® NOT JUST AN ORDINARY STERILISER ISTRUZIONI PER L’USO OPERATING INSTRUCTION INSTRUCTION DE SERVICE GEBRAUCHSANWEISUNG INSTRUCCIONES DE OPERACIÓN MILLENNIUM B cod.
TABLE OF CONTENTS REVISIONS The following table lists subsequent editions/revisions of the manual. The “Description” field brief explains the subject of the latest revision. Code Ed. Rev. D#0BPAB5000X 1 D#0BPAB5000X 1 1 23-03-2010 Application of the EEC Directive 93/42 and subsequent changes. D#0BPAB5000X 1 2 07-04-2010 Declaration of conformity 0 Date 08-03-2010 Description First issue (translation from the original in Italian) TABLE OF CONTENTS INTRODUCTION ............................
TABLE OF CONTENTS ACQUISITION AND UPDATING OF THE AMBIENT PRESSURE VALUES ................................................... 17 STAND-BY MODE ........................................................................................................................................... 18 FILLING DISTILLED WATER ........................................................................................................................... 19 MANUAL FILLING ...........................................................
TABLE OF CONTENTS APPENDIX B – PROGRAMS .............................................................................................................. 58 INTRODUCTION .............................................................................................................................................. 58 PROGRAM SUMMARY TABLE - MILLENNIUM B ........................................................................................... 59 PROGRAM SUMMARY TABLE - MILLENNIUM B+ ............................
1. INTRODUCTION INTRODUCTION Dear Customer Thank you for choosing a product from M.O.COM. Srl. We hope that you will find it completely satisfactory. This manual describes all procedures for the correct use of the device and instructions for deriving the full benefit from its features. In any case, we will be available to provide explanations and to receive any suggestions you may have for improving our products or services.
1. INTRODUCTION PURPOSE OF THE MANUAL The purpose of this manual is to provide instructions for: – – – – becoming generally familiar with the product; its correct installation and configuration; its safe, efficient use; handling materials before and after sterilization. Its appendices also provide: – – – – – GENERAL WARNINGS the product's general technical specifications; sterilization program specifications; maintenance; troubleshooting; a variety of other documentation.
2. CONTENTS OF THE PACKAGE CONTENTS OF THE PACKAGE NOTE CHECK THE INTEGRITY OF THE PACKAGE UPON RECEIPT. DIMENSIONS AND WEIGHT A Once the package is opened, check that: – the supply matches the specifications of the order (see the accompanying document); – that there is no obvious product damage; Dimensions and weight B and B+ B2 A. Height B. Width C.
2. CONTENTS OF THE PACKAGE HANDLING THE PRODUCT Where possible, the packaged product must be handled using suitable mechanical means (forklift truck, transpallet, etc.) and following the instructions shown on the package. In the case of manual handling, the product must be lifted by two persons using the handles cut in the side of the box. Once removed from the box, the sterilizer must be lifted by two persons and transported on a cart or other similar device.
3. PRODUCT INTRODUCTION PRODUCT INTRODUCTION The Millennium series sterilisers are the revolutionary products offered by MO.COM in the field of small water steam sterilisers, equipped with type B (EN 13060) cycles, as well as the new point of reference with respect to safety, performance, flexibility and ease of use.
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3. PRODUCT INTRODUCTION CONTROL PANEL Liquid Crystal Display (LCD) Command keys The function of the command keys differ according to operating mode of the equipment.
3. PRODUCT INTRODUCTION OPERATING CYCLE EXAMPLE The Millennium series sterilisation programme can be effectively described as a succession of phases, each one with a very precise objective. For example, after loading the material in the chamber, closing the door, selecting the program and starting the cycle (and the consequent locking of the door opening mechanism), the standard program (for porous materials, 134 °C - 4’) offers the following sequence (see chart, below): 1.
4. INSTALLATION INSTALLATION INTRODUCTION The first and fundamental step in achieving good sterilizer operation, long life and complete use of its features is a correct, careful installation. Moreover, this precaution will avoid the danger of physical injury or property damage, not to mention malfunctions and damage to the machine. So, please follow the instructions in this chapter scrupulously. NOTE M.O.COM. CUSTOMER SUPPORT (SEE APPENDIX Z) WILL ANSWER YOUR QUESTIONS AND PROVIDE ADDITIONAL INFORMATION.
4. INSTALLATION GENERAL INSTALLATION PRECAUTIONS Obey the following warnings for the correct operation of the device and/or to avoid risky situations: – – – – – – – ELECTRICAL CONNECTIONS Install the sterilizer on a flat surface; if necessary, adjust the leveling feet to compensate for an irregular surface.
4. INSTALLATION MANAGING THE FILES BY MILLFLASH SW Launching the program Dialogue with the device Millflash software is a programme for Windows (versions 98, XP, and Vista) that allows users to download data contained in the USB key to the PC and then and process that data. Launch the Millflash program from its desktop icon, or select the executable program file. After launching the program, a window appears. containing the file reports folder (on the first launch it will be empty).
4. INSTALLAZIONE Saving the Report file To save files stored on the USB key to the PC, select the Save key (or File-Save from menu). The three keys and the window menu are disabled during the save process; the message “Ready” in the status bar shows is replaced by “Saving...”, followed by a number and by a progress bar that shows the progress of the save process for the individual files.
4. INSTALLATION File name The files saved on the PC are named “Mocom register”. Each new file is assigned a default name according to the information included in the original file: Es.: 10BM1234_00001_134PRION_190406_1024.dtl file extension “.dtl” (data logger) cycle start time cycle start date Type of the cycle Cycle counter (launched) Sterilizer’s serial number Files visualization A double click on the file name, will show the window with the file content.
