CEFLA MOCOM Supreme-17 User manual

97055023
Rev. 00
2019-03
Supreme-17 / Supreme-22 / Supreme-28
EN
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INDEX
1. FOREWORD.................................................................................................................................................................................................... 5
1.1. SYMBOLS USED........................................................................................................................................................................................5
1.2. SYMBOLS ON THE DEVICE ......................................................................................................................................................................5
1.3. RELEVANT EUROPEAN DIRECTIVES ......................................................................................................................................................5
1.4. CLASSIFICATION.......................................................................................................................................................................................5
1.5. INTENDED USE .........................................................................................................................................................................................6
1.5.1. IMPORTANT NOTES.........................................................................................................................................................................6
1.6. GENERAL WARNINGS...............................................................................................................................................................................6
1.7. RESIDUAL RISKS.......................................................................................................................................................................................7
1.8. INFORMATION ON MITIGATION OF RESIDUAL RISKS ...........................................................................................................................7
2. PACKAGE CONTENT..................................................................................................................................................................................... 8
2.1. DIMENSIONS AND WEIGHT......................................................................................................................................................................8
2.2. DESCRIPTION OF THE CONTENT............................................................................................................................................................9
2.3. PRODUCT HANDLING.............................................................................................................................................................................10
2.4. CONDITIONS FOR STORAGE AND TRANSPORT..................................................................................................................................10
3. GENERAL DESCRIPTION - PRODUCT PRESENTATION............................................................................................................................ 11
3.1. GENERAL CHARACTERISTICS...............................................................................................................................................................11
3.2. TECHNICAL SPECIFICATIONS ...............................................................................................................................................................12
3.2.1. SUMMARY TABLE...........................................................................................................................................................................12
3.3. SAFETY DEVICES....................................................................................................................................................................................14
3.4. WATER SUPPLY CHARACTERISTICS....................................................................................................................................................15
3.5. FRONT .....................................................................................................................................................................................................16
3.6. REAR........................................................................................................................................................................................................17
3.7. DISPLAY ICONS.......................................................................................................................................................................................18
3.8. EXAMPLE OF WORKING CYCLE ............................................................................................................................................................19
4. SETTING UP THE DEVICE............................................................................................................................................................................ 20
4.1. OVERALL DIMENSIONS..........................................................................................................................................................................20
4.2. COMPARTMENT DIMENSIONS FOR BUILT-IN INSTALLATION.............................................................................................................21
4.3. GENERAL PRECAUTIONS FOR INSTALLATION....................................................................................................................................21
4.4. POWER SUPPLY .....................................................................................................................................................................................21
4.5. ELECTRICAL CONNECTIONS.................................................................................................................................................................22
4.6. DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT............................................................................................................22
5. FIRST START-UP.......................................................................................................................................................................................... 23
5.1. STARTING................................................................................................................................................................................................23
5.2. MAIN MENU .............................................................................................................................................................................................24
5.3. UPPER DOOR OPENING.........................................................................................................................................................................24
5.4. DISCHARGE WATER RECOVERY AND DEMINERALIZATION SYSTEM ...............................................................................................25
5.4.1. INSTALLING THE RECIRCULATION FILTER INSIDE THE TANK...................................................................................................26
5.4.2. INSTALLING THE DEMINERALIZATION FILTER INSIDE THE TANK.............................................................................................27
5.4.3. SAFETY PRECAUTIONS.................................................................................................................................................................27
5.4.4. TECHNICAL SPECIFICATIONS.......................................................................................................................................................28
5.5. MAINTENANCE OF THE INTEGRATED DEMINERALISATION FILTER..................................................................................................28
5.6. FILLING DISTILLED WATER....................................................................................................................................................................29
5.6.1. MANUAL FILLING............................................................................................................................................................................29
5.6.2. AUTOMATIC FILLING......................................................................................................................................................................29
6. CONFIGURATION......................................................................................................................................................................................... 30
6.1. SETTINGS................................................................................................................................................................................................30
6.1.1. LANGUAGE.....................................................................................................................................................................................30
