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Extrema Plus

1. 66 OVERVIEW e ee e Dre eot bete eed 66 AEARM PROCEDURE RR D REISEN RH 66 Alarm occurring during the sterilization cycle nes 66 Alarm occurring out the sterilization cycle i 67 RESET OF THE SYSTEM eie tiec iet Hg eee ore eii det Haee oe iti 67 LIST OF THE ALARM CODES iti a u m ied eg ce rai cd Toig de dan aus 68 ANALYSIS AND RESOLUTION OF THE 5 eee 70 APPENDIX F DRAWINGS iaia 77 ELECTRICAL DRAWINGu rior lil tte con eR Ie Re opu oet Redde dede id 77 HYDRAULIC i 78 APPENDIX DECLARATION OF CONFORNMITY 79 APPENDIX H OPERATOR S NOTES 80 APPENDIX Z CUSTOMER SERVICGE 81 Extrema Plus 3 FOREWORDS Symbols used through the manual APPLICABLE EUROPEANS DIRECTIVES USE IDENTIFICATION Important notes Extrema Plus 1 FOREWORDS On thanking for the preference granted Ltd Co hopes that the performances of this product can result of Your complete satisfaction In this manual you will find all the procedures for the correct use and the indications for the complete exploitation o
2. nnn 34 INTRODUCTION aati ee ee en Ana 34 ABOUT THE SEPECTIQON aree chiar n 34 9 RUNNING THE STERILIZATION PROGRAM tti 35 GENERAL wan See euin aS D a ee ee ee 35 STARTING THE STERILIZATION PROGRAM nnn 35 SEQUENCE OF PROCESS L u iii 35 MANUAL INTERRUPTION OF THE PROGRAM nnns 39 RESULT OFTHE PROGRAM rta t ert er d Fer d reri i dde aun 40 PRINTING THE DATA OF THE CYCLE teh late 40 10 PRESERVING THE STERILIZED MATERIAL eene 41 GENERAL tende tti SA eite an sedo ni 41 auis coa EE 41 STORING ie finemente ni eee zi 41 2 Extrema Plus TABLE OF CONTENTS 11 TEST PROGRAMS i i i aa 42 OVERVIEW elia ala 42 HELIX FEST CEN io hi dai i late h go ia 42 VACUUM TE Si WT ebrea ERR bete 43 APPENDIX A TECHNICAL CHARACTERISTICS 45 OVEIRVIEWPTABLE tuit nib ite esi tes des a 45 SAFETYDEVIGCES MM BERN 46 CHARACTERISTICS OF THE FEEDING WATER see 47 APPENDIX B PROGRAWMSS 22 nia alain 48 INFRODUETION lt ue 48 OVERVIEW OF THE AVAILABLE PROGRAMS 49 DIAGRAMS OF THE STERILIZATION PROGRAMS 50 DIAGRAM OF THE TEST ne
3. 134c POROUS 134 C 4 00 PROGRAM 134c PRION 134 C 18 00 Time min EXTENDED DRYING PROGRAM 121c POROUS 121 C 20 00 Time min FRACTIONATED VACUUM 50 EXTENDED DRYING Extrema Plus APPENDIX B PROGRAMS 4 Pressure bar PROGRAM 134c HOLLOW PROCESS 134 C 4 00 Time min FRACTIONATED VACUUM SHORT DRYING Pressure bar PROGRAM 121c HOLLOW 121 C 20 00 PROCESS Time min FRACTIONATED VACUUM SHORT DRYING Extrema Plus 51 APPENDIX B PROGRAMS 4 Pressure bar PROGRAM 134c WRAPPED 134 C 4 00 PROCESS Time min SINGLE VACUUM EXTENDED DRYING A Pressure bar PROGRAM 121c WRAPPED 121 C 20 00 PROCESS Time min SINGLE VACUUM EXTENDED DRYING 52 Extrema Plus APPENDIX B PROGRAMS Pressure bar PROGRAM 134c SOLID PROCESS 134 C 4 00 Time min 1 00 SINGLE VACUUM SHORT DRYING 4 Pressure bar PROGRAM 121c SOLID 121 C 20 00 PROCESS Time min SINGLE VACUUM SHORT DRYING Extrema Plus 53 APPENDIX B PROGRAMS bar PROGRAM 134c EMERGENCY PROCESS 134 C 3 00 Time min 1 00 SINGLE VACUUM DRYING Pressure bar PROGRAM XXXc CUSTOM 134 C from 4 00 to 30 00 121 C from 20 00 to 30 00 SELECTION Temperature 134 C 121 C SELECTION aw tt Time 4 s30 134 C
4. Open the door to allow the test continuation At the end of self test the display shows EXTREMA PLUS SELFTEST PASSED ACQUISITION AND At the switching on the unit provides for the automatic reading of the environmental AUTOMATIC pressure value If the difference between currently read and stored pressure values see Chapter Setting the equipment par Setting the option in SETUP mode is higher UPDATING OF THE than a preset value the unit will update automatically the stored value after a short waiting ENVIRONMENTAL time otherwise the stored value remains unchanged PRESSURE VALUE Subsequently the unit will run the initial self test see previous paragraph and later on the LCD will display the following message accompanied by acoustic signal Pushing key ESC the unit will enter in STAND BY mode see next paragraph THE ACQUISITION PROCEDURE AND POSSIBLE UPDATING THE ENVIRONMENTAL PRESSURE VALUE WILL BE PERFORMED EACH TIME THE UNIT IS SWITCHED ON THROUGH THE MAINS SWITCH 16 Extrema Plus STAND BY STATE FILLING THE DISTILLED WATER Manual filling Extrema Plus 5 FIRST START UP Over the self test procedure the sterilizer goes in STAND BY state and the LCD display will show 31 05 1999 11 05 Cntr 00000 00000 with the current date and time on the upper line and the cycle counter on the lower line reporting two values the number of correctly completed cycl
5. Setting the STAND BY modes STAND BY option of the ADVANCED menu 26 Select EXTRA option for extending the drying phase of a selectable time period e g for particularly difficult load Enabling this option the following choice will be prompted TRA XX min 1 OK f ESC sind II gt lt E allowing to set the time period of the extra drying The extended time ranges from 1 to 15 minutes b Mode SHORT The following options are displayed gt STANDARD 7 FAST 4 Select STANDARD option for a preset time period drying about 4 minutes Select FAST option for a very short drying phase but forgoing the complete removal of the residual humidity Use the key then confirm by the key 2 8 Confirm the choices by the key 4 The program is stored at the selected position 5 IF THE PROGRAM CUSTOM IS ALREADY PRESENT IN A DIFFERENT PRESET POSITION THE CHOICE WON T BE ACCEPTED ON THE SCREEN THE FOLLOWING WARNING APPEARS ACCOMPANIED BY ACOUSTIC SIGNALING THIS PROGRAM IS ALREADY PRESET Es THE SELECTION CAN BE WHENEVER MODIFIABLE BY PERFORMING AGAIN THE PROCEDURE ABOVE DESCRIBED 5 THE LIST OF THE AVAILABLE PROGRAMS THEIR DIAGRAMS AND THE CHARACTERISTICS OF THE AUTOCLAVABLE MATERIAL DEPENDING ON THE PROGRAMS CAN BE FOUND IN APPENDIX B PROGRAMS The heating stage in STAND BY status pre heating can be set according to the high or low use of the unit and others possible considerations
6. Wrong connection of the temperature probe chamber wall to the pcb connector Short circuit of the temperature probe chamber wall Instable operation of the temperature probe sterilization chamber Release of the steam generator Provide for the manual reset of the thermostat installed on the rear safety thermostat side of the equipment see Chapter Product description Unscrew the protection plastic cap push on the red button for a click and replace the cap Switch off RESET and switch on again the equipment Release of the heating resistor safety thermostat Call for the Customer Service see Appendix Z Wrong operation of the steam generator or heating resistor Extrema Plus APPENDIX ALARM SIGNALING CODE POSSIBLE CAUSE SUGGESTED SOLUTION A250 Presence of water or condensation Perform the RESET according to the instructions inside the sterilization chamber Carefully dry the sterilization chamber and restart the program Do not introduce material soaked by water or liquid into the chamber Obstruction on the sterilization Provide for cleaning or replacing the draining filter hamber draining filter LE See Appendix C Maintenance Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Failure of the vacuum pump Call for the Customer Servic
7. As selected the STAND BY option by the key 1 the following menu will appears Select HIGH high preheating stage for intensive use and to reduce however the waiting time between one cycle and the other Select LOW low preheating stage for normal use maintaining an acceptable waiting time Select OFF preheating switched off for non continuous use In this case the waiting time will be longer 10 12 minutes starting from the cold start condition Use the key then confirm by the key 1 5 THE STAND BY OPERATING MODE HIGH LOW IS TIMED IN ORDER TO AVOID HIGH POWER CONSUMPTION OF THE HEATER SO AFTER 30 MINUTES WITH THE UNIT NOT HANDLED THE HEATER WILL BE DISABLED EQUIVALENT TO THE MODE STAND BY OFF OPERATING ANY CYCLE KEY STERILIZATION OR TEST KEY OR SWITCHING OFF ON THE UNIT VIA THE MAINS SWITCH THE ORIGINAL STAND BY HIGH LOW WILL BE RESTORED Extrema Plus 6 SETTING THE EQUIPMENT Setting the Drying To allow the effective drying for the different types of load and in all the conditions the Options DRYING OPTions of the ADVANCED menu drying modes must be correctly selected Operates as follows 1 Select DRYING OPT and confirm by the key 4 to access the following menu ONG 1 gt L SHORT 4 Choice LONG long drying typical in cycles for WRAPPED and POROUS materials or SHORT short drying typical in cycles for SOLID UNWRAPPED and HOLLOW materials
8. See Chapter Preparing the material to be sterilized Wrong selection of the sterilization Choose the proper sterilization program for the type of program material to be sterilized See Table in Appendix B Obstruction on the sterilization Provide for cleaning or replacing the draining filter hamber draining filter cnamper araning See Appendix C Maintenance Oxidation traces or Poor quality of the tools Check the quality of the tools showing the problem spots on the tools make sure that the material of the tools is autoclavable Poor quality of the distilled water Empty the reservoir and fill it with high quality distilled water possibly obtained by inverse osmosis See Characteristics of the feeding water in Appendix A Technical characteristics Organic or inorganic residues on Carefully clean the material before the sterilization the tools cycle See Chapter Preparing the material to be sterilized Contact among tools of different Separate the tools of different metal with proper metal expedients See Chapter Preparing the material to be sterilized Presence of calcareous residues on Perform the cleaning of the equipment and parts as the wall of the sterilization chamber indicated and or accessories See Appendix C Maintenance Bluing or blackening of Wrong selection of the sterilization Verify the adequacy of the temper
9. Setting the Printer Options PRINT OPTions of the ADVANCED menu 28 If the sterilizer is connected to a printer for the recording of the sterilization data set the necessary parameters in order to guarantee the correct operation Proceed as follows 1 By selecting the item PRINT OPT and confirming it by the key J appear the following menu gt PRINTER REPORT a The item PRINTER opens a next menu for selecting the line feed mode accordingly with the printer used whereas the item REPORT is used to set the number of the printouts and to enable the reprint of the last performed program a PRINTER menu By selecting the item PRINTER the following screen is proposed Choice CR if you are using printers that carry out the form feed through a CR command Carriage Return choice CR LF for printers needing a CR LF command Carriage Return Line Feed or OFF to disable the data printout L3 LOOKUP IN THE PRINTER MANUAL FOR FINDING THE COMMANDS USED CR CR LF IF THIS INFORMATION ARE NOT AVAILABLE CARRY OUT A TEST PRINTOUT WITH BOTH THE OPTIONS TO INDIVIDUALIZE THE CORRECT OPERATING SETTING b REPORT menu By selecting REPORT the following choice is proposed co gt N E P INT A S R s 1 R T al Select NR COPIES to set the number of the printout copies of the data at the end of the sterilization process if the printer is connected Appears the following screen ES X 7 f ESC
10. Use the key then confirm by the key J 2 Depending on the choice LONG or SHORT two different menus are displayed a LONG option Select STANDARD to enable for WRAPPED and POROUS cycles a fixed time drying WITH HEAVY LOADS OR PECULIAR MATERIALS THE STANDARD OPTION MIGHT SOMETIMES NOT GUARANTEE A PERFECT RESULT THIS CASE EXTEND THE DRYING PHASE BY USING THE EXTRA MODE Select INTELLIGENT to enable an automatic drying characterized with a duration higher or lower the standard one depending on the load volume quantity and typology WITH COMPLEX LOAD WRAPPED INSTRUMENTS IN STERILIZATION CONTAINER THE INTELLIGENT OPTION MIGHT NOT CORRECTLY OPERATE WITH RESULTS LOWER THE EXPECTATION IN THIS CASE USE THE STANDARD EXTRA OPTIONS AS NECESSARY Select EXTRA option for extending the drying phase of a selectable time period e g for particularly difficult load Enabling this option the following choice will be prompted EXTR 4J20K 1 x X min t ESC 4 where the duration of the extra drying can be set in the range of 1 15 minutes SHORT option DARD 1 4 Select STANDARD to enable for SOLID and HOLLOW cycles a fixed time drying Select FAST to minimize the drying time forgoing however a perfect removal of the residual humidity Scroll the options through the key then confirm by the key J Extrema Plus 27 6 SETTING THE EQUIPMENT
11. tee de eee ia 18 DRAINING TANK WATER LEVEL SIGNALING sss 18 6 SETTING THE EQUIPMENT 19 INTRODUCTION rer ayapa rn rd ict dre dae Hcet de sad 19 STARTING THE SETUP PROGRAM itt E P e Adan 19 FUNCTION OF THE KEYS IN SETUP MODE nemen ener 19 DESCRIPTION OF THE MENU OPTIONS enne 21 DEFAULT SETTING S u ineat eerie 22 SETTING THE OPTIONS IN SETUP n 23 language anu n eue Dope RR un nah REED 23 Date 23 Time optioni iraniana ayaman aw doe Bis alus ay 23 Setting the preset sterilization Programs 24 Setting the STAND BY modes iii 26 Setting the Drying Options iode ua usa us qua u a ilo 27 Setting the Printer Options ii 28 Setting the tank Filling reiner tae eere o ee reed eee jet 29 Acquisition of the environment pressure eene nennen 29 Manual activation of the door locking mechanism 30 Adjusting the ECD uu u saa 30 EXIT FHESETUP MODE u 2 Sun REEF RH 30 7 PREPARING THE MATERIAL TO BE STERILIZED eene 31 INTRODUCTION ep 31 HANDLING THE MATERIAL BEFORE STERILIZING 31 ARRANGEMENT OF THE LOAD renes nn nnn 32 8 SELECTING THE STERILIZATION PROGRAM
12. 0g HT VT Extrema Plus 11 TEST PROGRAMS If the steam is correctly penetrated the ink color on the whole length of the strip will be completely turned compared to the start conditions on the contrary insufficient penetration the change will be only partial or missing gt NORMALLY THE TURNING OCCURS FROM CLEAR COLOR YELLOW ETC TOWARD A DARK COLOR BLUE VIOLET OR BLACK IN EVERY CASE METICULOUSLY FOLLOW THE INSTRUCTIONS SUPPLIED BY THE MANUFACTURER ABOUT THE WAY FOR USING AND INTERPRETING THE INDICATOR DEVICE The time of the test is about 22 minutes If a printer is installed on opening the door at the end of the program a report of the performed test will be released including the main data Affix the chemical indicator in the foreseen area sign the document and file it For more details about the printing reports refer to the examples in Appendix B Programs For selecting the VT program press one or more times the SELECTION TEST key until relative signaling turns on LCD display visualizes VACUUM TEST STAND BY Temperature display C shows Pressure display bar shows the value of the maximum vacuum reached with the sterilization cycle 0 90 Timer display shows 00 00 The Vacuum Test VT program must be carried out with the sterilization chamber unloaded and with trays and tray holder only L3 CARRY OUT THE VACUUM TEST AS FIRST CYCLE AT THE SWITCHING O
13. Arrange the tools of different metal stainless steel moderate steel aluminum etc on different trays or however well separate between them n case of not stainless steel tools interpose a sterilization paper napkin or muslin cloth between tray and tool avoiding direct contacts between the two different materials Arrange however the objects sufficiently outdistanced in order they maintain the layout for the whole sterilization cycle Verify all the tools are sterilized in open position Arrange the cutting tools scissors lancets etc so they cannot come in contact during the sterilization process if necessary use a cotton cloth or gauze to isolate and protect them Arrange the containers glasses cups test tubes etc on one side or inverted position avoiding possible water stagnation Don t overload the trays over the stated limit see Appendix A In a lot of situations this maximum admitted value might be excessive in this case always use a bit of common sense Don t stack the trays one above the other or put them in direct contact with the walls of the sterilization chamber Always use the supplied tray holder To introduce and extract the trays from the sterilization chamber always use the supplied special tray removal tong gt DETECT THE PROCESS RESULT SET A STERILIZATION INDICATOR TEST PER EACH TRAY THIS PRECAUTION AVOIDS FROM PROCESSING ONCE AGAIN THE SAME LOAD
14. SAFETY DEVICES Extrema Plus is provided with the followings safety devices a brief description of their function is given on the following Mains fuses see the data on the overview table Protection of the whole equipment against possible failures of the heating resistors Action interruption of the electric power supply Protection fuses on electronic circuits see the data on the overview table Protection against possible failures of the mains transformer primary circuit and low voltage loads Action interruption of one or more low voltage circuits Thermal cutouts on the mains transformer windings Protection against possible vacuum pomp and mains transformer primary winding overheating Action temporary interruption up to the cooling of the winding Safety valve 2 4 bar Protection against possible sterilization chamber over pressure Action release of the steam and restoration of the safety pressure Manually resettable thermostat on steam generator 270 C Protection for possible steam generator overheating Action interruption of the steam generator power supply Manually resettable thermostat on chamber heating resistors 200 C Protection for possible overheating of the chamber heating resistors Action interruption of the power supply of the chamber resistors Safety micro switch for the door status Comparison for the correct closing position of the sterilization chamber door Action
15. SINGLE VACUUM 20 30 121 C or FRACTIONATED VACUUM Time min SELECTION EXTENDED DRYING or SHORT DRYING 54 Extrema Plus APPENDIX PROGRAMS DIAGRAM OF THE TEST PROGRAMS A Pressure bar PROGRAM HELIX TEST HT PROCESS 134 C 3 00 Time min FRACTIONATED VACUUM Pressure bar Intermediate condition for the continuation of the test P2P1 lt 1 10 12 11 300 5 minutes VACUUM PHASE WAITING Extrema Plus SHORT DRYING PROGRAM VACUUM TEST VT 0 80 bar End condition for positive test result P3 P2 lt 0 02 bar 3 2124600 s Time min 10 minutes LEAKAGE 55 APPENDIX PROGRAMS EXAMPLES OF PRINTING REPORTS Normal program report Model EXTREMA PLUS S N 99 XP 0000 Counter 0007 0015 Selection 134c SOLID Temperature 134 C Pressure 2 10 bar Process time 4 min Stand by LOW Vacuum Pulses SINGLE Drying FAST CYCLE START 23 06 99 12 14 Time 00 01 CS 079 4 0 00 02 02 1PV 093 7 0 89 05 48 ET 135 6 2 15 06 02 SS 135 9 2 17 07 02 135 6 2 14 08 02 135 5 2 14 09 02 135 4 2 14 10 02 135 5 2 15 10 03 SE 135 5 2 15 10 37 DS 104 1 0 00 11 41 SPD 047 5 0 90 12 08 DE 047 6 0 84 13 12 CE 084 6 0 04 06 02 MAX 136 0 09 59 MIN 135 4 Drying Pulses 01 CYCLE END 23 06 99 12 27 STERILIZATION POSITIVE OPERATOR Model EXTREMA PLUS S N 99 XP 0000 Counter 0007 001
