en
en
en
Rev. 03
2021-03
97055020
EN
Contents
1. FOREWORD .................................................................................................................................................................................................... 4
1.1. SYMBOLS USED ........................................................................................................................................................................................4
1.2. SYMBOLS ON THE DEVICE ......................................................................................................................................................................4
1.3. RELEVANT EUROPEAN DIRECTIVES ......................................................................................................................................................4
1.4. CLASSIFICATION .......................................................................................................................................................................................4
1.5. INTENDED USE .........................................................................................................................................................................................5
1.5.1. IMPORTANT NOTES .........................................................................................................................................................................5
1.6. GENERAL WARNINGS...............................................................................................................................................................................5
1.7. RESIDUAL RISKS.......................................................................................................................................................................................6
1.8. INFORMATION ON MITIGATION OF RESIDUAL RISKS ...........................................................................................................................6
2. PACKAGE CONTENT ..................................................................................................................................................................................... 7
2.1. DIMENSIONS AND WEIGHT ......................................................................................................................................................................7
2.2. DESCRIPTION OF THE CONTENT ............................................................................................................................................................8
2.3. PRODUCT HANDLING ...............................................................................................................................................................................9
2.4. CONDITIONS FOR STORAGE AND TRANSPORT ....................................................................................................................................9
3. GENERAL DESCRIPTION - PRODUCT PRESENTATION............................................................................................................................ 10
3.1. GENERAL CHARACTERISTICS ...............................................................................................................................................................10
3.2. TECHNICAL SPECIFICATIONS ...............................................................................................................................................................11
3.2.1. SUMMARY TABLE ...........................................................................................................................................................................11
3.3. SAFETY DEVICES....................................................................................................................................................................................13
3.4. WATER SUPPLY CHARACTERISTICS ....................................................................................................................................................13
3.5. FRONT .....................................................................................................................................................................................................14
3.6. REAR ........................................................................................................................................................................................................15
3.7. LCD ICONS ..............................................................................................................................................................................................16
3.8. EXAMPLE OF WORKING CYCLE ............................................................................................................................................................17
4. SETTING UP THE DEVICE............................................................................................................................................................................ 18
4.1. OVERALL DIMENSIONS ..........................................................................................................................................................................19
4.2. COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATION .............................................................................................................20
4.3. GENERAL PRECAUTIONS FOR INSTALLATION ....................................................................................................................................20
4.4. POWER SUPPLY .....................................................................................................................................................................................20
4.5. ELECTRICAL CONNECTIONS .................................................................................................................................................................21
4.6. DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT ............................................................................................................21
5. FIRST START-UP .......................................................................................................................................................................................... 22
5.1. STARTING ................................................................................................................................................................................................22
5.2. MAIN MENU .............................................................................................................................................................................................23
5.3. FILLING DISTILLED WATER ....................................................................................................................................................................23
5.3.1. MANUAL FILLING ............................................................................................................................................................................23
5.3.2. AUTOMATIC FILLING ......................................................................................................................................................................23
6. CONFIGURATION ......................................................................................................................................................................................... 24
6.1. SETTINGS ................................................................................................................................................................................................24
6.1.1. LANGUAGE .....................................................................................................................................................................................24
6.1.2. DATE AND TIME..............................................................................................................................................................................25
6.1.3. PREHEATING ..................................................................................................................................................................................25
6.1.4. WATER FILLING ..............................................................................................................................................................................26
6.1.5. DISPLAY ..........................................................................................................................................................................................27
6.1.6. TEST REMINDER ............................................................................................................................................................................27
6.1.7. SERVICE .........................................................................................................................................................................................27
7. PREPARATION OF THE MATERIAL ............................................................................................................................................................ 28
7.1. TREATING THE MATERIAL BEFORE STERILIZATION ...........................................................................................................................28
7.2. ARRANGING THE LOAD ..........................................................................................................................................................................29
7.3. POSITIONING AND USE OF TRAY HOLDER SUPPORT ........................................................................................................................31
8. STERILIZATION CYCLES ............................................................................................................................................................................. 33
8.1. EXTRA DRYING .......................................................................................................................................................................................34
8.2. DELAY START..........................................................................................................................................................................................35
8.3. EXECUTION OF THE CYCLE...................................................................................................................................................................36
8.4. CYCLE OUTCOME ...................................................................................................................................................................................36
8.5. DOOR OPENING AT THE END OF THE CYCLE......................................................................................................................................36
8.6. USER-DEFINED CYCLE...........................................................................................................................................................................37
9. MATERIAL STORAGE .................................................................................................................................................................................. 38
10. TEST PROGRAMS ........................................................................................................................................................................................ 39
10.1. HELIX TEST/B-D CYCLE ..........................................................................................................................................................................39
10.2. VACUUM TEST CYCLE ............................................................................................................................................................................40
10.3. DOOR OPENING ......................................................................................................................................................................................41
10.4. MANUAL INTERRUPTION ........................................................................................................................................................................42
11. USED WATER DRAIN ................................................................................................................................................................................... 43
12. DATA MANAGEMENT .................................................................................................................................................................................. 44
2 EN
12.1. PRINT MANAGEMENT .............................................................................................................................................................................44
12.2. PRINT LABELS .........................................................................................................................................................................................45
12.3. DOWN. CYCLE DATA ..............................................................................................................................................................................46
12.4. WIFI ..........................................................................................................................................................................................................47
12.5. ETHERNET ...............................................................................................................................................................................................50
12.5.1. CONNECTION TO A LOCAL NETWORK EQUIPPED WITH DHCP SERVER, WITH STERILISER CONFIGURED WITH STATIC IP50
12.5.2. CONNECTION TO A LOCAL NETWORK MANUALLY CONFIGURED WITH "STATIC” IPs ............................................................51
13. APPENDIX – PROGRAMS ............................................................................................................................................................................ 52
13.1. SUMMARY TABLE OF 17 220 V - 240 V CYCLES ...................................................................................................................................53
13.2. SUMMARY TABLE OF 17 120 V CYCLES ................................................................................................................................................55
13.3. SUMMARY TABLE OF 22 220 V - 240 V CYCLES ...................................................................................................................................57
13.4. SUMMARY TABLE OF 22 120 V CYCLES ................................................................................................................................................59
13.5. SUMMARY TABLE OF 28 220 V - 240 V CYCLES ...................................................................................................................................61
13.6. SUMMARY TABLE OF 28 120 V CYCLES ................................................................................................................................................63
13.7. STERILISATION PROGRAM DIAGRAM ...................................................................................................................................................66
13.8. DIAGRAMS OF THE TEST PROGRAMMES ............................................................................................................................................68
13.9. EXAMPLES OF PRINTED REPORTS.......................................................................................................................................................69
14. APPENDIX - MAINTENANCE........................................................................................................................................................................ 70
14.1. ORDINARY MAINTENANCE PROGRAMME ............................................................................................................................................70
14.2. SCHEDULED MAINTENANCE MESSAGES .............................................................................................................................................71
14.3. DESCRIPTION OF MAINTENANCE INTERVENTIONS ............................................................................................................................72
14.3.1. CLEAN GASKET AND PORTHOLE .................................................................................................................................................72
14.3.2. CLEAN STERILIZATION CHAMBER AND ACCESSORIES .............................................................................................................72
14.3.3. EXTERNAL SURFACE CLEANING AND DISINFECTION ...............................................................................................................72
14.3.4. BOILER FILTER CLEANING ............................................................................................................................................................72
14.3.5. DOOR LOCK LUBRICATION ...........................................................................................................................................................72
14.3.6. DUST FILTER CLEANING ...............................................................................................................................................................73
14.3.7. REPLACE THE BACTERIOLOGICAL FILTER .................................................................................................................................73
14.3.8. BOILER GASKET REPLACEMENT .................................................................................................................................................73
14.4. PERIODIC STERILIZER VALIDATION .....................................................................................................................................................73
14.5. DEVICE USEFUL LIFE .............................................................................................................................................................................74
14.6. DISPOSING THE EQUIPMENT WHEN NO LONGER USED ....................................................................................................................74
15. APPENDIX - GENERAL PROBLEMS............................................................................................................................................................ 75
15.1. TROUBLESHOOTING ..............................................................................................................................................................................75
16. APPENDIX – ALARMS .................................................................................................................................................................................. 77
16.1. ALARM INTERVENTION ..........................................................................................................................................................................77
16.2. ALARM DURING A CYCLE .......................................................................................................................................................................77
16.3. SYSTEM RESET ......................................................................................................................................................................................78
17. ALARM CODES............................................................................................................................................................................................. 79
17.1. ERRORS (CATEGORY E) ........................................................................................................................................................................79
17.2. ALARMS (CATEGORY A) .........................................................................................................................................................................81
17.3. HAZARDS (CATEGORY H) ......................................................................................................................................................................83
17.4. SYSTEM ERRORS (CATEGORY S) .........................................................................................................................................................84
17.5. TROUBLESHOOTING ..............................................................................................................................................................................85
17.5.1. ERRORS (CATEGORY E) ...............................................................................................................................................................85
17.5.2. ALARMS (CATEGORY A) ................................................................................................................................................................87
17.5.3. HAZARDS (CATEGORY H) .............................................................................................................................................................90
17.5.4. SYSTEM ERRORS (CATEGORY S) ................................................................................................................................................91
18. APPENDIX - ACCESSORIES ........................................................................................................................................................................ 92
EN 3
1. FOREWORD
The instructions inform the user on how to properly operate the device. It is extremely important to read this manual carefully and thoroughly before
using the device.