6.1.2. DATE AND TIME..............................................................................................................................................................................31
6.1.3. UNIT OF MEASUREMENT ..............................................................................................................................................................32
6.1.4. SCREEN AND AUDIO......................................................................................................................................................................32
6.1.5. PREHEATING..................................................................................................................................................................................34
6.1.6. WATER FILLING..............................................................................................................................................................................35
6.1.7. PRINTERS.......................................................................................................................................................................................36
6.1.7.1. PRINT LABELS................................................................................................................................................................................37
7. CYCLE LIST.................................................................................................................................................................................................. 38
8. CONNECTIVITY............................................................................................................................................................................................. 40
8.1. WIFI..........................................................................................................................................................................................................40
8.2. MANUAL DHCP........................................................................................................................................................................................41
8.3. ETHERNET CONNECTIVITY....................................................................................................................................................................41
8.4. NFC ..........................................................................................................................................................................................................41
9. USER MANAGEMENT .................................................................................................................................................................................. 42
9.1. CREATE NEW..........................................................................................................................................................................................43
9.2. CHANGE...................................................................................................................................................................................................43
9.3. CHANGE PIN............................................................................................................................................................................................44
9.4. ASSOCIATE NFC.....................................................................................................................................................................................45
9.5. USER PIN REQUEST...............................................................................................................................................................................45
9.6. USER DELETION .....................................................................................................................................................................................46
9.7. USERS LIST.............................................................................................................................................................................................47
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10. INSTRUCTIONS ............................................................................................................................................................................................ 48
11. SERVICE....................................................................................................................................................................................................... 48
12. PREPARATION OF THE MATERIAL ............................................................................................................................................................ 49
12.1. TREATING THE MATERIAL BEFORE STERILIZATION...........................................................................................................................49
12.2. ARRANGING THE LOAD..........................................................................................................................................................................50
12.3. POSITIONING AND USE OF TRAY HOLDER SUPPORT........................................................................................................................52
13. STERILIZATION CYCLES............................................................................................................................................................................. 53
13.1. DELAYED START.....................................................................................................................................................................................54
13.2. EXTRA DRYING.......................................................................................................................................................................................55
13.3. EXECUTION OF THE CYCLE...................................................................................................................................................................55
13.4. CYCLE OUTCOME...................................................................................................................................................................................55
13.5. DOOR OPENING AT CYCLE END ...........................................................................................................................................................56
13.6. USER-DEFINED CYCLE...........................................................................................................................................................................57
14. MATERIAL STORAGE .................................................................................................................................................................................. 58
15. TEST PROGRAMS........................................................................................................................................................................................ 59
15.1. VACUUM TEST CYCLE............................................................................................................................................................................59
15.2. HELIX / BOWIE DICK TEST......................................................................................................................................................................60
15.3. VACUUM CYCLE + HELIX / BOWIE - DICK TEST....................................................................................................................................60
15.4. TEST REMINDER.....................................................................................................................................................................................61
15.5. H2O TEST ................................................................................................................................................................................................62
15.6. DOOR OPENING......................................................................................................................................................................................63
15.7. MANUAL INTERRUPTION........................................................................................................................................................................63
16. USED WATER DRAIN................................................................................................................................................................................... 64
17. STERILIZER INFORMATION ........................................................................................................................................................................ 64
18. DATA MANAGEMENT .................................................................................................................................................................................. 65
18.1. CYCLE DOWNLOAD................................................................................................................................................................................65
