
maintenance will be required
Figure 28
- STATE I/O: allows to display the state of the analogical and digital inlet devices and of
the digital outlet devices which characterize the current state of the system and allows
to chage the type of supply from electricity to steam supply (obviously only in the
combined functioning sterilizers).
As for the state of the analogical inlet devices, the following information can be
displayed:
o The temperature read in the cavity;
o The temperature read in the sterilization chamber by the fixed probe;
o The temperature read in the sterilization chamber by the mobile probe
(optional);
o The pressure read in the sterilization chamber;
o The pressure read in the room (the pressure value to which the control system
refers to allow the door opening);
Push the field next to the “current heating” writing to pass from the electrical functioning to
the steam functioning (if foreseen).

Figure 29
The state of the inlet and outlet devices is described by the “ON” or “OFF” value written
near the description of the I/O ways.
Push the “INGR”, “OUT1” e “OUT2” buttons to reach the pages of the inlet and outlet
devices.
Figure 30
Figure 31

The state of all inlet and outlet ways is described with a diagram in the “GRAPH.
STATE” page (synoptic diagram of the appliance).
Figure 32
- NOTE BOOK: this page can be used as a blackboard. After selecting the preferred
instrument and colour, it is possible to draw simply touching with a fingerthe black part
of the page.
Figure 33
- PRINTER UTILITY: allows to carry out some operations on the printer from the panel.
The possible operations are:
o restore: resets the hardware of the printer and arrange it for functioning (with this
procedure the printer is set so as to be used by the control system) ;
o cancel print: cancel the printing in progress
o skip 1 line: the printer goes one line forward;
o skip 4 lines: the printer goes four lines forward;

Figure 34
- A4 PRINTER UTILITY: allows to carry out some operations on the external (optional)
printer.
The possible actions are:
o restore: resets the hardware of the printer and arrange it for functioning;
o cancel print: cancel the printing in progress
o skip 1 line: the printer goes one line forward;
o skip 4 lines: the printer goes four lines forward;
Figure 35
- GENER. DRAINAGE: allows to do manually the drainage of the steam generator

“MAINTENANCE” menù
The “MAINTENANCE” menù is protected by a password and only responsible personnel

knowing the password can have access to it.
Figure 36
The following operations can be started from the main page of this menù:
- “UPDATE CLOCK”: allows to modify date and time;
Figure 37
- “MANUAL CONTROLS”: allows to activate by hand the outlet devices of the control
system to check the functioning of motors, valves, etc.
These operations are subdue to all safety conditions granting the safety of the
operator.1
1
When manual controls have been activated, it is no more possible to make the machine function

Figure 38
Before manual controls can be used, it is necessary to activate the function by pushing
the “DISABLED MANUALS”, and to set the limits for the functioning of the cavity and
of the chamber by pushing their fields in the “LIMITS” column. The fields in the
“CONTR” and “REC” columns indicate the state of the analogical inlet devices (the
values of the physical parameters read) of the control system and of the recording
system respectively.
Manual controls can be activated only at the end of the sterilization cycle and at the
download of the sterilized material.
Figure 39
Push the INGR, OUT1 and/or OUT2 buttons to display the “OUTLET CONTROL”
and “INLET STATE” pages.
Push the field near the description to activate a specific outlet devices.
The outlet device is activated only if this action is not dangerous for the operator.

Figure 40
The page of the inlet devices allows only to display the state of the digital inlet
devices.
Figure 41
The state of all inlet and outlet ways is described with a diagram in the “GRAPH.
STATE” page (synoptic diagram of the appliance).
In this page it is possible to activate the several digital outlets of the control system
simply clicking on their enter buttons (motors, valves, etc.).
Figure 42

- “REST. CONST. DATA”: allows to restore all standard settings established by the
manufacturer;
Figure 43
“CONFIGURATION” menù
The “CONFIGURATION” menù is protected by a password and only responsible personnel

knowing the password can have access to it.
Figure 44
From the main page of this menù it is possible to activate the following activities:
- “SYSTEM DATA”: this menù allows to define some settings of the sterilizer. The
following parameters can be set:

Figure 45
o “END PHASE / END CYCLE”: with this setting the person responsible for the
sterilizer allows or does not allow the generic operator to force the process of
the authomatic cycle.
o “SEMI-AUTHOMATIC CYCLE”: this parameter sets the execution mode f the
sterilization cycle. If the parameter is set on “NO” the cycle is carried out in a
completely authomatic way; if the parameter is set on “YES” the cycle is carried
out in a semiauthomatic way: in this case the sequence of the phases is not
rigorously established but it is defined during the sterilization cycle (every single
phase is carried out totally autonomously).
o “WORK Selection”: this parameter allows to choose the modes of starting a
sterilization cycle. The options are:
“OPERATOR”: the work program is established by the operator next to
the machine;
“SYSTEM”: the sterilizer follows the STERILCOLUSSI driving program.
The operator has only to push the start button to start the cycle wthout
setting other data;
“BY REQUEST”: the generic operator next to the machine can choose if
waiting for the data from STERILCOLUSSI program or setting directly a
sterilization program;
o “print Diagram in cycle”: if not active the sterilizationb cycle is not printed (this
function depends on the presence of another recording data system; even if this
system is not present the cycle will be printed;
o “Print Events at End Cycle”: if active, prints the events of the cycle completed;
o “ETHERNET/CARD Datat”: (optional) allows to activate/deactivate the network
card;
o “Sheet Printer sensitivity”: allows to sregulate the sensitivity of the paper in use;
o “Audible Alarm” if switched on, indicates the alarm state or that the cycle is
ended.
o “Automatic Unload”: (optional) allows the automatic load and unload of the
sterilizer (with MAC and MAS apparatus)