This publication must not be reproduced, copied or transferred in any manner (electronically, mechanically, via photocopies, translations or other
means) without the prior written consent of the manufacturer.
The manufacturer has a company policy of continual development. Therefore, some of the instructions, specifications and figures given in this manual
may slightly differ from the purchased product. The manufacturer reserves the right to make changes to this manual without giving prior notice.
The original text is in Italian; this is a translation from the original in Italian.
NOTE: CAUTION:
Pay particular attention to the paragraphs marked with the Potential danger for people, environment and property.
symbol shown. Follow the procedures indicated in the manual to prevent
potential damage to materials, devices and/or property.
Potential danger due to high temperature. Disposal symbol in accordance with Directive 2012/19/EU.
Device in compliance with essential requirements of Directive Refer to the user manual.
93/42/EU and subsequent modifications.
Notified body: IMQ spa
Device compliant with the requirements set out in the Directive Ukrainian national symbol of conformity.
2014/68/EU (PED) - category I for 17 l sterilizers; category II
for 22 and 28 l sterilizers.
Notified body: Rina Services S.p.A.
UA.TR.101
ON/OFF switch. Fuses 2xT15A 250V.
2xT15A 250V
1.4. CLASSIFICATION
Classification of the device according to the rules indicated in Annex IX of Directive 93/42/EEC and subsequent modifications and integrations: CLASS
IIB.
4 EN
1.5. INTENDED USE
The product described in this manual is only intended for sterilization of reusable surgical instruments and materials.
DEVICE INTENDED FOR PROFESSIONAL USE
The use of the device is strictly reserved to qualified personnel. It must never be used or handled by untrained and/or unauthorised
persons.
The device must not be used for the sterilization of fluids, liquids or pharmaceutical products.
The sterilizer is not a mobile or portable device
Failure to comply with the above exempts the manufacturer from all liability.
EN 5
1.7. RESIDUAL RISKS
FOR THE USER
• Contamination due to improper handling of the load;
• Burn by contact with hot surfaces or fluids.
Contamination due to material unsuitable to sterilization or not compliant with instructions for use.
• Check that the contaminated material is compatible with the selected sterilization process;
• Immediately separate the materials to be sterilized from those that must not be subjected to such process or are not able to withstand it.
Contamination due to unsterilised material caused by wrong final assessment of sterilization process.
The sterilization process electronic control system monitors the various phases, at the same time checking that the various parameters are respected; if
any type of anomaly is encountered during the cycle, the program is immediately interrupted, generating an alarm identified by a code, with a relative
message explaining the nature of the problem.
Furthermore, the sterilization process can be checked by means of:
CHEMICAL INDICATORS
that monitor the sterilization process by providing information, together with the control of physical and biological parameters, on the conditions occurred
in the sterilization chamber during the process.
The final toning of the process indicator does not certify that the product is sterile but only that the device has been subjected to a sterilization process. If
the toning does not occur, the operator in charge of releasing the sterile material, that must not be used, must find out why.
PHYSICAL INDICATORS
They include the reading of machine data and the execution of specific tests indicated during the validation phase for that specific cycle/load/autoclave.
This control system can include:
• Direct reading of the synoptic system (thermometer, pressure gauge, recorder, etc.);
• Reading of prints/labels/files on which the data detected by the synoptic system are stored (parameters);
• Execution of specific tests (vacuum test, Bowie-Dick test, Helix test).
The operator in charge of the process certifies the validity of the load at the end of every cycle by means of the parametric release.
6 EN
2. PACKAGE CONTENT
Check the integrity of the product package upon receipt.
In case of wrong delivery, missing parts or any type of damage, inform immediately and in detail the reseller and the carrier that made the
delivery.
EN 7
2.2. DESCRIPTION OF THE CONTENT
4 Lubricant for door locking mechanism; 10 Plastic tube for direct water drainage, with fastening clamp;
8 EN
2.3. PRODUCT HANDLING
The packed product must be handled using, where possible, suitable mechanical means (lift truck, pallet truck, etc.) and following the indications on the
package.
In case of manual handling, the product must be lifted by two persons using the suitable available means.
Once the sterilizer has been removed from the package, it must be lifted by two persons using the suitable available means and handled, if possible,
using a truck or similar means.
We recommend to transport and store the device at a temperature not below 5°C. Extended exposure to low temperatures may
damage the product.
Store the original package and use it for any transport of the device. Using a different package may damage the product during shipping.
Before transport, leave the device turned off for about 30 minutes after the last program finishes and drain the distilled water and
used water tanks so that all the internal parts will have time to cool down.
EN 9
3. GENERAL DESCRIPTION - PRODUCT PRESENTATION
3.1. GENERAL CHARACTERISTICS
The device is an electronic water steam sterilizer, entirely operated by a micro-processor, with a large, printed stainless steel sterilization chamber.
It is characterized by an advanced fractionated vacuum system for the complete removal of air, even from hollow, porous materials, and an effective
final vacuum drying phase capable of eliminating all traces of humidity from any load.
The exclusive steam generation system, the effective hydraulic circuit and the electronic management (integrated by high-precision sensors) ensure a
high execution speed of the process and an excellent stability of thermodynamic parameters.
Moreover, its Process Evaluation System constantly monitors all the machine's “vital” parameters in real-time, guaranteeing absolute safety and a
perfect result.
The device offers users 6 sterilization programs (one of which completely programmable), all equipped with customisable, optimised drying for the fast,
effective sterilization of the various types of load (instruments and materials) used in a medical environment.
All the cycles can immediately be selected on the clear LCD screen, which also allows extensive configuration of the device according to the user’s
needs.
Like in the best tradition, also the new range of autoclaves features the most complete and advanced safety systems available today, to ensure the user
against any operation, electrical, mechanical, thermal or functional fault.
For the description of safety devices, refer to technical characteristics appendix.
10 EN
3.2. TECHNICAL SPECIFICATIONS
3.2.1. SUMMARY TABLE
EN 11
WATER STEAM STERILIZER
Device
17 22 28
220-240 V 50 Hz Main power cord Plug CEE 7 / VII IEC 250V-16A 50 Hz
3x1.5 sq.mm cable from -25 to 70° C
C19 connector according to IEC 60320 UL 498, CSA C22.2
220 V 60 Hz Main power cord: NEMA 6-15P plug 250V-15A
SJT 14 AWG / 3C 300V 60° C
C19 connector according to IEC 60320
Device 17 22 28
Class
Category I Category II Category II
(according to Directive 2014/68/EU PED)
Working -0.8 ÷ 2.4 -0.8 ÷ 2.4 -0.8 ÷ 2.4
pressure barg barg barg
Safety
2.4 barg 2.4 barg 2.4 barg
device set
500 kPa 500 kPa 500 kPa
PT
(abs) (abs) (abs)
PS 2.4 barg 2.4 barg 2.4 barg
10 ÷ 140 10 ÷ 140 10 ÷ 140
TS
°C °C °C
Fluid
2 2 2
Group
12 EN
3.3. SAFETY DEVICES
The sterilizer is equipped with the following safety devices for which we provide a brief description of their function:
• Mains fuses (see data in summary table)
Protection of the whole device against possible failures of heating elements.
Action: power supply interruption.
• Electronic circuit protection fuses (see data in summary table)
Protection against possible failures of the primary circuit of the transformer and of low voltage users.
Action: interruption of one or more low voltage circuits.
• Thermal circuit-breakers on mains voltage windings
Protection against possible overheating of pump motors and of transformer primary winding.
Action: temporary cut-off (until cooling) of the winding.
• Safety valve
Protection against overpressure in the sterilization chamber.
Action: release of the steam and restoration of the safety pressure.
• Safety thermostat with steam generator manual reset
Protection against steam generator overheating.
Action: cut-off of the electricity to the steam generator.
• Safety thermostat with chamber heating element manual reset
Protection against overheating of the heating elements of the container under pressure.
Action: cut-off of the electricity to the chamber heating element.
• Door position safety microswitch
Confirmation of the correct closing position of the door of the container under pressure.
Action: signalling of wrong door position.
• Motor-driven door lock mechanism with electromechanical protection (pressure switch)
Protection against accidental opening of the door (even in a blackout).
Action: prevents accidental opening of the door during a program.
• Door locking mechanism safety microswitch
Striker for the correct closing position of door locking system.
Action: signalling of failed or wrong operation of door locking mechanism.
• Self-levelling hydraulic system
Plumbing system structure for the spontaneous levelling of the pressure in the case of a manual interruption of the cycle, alarm or blackout.
Action: automatic restoration of atmospheric pressure in the sterilization chamber.
• Integrated system for evaluating the sterilization process
Continuous verification of the sterilization process parameters entirely managed by microprocessor.
Action: immediate interruption of the program (in case of malfunction) and generation of alarms.
• Sterilizer operation monitoring
Real-time oversight of all significant parameters when the machine is powered.
Action: generation of alarm messages (in the case of anomaly) with possible interruption of the cycle.
EN 13
3.5. FRONT
1 Model
2 Control panel and LCD screen
3 Door
4 Power switch
5 Dust filter
1 Sterilisation chamber
2 Bacteriological filter
3 Door locking system
4 Water drainage filter
5 Distilled water top-up quick coupling
6 Distilled water drainage quick coupling
7 Waste water drainage quick connector
8 Door
9 Steam diffuser
14 EN
3.6. REAR
1 Fastening slots for rear spacers
2 Heat exchanger
3 Connection for direct water drainage
4 Connection for automatic distilled water filling (only for EV AUX kit
and external pump kit)
5 Data plate
SERIAL NUMBER LABEL
(See image *)
6 Ethernet cable connection (max length 29 m)
7 Serial cable connection
8 Automatic filling electrical connection (only for EV AUX kit and
external pump kit)
9 Network fuses
10 Power cable connection
(*)
EN 15
3.7. LCD ICONS
The screens in the following pictures may vary in shapes and colours, but their contents are the same as shown on the sterilizer display.