19. APPENDIX –PROGRAMS ............................................................................................................................................................................ 66
19.1. SUMMARY TABLE OF 17 220 V - 240 V CYCLES ...................................................................................................................................67
19.2. SUMMARY TABLE OF 17 120 V CYCLES................................................................................................................................................69
19.3. SUMMARY TABLE OF 22 220 V - 240 V CYCLES ...................................................................................................................................71
19.4. SUMMARY TABLE OF 22 120 V CYCLES................................................................................................................................................73
19.5. SUMMARY TABLE OF 28 220 V - 240 V CYCLES ...................................................................................................................................75
19.6. SUMMARY TABLE OF 28 120 V CYCLES................................................................................................................................................77
19.7. STERILIZATION PROGRAM DIAGRAM...................................................................................................................................................80
19.8. DIAGRAMS OF THE TEST PROGRAMMES ............................................................................................................................................82
20. APPENDIX - MAINTENANCE........................................................................................................................................................................ 83
20.1. ORDINARY MAINTENANCE PROGRAMME............................................................................................................................................83
20.2. SCHEDULED MAINTENANCE MESSAGES.............................................................................................................................................84
20.3. DESCRIPTION OF MAINTENANCE INTERVENTIONS............................................................................................................................85
20.3.1. CLEAN GASKET AND PORTHOLE.................................................................................................................................................85
20.3.2. CLEAN STERILIZATION CHAMBER AND ACCESSORIES.............................................................................................................85
20.3.3. EXTERNAL SURFACE CLEANING AND DISINFECTION ...............................................................................................................85
20.3.4. BOILER FILTER CLEANING............................................................................................................................................................85
20.3.5. DOOR LOCK LUBRICATION...........................................................................................................................................................86
20.3.6. DUST FILTER CLEANING...............................................................................................................................................................86
20.3.7. REPLACE THE BACTERIOLOGICAL FILTER.................................................................................................................................86
20.3.8. CLEANING AND DISINFECTION OF FILTERS AND WATER TANKS.............................................................................................86
20.3.9. DEMINERALIZATION SYSTEM CARTRIDGE REPLACEMENT......................................................................................................87
20.3.10.RECIRCULATION SYSTEM CARTRIDGE REPLACEMENT............................................................................................................87
20.3.11.BOILER GASKET REPLACEMENT .................................................................................................................................................87
20.4. PERIODIC STERILIZER VALIDATION .....................................................................................................................................................88
20.5. DEVICE USEFUL LIFE .............................................................................................................................................................................88
20.6. DISPOSING THE EQUIPMENT WHEN NO LONGER USED....................................................................................................................88
21. APPENDIX - GENERAL PROBLEMS............................................................................................................................................................ 89
21.1. TROUBLESHOOTING ..............................................................................................................................................................................89
22. APPENDIX –ALARMS.................................................................................................................................................................................. 91
22.1. ALARM INTERVENTION ..........................................................................................................................................................................91
22.2. ALARM DURING A CYCLE.......................................................................................................................................................................91
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23. SYSTEM RESET............................................................................................................................................................................................ 92
24. ALARM CODES............................................................................................................................................................................................. 93
24.1. ERRORS (CATEGORY E)........................................................................................................................................................................93
24.2. ALARMS (CATEGORY A).........................................................................................................................................................................95
24.3. HAZARDS (CATEGORY H) ......................................................................................................................................................................97
24.4. SYSTEM ERRORS (CATEGORY S).........................................................................................................................................................98
24.5. TROUBLESHOOTING ..............................................................................................................................................................................99
24.5.1. ERRORS (CATEGORY E) ...............................................................................................................................................................99
24.5.2. ALARMS (CATEGORY A)..............................................................................................................................................................102
24.5.3. HAZARDS (CATEGORY H) ...........................................................................................................................................................105
24.5.4. SYSTEM ERRORS (CATEGORY S)..............................................................................................................................................106
25. USER PIN RESET ....................................................................................................................................................................................... 108
26. APPENDIX - ACCESSORIES...................................................................................................................................................................... 108
27. LOCAL PRINTER CONNECTION................................................................................................................................................................ 110
27.1. NETWORK PRINTER CONNECTION.....................................................................................................................................................110
28. APPENDIX - SPARE PARTS AND ACCESSORIES.................................................................................................................................... 111
29. APPENDIX - TECHNICAL SERVICE........................................................................................................................................................... 112
30. APPENDIX - WARNINGS AND LOCAL REGULATIONS............................................................................................................................ 112
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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.
