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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