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APPENDIX G – DECLARATION OF CONFORMITY

Manufacturer's Name:

M.O.COM. S.r.l. - Manufacture of Dental Accessories

Manufacturer's Address:

Via delle Azalee, 1 - 20090 Buccinasco (MI) - ITALY

Product description:

Steam sterilizer

Model:

Constructed in:

ITALY

The undersigned declares that the above material

conforms

to the EEC Directives 93/42 - 2004/108 - 73/23 (and following updates).

Reference standards:

EN 61010-1 EN 61010-1-A2 EN 61010-2-040

CEI EN 50081-1 CEI EN 50082-1

EN 55014 EN 55022 EN 60555-2 EN 60555-3

EN 61000-4-2 EN 61000-4-3 EN 61000-4-4 EN 61000-4-5

EN 61000-4-6 EN 61000-4-8 EN 61000-4-11 ENV 50204

EN 13060

31/012008

Date

Signature

Alfio VILLA

Name and Surname

Legal Representative

Function

DECLARATION OF CONFORMITY

Application of Directives 93/42/CEE - 2004/108/CEE - 73/23/CEE

Содержание millenium B2

Страница 1: ...Quality System certified by STEAM STERILIZER OPERATING MANUAL Ed 1 Rev 5 Date January 2008...

Страница 2: ...E OF CONTENTS 1 INTRODUCTION 1 APPLICABLE EUROPEAN DIRECTIVES 1 INTENDED USE 1 PURPOSE OF THE MANUAL 2 GENERAL WARNINGS 2 2 CONTENTS OF THE PACKAGE 3 DIMENSIONS AND WEIGHT 3 DESCRIPTION OF THE CONTENT...

Страница 3: ...on programs 25 Setting the STAND BY mode 29 Setting the printing mode 30 Setting the tank filling mode 32 Setting the water draining mode 32 Acquisition of the ambient pressure 33 Adjusting the contra...

Страница 4: ...distilled water tank 69 Safety valve maintenance 69 Clean replace the drain filter 69 Replace bacteriological filter 70 Replacing the paper in the printer 70 PERIODIC STERILIZER VALIDATION 71 RECYCLI...

Страница 5: ......

Страница 6: ...ndards and doesn t represent any danger for the operator if used according to the following instructions The product is in accordance with the following European Directive as applicable 73 23 CEE for...

Страница 7: ...erve the following precautions in order to avoid injury or property damage Use ONLY distilled water of high quality WARNING THE USE OF WATER OF INADEQUATE QUALITY CAN SEVERELY DAMAGE THE DEVICE SEE AP...

Страница 8: ...LED DESCRIPTION TO THE RESELLER AND THE TRANSPORTER THAT MADE THE DELIVERY DESCRIPTION OF THE CONTENTS The package contains Steam sterilizer Stainless steel wire instrument tray 5 pcs Ref 1 Stainless...

Страница 9: ...wo persons and transported on a cart or other similar device WARNING WE RECOMMEND THAT THE DEVICE BE TRANSPORTED AND STORED AT A TEMPERATURE NO LOWER THAN 5 C PROLONGED EXPOSURE TO LOW TEMPERATURE AN...

Страница 10: ...se capable of eliminating all traces of humidity from any load Its exclusive steam generation system effective plumbing circuit and electronic management supplemented by high precision sensors guarant...

Страница 11: ...er paper output slot On Off switch Bacteriological filter Sterilization chamber Door microswitch Distilled water fill quick connector Door Used water drain quick connector Water drain plug and filter...

Страница 12: ...fety thermostat and manual rearm Connection for directly draining the used water tank Connection for automatically filling the distilled water tank Steam generator safety thermostat and manual rearm J...

Страница 13: ...ter confirmation of the value option selected Sterilization cycle selection Value increment Forward scroll of the menu options Test cycle selection Value decrement Backward scroll of the menu options...

Страница 14: ...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 ventila...

Страница 15: ...is shown on the back of the machine COMPARTMENT DIMENSIONS FOR BUILT IN INSTALLATIONS When installing the sterilizer inside a cabinet you must provide adequate space all around the device 10cm specia...

Страница 16: ...reely all the way to the socket Install the device that any external fill drain tubing is not bent or crushed They must run freely to the drain tank ELECTRICAL CONNECTIONS The sterilizer s must be con...

Страница 17: ...it on the filling connector taking care to push it completely on Lock the tube to connector with the plastic tie provided Insert the other end of the tube on the tap of the filling tank Make sure tha...