1.1. SYMBOLS USED
NOTE:
Pay particular attention to the paragraphs marked with the
symbol shown.
CAUTION:
Potential danger for people, environment and property.
Follow the procedures indicated in the manual to prevent
potential damage to materials, devices and/or property.
1.2. SYMBOLS ON THE DEVICE
Potential danger due to high temperature.
Disposal symbol in accordance with Directive 2012/19/EU.
Device in compliance with essential requirements of Directive
93/42/EU and subsequent modifications.
Notified body: IMQ spa
Refer to the user manual.
Device compliant with the requirements set out in the Directive
2014/68/EU (PED), category II, for 22 and 28 l sterilizers.
Notified body: CSI spa
UA.TR.101
Ukrainian national symbol of conformity.
Device compliant with the requirements set out in the Directive
2014/68/EU (PED), category I, for 17 l sterilizers.
Notified body: CSI spa
1.3. RELEVANT EUROPEAN DIRECTIVES
The product described in this manual is manufactured in accordance with the highest safety standards and doesn't represent any danger for the operator
if used according to the following instructions. The product is complying with the following European Directives as applicable:
93/42/EEC,
and subsequent amendments and additions, concerning medical devices.
2011/65/EU,
(Rohs II) on restriction of hazardous substances in electrical and electronic devices.
The product complies with Standard EN 13060:2014.
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.
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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
1.5.1. IMPORTANT NOTES
Information contained in this manual are subject to change without notice.
The manufacturer is not responsible for direct, indirect or accidental damage resulting from or relating to the provision or use of this information.
This document may not be reproduced, adapted or translated, in part or in full, without the prior written permission of the manufacturer.
1.6. GENERAL WARNINGS
When using this product, always follow the instructions in the manual and never use it for anything other than its intended purpose.
The user is responsible for any legal requirements relating to the installation and use of the product. The manufacturer will not be held
responsible for any breakage, malfunction, property damage or injury to people in the event that the product is not installed or used
correctly, or proper maintenance is not carried out.
Please observe the following precautions in order to avoid injury or property damage:
•Use ONLY demineralised and/or distilled water of high quality (IF THE DEMINERALISATION FILTER IS NOT PRESENT IN THE FILLING TANK).
The use of water of inadequate quality can severely damage the device.
See technical characteristics appendix in this regard.
•Do not pour water or other fluids on the device;
•Do not pour flammable substances on the device;
•Do not use the system in the presence of flammable or explosive gases or vapours;
•Before performing any maintenance or cleaning intervention, ALWAYS DISCONNECT power supply.
Whenever it is not possible to disconnect the power supply
from the device, or if the external mains switch is distant
or not visible to the maintenance technician, place a “work
in progress” sign on the external mains switch after having
turned it off.
•Make sure the electrical system is grounded according to current laws
and/or standards;
•Do not remove any label or nameplate from the device; request new
ones, if necessary.
•Use only original spare parts.
Failure to comply with the above exempts the manufacturer from all liability.
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1.7. RESIDUAL RISKS
FOR THE USER
•Contamination due to improper handling of the load;
•Burn by contact with hot surfaces or fluids.
FOR THE PATIENT
•Contamination due to unsterilised material caused by wrong cleaning treatment before sterilization;
•Contamination due to implementation of a wrong reuse process;
•Contamination due to material unsuitable to sterilization or not compliant with instructions for use;
•Contamination due to unsterilised material caused by wrong final assessment of sterilization process;
•Contamination due to missing or wrong scheduled maintenance;
•Contamination due to missing periodic validation.
1.8. INFORMATION ON MITIGATION OF RESIDUAL RISKS
FOR THE USER
Contamination due to improper handling of the load.
See chapter PREPARING THE MATERIAL.