A Cycle counter
B Selection for data management
C Selection of sterilization and test cycles
D Date
E Time
F Door opening
G Selection of the sterilizer settings (Setup)
H Menu selection button
I Info button
L Confirmation Button
M Hidden information button (reserved to Service)
If the hidden information button (M) is pressed unintentionally, information on the device is displayed.
To exit the screen, press the hidden information button again.
This button is used during service operation.
Other particular symbols relating to the various conditions of use will be described in the relative paragraphs.
16 EN
3.8. EXAMPLE OF WORKING CYCLE
The sterilization program can be effectively described as a succession of phases, each one with a very precise objective.
For example, the universal program (cycle B, 134°C - 4’): after loading the material in the chamber, closing the door, selecting the program and starting
the cycle (after locking the door opening mechanism), the following sequence will be suggested (see the graph below):
1 Preheating the generator and sterilization chamber;
2 Removing the air and penetration of steam in the material through a series of vacuum (extraction of the fluid from the sterilization chamber) and
pressure (injection of steam into the chamber) phases;
3 Raising the pressure, with the consequent increase in the temperature of the steam, until reaching the conditions required for sterilization (in the
example, 134°C);
4 Stabilizing the pressure and temperature;
5 Sterilizing for the required time (in the example, 4 minutes);
6 Depressurizing the sterilization chamber;
7 Vacuum-drying phase;
8 Ventilating the load with sterile air;
9 Bringing the pressure of the sterilization chamber back to the atmospheric level.
Having reached this last phase, you can unlock the door and remove the load from the sterilization chamber.
It should be emphasized that phases 1, 3, 4, 6 and 9 are identical in all cycles, with slight variations of duration that are solely dependent on the quantity
and consistency of the load and the heating conditions of the sterilizer while phases 2, 5, 7 and 8 clearly vary their configuration and/or duration on the
basis of the cycle selected (and, as a consequence, the type of load) and the choices made by the user.
A PRESSURE (BAR)
B PROCESS
C TIME (MIN)
D FRACTIONATED VACUUM
E VACUUM DRYING
EN 17
4. SETTING UP THE DEVICE
The safety of every system which integrates the device is responsibility of the system assembler.
The first and essential step for a proper operation of the sterilizer, its durability over time and complete use of its features is a correct and careful
commissioning. Moreover, this precaution will avoid the danger of physical injury or property damage, not to mention malfunctions and damage to the
device.
Please follow meticulously the instructions contained hereafter in this chapter.
Technical service department (see appendix) is available for any doubt or further information. The sterilizer is placed on the marked only after
having passed all the checks required. It does not require any additional calibration for commissioning.
Total weight 50 kg 51 kg 52 kg
18 EN
4.1. OVERALL DIMENSIONS
Centre distance and maximum overall dimensions of the sterilizer feet, with and without rear spacers.
A Feet
B Rear spacers
EN 19
4.2. COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATION
When installing the sterilizer inside a cabinet, you must provide adequate space all around the device to provide effective ventilation as well as an
opening in the back (180 sq.cm) that, in addition to allowing the passage of the power cord, will also provide an adequate air flow and the consequent
optimum cooling of the heat exchanger.
Mount the rear spacers supplied to ensure that the sterilizer is placed at the correct distance from the wall.
The compartment where the sterilizer will be installed must have the following minimum dimensions:
Depth 600 mm
Compartment dimensions lower than those shown may compromise the correct circulation of air around the device and may not
provide adequate cooling, with the consequent deterioration of performance and/or possible damage.
If the main switch is inaccessible when installed in the compartment, use an electric plug that incorporates an on/off switch.
Do not remove the upper cover nor any other external part. The device must be completely installed in the compartment.
Please refer to appendix “technical characteristics” for complete technical data.
20 EN
4.5. ELECTRICAL CONNECTIONS
This information is shown on the back of the machine.
The sterilizer must be connected to a socket of the electric system having adequate capacity for the absorption of the device and properly earthed, in
accordance with laws and/or regulations in force.
The socket must be properly protected through magneto-thermal and differential circuit breakers having the following characteristics:
• Rated current In 16 A
• Residual current IDn 0.03 A
The manufacturer is not responsible for any damage caused by the installation of the sterilizer with unsuited and/or not properly
earthed electric systems.
Always connect the power cord directly to the power outlet.
Do not use extensions, adapters or other accessories.
The position of the union of the centralized draining point must be lower than the resting surface of the sterilizer.
Otherwise, the tank may not be emptied correctly.
EN 21
5. FIRST START-UP
The time required to start the sterilizer is approximately 30 seconds.
5.1. STARTING
Once the sterilizer has correctly been installed, turn it on with the main switch on the right-hand side of the machine.
When the device is first turned on, the display shows the selection of
LANGUAGE, DATE and TIME settings.
Once LANGUAGE, DATE and TIME have been set, the PREHEATING
screen appears.
See section PREHEATING in chapter SETTINGS to set the relevant
parameters.
22 EN
5.2. MAIN MENU
At the end of starting procedure the main menu is displayed on the side.
The sterilizer waits for the program selection (see "Program selection"
Chapter).
The tank must be filled before the cycle starts or after its completion.
Do not fill/empty tanks during cycle execution in order to prevent water or hot steam leaks.
EN 23
6. CONFIGURATION
The sterilizers offer a wide range of customisable options. The user can thus configure the device according to his/her own needs, adapting the
performance based on, for example, the type of activity carried out, the type of material to be sterilised and the frequency of use.
Using the configuration program, the user can set a series of options available in user-friendly menus.
Use the configuration program whenever necessary.
A correct customisation of the device provides the best performance and the most satisfactory use.
The technical service department (see appendix) is available to help users by providing suggestions or advices on the best way to use the
options in the configuration program.
6.1. SETTINGS
To enter the configuration program, select the icon shown on the side
and press OK.
6.1.1. LANGUAGE
Select LANGUAGE option and confirm by pressing OK.
Select the desired language scrolling the list with arrows ( and ) and
confirm by pressing OK.
24 EN
6.1.2. DATE AND TIME
Select DATE AND TIME option and confirm by pressing OK.
Select the field to be modified using the arrows and confirm using OK.
Use + and - buttons to adjust the value.
Confirm using OK and adjust the other fields.
Press EXIT icon to save the selections and go back to the previous
menu.
6.1.3. PREHEATING
Select the PREHEATING option and confirm by pressing OK.
When the PREHEATING is active, the INTERVAL control allows setting the maximum operating time, after which the warming up is disabled.
A value of 30 to 120 minutes can be set.
Preheating is only activated when the first (sterilization or test) cycle is complete, or if the cycle fails and only if it is not a vacuum test. This allows to run
a vacuum test as first cycle when the device is turned on and repeat it if it does not succeed.
Interval minutes should be set according to the number of cycles that are planned in one day.
The set time approximately corresponds to the pause between one cycle and the other.
In this way, the device stays warm and heating time is reduced.
EN 25
6.1.4. WATER FILLING
Select WATER FILLING option and confirm by pressing OK.
26 EN
6.1.5. DISPLAY
Select DISPLAY option to adjust brightness and contrast of the screen,
confirm by pressing OK.
Select the field to be modified using the arrows and confirm using OK.
Use + and - buttons to adjust the value.
Confirm using OK and adjust the other fields.
When the TEST REMINDER option is set, a pop-up will remind the user
to run the test according to the chosen frequency.
6.1.7. SERVICE
EN 27
7. PREPARATION OF THE MATERIAL
Always use personal protective equipment.
First of all, it should be recalled that, when handling and managing contaminated material, it is a good idea to take the following precautions:
• Wear rubber gloves of suitable thickness and the specific protective mask on your face;
• Clean your gloved hands with a germicide detergent;
• Always carry the instruments on a tray;
• Never carry them in your hands;
• Protect your hands from contact with any sharp points or edges; this will avoid the risk of contracting a dangerous infection;
• Immediately remove any article that does not need to be sterilized or that is not capable of withstanding the process;
• Carefully wash your still gloved hands when done handling non-sterile material;
• All materials and/or instruments to be sterilized must be perfectly clean, without any type of residue (deposits of organic/inorganic material, fragments
of paper, cotton/gauze pads, lime, etc.).
In addition to causing problems during sterilization, the failure to clean and remove residue can damage the instruments and/or sterilizer itself.
28 EN
7.2. ARRANGING THE LOAD
To get the best effectiveness of the sterilization process and preserve the material over time, increasing its useful life, follow the instructions below.
Place one sterilization chemical indicator per tray to indicate when the process is complete: this will allow avoiding an unnecessary repetition of
the process on the same load or, worse, the use of unsterilised material. If packed material is sterilized, place the indicator inside one of the
packages.
Note for rubber and plastic hoses:
• Always rinse before use with pyrogen-free water; do not dry;
• Arrange hoses on tray so that their ends are not obstructed or
squashed;
• Do not bend or twist hoses, but leave them as linearly stretched as
possible.
EN 29
Notes for packed material:
• Individually pack the instruments or, in case several instruments are
placed inside the same bag, make sure they are made of the same
metal;
• Seal the case with a thermosealer or adhesive tape for autoclaves;
• Do not use metal staples, needles or the like, as sterility could be
affected;
• Lay the bags so as to avoid the creation of air pockets, which could
potentially prevent steam correct penetration and removal;
• Position bags in such a way to leave the paper side up and the plastic
side down (tray side);
• In any case, make sure that this position proves effective, reverting it, if
necessary;
• If possible, using a suitable support, position bags at right angles with
tray;
• Never stack bags one on top of the other.
