Clan li2er Lo STEAM STERILIZER 7% Extrema Plus OPERATING MANUAL C € 0051 fiocomfocom CONTENTS CONTENTS UPDATING 4. FOREWORDS.. 1 APPLICABLE EUROPEANS DIRECTIVES... ‘SCOPE OF THE MANUAL.. ‘The following table lists the updating history of the Operating Manual, The lield “Description” shorly explains the ‘modifications, . GENERAL WARNINGS. 2. PACKING ,. 1 0 | 09-99 | First issue PACKING CONTENTS LIFTING AND TRANSPORT. 1 1 | 11-99 | General amendment | | | Eait,_| Rev] Date Doseription = ) DIMENSIONS AND WEIGHT cu | [— 3. GENERAL DESCRIPTION. 1 2 | 05-01 |Pages 8 and 4 INTRODUCTION. 1 3 | 06-01 | Pages 11, 12, 14, 62, 66, 68 GENERAL FEATURES. | 1 4 | 08-01 | Dectaration of Conformity a cae ceereeaearonS ' REAR DEVICES. 2 0 | 11-01 | Updating to EPROM release 2 CoRAND PANEL 2 1 _ | 08-02 | New phone number and e-mail address (page 83) OPERATING CYCLE EXAMPLE. 4. INSTALLATION...... INTRODUCTION... semen DIMENSIONS FOR BUILD MOUNTING. GENERAL INSTALLATION DIRECTIONS ELECTRICAL CONNECTIONS CONNECTING THE DRAINING TANK. CENTRALIZED DRAINING SYSTEM CONNECTION. EXTERNAL FILLING TANK CONNECTION CONNECTION TO A PRINTER... ACQUIRING THE ENVIRONMENT PRESSURE VALUE .. i 6. FIRST START-UP. | ‘SWITCHING ON. INITIAL SELF-TEST.... ! ACQUISITION AND AUTOMATIC UPDATING OF THE ENVIRONMENTAL PRESSURE. i VALUE... 7 Sele 16 STAND-BY STATE... 7 FILLING THE DISTILLED WATER, al T DRAINING TANK WATER LEVEL SIGNALING... 18 _ 6. SETTING THE EQUIPMENT... 419 INTRODUCTION... . 19 STARTING THE SETUP PROGRAM...... ene eee 1: FUNCTION OF THE KEYS IN SETUP MODE 19 DESCRIPTION OF THE MENU OPTIONS 24 Extrema Plus 7 “”CONTENTS fiJocom CONTENTS DEFAULT SETTINGS ....c.c SETTING THE OPTIONS IN SETUP MODE... EXIT THE SETUP MODE... : . PREPARING THE MATERIAL 70 BE STERILIZED .. D-GENERAL PROBLEMS INTRODUCTION... OVERVIEW. — ‘TREATEMENT OF THE MATERIAL BEFORE STERILIZING ARRANGEMENT OF THE LOAD... 8. SELECTING THE STERILIZATION PROGRAM orsessssssn INTRODUCTION. 35 OVERVIEW vrs ABOUT THE SELECTION... vee a ‘ALARM PROCEDURE. 9, RUNNING THE STERILIZATION PROGRAM RESET OF THE SYSTEM GENERAL. eee STARTING THE STERILIZATION PROGRAM. ‘SEQUENCE OF PROCESS... MANUAL INTERRUPTION OF THE PROGRAM... RESULT OF THE PROGRAM... PRINTING THE DATA OF THE CYCLE. 40. PRESERVING THE STERILIZED MATERIAL. GENERAL. HANDLING STORING... 7 11. TEST PROGRAM! sree OVERVIEW. HELIX TEST (HT)... VACUUM TEST (VT)... APPENDIXES A- TECHNICAL CHARACTERISTICS OVERVIEW TABLE. SAFETY DEVICE: CHARACTERISTICS OF THE FEEDING WATER... B - PROGRAMS. INTRODUCTION. esssninnetnnnnnennnnninains OVERVIEW OF THE AVAILABLE PROGRAMS DIAGRAMS OF THE STERILIZATION PROGRAWS DIAGRAM OF THE TEST PROGRAMS EE EXAMPLES OF PRINTING REPORTS. C - MAINTENANCE....... INTRODUCTION Extrema Plus E - ALARM SIGNALING, F - DRAWINGS G - DECLARATION OF CONFORMITY .. H- OPERATOR'S NOTE.. Z~ CUSTOMER SERVICE Extroma Plus ORDINARY SCHEDULED MAINTENANCE...... MAINTENANCE OPERATIONS... atte PERIODIC VALIDATION OF THE STERILIZER wens 60 ANALYSIS AND RESOLUTION OF THE PROBLEMS... MANUAL RELEASE OF THE DOOR LOCKING MECHANISM LIST OF THE ALARM CODES... ANALYSIS AND RESOLUTION OF THE PROBLEMS.. ELECTRICAL DRAWING. HYDRAULIC DRAWINGeee eee CONTENTS fijocom fijJocom 4. FOREWORDS FOR (On thanking forthe pofecance granted, M.O.COM, Le. Co. hopes thatthe performances of sediadeahasi this product can result of Your complete satisfaction, {In this manual you wil find all the procedures for the correct use and the Indications for the ‘complete expioltation of the equipment performances. We remain at your disposal for any more explanation, as well as suggestions turned to Improve the product and the service. i Important notes | “pay particular attention to the paragraphs marked by the finger t ‘symbol. ATTENTION! This symbol points out a potential danger for people. Please operate according to the suitable procedures of the manual In order to 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 gf the manual in order to ible damages to material, equipment and/or 