16. Temperature display C shows the nominal value 134 Pressure display bar shows the nominal value 2 10 Timer display 8 shows the foreseen time of the process 3 30 mm ss The test device is a PTFE pipe long 1 5 m and of internal diameter of 2 mm with a small watertight screw capsule mounted on one end containing an opportune chemical indicator The other end of the pipe is free to allow the penetration of the steam For performing the test insert the chemical indicator consisting of a paper strip with a special reacting inch inside the capsule of the device that must be always perfectly dried Close the capsule in such a way no leakage through the gasket is possible c THE DEVICE AND THE CHEMICAL INDICATORS FOR THE HELIX TEST HT ARE NOT SUPPLIED WITH THE EQUIPMENT FOR MORE INFORMATION CONTACT ASSISTENZA CLIENTI SEE APPENDIX 7 Set the device on the middle tray of the equipment approximately in the center Don t introduce other material inside the chamber Close the door and start the program through the key START The program Led HT will flash for all through the program 57 ALLTHE INDICATIONS DISPLAYED DURING THE CYCLE ARE THE SAME AS DESCRIBED ON THE CHAPTER RUNNING A STERILIZATION PROGRAM At the end of the program recovery the test device from the sterilization chamber open the capsule and remove the indicator from its place Extrema Plus VACUUM TEST VT
17. Call for the Customer Service see Appendix Z 70 Extrema Plus APPENDIX ALARM SIGNALING CODE POSSIBLE CAUSE SUGGESTED SOLUTION Connecting pipe between external Perform the RESET according to the instructions tank and sterilizer not correctly Verify the connection of the water filling pipe tighten both ends on the connected fitting through the supplied plastic clips Eliminate possible obstructions on the pipe route Failure of the water pump Call for the Customer Service see Appendix Z Problem on the hydraulic circuit Call for the Customer Service see Appendix Z Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Sterilization chamber too much Perform the RESET according to the instructions arm is Carry out the test with the sterilization chamber at moderate temperature for instance in the morning at the first switching on of the equipment Problem on the hydraulic circuit Call for the Customer Service see Appendix Z Excess of damp inside the Perform the RESET according to the instructions sterilization chamber Carefully dry the sterilization chamber and restart the program Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Proble
18. Mains fuses 6 3 x 32 mm F 16A 250V Power supply board fuses 5 x 20 mm F1 T 3 15A 250V on loads 230V F2 2 250V primary winding 230V of the mains transformer T 2 250V winding 5V of the mains transformer 24 2 250V winding 8V of the mains transformer 25 1A250V winding 12V of the mains transformer F6 T 6 3A 250V on loads 24V Environmental operating conditions Temperature 15 C 35 C Relative humidity 80 max without condensation Height 3000 m above see level 10 1 0 010 m with tray holder installed Capacity of the distilled water reservoir about 4 61 at level MAX about 0 81 at level MIN Sterilization programs Available 11 see Appendix B Preset 4 1 fixed 3 TH Test programs Helix Test Vacuum Test Total sterilizable mass Solid hollow unwrapped material Solid hollow wrapped material max Porous material Sterilizable mass per tray Solid hollow unwrapped material Solid hollow wrapped material max Porous material Sterilizable mass per each item max Solid hollow unwrapped material Solid hollow wrapped material Porous material Pre heating time from cold about 12 min Parallel interface printer DB 25 pin connector female Serial interface DB 9 pin connector female Bacteriologic filter PTFE Porosity 0 2 um Connection 1 8 NPT male connector Extrema Plus 45 APPENDIX TECHNICAL CHARACTERISTICS
19. TIME option in the BASIC menu Extrema Plus 6 SETTING THE EQUIPMENT We now analyze in detail how to enable the different available options proceeding with the order as shown in the previous paragraph Description of the menu options Select the option LANGUAGE with the key the following screen will be shown gt ENGLISH 7 other language y Select the desired language Scroll the list by the key or and confirm with the key to store the choice With the confirmation command you re enter in the second level menu FROM NOW ON THE SETUP MENU WILL BE SHOWN IN THE SELECTED LANGUAGE As selected the option DATE through the key 4 the following screen will be shown dd mm yy J gt 1 Carry out the following operations Day indication is flashing adjust for the current date through the keys and Confirm through the key 4 Month indication is flashing adjust for the current month through the keys and Confirm through the key J Year indication is flashing adjust for the current year through the keys and Confirm through the key 4 With the last confirmation the set date will be stored and the second level of the menu returned As selected the option TIME through the key the following screen will be shown hh mm 1 J gt Carry out the following operations Hour indication is flashing adjust for the current hour through the keys and Confirm thro
20. Use the key to set the desired number of copies maximum 5 Confirm through the key J The item PRINT LAST allows to reprint the report of the last performed cycle both correctly terminated or interrupted due to an alarm The following choice is proposed gt NORMAL 1 EXTENDED The option NORMAL enables a normal printout that is the reduced one with the meaningful data of the cycle and outputted at the end of a cycle correctly performed whereas the item EXTENDED enables the complete printout that is a report containing all the data typical for a cycle interrupted by an alarm LS IF THE LAST CYCLE HAS BEEN CORRECTLY COMPLETED OR INTERRUPTED THROUGH A MA NUAL STOP THE REPRINT IN NORMAL EXTENDED MODE CAN BE PERFORMED IF THE LAST CYCLE HAS BEEN INTERRUPTED DUE TO AN OCCURRED ALARM EXCLUDED A MANUAL STOP ONLY THE EXTENDED MODE WILL BE AVAILABLE Extrema Plus Setting the tank Filling mode FILLING option of the ADVANCED menu Acquisition of the environment pressure SET 0 bar option of the SPECIAL menu Extrema Plus 6 SETTING THE EQUIPMENT By entering the reprint command the display will show the following message G NOW PRINTIN PLEASE WAIT that will remain on until the end of the print Use the key to move through the menu and confirm by the key J Extrema Plus allows to perform both manually and automatically the topping up of the internal distilled water re
21. Whereas the phases 1 3 4 6 and 9 are essentially identical for all the cycle types with little time differences depending on the quantity and consistence of the load and heating conditions the phases 2 5 7 and 8 sharply vary their configuration and duration depending on the selected cycle and accordingly on the load typology and on the choices operated by the user A standard program can be outlined with the following graph Pressure bar EXTREMA Plus Time min FRACTIONATED VACUUM VACUUM DRYING CF FOR DETAILS ABOUT THE AVAILABLE PROGRAMS REFER TO APPENDIX B PROGRAMS 4 INSTALLATION INSTALLATION INTRODUCTION DIMENSIONS FOR BUILD MOUNTING 10 For the right operation features exploitation and life extension of the sterilizer the first and basic step is the correct and careful installation Such precaution besides avoids possible malfunctions or damages to the equipment as well as possible danger situations for property and people We suggest to meticulously follow the warnings reported on this chapter LS Assistenza CLIENTI M O COM SEE APPENDIX Z IS AT YOUR DISPOSAL FOR ANY QUESTION OR FURTHER INFORMATION THE STERILIZER IS FORWARDED AFTER HAVING PASSED SET OF PROGRAMMED CONTROLS THEREFORE FURTHER CALIBRATIONS FOR THE OPERATION ARE NOT NECESSARY ANY MORE Dimensions and weigh 2 ensions and weight gt Height total 400 mm n Width
22. ALARM PROCEDURE THE TEMPERATURE C AND PRESSURE BAR DISPLAYS WILL SHOW ALWAYS THE CURRENT VALUES OF THE STERILIZATION CHAMBER The alarm procedure is designed in order to avoid the user from any possible confusion between an anomalous cycle and a cycle correctly completed and consequently from unintentionally using of the not sterile material The performing of the alarm procedure differs according to whether it occurs during or out the program execution and is structured for driving the user until the final RESET of the sterilizer If the alarm occurs during the sterilization or test program the LCD will show Alarm message LEVELLING Reached the safety conditions the equipment enables a special procedure on the first asking the user for manually unlocking the door with the following message PRESS 1 TO UN THE DOOR Press the key ff to unlock the door locking mechanism The following message appears Al arm message THE DOOR Opened the door the user is required to reset the equipment Alarm message RESET SYSTEM Extrema Plus Alarm occurring out the sterilization cycle RESET OF THE SYSTEM gt 3s Extrema Plus APPENDIX E ALARM SIGNALING or according to the preset RESET modes Alarm message ALARM 5 IFAPRINTER IS INSTALLED ON OPENING THE DOOR AT THE END OF THE CYCLE THE REPORT NORMAL OR EXTENDED ACCORDING TO T
23. APPENDIX E ALARM SIGNALING 040 101 72 POSSIBLE CAUSE SUGGESTED SOLUTION Lacking of water in the external tank Perform the RESET according to the instructions t tic filling automatic filling Fill the tank with sufficient distilled water and remember to periodically verify the level Connecting pipe between the Perform the RESET according to the instructions external tank and sterilizer not correctly connected Verify the connection of the water filling pipe tighten both ends on the fitting through the supplied plastic clips Eliminate possible obstructions on the pipe route Failure of water pump Call for the Customer Service see Appendix Z Failure of the temperature probe of the sterilization chamber PT1 Failure of the temperature probe of the steam generator PT2 Failure of the temperature probe of the heating resistor PT3 Failure of the temperature probe of the chamber wall PT4 Wrong connection of the temperature probe sterilization chamber to the pcb connector Short circuit of the temperature probe sterilization chamber Wrong connection of the temperature probe steam generator to the connector Call for the Customer Service see Appendix Z Short circuit of the temperature probe steam generator Wrong connection of the temperature probe heating resistor to the pcb connector Short circuit of the temperature probe heating resistor
24. APPENDIX E ALARM SIGNALING ANALYSIS AND RESOLUTION OF THE PROBLEMS Depending on the occurred alarm type the indications to find the possible causes and restore the correct operation are listed on the following table POSSIBLECAUSE CAUSE SUGGESTED SOLUTION ERRORS category E Sudden interruption of the electric Wait for the return of the electric power supply and perform the RESET power supply black out according to the instructions Verify the correct sterilization of the load before using the treated material Accidental switching off of the main Reconnect the plug and or switch on the equipment and perform the switch and or disconnection of the RESET according to the instructions plug from the a c socket ar Verify the correct sterilization of the load before using the treated material Mains fuses burned Replace the fuses of same type and value see Table in Appendix A Technical characteristics Switch on the equipment and perform the RESET according to the instructions Verify the correct sterilization of the load before using the treated material Door open or not correctly close Perform the RESET according to the instructions START Correctly close the door and restart the cycle Failure of the door micro switch Call for the Customer Service see Appendix Z Door locking mechanism not Perform the RESET according to the instructions correctly act
25. OPERATOR 57 APPENDIX MAINTENANCE INTRODUCTION ORDINARY SCHEDULED MAINTENANCE 58 APPENDIX C MAINTENANCE In order to guarantee a sure and efficient operation for the whole life of the equipment a regular maintenance by the user as well as the correct use are necessary ES FOR A BETTER QUALITY OF THE MAINTENANCE IT IS NECESSARY TO INTEGRATE THE ORDINARY CONTROLS WITH PERIODIC CHECK UP BY THE SERVICE REFER TO APPENDIX Z In addition a periodic validation of the sterilizer i e the check of the thermodynamic process parameters comparing them to the reference values measured by tools suitably adjusted is fundamental Refer to the paragraph Validation of the sterilizer in the following of this appendix The ordinary maintenance as described below consists of easy manual operations and preventive interventions by the use of simple tools IN CASE OF REPLACEMENT OF COMPONENTS OR EQUIPMENT PARTS REQUIRE FOR AND OR ONLY ORIGINAL SPARE PARTS The following table reports an overview of the maintenance actions and frequency to be performed on the sterilizer in order to maintain it always efficient We suggest to shorten the maintenance interval in case of heavy use Cleaning of the gasket and parabola BAY Cleaning of the external surfaces Cleaning of the sterilization chamber and accessories WEEKEY Desinfection of the external surfaces Lubrication of the door locking mechanism Maintenance o
26. OR FOR THE WORSE FROM USING A NOT STERILIZED MATERIAL WRAPPED MATERIAL HAS TO BE TREATED SET THE INDICATOR TEST INSIDE ONE OF THE WRAPS Extrema Plus Extrema Plus 7 PREPARING THE MATERIAL TO BE STERILIZED Indications for rubber and plastic pipes Always rinse with pyrogen free water before the use don t dry them Arrange the pipes the tray so that extremities are not obstructed neither crushed Don t provoke pleats neither winds but leave stretched more linearly as possible Indications for packets and wrappings Arrange the wrappings one close to the other suitably outdistanced and absolutely not piled up avoiding that they come to contact with the walls of the chamber In case special objects have to be wrapped always use a suitable porous material sterilization paper napkins of muslin etc closing the wrap with autoclave adhesive ribbon Indications for wrapped material Wrap the tools one by one or if more tools have to be set in the same wrap verify that they are of the same metal Seal the wrap with autoclave adhesive ribbon or by a thermal sealer Don t use metallic clips pins or other as this jeopardizes the maintenance of the sterility Arrange the envelopes in order to avoid the formation of air pockets that potentially could hamper the correct penetration and removal of the steam Turn the envelopes in order to set the pl
27. PRINTING OPTION HOLD DOWN THE KEY ESC on THE COMMAND PANEL WHILE OPENING THE DOOR For the details concerning the printing options refer to the report examples in Appendix B Programs Extrema Plus PRESERVING THE STERILIZED MATERIAL GENERAL HANDLING STORING Extrema Plus 10 PRESERVING THE STERILIZED MATERIAL The sterilized material has to adequately be handled and preserved to maintain own sterility in time until its use An improper maintenance can provoke its fast recontamination However this provokes an hazardous situation as the alternative is to use the contaminated material unconsciously in many cases with risk for both operator and patient or to perform a new sterilization process with inevitable waste of time and resources Therefore we retain useful to give some basic advice letting the operator make further carefully investigations By assuming that the sterilizer is arranged in a clean place without dust and damp pay attention to the following indications when handling and moving the sterile material 1 Remove the load from the sterilization chamber by wearing cleaned or better sterile gloves and white uniform For greater precaution put a protective mask on the face 2 Place the trays on a dry table suitably cleaned and disinfected Pay attention to outdistance or however separate the sterile material from the area of the contaminated material to be sterilized 3 Touch the
28. manual door unlocking by the user PRESS l TO UN THE DOOR Push on the key fl to release the locking mechanism The message changes to UAL 5 MAN TOP OPEN THE DOOR Finally on opening the door it is asked for resetting the equipment MANUAL RESET STOP SYSTEM The system RESET is performed by holding pressed for 3 seconds and more the key PROGRAM SELECTION until a confirmation acoustical signal On opening the door and if a printer is installed the report of the performed sterilization cycle will be printout containing the error signaling E999 Check this report sign and file it in a sure place Refer to the report examples in Appendix B Programs After the RESET the equipment enters in STAND BY state and now will be ready to perform a new program FOR THE COMPLETE DESCRIPTION OF THE ALARMS SEE APPENDIX E ALARM INDICATIONS AFTER A MANUAL INTERRUPTION OF THE PROGRAM MANUAL STOP ALWAYS VERIFY THE STATE OF THE LED PROCESS BEFORE USING THE TREATED MATERIAL OF THE STERILIZATION CHAMBER IF THE SIGNALING IS STEADY ON THE LOAD CAN BE CONSIDERED STERILE AND CONSEQUENTLY USED VVE RECOMMEND ITS IMMEDIATE USE ON THE CONTRARY IF THE LED 1 OFF THE MATERIAL CONTAINED INTO THE STERILIZATION CHAMBER CANNOT BE CONSIDERED STERILE AND MUST NOT ABSOLUTELY BE USED 39 9 RUNNING THE STERILIZATION PROGRAM RESULT OF THE PROGRAM PRINTING THE DATA OF THE CYCLE 40 After the completion o