Figure 46
o “Reference Low temp. °C”: sets the value of the temperature on which the
lowest reference line, present in the trend and in the print of the sterilization
cycle, is positioned. This line is useful to verify the movement of the temperature
during the sterilizing phase;
o “Reference High temp. °C”: sets the value of the temperature on which the
highest reference line, present in the trend and in the print of the sterilization
cycle, is positioned. This line is useful to verify the movement of the temperature
during the sterilizing phase;
- “OPERATORS”:allows to fill in the file on the operators authorized to make the

sterilizer work.
Figure 47
Clicking on an empty field, it is possible to insert a new operator, instead, clicking on

a field with the name of an operator, it is possible to modify the data about him/her,
or to erase the operator.
In every case the following window appears:

Figure 48
Clicking the field “Code” the keyboard for the insertion of the operator (numerical)
password appears; at this point fill in the fields writing “Name” and “Surname”.
After the insertion confirm the data pushing “UPDATE”
By pushing “PRINT”it is possible to print the list of all operators authorized to use
the sterilizer.
- “PROGRAMS”: allows to define the “USERS” programs.
Figure 49
Clicking an empty field it is possible to insert a new program, while clicking on a

field containing a program it is possible to modify its setting parameters. In both
cases the following window appears.
Figure 50
To set the sterilization programs follow this procedure:

1. insert the name of the program by pushing the field with the “”program” writing;

2. set the preparation temperature pushing the field near the “Prep. T.°C” label.the
temperature of preparation is the temperature of the cavity at the end of the
sterilization cycle: this temperature must be maintained untill the sterilizer door is
opened;
3. establish which door can be opened at the end of the sterilization cycle having a
positive result (in case of negative result it will always be pssible to open only the
door on the load side);
4. set the sequence of the phases of the sterilization cycle: immediately over the first
line available for the insertion of one sterilization phase, 4 areas corresponding to
the four sensitive areas defined in each line are highlighted with different colours.
Push correspondingly to the third or fourth sensitive area, to select a phase. By
pushing correspondingly to the second area, the phases follow a specific sequence,
by pushing correspondingly to the third area the phases follow the contrary
sequence. Once the sequence has been chosen, push correspondingly to the first
area to add or cancel a phase trough the menù that will appear.
Figure 51
5. set the properties of every phase: in order to do this, push correspondingly to the
fourth area
Figure 52

Characteristics of the phases of the sterilization programs
- Seal control:
Figure 53
o “JACKET temperature °C”: allows to set the temperature to be reached by the

cavity before activating the gasket seal;
o “CONTROL time”: sets the time to be waited for, before generating an alarm
indicating problems in the seal system;
o “SEAL type”: select the type of seal used in the cycle in progress:
by steam – the steam injected in the hole containing the gasket pushes
the gasket against the window;
by air – the air injected in the hole containing the gasket pushes the
gasket against the window;
mechanic – a gasket is kept pressed between the door and the ring that
holds the gasket welded on the autoclave;

- Homogenization:
Figure 54
o “JACKET temperature °C”: allows to set the temperature to be maintained in the

cavity during the whole phase;
o “No of pulses”: establishes the number of homogenization pulses to be done
(during a pulse vacuum is created in the chamber and the chamber is capt into
pressure through steam injection: in this case it is granted that the air is
removed from the load to be sterilized).
o “LOW point bar”: sets in the first field the pressure of the first vacuum value
which the machine must reach, in the second field the variation of pressure that
is added to every pulse to find vacuum values characterizing the following
pulses, in the third field the period of time in which the machine remains at the
vacuum value reached at every pulse.
o “High point bar”: sets in the first field the value of the first pressure pulse which
the machine must reach, in the second field the variation of that is added to
every pulse to find the value of the following pressure pulses, in the third field
the period of time in which the machine remains at the pressure value.

- Sterilization
Figure 55
o “JACKET Temperature °C”: allows to set the temperature to be maintained in

the cavity during the whole phase;
o “CHAMBER Temperature °C”: allows to set the temperature value at which the
counting of the sterilization time starts
o “bar Control Pressure”: sets the pressure with which the sterilization plateau is
controlled the conditions of sterilization are maintained by controlling the
pressure while the temperature is capt under control for the checks necessary to
the convalidation of the sterilization cycles.
o “Phase Duration (mm:ss): sets the size of the sterilization plateau.
o “PROBE Type”: establishes the probe to be considered while surveying the
temperature of the chamber. Fixed the probe and the mobile (optional) probe
available.
- Aeration
Figure 56

o “Vacuum to be reached bar”: sets the vacuum value to be reached by the
autoclave to grant the load cooling.
o “Phase Duration (mm:ss): sets the period of time for which the vaccum
condition described before must be maintained

- Vacuum Test
Figure 57

o “Vacuum to be reached bar”: sets the vacuum value to be reached by the
autoclave before trhe stabilization phase.
o “Stabilization Time (mm:ss): sets the duration of the stabilization phase (after the
vacuum conditions set before have been reached, the autoclave stops the
vacuum pump and closes all inlet and drain pipes of the autoclave and remains
in this condition for the time set with this parameter.
o “Test time (mm:ss): at the end of stabilization phase the actual vacuum test
begins. During the period of time dimensioned with this parameter, the system
checks that there is not no vacuum leack over 1,3 mmbar/min.
- Heating
Figure 58

counting of the time for which the temperature set must be maintained starts.
o “Control Pressure bar: sets the pressure with which the heating phase is
controlled.
o “Phase Duration (mm:ss): sets the size of the plateau in the heating phase.
o “PROBE Type”: establishes the probe to be considered while surveying the
temperature of the chamber. Fixed the probe and the mobile (optional) probe
available.