Страница 18: ...nect the plug of the level sensor to the jack optional on the back of the device see figure NOTE MAKE SURE THE PLUG IS CORRECTLY INSERTED A POOR CONNECTIN IS INTERPRETED AS A MAX LEVEL SIGNAL WITH A C...

Страница 19: ...NNECTION TO A CENTRALIZED DRAINING POINT Follow the instructions shown below for a correct direct connection to a centralized draining point Insert the silicone tube provided or other suitable plastic...

Страница 20: ...I L L E N N I U M B 2 R E x x x x B G y y y y y y C H E C K U P C O M P L E T E ACQUISITION AND UPDATING OF THE AMBIENT PRESSURE VALUES The sterilizer measures the ambient pressure for the correct op...

Страница 21: ...EATING MODE PRINT THE DATA AND FILL THE TANK PLEASE REFER TO THE CHAPTER CONFIGURING THE DEVICE At regular intervals the first two lines on the display alternate with the modes set for printing ON OFF...

Страница 22: ...al lever located on the side of the connector and detach the quick connector 9 Refill the container 2 l and repeat the operations described in points 2 3 and 4 a second time 10 When the MAX level icon...

Страница 23: ...r near the sterilizer and put the free end of the supplied tube into the tank 2 Connect the quick connector to the corresponding female connector under the chamber entrance marked pushing until you he...

Страница 24: ...P PROGRAM STARTING AND ENTERING THE SETUP MODE To start the SETUP program hold down the key on the control panel for several seconds until the display shows M I L L E N N I U M B 2 S E T U P t o c o n...

Страница 25: ...set to enter to exit CR TYPE CR LF TYPE EXIT TYPE 1 TYPE 2 EXIT ACQUISITION OF THE AMBIENT PRESSURE to enter to exit ADJUSTMENT OF THE LCD CONTRAST to set to exit 1st PRESET 134c POROUS starting from...

Страница 26: ...XIT exit the BASIC menu and return to the main menu ADVANCED Menu The Advanced menu advanced options consists of the items PROGRAMMES setting preselected sterilization programs shown on the LCD displa...

Страница 27: ...RATION OPTIONS 3 r d P R E S E T 1 3 4 C W R A P P E D E X T R A D R Y I N G 0 5 4 t h P R E S E T 1 3 4 C E M E R G E N C Y F A S T D R Y I N G 1 s t P R E S E T 1 3 4 C P O R O U S S T A N D A R D D...

Страница 28: ...own in the previous paragraph Select LANGUAGE using the key The following screen will appear I T A L I A N O E N G L I S H F R A N A I S D E U T S C H E S P A O L Select the desired language Move usin...

Страница 29: ...wer on from the main switch This makes sure that the machine can only be powered on by authorized personnel but afterwards it can be used by others without limitation Select ANY CYCLE START to protect...

Страница 30: ...ROGRAMS using the key the following menu appears 1 s t P R E S E T 2 n d P R E S E T 3 r d P R E S E T 4 t h P R E S E T E X I T Define the position 1 2 3 or 4 to which the sterilization program will...

Страница 31: ...al loads Move using the and keys and confirm with the key NOTE WITH LARGE LOADS OR SPECIAL MATERIALS THE STANDARD OPTION MAY NOT PROVIDE A PERFECT RESULT IN THIS CASE EXTEND THE DRYING PHASE BY USING...

Страница 32: ...firm with the key NOTE THE DURATION OF THE STERILIZATION PROCESS IS VARIABLE FROM 4 TO 30 MINUTES FOR THE PROGRAM AT 134 C AND FROM 20 TO 30 MINUTES FOR THE PROGRAM AT 121 C 3 After selecting the time...

Страница 33: ...e CUSTOM program is already present in another position the selection is not accepted The following warning appears on the display along with a beep T H I S P R O G R A M I S A L R E A D Y P R E S E T...

Страница 34: ...ll be longer up to about 10 12 minutes for a cold start Move using the and keys confirm with the key On the other hand when the ST BY TIME OUT option is selected it is possible to set the time for dea...

Страница 35: ...or test cycle Select INTERNAL to enable the thermal printer set inside the front of the sterilizer In this case another menu opens T Y P E 1 T Y P E 2 E X I T Select Type 1 for the model 1 of the pri...

Страница 36: ...CARRIED OUT ONLY IN MODE AT CYCLE END Activate NR COPIES to set the number of copies of the cycle report to print at the end of the program The following text appears C O P I E S X X t o s e t t o e...

Страница 37: ...case as reached the minimum water level icon MIN on in the internal tank the equipment enable the auxiliary water feeding pump for a pre set time or a time needed to reach the maximum level icon MAX...