4. INSTALLATION CONNECTING AN EXTERNAL WATER FILLING TANK To avoid having to periodically fill the water tank (see Chapter 5, “First Start-Up”), it is possible to connect the sterilizer to an external filling tank (supplied as an option), that the user will periodically fill, or to a commercially-available, reverse-osmosis water purification system with accumulation tank.
4. INSTALLATION CONNECTING DEMINERALIZER MILLDROP The sterilizer can be connected to MILLDROP (water treatment system by reverse osmosis) warranting the automatic reservoir filling with high quality demineralized water. Refer to MILLDROP operating manual for the installation instructions. NOTE FOR THIS OPTION SETTING, AUTOMATIC FILLING OPTION”.
5. FIRST START-UP FIRST START-UP Once the sterilizer has been correctly installed, it may be turned on and prepared for use. Turn on the equipment by the main (luminous) switch located on the right side of the machine. TURNING ON THE EQUIPMENT NOTE DO THIS WITH THE STERILIZER'S DOOR OPEN. INITIAL AUTOMATIC TEST When turned on, the control panel lights up and beeps so you can visually check its correct operation. The panel then displays this message: Apparatus serial number Firmware version R .
5. FIRST START-UP STAND-BY MODE After the initial test, the sterilizer goes to STAND-BY mode and the display shows: C S 2 ‐ o t 3 0 u a . . n t e r x x x x x / y y y y y n d ‐ b y H I G H 6 ° C 0 1 / 0 2 / 1 0 0 1 b a r 1 8 : 1 3 : 0 5 The upper line is the cycle counter for sterilizations performed, with the number of correctly completed cycles on the left and the total number started on the right. The line below shows the Stand-by status and the preheating mode (High-Low-Off).
5. FIRST START-UP FILLING DISTILLED WATER The first time the sterilizer is used, and later when the MIN water level indicator comes on, you will have to fill, or top-off, the internal distilled water tank. Manual filling With reference to the figure (and with the door open), proceed as follows: 1. Fill the manual container (2 l) with distilled water, keeping it horizontal; 2.
5. FIRST START-UP MAX LEVEL IN THE INTERNAL/ EXTERNAL DRAIN TANK When the water level in the internal or external drain tank reaches the MAX level, the LCD display alternatively lights the MAX and MIN icons. NOTE IN THIS CONDITION THE UNIT WILL GENERATE AN ALARM INDICATION (SEE APPENDIX E ALARM) AS YOU ATTEMPT TO LAUNCH A STERILIZATION CYCLE. In this case, empty the internal or external draining tank. Emptying the internal tank Referring to the figure, open the door and operate in the following way: 1.
6. CONFIGURATION CONFIGURATION INTRODUCTION The Millennium series offers users the possibility of personalisation which has never been offered by any other steam steriliser.Users may configure the device to meet their own needs. For example, the device's performance may be adapted on the basis of the type of activity, the type of material to be sterilized or its frequency of use. The SETUP program allows selecting from numerous options that users activate through an intuitive, easy-to-use menu.
6. CONFIGURATION MILLENNIUM Configuration menu diagram: NOTES When USCITA (EXIT) is selected, the previous menu level is restored (the ESC key on the panel has the same function as the USCITA (EXIT) key). When the last menu OPTION available is selected (or when recording is confirmed) the previous menu level is restored.) si ritorna al livello di menu precedente.
6. DESCRIPTION OF THE MENU ITEMS CONFIGURATION Now, we describe the meaning of the various main menu and second-level menu items. MAIN MENU The main menu has 6 entries that open additional (second-level) menus: BASIC ADVANCED SPECIAL SERVICE DATA REVIEW EXIT SETUP (basic options) (advanced options) (special options) (menu not accessible to users) (summary of options selected) (exit the SETUP program and return to normal operation.
6. CONFIGURATION R .
6. DEFAULTS SETTINGS CONFIGURATION The sterilizer leaves the factory with the following settings: DATE: TIME: PROGRAMS: current date current time Preset 1: Preset 2: Preset 3: Preset 4: 134°C B CYCLE (standard drying) 134°C HOLLOW (standard drying) 134°C SOLID (standard drying) 134°C EMERGENCY NOTE THE PROGRAMS INDICATED SHOULD BE CONSIDERED AS PREFERENTIAL SETTINGS. HOWEVER, OTHER COMBINATIONS ARE POSSIBLE BASED ON THE DESTINATION MARKET.
6. CONFIGURATION Setting the time (TIME SETTING on the BASIC menu) When TIME SETTING is selected with the ↵ key, you will see: h h : m m : s s + / ‐ t o s e t ↵ t o e n t e r ⇑ t o e x i t Proceed as follows: – The hours flash: set the current hour with the + and - keys. Confirm with ↵. – The minutes flash: set the current value with the + and - keys. Confirm with ↵. The time is stored. Once the last confirmation is given, you return to the second-level menu.
6. CONFIGURATION NOTE TO CHANGE THE PASSWORD, FIRST SELECT THE DISABLE OPTION, WHICH CANCELS THE PREVIOUS PASSWORD, AND THEN SELECT THE ANY POWER-ON OR ANY CYCLE START OPTION, ENTERING THE NEW PASSWORD AS DESCRIBED ABOVE. Setting the sterilization programs (PROGRAMS on the ADVANCED menu) The program setting and their storing in four pre-set positions is achieved in various steps using several menus in sequence. Each pre-set position can be associated to a standard or user configurable cycle (CUSTOM).