- Cooling
Figure 59

counting of the time for which the temperature set must be maintained starts;
o “Control Pressure”: sets the pressure with which the heating process is
controlled;
o "Phase Duration": sets the width of the plateau of heating phase;
o “PROBE Type”: defines the probe to be considered in detecting the temperature
of the chamber. The options are fixed probe and mobile probe (optional);

4.5. PRINT MANAGEMENT
The documents released by the control and the recording system allow to evaluate
carefully and precisely the result of the sterilization process: each process can be
approved according to the regulations in force
The system is set to print the dia and the events happened during the sterilization cycle
and surveyd by the recording system (Figure 60);
it is possible to reprint the diagram of the latest cycle recorded by the control system
(Figure 61), the parameters of the sterilization programs (Figure 62), the sampling of the
latest cycle carried out, also establishing the sampling interval (Figure 63), the events
generated (Figure 64), the list of the operators authorized to use the appliance (Figure 65),
the maintenance operations carried out (Figure 66), and the surveys on the starting up of
the components assembled on the sterilizer (Figure 67)

Figure 61: Print of the Control PLC
Figure 60: Print of the Recording PLC

Figure 62: Parameters of the memorized
sterilizing programs

Figure 65: List of the operators authorized to

use the sterilizer
Figure 66: Print of the maintenance

interventions
Figure 63: List of the samplings of a

sterilization cycle
Figure 67: Surveys on the starting up of

sensitive components
Figure 64: List of the events of a sterilization

cycle

4.6. CYCLE DIAGRAMS2
bar cent.bar
PRESSURE GRAPH T°C

2.5 350 139
3,5 minuts
2.0 300
133.7
1.5 250
127.6
PRESSURE
1.0 200 TEMPERATURE GRAPH 120.4
0.5 150
111.6
0 100
time (MINUTS) 80
2.5 5 7.5 10 12.5 15.0 17.5 20.0
-0.5 50
VACUUM
-1.0 0
BOWIE & DICK

TEST
bar cent.bar T°C
2.5 350 139
2.0 300
133.7
1.5 250
127.6
PRESSURE
1.0 200 120.4
0.5 150 ASSESTAMENTO 111.6

TEST VUOTO
0 100
time (MINUTS) 80
0 2.5 5 7.5 10 12.5 15.0 17.5 20.0 22.5
-0.5 -50
VACUUM
-1.0 0
VACUUM TEST
PROGRAM

bar cent.bar PRESSURE GRAPH T°C
139
2.5 350
5 minuts
2.0 300
133.7
1.5 250
127.6
PRESSURE
1.0 200 120.4

TEMPERATURE GRAPH
0.5 150
111.6
0 100
time (MINUTS) 80
0 2.5 5 7.5 10 12.5 15.0 17.5 20.0 22.5
-0.5 -50
VACUUM
-1.0 0
5 minuts
INSTRUMENTS SACH
PROGRAMS
cent.bar PRESSURE GRAPH T°C

2.5 350 139
5 minuts
TEMPERATURE GRAPH
2.0 300
133.7
1.5 250
127.6
PRESSURE
1.0 200 120.4
0.5 150
111.6
0 100
time (MINUTS) 80
0 5 7.5 10 12.5 15 20
-0.5 -50
VACUUM
-1.0 0
5 min:
TEXTILES 134°C
PROGRAM

bar cent.bar
PRESSURE GRAPH T°C
2.5 350 139
2.0 300
133.7
1.5 250 20 minuts

127.6
PRESSURE
1.0 200 120.4
0.5 150 TEMPERATURE GRAPH

111.6
0 100
80
5 10 15 20 25
-0.5 -50
VACUUM
-1.0 0
time (MINUTS)
RUBBER 121°C
PROGRAM
2
These diagrams have only an exemplifying aim

4.7. CARE OF THE STERILIZED MATERIAL
The sterilized material must be adaquately served to maintain its sterile property until the
next use.
An inadequate care can cause a new contamination of the material.

This generates, in every case, a damaging situation, because as an alternative, the
contamined material (almost unconsciously) would be used, creating risks for the user, or,
in the other case, the sterilization cycle would be repeated (wasting inevitably time and
resources)
Follow these advice to use as well the sterilized material:
- Remove the load from the sterilization chamber using clean (better if sterilized) gloves
and overall;
- Put the containers or the material on a dry and adequately clean and disinfected plan;
- Be carefull that the sterile material is placed separately from the contamined material
which has to be sterilized;
- Let the material get cold before transporting (and then stocking) it
- Save the material and/or the instruments in the envolvements used for the sterilization
cycle;
- Save the material in a dry, clean and disinfected place. If possible, prefer closed spaces
lighted by ultruviolet lamps;
- Distinguish sterile material by putting on it sterilization date, expiry date and lot
placement;
- Use first the material saved for more time. It allows to have material homogeneusly
served, avoiding saving the material too much time.

5 MAINTENANCE AND PERIODICAL CLEANING
5.1. PERIODIC CLEANING
Stainless steel is so resistant against corrosion because an oxide film creates on its
surface, on a molecular level, when exposed to air.
For this reason, any cause preventing the film from beeing formed, reduces its resistance
to corrosion.
It is clearly necessary to clean frequently all stainless steel surfaces (see Figure 68),
especially internal surfaces, using a damp cloth imbued with soap or simple cleansing
agents, not added with abrasives or chlorates.
Figure 68
To remove stains or processing residues from the sterilizing chamber, wash them with hot
water before they harden. If the residues have already hardened, use water and soap with
the help of a broomcorn brush, or else, for the most stubborn cases, use a stainless steel
wool pad. Rub in the glaze direction only.
Rust marks, caused by improper maintenance, can be removed by using products suitable
for this purpose, such as "Solilax, Diversy-Hankel, Oakite, Benckiser" etc.
Calcium deposits can be removed by using pollution removing products, provided that
these do not contain chlorates. Never use sodium hypochlorite (bleach), chlorydric acid or
solutions that contain them.