3 5 - 3 APPLICABLE ‘The product described in this manual is manufactured in accordance with the highest safoty EUROPEANS standards and doesnt represent any danger for tho operator If used according to the pes following instructions. ‘The product is in accordance with the following European Directive as applicabt 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); 99/42/CEE, _conceming the medical devices (and following modifications); | | : 73I23ICEE, for the approximation to the legislation of the Members States related to low i Important notes a ‘THE INFORMATION INCLUDED IN THIS MANUAL ARE SUBJECT TO CHANGES WITHOUT ANY notice, a MO.COM. L1D. Co. WON'T BE RESPONSIBLE FOR DRECT, INDIRECT, ACCIDENTAL, ‘CONSEQUENT DAMAGES OR OTHER DAMAGES RELATED TO THE SUPPLY OR THE USE OF SUCH INFORMATION. i ANY REPRODUCTION, MODI FICATIONS OR TRANSLATION OF THIS MANUAL OR PARTS OF IT IS FomBoDenWrHOUT PREVIOUS WRITTEN AUTHONZATION HLO COM. LTD. CO. ! | v Extrema Plus Extrema Plus . o 1re 1-FOREWORDS SCOPE OF THE MANUAL GENERAL WARNINGS fipocom ‘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. Inthe appendix you wil fin: 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. lp THE PRODUCT IS NOT CORRECTLY INSTALLED AND USED, OR A SUITABLE MAINTENANCE IS NOT OPERATED, THE MANUFACTURER CANNOT SE CONSIDERED RESPONSIBLE OF POSSIBLE BREAKS, MALFUNCTIONS, DAMAGES, LESIONS TO PROPERTY ANO/OR PEOPLE. ps ‘THE USER IS RESPONSIBLE FOR THE LEGAL FULFLLMENTS 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 distiled water only. The use of water of Inadequate quality could seriously damage the equipment. ‘Soe Appendlx A, Technical Characteristics. ~ Donal pour any water or liquids over the equipment; — enot pour inflammable substances over the equipment; Donat 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 impossib’e or the extemal mains breaker is far or not visible from the People performing the maintenanca, 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 RESPONSIBLITY OF THE (MANUFACTURER TO DECAY . Extrema Plus fiJocom PACKING DIMENSIONS AND WEIGHT PACKING CONTENTS Extrema Plus 2-PACKING Height 610 mm width 880 mm Depth 570 mm Total weight about 70 kg [@ on secewwe 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. GH Ww case oF WRONG GUPPLY, MISSING PARTS OR DAMAGES OF WHATEVER TYPE, PLEASE [MMEDIATELY INFORM AND INDETALL THE RETAILER AND THE FORWARDER THAT HAS CARRIED ‘OUT THE DELIVERY. In tho hox of the accossorios FUG EE C oes 2 = (as Jee ‘Tho packing contains the following itoms: — Extrema Plus steam sterlizer; ~ Three stainless stee! wire trays (Ref. 1); — One stand stainless steel tray-holders (Ref. 2); — Operating Manuel (Ref. 3); — Warranty certificate (Ref. 4) (see note). Box for provision accessories containing: + Tray removal tong (Ref. 5); + Tank of 2ltres provided with fast iting for manual dstiled water filing (Ref. 6);2- PACKING LIFTING AND TRANSPORT filocom + Pipe provided with fat fting for intemal reservoir dralning (Ref. 7) ‘+ Additional bacteriological itor (Ret. 8); + Draining tank (10 9 (Ret. 8); ‘+ Sticane pipes for stelizer- draining tank connection (Ref. 10); + Exlerna filing tank (101) (Re. 14) and tap (Ref. 12); + Tube fiting, toon tape end plastic clips (Ret. 13); + Spociel too! for door mechanism unlocking (Ret. 14). ‘+ Hexagonel spanner @ 14 mm (Ref. 15) (Keep owe THe GUARANTEE CERTIMCATE TOGETHER THE NVOKE, “The packed product should be handled by using, where possible, suitable mechanic tools (cart elevator, transpallet, ec.) 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 O°C. A PROLONGED EXPOSURE AT LOWER TEMPERATURE COULD CAUSE DAMAGES TO A We RECOMNEND TO TRANSPORT AND STORE THE EQUIPMENT AT A TEMPERATURE HIGHER “THE PRODUCT. OG store Tie ORIGINAL PACK THAT WIL. 