Страница 38: ...first time the sterilizer is used and after any reinstallation the sterilizer must acquire the ambient pressure This operation is necessary or the correct operation of several of the device s auxilia...

Страница 39: ...ur usual working position and adjust the contrast until the display is as clear and readable as possible EXIT THE CONFIGURATION MODE Completed the sterilizer configuration proceed as follows to return...

Страница 40: ...points or edges this will avoid the risk of contracting a dangerous infection Immediately remove any article that does not need to be sterilized or that is not capable of withstanding the process Care...

Страница 41: ...for positioning on trays Arrange instruments made of different metals stainless steel tempered steel aluminum etc on different trays or well separated from each other In the case of instruments not m...

Страница 42: ...uments individually or when more than one instrument are placed in the same wrapping make sure that they are made of the same metal Seal the wrapping with adhesive tape for autoclaves or heat sealing...

Страница 43: ...eys Confirm with the key The display does not offer any active preselection The device is waiting for the user to select a program Press the PROGRAM SELECTION key one or more times until you reach the...

Страница 44: ...A STERILIZATION CYCLE AND THE FOLLOWING MESSAGE APPEARS ON THE DISPLAY WITH A BEEP S E L E C T A P R O G R A M P L E A S E WARNING IF YOU USE A PROGRAM THAT IS INAPPROPRIATE FOR THE TYPE OF MATERIAL T...

Страница 45: ...e Material and selecting the desired program close the door until you hear the click The door status icon flashes door closed Press the START button NOTE IF A PASSWORD HAS BEEN ENABLED WITH THE OPTION...

Страница 46: ...will show the following parameters Pressure of the sterilization chamber bar Temperature of the sterilization chamber C Progressive time of the sterilization cycle mm ss 1 1 3 4 C P O R O U S W A R M...

Страница 47: ...U R E P U L S E 1 0 8 0 C 0 4 7 b a r 0 3 5 8 At the end of the pressure rise the steam mixed with residual air is discharged and the second emptying of the sterilization chamber begins 2nd VACUUM PU...

Страница 48: ...d sophisticated management of the plumbing circuit the pressure and temperature are maintained constant within the limits required by the program A countdown begins of the sterilization time The displ...

Страница 49: ...y a VENTILATION phase in which fresh sterile air is injected while maintaining a vacuum in the chamber to eliminate condensate and cool the load 1 1 3 4 C P O R O U S V E N T I L A T I O N 8 4 4 C 0 7...

Страница 50: ...the device goes to STAND BY mode as previously set When the door is opened the report for the sterilization cycle executed is automatically produced Check the document initial it in the space provide...

Страница 51: ...NOTE THE OPERATOR CAN ALSO REQUEST AN EXTENDED PRINTOUT OF THE STERILIZATION PROCESS DATA INCLUDING THE RECORDED VALUES OF ALL THE SENSORS INSTALLED ON THE MACHINE TO START THIS PRINT FUNCTION HOLD DO...

Страница 52: ...port examples shown in Appendix B Programs After the RESET the device goes to STAND BY mode ready to execute a new program NOTE WHENEVER AN ALARM IS GENERATED IN CERTAIN PHASES OF THE CYCLE AN AUTOMAT...

Страница 53: ...king extreme care not to cut or damage the wrappings 4 Let the instruments cool before any transport and subsequent storage If necessary for transport transfer the material using dry clean and disinfe...

Страница 54: ...il the display reads H E L I X B D T E S T 1 3 4 0 C 2 1 5 b a r 0 3 3 0 The test device is a 1 5 m tube made of PTFE with an internal diameter of 2 mm with a small sealed screw capsule attached to on...

Страница 55: ...t and file it in a suitable place For complete details about printing summaries please refer to the report examples shown in Appendix B Programs VACUUM TEST To select the VACUUM TEST program press the...

Страница 56: ...gram When the pre set pressure is reached 0 80 bar the pump stops and the pressure stabilization phase begins WAITING PERIOD which lasts 5 minutes shown on the display as a scalar value V A C U U M T...

Страница 57: ...E EXCEEDS THE PRE SET LIMIT THE PROGRAM IS INTERRUPTED AND ALARM MESSAGE IS GENERATED SEE A COMPLETE DESCRIPTION OF THE ALARMS IN APPENDIX E The duration of the test is about 18 minutes When the door...

Страница 58: ...g rear connections Nominal power 2300 W 10A Insulation class Class I Installation category Cat II Environment of use Internal use Noise level 60 db A Environmental operating conditions Temperature 15...

Страница 59: ...essure 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...