6. CONFIGURATION As a function of the choices made, you will go to one of two alternative menus that allow selecting the type of drying to associate to the selected program. a) Programs with short drying (HOLLOW, SOLID, EMERGENCY): → S T A N D A R D D R Y I N G F A S T D R Y I N G E X I T + ↑ ↓ ‐ It is possible to select STANDARD mode (the default setting) or FAST (reduced drying, recommended for light loads). Move using the + and - keys and confirm with the ↵ key.
6. CONFIGURATION To define the CUSTOM program to associate to one of the pre-set position (1, 2, 3 or 4) proceed as follows: 1. Select PROGRAMS, select the program number to which the program is to be associated (see the previous description) and then select CUSTOM in the next screen; the following menu appears: → 1 3 4 ° C 1 2 1 ° C E X I T P R O C E S S P R O C E S S + ↑ ↓ ‐ Select 121 °C to perform a custom program with a sterilization process at 121 °C or 134 °C for one at 134 °C.
6. CONFIGURATION 5. Depending on the selection (SHORT or LONG) one of two different menus will open (these menus are the same for the standard cycles), i.e.: In SHORT mode the following is displayed: → S T A N D A R D D R Y I N G F A S T D R Y I N G E X I T + ↑ ↓ ‐ In LONG mode the following is displayed: → S I E E T N X X A T T I N D A R D D R Y I N G E L L . D R Y I N G R A D R Y I N G T + ↑ ↓ ‐ For the choice criteria, refer to the instruction of page 26.
6. Setting the STAND-BY mode (STAND-BY OPTIONS on the ADVANCED menu) CONFIGURATION Based on the equipment's frequency of use, or other considerations, it is possible to select the heating level during the STAND-BY (preheating) phase and the time beyond which STAND-BY is deactivated.
6. CONFIGURATION Setting the printing mode (PRINT OPTIONS on the ADVANCED menu) The sterilizer is equipped with a printer for recording sterilization program data; it is necessary to set the parameters required for its proper operation. 1.
6. b) CONFIGURATION Item REPORT The following screen appears: → P N P E R R R X I N T O U T M O D E . C O P I E S I N T L A S T I T + ↑ ↓ ‐ Select item PRINTOUT MODE to chose the mode the data are printed: The following options appear: → A T C Y C L E E N D S T E P B Y S T E P E X I T + ↑ ↓ ‐ Select AT CYCLE END to print the report al the end of the cycle.
6. CONFIGURATION NOTE IF THE LAST CYCLE COMPLETED CORRECTLY (OR WAS INTERRUPTED BY MANUAL STOP) IT WILL BE POSSIBLE TO REPRINT IT IN EITHER NORMAL OR EXTENDED MODE. IF THE LAST CYCLE WAS INTERRUPTED BY AN ALARM (MANUAL STOP EXCLUDED) IT ONLY THE EXTENDED MODE WILL BE AVAILABLE. Following the reprint command, this message will be displayed: N O W T H E P R I N T I N G R E P O R T P L E A S E W A I T . . . which will remain on the screen until printing is finished.
6. CONFIGURATION When INTERNAL DRAIN is enabled, the reading of the MAX level sensor in the internal tank is enabled. The EXTERNAL DRAIN command also activates the MAX level sensor located in the external tank. NOTE THE LEVEL SENSOR IN THE INTERNAL TANK REMAINS ACTIVE IN ANY CASE, TO PREVENT A POSSIBLE MALFUNCTION OF THE EXTERNAL TANK OR A MISSING OR FAULTY CONNECTION OF THE OPTIONAL EXTERNAL DRAIN TANK. IN THE CASE OF AN INSTALLATION WITH THE DRAIN CONNECTED TO THE CENTRAL SYSTEM, SELECT INTERNAL DRAIN.
6. CONFIGURATION Adjusting the contrast of the liquid crystal display (LCD CONTRAST on the SPECIAL menu) The LCD contrast adjustment allow to obtain the screen reading as clear as possible, compensating different sterilizer positioning or ambient brightness. When LCD CONTRAST is activated, this screen appears: A D J U S T M E N T O F T H E L C D C O N T R A S T + / ‐ t o s e t ⇑ t o e x i t Press the + key increases the contrast while the - key decreases it.
7. PREPARING THE MATERIAL PREPARING THE MATERIAL The sterilization process can be considered effective, reliable and repeatable so long as the material is suitably treated first and then correctly arranged in the sterilization chamber in an orderly manner.
7. PREPARING THE MATERIAL For handles (turbines, contra-angles, etc.), supplement the above with treatment in suitable dedicated devices that provide effective internal cleaning (occasionally including lubrication). NOTE THE END OF THE STERILIZATION PROGRAM, REMEMBER TO LUBRICATE THE INTERNAL HANDLE MECHANISMS USING THE SPECIAL STERILE OIL.
7. PREPARING THE MATERIAL Notes for rubber and plastic tubing OK – – – Always rinse before use with pyrogen-free water; do not dry them; Arrange the tubing on the tray so that their ends are not obstructed or crushed. Do not bend or wind them, but allow them to lie as straight as possible. Notes for packets and packages – OK – Arrange packages side-by-side, suitably spaced and absolutely not piled, to avoid their coming in contact with the walls of the chamber.