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 1S NECESSARY TO EMPTY THE INTERNAL DISTILLED WATER RESERVOIR, AFTER HAVING SWITCHED OFF THE EQUIPMENT FOR ABOUT 30 MINUTES [FROM THE LAST GYCLE, IN OROER TO ALLOW THE COOLING OF ALL THE INTERNAL HOT ELEMENTS, Extrema Plus fiocom GENERAL DESCRIPTION INTRODUCTION GENERAL FEATURES Extrema Plus 3— PRODUCT DESCRIPTION Extrema Plus is the MO.COM. proposal for the new millennium and represents the “state of art” conceming safety and performances as well as the technological frontier in the field of the small steam storiizers, Extrema Plus is @ sophisticated equipment but of very friendly use, adaptable to the diferent demands thanks to the wide possiblities of configuration and choice of the eycles. ‘The equipment is able to treat in fast way every type of load through various patented systoms 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 tho performances to the different job requirements, Extrema Plus, thanks to the friendly use, reduced dimensions and agreeable design, represents the ideal partner forthe professional requiring the maximum sterilization safely. Extrema Plus is a completely microprocessored steam sterlizer, with a 17 [tres sterilization chamber. It is characterized by an advanced fractionated vacuum system for the complete alr removal also from hollow and porous materials as well as by an effective final vacuum {drying phaso 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 tho thermodynamic parameters during the whole sterilization process. Allthis guarantees a perfect result! Extrema Plus offers 11 sterilization programs (including one program completely programmable), oplimized for an effective and fast 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 commend 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-3Y) 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 filing possitiliies and other features can be completely configurabie, For more information, refer to Chapter “Setting the equipment”. Finally Extrema Plus has the most sophisticated and advanced safety systems in order to ‘quarantee the user against possible operation anomalies, both electric, mechanics, thermal and biologic type. For THE DESCRIPTION OF THE SAFETY DEVICES REFER TO APPENDIX A (TECHNICAL CHARACTERISTICS), ” 53 PRODUCT DESCRIPTION fiocom FRONT DEVICES Door handle Command panel Door Parallel printer Interface 25-pin connector Soria! interface 9-pin connector Bactoriologic flor Filing polnt ofthe distilled water reservoir Storilsation chamber Door status micro- ‘switch Doorlocking Water stopper Draining point of the distiled water reservoir Resin sponge Porthole 6 Extrema Plus | fiocom REAR DEVICES Extrema Pius 3— PRODUCT DESCRIPTION Vent-hole of the distilled ‘water reservoir i ] | | ‘Automatic water filing ee ee point Sofoty valve Heat exchanger Manufacturing plate Mains switch TUUUU UTP sO AOA Mains fuses a SE Aslusiabe rearfoot a Inlet of draining tank level probe Power supply cord Manually resettable thermostat ‘= Pipe fitting for steam draining Pipe fiting for condensation draining3-PRODUCT DESCRIPTION ‘COMMAND PANEL Process running LED Door status LED ‘Temperature display Pressure display Timer display Selected program signalling LED Solected Test signalling LED a fiocom Liquid crystal display (eo) ‘arm LED MAX reservoir level signalling LED MIN reservoir level signalling LED StartStop key (Enter key in the Setup phase) Storlisation program (+4) key (Menu scroll upward koy in the Setup phase) ‘Test program key (Menu scroll downward in the Sotup phaso) Escape key (Setup ‘enabling with relating LED) Extrema Plus fiocom OPERATING CYCLE EXAMPLE Extrema Plus 3- PRODUCT 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 (Le. program 1 at 134°C for porous material), after having loaded the materiel in the chamber, closod the door, selected the program and slaried 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 ({luid exhaustion from the sterilization chamber) and pressure phases (steam centering into the chamber); 3. Pressure increasing, with consequent steam temperature increasing up to the preset sterlization conditions (for the example, 134°C); 4, Stabilization of the pressure and temperature conditions inside the sterilization chamber; 3. 