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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