8. PROGRAM SELECTION PROGRAM SELECTION INTRODUCTION Program selection is fundamental for a successful sterilization process. Since each instrument, or material in general, has different shape, consistency and properties, it is important to identify the most suitable program for it, both for preserving its physical characteristics (avoiding or, at any rate, limiting alterations) as well to guarantee the most effective sterilization. NOTE A GUIDE TO SELECTING THE MOST SUITABLE PROGRAM APPENDIX B (PROGRAMS).
8. PROGRAM SELECTION NOTE IF NO STERILIZATION PROGRAM IS SELECTED, THE EQUIPMENT CANNOT START 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 TO BE STERILIZED (SEE APPENDIX B) THE EFFECTIVENESS OF THE STERILIZATION PROCESS IS NOT GUARANTEED.
9. RUNNING THE PROGRAM RUNNING THE CYCLE A sterilization cycle consists of a determined number of phases. The number and duration of the phases can differ for the programs, based on the type of air extraction, sterilization process and drying method.
9. RUNNING THE PROGRAM Door locking The equipment locks the door. The door status icon remains steady on (door locked). When START is pushed, and for the entire sterilization cycle, the lower lines of the display 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 3 4 ° C B C Y C L E W A R M U P 1 0 1 . 9 ° C 0 .
9. RUNNING THE PROGRAM First vacuum phase When the optimum temperature is reached, the first vacuum phase (1st VACUUM PULSE) is started and brings the chamber pressure down to the established value. The display shows: 1 3 4 ° C B C Y C L E 1 . V A C U U M P U L S E 8 4 . 1 ° C ‐ 0 . 6 9 b a r 0 1 : 2 5 1 First rise in pressure When the pre-set vacuum value is reached, steam is injected and the pressure begins to rise (1st PRESSURE PULSE), until the established value is reached. 1 3 4 ° C B C Y C L E 1 .
9. RUNNING THE PROGRAM Third rise in pressure Thermodynamic equilibrium After the last vacuum phase, the pressure in the sterilization chamber must rise to the value set for the sterilization process (3rd PRESSURE PULSE), always through the injection of steam. 1 1 3 4 ° C B C Y C L E 3 . P R E S S U R E P U L S E 1 2 8 . 6 ° C 1 .
9. RUNNING THE PROGRAM Drying After the steam under pressure is released, its forced removal begins with the vacuum pump (DRYING): for this purpose, low pressure is created in the sterilization chamber to facilitate the evaporation of the steam and its consequent elimination. As a function of the type of drying set, one of the following screens will appear: 1 3 4 ° C B D R Y I N G 1 0 1 . 1 ° C 0 . 0 0 b a r C Y C L E ( N O R ) 1 3 4 ° C B D R Y I N G 1 0 1 . 1 ° C 0 .
9. RUNNING THE PROGRAM NOTE AT THE END OF THE CYCLE, AND UP TO THE OPENING OF THE DOOR, THE HEATING ELEMENTS ARE OFF. AS A CONSEQUENCE, THE DEVICE IS SLOWLY COOLING REGARDLESS OF WHAT THE STAND-BY MODE IS. NOTE WHENEVER THE STERILIZER'S' DOOR IS NOT OPENED AT THE END OF THE CYCLE, THE VACUUM PUMP IS PERIODICALLY ACTIVATED TO REMOVE ANY TRACES OF CONDENSATE FROM THE STERILIZATION CHAMBER. THE DISPLAY SHOWS: F O R C E D V E N T I L A T I O N ⇑ t o s t o p 3 5 . 2 ° C ‐ 0 .
9. RUNNING THE PROGRAM CHECK OF THE CYCLE DATA REPORT However, it is a good practice to check that the print report issued at the end of the sterilization program, also specifies a positive outcome. At the end of the cycle, the salient data for the thermodynamic parameters of the sterilization, temperature and pressure (°C and bar), and time (minutes) of the sterilization cycle, with particular attention to the sterilization phase true and proper, is printed by simply opening the door.
9. RUNNING THE PROGRAM The following message is then displayed: M A N U A L S T O P O P E N T H E D O O R 8 5 . 8 ° C E 9 9 9 ‐ 0 . 0 1 b a r 2 6 : 0 1 Finally, when the door is opened, you will be asked to reset the device by the following message: M A N U A L S T O P R E S E T S Y S T E M 8 5 . 5 ° C E 9 9 9 ‐ 0 . 0 1 b a r 2 6 : 0 1 To RESET the system, hold down, for at least three seconds, the PROGRAM SELECTION key until you hear the confirming beep.
10. STORING STERILIZED MATERIALS STORING STERILIZED MATERIALS The sterilized material must be adequately treated and stored to maintain its sterility over time, until its use. INTRODUCTION This leads to problems regardless of what you do since you will either be using recontaminated material (most of the time unconsciously), placing the user and patient at risk, or you will have to run the sterilization cycle again, with an inevitable waste of time and resources.
11. TEST PROGRAMS TEST PROGRAMS INTRODUCTION To protect the safety of users and patients, a fundamental process like sterilizing medical devices should be periodically checked. In this regard, Millennium B+ offers the possibility of, simply and automatically, executing two distinct test programs: • • HELIX/BD Test Vacuum Test The HELIX/BD Test program executes a cycle at 134 °C characterized, however, by a sterilization phase of a particular duration (3.
11. TEST PROGRAMS The cycle phases are analogous to what is described in the Chapter, “Running a Sterilization Program”. At the end of the program, remove the test device, open the capsule and remove the indicator from its housing. If the steam has correctly penetrated, the ink will have completely changed color from what it was before, along the entire length of the strip; if not (insufficient penetration) there will be only a partial variation or none at all.