29. operation as follows Symbol ENTER function to confirm the data START STOP key Symbol increment scrolling up function program selection key Symbol decrement scrolling down function test selection key Symbol 1 ESC function to exit the option SETUP key This key configuration remains valid for SETUP mode 19 6 SETTING THE EQUIPMENT ra ENGLISH M other languages BASIC LANGUAGE DATE TIME EXIT ADVANCED PROGRAMS 2nd PRESET 3rd PRESET 1342 SOLID 121c SOLID 4th PRESET 134c WRAP 121c WRAP EXIT 134c HANDPC 121 134c EMERGN STANDARD INTELLIGENT EXTRA STANDBY HIGH XXXc CUSTOM 134c TIME XX 1 TO XT f EsC 4 FRACTIONAT SINGLE I I LONG DRY SHORT DRY EXIT EXIT EXIT STANDARD STANDARD FAST INTELLIGENT EXTRA LONG p EXIT SHORT EXIT STANDARD FAST EXIT CR LF PRINT PRINTER EXIT EXIT COPIES X t K ok 5 NR COPIES FILLING AUTOMATIC PRINT LAST NORMAL DRYING OPT PRINT REPORT EXIT MANUAL EXIT EXTENDED EXIT SPECIAL SET 0 bar SET VALUES IF THE DOOR CURRENTVALUE TIMED J ok f EsC ISOPEN EETINTOMEMOR MESSAGE DOOR LOCK IF THE DOOR UN
30. reservoir with distilled water until the lighting of the green Led MAX or at least the turning off of the red Led MIN Verify the alarm code and operate consequently See following paragraphs Alarm signaling Alarm codes and Troubleshooting Verify the correct top ferrule locking of the safety valve NOTE Let the equipment cool or use gloves to avoid from burning oneself when you are touching the valve Extrema Plus APPENDIX D GENERAL PROBLEMS PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION At the end of the program CYCLE COMPLETE it is impossible to open the door Presence of water on the table of the sterilizer Presence of water around the draining tank Difficulty for reaching the correct vacuum in the chamber problems of drying presence of water in the sterilization chamber at the end of the cycle etc Extrema Plus Residual pressure inside the Wait for some minutes until the pressure return to the chamber 0 00 bar and retry to open the door NOTE LCD displays the message Verify that the bacteriologic filter is not obstructed and NOW LEVELLING if necessary replace it PLEASE WAIT The procedure for storing the environment pressure value function SET 0 bar has not been correctly performed Call for the Customer Service see Appendix Z The safety friction of the handle is Push on the handle pay attention to not damage it loosen against the equipment until to
31. signaling of wrong position of the door Doorlocking mechanism with bistable electromagnet Protection against accidental opening of the door also in case of black out Action impediment of the accidental opening of the door during the program Safety micro switch on the door locking mechanism Comparison for the correct closing position of the locking system Action signaling of the unsuccessful or incorrect operation of the door locking mechanism Self leveling hydraulic system Hydraulic system for the natural pressure leveling in case of manual cycle interruption alarm or black out Action automatic restoration of the atmospheric pressure inside the sterilization chamber On board system for the sterilization process evaluation Continuous monitor of the sterilization process parameters fully microprocessor managed Action immediate interruption of the program in case of anomaly and generation of alarms Monitoring of the sterilizer operation Real time monitoring of all the meaningful equipment parameters Action generation of alarm messages in case of anomaly with possible interruption of the cycle 46 Extrema Plus APPENDIX TECHNICAL CHARACTERISTICS CHARACTERISTICS OF THE FEEDING WATER DESCRIPTION VALUES IN THE DISTILLED VALUES IN THE WATER CONDENSED LEAD lt 0 05 mg l lt 0 05 mg l HEAVY METAL RESIDUES lt 0 1 mg l lt 0 1 mg l except iron cadmium and lead sediments
32. sterilization chamber We notice that the organic residues or deposits of substances used in the medical practice are obviously receptacles of microorganisms and can hamper the contact of the steam with the instrument surfaces inactivating at least locally the lethal process that the sterilization normally guarantees An incorrect arrangement of the load can lead to a difficult and sometimes impossible flowing and or penetration of the steam on the material with imaginable consequences The drying process can strongly be also affected by this factor Therefore we suggest some basic directions concerning this aspects leaving the user to deepen the problem in the most opportune way Before everything we remember some precautions that are basic for the handling and moving the contaminated material Wear rubber gloves of suitable thickness Wash one s hands already covered by the gloves with a germicide detergent Always use tray to move the tools never transport them directly picking up by hand Protect the hands from the contact of possible sharpened or cutting parts in order to avoid the risk of dangerous infections Immediately separate each item that has not to be sterilized or is not be able to support this process Wash carefully one s hands covered with the gloves as the handling the not sterile material is over the material and or instruments to be sterilized should be then perfec
33. supplied silicone pipe on the filling point on the rear of the equipment taking care to plug in it completely lt gt Clip Filling tank Teflon C BB A 2 tero e e Clip A m 3 Silicone pipe E Lock the pipe by using a supplied plastic clip Cut the pipe according to the desired distance and mount the opposite end on the output of the tap of the filling tank Check that the pipe is running freely from the unit towards the filling tank without any bend crush or obstruction Loosen the top cup to let the water to flow take care to also remove the possible gasket or under cup Turn in open position the tap of the filling tank Lm FOR THE SETTING OF THE AUTOMATIC FILLING REFER TO CHAPTER SETTING THE EQUIPMENT PLEASE TAKE CARE TO ACTIVATE THIS FUNCTION ONLY AFTER THE TANK HAS BEEN FILLED WITH DISTILLED WATER WHERE AVAILABLE THE EXTERNAL FILLING TANK CAN DIRECTLY FED BY WATER DEPURATION PLANT AN INVERSE OSMOSIS SYSTEM IS RECOMMENDED PROVIDED WITH THE NECESSARY CONTROLS AND OPPORTUNELY CONNECTED Please contact Assistenza Clienti M O COM see Appendix Z for further in formations and advice about the connection of different water purification systems to the sterilizer 14 Extrema Plus CO
34. the atmospheric pressure not ATM2 TIMEOUT performed within the timeout A255 2 vacuum pulse not performed within the PP2 TIMEOUT timeout PROGRAM SELECTION ke A256 3 vacuum pulse not performed within the PV3 TIMEOUT d timeout A257 3 raising towards the atmospheric pressure not ATM3 TIMEOUT performed within the timeout A258 3 vacuum pulse not performed within the PPP TIMEOUT timeout A259 PROCESS phase not started within the timeout PROCESS TIMEOUT HAZARDS category H H150 Failure of the pressure probe MPX MPX BROKEN H160 Short circuit disconnection of the pressure MPX SHORTCIRCUIT Switching off the equipment probe MPX OFF H170 Instability of the pressure probe MPX MPX FLICKERING H400 Ratio Peon T unbalanced Pcon gt T P T PROBLEM PROCESS phase H401 Ratio T Pconv unbalanced T gt Pconv T P PROBLEM PROCESS phase H402 Temperature over the MAX limit T OVER LIMIT PROCESS phase H403 Temperature under MIN limit T UNDER LIMIT PROCESS phase H404 Temperature fluctuating over the limit PT1 FLUCTUATING PROCESS phase H405 Pressure over the MAX limit P OVER LIMIT PROGRAM SELECTION PROCESS phase key H406 Pressure under the MIN limit P UNDER LIMIT PROCESS phase H990 Over pressure OVERPRESSURE sterilization chamber MPX H991 Over heating OVERHEATING PT1 sterilization chamber PT1 H992 Over heating OVERHEATING PT2 steam generator PT2 H993 Over heating OVERHEATING PT3 band heating resistor PT3 Extrema Plus 69
35. the following way with open door on referring to the figure water levelA 1 Hold horizontally the manual filling tank and MIN fill it of distilled water 2 1 i 2 Connect the fast fitting of the rubber pipe to the inlet mounted on the top right front of the equipment pushing for a click 3 Position vertically the tank and loosen the cap taking care do not upset water on the machine 4 Now the water will start to flow into the internal reservoir 5 On continuing the filling the MIN level indicator turns off 6 Continue up to dry out the tank 17 5 FIRST START UP 7 the tank and lower it below the connection point holding it horizontally 8 Push on the metallic clip of the fitting and remove the rubber pipe 9 Fill again the tank 2 l and repeat once again the steps 2 3 and 4 10 As the Led MAX turns on accompanied by an acoustic signal interrupt the filling and operates as described at the steps 7 and 8 m TO START THE STERILIZATION PROGRAM IS NOT NECESSARY THAT THE LED MAX IS TURNED ON IT IS SUFFICIENT THAT THE LED MIN IS TURNED OFF Automatic filling When the automatic filling system through external tank is installed see Chapter Installation the filling will occur automatically since the automatic filling option is selected Obviously for the correct operation the user has to prior fill the external tank 5 USE HIGH QUALITY DISTILLED WATER FOR
36. whereas the LCD display is showing the description of the selected sterilization program and the active status of the machine i e STAND BY ON PRESSING THE SELECTION KEY THE FIRST PROPOSED STERILIZATION PROGRAM IS THE LAST PERFORMED CYCLE For example LCD will show the cycle indication 134c P S STAN OROU DARD The second row of the LCD is showing for about 10 seconds the currently set drying mode of the cycle Subsequently LCD changes to show the operating status of the unit 134c POROUS To cancel this selection press shortly the ESC key on the command panel CF WHEN YOU ARE SELECTING THE CUSTOM CYCLE THE LCD WILL SHOW IN ADDITION TO THE DRYING MODE AS ABOVE THE INITIAL VACUUM MODE FRACTIONATED F OR SINGLE S 134c CUSTOM F EXTRA 05 THE SECOND ROW AFTER ABOUT TEN SECONDS CHANGES TO SHOW THE OPERATING STATUS OF THE UNIT 134c CUSTOM STAND BY IF NONE SELECTION IS ENTERED THE EQUIPMENT CANNOT START ANYWAY BY PUSHING ON THE START KEY WITHOUT HAVING SELECTED A PROGRAM THE LCD DISPLAY WILL SHOW THE FOLLOWING MESSAGE ACCOMPANIED BY AN ACOUSTIC SIGNAL SELECT PROGRAM PLEASE CONTEMPORARILY ALL LED S RELATING THE STERILIZATION AND TEST PROGRAMS WILL FLASH A THE USE OF IMPROPER PROGRAM FOR THE OF MATERIAL TO STERILIZED SEE APPENDIX B DOESN T GUARANTEE THE EFFECTIVENESS OF THE STERILIZATION PROCESS Extrema Plus RUNNING THE STERILIZATION PROG
37. without sediments lt 9 02mmoit HARDNESS lt 0 02 mmol l lt 0 02 mmol l THE USE OF STEAM GENERATED WATER WITH CONTAMINANTS EXCEEDING THE VALUES INDICATED ON THE ABOVE TABLE CAN NOTABLY SHORTEN THE LIFE OF THE STERILIZER BESIDES THIS CAN PRODUCE AN INCREASE OF THE OXIDATION ON THE MOST SENSITIVE MATERIALS AND AN INCREASE OF THE CALCAREOUS RESIDUES ON GENERATOR CHAMBER INTERNAL SUPPORTS TRAYS AND TOOLS Extrema Plus 47 APPENDIX B PROGRAMS APPENDIX PROGRAMS INTRODUCTION The steam sterilization is suggested for nearly all the materials and tools on condition that these are able to support without damages a minimum sterilization temperature of 121 C on the contrary other sterilization systems at lower temperature should be used The material normally autoclavable into a steam sterilizer is as follows Stainless steel surgical instruments Stainless steel generic tools Carbon steel generic tools Dynamic instruments motorized by air or gears turbines contrangles ablation tools etc Glass articles Mineral basis articles Heat proof plastic articles Heat proof rubber articles Heat proof textile articles Treatment material gauze tampons etc Other autoclavable generic material gt DEPENDING ON THE CONFORMATION SOLID HOLLOW POROUS PACKING PAPER PLASTIC WRAPPING STERILIZATION 48 PAPER CONTAINER MUSLIN ETC AND HEAT PROOF CHARACTERISTIC OF THE MATERIAL
38. 31 7 11 18 SS 135 9 42 47 148 5 113 5 132 6 11 28 135 3 2 16 153 6 1159 133 0 15 19 SE 135 5 2 15 1574 126 5 132 5 15 34 122 134 4 41 07 157 0 126 8 131 2 15 49 12F 108 3 0 25 1564 1268 119 9 15 53 DS 104 4 0 00 156 1 1266 116 2 16 04 12F 094 2 0 50 155 1 125 9 112 4 16 19 12F 069 2 0 73 153 7 124 5 112 9 16 34 12F 059 2 0 81 152 3 123 4 113 5 16 49 12F 053 8 0 87 1512 1229 113 6 16 57 SPD 048 4 0 90 150 9 1227 113 5 17 04 13F 047 1 0 80 151 0 122 5 113 5 19 34 13F 042 3 0 89 153 3 122 0 1122 19 38 13F 042 4 0 79 153 5 1221 112 2 22 55 EPD 094 9 0 90 153 3 121 7 112 3 23 10 14F 101 4 0 67 154 0 121 7 112 3 23 25 14F 105 4 0 57 153 7 121 5 112 3 24 55 DE 1126 047 1496 119 1 111 2 25 28 E15 115 2 0 10 143 0 118 4 110 7 25 33 CE 115 8 0 04 1474 110 1 110 7 11 20 MAX 1359 15 11 MIN 135 4 Drying pulses 05 CYCLE END 25 06 99 10 17 STERILIZATION POSITIVE OPERATOR EXTENDED REPORT REQUESTED BY THE OPERATOR Report following a Manual Stop Model EXTREMA PLUS SIN 99 XP 0000 Counter 0007 0015 Selection 134c POROUS Temperature 134 2 10 Process time 4 min Stand by HIGH Vacuum Pulses FRACTIONATED Drying STANDARD CYCLE START 24 06 99 11 13 Time 00 01 CS 077 6 0 01 01 40 1PV 088 7 0 89 04 40 1PP 120 6 1 00 05 40 2PV 062 9 0 79 07 10 2PP 135 6 1 00 08 20 3PV 135 5 0 79 11 20 ET 135 4 2 15 11 39 SS 135 5 2 17 12 39 135 5 2 14 13 39 104 1 2 15 14 39 047
39. 5 2 15 STERILIZATION NEGATIVE OPERATOR ALARM CODE E999 DESCRIPTION MANUAL STOP Report following a Black Out Model EXTREMA PLUS SIN 99 XP 0000 Counter 0006 0012 Selection 134c CUSTOM Temperature 134 2 10 Process time 07 min Stand by HIGH Vacuum pulses FRACTIONATED Drying FAST CYCLE START 24 06 99 15 31 BLACK OUT 24 06 99 15 45 STERILISATION NEGATIVE OPERATOR ALARM CODE E000 DESCRIPTION BLACK OUT Extrema Plus Report following Alarm Model SIN Counter Selection Temperature Pressure Process t ime Stand by Vacuum pulses Drying CYCLE START EXTREMA PLUS 99 XP 0000 0007 0015 134c POROUS 134 C 2 10 Bar 4 min HIGH FRACTIONATED STANDARD 26 06 99 11 30 Time TI P 13 T4 00 01 CS 075 1 0 00 130 9 115 2 093 4 00 11 2F 074 9 0 28 133 3 114 2 094 0 00 21 2F 0744 046 146 3 113 2 094 5 00 31 2F 074 3 0 57 1526 112 2 095 0 00 35 E2 074 3 0 59 1542 1119 0952 00 51 078 9 0 62 152 2 110 4 095 6 01 01 4F 074 9 0 73 1466 1096 095 7 01 11 4F 058 5 0 82 146 8 108 9 095 7 01 21 4 051 3 0 83 148 2 108 2 095 7 01 27 E4 047 8 0 89 1493 107 7 095 7 01 57 1PV 047 8 0 90 1553 1058 095 4 02 07 6F 076 5 0 57 149 9 105 2 095 1 02 17 6F 081 1 0 49 142 1 104 6 094 6 08 15 9F3 068 4 0 76 151 8 104 7 102 3 08 22 3PV 061 1 0 79 153 6 1045 1017 08 32 10F 097 4 0 01 154 7 104 0 100 8 08 42 10F 104 6 0 24 148 9 103 7 101 0 11 04 135
40. 5 Selection 1 34c POROUS Temperature 134 2 10 Process time 4 min Stand by HIGH Vacuum Pulses FRACTIONATED Drying STANDARD CYCLE START 25 06 99 09 52 Time 00 01 CS 075 1 0 00 01 57 1PV 047 5 0 90 04 53 1 120 5 1 00 06 00 2PV 061 1 0 80 07 15 2PP 120 4 0 98 08 22 3PV 061 1 0 79 11 04 ET 135 5 2 15 11 18 SS 135 9 2 17 12 18 135 4 2 14 13 1B 135 5 2 15 14 18 135 4 2 14 15 18 135 5 2 15 15 19 SE 135 5 2 15 15 53 DS 104 4 0 00 16 57 SPD 048 4 0 90 22 55 EPD 094 9 0 86 Z4 55 DE 112 6 0 47 5 BB CE 115 8 0 04 11 20 MAX 135 9 15 11 MIN 135 4 Drying Pulses 05 CYCLE END 25 06 99 10 17 STERILIZATION POSITIVE OPERATOR 56 Extended program report required by operator Model EXTREMA PLUS S N 99 XP 0000 Counter 0007 0015 Selection 134c POROUS Temperature 134 C Pressure 2 10 Bar Process t ime 4 min Stand by HIGH Vacuum pulses FRACTIONATED Drying STANDARD CYCLE START 25 06 99 09 52 Time T1 P T2 T3 T4 00 01 CS 075 1 0 00 130 9 115 2 093 4 00 11 2F 074 9 0 28 133 3 114 2 094 0 00 21 2F 074 4 0 46 146 3 113 2 094 5 00 31 2F 074 3 0 57 152 6 112 2 095 0 00 35 E2 074 3 0 59 154 2 111 9 095 2 00 51 E3 078 9 0 62 152 2 110 4 095 6 01 01 4 074 9 0 73 146 6 109 6 095 7 08 15 9F3 068 4 0 76 151 8 104 7 102 3 08 22 3PV 061 1 0 79 153 6 104 5 101 7 08 32 10F 097 4 0 01 154 7 104 0 100 8 08 42 10F 104 6 0 24 148 9 103 7 101 0 11 04 135 5 4245 143 3 111 7 1
41. 5 42 15 143 3 111 7 131 7 11 18 SS 135 9 2 17 148 5 113 5 132 6 11 28 135 3 2 16 153 6 1159 133 0 15 19 SE 135 5 2 15 157 4 126 5 132 5 15 34 122 1344 1 07 157 0 126 8 131 2 15 49 122 108 3 0 25 156 4 1268 119 9 15 53 DS 104 4 40 00 156 1 126 6 116 2 STERILISATION NEGATIVE ALARM CODE A112 DESCRIPTION PTC SHORTCIRCUIT CAUTION PLEASE REFER TO USER MANUAL Extrema Plus HELIX TEST program report Model EXTREMA PLUS P N 99 XP 0000 Counter 0011 0019 Selection ELIX TEST Temperature 134 C Pressure 2 10 bar Process time 3 5 min CYCLE START 25 06 99 16 38 Time 00 01 CS 076 4 0 00 02 06 1PV 089 3 0 89 04 35 1PP 120 4 0 99 05 45 2PV 062 5 0 78 07 02 2PP 120 2 0 97 08 15 3PV 061 1 0 79 11 00 ET 135 6 2 15 11 14 55 136 0 2 17 12 14 135 6 2 14 13 14 135 6 2 15 14 14 135 5 2 14 14 45 SE 135 4 2 14 15 20 DS 111 5 0 00 16 34 SPD 047 8 0 89 18 21 EPD 059 5 0 86 19 21 DE 075 4 0 50 20 06 CE 078 7 0 04 11 13 MAX 136 0 14 44 MIN 135 4 Drying pulses 01 CYCLE END 25 06 99 16 38 HELIX TEST COMPLETE Please attach the indicator hereunder OPERATOR APPENDIX B PROGRAMS VACUUM TEST program report Model P N Counter Selection EXTREMA PLUS 99 XP 0000 0011 0019 VACUUM TEST CYCLE START 29 06 99 11 37 Time C bar 0000 CS gt PUMOFI 0350 002 01 39 E1F 037 4 0 90 6 39 E2F 038 4 0 90 16 39 042 0 0 90 17 54 045 5 0 10 CYCLE END 29 06 99 11 41 VACUUM TEST POSITIVE
42. AM AT 134 C AND BETWEEN 20 AND 30 MINUTES FOR THE PROGRAM AT 121 C 5 As set the time appear the menu for selecting the type of the initial vacuum gt FRACTIONATED 71 SINGLE Choice FRACTIONATED to perform a fractionated vacuum SINGLE for one vacuum phase only Use the key then confirm by the key 4 Now a next menu is shown where the drying modes can be selected DRY 1 SHORT DRY Choice LONG to dry in properly way the porous and or wrapped instruments or SHORT in case of load with unwrapped or hollow instruments Use the key then confirm by the key J Depending on the option selected LONG or SHORT two different menus will be prompted a Mode LONG The following options are available Select STANDARD option for a long preset time drying about 10 minutes gt WITH BIG LOAD OR SPECIAL MATERIAL THE STANDARD OPTION MIGHT NOT GUARANTEE SOMETIMES A CORRECT RESULT IN THIS CASE EXTEND THE DRYING PHASE WITH THE EXTRA OPTION Select INTELLIGENT to enable an automatic drying characterized with a duration higher or lower the standard one depending on the load volume quantity and typology CF WITH COMPLEX LOAD E G WRAPPED INSTRUMENTS IN STERILIZATION CONTAINER THE INTELLIGENT OPTION MIGHT NOT CORRECTLY OPERATE WITH RESULTS LOWER THE EXPECTATION IN THIS CASE USE THE STANDARD OR EXTRA OPTIONS AS NECESSARY 25 6 SETTING THE EQUIPMENT