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; 9. Chamber pressure leveling up to atmospheric value. 5. 6 7. 8 ‘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 chambor paying attention to use proper precautions. Whereas the phases 1, 3, 4, 6 and 9 are essentially identical for all the cycle types, with litle 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: re EXTREMA, m4 SM For DETALs ABOUT THE AVALABLE PROGRAMS, REFER TO APPENDX B (PROGRAMS)4- INSTALLATION INSTALLATION INTRODUCTION DIMENSIONS FOR BUILD MOUNTING 10 focom For the right operation, features exploitation and Ife extension of the sterizer, the first and basic step Is the correct and careful installation. ‘Such precaution besides avoids possible malfunctions or damages to the equipment, as \woll as possible danger situations for property and people. We suggest to meticulously follow the warnings reported on this chapter. SF MO.COM. Service (see APPENDIX Z) 18 AT YOUR DISPOSAL FOR ANY QUESTION OR FURTHER INFORUATION. (7 The steRI.zeR Is FORWARDED AFTER HAVING PASSED A SET OF PROGRAMMED CONTROLS. “THEREFORE FURTHER CALIBRATIONS FOR THE OPERATION ARE NOT NECESSARY ANY MORE. Dimensions and weight = Helght (total) 400mm = Width (otal 458mm = Depth {excluded rear fitings) 515mm = Weight (otal about 55 kg Power supply ‘The electric plant to which the sterlzer is connected has to correctly be sized according to the electric characteristics of the equipment. The raling data are reported on the plate on the rear panel of the machine. @F instau THE EQUIPMENT SO THAT THE PLUG OF THE MANS CABLE CAN BE EASILY ACOESSELE. A Venry THe ADEQUACY OF THE ELECTRIC PLANT, PARTICULARLY FOR THE EARTH comesron. In case the steriizer has to be sot into a piece of furniture It Is necessary to provide a suitable space all around the equipment in order to assure an offective ventilation, as well ‘a8 @ 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 following minimum dimensions. = Height = 500 mm — Width 850 mm = Depth 570 mm Extrema Plus fijocom GENERAL INSTALLATION DIRECTIONS ELECTRICAL CONNECTIONS Extrema Plus 4-— INSTALLATION BUND DIMENSIONS SMALLER THAN THE INDICATED ONES CAN JEOPARDZE THE AR CIRCULATION AROUND THE EQUIPMENT AND NOT GUARANTEE A SUITABLE COOLING, WTH ‘CONSEQUENT REDUCTION OF THE PERFORMANCES ANDIOR POSSIBLE DAMAGES. [Wy CASE THE STERLIZER INSTALLATION MAKES THE MAINS BREAKER INACCESSIBLE, USE A MAINS SOCKET INCORPORATING A SWITCH, DON'T REMOVE THE CARTER NEITHER OTHER EXTERNAL ELEMENTS. ARRANGE INTO THE [BUILD THE EQUIPMENT COMPLETE IN EVERY PART, ll ee FOR THE COWPLETE TECHNICAL DATA REFER TO APPENDIX A. (TECHNICAL (CHARACTERISTICS) In order to assure the correct operation of the equipment andior avoid situations of risk, cbserve the following directions: Instal the sterilizer on plain surface; eventually adjust the rear feet to match possible irregularities. Ver that the plan ia able to support the weight ofthe equipment (abt. 65 kg) ~ Allow a suitable space for the ventilation (at feast 19 om) 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 ‘a8 above indicated, avoiding possible obstruction of ihe air sk — Donat install the sterilizer near tubs, sinks or analogous places, avoiding the contact with water or iqud. Otherwise, short circuits andlor situations of potential dangor for the operator could occur; — onot install the storlzor in environments characterized by the presence of excessive humidity or in room with poor ventiaton; ~ o_not install the steriizer in environments characterized by the presence of inflammable and explosive gas ot vapors; — Insta the equipment in such a way the power supply cable could not be bent or crushed. The cable should run freely to AC. socket — Install the equipment in such a way the cralning pipelines could not be bent or ‘crushed. They should run freely to the extemal draining tank, Tho storlizor should be connectod, in compliance