11. TEST PROGRAMS Close the door and start the program with the START key. NOTE IF A PASSWORD HAS BEEN SET WITH THE ANY CYCLE START OPTION (SEE THE CHAPTER, CONFIGURATION, SETTING THE PASSWORD), YOU WILL BE ASKED TO ENTER THE ACCESS CODE. IN ADDITION, THE EQUIPMENT CHECKS THE PRINTER PAPER PRESENCE (OPTIONAL). POSSIBLE WARNING MESSAGES, AND THE CONSEQUENT ACTIONS TO CARRY OUT, ARE THE SAME AS DESCRIBED FOR A STANDARD STERILIZATION CYCLE.
11. TEST PROGRAMS When the program finishes, the display will read: V A C U U M T E S T T E S T P A S S E D ‐ 0 . 0 1 b a r 1 7 : 4 4 The end of the program is signaled with a beep. NOTE IF THE PRESSURE CHANGE EXCEEDS THE PRE-SET LIMIT, THE PROGRAM IS INTERRUPTED AND ALARM MESSAGE IS GENERATED. SEE A COMPLETE DESCRIPTION OF THE ALARMS IN APPENDIX E . When the door is opened at the end of the program, a report of the test cycle is printed with all the salient data.
APPENDIX A – TECHNICAL CHARACTERISTICS APPENDIX A – TECHNICAL CHARACTERISTICS SUMMARY TABLE Device Steam Sterilizer Classification (according to the Directive 93/42/EEC and subsequent changes) II b Model M.O.COM. S.r.l. Via delle Azalee, 1 20090 BUCCINASCO (MI) - ITALIA Manufacturer 220V - 240 V~ Power supply voltage Frequency 50/60 Hz Mains fuses (6.
APPENDIX A – TECHNICAL CHARACTERISTICS SAFETY DEVICES The sterilizer is equipped with the following safety devices for which we provide a brief description of their function: – Mains fuses (see summary table data) Protection inside the device against a fault in the heating elements. Action: cuts the electricity. – Fuses protecting the electronic circuits (see summary table data) Protection against a fault in the primary transformer circuit and low voltage uses.
APPENDIX A – TECHNICAL CHARACTERISTICS WATER SUPPLY CHARACTERISTICS DESCRIPTION WATER SUPPLY VALUES VALUES IN CONDENSATE DRY RESIDUE < 10 mg/l < 1 mg/l SILICON OXIDE SiO2 < 1 mg/l < 0.1 mg/l < 0.2 mg/l < 0.1 mg/l CADMIUM < 0.005 mg/l < 0.005 mg/l LEAD < 0.05 mg/l < 0.05 mg/l HEAVY METAL RESIDUES (except iron, cadmium and lead) < 0.1 mg/l < 0.1 mg/l < 2 mg/l < 0.1 mg/l PHOSPHATES < 0.5 mg/l < 0.
APPENDIX B – PROGRAMS APPENDIX B – PROGRAMS INTRODUCTION The steam sterilizer is appropriate for almost all materials and instruments, so long as they are able to tolerate, without damage, a minimum temperature of 121 °C (otherwise, you will need to use other low-temperature sterilization systems).
APPENDIX B – PROGRAMS PROGRAM SUMMARY TABLE - MILLENNIUM B 20 B B F F F L L L 39÷42 53÷56 54÷57 525 550 550 Average energy consumption (kWh/cycle) Average consumption H2O (ml/cycle) Total cycle time (average load ÷ max load) Pre-vacuum (F=fractionated; S=single) Cycle type (EN 13060: 2004) Holding time (min) Pressure (bar) 1,10 >18 B 0,8 0,9 0,8 MAX MASS PER ARTICLE (kg) 121 2,10 4 Porous, unpackaged material Porous material in single package Porous material in double packag
APPENDIX B – PROGRAMS PROGRAM SUMMARY TABLE - MILLENNIUM B+ 20 B B F F F L L L 31÷34 45÷48 48÷51 525 550 550 Average energy consumption (kWh/cycle) Average consumption H2O (ml/cycle) Total cycle time (average load ÷ max load) Pre-vacuum (F=fractionated; S=single) Cycle type (EN 13060: 2004) Holding time (min) Pressure (bar) 1,10 >18 B 0,8 0,9 0,8 MAX MASS PER ARTICLE (kg) 121 2,10 4 Porous, unpackaged material Porous material in single package Porous material in double packa
APPENDIX B – PROGRAMS PROGRAM SUMMARY TABLE - MILLENNIUM B2 20 B B F F F L L L 39÷42 53÷56 54÷57 675 700 700 Average energy consumption (kWh/cycle) Average consumption H2O (ml/cycle) Total cycle time (average load ÷ max load) Pre-vacuum (F=fractionated; S=single) Cycle type (EN 13060: 2004) Holding time (min) Pressure (bar) 1,10 >18 B 0,8 0,9 0,8 MAX MASS PER ARTICLE (kg) 121 2,10 4 Porous, unpackaged material Porous material in single package Porous material in double packa
APPENDIX B – PROGRAMS NOTES 1) FRACTIONATED = PRE-VACUUM WITH THREE VACUUM PULSES (SEE FIGURES IN THE FOLLOWING PAGES) SINGLE = PRE-VACUUM WITH SINGLE VACUUM PULSE (SEE FIGURES IN THE FOLLOWING PAGES) 2) LONG = TYPICAL OF B CYCLES AND WRAPPED CYCLES SHORT = TYPICAL OF HOLLOW AND SOLID CYCLES 3) ACCESS TO A CUSTOM CYCLE DOES NOT REQUIRE A PASSWORD. NONE OF THE COMBINATIONS POSSIBLE IN THE CUSTOMIZATION PHASE CREATE ANY RISKS OR DANGERS OF INJURY TO THE OPERATOR OR DAMAGE TOT HE DEVICE .