Страница 60: ...pH VALUE 5 7 5 7 APPEARANCE colorless transparent without sediments colorless transparent without sediments HARDNESS 0 02 mmol l 0 02 mmol l NOTE WHEN PURCHASING DISTILLED WATER ALWAYS CHECK THAT THE...

Страница 61: ...ssed air turbines or mechanical transmission counter angles tooth scalers Glass articles Mineral based articles Articles made of heat resistant plastic Articles made of heat resistant rubber Heat resi...

Страница 62: ...al in single package 1 00 0 30 0 25 Porous material in double package 0 75 0 25 0 20 Hollow instruments in single package 4 00 1 25 0 25 121 C POROUS 121 1 10 20 B F L 54 58 700 0 8 Solid and hollow i...

Страница 63: ...E FIGURES IN THE FOLLOWING PAGES 2 LONG 10 MINUTES VACUUM DRYING TYPICAL OF POROUS AND WRAPPED CYCLES SHORT 4 MINUTES VACUUM DRYING TYPICAL OF HOLLOW AND SOLID CYCLES 3 ACCESS TO A CUSTOM CYCLE DOES N...

Страница 64: ...OGRAM 134c POROUS 134 C 4 00 Pressure bar 0 00 1 00 2 00 2 10 0 80 Time min LONG DRYING PROCESS PRE VACUUM PROGRAM 134c PRION 134 C 18 00 0 00 1 00 1 10 Pressure bar Time min LONG DRYING PROCESS FRACT...

Страница 65: ...AM 134c HOLLOW 134 C 4 00 Pressure bar 0 00 1 00 2 00 2 10 1 00 Time min SHORT DRYING PROCESS FRACTIONATED PRE VACUUM 0 80 PROGRAM 121c HOLLOW 121 c 20 00 0 00 1 00 1 00 Time min SHORT DRYING PROCESS...

Страница 66: ...AM 134c WRAPPED 134 C 4 00 Pressure bar 0 00 1 00 2 00 2 10 1 00 Time min LONG DRYING PROCESS ONE SHOT PRE VACUUM PROGRAM 121c WRAPPED 121 C 20 00 Pressure bar 0 00 1 00 1 10 1 00 Time min LONG DRYING...

Страница 67: ...RAM 134c SOLID 134 C 4 00 Pressure bar 0 00 1 00 2 00 2 10 1 00 Time min SHORT DRYING PROCESS ONE SHOT PRE VACUUM PROGRAM 121c SOLID 121 C 20 00 Pressure bar 0 00 1 00 1 00 Time min SHORT DRYING PROCE...

Страница 68: ...DRYING PROCESS ONE SHOT PRE VACUUM PROGRAM XXXc CUSTOM 134 C from 4 00 to 30 00 121 C from 20 00 to 30 00 Pressure bar 0 00 1 00 2 00 2 10 1 00 Time min SETUP ONE SHOT PRE VACUUM or FRACTIONATED PRE...

Страница 69: ...min SHORT DRYING PROCESS FRACTIONATED PRE VACUUM PROGRAM VACUUM TEST VT 0 80 bar Pressure bar P0 0 00 1 00 Time min 0 80 t1 t2 t1 300 s 5 minutes 10 minutes P1 P2 P3 P2 P1 P0 P1 10 t3 t2 600 s WAITIN...

Страница 70: ...6 6 109 6 095 7 01 27 047 8 0 78 149 3 107 7 095 7 01 57 047 8 0 80 155 3 105 8 095 4 02 07 076 5 0 57 149 9 105 2 095 1 02 17 081 1 0 49 142 1 104 6 094 6 08 15 068 4 0 76 151 8 104 7 102 3 08 22 061...

Страница 71: ...0 126 8 131 2 19 49 108 3 0 25 156 4 126 8 119 9 19 53 DS 104 4 0 00 156 1 126 6 116 2 STERILISATION NEGATIVE ALARM CODE A112 DESCRIPTION PTC SHORTCIRCUIT CAUTION PLEASE REFER TO USER MANUAL Cycle Re...

Страница 72: ...KLY Clean the sterilization chamber and relative accessories Disinfect external surfaces MONTHLY Clean the internal and external if installed distilled water tank Safety valve maintenance Clean or rep...

Страница 73: ...or similar product after first checking its contents on the label Dry the surfaces and remove any residue before using the device Clean all the external parts using a clean cotton cloth dampened with...

Страница 74: ...e safety valve located on the rear of the machine 2 Loosen the knurled locking ring with your fingers or a suitable tool inserted in the two holes in the ring itself turning counter clockwise until it...