Always pack instruments if they have to be stored for a long time.
Refer also to the indications given in chapter “sterilized material storage”.
Program selection is an essential operation for the correct performance of the sterilization process.
Since all instruments, or material in general, have a different structure, consistency and properties, the most suitable program must be identified,
both to preserve the physical characteristics (avoiding or, in any case, limiting its alterations) and to ensure the best effectiveness of the sterilization
process.
A guide for the selection of the correct program based on the load is present inside Programs Appendix.
30 EN
7.3. POSITIONING AND USE OF TRAY HOLDER SUPPORT
Tray holder support can be used in "tray" version (5/6 compartments
based on the sterilizer model).
Or, if tray holder support is extracted and turned by 90°, it can be used to
house special "boxes" (3/4 compartments based on sterilizer model).
In any case, it is possible to position the boxes (3 or 4
depending on the sterilizer model) vertically.
EN 31
32 EN
8. STERILIZATION CYCLES
A sterilization cycle consists of a determined number of phases.
The number and duration of the phases can differ for the different cycles, based on the type of air extraction, sterilization process and drying methods:
• 134°C Universal
• 121°C Universal
• 134°C Prion
• 134°C Hollow
• 134°C Flash
• User-defined
The electronic control system monitors the various phases, at the same time checking that the various parameters are respected; if any type of anomaly
is encountered during the cycle, the program is immediately interrupted, generating an alarm identified by a code, with a relative message explaining the
nature of the problem.
With this type of control, when you select a suitable sterilization program, you are guaranteed an effective sterilization under any conditions.
EN 33
8.1. EXTRA DRYING
Select EXTRA DRYING option by pressing the indicated button.
Use + and - buttons to set the additional drying time and confirm.
After the confirmation, the extra drying value appears near the total cycle
time.
34 EN
8.2. DELAY START
Select DELAY START option by pressing the indicated button.
Use + and - buttons to set the additional start delay and confirm.
EN 35
8.3. EXECUTION OF THE CYCLE
Press START to start the cycle with selected active options.
WARMING UP
FIRST VACUUM PHASE
FIRST PRESSURE RISE
SECOND VACUUM PHASE
SECOND PRESSURE RISE
THIRD VACUUM PHASE
THIRD PRESSURE RISE
STERILIZATION
STEAM DISCHARGE
DRYING
VENTILATION
CYCLE COMPLETION
36 EN
8.6. USER-DEFINED CYCLE
To set parameters select the following item and confirm.
Select button
Use + and - buttons to adjust the value. Confirm using OK and adjust the
other fields.
Once you have made the selections, using the exit button, save settings
and go back to the previous screen.
EN 37
9. MATERIAL STORAGE
The sterilized material must be adequately treated and stored to maintain its sterility over time, until its use.
Inadequate storage can cause rapid recontamination.
This leads to problems regardless of what you do since you will either be using recontaminated material (most of the time unconsciously), placing the
user and patient at risk, or you will have to run the sterilization cycle again, with an inevitable waste of time and resources.
For this reason, we think it will be useful to provide several basic suggestions, leaving the operator the task of further study of specific texts.
Assuming that the sterilizer is located in a clean place, free of dust and not too damp, the following precautions should be taken when handling and/or
carrying sterile material:
1 Remove the load from the sterilization chamber wearing gloves and a clean, or even better, sterilized smock. As an additional precaution, wear a
protective mask on your face;
2 Rest the trays on a dry, suitably clean and disinfected surface. Take care to distance or, at any rate, separate the sterile material from the area where
contaminated material is kept waiting to be sterilized;
3 Touch the material and/or instruments as little as possible, taking extreme care not to cut or damage the wrappings;
Let the instruments cool before any transport (and subsequent storage). If necessary for transport, transfer the material using dry, clean and disinfected
containers.
The containers must be closed or, if open, covered with clean cloths.
Before use, sterile material must be stored using the appropriate techniques.
These will significantly slow recontamination:
1 Store the material and/or instruments in the protective wrappings that were used during sterilization. Do not wrap the instruments after sterilization
since, in addition to being useless and completely senseless, is also potentially harmful;
2 Store the material in a dry, suitably clean and disinfected place, far from the area where infected material passes. If possible, use closed
compartments equipped with ultraviolet light;
3 Identify the sterile material by attaching the sterilization date (enclosing a copy of the printed report or an adhesive label);
4 First use the material that has been stored the longest (FIFO, "First In First Out"). This results in material that is homogeneously stored, avoiding
storing it for too long, with the consequent risks.
5 Never store material for too long. In fact, do not overlook the fact that materials will tend to degrade and be recontaminated in a finite time, even when
the above instructions are followed.
Consult the specifications provided by the manufacturer of the packaging material relative to the maximum allowed storage time.
Such storage times may vary from country to country, according to the local legal requirements.
38 EN
10. TEST PROGRAMS
To protect the safety of users and patients, a fundamental process like sterilizing medical devices should be periodically checked.
The device offers the possibility of easily and automatically executing two distinct test cycles:
• HELIX TEST / B&D;
• VACUUM TEST;
To select the Helix Test/B&D cycle, select Helix Test/B&D using the
arrows and confirm with OK.
The HELIX test device (in accordance with EN 867-5 specifications) consists of a 1.5 m-long PTFE tube, with an inside diameter of 2 mm to whose end
a small hermetically-sealed screw cap is fastened, able to contain an appropriate chemical indicator.
The other end of the tube is left free so that the steam can penetrate and you can assess its effectiveness.
To conduct the test (with reference to standard EN 13060), insert the chemical indicator, consisting of a paper strip with a special reagent ink in the
device cap (always to be used perfectly dry). Tighten the cap in such a way that seepage through the gasket is not possible.
The test device and the chemical indicators to execute the helix/b&d test cycle are not provided with the device.
For information in this regard, contact technical service department (see appendix).
Place the device roughly in the middle of the central tray. Do not insert other material in the chamber. Close the door and start the cycle.
The test cycle takes place with a succession of phases similar to those described for a normal sterilization cycle.
At the end of the cycle, remove the test device from the chamber, open the cap and remove the indicator from its housing.
If the steam has correctly penetrated, the ink will have completely changed its original colour over the entire length of the strip; if not (insufficient
penetration), there will only be a partial colour change or even no change at all.
Toning usually occurs from a light colour (beige, yellow, etc.) to a dark colour (blue, violet or black).
In any event, strictly follow the instructions and any additional technical details provided by the indicator manufacturer.
EN 39
10.2. VACUUM TEST CYCLE
The VACUUM TEST cycle allows testing perfect seal of the sterilizer hydraulic system.
Measuring the variation of the degree of vacuum in a defined time-frame and comparing it with pre-established limit values, you can determine how
good the seal of the sterilization chamber, tubes and the various interception devices is.
To select the VACUUM TEST cycle, select VACUUM TEST using the
arrows and confirm with OK.
The cycle must be run with the sterilization chamber empty, and only the trays and their supports inserted.
We suggest to run this test at the beginning of each working day with chamber at ambient temperature.
A high chamber temperature affects the variation in the vacuum value measured during the test; the system is therefore programmed to prevent
execution of the test when the operating conditions are inadequate.
Close the door and start the program.
The vacuum phase starts immediately and the pressure value (bar) and the countdown from the start of the test cycle are shown on the display.
If the pressure variation exceeds the limit defined, the program is interrupted and an alarm message generated.
For the complete description of the alarms refer to appendix.
40 EN
10.3. DOOR OPENING
To open the autoclave door, press and hold the button shown in the
figure.
EN 41
10.4. MANUAL INTERRUPTION
The cycle can be interrupted by the operator in any moment, by holding
down the key indicated in the figure for about three seconds.
The command generates E999 error since the cycle could not finish correctly.
If the cycle is interrupted during certain phases, an automatic cleaning procedure of the internal hydraulic circuit starts.
For the complete description of the alarms refer to “alarms” appendix.
Press and hold RESET for about three seconds to open the door.
After a manual interruption of the program, the load must not be used since the sterilization is not ensured.
42 EN
11. USED WATER DRAIN
When the water maximum level is reached, a specific message is displayed.
EN 43
12. DATA MANAGEMENT
To enter the DATA MANAGEMENT section, select the following icon and
press OK button.
This section allows you to set the following parameters:
• Print management;
• Downl. cycle data;
• Wi-Fi;
• Ethernet.
44 EN
12.2. PRINT LABELS
At the end of the cycle, when pressing the button indicated, the following
page is displayed only if the printer is connected to the sterilizer and set
for label printing (settable from print management).
Select the field to be set using the arrows (number of labels to be printed
at the end of the cycle and material expiration), confirm using OK.
Use + and - buttons to adjust the value.
Confirm using OK and adjust the other fields.
Once you have made the selections, using the exit button, save settings
and go back to the previous screen.
With REPORT option set, select PRINT LAST CYCLE to print the
summary report of the last cycle.
With LABELS option set, the PRINT LABELS screen will be displayed.
EN 45
12.3. DOWN. CYCLE DATA
By selecting DOWNL. CYCLE DATA, it is possible to copy data about
the cycles carried out, stored in the inner memory of the sterilizer, on a
USB key.
The USB key must be formatted according to the instructions
set forth in: appendix - technical characteristics, summary table.
46 EN
The sterilization test / cycle report files are downloaded in PDF
format.