APPENDIX B – PROGRAMS STERILIZATION PROGRAM DIAGRAM Pressure (bar) PROGRAM 134°C B CYCLE 134c POROUS PROCESS 134°C - 4' 00'' 2.10 PROGRAM 134c PRION 134°C - 18' 00'' 2.00 1.00 Time (min) 0.00 -0.80 PRE-VACUUM LONG DRYING Pressure (bar) PROGRAM 121c POROUS 121°C B CYCLE 121°c - 20'00'' PROCESS 1.10 1.00 Time (min) 0.00 -0.
APPENDIX B – PROGRAMS Pressure (bar) PROGRAM 134c HOLLOW 134°C - 4'00'' PROCESS 2.10 2.00 1.00 Time (min) 0.00 -0.80 -1.00 FRACTIONATED PRE-VACUUM SHORT DRYING Pressure (bar) PROGRAM 121c HOLLOW 121°c - 20'00'' PROCESS 1.10 1.00 Time (min) 0.00 SHORT DRYING -1.
APPENDIX B – PROGRAMS Pressure (bar) PROGRAM 134c WRAPPED 134°C - 4'00'' PROCESS 2.10 2.00 1.00 Time (min) 0.00 -1.00 ONE SHOT PRE-VACUUM LONG DRYING Pressure (bar) PROGRAM 121c WRAPPED 121°C - 20'00'' PROCESS 1.10 1.00 Time (min) 0.00 -1.
APPENDIX B – PROGRAMS PROGRAM 134c SOLID 134°C - 4'00'' Pressure (bar) PROCESS 2.10 2.00 1.00 Time (min) 0.00 -1.00 ONE SHOT PRE-VACUUM SHORT DRYING PROGRAM 121c SOLID 121°C - 20'00'' Pressure (bar) PROCESS 1.10 1.00 Time (min) 0.00 -1.
APPENDIX B – PROGRAMS Pressure (bar) PROGRAM 134c EMERGENCY 134°C - 3'00'' PROCESS 2.10 2.00 1.00 Time (min) 0.00 -1.00 ONE SHOT PRE-VACUUM DRYING PROGRAM XXXc CUSTOM 134°C - from 4'00'' to 30'00'' 121°C - from 20'00'' to 30'00’’ Pressure (bar) 2.10 2.00 SETUP Temperature:134°C 121°C SETUP ONE SHOT PRE-VACUUM or FRACTIONATED PRE-VACUUM Time: 4’÷30’ (134°C) 20’÷30’ (121°C) 1.10 1.00 Time (min) 0.00 SETUP LONG DRYING or SHORT DRYING -1.
APPENDIX B – PROGRAMS DIAGRAMS OF THE TEST PROGRAMMES Pressure (bar) PROGRAM BOWIE & DICK TEST 134°C - 3'00'' PROCESS 2.10 2.00 1.00 Time (min) 0.00 -1.00 SHORT DRYING FRACTIONATED PRE-VACUUM PROGRAM VACUUM TEST (VT) -0.80 bar Pressure (bar) 1.00 Intermediate condition for the continuation of the test (P2-P1) < (P0-P1)/10 P0 (P3-P2) < 0.02 bar t3 = t2+600 s t2 = t1+300 s t1 0.00 End condition for positive test result 5 minutes 10 minutes WAITING LEAKAGE VACUUM PHASE P2 -0.
APPENDIX B – PROGRAMS EXAMPLES OF PRINTED REPORTS Cycle Report (extended) at the operator's request Cycle Report (normal) Report following a Manual Stop Model S/N Ver. SW Counter Selection Temperature Pressure Process time Stand-by Pre-vacuum Drying MILLENNIUM B+ 10 BP 0001 Exxxx/BPyyyyyy 0007/0015 134 °C SOLID 134 °C 2.10 bar 4 min LOW SINGLE FAST Model S/N Ver.
APPENDIX B – PROGRAMS Report following an alarm Model S/N Ver. SW Counter Selection Temperature Pressure Process time Stand-by Pre-vacuum Drying MILLENNIUM B+ 10 BP 0001 Exxxx/BPyyyyyy 0007~001 134 °C B CYCLE 134 °C 2.10 Bar 4 min HIGH FRACTIONATED STANDARD CYCLE START 01/02/10 11:30 Time T1 P T2 T3 ------------------------------------------------------------------00:01 CS 075.1 -0.00 130.9 115.2 00:11 074.9 -0.28 133.3 114.2 00:21 074.4 -0.46 146.3 113.2 00:31 074.3 -0.57 152.6 112.2 00:35 .. 074.
APPENDIX C – MAINTENANCE APPENDIX C – MAINTENANCE In addition to correct use, the user needs to perform ordinary maintenance in order to guarantee safe, efficient operation over the device's entire life. INTRODUCTION For better quality maintenance, supplement ordinary checks with regular periodic examinations by the service department (see Appendix Z). It is also fundamental to perform a periodic sterilizer validation, i.e.