After having cleaned and carefully dried all stainless steel surfaces, they must be
protected with special products that polish the surfaces and prevent the penetration of
humidity and/or dirt which cause the corrosion. Some of these products are, for example,
"Polish cleaner" or "Cerfact 200".
For further information relevant to the cleaning operations, see the “routine maintenance”
chapter.
Do not use sodium hypoclorite, hydrocloric acid or solutions containing

them.
Take particular care not to allow any drop of water to go inside the
apparatus. Never use jets of water directed towards the machine in order to
avoid any infiltration and damage of the inner parts.
Avoid contact with purely ferrous materials which could contaminate the
surface and cause corrosion holes damaging the machine irreparably.
Do not clean with alchool or corrosive substances the control panel and the
appliance

5.2. ROUTINE MAINTENANCE / PERIODIC CONTROLS
In order to grant a safe and efficient functioning of the machine as long as possible, the
user is requested to take care of correct use and regular maintenance.
Maintenance operations are explained in Table 4 .
FREQUENCY ACTION OPERATOR

EVERY DAY - clean with a soft and damp cloth the internal Sterilisation
parts of the sterilization chamber (only with cold operator
chamber);
- clean the accessible external parts (see
PARAGRAPH 5.1);
- check the cleaning conditions of the chamber
drain filter: if the filter is obstructed, call the
maintenance expert;
- check the presence of paper in the printer;
EVERY 15 - unload the generator (in electric appliance or Trained
DAYS appliance equipped with heating exchanger) maintenance
operator.
EVERY 30 - clean the technical space of the appliance; Trained
DAYS - verify the safety valve (open the valve through maintenance
its own device); operator..
- verify the safety pressure switch (pre1-
generator pressure switc, pre2 – gasket
pressure switch, pre3 – door lock pressure
switch, pre4 – water pressure switch, pre5- air
pressure switch);
- verify the quality of the feedwater (for machines
equipped with generator);
- Lubrificate the door guides and the
corresponding slides with a light covering of
high-temperature resistant grease;
- Verify and eventually clean the generator drain
filter;
EVERY 180 - Verify it is not possible to start a sterilisation Sterilization
DAYS cycle with open door. To do this, push the operator
“sterilisation button in the main menù; this
message will appear: “be careful, doors not
closed”
- Furtherry verify that by pushing the button
“OPEN DOOR” it won’t be possible to open the
door during the execution of the sterilisation
cycle.
During this operation do not stand in the danger
zone

EVERY 600 - Replace the gaskets: remove the gasket, clean Trained
CYCLES or the groove very well with a scotch brite cloth or maintenance
EVERY 180 with a cloth imbued with denatured alchool, put a operator.
DAYS new gasket covered with talcum powder in the
groove.
EVERY 180 - Clean, verify and eventually replacevisual level Qualified
DAYS or control device. To clean the tube of the level maintenance
EVERY 1000 control device, switch alternatively the taps operator.
CYCLES sectioning the device; if big limestone residues
remain, check and eventually clean the lower
inlet pipe. Before reassembling the device,
replace the gaskets;
- Verify the presence of rust residues and
eventually remove them;
- Verify the connections in the electric panel: tight
the terminals with special attention to the power
cable;
- Verify the state of contact switches (with special
care of the heating resistances contact switches)
and, if necessary, replace them;
- Verify the resistances fuses and, if necessary,
replace them;
- Verify the efficiency of all no return valves (with
special attention to water loading, chamber
drain, chamber suction, vacuum pump drain);
- Control and, if necessary, remove calcium
deposits from the steam generator (if present);
- Clean the sterilisation chamber very well after
having removed the eventual internal structures;
- Control, clean and lubrificate the door moving
devices and,if necessary, replace consumpted
parts (door guides and slides);
- Verify the joints, unions and pipes seal: if any
union is disassembled, cover the threads with a
veil of sylicon grease (sufficiently reistant to the
temperature used);
- Control and, if necessary clean or replace the
level control devices

EVERY 360 - Replace the sterile filter Qualified

DAYS OR - Calibrate the measuring chains and verify their maintenance
EVERY 2000 setting; operator.
CYCLES - Verify,clean and regulate the chain of the door
moving system
- Clean the filter of the feedwater
- Verify and clean the flux regulator
- Verify and clean air and condensed water
drains
- Verify the efficiency of manometers and
manovacuummeters and, if necessary, clean the
connection
- Control and, if necessary, remove calcium
deposits from the resistance elements of the
generator (if present);
- Verify the efficiency of the door opening/closing
devices;
Table 4
A sterilization operator is an expert assigned to the use of the machine. A trained

maintenance operator is a generical maintenance operator who works for the structure
owning the machine (he has to be trained to carry out these operations); a qualified
maintenance operator is a technician who works for Icos Impianti Group Spa or a
technician working for a Icos Impianti Group Spa concessionary agency for technical
service or a technician who works for the company owning the machine and who attended
a specific training course at Icos Impianti Group Spa
For any defect or replacement concerning the valves and/or the safety
devices contact the manufactorer
During the maintenance operations it is necessary that the appliance has no

voltage
If it is necessary to remove panelling, this operation must be carried out only

by specialized personnel. In this case the appliance must not be used and it
is necessary to separate it from the several supplies
The maintenance operation on safety components indicated in table 5 safety

devices must be carried out only by qualified Icos Impianti Group Spa
maintenance operators.

SAFETY DEVICES
Component Function Identification and location
Safety-valve 2,70 Protects from the Located behind the electric control panel
bar overpressures
Seal pressure Ensures the gasket Located inside the panelling, on the electric
switch door seal control panel side, and identified as PRE 2
Chamber pressure Protects from the Located inside the panelling, on the electric
switch overpressures while control panel side, and identified as PRE 3
opening the doors
Generator pressure Protects from the Located inside the panelling, on the electric
switch generator control panel side, and identified as PRE 1
overpressures
Pressure transducer Records the chamber Located inside the panelling, on the electric
pressures control panel side
PT 100 probe Measures the Located above the sterilizing chamber and
(reference measure interspace pressure connected to the pressure converter inside
point) the electric control panel
2PT100 probe Measures the Located underneath the sterilizing chamber
(reference measure chamber pressure and connected to the pressure converter and
point) to the terminals inside the electric control
panel
Converter Converts in Ohm the Located inside the electric control panel and
values transmitted by identified by the writing “PT100 probes”
the PT100 probes in
mA
Mini-fuse Protects the primary Located inside the electric control panel and
F2 A; 250V of the transformer identified as “F3” and “F8”
Mini-fuse Protects the PLC Located inside the electric control panel and
F6,3 A; 250V identified as “F4”
Mini-fuse Protects the PLC Located inside the electric control panel and
F4 A; 250V identified as “F5”
Fuse Protects the Located inside the electric control panel and
32 A gL; 400V (U31) resistance identified as “F6”
50 A gL/gG; 400V
(U32)
Lovato overload Protects the water Located inside the electric control panel and
cut-out loading pump identified as “T1”
Lovato overload cut- Protects the vacuum Located inside the electric control panel and
out pump identified as “T2”
Lovato overload Protects the Located inside the electric control panel and
cut-out gearmotor identified as “T3”
Table 5 safety devices

We declare that all risks related to the failures of pressure switches, temperature
controllers and safety closing door have been considered and we certify that they can’t
cause any addition risk to the machine operation.