43. AND BY status ready to perform a new program gt IF THE CYCLE INTERRUPTION OCCURS DURING PARTICULAR PHASES A CLEANING PROCEDURE OF THE HYDRAULIC CIRCUIT WILL START ON THE NEXT CYCLE WITH THE FOLLOWING MESSAGE ON LCD 134c POROUS CIRCUIT CLEANING Over the cleaning procedure the sterilization cycle selected will start automatically 67 APPENDIX E ALARM SIGNALING LIST OF THE ALARM CODES The alarm codes LCD messages and consequent RESET modes are listed in the following CODE ALARM DESCRIPTION LCD MESSAGE RESET MODE ERRORS category E E000 Black out BLACK OUT E010 Door open DOOR OPEN E020 Door unlocked DOOR UNLOCKED E021 Door locked DOOR LOCKED E030 Minimum water level in the filling tank MIN WATER MIN E031 Maximum water level in the filling tank MAX EXHAUST MAX E041 Too much frequent filling up of the tank FILLING PROBLEM PROGRAM SELECTION automatic filling key E900 Unsuccessful Vacuum Test TEST FAILED during the LEAKAGE phase E901 Unsuccessful Vacuum Test TEST FAILED during the WAITING phase E902 Unsuccessful Vacuum Test TEST FAILED timeout vacuum pulses exceeded E999 Manual interruption of the cycle MANUAL STOP ALARMS category A A022 Problem of the door locking mechanism LOCKING PROBLEM A032 Problem of the level probes LEVEL PROBLEM A040 Unsuccessful reservoir filling FILLING PROBLEM automatic fi
44. HE TYPE OF THE OCCURRED ALARM RELATIVE TO THE STERILIZATION PROGRAM JUST PERFORMED AND INCLUDING THE ERROR SIGNALING WILL BE PRINTED VERIFY THE PRINTOUT SIGN IT ON THE SPECIAL SPACE AND FILE IT IN A PROPER PLACE REFER TO THE PRINTOUT EXAMPLES IN APPENDIX B PROGRAMS If the alarm occurs out the sterilization or test program the following message will be shown Alarm message ALARM or according to the foreseen RESET modes Alar m me ge WARNI ssa NG which will automatically change with the message Alarm message RESET SYSTEM THE ALARMS OCCURRED OUT OF THE PROGRAM WILL NOT PRODUCE ANY REPORT The RESET of the system can be performed in two alternative ways according to the type of alarm occurred see table of the paragraph List of the alarm codes following this appendix pressing for about 3 seconds the PROGRAM SELECTION key An acoustic signal will be generated as RESET confirmation switching off and on the equipment through the mains switch On turning on the sterilizer the normal initial autotest will be performed gt IF THE EQUIPMENT HAS SWITCHED OFF MAINS SWITCH IN OFF BEFORE THE RESET THROUGH THE PROPER KEY WILL CAUSE FURTHER ALARM BLACK OUT cope E000 AT THE NEXT SWITCHING ON IN FACT THE ALARM PROCEDURE WILL BE CONSIDERED NOT COMPLETED IF MISSED THE CORRECT AND COMPLETE RESTORATION After the RESET and the possible technical service the equipment will go in ST
45. ING that generates into the chamber an internal negative pressure to facilitate the steam exhausting Now the LCD display will show 134c POROUS VACUUM DRYING The process signaling remains 37 9 RUNNING THE STERILIZATION PROGRAM Ventilation Ambient pressure levelling Cycle completed 38 The vacuum drying phase is then followed by the ventilation phase VENTILATION during which on maintaining the vacuum into the chamber sterile and fresh air is entered to eliminate the condensation and cool the load On the LCD display appears 134c POROUS VENTILATION The process signaling remains Ended the ventilation phase the chamber will be vented by letting the sterile air enter the chamber LEVELLING that will reach the atmospheric pressure value and allow the door opening to recovery the load LCD display changes to 134c POROUS LEVELLING The process signaling remains As the pressure into the sterilization chamber reaches the pre set safety limits the door locking mechanism will be released Consequently the door status signaling starts flash and contemporary an acoustic warning signaling is generated Now the screen will show 134c PO OUS PL The process signaling is still ON Open the door and recover the sterilized material by using the supplied tray removal tong ON OPENING THE DOOR AND IF PRINTER IS INSTALLED REPORT OF THE STERI
46. ISONYIHL ra FONVISISIY ONVA N STAVO o d Ii anavo Wid vele ve 9 3 Lu ig 9 a ix va WANOWA SIX Moez 5 et 3 xnv z za OzH L 13NOVA 4 wood Aa p ldo s 00L1d AS v 00L1d 35 TYOIOHOL 00 19 e avo 00 18 L TP 00 14 SNV3 n AYVTASIO CHVOBAIM aol ATlvuvd 77 Extrema Plus APPENDIX F DRAWINGS HYDRAULIC DRAWING yue BuiureJq JoBueuoxe 1 tL vAA Jojesouab JodeA Jequieuo UONEZI II9 S _ SAA Extrema Plus Kayes B E oiBojouejoeg Joyy 78 APPENDIX 6 DECLARATION OF CONFORMITY APPENDIX G DECLARATION OF CONFORMITY DECLARATION OF CONFORMITY Application of the EEC Directives 93 42 89 336 73 23 Sistemi innovativi di sterilizzazione Name of the Manufacturer M O COM S r l Manifattura Odontoiatrica Complementare Address of the Manufacturer Via delle Azalee 1 20090 Buccinasco MI ITALY Product description Steam s
47. LIZATION CYCLE WILL BE PRINTOUT CHECK THIS REPORT SIGN ON THE PROPER LINE AND FILE IT IN A SURE PLACE REFER TO THE REPORT EXAMPLES IN APPENDIX B PROGRAMS ON OPENING THE DOOR THE EQUIPMENT GOES IN THE STAND BY STATE REPEAT THE PROCEDURES DESCRIBED IN THE CHAPTER SELECTING THE STERILIZATION PROGRAM IF A NEW STERILIZATION CYCLE HAS TO BE PERFORMED COMPLETED THE PROGRAM AND UNTIL THE DOOR IS NOT OPENED THE HEATING RESISTORS ARE DISABLED ACCORDINGLY THE EQUIPMENT WHATEVER IS THE CURRENT STAND BY MODE COOLS DOWN SLOWLY Now the equipment is ready to perform a new cycle 227 COMPLETED THE PROGRAM WHENEVER THE DOOR IS NOT OPENED THE VACUUM PUMP IS PERIODICALLY ACTIVATED TO REMOVE ANY TRACE CONDENSATE FROM THE STERILIZATION CHAMBER ON THE LCD IT APPEARS ACTIVE SUCT ION f TO STOP PUMP Extrema Plus MANUAL INTERRUPTION OF THE PROGRAM Extrema Plus 9 RUNNING THE STERILIZATION PROGRAM If necessary the program can be manually interrupted by the operator in whatever moment by holding pressed START STOP key for three seconds This command is detected by the equipment as an alarm for the program is not correctly completed Accordingly and until the safety conditions are not reached the LCD display is showing whereas the timer display is showing the error code E999 and an acoustic signaling sounds Reached the safety conditions the machine activates a special procedure asking for a
48. MPLETE IN EVERY PART 4 NA 5 THE COMPLETE TECHNICAL DATA REFER TO APPENDIX A TECHNICAL CHARACTERISTICS Extrema Plus GENERAL INSTALLATION DIRECTIONS ELECTRICAL CONNECTIONS Extrema Plus 4 INSTALLATION In order to assure the correct operation of the equipment and or avoid situations of risk observe the following directions Install the sterilizer on a plain surface eventually adjust the rear feet to match possible irregularities Verify that the plan is able to support the weight of the equipment abt 55 kg Allow a suitable space for the ventilation at least 10 cm each side all around the sterilizer particularly on the back side In case the equipment is set into a piece of furniture verify the respect of the warnings as above indicated avoiding possible obstruction of the air slots Do not install the sterilizer near tubs sinks or analogous places avoiding the contact with water or liquid Otherwise short circuits and or situations of potential danger for the operator could occur Do not install the sterilizer in environments characterized by the presence of excessive humidity or in rooms with poor ventilation Do not install the sterilizer in environments characterized by the presence of inflammable and explosive gas or vapors Install the equipment in such a way the power supply cable could not be bent or crushed The cable should run freely to A C
49. N OF THE EQUIPMENT esa IN ORDER TO AVOID THAT THE HEATING EFFECT INFLUENCES THE VACUUM CHANGE VALUE READ DURING THE VACUUM TEST THE SYSTEM IS PROGRAMMED TO DISABLE THE TEST IF THE CHAMBER TEMPERATURE SENSOR IS READING A VALUE HIGHER THAN 50 C If you are trying to launch the test program with chamber temperature higher than the above preset value LCD will show the following WARNING PT1 TOO HIGH After a few seconds the unit will automatically return in STAND BY mode and will be ready for a new command To quickly fall the chamber temperature and allow the Vacuum Test left open the door until a lower temperature is reached Close the door and launch the program through the START key The program Led VT will flash for all through the program The vacuum phase immediately starts and the LCD display will show VACUUM TEST VACUUM PULSE 43 11 TEST PROGRAMS 44 The Temperature display C will visualize while the Pressure bar and Timer displays will show respectively the real time updated value of the pressure and the total time from the start of the cycle As soon as the preset pressure value 0 90 bar is reached the vacuum pump is arrested and the pressure stabilization phase WAITING activated for 5 minutes LCD display is showing the following message VACUUM TEST WAITING 05 00 During this phase an offset of only 1096 of the vacuum maximum value is admitted without bearin
50. NNECTION A PRINTER ACQUIRING THE ENVIRONMENT PRESSURE VALUE Extrema Plus 4 INSTALLATION To get a control with the most significant data a standard needle i e IBM Proprinter or Epson 70 or thermal printer equipped with Centronics parallel interface can be connected to the sterilizer printer port This strip can be filed as tracability report of the carried out sterilization process 5 IN CASE OF THERMAL PRINTER STORE THE STRIP IN PLACE ADEQUATE FOR PROTECTING IT FROM LIGHT AND OR HEAT SOURCES Connect the printer to the sterilizer port through a parallel cable maximum length 2m provided one side with DB 25 male connector sterilizer side For setting the printer and choice the report characteristics refer to Chapter Setting the equipment gt THE EQUIPMENT IS ABLE TO MANAGE ALSO LASER OR INKJET PRINTERS HOWEVER THESE TYPES OF PRINTERS REQUIRE AT THE END OF EACH PRINTED PAGE A FORM FEED FF INSTEAD OF LINE FEED LF COMMAND THAT IS NOT MANAGED BY THE STERILIZER TO GET THE PRINTOUT WILL BE THEREFORE NECESSARY TO ENABLE THE FORM FEED KEY NORMALLY PROVIDED ON THE PRINTER For the correct operation of internal auxiliary systems it is necessary that the sterilizer acquires the environment pressure value of the installation site before starting the first operation cycle The procedure is described in the Chapter Setting the equipment see paragraph Option selection in the SETUP program Please re
51. OLLOWING MESSAGE WILL BE PRODUCED AND MAINTAINED UNTIL THE DOOR IS NOT OPEN OPEN THE DOOR TO CONTINUE Confirm the command by the key 4 to acquire data The following message will appear RRENT VALUE C E INTO MEMORY U s T followed by an acoustic signal gt TO RENDER EFFECTIVE THE ACQUIRED AMBIENT PRESSURE VALUE IT IS NECESSARY EXIT THE SETUP MODE SWITCH OFF AND THEN ON THE DEVICE BY USING THE MAINS SWITCH 29 6 SETTING THE EQUIPMENT Manual activation of the door locking mechanism DOOR LOCK option of the SPECIAL menu Adjusting the LCD contrast LCD CONTRAST option of the SPECIAL menu EXIT THE SETUP MODE 30 This option may be used to manually activate the door locking mechanism for instance to check its correct operation or to unlock at the end of the cycle the door of the sterilization chamber remained blocked for the failure of the electromagnet By selecting the option DOOR LOCK the following choice is proposed LOCK UNLOCK By the option LOCK key a command pulse is generated to disable the door lock whereas by the option UNLOCK key a reverse command is generated that is to enable the door lock mechanism Use the key to exit the option as the item EXIT is not available in this screen a ON EXITING THE SETUP MODE THE DOOR LOCKING SYSTEM WILL BE AUTOMATICALLY RELEASED Adjust the contrast of the LCD display to compensate different environ
52. PERATING CYCLE EXAMPLE Extrema Plus 3 GENERAL DESCRIPTION The sterilization program of Extrema Plus can properly be described by a sequence of phases each with a well defined activity Considering the example of the most complete program i e program 1 at 134 C for porous material after having loaded the material in the chamber closed the door selected the program and started the cycle by the START key with consequent blocking of the door locking mechanism the following sequence will run 1 Pre heating of the steam generator and sterilization chamber 2 Chamber air removal and steam penetration inside the load through a series of vacuum fluid exhaustion from the sterilization chamber and pressure phases steam entering into the chamber 3 Pressure increasing with consequent steam temperature increasing up to the preset sterilization conditions for the example 134 C 4 Stabilization of the pressure and temperature conditions inside the sterilization chamber Run of the sterilization process for the preset time for the example 4 minutes Chamber pressure decreasing through steam discharge Vacuum drying phase Venting phase through sterile air NO m Chamber pressure leveling up to atmospheric value As reached this last phase the door locking mechanism will be released and the door can be opened to recovery the load from the sterilization chamber paying attention to use proper precautions
53. RAM GENERAL STARTING THE STERILIZATION PROGRAM SEQUENCE OF PROCESS Preheating Extrema Plus 9 RUNNING THE STERILIZATION PROGRAM The sterilization program runs along a cycle characterized by a lot of phases The number and the duration of the phases can differ between the programs depending on the air exhausting sterilization process and drying modes The electronic control system monitors the running of the different phases verifying at the same time if the parameters are correctly respected if whatever type of anomaly is detected during the cycle the program will immediately be interrupted and enter in alarm status identified by code and proper message showing the nature of the problem With this type of control the perfect sterilization in every condition will be guaranteed whatever is the sterilization program selected Now that the load is arranged into the sterilization chamber with the precautions described on the Chapter Preparing the material to be sterilized and the desired program selected close in right way the door The Door Status Led GI is flashing door closed Push on the key START The door locking mechanism is engaged The Door Status Led changes to ON state door locked After the START command and for all the sterilization cycle the displays will show the following values Temperature Display temperature of the sterilization chamber C Pressure Disp
54. STEAM STERILIZER Extrema Plus OPERATING MANUAL Edition 2 OCOI Revision 2 Date May 2004 Sistemi innovativi di sterilizzazione TABLE OF CONTENTS UPDATING The following table lists the updating history of the Operating Manual The field Description shortly explains the modifications Rev Date Description 09 99 First issue LA oo pes sese O 1 2 090t Pegesdand _ _______ 08 01 Declaration of Conformity 2 11 01 Updating to EPROM release 2 08 02 New phone number and e mail address page 83 05 04 Afew text changes TABLE OF CONTENTS T FOREWORD S 1 Symbols used through the 1 APPLICABLE EUROPEANS 1 YSE IDENTA OAT O N ua cocta nee eere Ere aaa 1 Important rotes eoi uu rice E Eee ceo tecti e Bassa cor ie cete ta boe esa Ez ea ba bees 1 SCOPE OF THE MANUAL oretenus dese sabes eran 2 GENERAL WARNINGS edet etre een Rel folie a M eie 2 2 PACKAGE CONTE N iii 3 DIMENSIONS AND WEIGHT 3 PACKING CONTENTS hee enel eher tents 3 LIFTING AND TRANSPOR ahi tttm eerte eerte 4 3 GENERAL DESCRIPTION e erret ere neee s ae nhu anna nnno neuen nua nana na aane anna au nns 5 INTRODUCTION L su ustusqa nias u a tete ab te anzi 5 GENERAL BEAT RES iz cece nitet yma ae ana ea 5 FRONIDEVICES 5 Sasan uni
55. Set Saam iii 6 REAR DEVIGES uuu unan 7 CONMMAND PANEL u usu iena E 8 OPERATING GYCLE EXAMPLE ul L i 9 METTRE 10 INTRODUCTIONS ih RL ni ee age 10 Dimensions and weight i 10 5 fasti cla E a ain reet Ioia iii iii lele eg arenas 10 DIMENSIONS FOR BUILD MOUNTING 10 GENERAL INSTALLATION DIRECTIONS essent nne 11 ELECTRICAL CONNEG TIONS cortice ertt toe erc meth 11 CONNECTING THE DRAINING TANK nennen enne enne nnne 12 CENTRALIZED DRAINING SYSTEM CONNECTION 13 Extrema Plus 1 TABLE OF CONTENTS EXTERNAL FILLING TANK CONNECTION 14 CONNECTION TO A PRINTER ii 15 ACQUIRING THE ENVIRONMENT PRESSURE VALUE 15 BS FIRST START UP ione 16 SWITCHING ON i iecit ata te an eren n lee d rests cere densi dd 16 INITIAE SELCE TEST rm 16 ACQUISITION AND AUTOMATIC UPDATING OF THE ENVIRONMENTAL PRESSURE VALUE tent then unen miele i ieri 16 STAND BY STATE lo gia inclini 17 FILLING THE DISTILLED WATER rennen 17 orc tee te Re ERR OE SEIS EORR EAA i 17 Automatic a
56. THE CORRECT STERILIZATION PROGRAM MUST BE SELECTED BY REFERRING TO THE TABLE OF THE NEXT PAGE Extrema Plus APPENDIX PROGRAMS OVERVIEW THE AVAILABLE PROGRAMS NOMINAL MAIN DATA OF THE VALUES PROGRAM 21851 ul 22 E x E PROGRAM D El EB a AUTOCLAVABLE NOTES 5 E 5 eo SE co NAME toc ve 5 5 MATERIAL 50 2s 3 E 3 rg Eo 9 gt Q2 amp Z Ped o a Sz gE o L3 Il 3 Il u uU E 2 134c Porous material Fixed on preset nr 1 134 0 50 Wrapped hollow not changeable POROUS instruments Porous material 134c PRION 134 0 50 Wrapped hollow instruments 424c Porous material 121 E 42 48 0 45 Wrapped hollow POROUS instruments 134c Unwrapped hollow 121 sme mpm ER 1 _ sito meae s s welon memes ___ iisas Unwrapped solid 134c 134 240 3 5 EMERGENCY instruments 134 134 2 10 4 gt Material and instruments Cycle duration CULTO or or or F S L C n d n d according to the depending on the 121 1 10 20 gt configured cycle setting up _ Test device VACUUM TEST Rea nana Empty Empty chamber EN N o MAX LOAD 0 5 kg 0 30 FAST Extrema Plus 49 APPENDIX PROGRAMS DIAGRAMS OF THE STERILIZATION PROGRAMS 4 Pressure bar FRACTIONATED VACUUM 4 Pressure bar PROCESS PROCESS
57. THE INDICATIONS CONCERNING THE WATER SEE APPENDIX A TECHNICAL CHARACTERISTICS For the setting of the automatic filling option refer to Chapter Setting the equipment THE AUTOMATIC FILLING SYSTEM NEVER HAS TO WORK DRYED A PREMATURE USURY OF THE AUXILIARY WATER INJECTION POMP MIGHT OCCUR PERIODICALLY VERIFY THE LEVEL OF THE WATER INTO THE EXTERNAL TANK DRAINING TANK The max water level value in the draining tank is properly signaled by the alternate turning WATER LEVEL on of the red Led MIN and green Led MAX on the command panel of the unit Provide for the draining of the external tank SIGNALING ani DO NOT DRAIN COMPLETELY THE TANK BUT LEAVE LAYER OF WATER CORRESPONDING X TO THE SIGN STAMPED ON THE TANK OTHERWISE THE SOUND LEVEL OF THE WATER DISCHARGE AND THE OUTFLOW OF THE STEAM FROM THE VENT HOLE WILL INCREASE CONSIDERABLY IN CASE OF WRONG LEVEL SIGNALING ON THE COMMAND PANEL THE WATER LEVEL IN THE DRAINING TANK IS LOWER THE MAX LEVEL CHECK FOR THE CORRECT CONNECTION OF THE PROBE S PLUG INTO THE REAR SOCKET OF THE UNIT A FALSE CONNECTION CAUSES THIS WRONG SIGNALING 18 Extrema Plus SETTING THE EQUIPMENT INTRODUCTION STARTING THE SETUP PROGRAM m FUNCTION OF THE KEYS IN SETUP MODE Extrema Plus 6 SETTING THE EQUIPMENT Extrema Plus offers new and wider customization possibilities The configuration of the sterilizer can be suited to user s demands by