Burn by contact with hot surfaces or fluids.
To extract the sterile material, once the sterilization process has been completed with saturated steam at 121° or 134°, proceed as follows:
•Always wear PPE suitable for the handling of hot material and gloves of appropriate material and thickness;
•Clean your gloved hands with a germicide detergent;
•Always use the special tool, supplied as standard, to extract the trays from the sterilization chamber;
•Avoid any contact of trays and material with contaminated and/or non-heat-resistant surfaces;
•Handle the sterile material making sure not to damage any packages, bags and containers serving as a barrier.
FOR THE PATIENT
Contamination due to unsterilised material caused by wrong cleaning treatment before sterilization.
See chapter TREATING THE MATERIAL BEFORE STERILIZATION.
Contamination due to implementation of a wrong reuse process.
Make sure to use sterile material.
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.
Contamination due to missing or wrong scheduled maintenance.
The sterilizer, based on a preset programming, displays a warningmessage relating to thescheduledmaintenance necessary to ensurethe good operation
of the device.
Contamination due to missing periodic validation.
See chapter PERIODIC STERILIZER VALIDATION.
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2. PACKAGE CONTENT
Check the integrity of the product package upon receipt.
2.1. DIMENSIONS AND WEIGHT
Once the package is opened, check that:
•The supply matches the specifications of the order (see the delivery note);
•There is no visible damage to the product.
Dimensions and weight
AHeight
600 mm
BWidth
600 mm
C Depth
700 mm
Total weight
68 kg
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.
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2.2. DESCRIPTION OF THE CONTENT
In addition to the sterilizer, the package contains:
1
Instrument trays:
-5 pcs for 17 and 22
-6 pcs for 28;
9
Allen wrench (for door manual unlocking);
2
Tray holder support;
10
Plastic tube for direct water drainage, with fastening clamp;
3
Operator’s documentation and safety valve’s EC Declaration of
Conformity;
11
Rear spacers;
4
Lubricant for door locking mechanism;
12
USB key containing:
User manual and DataSter Software;
5
Tray extractor;
13
Filling tank demineralisation filter;
6
Additional bacteriological filter.
14
Discharge tank recirculation filter;
7
Rubber hose with quick coupling for manual water drainage;
15
Discharge tank recirculation filter union
(to be used when recirculation filter is not present);
8
Angled union + straight union;
16
Funnel for water loading.
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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 usingthe 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 maydamage
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.
2.4. CONDITIONS FOR STORAGE AND TRANSPORT
TEMPERATURE: between +5° C and +70° C
HUMIDITY: between 20% and 80%
PRESSURE: between 50 and 110 kPa
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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.
A lighting system is activated when the door is opened for the working area in front of the sterilization chamber, allowing performing daily operations with
increasing ease and comfort. There is also a remote light signalling device integrated into the front panel of the device.
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.
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3.2. TECHNICAL SPECIFICATIONS
3.2.1. SUMMARY TABLE
Device
WATER STEAM STERILIZER
17
22
28
Class (according to Directive
93/42/EEC and subsequent
amendments)
IIb
Manufacturer
CEFLA s.c.
Headquarters
Via Selice Provinciale 23/A –40026 Imola (BO) IT
Input voltage
220 V - 240 V~ 50 Hz
220 V - 230 V~ 60 Hz
120V~ 60 Hz
Network fuses
(6.3 x 32 mm)
F 15A 250V
Electronic board fuses
(5 x 20 mm)
F1: T3.15A 250V (transformer primary 220/240 V~ 50 Hz 220/230 V~ 60 Hz)
F2: T3.15A 250V (transformer primary 120 V~ 60 Hz)
Nominal power
2300 W
1440 W (120V~ / 60 Hz)
Insulation class
Class I
Installation category
(according to EN 61010)
Cat. II
Operational environment
Indoor use
HUMID LOCATION
(EN 61010 extended environmental conditions)
A-weighted sound power
level (ISO 3746)
< 67 db (A)
Degree of protection (IP Code) (EN
60529:1991+A1:2000+A2:2013)
IP21
Environmental operating conditions
Temperature: +15°C ÷ +35°C
Relative humidity: between 20% and 80% max
non-condensing
Altitude: min -100 m / max. 3000 m (a.s.l.)