6 ERROR MESSAGES – BREAKDOWNS
Analisys of error messages

Rev. 0 date: 19/10/01
N Description of the trouble
Error message Suggested solution Executor
r. and its possible cause
Check:
Moving the key-selector on 1) for live voltage;
“I” the machine does not 2) for the main
switch on switch upside
Possible causes: the machine;
1) the machine has no 3) that the main
voltage; switch of the
2) the main switch electric panel is
Trained
upside the machine is switched on;
-- maintenance
switched off ; 4) for the
operator
3) the main switch of the intervention of
electric panel is the safety
switched off; devices;
4) the machine safety 5) for the
devices intervened; efficiency of the
5) transformer or power transformer
feeder damaged and/or the
power feeder.
Switch off and switch
on again the machine.
Trained
Control PLC Malfunctioning of the Control If the problem
0 maintenance
locked!!! PLC persists, contact
operator
Colussi customer
service
Reset the alarm and
Front door The security of the front repeat the process of Sterilisation
1
safety??? door has been pressed closing or opening operator.
door
Reset the alarm and
Rear door The security of the rear door repeat the process of Sterilisation
2
safety??? has been pressed closing or opening operator.
door
Trouble with Trained
Problems in the autoclave If the problem
3 control plc maintenance
management program persists, contact
(xob8) operator
Colussi customer
service
4 ???????????? Available for the system
Trouble with Trained
5 control plc maintenance
(xob10) operator
Colussi customer
service
6 Trouble with Problems in the autoclave Switch off and switch Qualified


Rev. 0 date: 19/10/01
control plc management program on again the machine. maintenance
(xob12) If the problem operator
persists, contact
Colussi customer
service
Trained
Trouble with If the problem
7 PLC functionality test failure maintenance
control plc (test) persists, contact
operator
Colussi customer
service
Control plc Trained
The analogicalal card does If the problem
8 analogicalal maintenance
not answer. persists, contact
card? operator
Colussi customer
service
If the problem persists
The probe does not read or
verify the probe, the
gives no data to the PLC.
converter and the
Possible causes: Trained
control plc analogicalal card. To
9 - damaged probe; maintenance
cavity probe? replace one of these
- converter breakdown; operator
components and to
- analogicalal card
set again the
breakdown.
measuring system
contact Colussi
customer service.
converter and the
Control plc fixed analogicalal card. To
probe? replace one of these
components and to
- analogicalal card
set again the
breakdown.
measuring system
contact Colussi
customer service.
The probe does not read or Switch off and switch
gives no data to the PLC. on again the machine. Trained
Control plc
11 Possible causes: If the problem persists maintenance
mobile probe ?
- damaged probe; verify the probe, the operator
- converter breakdown; converter and the


Rev. 0 date: 19/10/01
- analogical card analogical card. To
breakdown. replace one of these
components and to
set again the
measuring system
contact Colussi
customer service.
The transducer does not If the problem persists
read or gives no data to the verify the transducer
PLC. and the analogical Trained
Control plc
12 Possible causes: card. To replace one maintenance
press. transd.?
- damaged transducer; of these components operator
- analogical card and to set again the
breakdown. measuring system
contact Colussi
customer service.
[only for machine with one
PLC]
converter and the
gives no data to the PLC. Trained
Control plc fixed analogical card. To
13 Possible causes: maintenance
probe (no rec.)? replace one of these
- damaged probe; operator
components and to
- converter breakdown;
set again the
- analogicalal card
measuring system
breakdown.
contact Colussi
customer service.
[only for machine with one
PLC]
converter and the
Control plc gives no data to the PLC. Trained
analogical card. To
14 mobile probe Possible causes: maintenance
replace one of these
(no rec.)? - damaged probe; operator
components and to
- converter breakdown;
set again the
- analogicalal card
measuring system
breakdown.
contact Colussi
customer service.
Switch off and switch Trained
Control PLC Malfunctioning of the Control
16 on again the machine. maintenance
locked!!! PLC
If the problem operator


Rev. 0 date: 19/10/01
persists, contact
Colussi customer
service
Troubles with Trained
If the problem
17 record. plc No answer from I/O devices maintenance
persists, contact
(xob 5) operator
Colussi customer
service
Troubles with One of the external Trained
If the problem
18 record. plc peripheral (eg. modem, etc.) maintenance
persists, contact
(xob 6) is in error operator
Colussi customer
service
19 record. plc maintenance
(xob 8) operator
Colussi customer
service
(xob 9) operator
Colussi customer
service
(xob10) operator
Colussi customer
service
(xob12) operator
Colussi customer
service
If the problem
23 record. plc PLC functionality test failure maintenance
persists, contact
(test) operator
Colussi customer
service
24 Record. plc The analogical card does Switch off and switch Trained