with the laws andor directives in-force, toa mains socket of the electric plant with a power rato sultable for the equipment consumption, provided with earth connection and max impedance of [2 line | = 0.0108; [Z neutral | 0.0073. ‘Tho mains socket should be suitably protected through dliferentia switch having the following characteristics: Mone te (@ he sunuracTURER 1S NOT LIBLE FOR THE DAMAGES CAUSED BY AN INSTALLATION \WHERE A NOT SUTABLE ELECTRIC PLANT ANCYOR EARTH CONNECTION ARE PROVIDED, In case the mains plug doesn't match the socket, replace the cable plug with a suitable type of same elactrical characteristics or anyway suitable for the electrical requirements of the equipment. The plug choice and replacement is on care and responsibilty of the user. (@™ Dircoey connect THE CABLE TO THE WANS SOCKET. DON'T USE EXTENSIONS, ADAPTERS OR OTHER ACCESSORIES, 1"4—INSTALLATION CONNECTING THE DRAINING TANK 2 During the program running, the steam and condensation water is conveyed in a special ‘supplied tank extornal fo the equipment. (WF carcok FoR THe CORRECT NGTALLATIN OF THE GLENCER ON THE FITTING A OF THE ORANG TANK For the correct connection of the tank, proceed as follows: — Mount the ends of two supplied pipes ‘on the ftings marked A and B, iaking ‘care to plug in completely the pipes. = Lock the pipes on the fittings by using ‘the supplied past clips; — Cul the pipes according to the desired distance and mount the opposite ends ‘on the two fitings of the draining tank, taking care to match the correct connection (A-A and B-B), as shown in the figure; — Lock the pipes on the fittings by using NPS >. the supplied plastic clips; (WH heck mar THE CONNECTED PRES ARE RUNNING FREELY FROM THE UNIT. HPS TOWARDS THE ORAINNG — TANK WITHOUT ANY END, CRUSH OR ‘OBSTRUCTION. = Plug the jack of the level probe in the ‘socket mounted on the rear side of the ‘equipment (see figure); Dralning tank (@ cusck For THE CORRECT MOUNTING ‘OF THE PLUG. IF NOT CONNECTED, ‘THE EQUIPMENT WILL DETECT A FALSE MAX LEVEL IN THE DRAINING TAKK, WITH CONSEQUENT LIGHTING OF THE LeD ON THE COMMAND PANEL (SEE (CHAPTER 5 “FIRST START-UP") AND ALARM SIGNALING GENERATION F THE ‘START COMMAND IS ENTERED. Minimum water leva — Fill the tank of normal tap water up to the level marked on the tank. (© PERIODICALLY EMPTY THE TANK HAVING CARE TO LET ALWAYS A NINAUM OF WATER INSIOE ‘THE TANK CORRESPONDING TO THE MARKED LEVEL, OTHERWISE THE NOISE CAUSED BY THE STEAM DISCHARGE AND THE STEAM EXIAUSTION FROM THE VENT HOLE WILL INCREASE NoTICEABLY. CAREFULLY CONNECT ALL ELEMENTS OF THE DRAINING CIRCUIT IN ORDER TO AVOID iy [NORMALLY HOT WATER AND PRESSURIZED STEAM GOES OUT FROM THE DRAINING FITTINGS. [DAMAGES AND INJURIES TO PROPERTY ANDIOR PEOPLE , Extrema Plus fipocom 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 vvent-hole, remove the screw plug from ‘the side fing of the tank and sorew it ‘on the previous vent-hol ~ Serew a supplied 118" pipe fiting on ‘he side fiting; = Uso tafion ribbon or fiting sealing to get a perfect seal; = Uso one spanner for holding the nut and a socond spanner for tightening the pipe fing — Mount on the fitting a pipe of suitable material and. sizes. (not supplied), taking care to plug in t completo. = Lock the pipe on the iting by using the supplied plasiacips = Adapt the centralized draining circuit to match this new link (consult a specialized plumber): — Connect the opposite ond of the pipe to the draining plant and verify the sealing. — Chock that the pipe is running freely from the extemal tank to the centralized draining pant, without any bend, crush or obstruction, “The elements should be arranged according to the following scheme (example): Ccennectn pit vomecaneaed epee ‘Sizer <= ‘CENTRALIZED ‘SYSTEM. x ‘Conecton git tothe rng wrk ‘ron tek (© stateo "x" THE GROUND-FITTING PONT HEIGHT ON THE TANK, THE CONNECTION POINT TO, ‘THE CENTRALIZED DRAINNG SYSTEM MUST BE AT A QUOTA ENGLISH +? (ether language) Select the desired