At the end of the download it is possible to remove the stick.
Do not turn on the sterilizer if USB key is inserted.
12.4. WIFI
Select Wi-Fi to connect the sterilizer to a local Wi-Fi network.
EN 47
After selecting the network, enter the login password.
It is possible to delete an entered password with the Reset Password
command.
The MANUAL entry of the network allows manual typing of SSID and
PASSWORD (PSW) of the desired network.
After entering the network (SSID) name, enter the login password.
It is possible to delete the network (SSID) name or the password entered
using Reset SSID and Reset Password commands.
48 EN
Select SETUP to access a manual entry menu for all network data.
EN 49
12.5. ETHERNET
Select ETHERNET to connect the sterilizer to a local Ethernet network.
12.5.1. CONNECTION TO A LOCAL NETWORK EQUIPPED WITH DHCP SERVER, WITH STERILISER CONFIGURED WITH STATIC IP
In order to avoid checking often the TCP-IP number assigned dynamically from a DHCP Server, it is possible to assign manually a fixed number of the
dynamic numbering of the local network.
To avoid conflicts it is essential to:
• Configure DHCP Server so that it does not assign the selected number to other devices.
Or:
• Assign statically a number out of the range assigned by the DHCP server to the sterilizer.
For the information needed for a correct configuration check DHCP server settings of the local network.
50 EN
12.5.2. CONNECTION TO A LOCAL NETWORK MANUALLY CONFIGURED WITH "STATIC” IPs
If the local network is configured in static mode, you need to assign the
IP number as follows:
• Display the Ethernet configuration page;
• Make sure that manual configuration is selected.
EN 51
13. APPENDIX – PROGRAMS
Water steam sterilization is suitable for almost all the materials and instruments, provided that they can bear without damage a minimum temperature
of 121°C (if this is not the case, other low-temperature sterilization systems must be used).
The following material can normally be sterilized with water steam:
• Stainless steel surgical/generic instruments;
• Carbon steel surgical/generic instruments;
• Rotating and/or vibrating instruments driven by compressed air (turbines) or mechanical transmission (contra angles, tooth scalers);
• Glass items;
• Mineral-based items;
• Heat-resistant plastic items;
• Heat-resistant rubber items;
• Heat-resistant textiles;
• Medication materials (gauze, pads, etc.);
• Other generic material suitable for autoclave treatment.
Depending on the material conformation (solid, hollow or porous), on any package containing it (paper/plastic bag, paper for sterilization,
container, muslin napkins, etc.) and on its resistance to heat, it is essential to choose the suitable sterilization program, referring to the table in
the next page.
The device must not be used for the sterilization of fluids, liquids or pharmaceutical products.
"Prion” cycle
The reference standard for this device, EN 13060, does not lay down any requirements for inactivation processes that cause spongiform
encephalopathies as scrapie, bovine spongiform encephalopathy and creutzfeldt-jakob disease.
The cycle named “prion” (18 min at 134°C) applies national regulations, which indicate this modified steam sterilization process as part of a
prion decontamination program.
52 EN
13.1. SUMMARY TABLE OF 17 220 V - 240 V CYCLES
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Unwrapped porous
1.00 0.30 0.30
materials
Porous materials in
0.75 0.25 0.25
single pack
Porous materials in
0.60 0.20 0.20
double pack
134°C
134 2.1 4(*) B F 13 45 550 0.75
UNIVERSAL Solid and hollow
3.00 1.00 0.50
materials in single pack
Unwrapped porous
1.00 0.30 0.30
materials
Porous materials in
0.75 0.25 0.25 For wrapped
single pack
materials and
Porous materials in instruments (single
0.60 0.20 0.20 and double pack), it
double pack
is advisable to use
134°C PRION 121 1.1 20 B F 13 61 600 0.75 the 3-tray
Solid and hollow
3.00 1.00 0.50 configuration
materials in single pack
Unwrapped porous
1.00 0.30 0.30
materials
Porous materials in
0.75 0.25 0.25
single pack
Porous materials in
121°C 0.60 0.20 0.20
121 1.1 20 B F 13 61 600 0.75 double pack
UNIVERSAL
Solid and hollow
3.00 1.00 0.50
materials in single pack
EN 53
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Solid and hollow
instruments in double 1.50 0.50 0.25
pack
Unwrapped hollow
6.00 1.20 0.50
134°C instruments
HOLLOW 134 2.1 4(*) S F 4 33 550 0.65
UNWRAPPED Unwrapped solid
6.00 1.20 0.50
instruments
Solid and hollow It is advisable to use
instruments "B" in 3.00 1.00 0.25 the 3-tray
single pack configuration
134°C FLASH 134 2.1 4(*) S S 13 36 350 0.55
Unwrapped solid and
6.00 1.20 0.50
hollow materials "B"
Unwrapped solid
4÷30
instruments (other load Variable parameters
XXX°C USER 134- 2.1- - 5÷3
n.a. F/S n.a. n.a. n.a. types are possible n.a. n.a. n.a. depending on the
(see note) 121 1.1 20÷3 0
depending on the user settings made
0
settings)
HELIX/BD Test device only
134 2.1 3.5 - F 1 20 - - - - -
TEST (without another load)
VACUUM
- -0.8 - - - - 18 - - Empty chamber - - -
TEST
VACUUM +
HELIX/BD
TEST - - - - - - 42 - - - - - -
(executable in
sequence)
54 EN
13.2. SUMMARY TABLE OF 17 120 V CYCLES
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Unwrapped porous
1.00 0.30 0.30
materials
Porous materials in
0.75 0.25 0.25
single pack
Unwrapped porous
1.00 0.30 0.30
materials
Porous materials in
0.75 0.25 0.25
single pack
EN 55
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Unwrapped solid
4÷30 instruments (other load Variable parameters
XXX°C USER 135- 2.2-
- n.a. F 5÷30 n.a. n.a. n.a. types are possible n.a. n.a. n.a. depending on the
(see note) 121 1.1
20÷30 depending on the user settings made
settings)
VACUUM
- -0.8 - - - - 18 - - Empty chamber - - -
TEST
VACUUM +
HELIX/BD
TEST - - - - - - 50 - - - - - -
(executable in
sequence)
56 EN
13.3. SUMMARY TABLE OF 22 220 V - 240 V CYCLES
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Unwrapped porous
1.20 0.40 0.30
materials
Porous materials in
1.00 0.30 0.25
single pack
Porous materials in
0.75 0.25 0.20
double pack
134°C
134 2.1 4(*) B F 15 46 700 0.8 Solid and hollow
UNIVERSAL 4.00 1.25 0.50
materials in single pack
Unwrapped porous
1.20 0.40 0.30
materials
Porous materials in
1.00 0.30 0.25
single pack
For wrapped
Porous materials in materials and
0.75 0.25 0.20
double pack instruments (single
134°C PRION 134 2.1 18 B F 15 60 750 0.9 and double pack), it
Solid and hollow is advisable to use
4.00 1.25 0.50
materials in single pack the 3-tray
configuration
Unwrapped solid and
7.50 1.20 0.25
hollow materials
Solid and hollow
instruments in double 2.00 0.60 0.25
pack
Unwrapped porous
1.20 0.40 0.30
materials
Porous materials in
1.00 0.30 0.25
single pack
Porous materials in
0.75 0.25 0.20
double pack
121°C
121 1.1 20 B F 15 63 750 0.8
UNIVERSAL Solid and hollow
4.00 1.25 0.50
materials in single pack
EN 57
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
UNWRAPPED
Unwrapped solid
7.50 1.50 0.50
instruments
Unwrapped solid
4÷30 instruments (other load Variable parameters
XXX°C USER 134- 2.1-
- n.a. F/S 5÷30 n.a. n.a. n.a. types are possible n.a. n.a. n.a. depending on the
(see note) 121 1.1
20÷30 depending on the user settings made
settings)
VACUUM
- -0.8 - - - - 18 - - Empty chamber - - -
TEST
VACUUM +
HELIX/BD
TEST - - - - - - 46 - - - - - -
(executable in
sequence)
58 EN
13.4. SUMMARY TABLE OF 22 120 V CYCLES
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Unwrapped porous
1.20 0.40 0.30
materials
Porous materials in
1.00 0.30 0.25
single pack
Unwrapped porous
1.20 0.40 0.30
materials
Porous materials in
1.00 0.30 0.25
single pack
For wrapped
Porous materials in materials and
0.75 0.25 0.20
121°C double pack instruments (single
RUBBER & 121 1.1 20 B F 15 75 750 0.8 and double pack), it
PLASTIC Solid and hollow is advisable to use
4.00 1.25 0.50
materials in single pack the 3-tray
configuration
Unwrapped solid and
7.50 1.20 0.25
hollow materials
Solid and hollow
instruments in double 2.00 0.60 0.25
pack
Unwrapped hollow
7.50 1.50 0.50
instruments
135° HOLLOW
135 2.2 4(*) S F 5 46 750 0.7
UNWRAPPED Unwrapped solid
7.50 1.50 0.50
instruments
EN 59
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Unwrapped solid
4÷30 instruments (other load Variable parameters
XXX°C USER 135- 2.2-
- n.a. F 5÷30 n.a. n.a. n.a. types are possible n.a. n.a. n.a. depending on the
(see note) 121 1.1
20÷30 depending on the user settings made
settings)
VACUUM
- -0.8 - - - - 18 - - Empty chamber - - -
TEST
VACUUM +
HELIX/BD
TEST - - - - - - 50 - - - - - -
(executable in
sequence)
60 EN
13.5. SUMMARY TABLE OF 28 220 V - 240 V CYCLES
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Unwrapped porous
1.50 0.50 0.50
materials
Porous materials in
0.90 0.30 0.30
double pack
134°C
134 2.1 4(*) B F 17 56 900 0.8
UNIVERSAL Solid and hollow materials
5.00 1.50 0.75
in single pack
Porous materials in
0.90 0.30 0.30
121°C double pack
121 1.1 20 B F 17 69 950 0.9
UNIVERSAL Solid and hollow materials
5.00 1.50 0.75
in single pack
EN 61
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
UNWRAPPED
Unwrapped solid
9.00 1.50 0.50
instruments
Unwrapped solid
Variable
4÷30 instruments (other load
XXX°C USER 134- 2.1- parameters
- n.a. F/S 5÷30 n.a. n.a. n.a. types are possible n.a. n.a. n.a.