Rev. 0 date: 19/10/01
Analogical not answer. on again the machine. maintenance
card? If the problem operator
persists, contact
Colussi customer
service
converter and the
Record. plc analogical card. To
fixed probe? replace one of these
components and to
- analogical card
set again the
breakdown.
measuring system
contact Colussi
customer service.
converter and the
Record. plc analogical card. To
mobile probe? replace one of these
components and to
- analogical card
set again the
breakdown.
measuring system
contact Colussi
customer service.
The transducer does not If the problem persists
read or gives no data to the verify the transducer
PLC. and the analogical Trained
Record. plc
27 Possible causes: card. To replace one maintenance
press. transd.?
- damaged transducer; of these components operator
- analogical card and to set again the
contact Colussi
customer service.
The probes of the 2 systems Switch off and switch
(recording, control) provide on again the machine.
Probes out of Trained
conflicting readings or one If the problem persists
28 tollerance in maintenance
of the two do not give data verify the probe, the
sterilizing operator
to the PCL. converter and the
Possible causes: analogical card. To


Rev. 0 date: 19/10/01
- damaged probe; replace one of these
- converter breakdown; components and to
- analogical card set again the
contact Colussi
customer service.
The pressure transducers of on again the machine.
the 2 systems (recording, If the problem persists
control) provide conflicting verify the transducer
Press.transd. readings or one of the two and the analogical Trained
29 out of tollerance do not give data to the PCL card. To replace one maintenance
in cooling Possible causes: of these components operator
- damaged transducer; and to set again the
- analogical card measuring system
breakdown. contact Colussi
customer service.
Machine lock set by the Trained
Checksum plc Contact Colussi
30 manufacturer or malfunction maintenance
record.+contr.? customer service.
of the PLC's motherboard operator
The pressure in the
chamber is so high that it
does not allow the doors
opening, or the pressure Verify:
switch does not allow the 1) the efficiency of
doors opening. the pressure
Possible causes: switch
Door safety - the chamber has not 2) the efficiency of Qualified
32 pressure been evacuated the circuit maintenance
switch? because the drain valves; operator
circuit is obstructed; 3) that there are
- the pressure switch no obstructions
does not work in the drain
correctly and circuit pipes.
signalize pressure in
the chamber even if it
is not present.
Overpressure in the
generator/cavity.
Possible causes:
Gener./cavity Verify the efficiency of Qualified
- the condenser in the
33 pressure the condenser; maintenance
cavity is obstructed
switch? calibrate the system; operator
and does not drain
the air present in the
generator/cavity, so


Rev. 0 date: 19/10/01
that there is pressure
but no temperature;
- the temperature
measuring system is
not calibrated.
Verify:
1) the presence of
water in the
feed circuit
upside the
appliance;
2) that the
Signalises there is no water interceptions
in the feed line. upside the
Possible causes: machine are
1) there is no water in open; 1,2,3,4)
the circuit upside the 3) that the no Trained
appliance; return valve is maintenance
No water in
34 2) the water pressure is not locked; operator
line!!
not sufficient; 4) that the 5) Qualified
3) the water flow is not pressure and maintenance
sufficient; the water flow operator
4) the pressure switch are according
does not work to the field
efficiently. specified by the
manufacturer;
5) the efficiency of
the water in line
pressure switch
and, if
necessary,
replace it.


Rev. 0 date: 19/10/01
Verify:
1) the
compressed air
supply circuit
upside the
Signalises there is no appliance;
compressed air in the feed 2) that the
line. interceptions
Possible causes: upside the
1) there is no machine are
compressed air in open; 1,2,3)
the circuit upside the 3) that the Trained
appliance; pressure and maintenance
No compressed
35 2) the compressed air the operator
air in line!!
pressure is not compressed air 4) Qualified
sufficient; capacity are maintenance
3) the compressed air according to operator.
capacity is not the field
sufficient; specified by the
4) the pressure switch manufacturer;
does not work 4) the efficiency of
efficiently. the
compressed air
in line pressure
switch and, if
necessary,
replace it.
Open the electric
panel and reset the
Signalises the intervention thermal device Trained
Thermal
36 of one engine safety thermal intervened before. If maintenance
intervention!!
device. the problem persists, operator
contact Colussi
customer service
Signalises the the Reset the normal
No auxiliaries Sterilisation
37 emergency button has been state unlocking the
voltage! operator.
pushed. emergency button.
The machine can not load Verify:
water. 1) the fuses or the
1,2) Trained
Possible causes: thermal device
maintenance
1) the pump safety of the water
operator,
Problems with devices upside the pump;
38 3,4,5,6)
water load!! machine have 2) the efficiency of
Qualified
intervened; the water
maintenance
2) the water pump does pump;
operator.
not work; 3) any obstruction
3) the water load of the tube or


Rev. 0 date: 19/10/01
contact switch does the filter which
not work; takes water to
4) the tube or the filter the pump
which takes water to 4) any obstruction
the pump is of the tube
obstructed; which comes
5) the tube which comes out of the
out of the pump is pump;
obstructed; 5) the efficiency of
6) the level control the level
device does not work; control;
7) the level control 6) the efficiency of
probes are encrusted the level control
and can not feel the probes.
presence of the
water.
The machine can not have
or maintain gaskets seal Verify:
against the door. 1) the state of the
Possible causes: gasket;
1) Trained
1) the door gasket is 2) any obstruction
maintenance
comsumpted or in the gasket
operator;
Problems with damaged; inlet pipe;
39 2,3,4)
gaskets seal!! 2) the gasket inlet pipe 3) the efficiency of
Qualified
is obstructed; the gasket
maintenance
3) the gasket steam inlet steam valve;
operator
valve does not work; 4) the seal of the
4) there are some leaks gasket drain
in the gasket drain circuit.
circuit.
The door on the load side is
not closed or the door
closed signal does not reach
1) check the door has
the control PLC.
been closed;
Possible causes:
2) Verify:
1) the door has not been
- the efficiency of 1)
closed by the
the door stop Sterilisation
operator;
Front door not device; operator.
40 2) the door closing stop
closed !! - the efficiency of 2) Qualified
device is damaged
the PLC input maintenance
ane can not feel the
device; operator
door coming;
- the door
3) the signal of the stop
moving.
device is not
managed by the PLC
input card;
4) the door is out of its