Страница 75: ...ter door and access the paper compartment 3 remove the empty roll and place a new roll of thermal paper so that the paper unrolls off the top the roll must have the following dimensions width 57 mm di...

Страница 76: ...quirements for the medical devices marked with STERILE indication supply an effective guide tool for carrying out the verifications on the steam sterilizers Since in addition to specific experience an...

Страница 77: ...ng Wait for the sterilizer to reach the proper operating conditions for starting the program NOTE Under normal conditions the average preheating time is about 10 15 minutes The MIN water level icon is...

Страница 78: ...the chamber drying problems presence of water in the sterilization chamber at the end of the cycle etc The air intake on the frame and or the cover are obstructed or the heat exchanger is not sufficie...

Страница 79: ...ected program in relation to the material to be treated See the Summary Table in Appendix B Programs Wrong printer configuration Configure the sterilizer for the type of printer used Configuration pro...

Страница 80: ...on of the alarm causes the interruption of the cycle or the normal equipment operation with the relative appearance of an alarm code and a message on the display accompanied by a beep and the lit alar...

Страница 81: ...a r 1 1 4 3 Perform a RESET described below and then turn off the equipment and check the error or make the repair NOTE WHEN THE DOOR IS OPENED THE REPORT NORMAL OR EXTENDED DEPENDING ON THE TYPE OF...

Страница 82: ...is RESET in two alternative ways depending on the alarm that occurred see the Alarm Code List further below in this appendix 1 Press the PROGRAM SELECTION key for about 3 seconds A beep confirms the R...

Страница 83: ...timeout exceeded TEST FAILED E 999 Manual cycle interruption MANUAL STOP Press key 3 seconds ALARMS category A A 022 System door lock microswitches failed OFF OFF LOCKING PROBLEM A 023 System door loc...

Страница 84: ...not completed within timeout PPD TIME OUT Press key 3 seconds HAZARDS category H H 150 MPX pressure sensor broken MPX BROKEN H 160 MPX pressure sensor short circuited not connected MPX SHORTCIRCUIT T...

Страница 85: ...ical Support Department see Appendix Z Water level in the fill tank below minimum MIN level Perform RESET following the instructions Top off the water until the MAX level indicator comes on or at leas...

Страница 86: ...e load has been correctly sterilized see LCD indicators before using the material ALARMS category A A 022 Limit microswitch es on the door lock mechanism broken A 023 Limit microswitch es on the door...

Страница 87: ...until you hear a click and replace the cap Turn off RESET and then turn on the device If the problem persists contact the Technical Support Department see Appendix Z Presence of water or condensate in...

Страница 88: ...uctions Carefully clean the gasket with a clean cotton cloth dampened with water Start the program again Vacuum pump broken A 253 Problem in the plumbing circuit Contact the Technical Support Departme...

Страница 89: ...lowing the instructions Check the quantity of the material in the sterilization chamber and make sure that it does not exceed the maximum allowed quantity depending on the type of load See the Summary...

Страница 90: ...Problem in the plumbing circuit Problem in the plumbing circuit H 404 Steam generator malfunction Problem in the plumbing circuit H 405 Steam generator malfunction Problem in the plumbing circuit H 4...

Страница 91: ...APPENDIX F DIAGRAMS 86 APPENDIX F DIAGRAMS ELECTRICAL DIAGRAM BOARD TYPE G MAINS FILTER DOOR SWITCH SEC TANK MAX LEVEL PROBE FAN 24V JACK FOR MAX LEVEL PROBE CONNECTION ON EXTERNAL TANK OPTION...

Страница 92: ...SE Door Door lock Motor lock EV1 EV2 EV3 EV4 EV5 EV6 STEAM GEN PUMP 24V F 16A ELECTRONIC BOARD TYPE T EC output Aux pump Pump injection Fan Vacuumpump Bandage Generator Line P trafo S trafo AC LPT F1...

Страница 93: ...APPENDIX F DIAGRAMS 88 PLUMBING DIAGRAM Air CHAMBER Recovery tank Air Main tank...

Страница 94: ...t the above material conforms to the EEC Directives 93 42 2004 108 73 23 and following updates Reference standards EN 61010 1 EN 61010 1 A2 EN 61010 2 040 CEI EN 50081 1 CEI EN 50082 1 EN 55014 EN 550...

Страница 95: ...APPENDIX H NOTES PER THE OPERATOR 90 APPENDIX H NOTES PER THE OPERATOR...

Страница 96: ...suggestions and advice on steam sterilization procedures In this regard please refer to the following address M O COM Srl Customer Support Via delle Azalee 1 20090 Buccinasco MI ITALY Tel 39 02 457015...

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