(see note) 121 1.1 depending on the
20÷30 depending on the user
settings made
settings)
VACUUM
- -0.8 - - - - 18 - - Empty chamber - - -
TEST
VACUUM +
HELIX/BD
TEST - - - - - - 46 - - - - - -
(executable in
sequence)
62 EN
13.6. SUMMARY TABLE OF 28 120 V CYCLES
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
Unwrapped porous
1.50 0.50 0.50
materials
Unwrapped porous
1.50 0.50 0.50
materials
Unwrapped solid
Variable
4÷30 instruments (other load
XXX°C USER 135- 2.2- parameters
- n.a. F 5÷30 n.a. n.a. n.a. types are possible n.a. n.a. n.a.
(see note) 121 1.1 depending on the
20÷30 depending on the user
settings made
settings)
EN 63
BASIC CYCLE
NOMINAL VALUES STERILIZABLE MATERIALS NOTES
PARAMETERS
consumption
Pre-vacuum (F=fractionated; S=single)
energy
Retention time (min)
Temperature (°C)
Pressure (bar)
(kWh/cycle)
Average
TYPE
HELIX/BD Test device only (without
135 2.2 3.5 - F 1 24 - - - - -
TEST another load)
VACUUM
- -0.8 - - - - 18 - - Empty chamber - - -
TEST
VACUUM +
HELIX/BD
TEST - - - - - - 50 - - - - - -
(executable in
sequence)
(*) To set a sterilization time of 5.5 minutes, contact the Technical Service.
Single Pre-Vacuum = 1 pre-vacuum; -0.8 bar (see figures in the following pages).
Fractionated Pre-Vacuum = 3 pre-vacuum; -0.8 bar each (see figures in the following pages).
Definition of hollow loads in accordance with standard EN13060:2014.
The term “hallow loads” in this manual refers both to “narrow lumen” elements (paragraph 3.18 EN 13060:2014) and “simple hollow” elements
(paragraph 3.30 EN 13060:2014).
The term "hollow load B" refers ONLY to the elements defined as "simple hollow" (paragraph 3.30 EN 13060:2014).
64 EN
PRESSURE, TIME AND TEMPERATURE
In compliance with EN 13060: 2014 for operating cycles
134°C cycles
Max pressure
EN 13060:2014 Time (minutes) Min temperature Max temperature Min pressure (bar)
(bar)
1 CS --- --- --- --- ---
t1 1PV --- --- --- -0.81 -0.79
t2 1PP --- --- --- +0.97 +1.03
t3 2PV --- --- --- -0.81 -0.79
t4 2PP --- --- --- +0.97 +1.03
t5 3PV --- --- --- -0.81 -0.79
t6 SS 4 / 5.5 +134 +138 +2.04 +2.40
t7 SE 4 / 5.5 +134 +138 +2.04 +2.40
t8 DS --- --- --- -0.81 -0.79
t9 DE --- --- --- --- ---
2 CE --- --- --- -0.02 +0.02
121°C cycles
Max pressure
EN 13060:2014 Time (minutes) Min temperature Max temperature Min pressure (bar)
(bar)
1 CS --- --- --- --- ---
t1 1PV --- --- --- -0.81 -0.79
t2 1PP --- --- --- +0.97 +1.03
t3 2PV --- --- --- -0.81 -0.79
t4 2PP --- --- --- +0.97 +1.03
t5 3PV --- --- --- -0.81 -0.79
t6 SS 20 +121 +125 +1.05 +1.31
t7 SE 20 +121 +125 +1.05 +1.31
t8 DS --- --- --- -0.81 -0.79
t9 DE --- --- --- --- ---
2 CE --- --- --- -0.02 +0.02
EN 65
13.7. STERILISATION PROGRAM DIAGRAM
PROGRAM A PRESSURE (BAR)
134°C UNIVERSAL B PROCESS
134°C – 4’ 00’’ C TIME (MIN)
D FRACTIONATED VACUUM
PROGRAM E VACUUM DRYING
134°C PRION
134°C – 18’ 00’’
66 EN
PROGRAM A PRESSURE (BAR)
134°C HOLLOW UNWRAPPED B PROCESS
134°C – 4’00’’ C TIME (MIN)
F FRACTIONATED PRE-VACUUM
H SHORT DRYING
EN 67
13.8. DIAGRAMS OF THE TEST PROGRAMMES
PROGRAM A PRESSURE (BAR)
HELIX B&D TEST B PROCESS
134°C – 3’0’’ C TIME (MIN)
F FRACTIONATED PRE-VACUUM
H SHORT DRYING
68 EN
13.9. EXAMPLES OF PRINTED REPORTS
(WITH OPTIONAL PRINTER)
PROGRAM PRINTING (STANDARD) PROGRAM PRINTING HELIX/BD TEST PROGRAM PRINTING VACUUM TEST
The text printed on the receipt remains for a couple of years, if correctly stored (away from any source of heat and in a cool, dry place). Store
thermal receipts using cellulose envelopes, do not use plastic bags.
EN 69
14. APPENDIX - MAINTENANCE
In addition to correct use, the user needs to perform ordinary maintenance in order to guarantee safe, efficient operation over the device’s entire life.
For better quality of maintenance, supplement routine checks with regular periodic check-ups that can be performed by Technical Service Department
(see Appendix).
It is also fundamental to perform a periodic sterilizer validation, i.e. a check of process thermo-dynamic parameters and their comparison with the
reference values detected by duly calibrated tools. Refer to 'Sterilizer periodic validation' in the next part of the Appendix.
The ordinary maintenance described below consists in easy manual operations and preventive interventions involving simple instruments.
In the event of replacement of components or parts of the device, request and/or use original spare parts only.
70 EN
14.2. SCHEDULED MAINTENANCE MESSAGES
The sterilizer periodically displays warning messages relevant to "routine" maintenance operations that must be carried out in order to ensure the proper
operation of the device.
WARNING MESSAGE
BOILER FILTER CLEANING
DOOR LOCK LUBRICATION
DUST FILTER CLEANING
BACTERIOLOGICAL FILTER REPLACEMENT
BOILER GASKET REPLACEMENT
GENERAL SERVICE
The formation of white spots on the base of the internal wall of the chamber means that you are using poor quality demineralised water.
EN 71
14.3. DESCRIPTION OF MAINTENANCE INTERVENTIONS
Let’s now look at the various operations to be carried out.
72 EN
14.3.6. DUST FILTER CLEANING
Remove the dust filter (A) from the lower part of the autoclave,
thoroughly rinse it with water and dry it before refitting it.
The filter can be cleaned using a jet of compressed air, making sure not
to disperse any dust into the environment.
EN 73
14.5. DEVICE USEFUL LIFE
Water steam sterilizer service life is of 10 years (average use: 5 cycles/day, for 220 days/year). For normal use, it is expected that the device is used
and maintained according to the instructions provided by the manufacturer.
74 EN
15. APPENDIX - GENERAL PROBLEMS
If while using the device a problem or an alarm occurs, this DOES NOT mean that the device is out of order.
It may not, in fact, be related to a breakdown but, more probably to an anomalous situation, often merely transitory (such as a blackout), or incorrect
use.
In any case, it is important to first identify the cause of the failure and then take suitable corrective actions, either autonomously or with the intervention
of the Technical Service Department (see Appendix).
For this purpose, below, we provide instructions for diagnosing and resolving general problems, in addition to a precise description of the alarm codes,
their meaning and their solution.
15.1. TROUBLESHOOTING
If your sterilizer is not working correctly, please make the following checks before contacting the Technical Service Department:
EN 75
PROBLEM POSSIBLE CAUSE SUGGESTED SOLUTION
Contact between instruments made of different Separate instruments made of different metals.
metals. (See Chapter “Preparing the material”).
Clean the chamber and the accessories as
Presence of limescale residues on the wall of the
prescribed.
chamber and/or accessories.
(See Appendix “Maintenance”).
Choose the sterilization program suitable for the type
Blackening of the instruments or of material to be treated.
Wrong selection of the sterilization program.
damage to the material. (See the Summary Table in "Programs"
Appendix).
76 EN
16. APPENDIX – ALARMS
If the problem persists, contact the technical service (see APPENDIX) communicating the sterilizer model and serial number.
These data are indicated on the registration plate on the rear side of the device and on the declaration of conformity and can be viewed also by
means of the “sterilizer information” command.
Every time an anomalous condition occurs during the operation of the sterilizer, an alarm is generated, identified by a specific code (consisting of a
letter followed by a 3-digit number).
Alarm codes are divided into four categories:
E= ERROR/WARNING
Incorrect handling and/or use or a cause outside the device.
The problem can normally be solved by the user.
Code format: Exxx (xxx = identification number 000 ÷ 999)
A = ALARM
First level fault
The problem can normally be solved on site by a specialised technician.