58. TIL LCDCONTRAST IS CLOSED DOOR OPENING EXIT LOCK UNLOCK INCREASE DECREASE ESC TO EXIT ACCESSIBLE BY TECHNICAL SERVICE ONLY FLOWCHART OF THE SETUP MENU In SETUP mode various menu options are available and organized on more levels through connected in logical way X USE KEY AND TO SCROLL THE OPTIONS THE XXXc XXXXXX XXXX KEY 1 TO CONFIRM STORE THE CHOICE SELECT EXIT ITEM AND CONFIRM WITH KEY OR USE KEY TO COME BACK ONE MENU LEVEL CONFIRMING STORING THE LAST OPTION YOU COME BACK AT THE CORRESPONDING 2 og 2 MENU LEVEL EXIT SETUP MODE AND RETURN TO STAND BY MODE 20 Extrema Plus DESCRIPTION OF THE MENU OPTIONS Extrema Plus 6 SETTING THE EQUIPMENT On the following the meaning of the main menu and second level options are described MAIN MENU The main menu of the SETUP program has 6 options that recall further menus second level BASIC basic options ADVANCED advanced options SPECIAL special options SERVICE not user available REVIEW review of the selected options EXIT exit the SETUP mode and return to normal operation See paragraph Exit the SETUP mode gt THE WAY FOR SETTING THE DIFFERENT OPERATING MODES IS DESCRIBED ON THE PARAGRAPH SETTING THE OPTIONS IN THE SETUP MODE BASIC Menu BASIC menu basic options is formed by the following options LANGUAGE current language setting DATE curr
59. UCT IS NOT CORRECTLY INSTALLED AND USED OR A SUITABLE MAINTENANCE IS NOT OPERATED THE MANUFACTURER CANNOT BE CONSIDERED RESPONSIBLE OF POSSIBLE BREAKS MALFUNCTIONS DAMAGES LESIONS TO PROPERTY AND OR PEOPLE THE USER IS RESPONSIBLE FOR THE LEGAL FULFILLMENTS CONCERNING THE INSTALLATION In order to avoid any danger situations with possible consequent damages or lesions to property and or people the following precautions should be followed Use high quality distilled water only The use of water of inadequate quality could seriously damage the equipment See Appendix A Technical Characteristics Do not pour any water or liquids over the equipment Do not pour inflammable substances over the equipment Do not operate on the equipment in presence of explosive or inflammable gas Before any maintenance or cleaning action ALWAYS REMOVE the power mains If this precaution is impossible or the external mains breaker is far or not visible from the people performing the maintenance affix the poster WORKS IN PROGRESS on the external breaker after having positioned it on OFF Make sure that the electric plant is provided with the earth connection in accordance with the current laws Do not remove any label or plate from the equipment in case call for new ones Use exclusively original spare parts THE NOT OBSERVANCE OF WHAT ABOVE DESCRIBED MAKES ANY RESPONSIBILITY OF THE MANUFACTURER TO DECAY E
60. UPPLIED THE MANUFACTURER OF THE PACKING MATERIAL FOR THE MAXIMUM STORING TIME ADMITTED 41 11 TEST PROGRAMS TEST PROGRAMS OVERVIEW HELIX TEST HT 42 For protecting both operator and patient safety the functionality and effectiveness of an important process as the sterilization of medical devices must be periodically verified For this reason Extrema Plus offers the possibility to perform in simple and automatic way two different test programs e Helix Test HT e Vacuum Test VT Helix Test HT allows to perform a cycle at 134 C characterized by a special time of the sterilization phase 3 5 min the cycle is provided with fractionated vacuum like the POROUS and HOLLOW programs Through a proper device it is possible to value the correct penetration of the steam inside the porous loads see next paragraph Such cycle is also proper to measure the penetration of the steam inside the porous loads standard Bowie amp Dicks test packet Vacuum Test VT allows to verify the perfect watertight of the hydraulic circuit of the sterilizer By measuring the vacuum offset within a stated time and comparing it with preset limit values it is possible to determine the quality of the sterilization chamber and connecting pipelines watertight For selecting the HT program press one or two times the TEST SELECTION key until the relative signaling turns on LCD display visualizes HELIX TEST STAND BY
61. a Plus is a sophisticated equipment but of very friendly use adaptable to the different demands thanks to the wide possibilities of configuration and choice of the cycles The equipment is able to treat in fast way every type of load through various patented systems and the operation completely microprocessor controlled Besides Extrema Plus allows a better approach by the user that rather than to conform himself to the machine characteristics can communicate with it for configuring the performances to the different job requirements Extrema Plus thanks to the friendly use reduced dimensions and agreeable design represents the ideal partner for the professional requiring the maximum sterilization safety Extrema Plus is a completely microprocessored steam sterilizer with a 17 litres sterilization chamber It is characterized by an advanced fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by an effective final vacuum drying phase able to eliminate any trace of condensation from the load An exclusive steam generation system combined with the electronic management and high accuracy sensors guarantees an high process speed and high stability of the thermodynamic parameters during the whole sterilization process All this guarantees a perfect result Extrema Plus offers 11 sterilization programs including one program completely programmable optimized for an effective and f
62. ad carefully the indications supplied THE EQUIPMENT LEAVES THE FACTORY WITH THE PRESSURE VALUE RELATING THE PRODUCTION ENVIRONMENT STORED INTO THE MEMORY NOT CORRECTLY WORK WITH DIFFICULT OR IMPOSSIBLE DOOR OPENING AT THE END OF N IF THE PRESSURE ACQUISITION PROCEDURE IS NOT PERFORMED THE EQUIPMENT WOULD THE PROGRAM 15 5 FIRST START UP FIRST START UP Once the sterilizer has correctly been installed you can proceed to the switching on and equipment configuration SWITCHING ON Switch on the sterilizer through the mains switch mounted on the rear side gt gt PERFORM THIS ACTION WITH THE DOOR OF THE STERILIZER IN OPEN POSITION IN ORDER TO ALLOW THE INITIAL CONTROL OF THE SAFETY SYSTEM TO OPERATE CORRECTLY INITIAL SELF TEST At the switching on the equipment turns on in sequence all the front indicators of the command panel allowing a visual check by the user for possible anomalies The turn on of the signaling is accompanied by an acoustic signal Ended this check phase the machine performs the automatic test of the safety block of the closing system On the liquid crystal display LCD the following message will appear EXTREMA PLUS SELFTEST LS IF THE DOOR WAS CLOSED THE AUTOMATIC TEST OF THE SAFETY BLOCK CANNOT OCCUR AND THE SELF TEST IS INTERRUPTED ON THE LCD DISPLAY THE FOLLOWING MESSAGE APPEARS ACCOMPANIED BY ACOUSTIC SIGNALS v om z x m n C 2
63. adapting for instance the characteristics of the machine depending on the use frequency and the type of material to be treated Through a sophisticated SETUP program a lot of options can be selected by the user through a friendly and easy menu EF USE THE SETUP PROGRAM EVERY TIME YOU NEED A CORRECT CUSTOMIZATION OF THE EQUIPMENT ALLOWS TO GET THE BEST PERFORMANCES AND THE MAXIMUM SATISFACTION FOR THE USE 57 Assistenza CLIENTI M O COM SEE APPENDIX Z IS AT DISPOSAL OF THE USERS TO SUPPLY SUGGESTIONS OR ADVICES FOR THE BETTER USE THE OPTIONS AVAILABLE IN THE SETUP PROGRAM To enable the SETUP program push for a few seconds on the SETUP key the lowest key on the command panel up to the liquid crystal display shows EXTREMA PLUS SETUP The Led closed the key turns on and stays on for all the setup phase to signal this operating status After a moment the display will show PRESS Press the key ENTER 4 to enter the SETUP program Now the display is showing the first level options of the menu see paragraph Flowchart of the SETUP program On the contrary press the key ESC fl to exit the SETUP program and return to the normal operation gt THE SETUP PROGRAM CAN ONLY RECALLED FROM STAND BY STATE DURING THE EXECUTION OF THE PROGRAM THE SETUP MODE CANNOT BE ACCESSED In the SETUP mode the keys have the function indicated on the right of the key on the background of the command panel and differs from the normal
64. alized draining circuit to match this new link consult a specialized plumber Connect the opposite end of the pipe to the draining plant and verify the sealing Check that the pipe is running freely from the external tank to the centralized draining plant without any bend crush or obstruction Sterilizer zx m Da Draining tank The elements should be arranged according to the following scheme example Connection point to the centralized system CENTRALIZED SYSTEM Connection point to the draining tank STATED X THE GROUND FITTING POINT HEIGHT ON THE TANK THE CONNECTION POINT TO THE CENTRALIZED DRAINING SYSTEM MUST BE AT A QUOTA lt 30 MM HIGHER QUOTAS CAN JEOPARDIZE THE CORRECT EMPTYING OF THE TANK 13 4 INSTALLATION ocom EXTERNAL In order to eliminate the recurrent manual distilled water topping up see Chapter First FILLING TANK start up it is possible to connect the sterilizer to the supplied external filling tank 10 1 CONNECTION that should be periodically filled by the user automatic filling In this case the filling of the internal reservoir will be automatically controlled by a pump as feature soon as the water level of the internal reservoir reaches the MIN level For the correct connection of the filling tank proceed as follows Mount the supplied tap on the bottom hole of the filling tank use the teflon rubber or other sealing to get a perfect seal Mount the
65. amber and the pressure increases 1 PRESSURE PULSE up to reach the preset value LCD display shows 134c POROUS 1 PRESSURE PULSE The process signaling remains turned off At the end of the pressure phase the steam is discharged and starts the second vacuum phase of the sterilization chamber 2 VACUUM PULSE LDC display shows 134c POROUS 2 VACUUM PULSE The process signaling remains turned off The second vacuum phase is followed by a new steam enter into the sterilization chamber and consequently the pressure raises once again 2 PRESSURE PULSE LCD display shows 134c POROUS 2 PRESSURE PULSE The process signaling remains turned off Follows a new discharge of the steam and the start of a third vacuum phase 3 VACUUM PULSE LCD display shows 134c POROUS 3 VACUUM PULSE The process signaling eO remains turned off This vacuum phase is followed by a last steam enter into the sterilization chamber and the pressure increases once again 3 PRESSURE PULSE up to the value preset for the sterilization process On the LCD display appears 134c POROUS 3 PRESSURE PULSE The process signaling eO remains turned off Extrema Plus Thermodynamic equilibration Sterilization process Steam discharge Vacuum drying Extrema Plus 9 RUNNING THE STERILIZATION PROGRAM On reaching the pressure and temperature values for the selected program the program waits few sec
66. ast sterilization of different tools and materials used in medical environment particularly the dental one Four programs is directly recalled through a proper selection key on the command panel Program 1 is preset and not modifiable cycle at 134 C for porous material whereas the programs 2 3 and 4 can be modified by the user in order to have at one s disposal those more proper to the needs Besides the sterilization programs the sterilizer offers the facility to choice the preheating modes STAND BY according to the frequency usage and the drying modes according to the selected program type and possible problems occurring with some loads or special materials The print options of the cycle reports the water filling possibilities and other features can be completely configurable For more information refer to Chapter Setting the equipment Finally Extrema Plus has the most sophisticated and advanced safety systems in order to guarantee the user against possible operation anomalies both electric mechanics thermal and biologic type 5 FOR THE DESCRIPTION OF THE SAFETY DEVICES REFER TO APPENDIX A TECHNICAL CHARACTERISTICS 3 GENERAL DESCRIPTION FRONT DEVICES Door handle Command panel Door Parallel printer interface 25 pin connector Serial interface 9 pin connector Bacteriologic filter 279 Resin sponge Porthole Filling point of the distilled
67. astic part downward tray side and the paper part upward Verify the correctness of this position reversing it if necessary f possible arrange the envelopes on the edge by using a proper stand Never pile up the envelopes ALWAYS WRAP THE TOOLS IN CASE OF PROLONGED STORE SEE ALSO THE CHAPTER PRESERVING THE STERILIZED MATERIAL 33 8 SELECTING THE STERILIZATION PROGRAM SELECTING THE STERILIZATION PROGRAM INTRODUCTION ABOUT THE SELECTION 34 The program choice is fundamental for the success of the sterilization process Since every tool or material has conformation consistence and different characteristics it is very important to individualize the more suitable program both to preserve its physical characteristics avoiding or however limiting any alterations and to guarantee the better sterilization effectiveness LS GUIDE FOR SELECTING THE PROPER PROGRAM VERSUS THE LOAD IS SHOWN IN THE APPENDIX B PROGRAMS Switch on the equipment as described in the Chapter First start up The display doesn t propose any active pre selection The equipment is waiting for the program selection by the user Operate on the Program Selection key pressing it one or more times up to the desired program preset program 1 2 3 or 4 signaled by the turning on of the relative Led The temperature C pressure bar and time displays will show the set point values of the selected cycle
68. ature of the the materials program sterilization program selected according to the material to be treated See Table in Appendix B Programs The printer if installed Printer not switched on Switch on the printer doesn t print the report P 7 Parallel cable not correctly Verify that the cable used is suitable for the printer and connected or wrong model correctly connected Sterilizer not correctly configured Provide for setting the equipment according to the for the use of the printer used printer See Chapter Setting the equipment gt IF THE PROBLEM PERSISTS CALL FOR THE CUSTOMER SERVICE SEE APPENDIX Z BY COMMUNICATING THE MODEL AND THE SERIES NUMBER OF THE STERILIZER THESE DATA MAY BE FOUND ON THE MANUFACTURING PLATE ON THE REAR SIDE OF THE EQUIPMENT AND ON THE GUARANTEE CERTIFICATE 64 Extrema Plus APPENDIX D GENERAL PROBLEMS MANUAL RELEASE OF THE DOOR LOCKING MECHANISM In case of failure of the door safety lock it is possible to release it manually through the supplied tool Operate as follows 1 om Move forward the sterilizer putting it out the support plane of some centimeter in order to access the hole corresponding to the mechanism movement axle Firmly hold the equipment pay attention do not fall it down avoiding damages or injuries to property and or people Insert the special supplied tool Ref 15 see page 3 into the hole below the frame Screw
69. ct connection of the tank proceed as follows Mount the ends of two supplied pipes on the fittings marked A and B taking care to plug in completely the pipes Lockthe pipes on the fittings by using the supplied plastic clips Cut the pipes according to the desired distance and mount the opposite ends on the two fittings of the draining tank taking care to match the correct connection A A and B B as shown in the figure Lockthe pipes on the fittings by using the supplied plastic clips CHECK THAT THE CONNECTED PIPES RUNNING FREELY FROM THE UNIT TOWARDS THE DRAINING TANK WITHOUT ANY BEND CRUSH OR OBSTRUCTION Plug the jack of the level probe in the socket mounted on the rear side of the equipment see figure CHECK FOR THE CORRECT INSTALLATION OF THE SILENCER ON THE FITTING OF THE Clips 9 Level probe Silicone pipes Vent hole Draining tank Minimum water level CHECK FOR THE CORRECT MOUNTING OF THE PLUG IF NOT CONNECTED THE EQUIPMENT WILL DETECT A FALSE MAX LEVEL IN THE DRAINING TANK WITH CONSEQUENT LIGHTING OF THE LED ON THE COMMAND PANEL SEE CHAPTER 5 FIRST START UP AND ALARM SIGNALING GENERATION IF THE START COMMAND IS ENTERED Fill the tank of normal tap water up to the l
70. ctions for their solution are supplied in the following ANALYSIS AND RESOLUTION OF THE PROBLEMS If Your sterilizer doesn t work correctly please perform the followings verifications before contacting the Customer Service PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION The sterilizer doesn t switch on After the START command the sterilization cycle doesn t start The red Led MIN turns on The red Led Alarm turns on The safety valve intervenes 62 The plug of the power supply cable is not correctly plugged in the socket Voltage lack at the output socket The mains switch and or the automatic circuit breaker are in OFF state The mains fuses are burned The equipment is performing the pre heating phase WARMUP The distilled water level of the internal reservoir is lower the minimum level An alarm signaling has been generated with a proper code see TIMER display and message see LCD display Anomalous over pressure inside the chamber Plug in correctly the power supply cable Verify the cause of the voltage lacking and try to recovery it Set the switch in ON position Replace the fuses with others of the same type and value See Appendix A Technical characteristics Wait for the sterilizer reaches the correct thermal conditions for the start of the sterilization cycle NOTE Under normal operating conditions the preheating average time is about 12 minutes Topping up the