APPENDIX C – MAINTENANCE The user is given warning messages with the following frequency: The frequencies indicated are calculated considering a "standard use" of the machine, that is, a machine used correctly and stored in an appropriate environment. ALERT MESSAGES CHAMBER FILTER CLEANING FREQUENCY Every 200 cycles BACTERIOLOGICAL FILTER REPLACEMENT Every 400 cycles CHAMBER GASKET REPLACEMENT Every 1.000 cycles GENERAL REVISION Every 3.
APPENDIX C – MAINTENANCE DANGER BEFORE PERFORMING ORDINARY MAINTENANCE, MAKE SURE THAT THE POWER SUPPLY CORD IS REMOVED FROM THE MAINS SOCKET. WHENEVER IT IS NOT POSSIBLE, PUT IN OFF THE EXTERNAL BREAKER OF THE EQUIPMENT POWER SUPPLY LINE. IF THE EXTERNAL BREAKER IS FAR AWAY OR, AT ANY RATE, NOT VISIBLE TO THE MAINTAINER, PLACE A WORK IN PROGRESS SIGN ON THE EXTERNAL BREAKER AFTER TURNING IT OFF.
APPENDIX C – MAINTENANCE Cleaning the internal tank 1. Place an empty basin on the ground, next to the steriliser, where the free end of the tube supplied is inserted. 2. Insert the tube in the quick coupling identified as "Service", located on the left, front side. 3. Allow the tank to empty completely, and then disconnect the tube. 4.
APPENDIX C – MAINTENANCE Clean/replace the drain filter With use, various residues will probably tend to accumulate inside the filter, obstructing the lower drain tube over time. To clean (or replace) the filter, open the sterilizer door and remove the cap (1) with a 12mm hex. wrench (supplied). Loosen the fitting (2) that contains the filter(3). Take the filter off the support and put it under running water to thoroughly clean.
APPENDIX C – MAINTENANCE PERIODIC STERILIZER VALIDATION As happens with all equipment, it is possible, and sometimes inevitable, to have a decrease in performance and the effectiveness of components along its lifespan, in a period of time dependent on its frequency of use.
APPENDIX D – GENERAL PROBLEMS APPENDIX D – GENERAL PROBLEMS INTRODUCTION If you run into a problem or alarm while using the device, you should not be immediately concerned. It may not, in fact, be related to a breakdown but, more probably to an anomalous situation, often merely transitory (such as a blackout), or incorrect use.
APPENDIX D – GENERAL PROBLEMS PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION Check the tightness of the fittings; if necessary, Drain connectors or tubing (optional reassemble, paying more attention to sealing. external tank) not correctly Check that the tubes to the drain tank are completely connected to the device. pushed onto the connectors; make sure that the plastic ties have been applied. There is water on the support surface of the sterilizer.
APPENDIX D – GENERAL PROBLEMS PROBLEM (continue) Blackening of the instruments or damage to the material. POSSIBLE CAUSE PROPOSED SOLUTION Contact between instruments made of different metals. Separate instruments made of different metals. Lime residue on the wall of the sterilization chamber and/or accessories. Clean the device and its parts, as required. (See Appendix C “Maintenance”). (See the Chapter, “Preparing the Material”).
APPENDIX E – ALARMS APPENDIX E – ALARMS INTRODUCTION Every time an anomalous condition occurs during the operation of the sterilizer, an alarm is generated, identified by a specific code (consisting of a letter followed by a 3-digit number). Alarm codes are divided into three categories: • E = ERROR Wrong maneuver and/or use, or a cause external to the device. A problem that can generally be fixed by the user.
APPENDIX E – ALARMS At the end of what has been described and having reached safe conditions, the machine activates a special procedure, that asks the user to manually unlock the door: P R E S S ⇑ U N L O C K T H E 1 0 1 . 0 ° C 0 . 0 1 b a r T O D O O R X X X X 1 1 : 4 0 Press the ⇑ key to unlock the door lock mechanism; the following message appears: ( A l a r m M e s s a g e ) O P E N T H E D O O R 1 0 0 . 8 ° C X X X X 0 .
APPENDIX E – ALARMS which is automatically transformed to the message: ( A l a r m R E S E T 8 0 . 5 ° C 0 . 0 0 b a r M e s s a g e ) S Y S T E M X X X X Perform a RESET (described below) and then turn-off the device and check the alarm. NOTE ALARMS THAT INTERVENE OUTSIDE OF A PROGRAM DO NOT PRODUCE A PRINTED REPORT. RESETTING THE SYSTEM The system is RESET in two alternative ways, depending on the alarm that occurred (see the Alarm Code List further below in this appendix): 1.
APPENDIX E – ALARMS ALARM CODES The list of alarm codes and, consequently, the messages displayed on the LCD and relative RESET mode, is as follows: CODE ALARM DESCRIPTION LCD INDICATION RESET MODE ERRORS (category E) E 000 Blackout BLACK-OUT E 010 Door open DOOR OPEN E 020 Exceeded timeout for activating door lock system (closing) DOOR UNLOCKED E 021 Exceeded timeout for activating door lock system (opening) DOOR LOCKED E 030 Water in the fill tank at minimum (MIN) level E 031 Water in
APPENDIX E – ALARMS CODE ALARM DESCRIPTION A 250 1st vacuum pulse not reached within timeout PV1 TIMEOUT A 251 1st rise to atmospheric pressure not reached within timeout ATM1 TIMEOUT A 252 1st pressure pulse not reached within timeout PP1 TIMEOUT A 253 2nd vacuum pulse not reached within timeout PV2 TIMEOUT A 254 2nd rise to atmospheric pressure not reached within timeout ATM2 TIMEOUT A 255 2nd pressure pulse not reached within timeout PP2 TIMEOUT A 256 3rd vacuum pulse not reached wi
APPENDIX E – ALARMS ANALYSIS AND RESOLUTION OF PROBLEMS Based on the type of alarm, below we provide instructions for identifying the possible causes and restoring correct operation: CODE POSSIBLE CAUSE PROPOSED SOLUTION ERRORS (category E) E 000 Sudden power failure (blackout). Wait for electricity to return and perform RESET following the instructions. Accidentally turning-off the main switch and/or pulling the plug out of the socket.