Code format: Axxx (xxx = identification number 000 ÷ 999)
H = HAZARD
Second level fault
The problem can normally be solved by the Technical Service Centre.
Code format: Hxxx (xxx = identification number 000 ÷ 999)
S = SYSTEM ERROR
Electronic system error (HW-FW).
Code format: Sxxx (xxx = identification number 000 ÷ 999)
In case of alarm, switch off the device only after having followed the indications displayed and having carried out the reset (see “Resetting the
system” paragraph).
EN 77
16.3. SYSTEM RESET
The system can be reset in two alternative ways, depending on the type of alarm occurred (see the List of alarm codes below in this appendix):
1 Pressing the OK button;
2 Following the instructions displayed and holding down the RESET button for about 3 seconds.
Press the "padlock" button for 3 seconds to open the sterilizer door:
Press the RESET button for approx. 3 seconds to go back to the main
menu.
After the RESET and any technical operation necessary to eliminate the fault, the device will be ready to perform a new program.
Never turn off the device before carrying out the reset.
78 EN
17. ALARM CODES
The list of alarm codes, the relevant messages displayed and RESET modes, are indicated in the following table:
OVERVOLTAGE
E001 Voltage of power supply line too high 2, 3
CONTACT TECH. SERVICE
FAN PROBLEM
E007 One of the two fans is not working properly 1
CONTACT TECH. SERVICE
DOOR OPEN
E010 Door open 2
CLOSE DOOR
TEST REMINDER
E050 Reminder to run Vacuum Test cycle 1
RUN VACUUM TEST
TEST REMINDER
E051 Reminder to run Helix Test cycle 1
RUN HELIX TEST
TEST REMINDER
E052 Reminder to run Vacuum + Helix Test combined cycle RUN 1
VACUUM+HELIX TEST
ETHERNET CONFIG. ERROR
E060 The autoclave cannot connect to Lan network 1
CHECK SETTINGS
Cloud firmware version is not the correct one compared to Process CLOUD FW
E141 firmware version. Malfunctions may occur during connection with Wi-Fi, VERSION NOT CORRECT 1
Ethernet or Cloud PLEASE UPDATE THE FW
TEST FAILED
Vacuum test failed
E900 SECOND STEP 3
(during TEST PHASE)
CONTACT TECH. SERVICE
TEST FAILED
Vacuum test failed
E901 FIRST STEP 3
(during STAND-BY PHASE)
CONTACT TECH. SERVICE
EN 79
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE
TEST FAILED
Vacuum test failed
E902 VACUUM NOT ACHIEVED 3
(vacuum pulse time-out exceeded)
CONTACT TECH. SERVICE
REMOTE SERVICE
E998 Remote maintenance activity in progress 1
ACTIVE
1 = OK (warning)
2 = OK + Stopped cycle start
3 = Cycle failed + OK + RESET
80 EN
17.2. ALARMS (CATEGORY A)
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE
FILL.WATER LEVEL
A032 Problem with the level sensor of the filling tank SENSOR PROBLEM 1
CONTACT TECH. SERVICE
FAILED WATER INLET
A040 The tank has not been filled (only with automatic filling system) CHECK 1
AUTOMATIC LOAD
WATER FILLING
The MAX water level in the filling tank has been reached abnormally
A042 MAXIMUM LEVEL 1
(automatic filling)
CHECK TANK
CHAMBER PROBE
Temperature sensor PT1 broken
A101 PT1 OPEN CIRCUIT 2, 3
(sterilization chamber)
CONTACT TECH. SERVICE
GENERATOR PROBE
A102 Temperature sensor PT2 broken (steam generator) PT2 OPEN CIRCUIT 2, 3
CONTACT TECH. SERVICE
HEATING BAND PROBE
A103 Temperature sensor PT3 broken (heating element) PT3 OPEN CIRCUIT 2, 3
CONTACT TECH. SERVICE
CONDUCTIVITY SENSOR
Temperature sensor PT5 broken (conductivity measurement
A105 PT5 OPEN CIRCUIT 1
compensation)
CONTACT TECH. SERVICE
CHAMBER PROBE
A111 Temperature sensor PT1 short-circuited (sterilization chamber) PT1 SHORT-CIRCUIT 2, 3
CONTACT TECH. SERVICE
GENERATOR PROBE
A112 Temperature sensor PT2 short-circuited (steam generator) PT2 SHORT-CIRCUIT 2, 3
CONTACT TECH. SERVICE
HEATING BAND PROBE
A113 Temperature sensor PT3 short-circuited (heating element) PT3 SHORT-CIRCUIT 2, 3
CONTACT TECH. SERVICE
CONDUCTIVITY SENSOR
Temperature sensor PT5 short-circuited (conductivity measurement
A115 PT5 SHORT-CIRCUIT 1
compensation)
CONTACT TECH. SERVICE
PROCESS BOARD ERROR
A116 ADC error 2, 3
CONTACT TECH. SERVICE
DOOR MOTOR
A117 Door motor overcurrent error 2, 3
OVERCURRENT
PROCESS BOARD ERROR
A120 Reference heating element acquisition chain fault 2, 3
CONTACT TECH. SERVICE
PROCESS BOARD ERROR
A121 Reference heating element acquisition chain fault 2, 3
CONTACT TECH. SERVICE
PROCESS BOARD ERROR
A122 Reference heating element acquisition chain fault 2, 3
CONTACT TECH. SERVICE
Wi-Fi MODULE ERROR
A126 Connection error with Wi-Fi module 1
CONTACT TECH. SERVICE
SOLENOID VALVE 1 ERROR
A131 Solenoid valve 1 failed 2, 3
CONTACT TECH. SERVICE
SOLENOID VALVE 2 ERROR
A132 Solenoid valve 2 failed 2, 3
CONTACT TECH. SERVICE
SOLENOID VALVE 3 ERROR
A133 Solenoid valve 3 failed 2, 3
CONTACT TECH. SERVICE
SOLENOID VALVE 4 ERROR
A134 Solenoid valve 4 failed 2, 3
CONTACT TECH. SERVICE
SOLENOID VALVE 5 ERROR
A135 Solenoid valve 5 failed 2, 3
CONTACT TECH. SERVICE
SOLENOID VALVE 6 ERROR
A136 Solenoid valve 6 failed 2, 3
CONTACT TECH. SERVICE
CLOUD FW
A140 Error during Cloud firmware update 1
UPDATE ERROR
FAULTY CURRENT DRAW CONTACT
A145 Faulty current draw detected 2, 3
TECH. SERVICE
SOLENOID VALVE DRIVER ERROR
A146 Solenoid valves control driver fault 2, 3
CONTACT TECH. SERVICE
DOOR MOTOR DRIVER ERROR
A147 Door motor control driver fault 2, 3
CONTACT TECH. SERVICE
STEAM GENERATOR
A201 Heating not executed within time-out (steam generator) RESISTOR OPEN CIRCUIT 3
CONTACT TECH. SERVICE
HEATING BAND
A202 Heating not executed within time-out (tube bundle heating element) OPEN CIRCUIT 3
CONTACT TECH. SERVICE
EN 81
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE
1PV TIMEOUT
A250 1st pulse with vacuum not reached within time out CHECK LOAD 3
CHECK CHAMBER FILTER
ATM1 UPSTROKE TIMEOUT
A251 1st rise back up to atmospheric pressure not reached within the time-out 3
CONTACT TECH. SERVICE
1PP UPSTROKE TIMEOUT
A252 1st pressure pulse not reached within the time-out 3
CONTACT TECH. SERVICE
2PV TIMEOUT
A253 2nd pulse with vacuum not reached within time out CHECK LOAD 3
CHECK CHAMBER FILTER
ATM2 UPSTROKE TIMEOUT
A254 2nd rise back up to atmospheric pressure not reached within the time-out 3
CONTACT TECH. SERVICE
2PP UPSTROKE TIMEOUT
A255 2nd pressure pulse not reached within the time-out 3
CONTACT TECH. SERVICE
3PV TIMEOUT
A256 3rd pulse with vacuum not reached within time out CHECK LOAD 3
CHECK CHAMBER FILTER
ATM3 UPSTROKE TIMEOUT
A257 3rd rise back up to atmospheric pressure not reached within the time-out 3
CONTACT TECH. SERVICE
3PP UPSTROKE TIMEOUT
A258 3rd pressure pulse not reached within the time out 3
CONTACT TECH. SERVICE
ATM3 DOWNSTROKE TIMEOUT
A260 Chamber depressurization not reached within time out CHECK LOAD 3
CHECK CHAMBER FILTER
PRESSURE LEVELLING
A261 Chamber levelling not reached within time out TIMEOUT 3
CONTACT TECH. SERVICE
PD PRESSURE
A262 Vacuum pulsation during drying not executed within time-out UPSTROKE TIMEOUT 3
CONTACT TECH. SERVICE
ATM1 DOWNSTROKE TIMEOUT
A353 1st drop to atmospheric pressure not completed within the time-out CHECK LOAD 3
CHECK CHAMBER FILTER
ATM2 DOWNSTROKE TIMEOUT
A356 2nd drop to atmospheric pressure not completed within the time-out CHECK LOAD 3
CHECK CHAMBER FILTER
SPD PRESSURE
A360 Vacuum pulsation after maintenance step not executed within time-out DOWNSTROKE TIMEOUT 3
CONTACT TECH. SERVICE
PD PRESSURE
A362 Chamber depressurisation during drying not reached within time-out DOWNSTROKE TIMEOUT 3
CONTACT TECH. SERVICE
1 = OK (warning)
2 = OK + Stopped cycle start
3 = Cycle failed + OK + RESET
82 EN
17.3. HAZARDS (CATEGORY H)
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE
PRESSURE
H150 MPX pressure sensor broken/not connected SENSOR OPEN CIRCUIT 2, 3
CONTACT TECH.SERVICE
PRESSURE
H160 MPX pressure sensor short-circuited SENSOR SHORT-CIRCUIT 2, 3
CONTACT TECH.SERVICE
INCORRECT P/T RATIO
H400 Pconv/T ratio not balanced (Pconv>T) (STERILIZATION phase) 3
CHECK LOAD
INCORRECT T/P RATIO
H401 T/Pconv ratio not balanced (T>Pconv) (STERILIZATION phase) 3
CHECK LOAD