71. devices Method for the validation and systematic control of the steam sterilization and EN 556 Sterilization of the medical devices Requirements for the medical devices marked with STERILE indication supply an effective guide tool for carrying out the verifications on the steam sterilizers Since these controls require besides a specific experience and knowledge the use of a special tools high accuracy sensors and probes data logger dedicated software etc properly verified and adjusted it is necessary to address to companies specialized in this activity Assistenza Clienti M O COM see Appendix Z is at your disposal to supply every possible information concerning the periodic validation of the sterilizers 61 APPENDIX D GENERAL PROBLEMS APPENDIX D GENERAL PROBLEMS OVERVIEW If during the equipment use a problem or an alarm signaling occurs it is not the case to immediately worry This could not be caused by a breakdown but more probably by an abnormal situation often only transitory for instance a black out or by an incorrect use In any case it is important to individualize beforehand the cause of the anomaly and to carry out the opportune corrective actions autonomously or by calling the Customer Service To this purpose the indications for the diagnosis and resolution of the general problems as well as an accurate description of the alarm codes their meaning and the consequent a
72. e see Appendix Z Problem on the hydraulic circuit Wrong operation of the water pump Call for the Customer Service see Appendix Z Problem on the hydraulic circuit Release of the steam generator Provide for the manual reset of the thermostat on the rear side of the safety thermostat equipment see Chapter Product description Unscrew the protection plastic cap push on the red button until a click and replace the cap Switch off RESET and switch on the equipment Release of the heating resistor safety thermostat Call for the Customer Service see Appendix Z Wrong operation of the steam generator or heating resistor Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Too much load Perform the RESET according to the instructions Verify the quantity of material into the sterilization chamber and pay attention to not exceed the maximum admitted quantity according to the load typology see Table in Appendix A Technical characteristics Problem of the hydraulic circuit Call for the Customer Service see Appendix Z Release of the steam generator Provide for the manual reset of the thermostat on the rear side of the safety thermostat equipment see Chapter Product description Unscrew the protection plastic cap push on the red button until a click and replace the cap Switc
73. e back side of the sterilizer Loosen the grained ferrule with the fingers or with a proper tool inserted in the two holes of the ferrule and turn counterclockwise until you get the stop and the idle stroke Screw the ferrule again Repeat the operation at least for a couple of times At the end tighten the ferrule definitively THIS OPERATION IS NECESSARY TO GUARANTEE THE CORRECT OPERATION OF THE VALVE IN THE COURSE OF THE TIME At the end of the maintenance verify that the ferrule is completely tighten and locked During the use the accumulation of residues within the filter could gradually obstruct the lower draining duct For cleaning or replace the filter open the door of the sterilizer and remove the nut 1 with a hexagonal wrench n 14 Then remove the water stopper 2 and the relative gasket and by the same wrench unscrew the fitting 3 for accessing the filter 4 Remove the filter from the support and carefully clean it under a throw of running water using if necessary a pointed tool to remove possible extraneous bodies of greater dimensions If the filter cannot be recovered provide for the replacement with a new one Plug the filter in the support blocking it with a drop of pipe fitting sealing if available Reassemble all the parts following in opposite order the procedure paying attention to let the draining holes 5 remain at the level of the chamber wall Periodically eliminate the bacterial charge of the bact
74. e of the vacuum pump Call for the Customer Service see Appendix Z Problem on the hydraulic circuit 74 Extrema Plus APPENDIX ALARM SIGNALING CODE POSSIBLE CAUSE SUGGESTED SOLUTION A257 Wrong operation of the water pump Problem on the hydraulic circuit Call for the Customer Service see Appendix Z Release of the steam generator Provide for the manual reset of the thermostat on the rear side of the safety thermostat equipment see Chapter Product description Unscrew the protection plastic cap push on the red button until a click and replace the cap Switch off RESET and switch on again the equipment Release of the heating resistor safety thermostat Call for the Customer Service see Appendix Z Wrong operation of the steam generator or heating resistor Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Excess of load Perform the RESET according to the instructions Verify the quantity of material in the sterilization chamber and pay attention to not exceed the maximum admitted quantity according to the load typology see Table in Appendix A Technical characteristics Problem on the hydraulic circuit Call for the Customer Service see Appendix Z Release of the steam generator Provide for the manual reset of the thermostat on the rear side of the safety the
75. e pipelines towards the draining tank is connected to the tank completely fitted verify that the proper clamps are positioned on the pipes Lack of the closing tap of the tank Arrange the plastic screw tap on the tank in order to avoid accidental water escape Sterilization chamber draining filter Provide for the cleaning or replacement of the draining obstructed filter see Appendix C Maintenance Draining circuit obstructed or Verify the draining pipes and the fittings on which they draining pipes obstructed are fitted are without obstructions and runs freely from the equipment to the condensation recovery tank Air slots on the sides and or on the Remove every possible obstruction from the air slots rear obstructed or heat exchanger and from the heat exchanger insuf eiently aired Verify the equipment is not on direct contact with walls or surfaces see Chapter Installation 63 APPENDIX D GENERAL PROBLEMS POSSIBLE CAUSE PROPOSED SOLUTION Excessive damp on the Excess of material inside the Verify the quantity of sterilized material and make sure material and or the tools chamber do not overcome the maximum admitted quantities at the end of the according to the typology of the load progran See overview table in Appendix A Technical characteristics Load not correctly arranged Arrange the load particularly the wrapped one according to the indications
76. ent date setting TIME current time setting EXIT exit the BASIC menu and return to main menu ADVANCED menu ADVANCED menu advanced options is formed by the following options PROGRAMS preset sterilization programs selection as shown on the front panel by LED s 2 3 and 4 STAND BY stand by mode setting DRYING OPT dry mode setting PRINT OPT printer and printing option setting FILLING reservoir filling mode setting EXIT exit the ADVANCED menu and return to main menu SPECIAL menu SPECIAL menu special options is formed by the following options SET 0 bar local pressure acquiring DOOR LOCK door locking mechanism activation LCD CONTRAST display contrast adjustment EXIT exit the SPECIAL menu and return to main menu SERVICE menu SERVICE menu can be accessed by M O COM Service ONLY REVIEW menu REVIEW menu recall the current settings of the machine allowing the user to verify the exactness The following screens are available each formed by two lines LANGUAGE language that has been set XXXXXXX ENGLISH other language DATE date that has been set dd mm yyyy day month year TIME time that has been set hh mm hour minutes 21 6 SETTING THE EQUIPMENT DEFAULT SETTINGS 22 2nd PRESET XXXc XXXXXX 3rd PRESET XXXc XXXXXX 4th PRESET XXXc XXXXXX STAND BY XXXX DRYING OPTIONS XXXXX XXXXX PRINT OPTIONS XXXXX XX AUTOFILLING XXXXXX EXIT REVIEW pres
77. eriological filter by means of a sterilization process at 121 C for porous material program 121c POROUS At the end of the program screw it completely on the support THE PROCESS STERILIZATION DOESN T REMOVE THE OBSTRUCTION OF THE FILTER NEITHER PROLONGS IN ANY WAY ITS LIFE THEREFORE PLEASE FOLLOW THE REPLACEMENT INTERVALS AS REPORTED ON THE SCHEDULED MAINTENANCE TABLE At the expiration of the stated interval or whenever a visible obstruction of the filter is noticed signaled by a color markedly tending towards the grey unscrew the bacteriologic filter from the support replace it with a new one that must be screwed completely on the fitting LS SPARE BACTERIOLOGICAL FILTER IS SUPPLIED WITH THE EQUIPMENT TO REQUIRE ADDITIONAL FILTERS REFER TO THE APPENDIX Z SERVICE Extrema Plus PERIODIC VALIDATION OF THE STERILIZER Extrema Plus APPENDIX MAINTENANCE As for every equipment a decadence of the performances and components during the life depending on the utilization type and frequency is inevitable In order to guarantee a constant process safety it is necessary to verify at periodic expiration possibly yearly the process thermodynamic parameters pressure and temperature checking if these are remaining within admitted limits or not The performance validation of the sterilizer is at care and responsibility of the user The reference European standards EN 554 Sterilization of the medical
78. es on the left and all those that was initiated on the right LS THE CYCLE IS CONSIDERED INITIATED AT THE START COMMAND OF THE STERILIZATION CYCLE FIRST VACUUM PHASE EXCLUDING THE PREHEATING PHASE THE CYCLE IS CONSIDERED COMPLETED IF THE END OF THE PROGRAM IS REACHED SEE CHAPTER RUNNING THE STERILIZATION PROGRAM At regular intervals the following message alternates on the display STAND B Y MANUAL FI where the upper line shows the setting of the preheating mode STAND BY and lower line the filling mode of the distilled water reservoir FILLING LS THE DATE AND TIME SETTING AS WELL AS THE CHOICE OF THE PREHEATING MODES STAND BY AND RESERVOIR FILLING FILLING REFER TO CHAPTER SETTING THE EQUIPMENT The command panel shows all the LED s turned off apart the door status and water MIN MAX level signaling At the switching on of the equipment the led MIN will normally be turned on The displays will show Temperature display C current sterilization chamber temperature Pressure display bar current sterilization chamber pressure Timer display amp p The equipment is frozen waiting for the selection by the user of the desired sterilization program see Chapter Selecting the sterilization program Before using the sterilizer the first time and all the next times the red indicator MIN of the water level turns on it is necessary to fill or top up the distilled water reservoir Operate in
79. et program associated to Led 2 of the front panel name of the sterilization program preset program associated to Led 3 of the front panel name of the sterilization program preset program associated to Led 3 of the front panel name of the sterilization program stand by mode that has been set OFF LOW HIGH dry type that has been set LONG SHORT STND standard INTEL intelligent EXTRA STND standard FAST printer type selected printout number OFF CR CR LF number of copies tank filling mode that has been set ON automatic OFF manual exit REVIEW menu gt FOR THE OF THE ABOVE TERMS PARAGRAPH SETTING THE OPTIONS IN SETUP Extrema Plus is delivered with the following default settings DATE current date TIME current hour PROGRAMS Preset 1 134 C POROUS not modifiable by the user Preset 2 134 C HOLLOW modifiable by the user Preset 3 134 C SOLID modifiable by the user Preset 4 134 C EMERGENCY modifiable by the user THE PROGRAMS UNDER THE PRESETS 2 3 AND 4 PREFERRED SETTINGS OTHER COMBINATIONS ARE POSSIBLE FOR DIFFERENT MARKETS STAND BY HIGH DRYING Long STANDARD Short STANDARD PRINT Printer OFF Nr of copies 1 FILLING MANUAL Extrema Plus SETTING THE OPTIONS IN SETUP MODE Language option LANGUAGE option in the BASIC menu Date option DATE option in the BASIC menu Time option
80. evel marked on the tank PERIODICALLY EMPTY THE TANK HAVING CARE TO LET ALWAYS MINIMUM OF WATER INSIDE THE TANK CORRESPONDING TO THE MARKED LEVEL OTHERWISE THE NOISE CAUSED BY THE STEAM DISCHARGE AND THE STEAM EXHAUSTION FROM THE VENT HOLE WILL INCREASE NOTICEABLY NORMALLY HOT WATER AND PRESSURIZED STEAM GOES OUT FROM THE DRAINING FITTINGS CAREFULLY CONNECT ALL ELEMENTS OF THE DRAINING CIRCUIT IN ORDER TO AVOID DAMAGES AND INJURIES TO PROPERTY AND OR PEOPLE Extrema Plus CENTRALIZED DRAINING SYSTEM CONNECTION Extrema Plus 4 INSTALLATION To avoid the recurrent emptying of the draining tank it is possible to directly connect it to a centralized draining system In this case proceed as follows Remove the pipe fitting from the free vent hole remove the screw plug from the side fitting of the tank and screw it on the previous vent hole Screw a supplied 1 8 pipe fitting on the side fitting Use teflon ribbon or fitting sealing to get a perfect seal Use one spanner for holding the nut and a second spanner for tightening the pipe fitting Mount on the fitting a pipe of suitable material and sizes not supplied taking care to plug in it completely Lock the pipe on the fitting by using the supplied plastic clips Plug Free tube LF fitting To the zs draining plant B JH gt Draining Tube fitting Teflon Adapt the centr
81. f re usable surgical instruments and material THE USE OF THE EQUIPMENT IS STRICTLY LIMITED TO QUALIFIED PERSONEL NO GROUNDS JUSTIFY THE EQUIPMENT USE OR HANDLING BY UNSKILLED AND OR UNAUTHORISED PERSONEL THE DEVICE MUST NOT BE USED FOR THE STERILIZATION OF FLUIDS LIQUIDS OR PHARMACEUTICAL PRODUCTS s THE INFORMATION INCLUDED IN THIS MANUAL ARE SUBJECT TO CHANGES WITHOUT ANY NOTICE s MO COM LTD Co WON T BE RESPONSIBLE FOR DIRECT INDIRECT ACCIDENTAL CONSEQUENT DAMAGES OR OTHER DAMAGES RELATED TO THE SUPPLY OR THE USE OF SUCH INFORMATION gt REPRODUCTION MODI FICATIONS OR TRANSLATION OF THIS MANUAL OR PARTS OF IT IS FORBIDDEN WITHOUT PREVIOUS WRITTEN AUTHORIZATION BY M 0 COM LTD Co 1 FOREWORDS SCOPE OF THE MANUAL GENERAL WARNINGS The present manual has the scope to supply instructions for general knowledge of the product correct installation and configuration sure and efficient use correct treatment of the material before and after the sterilization In the appendix you will find technical characteristics of the product Specifications of the sterilization programs maintenance procedures analysis and solution of the problems additional documentation The product should be used in compliance with the procedures described in the manual and never for purposes differing from the foreseen ones AND USE OF THE PRODUCT IF THE PROD
82. f the cycle we recommend to verify the result of the sterilization If the cycle is over indication CYCLE COMPLETE without interruption caused by whatever alarms the complete asepsis of the material will be guaranteed A further verification tool is represented by the printout of the sterilization parameters It is a good rule if a printer is connected to the sterilizer to verify that the data printed on the report issued at the end of the sterilization program have a positive checking The print of the meaningful data relating the thermodynamic parameters pressure and temperature bar and C and time minutes of the sterilization cycle with special care on the sterilization phase will be automatically performed at the end of every cycle simply by opening the door Check the values on the report and the possible additional information to have further confirmation of the quality of the performed sterilization process Sign on the proper line and file the document for a possible future use Copies of the document can be eventually used for identifying the load or parts of it with sterilization date hour and details relative to the type of the performed cycle To choice the number of copies refer to the Chapter Setting up the equipment gt ON REQUEST BY THE OPERATOR IT IS POSSIBLE GET THE EXTENDED REPORT OF THE STERILIZATION PROCESS DATA INCLUDING THE VALUES OF ALL THE SENSORS INSTALLED ON THE EQUIPMENT TO START THIS
83. f the equipment performances We remain at your disposal for any more explanation as well as suggestions turned to improve the product and the service PAY PARTICULAR ATTENTION TO THE PARAGRAPHS MARKED BY THE FINGER SYMBOL OPERATE ACCORDING TO THE SUITABLE PROCEDURES OF THE MANUAL IN ORDER TO A ATTENTION THIS SYMBOL POINTS OUT A POTENTIAL DANGER FOR PEOPLE PLEASE PREVENT POSSIBLE DAMAGES TO THE USER AND OR TO THIRD PARTIES CAUTION THIS SYMBOL POINTS OUT A POTENTIAL DANGER FOR PROPERTY ACT ACCORDING TO THE SUITABLE PROCEDURES OF THE MANUAL IN ORDER TO PREVENT POSSIBLE DAMAGES TO MATERIAL EQUIPMENT AND OR PROPERTIES CAUTION This symbol points out a potential danger due to the presence of high temperature 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 in accordance with the following European Directive as applicable 73 23 CEE for the approximation to the legislation of the Members States related to low voltage equipment and following modifications 89 336 CEE for the approximation to the legislation of the Members States related to the electromagnetic compatibility and following modifications 93 42 CEE concerning the medical devices and following modifications The product described in this manual is exclusively intended for the sterilization o
84. f the safety valve MONTLY Cleaning or replacement of the draining filter Sterilization of the bacteriologic filter EVERY 3 6 MONTHS depending on the use frequency YEARLY Validation of the sterilizer see proper paragraph Replacement of the bacteriologic filter Always refer to the following general directions Do not wash the sterilizer with direct pressurized or rain throw water Possible water penetrations on electric and electronic components could jeopardize also irreparably the operation of the equipment or internal parts Do not use metal cleaning abrasive cloths metallic brushes or other abrasive materials or both solid and liquid products for cleaning the equipment or the sterilization chamber Do notuse chemical products or disinfectant substances for cleaning the sterilization chamber These products could provoke possible damages sometimes irremediable to the sterilization chamber Do not let the calcareous or dirty residues accumulate on the sterilization chamber door and gasket but provide for their periodic removal In the course of the time these residues could cause damages to the elements and jeopardize the operation of the components installed on the hydraulic circuit Extrema Plus OPERATIONS Cleaning the gasket and parabola Cleaning the external surfaces Cleaning the sterilization chamber and accessories Disinfecting the ex