APPENDIX E – ALARMS CODE POSSIBLE CAUSE Excessive humidity in the sterilization chamber. PROPOSED SOLUTION Perform RESET following the instructions. Carefully dry the inside of the sterilization chamber and start the program again. Perform RESET following the instructions. E 901 Air leaking through the gasket Carefully clean the gasket with a clean cotton cloth dampened with water. Start the program again. Problem in the plumbing circuit. Excessive humidity in the sterilization chamber.
APPENDIX E – ALARMS CODE A 111 POSSIBLE CAUSE PROPOSED SOLUTION Incorrect connection of the temperature sensor (sterilization chamber) to the connector. Temperature sensor short circuit (sterilization chamber). A 112 Incorrect connection of the temperature sensor (steam generator) to the connector. Temperature sensor short circuit (steam generator). A 113 Incorrect connection of the temperature sensor (heating element) to the connector. Contact the Technical Support Department (see Appendix Z).
APPENDIX E – ALARMS CODE POSSIBLE CAUSE PROPOSED SOLUTION Perform RESET following the instructions. Steam leaking through the gasket. Carefully clean the gasket with a clean cotton cloth dampened with water. Start the program again. Perform RESET following the instructions. Excessive load. A 252 Check the quantity of material in the sterilization chamber and make sure it does not exceed the maximum quantity allowed. (See the Summary Table in Appendix A, Technical Characteristics).
APPENDIX E – ALARMS CODE POSSIBLE CAUSE PROPOSED SOLUTION Perform RESET following the instructions. Presence of water or condensate in the sterilization chamber. Carefully dry the inside of the sterilization chamber and start the program again. Do not put material impregnated with water, or liquids in general, in the chamber. Perform RESET following the instructions. A 256 Air leaking through the gasket. Carefully clean the gasket with a clean cotton cloth dampened with water.
APPENDIX E – ALARMS CODE POSSIBLE CAUSE H 400 Problem in the plumbing circuit. H 401 Problem in the plumbing circuit. H 402 H 403 H 404 H 405 H 406 90 Steam generator malfunction. Problem in the plumbing circuit. Steam generator malfunction. Problem in the plumbing circuit. Problem in the plumbing circuit. Steam generator malfunction. Problem in the plumbing circuit. Steam generator malfunction. Problem in the plumbing circuit. Steam generator malfunction.
APPENDIX G – DECLARATION OF CONFORMITY DICHIARAZIONE DI CONFORMITÀ DECLARATION OF CONFORMITY DECLARATION DE CONFORMITE KONFORMITÄTSBESCHEINIGUNG DECLARACION DE CONFORMIDAD Applicazione della Direttiva 93/42/CEE e successive modifiche intervenute Application of the EEC Directive 93/42 and subsequent changes. Application de la Directive CEE 93/42 et modifications ultérieures. Anwendung der EWG Vorschriften 93/42 und nachfolgende Änderungen. Aplicación de la Directiva CEE 93/42 y los subsiguientes cambios.
APPENDIX G – DECLARATION OF CONFORMITY DICHIARAZIONE DI CONFORMITÀ DECLARATION OF CONFORMITY DECLARATION DE CONFORMITE KONFORMITÄTSBESCHEINIGUNG DECLARACION DE CONFORMIDAD Applicazione della Direttiva 93/42/CEE e successive modifiche intervenute Application of the EEC Directive 93/42 and subsequent changes. Application de la Directive CEE 93/42 et modifications ultérieures. Anwendung der EWG Vorschriften 93/42 und nachfolgende Änderungen. Aplicación de la Directiva CEE 93/42 y los subsiguientes cambios.
APPENDIX G – DECLARATION OF CONFORMITY DICHIARAZIONE DI CONFORMITÀ DECLARATION OF CONFORMITY DECLARATION DE CONFORMITE KONFORMITÄTSBESCHEINIGUNG DECLARACION DE CONFORMIDAD Applicazione della Direttiva 93/42/CEE e successive modifiche intervenute Application of the EEC Directive 93/42 and subsequent changes. Application de la Directive CEE 93/42 et modifications ultérieures. Anwendung der EWG Vorschriften 93/42 und nachfolgende Änderungen. Aplicación de la Directiva CEE 93/42 y los subsiguientes cambios.
APPENDIX H – NOTES PER THE OPERATOR APPENDIX H – NOTES PER THE OPERATOR 94
APPENDIX H – NOTES PER THE OPERATOR 95
APPENDIX Z – TECHNICAL SUPPORT APPENDIX Z – TECHNICAL SUPPORT FOR ANY REQUEST FOR TECHNICAL SERVICE FOR THE PRODUCT, WHETHER IN OR OUT OF WARRANTY, DIRECTLY CONTACT THE TECHNICAL SUPPORT DEPARTMENT OF THE DEALER OR RESELLER THAT SUPPLIED THE PRODUCT. M.O.COM. Srl is completely available to customers to provide any technical information about the product as well as to offer suggestions and advice on steam sterilization procedures. In this regard, please refer to the following address: M.O.COM.