Rev. 0 date: 19/10/01
guide;
5) the door is not
allowed to close
completely.
The door on the download
side is not closed or the
door closed signal does not
reach the control PLC.
Possible causes: 1) check the door has
1) the door has not been been closed;
closed by the 2) Verify:
operator; - the efficiency of 1)
2) the door closing stop the door stop Sterilisation
Back door not device is damaged device; operator.
41
closed! ane can not feel the - the efficiency of 2) Qualified
door coming; the PLC input maintenance
3) the signal of the stop device; operator
device is not - the door
managed by the PLC moving.
input card;
4) the door is out of its
guide;
5) the door is not allowd
to close completely.
The program's steps
sequence does not Qualified
Not executable Check the program
42 guarantee the safety and maintenance
phase!! sequence
performance of the operator
autoclave
Overpressure in the cavity.
Possible causes:
- the condenser in the
cavity is obstructed
and does not drain
Verify the efficiency of Qualified
cavity pressure the air present in the
43 the condenser; maintenance
switch??? cavity, so that there is
calibrate the system; operator
pressure but no
temperature;
- the temperature
measuring system is
not calibrated.
48 Cavity heating The machine can not heat Verify: 1) Trained


Rev. 0 date: 19/10/01
time?? the cavity in the time set 1) that the steam maintenance
before. delivery pipes operator;
Possible causes: are open; 2,3,4,5,6,7,8
1) the steam delivery 2) that the data ) Qualified
plant is closed; set are correct; maintenance
2) wrong data setting; 3) the efficiency of operator
3) problem in the circuit the circuit
taking steam to the valves;
cavity; 4) that there are
4) the water in the no obstructions
generator is not in the circuit
sufficient to grant the pipe;
quantity of steam that 5) that there are
is necessary for the no leaks in the
heating; circuit;
5) there is too much 6) the efficiency of
water in the the level
generator: it invades control;
the cavity causing a 7) the efficiency of
fall in temperature; the heating
6) problem in the device;
heating device; 8) the efficiency of
7) the cavity condensers the cavity
are obstructed and do condensers;
not drain the air or set the measuring
the condense present system.
in the
cavity/generator;
8) the system surveying
temperature is not
calibrated.
Verify:
1) that the data
The machine can not heat
are correctly
the chamber in the time set
set;
before.
2) the efficiency of Qualified
Chamber Possible causes:
49 the circuit maintenance
heating time ?? 1) wrong data setting;
valves; operator
2) problem in the circuit
3) that there are
taking steam in the
no obstructions
chamber.
in the circuit
pipe;
The machine can not make Verify:
the vacuum in the chamber 1) that the data Qualified
Vacuum
50 in the time set before. are correctly maintenance
chamber time??
Possible causes: set; operator
1) wrong data setting; 2) the efficiency of


Rev. 0 date: 19/10/01
2) problem in the the valves of
chamber suction the chamber
circuit; suction circuit;
3) the transducer and 3) that there are
the analogical card no obstructions
are not efficient; or leaks in the
4) the vacuum pump hydraulic
liquid ring is not circuit;
reached by water; 4) the efficiency of
5) leak in the gasket or the transducer
in the hydraulic and/or of the
circuit. analogical card
comparing the
values read by
the system to
those read by
the dial
manometers;
the valve
supplying water
o the liquid ring
of the vacuum
pump;
6) the condition of
the gasket and,
if necessary,
replace it.
N.B. if the transducer
and/or the analogical
card are replaced, the
measuring system
must be calibrated
again.
The machine can not reach Verify:
the right pressure value in 1) that the data
the chamber in the time set are correctly
before. set;
Possible causes: 2) the efficiency of
1) wrong data setting the transducer Qualified
Chamber
51 2) the transducer and and/or of the maintenance
pressure time??
the analogical card analogical card operator
are not efficient; comparing the
3) problem in the circuit values read by
taking steam in the the system to
chamber those read by
4) the condense drain the dial


Rev. 0 date: 19/10/01
system is not efficient manometers;;
the circuit
valves;
4) that there are
no obstructions
in the circuit
pipe;
the condense
drain system.
N.B. if the transducer
and/or the analogical
card are replaced, the
measuring system
must be calibrated
again.
1) control if any
alarm arose
The sterilization phase
during the
lasted longer than the MAX
phase;
time set.
2) try to start the
Possible causes:
cycle again. If
1) during the phase the 1,2)
the problem
electricity missed for Sterilisation
persists,
Out of a period; operator;
contact Colussi
52 sterilisation 2) a problem in the 3,4)
customer
time? heating element Qualified
service;
causes a fall in maintenance
Verify:
temperature and operator
stops the counting of
the heating
the sterilization time;
element;
3) the MAX time set was
4) that the data
too short
are correctly
set.
Verify:
The machine has not
1) that the data
reached the opening
are correctly
conditions in the time set
set;
before.
Opening Possible causes: Qualified
the circuit
53 conditions 1) wrong data setting maintenance
valves;
time?? 2) problems in the operator
3) that there are
chamber drain circuit;
no obstructions
3) the door safety
in the chamber
pressure switch is not
drain circuit
efficient.
pipes;


Rev. 0 date: 19/10/01
the door safety
pressure
switch.
Verify:
1) that the data
are correctly
The machine can not drain
set;
the chamber in the set time.
Chamber drain Possible causes:
time?? 1) wrong data setting;
valves; operator
2) problems in the
3) that there are
chamber drain circuit.
no obstructions
in the circuit
pipes.
During the sterilization
phase the temperature fell
below the minimum value
Set the system.
set.
Verify:
Possible causes:
1) that the steam
1) the steam delivery
pipes are open;
plant has been
2) that the data
closed;
are correctly Qualified
Low temper. In 2) during the sterilization
55 set; maintenance
sterilisation?? phase water was
3) the efficiency of operator
loaded;
the heating
3) the measuring
element;
system is not
calibrated;
the circuit
4) problem of the
valves;
heating element;
5) leak in the chamber
drain circuit.
During the sterilization
phase the temperature went
over the maximum value Set the measuring
set. system; Qualified
High temper. in
56 Possible causes: verify the condition of maintenance
sterilization??
1) the measuring the gasket and, if operator
system is not necessary, replace it.
calibrated;
2) leak in the gasket.
During the vacuum test the Set the measuring
Qualified
Failure vacuum machine can not keep the system;
57 maintenance
test!! leak under the limit set control the efficiency
operator
before. of the related circuit