85. g a test failure The time is counted down up to the completion of the phase Expired this time the effective pressure detection phase LEAKAGE starts with a duration of 10 minutes The LCD display will show VACUUM TEST 10 LEAKAGE 0 0 During this phase an offset of only 0 02 bar of the start value is admitted Higher variations lead to the test failure The time is counted down up to the completion of the phase Expired this time the pressure is returned to the atmospheric value and the LCD display will show VACUUM TEST PASSED An acoustic signaling points out the end of the program gt IF THE PROGRAM IS INTERRUPTED FOR A PRESSURE OFFSETS EXCEEDING THE PRE SET LIMITS AN ALARM MESSAGE WILL BE PRODUCED FOR THE DESCRIPTION OF THE ALARMS SEE APPENDIX E SOLUTION OF THE PROBLEMS The test lasts for about 18 minutes If a printer is installed on opening the door at the end of the program a report of the performed test will be released including the main data For more details about the printing reports refer to the examples in Appendix B Programs Extrema Plus APPENDIX TECHNICAL CHARACTERISTICS APPENDIX A TECHNICAL CHARACTERISTICS OVERVIEW TABLE Equipment Steam sterilizer Etema Plus B according to prEN 13060 Manufacturer M O COM S r l Via delle Azalee 1 20090 BUCCINASCO MI ITALY Power supply sid Power supply sid 220 230 V other voltages on request
86. h off RESET and switch on again the equipment Release of the heating resistor safety thermostat Call for the Customer Service see Appendix Z Wrong operation of the steam generator or heating resistor Extrema Plus 73 APPENDIX E ALARM SIGNALING CODE POSSIBLE CAUSE SUGGESTED SOLUTION A253 Presence of water or condensation Perform the RESET according to the instructions into the sterilization chamber Carefully dry the sterilization chamber and restart the program Do not introduce material soaked with water or liquid into the chamber Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Failure of the vacuum pump Call for the Customer Service see Appendix Z Problem on the hydraulic circuit Wrong operation of the water pump Problem on the hydraulic circuit Call for the Customer Service see Appendix Z Release of the steam generator Provide for the manual reset of the thermostat on the rear side of the safety thermostat equipment see Chapter Product description Unscrew the protection plastic cap push on the red button until a click and replace the cap Switch off RESET and switch on again the equipment Release of the heating resistor safety thermostat Call for the Customer Service see Appendix Z Wrong operation of the steam generator or heating res
87. ice see Appendix 2 Problem of the hydraulic circuit Wrong operation of the steam generator Problem of the hydraulic circuit Wrong operation of the steam generator Problem of the hydraulic circuit Wrong operation of the steam generator Problem of the hydraulic circuit _CODE _ Wrong operation of the steam H990 H991 H992 76 Extrema Plus APPENDIX DRAWINGS APPENDIX F DRAWINGS ELECTRICAL DRAWING Lig sg 51 20 gt 9 gt 728 19 1 zo 95 8 ES ES 22 o 29 o 29 28 o zd o9 Sx 3 or or ez a o 8 VOL and QNO HOLIVH3N39 HOdV m 9 ON9 5 8 Saw od gt fF i awo mod Wows S SE bs wid N woud Ag v IVLSOWYSHL 5 SHOLIVHSN3O YOdVA 1 AONVLSISSY o ti 04 anavo 198 SUIAVI 7 UL IV
88. ines contrangles etc integrate what above described with a treatment in special equipment for the internal cleansing and wiping sometimes including the lubrication operation 31 7 PREPARING THE MATERIAL TO BE STERILIZED ARRANGEMENT OF THE LOAD 32 ES AT THE END OF THE STERILIZATION PROGRAM REMEMBER TO LUBRICATE THE HANDPIECES INTERNAL MECHANISMS BY USING THE SPECIAL STERILE OIL THIS PRECAUTION GUARANTEES THAT THE USEFUL LIFE OF THE TOOL DOESN T RESULT IN ANY WAY REDUCED CONSULT THE INDICATIONS SUPPLIED THE MANUFACTURER OF THE INSTRUMENT MATERIAL TO BE STERILIZED BEFORE TREATING IT INTO THE AUTOCLAVE VERIFYING POSSIBLE INCOMPATIBILITIES METICULOUSLY FOLLOW THE USE INSTRUCTIONS OF THE CLEANSING OR DISINFECTANT PRODUCTS AND THE OPERATING MANUAL OF THE WASHING AND OR LUBRICATION AUTOMATIC EQUIPMENT As regards the textile material or in general the porous material as white uniforms napkins caps and other provides for a careful wash and dry before treating it in autoclave gt DON T USE DETERGENTS WITH HIGH CONTENT OF CHLORINE AND OR PHOSPHATES DON T BLEACH WITH CHLORINE PRODUCTS SUCH COMPONENTS COULD DAMAGE THE TRAY HOLDER TRAYS AND METALLIC TOOLS ARRANGED INTO THE STERILIZATION CHAMBER To get the better effectiveness of the sterilization process and to preserve the material in time follow the indications below reported General notes for the arrangement of the load on the trays
89. istor Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Excess of load Perform the RESET according to the instructions Verify the quantity of material in the sterilization chamber and pay attention to not exceed the maximum admitted quantity according to the load typology see Table in Appendix A Technical characteristics Problem of the hydraulic circuit Call for the Customer Service see Appendix Z Release of the steam generator Provide for the manual reset of the thermostat on the rear side of the safety thermostat equipment see Chapter Product description Unscrew the protection plastic cap push on the red button until a click and replace the cap Switch off RESET and switch on again the equipment Release of the heating resistor safety thermostat Call for the Customer Service see Appendix Z Wrong operation of the steam generator or heating resistor Presence of water or condensation Perform the RESET according to the instructions Carefully dry the in the sterilization chamber sterilization chamber and restart the program Do not introduce material soaked with water or liquid into the chamber Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Start again the program Failur
90. ivated on the start of the cycle START Correctly close the door pushing completely the handle and try to restart again the program Failure of the door locking Call for the Customer Service see Appendix Z mechanism Door locking system not released Perform the RESET according to the instructions COMPLETE cycle CYCLE Call the SETUP program and select the DOOR LOCK option in the i menu SPECIAL in order to operate manually the mechanism see Chapter Setting the equipment NOTE In case of unsuccessful result manually perform the releasing of the mechanism through the supplied tool Failure of the door locking Call for the Customer Service see Appendix 2 mechanism Internal reservoir water level under Perform the RESET according to the instructions the mini MIN Provide for filling up the water until the turning on of the Led MAX turning off at least of the Led MIN Failure of the MIN level signaling Call for the Customer Service see Appendix 2 Draining tank water level over the Perform the RESET according to the instructions MAX level g Provide for draining the tank letting a minimum level of water as marked to remain Cable of the draining tank level Perform the RESET according to the instructions signaling disconnected from the equipment Connect the jack of the level signaling cable to the inlet on the back of the sterilizer Failure of the MAX level signaling
91. lay bar pressure of the sterilization chamber bar Timer Display running time of the sterilization cycle The signaling led the selected program flashes for all the cycle X THE COUNTING OF THE TIME STARTS FROM THE START COMMAND FIRST VACUUM PHASE EXCLUDING THE PREHEATING PHASE It follows the description of the sterilization cycle phase by phase As example we will use the most complete and meaningful cycle i e the cycle relating the program 134 C POROUS preset 1 on the command panel provided with fractionated pre vacuum As entered the START command the first phase is represented by the preheating phase WARMUP in order to set the heating resistors on the preset condition foreseen for the start of the cycle The LCD display is showing 134c POROUS WARMUP The process signaling is off 35 9 RUNNING THE STERILIZATION PROGRAM First vacuum phase First pressure raising Second vacuum phase Second pressure raising Third vacuum phase Third pressure raising 36 Reached the stated heating conditions starts the first vacuum phase 1 VACUUM PULSE that reduce the pressure into the chamber at the preset value The following message appears on the screen p U A o 1 lt gt U v r o m The process signaling remains turned off Reached the preset vacuum value the steam enters into the ch
92. lling A101 Failure of the thermo resistor PT1 PTC BROKEN sterilization chamber A102 Failure of the thermo resistor PT2 PTC BROKEN steam generator A103 Failure of the thermo resistor PT3 PTC BROKEN heating resistor A104 Failure of the thermo resistor PT4 PTC BROKEN on the wall of the sterilization chamber Switching off the equipment A111 Short circuit of the thermo resistor PT1 PTC SHORTCIRCUIT sterilization chamber A112 Short circuit of the thermo resistor PT2 PTC SHORTCIRCUIT steam generator A113 Short circuit of the thermo resistor PT3 PTC SHORTCIRCUIT heating resistor A114 Short circuit of the thermo resistor PT4 PTC SHORTCIRCUIT on the wall of the sterilization chamber A121 Instability of the thermo resistor PT1 PTC FLICKERING sterilization chamber A200 Pre heating not performed within the timeout HEATING PROBLEM heating resistor problem A250 1 vacuum pulse not performed within the PV1 TIMEOUT SELECTION A251 1 raising towards the atmospheric pressure not ATM1 TIMEOUT key performed within the timeout 68 Extrema Plus APPENDIX E ALARM SIGNALING CODE ALARM DESCRIPTION LCD MESSAGE RESET MODE A252 1 vacuum pulse not performed within the PP1 TIMEOUT timeout A253 2 vacuum pulse not performed within the PV2 TIMEOUT timeout A254 2 raising towards
93. m on the hydraulic circuit Call for the Customer Service see Appendix Z Excess of damp in the sterilization Perform the RESET according to the instructions hamber Carefully dry the inside of the sterilization chamber and again restart the program Air leakage on the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Failure of the vacuum pump Call for the Customer Service see Appendix Z Problem on the hydraulic circuit Manual interruption of the Perform the RESET according to the instructions sterilization or test program see also Chapter Running the sterilization program Verify the correct load sterilization before using the treated material ALARMS category Door not completely open during Open completely the door verifying the closing hook doesn t prevent the initial automatic self test the activation of the mechanism Switch off RESET and switch on again the equipment Failure of the door locking Call for the Customer Service see Appendix Z mechanism Door locking mechanism released Perform the RESET according to the instructions ly during th for the Customer Service see Appendix 2 Water level signaling connector not Call for the Customer Service see Appendix 2 plugged in Failure of the level signaling s Extrema Plus 71
94. material and or the tools as less is possible paying very much attention do not lacerate or damage the wraps 4 Let the tools cool before transporting and storing If necessary use dry clean and disinfected containers to move the material The containers must be closed or if open type covered with clean cloths The sterile material on waiting for the use must be stored by taking opportune measures in order to slow as possible the contamination process 1 Preserve the material and or tools inside the protective wraps used for the sterilization Don t wrap the tools after the sterilization as such practice besides to be useless is completely without meaning 2 Store the material in a dry place suitably clean and disinfected away from areas where the infected material transits If possible prefer the closed areas provided with ultraviolet illumination 3 Identify the sterile material by affixing the sterilization date use a copy of the printed report or an adhesive labels 4 Inthe first place use the material stored for longer time by using a FIFO criteria first in first out This allows to have homogeneously stored material avoiding too long storing periods with consequent risks 5 Don t store for long time the material Do not neglect that even if the above indications have been followed the material tends however to degrade with a new contamination within a certain time CHECK ON THE SPECIFICATIONS S
95. mechanism unlocking Ref 13 e Hexagonal spanner 14 mm Ref 14 s KEEP HOME THE GUARANTEE CERTIFICATE TOGETHER THE INVOICE The packed product should be handled by using where possible suitable mechanic tools cart elevator transpallet etc and following the indications printed on the packing In case of manual handling the product should be moved by two people and using the proper handles provided on the box The sterilizer should be lifted out the box by two people and moved through a cart or similar means THAN 5 C A PROLONGED EXPOSURE AT LOWER TEMPERATURE COULD CAUSE DAMAGES TO N WE RECOMMEND TO TRANSPORT AND STORE THE EQUIPMENT AT A TEMPERATURE HIGHER E THE PRODUCT ES STORE THE ORIGINAL PACK THAT WILL BE USED FOR A POSSIBLE FUTURE TRANSPORT OF THE EQUIPMENT USE OF DIFFERENT PACK COULD CAUSE DAMAGES TO THE PRODUCT ON SHIPPING BEFORE MOVING THE STERILIZER IT IS NECESSARY TO EMPTY THE DISTILLED AND RECOVERY WATER TANKS AFTER THE EQUIPMENT HAS BEEN SWITCHED OFF FOR ABOUT 30 MINUTES FROM THE LAST CYCLE IN ORDER TO ALLOW THE COOLING OF ALL THE INTERNAL HOT ELEMENTS Extrema Plus GENERAL DESCRIPTION INTRODUCTION GENERAL FEATURES Extrema Plus 3 GENERAL DESCRIPTION Extrema Plus is the MO COM proposal for the new millennium and represents the state of art concerning safety and performances as well as the technological frontier in the field of the small steam sterilizers Extrem
96. mental lighting conditions By selecting the option LCD CONTRAST the following choice is proposed N DE E SE CR A CR AS E Use the option INCREASE key or DECREASE key to change the contrast accordingly Face the LCD display in normal working position and adjust the contrast for the better neatness of the writings Use the key ff to exit the option as the item EXIT is not available in this screen After having properly set all the options of the sterilizer proceed as follows to return in the normal operation mode Move to main menu see Flowchart of the SETUP menu 5 RETURN AT THE MAIN MENU FROM WHATEVER PART OF THE PROGRAM YOU ARE SIMPLY SELECT ONE OR MORE TIMES THE ITEM EXIT CONFIRMING THROUGH THE KEY 1 DISPLAYED IN THE CURRENT MENUS ALTERNATIVELY PUSH ON THE KEY ESC ONE OR MORE TIMES Select the item EXIT and confirm by the key 1 The display will show the message EXTREMA ETUP PLUS COMPLET S E After a few seconds the equipment returns to the normal operation mode and in STAND BY state Extrema Plus PREPARING THE MATERIAL TO BE STERILIZED INTRODUCTION HANDLING THE MATERIAL BEFORE STERILIZING Extrema Plus 7 PREPARING THE MATERIAL TO BE STERILIZED The process sterilization can consider effective reliable and repeatable on condition that the material is first suitably treated and subsequently tidy and correctly arranged into the
97. n ennt nennen 55 EXAMPLES OF PRINTING REPORTS glia ii lai 56 APPENDIX C MAINTENANCE 58 INTRODUCTION zen ror ilaele 58 ORDINARY SCHEDULED MAINTENANCE 58 MAINTENANCE OPERATIONS Mu mi a Shina SQ a u 59 Cleaning the gasket and parabola I s 59 Cleaning the external surfaces inneren neret nnn 59 Cleaning the sterilization chamber and a 59 Disinfecting the external surfaces rehenes rennen 59 Lubricating the door locking mechanism esee nene 59 Maintenance of the safety valve ennt nnne ne 60 Cleaning or replacement the draining filter sss 60 Sterilization of the bacteriological filter sse 60 Replacement of the bacteriological filter i 60 PERIODIC VALIDATION OF THE STERILIZER sse 61 APPENDIX D GENERAL PROBLEMNS 62 OVERVIEW whe Ria 62 ANALYSIS AND RESOLUTION OF THE 5 see 62 MANUAL RELEASE OF THE DOOR LOCKING 65 APPENDIX E ALARM SIGNALING
98. nd Your comments and or suggestions to the followings e mail addresses uc mocom it marketing and sales Besides You can send comments and or suggestions by letter or fax to the above indicated address Thanks in advance for the valuable assistance that you would supply to us Extrema Plus 81
99. onds to allow the homogenization of the temperature inside the chamber and load EQUILIBRATION LCD display is now showing The process signaling remains turned off On the stabilization of the thermodynamic parameters begins the real sterilization phase of the material PROCESS Thanks to the continuous monitor of the thermodynamic parameters and the complex management of the hydraulic circuit the pressure and temperature are maintained constant within the range stated by the program The countdown of the sterilization time starts and the time value is displayed on LCD with the following screen 134c POROUS PROCESS 04 00 Now the process signaling is flashing to signal that the sterilization process is progress 57 As THE PROCESS PHASE IS OVER THE PROCESS SIGNALING LED amp cHances TO ON STEADY STATE TO INDICATE THE COMPLETION OF THE STERILIZATION f IF FOR WHATEVER REASON THE STERILIZATION CYCLE IS INTERRUPTED BEFORE THE COMPLETION OF THE PROCESS PHASE THE SIGNALING REMAINS FLASHING IN THIS CASE THE MATERIAL INTO THE STERILIZATION CHAMBER CANNOT BE ANYWAY CONSIDERED STERILE AND MUST NOT ABSOLUTELY BE USED After the sterilization phase follows the steam exhausting from the sterilization chamber DEPRESSURIZATION The following screen appears 4c P DEPRESSU The process signaling remains ON The natural depressurization is followed by a steam forced removal through the vacuum pump action VACUUM DRY