Pressure: min 980 hPA / max 1045 hPA (a.s.l.)
External dimensions (HxWxD)
(rear connections excluded)
500 x 480 x 600 mm
Net weight:
unladen
unladen, with tray holder support
and trays
unladen, with tray holder support,
trays and water at MAX level
approx. 51 kg
approx. 54 kg
approx. 60 kg
approx. 52 kg
approx. 55 kg
approx. 61 kg
approx. 53 kg
approx. 56kg
approx. 62 kg
Sterilization chamber dimensions (D
x D)
250 x 350 mm
250 x 450 mm
280 x 450 mm
Sterilization chamber total volume
approx. 17 l
(0.017 cu. m)
approx. 22 l
(0.022 cu. m)
approx. 28 l
(0.028 cu. m)
Sterilization chamber usable
volume
(with tray holder support inserted)
approx. 10 l
(0.010 cu. m)
approx. 13 l
(0.013 cu. m)
approx. 19 l
(0.019 cu. m)
Sterilization chamber usable
dimensions
17 l (1.38x1.55x2.97) dm / 6.4
cu. dm
22 l (1.38x1.55x3.97) dm / 8.5 cu.
dm
28 l (1.72x1.66x3.96) dm / 11.3
cu. dm
Distilled water tank capacity (filling)
approx. 5.5 l (water at MAX level)
approx. 1 l (water at MIN level)
Sterilization programs
5 standard programs + 1 program defined by the user
Test programs
Helix/BD TEST
Vacuum Test
Vacuum Test+Helix/BD Test
Pre-heating time
(from cold)
approx. 10 min
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Device
WATER STEAM STERILIZER
17
22
28
USB connection
Stick capacity lower than or equal to 2GB: FAT formatting with 16K/sector
Keys capacity higher than 2GB:
FAT32 formatting with 16K/sector
Printer connection
Serial RS232 (printer cable max length 2.5 m)
Printer insulation class:
Class I or Class II
Printer power supply standard:
Compliant with Standard EN 60950.
(The safety of the sterilizer may be compromised in case of uncertified printer power supply unit)
120V 60Hz Main power cord:
Plug NEMA 5-15 125V-15A
Cable SJT 14 AWG/3C STYLE 1015 60°C
Connector C19 acc. to IEC 60320
220-240V 50Hz Main power cord:
Plug CEE 7/VII IEC 250V-16A 50 Hz
Cable 3x1.5 mm² -25 to 70 °C
Connector C19 acc. to IEC 60320 UL 498, CSA C22.2
220V 60Hz Main power cord:
Plug NEMA 6-15P 250V-15A
SJT 14 AWG/3C 300V 60°C
Connector C19 acc. to IEC 60320
Ethernet connection
RJ45 (max. cable length 29 m)
Wi-Fi
802.11 b/g/n (2.4 Ghz); WEP / WPA / WPA2-PSK encryption
Bacteriological filter (filter element
in PTFE)
Porosity: 0.027 microns
Connection: male connector 1/8" NPT
Maximum flow of drained water
Temperature of drained water
Maximum temperature of drained
water
1 l/min.
50° C
90° C
Total heat in Joule sent by the
sterilizer to the surrounding air in 1
hour of continue operation
17 l = 3.6 kJ
22 l = 4 kJ
28 l = 5.4 kJ
Manoeuvre/handling space
1 m x 1 m
Device
17
22
28
Class
(according to Directive 2014/68/EU
PED)
Category I
Category II
Category II
Working pressure
-0.8 ÷ 2.4
barg
-0.8 ÷ 2.4
barg
-0.8 ÷ 2.4
barg
Safety device set
2.4 barg
2.4 barg
2.4 barg
PT
700 kPa
(abs)
700 kPa
(abs)
700 kPa
(abs)
PS
2.4 barg
2.4 barg
2.4 barg
TS
10 ÷ 140
°C
10 ÷ 140
°C
10 ÷ 140
°C
Fluid
Group
2
2
2
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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.