Rev. 0 date: 19/10/01
Possible causes: valves.
1) the measuring
system is not
calibrated;
2) leak in the hydraulic
circuit
Verify:
The machine can not run the
1) that the data are
cooling of the chamber in
correctly set;
the preset time.
Possible causes:
the circuit
1) wrong data setting; Qualified
valves;
58 Cooling time?? 2) problems on the maintenance
3) that there are no
chamber cooling operator
obstructions in /
circuit
cooling circuits
3) malfunctioning of the
4) check the
cahmber mobile
mobile probe
probe.
functioning.
Verify:
1) that the data are
The machine can not drain
correctly set;
the gasket in the set time.
Gasket drain Possible causes:
time?? 1) wrong data setting;
valves; operator
2) problems in the gasket
3) that there are no
drain circuit.
obstructions in
the circuit pipes.
Power supply was
No power in Sterilisation
63 interrupted while the Push the start button.
cycle!!! operator.
machine was in cycle.

PROCEDURE FOR TAKING OUT THE LOAD IN CASE A FAILURE OCCURS TO THE
CONTROL SYSTEM
In case a failure occurs to the control system (PLC), it is possible to take out the load from
the machine by means of a switch located outside, on the electric control panel, and
identified as “S1”.
Follow this procedure:
1. Open the inspection opening

2. Switch on the S1 switch in ” position 0”
3. Wait for 60 seconds in order to allow the chamber pressure to go to zero
4. Move the”S1” selector in “position 2”, taking care that the high temperature
condense does not overflow
5. Wait for 10 minutes to allow the load to cool down then, proceed taking out the load
after having equipped yourself with the appropriate protections
6. Move again the ”S1” selector in ”position 1”, close the door and contact Colussi
service.
This procedure must be performed by personnel responsible for the sterilizer

only
A sterilization operator is an expert assigned to the use of the machine. A trained

maintenance operator is a generical maintenance operator who works for the structure
owning the machine (he has to be trained to carry out these operations); a qualified
maintenance operator is a technician who works for Icos Impianti Group S.p.A. or a
technician working for a Icos Impianti Group S.p.A. concessionary agency for technical
service or a technician who works for the company owning the machine and who attended
a specific training course at Icos Impianti Group S.p.A.

CHANGING PASSWORD’S PROCEDURE
TO THE ATTENTION OF THE RESPONSIBLE FOR THE STERILIZER
OBJECT: CHANGING OF THE CUSTOMER’S PASSWORD
Press the “CONFIGURATION” button on “MAIN MENU”
Press on “SYSTEM DATA” to go to the “SYSTEM DATA 1” page
Press for almost ten seconds after “SYSTEM DATA 1”; after this operation a keyboard will
appear
Now you can write your new personalized password.
In order to avoid that the operator doesn’t make non authorized modifications
(insert/modification of operator’s list, modification of the cus6tomer’s sterilizing programs
etc.) we suggest to replace the password set.

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Via E.

Ellero , 15 – 33080 Cusano di Zoppola (PN) ITALY

INSTALLATION, USE AND MAINTENANCE MANUAL

READ CAREFULLY THE FOLLOWING INSTRUCTIONS

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 1 of 87

1.1. PRODUCT PRESENTATION

3.1. STORAGE AND CONSERVATION CONDITIONS

4 INSTRUCTIONS FOR THE USE

4.1. STERILIZATION PROCEDURE

5 MAINTENANCE AND PERIDODICAL CLEANING

5.1. PERIODICAL CLEANING

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 3 of 87

CHANGING OF THE CUSTOMER’S PASSWORD

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 4 of 87

This document can’t be reproduced, modified or transleted without a written

1.1. PRODUCT PRESENTATION

COLUSSI “U 3” SERIES sterilizers are steam autoclaves characterized by an easy and

The first letter refers to the number of doors. It can be:

The second letter indicates how the steam generator operates:

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 5 of 87

This manual has been written to give instructions for:

1.3. GENERAL WARNINGS

a) uncorrect connections, according to “Rules for an efficient construction technique”, of:

e) removal of panels and electrical protections

f) inserting metal objects inside the machine

g) in case of a special type installation (eg. appliance installed in a pre-existing facilities,

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 6 of 87

Legal representatives of both public and private healthcare settings as well

DO NOT pour water or other liquids on the appliance

DO NOT pour inflamable substances on the appliance

Before every maintenance or cleaning operation disconnect always

Use absolutely only original replacements.

The manufacturer has no liability in case of non-observance of these

1.4. WARRANTY TERMS

Consumer materials and routine maintenance are excluded from the

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 7 of 87

Sterilising autoclaves must be used by responsible personnel

2.2. REFERENCE REGULATIONS

The autoclave is according to UNI EN 285:09, CEI EN 61010-1 e CEI EN 61010-2-040

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 8 of 87

2.3. CONSTRUCTIVE FEATURES

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 9 of 87

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 10 of 87

2.4. TECHNICAL FEATURES

MODEL U 31 P E/I U 31 N E/I U 31 P I U 31 N I

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 11 of 87

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 12 of 87

MODEL U 32 P E/I U 32 N E/I U 32 P I U 32 N I

MODEL U 32 P E/V U 32 N E/V

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 13 of 87

FOR ALL MODELS

Machine classification:( according to EN 61010-1 RULE)

Table 1: equipment features

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 14 of 87

For the U 31 series:

2.6 APPARATUS THERMAL DISPERSION:

2.6. OPERATING POSITION

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 15 of 87

Loading and unloading operations of the sterilized material must be carried

File Istru3nw11 Rev. 11 Data 27/04/11 pag. 16 of 87

2.8. WARNING LABELS:

It is strictly prohibited to remove and/or damage the danger warning labels

Replace the labels whenever they become illegible.