100. r eventually added with a bland neutral detergent Rinse carefully with distilled water paying attention do not let any residue remain on the chamber or accessories 3 DONOTUSE POINTED OR SHARP TOOLS TO REMOVE THE CALCAREOUS SPOTS FROM THE STERILIZATION CHAMBER IN CASE OF EVIDENT RESIDUES IMMEDIATELY VERIFY THE QUALITY OF THE DISTILLED WATER YOU ARE USING SEE APPENDIX A TECHNICAL CHARACTERISTICS For the desultory disinfection of the external surfaces both methylated spirit and detergents with a minimum percentage of sodium hypochlorite or equivalent can be used For a good maintenance of the equipment periodically perform the cleaning of all the external parts by using a cloth dampened with normal neutral cleansers or simply with water Carefully lubricate the mobile parts and articulations of the door locking mechanism using silicone oil or analogous spray product Pay attention do not sprinkle the lubricant on sterilization chamber gasket and the inside part of the parabola Ej DO NOT USE GREASE OR OTHERS SOLID PRODUCTS AS THEY COULD PRODUCE IN THE COURSE OF THE TIME INCRUSTATIONS AND CONSEQUENT JAMS OF THE MECHANISM 59 APPENDIX MAINTENANCE Maintenance of the safety valve Cleaning or replacement the draining filter Sterilization of the bacteriological filter Replacement of the bacteriological filter 60 Access the safety valve on th
101. rmostat equipment see Chapter Product description Unscrew the protection plastic cap push on the red button until a click and replace the cap Switch off RESET and switch on again the equipment Release of the heating resistor safety thermostat Call for the Customer Service see Appendix Z Wrong operation of the steam generator or heating resistor Excess of load Perform the RESET according to the instructions Verify the quantity of material in the sterilization chamber and pay attention to not exceed the maximum admitted quantity according to the load typology see Table in Appendix A Technical characteristics Air leakage from the gasket Perform the RESET according to the instructions Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program Problem on the hydraulic circuit Call for the Customer Service see Appendix Z Extrema Plus 75 APPENDIX E ALARM SIGNALING CODE POSSIBLE CAUSE SUGGESTED SOLUTION HAZARDS category H Break of the pressure probe MPX Wrong connection of the pressure probe cable to the p c b connector Short circuit of the pressure probe MPX Instable operation of the temperature probe sterilization chamber Problem of the hydraulic circuit Problem of the hydraulic circuit Wrong operation of the steam generator Problem of the hydraulic circuit generator Call for the Customer Serv
102. servoir in automatic mode the water will be drawn from an external tank properly connected to the equipment see Chapter Installation As selected the option FILLING the following choice is proposed AUTOMATIC 1 MANUAL Select item AUTOMATIC to enable the automatic filling In this operation mode as the minimum water level of the internal reservoir is reached red Led MIN turns on the system will provide to supply the reservoir with water for a preset time However if the maximum level is reached green Led MAX turns on before the expiration of the preset time the automatic filling will be disabled in advance ES ACTIVATE THE AUTOMATIC FILLING OPTION ONLY AFTER THE EXTERNAL TANK HAS BEEN FILLED WITH HIGH QUALITY DISTILLED WATER PLEASE ALSO REMEMBER TO OPEN THE TAP PUT ON THE TANK In MANUAL mode the topping up have to be made manually Use the key to move through the option and confirm by the key 1 At the first set up and after each new installation of the sterilizer the user must activate the acquisition of the environment pressure value This operation is necessary for the correct operation of the internal auxiliary systems of the equipment By selecting the option SET 0 bar the following screen will show SET VAL UE 4 ft ESC EF VERIFY THAT THE DOOR OF THE STERILIZER IS COMPLETELY OPEN ON THE CONTRARY IF YOU ATTEMPT TO PERFORM THE PRESSURE ACQUISITION WITH THE DOOR CLOSED THE F
103. set it in the position parallel with the door Retry to open the door The door locking system is After having reset the alarm code E021 verify that remained engaged at the end of the the handle is in the correct closing position le Call the SETUP program and the DOOR LOCK option in the menu SPECIAL for the manual command of the mechanism see Chapter Setting the equipment NOTE In case of unsuccessful carry out the manual unlocking through the supplied tool see note at the end of this appendix Fittings or draining pipelines not Verify the locking of the fittings if necessary perform correctly connected the assembly with greater attention to the sealing see Chapter Installation Check that the pipelines towards the draining tank are completely fitted verify that the proper clamps are positioned on the pipes Feeding water pipe coming from the Verify the locking of the pipe if necessary perform the external reservoir not correctly assembly with greater attention to the sealing see connected Chapter Installation Check that the pipelines coming from the external tank is completely fitted verify that the proper clamp is positioned on the pipe Steam leakage from the gasket At the end of the cycle clean with a dampened cloth the gasket and the parabola of the chamber Check for possible damages on the gasket Carry out a new cycle and verify the condition Draining pipes not correctly Check that th
104. socket Install the equipment in such a way the draining pipelines could not be bent or crushed They should run freely to the external draining tank The sterilizer should be connected in compliance with the laws and or directives in force to a mains socket of the electric plant with a power rate suitable for the equipment consumption and provided with earth connection The mains socket should be suitably protected through differential switch having the following characteristics Diferential switch Mains socket Rating current I 16A with earth pin Differential current lAn 0 03A Mains switch THE MANUFACTURER IS NOT LIABLE FOR THE DAMAGES CAUSED BY AN INSTALLATION WHERE A NOT SUITABLE ELECTRIC PLANT AND OR EARTH CONNECTION ARE PROVIDED In case the mains plug doesn t match the socket replace the cable plug with a suitable type of same electrical characteristics or anyway suitable for the electrical requirements of the equipment The plug choice and replacement is on care and responsibility of the user Ej DIRECTLY CONNECT THE CABLE TO THE MAINS SOCKET DON T USE EXTENSIONS ADAPTERS OR OTHER ACCESSORIES 11 4 INSTALLATION CONNECTING THE DRAINING TANK 12 During the program running the steam and condensation water is conveyed in a special supplied tank external to the equipment DRAINING TANK For the corre
105. terilizer Model EXTREMA PLUS Made in ITALY The undersigned hereby declares that the above mentioned goods entirely conform to the EEC Directives 93 42 89 336 73 23 and following updates Reference standards EN 61010 1 EN 61010 1 A2 EN 61010 2 041 CEI EN 50081 1 CEI EN 50082 1 EN 55014 EN 55022 EN 60555 2 CEI 77 3 EN 60555 3 77 4 EN 61000 4 2 61000 4 3 61000 4 4 ASME VIII Div 1 Add 1999 DIN 58946 5 TRD 421 TRD 511 Date Signature 01 01 2000 Alfio VILLA Name and Surname Legal Agent Function Extrema Plus 79 APPENDIX OPERATOR S NOTES APPENDIX OPERATOR S NOTES 80 Extrema Plus APPENDIX 2 CUSTOMER SERVICE APPENDIX 2 CUSTOMER SERVICE FOR ANY SERVICE INTERVENTION BOTH DURING AND OUT THE PRODUCT WARRANTY PERIOD PLEASE CALL DIRECTLY THE CUSTOMER SERVICE OF THE AGENT OR RETAILER THAT SUPPLIED THE EQUIPMENT M O COM Ltd Co is at complete disposal of the Customers for any technical additional information concerning the product as well as for any suggestions on the steam sterilization procedures Please contact at the following address M O COM Srl Assistenza Clienti Via delle Azalee 1 20090 Buccinasco MI ITALY Tel 39 02 45701505 Fax 39 02 45701258 e mail at mocom it To help us in product quality and service improving please se
106. ternal surfaces Lubricating the door locking mechanism Extrema Plus APPENDIX MAINTENANCE L3 THE PRESENCE OF WHITE SPOTS AT THE BASE OF THE INSIDE WALL OF THE CHAMBER MEANS THE USE OF POOR QUALITY DEMINERALIZED WATER MAINS SWITCH OF THE STERILIZER IS IN OFF POSITION EQUIPMENT SWITCHED OFF IF THE DISCONNECTION OF THE ELECTRIC POWER SUPPLY OF THE EQUIPMENT IS NOT POSSIBLE AND THE EXTERNAL MAINS BREAKER IS FAR OR HOWEVER NOT VISIBLE TO THE PERSON IN CHARGE OF THE MAINTENANCE THE NOTICE WORK IN PROGRESS musT BE POSITIONED ON THE BREAKER AFTER HAVING SWITCHED IT IN OFF POSITION N BEFORE CARRYING OUT THE ORDINARY MAINTENANCE OPERATIONS CHECK THAT THE With reference to the previous table the operations concerning the different maintenance actions are here synthetically described In order to eliminate the calcareous residues cleanse the chamber and parabola gasket with a clean cotton cloth soaked with bland water and vinegar solution or analogous products verifying in advance the content reported on the label Dry the surfaces and remove every possible residue before using the equipment Clean all the external parts by using a clean cotton cloth dampened with water eventually added with some neutral detergent Dry the surfaces and remove every possible residue before using the equipment Clean sterilization chamber tray holder and trays and all the internal surfaces with a clean cotton cloth soaked with wate
107. the tool on threaded shaft of the electromagnet without tightening Pull downward the tool until the mechanism is unlocked Unscrew the tool and remove it Arrange the equipment on the support plane Open the door and recover the load Extrema Plus 65 APPENDIX E ALARM SIGNALING ocom OVERVIEW ALARM PROCEDURE Alarm occurring during the sterilization cycle 66 APPENDIX E ALARM SIGNALING Each time an anomalous condition occurs during the sterilizer operation an alarm signaling with a specific code formed by one letter and three figures will be generated The alarm codes are divided in three categories e E ERROR Wrong action and or use or external equipment cause Problem generally recoverable by the user Code format Exxx xxx identification number 000 999 e A ALARM Failure of first level not concerning the safety Problem generally recoverable on site by a specialized technician Code format Axxx xxx identification number 000 999 e H HAZARD Failure of second level involving the safety Problem generally recoverable by the Customer Service Code format Hxxx xxx identification number 000 999 The intervention of the alarm procedure causes the interruption of the program or the normal operation associated with the alarm code displaying a message on LCD display see table below an acoustic signaling and the lighting of the alarm red led steady or intermittent 5 DURING THE
108. tion IF AN IDENTICAL STERILIZATION PROGRAM 15 ALREADY PRESENT IN A DIFFERENT PRESET POSITION THE CHOICE WON T BE ACCEPTED ON THE SCREEN THE FOLLOWING WARNING APPEARS ACCOMPANIED BY ACOUSTIC SIGNALINGS THIS PROGRAM IS ALREADY PRESET 5 THE SELECTION CAN BE WHENEVER MODIFIABLE BY PERFORMING AGAIN THE PROCEDURE ABOVE DESCRIBED To configure a CUSTOM cycle proceed as follows 1 As selected the PROGRAMS option through the key the following menu appears Choice the position on the command panel 2 3 or 4 the CUSTOM sterilization program has to be associated and select the item through the keys and Confirm by the key J 2 Once entered in the available program list select the item XXXc CUSTOM through the keys and gt XXXc CUSTOM Confirm through the key 4 Extrema Plus Extrema Plus 6 SETTING THE EQUIPMENT 3 Now the new menu allowing the choice of the sterilization temperature appears gt 134c 1 121c Select 121c for a CUSTOM program with a sterilization process at 121 C or 134c for a program at 134 C Move on the choice by using the keys and confirm by the key J Then the following screen will be shown TIME XX min 1 requiring to choice the duration of the sterilization process Use the key to adjust the value then confirm by the key 1 esa THE STERILIZATION PROCESS TIME RANGES BETWEEN 4 AND 30 MINUTES FOR THE PROGR
109. tly cleaned and deprived of whatever kind residues organic and inorganic deposits fragments of paper buffer of cotton or gauze calcareous residues etc CF THE LACK OF THE CLEANING AND REMOVAL RESIDUE PROCEDURE BESIDES TO CAUSE PROBLEMS DURING THE STERILIZATION PROCESS CAN PROVOKE DAMAGES TO THE TOOLS AND OR THE VERY SAME STERILIZER For an effective cleaning proceed as follows 1 Rinse the tools under a throw of running water immediately after the use 2 Separate the metallic instruments according to the material type carbon steel stainless steel brass aluminum chrome etc in order to avoid electrolyte oxidation 3 Wash by using an ultrasonic equipment with a mixture of water and germicidal solution taking care to follow the recommendations of the manufacturer 4 For the best results use a neutral pH detergent specifically studied for the ultrasonic washing 3 SOLUTIONS CONTAINING FENOLIS OR QUATERNARY AMMONIUM MIXTURES COULD CAUSE CORROSION ON THE TOOLS AND METALLIC PARTS OF THE ULTRASONIC EQUIPMENT 5 After the washing carefully rinse the tools and verify the complete elimination of the residues if necessary repeat the washing cycle or operate manually POSSIBLE USE DEJONIZED OR DISTILLED WATER FOR THE RINSING OPERATION IN ORDER TO PREVENT THE FORMATION OF CALCAREOUS STAINS IF HIGH HARDNESS TAP WATER IS USED FOR THIS OPERATION IT IS ADVISED TO ALWAYS DRY THE INSTRUMENTS For the handpieces turb
110. total 456 mm Depth excluded rear fittings 515 mm Weight total about 55 kg j 515 456 Power supply 4 The electric plant to which the sterilizer is connected has to correctly be sized according to the electric characteristics of the equipment The rating data are reported on the plate on the rear panel of the machine INSTALL THE EQUIPMENT SO THAT THE PLUG OF THE MAINS CABLE CAN EASILY ACCESSIBLE VERIFY THE ADEQUACY OF THE ELECTRIC PLANT PARTICULARLY FOR THE EARTH CONNECTION In case the sterilizer has to be set into a piece of furniture it is necessary to provide a suitable space all around the equipment in order to assure an effective ventilation as well as a free space in the rear in order to allow the passage of the draining pipelines and power supply cord and to assure an adequate air flow for the cooling of the heating exchanger Accordingly it is important that the build for the installation has the minimum dimensions as in figure BUILD DIMENSIONS SMALLER THAN THE INDICATED ONES CAN FOPARDIZE THE AIR CIRCULATION AROUND THE NT AND NOT GUARANTEE A SUITABLE COOLING x NSEQUENT REDUCTION OF THE PERFORMANCES AND OR POSSIBLE DAMAGES 500 L3 IN CASE THE STERILIZER INSTALLATION MAKES THE MAINS BREAKER INACCESSIBLE USE A MAINS SOCKET ib INCORPORATING A SWITCH f DON T REMOVE THE CARTER NEITHER OTHER EXTERNAL ELEMENTS ARRANGE INTO THE BUILD THE 570 550 EQUIPMENT CO
111. ugh the key 4 Minute indication is flashing adjust for the current minutes through the keys and Confirm through the key 4 With the last confirmation the set time will be stored and the second level of the menu returned 23 6 SETTING THE EQUIPMENT Setting the preset sterilization Programs PROGRAMS option of the ADVANCED menu 24 The selection of the programs and their storing under the preset key of the command panel occurs by performing the following steps through different menu sequence It is possible to choose both the preset programs and the user configurable program CUSTOM We will see the two cases To select a PRESET program operate as follows 1 As selected the PROGRAMS option through the key 4 the following menu appears Choice the position on the command panel 2 3 or 4 the preset sterilization program has to be associated and select the item through the keys and Confirm by the key 4 2 Now the display is showing the list of the available cycles two lines in turn o gt DO 000000000 COUOSP5yyO O covvvs gt 2 1 1 1 1 1 1 1 1 1 X x N N N amp Through the keys and scroll the list to find the desired sterilization program 3 Confirm the choice by the key 4 The program will be stored at the selected posi
112. water reservoir Sterilisation chamber Door status micro switch Door locking Water stopper Draining point of the distilled water reservoir Extrema Plus REAR DEVICES Extrema Plus 3 GENERAL DESCRIPTION RECIPIENTE IN PRESSIONE Inlet of draining tank level probe Pipe fitting for steam draining Pipe fitting for condensation draining Vent hole of the distilled water reservoir Automatic water filling point Safety valve Heat exchanger Manufacturing plate Mains switch Mains fuses Adjustable rear foot Power supply cord Manually resettable thermostat 3 GENERAL DESCRIPTION COMMAND PANEL Process running LED Door status LED Temperature display Pressure display Timer display Selected program signalling LED Selected Test signalling LED FRACTIONATED VACUUM ocom Liquid crystal display LCD Alarm LED MAX reservoir level signalling LED MIN reservoir level signalling LED Start Stop key Enter key in the Setup phase Sterilisation program 1 4 key Menu scroll upward key in the Setup phase Test program key Menu scroll downward in the Setup phase Escape key Setup enabling with relating LED Extrema Plus O
113. xtrema Plus 2 CONTENT Height 610 mm Width 880 mm CONTENT Depth 570mm DIMENSIONS AND Total weight about 70 kg WEIGHT ON RECEIVING THE PRODUCT PLEASE VERIFY THAT THE PACKING IS INTACT IN EVERY PART Open the pack and check that The supply corresponds to the order specifications see delivery note there are not evident damages on the product c IN CASE OF WRONG SUPPLY MISSING PARTS OR DAMAGES OF WHATEVER TYPE PLEASE IMMEDIATELY INFORM AND IN DETAIL THE RETAILER AND THE FORWARDER THAT HAS CARRIED OUT THE DELIVERY PACKING CONTENTS ci A lt In the box of the accessories N The packing contains the following items Extrema Plus steam sterilizer Three stainless steel wire trays Ref 1 One stand stainless steel tray holders Ref 2 Operating Manual Ref 3 Warranty certificate Ref 4 see note Box for supplied accessories containing e Tray removal tong Ref 5 e Tank of 2 litres provided with fast fitting for manual distilled water filling Ref 6 Extrema Plus 3 2 PACKAGE CONTENT LIFTING AND TRANSPORT e Additional bacteriological filter Ref 7 e Draining tank 10 I Ref 8 e Silicone pipes for sterilizer draining tank connection Ref 9 e External filling tank 10 Ref 10 and tap Ref 11 e Tube fitting teflon tape and plastic clips Ref 12 e Special tool for door

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