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3.4. WATER SUPPLY CHARACTERISTICS
The sterilizer is equipped with a demineralisation filter fitted inside the filling tank, which allows supplying the device with standard water from the mains.
The quality of the water treated by the integrated filter is checked automatically through a conductivity sensor.
If the demineralisation filter is not present, ONLY use demineralised/distilled water having the following characteristics to supply the sterilizer.
DESCRIPTION
VALUES IN THE WATER SUPPLY
VALUES INSIDE RESIDUAL
DRY CONDENSATE
< 10 mg/l
< 1 mg/l
SILICON OXIDE SiO2
< 1 mg/l
< 0.1 mg/l
IRON
< 0.2 mg/l l
< 0.1 mg/
CADMIUM
< 0.005 mg/l
< 0.005 mg/l
LEAD
< 0.05 mg/l
< 0.05 mg/l
HEAVY METAL RESIDUES (iron, cadmium
and lead excluded)
< 0.1 mg/l
< 0.1 mg/l
CHLORIDES
< 2 mg/l
< 0.1 mg/l
PHOSPHATES
< 0.5 mg/l
< 0.1 mg/l
CONDUCTIVITY AT 20°C
< 15 µS/cm
< 3 µS/cm
pH VALUE
5 - 7
5 - 7
ASPECT
colourless, transparent, without sediment
colourless, transparent, without sediment
HARDNESS
< 0.02 mmol/l
< 0.02 mmol/l
When buying distilled water, make always sure that the quality and characteristics declared by the manufacturer are compatible with those
specified in the table.
The use of water for steam generation with contaminant levels exceeding those indicated in the above table can greatly shorten the
sterilizer lifetime.
This could also result in an increase of oxidation in the most sensitive materials as well as in an increase of limescale residues on
generator, boiler, internal supports, trays and instruments.
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3.5. FRONT
1 LCD touch screen control panel
2 Door
3 Power switch
4 Dust filter
5 USB port
6 NFC reader
1 Sterilization chamber
2 Bacteriological filter
3 Door locking system
4 Steam diffuser
5 Water drainage filter
6 Water top-up quick connector
7 Water drainage quick connector
8 Waste water drainage quick connector
9 Door
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3.6. REAR
1 Fastening slots for rear spacers
2 Heat exchanger
3 Connection for direct water drainage
4 Connection for distilled water automatic filling (only for PURE 100 /
500 and automatic filling accessory kit / AUX EV 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 PURE 100 / 500 and
automatic filling accessory kit)
9 Network fuses
10 Power cable connection
11 Connection for “overflow” drain
(*)
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3.7. DISPLAY 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 Door opening
B Settings
C Sterilizer information
D Performed cycle list
E Sterilization cycles
F Test cycles
G Custom cycle (customisable)
Other particular symbols relating to the various conditions of use will be described in the relative paragraphs.
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3.8. EXAMPLE OF WORKING CYCLE
The sterilisation 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.
Please refer to the programs appendix for more details on programs.
A PRESSURE (BAR)
B PROCESS
C TIME (MIN)
D FRACTIONATED VACUUM
E VACUUM DRYING
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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.
Dimensions and weight
17 l
22 l
28 l
A Height (total)
500 mm
B Width (total)
480 mm
C Depth (excluding rear
unions).
Note: in any case, the
sterilizer can be
positioned on a plane
of only 550
600 mm
Total weight
54 kg
55 kg
56 kg
4.1. OVERALL DIMENSIONS
Centre distance and maximum overall dimensions of the sterilizer feet, with and without rear spacers.
A Feet
B Rear spacers
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