TEMPERATURE BEYOND
H402 Temperature over the MAX limit (STERILIZATION phase) MAXIMUM LIMIT 3
CONTACT TECH. SERVICE
TEMPERATURE BELOW
H403 Temperature below the MIN limit (STERILIZATION phase) MINIMUM LIMIT 3
CONTACT TECH. SERVICE
ERRATIC TEMPERATURE
H404 Floating temperature over the limit (STERILIZATION phase) 3
CONTACT TECH. SERVICE
PRESSURE BEYOND
H405 Pressure over the MAX limit (STERILIZATION phase) MAXIMUM LIMIT 3
CONTACT TECH. SERVICE
PRESSURE BELOW
Pressure below MIN limit
H406 MINIMUM LIMIT 3
(STERILIZATION phase)
CONTACT TECH. SERVICE
INTERNAL TIMER ERROR
H410 Time measurement error 2, 3
CONTACT TECH. SERVICE
STERILIZATION
H411 Sterilization time error 3
TIME ERROR
PRESSURE BEYOND
H990 Excessive pressure (sterilization chamber, MPX) MAXIMUM LIMIT 2, 3
CONTACT TECH. SERVICE
PT1 OVERHEATING
H991 Overheating (sterilization chamber, PT1) 2, 3
CHECK LOAD
PT2 OVERHEATING
H992 Overheating (steam generator, PT2) 2, 3
CONTACT TECH. SERVICE
PT3 OVERHEATING
H993 Overheating (layer resistance, PT3) 2, 3
CONTACT TECH. SERVICE
1 = OK (warning)
2 = OK + Stopped cycle start
3 = Cycle failed + OK + RESET
EN 83
17.4. SYSTEM ERRORS (CATEGORY S)
CODE ALARM DESCRIPTION MESSAGE ON THE DISPLAY RESET MODE
FLASH MEMORY
S001 Flash memory 1 on process board failed NOT ACCESSIBLE 2, 3
CONTACT TECH. SERVICE
FLASH MEMORY
S002 Flash memory 2 on process board failed NOT ACCESSIBLE 2, 3
CONTACT TECH. SERVICE
PROBLEM WITH USB KEY
S005 USB stick not accessible 1
CHANGE KEY
USB KEY
S006 USB stick not accessible NOT ACCESSIBLE 1
CHANGE KEY
USB KEY FULL
S007 USB stick full 1
CHANGE KEY
PRINTER DISCONNECTED
S009 Printer not connected 1
CHECK CONNECTION
PRINTER PAPER OUT
S010 Printer: there is no paper or there might be a configuration error 1
CHECK PAPER
PRINTER:
S011 Printer cover open 1
DOOR OPEN
PRINTER: NOT READY
S012 Probable printer configuration error 1
TRY AGAIN
RUN BACKUP
S020 Cycle backup not done 1
DOWNLOAD NEW CYCLES
CYCLE MEMORY FULL
S021 Cycle storage limit exceeded 1
START OVERWRITING
Check, using a watchdog, that one of main tasks is not in crash SYSTEM ERROR
S030 2, 3
condition CONTACT TECH.SERVICE
Check, using a hardware watchdog, that one peripheral is not in SYSTEM ERROR
S031 2, 3
lock condition. CONTACT TECH.SERVICE
Check, using a watchdog, that one of main tasks is not in lock SYSTEM ERROR
S032 2, 3
condition (e.g. infinite loop) CONTACT TECH.SERVICE
SYSTEM ERROR
S034 SW malfunction 2, 3
CONTACT TECH.SERVICE
SYSTEM ERROR
S035 SW malfunction in solenoid valve management 2, 3
CONTACT TECH.SERVICE
SYSTEM ERROR
S040 Check the log saving in the Flash memory 2, 3
CONTACT TECH.SERVICE
LOG SAVE ERROR
S041 Cycle performed with 4-minute sterilization time at 134°C 1
CONTACT TECH. SERVICE
4-MINUTE STERILIZATION
S042 Cycle performed with standard drying 1
COMPLETED
STANDARD DRYING
S099 Error during cycle report creation CHECK 1
LOAD DRYING
PROBLEM IN CREATING
S100 SW malfunction CYCLE REPORT 2, 3
CONTACT TECH. SERVICE
1 = OK (warning)
2 = OK + Stopped cycle start
3 = Cycle failed + OK + RESET
84 EN
17.5. TROUBLESHOOTING
According to the type of alarm occurred, please find below the indications to detect the possible causes and restore the proper operation:
The alarm codes in the list can refer to functions that are not present on the models concerned in this Manual.
The main switch has accidentally been turned off Reconnect the plug and/or turn the device on again and RESET according
E000 and/or the power plug pulled from the socket. to the instructions.
Replace with good fuses of equal nominal value. (See the Summary Table
Network fuses blown. in Appendix Technical Characteristics).
Turn the device on again and RESET according to the instructions.
Reset according to the instructions. If the problem occurs again, have the
E001 Abnormal voltage peak on the mains.
mains electric system checked by a technician.
RESET according to the instructions.
Failure to main board.
Contact Technical Service (see Appendix).
Door lock mechanism limit microswitch failure. RESET according to the instructions.
E020 Try restarting the program a second time.
If the problem persists, contact Technical Service (see the Appendix).
Door lock system gearmotor failure.
Door lock mechanism limit microswitch failure. RESET according to the instructions.
E021
Contact Technical Service (see Appendix).
Door lock system gearmotor failure.
RESET according to the instructions.
E022 Door lock microswitches failure
Contact Technical Service (see Appendix).
E050 Reminder to run Vacuum Test cycle Run Vacuum Test as planned
E051 Reminder to run Helix Test cycle Run Helix Test cycle as planned
Reminder to run Vacuum + Helix Test combined
E052 Run Vacuum + Helix Test combined cycle as planned
cycle
Make sure that configuration parameters of the Lan network are correct.
E060 The autoclave cannot connect to Lan network Check that the Lan network chosen for the connection is working properly.
Contact Technical Service (see Appendix).
EN 85
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
Make sure that configuration parameters of the Wi-Fi network are correct.
Check that the router managing the Wi-Fi network is on and that the Wi-Fi
E061 The autoclave cannot connect to Wi-Fi network
network chosen for the connection is working properly.
Contact Technical Service (see Appendix).
Preheating activation with door open. The message
E070 Always close the door when the sterilizer is not in cycle
is displayed after 10 minutes and after 20 minutes.
E126 Cloud firmware update in progress Wait that the message disappears then turn the sterilizer off and back on.
Contact Technical Service
E130 The cycle you want to start is not enabled
(see Appendix).
Cloud firmware version is not the correct one
Update Cloud firmware or Process firmware to align the two firmwares to
compared to Process firmware version.
E141 the correct version.
Malfunctions may occur during connection with Wi-Fi,
Contact Technical Service (see Appendix).
Ethernet or Cloud
E999 Manual interruption of the sterilization or test cycle. RESET according to the instructions.
86 EN
17.5.2. ALARMS (CATEGORY A)
EN 87
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
88 EN
CODE POSSIBLE CAUSE SUGGESTED SOLUTION
EN 89
17.5.3. HAZARDS (CATEGORY H)
90 EN
17.5.4. SYSTEM ERRORS (CATEGORY S)
S042 Malfunction of control board or software Contact Technical Service (see Appendix).
S100 Malfunction of control board or software Contact Technical Service (see Appendix).
EN 91
18. APPENDIX - ACCESSORIES
Only use spare parts and accessories that meet the manufacturer’s specifications.
AUTOMATIC FILLING
FRONT FILLING
For the management of automatic filling accessories, refer to the manual of the relevant accessory.
EXTERNAL PRINTER
BARCODE READER
MY TRACE SOFTWARE
92 EN
19. PRINTER CONNECTION
Connect the printer to the RS232 serial port located on the rear of the
autoclave (see figure).
Refer to the printer manual for printer starting and paper loading.
EN 93
20. APPENDIX - SPARE PARTS AND ACCESSORIES
Only use spare parts and accessories that meet the manufacturer’s specifications.
Description Code
bacteriological filter 97290160
door gasket (17/22 l) 97400145
door gasket (28 l only) 97467176
demineralised water tank/chamber filter 97290210
94 EN
21. APPENDIX - TECHNICAL SERVICE
We will gladly provide any information you may need on the product as well as give you suggestions and advice on the water steam sterilization
procedures.
In this regard, please refer to the following address:
Cefla S.c.
Plant
Via Bicocca, 14/C
40026 - Imola (BO) IT
Tel. +39 0542 653441 Fax. +39 0542 653555
Headquarters
Via Selice Provinciale 23/A – 40026 Imola (BO) IT
EN 95
22. APPENDIX - WARNINGS AND LOCAL REGULATIONS
Please consult the Web site of the manufacturer to find a list of authorised representatives.
Before carrying out any technical service operations, consult the service manual containing the above instructions.
96 EN
www.cefla.com