language. Scroll the list by the key # or — and confirm withthe key «to slora the choice. With the confirmation command you re-ontorn the second level menu "@ Front Now on, THe SETUP MEWU WILL OE SHOWN IN THe SELECTED LANGUAGE. ‘As selectod the option DATE through the key «1, the following screen will be shown: ddimmiyy +t ae it Carry out the following oporations: = Day indication is flashing: adjust for the current date through the keys + and -. Confirm through the key «1 = Month indication is flashing: adjust for the current month through the keys + and -. Confirm through the key «1. = Year indication Is flash Confirm through the key «1. ‘adjust for the current year through the keys + and ~ ‘With the last confirmation the set date will be stored and the second level of the menu retumed. ‘As selected the option TIME through the key -J, the following screen will be shown: hhimm +7 a3 -t Carry out the following operations: = Hour indication is flashing: adjust for tho current hour through the keys + and -. Confirm through the key .1. — Minute incication is flashing: adjust for the current minutes through the keys + and =, Confirm through the key «1 With the last confirmation the sot time will bo 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 fiocom 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. Its possible to choose both the preset programs and the user configurable program (CUSTOM). We will ee the two casos. To select a PRESET program operate as follows: 1. As selected the PROGRAMS option through the key «, the following menu appears: 32nd PRESET +7 3th PRESET “4 4th PRESET Choice the position on the command panel (2, 3 or 4) the preset sterilization program hhas to be associated and select the ilom through the keys + and -. Confirm by tho key 1. 2. Now the display is showing the list of the available cycles (two lines in tur): > 434¢ SOLID +t 124¢ SOLID “4 134c¢ WRAPPED 124¢ WRAPPED 134c HANDPC 124¢ HANDPC 134¢ EMERGN 124¢ POROUS 134¢ PRION xXxXXe CUSTOM ‘Through the keys +and - scroll the lst to find the desired sterilization program, 3. Confirm the choice by the key 4. The program will be stored at the selected position. "1 aN WeNTICAL STERLZATION PROGRAM IS ALREADY PRESENT IN A DIFFERENT PRESET POSITION, THE CHOICE WON'T 8& ACCEPTED. ON THE SCREEN THE FOLLOWING WARNING APPEARS, ACCOMPANIED BY ACOUSTIC SIGNALINGS: THIS PROGRAM 18 ALREADY PRESET! "Tete SELECTION CAN 8E WHENEVER MODIFABLE BY PERFORMING AGAN THE PROCEDURE ‘ABOVE DESCREED. To configure a CUSTOM cycle, proceed as follows: 1. As selected the PROGRAMS option through the key ., the folowing menu appears: > 2nd PRESET 3th PRESET 4th PRESET Choice the position on the command panel (2, 3 or 4) the CUSTOM sterilization program has to be associated and select the ilem through the keys + and -. ‘Confirm by the key «| Extrema Plus fiocom Extroma Plus Then the following soreen will be shown: 5. As set the time, appeer the menu for selecting the type of the initial vacuum: 3. Now a next menu is shown where the drying modes can be selected: - Depending on the option selected (LONG or SHORT), two different menus will be 6 - SETTING THE EQUIPMENT Once entered in the available program list, select the item XXXe CUSTOM through the keys + and + > XXxXe CUSTOM +7 st Confirm through the key «1. . Now the new menu allowing the choles of the sterilization temperature appears: > 1346 +t 12416 -t Select 1216 for a CUSTOM program with a sterilization process at 121°C, or 184¢ for a program at 134°C. Move on the choice by using the keys + / - and confirm by the key «1. ME:XX min + u20k tsEsc - U roquiring to choice the duration ofthe sterilization process. Use the key +/- to adjust the value, then confirm by the key -. (Tae sTERIUZATION PROCESS TE RANGES SETWEEN 4 AND 30 MNUTES FOR THE PROGRAM AT 134°C, AND BETWEEN 20 AND 30 MINUTES FOR THE PROGRAM AT 121°C. > FRACTIONATED +7 SINGLE -t Choice FRACTIONATED fo perform a fractionated vacuum, or SINGLE for one pre- vacuum phase only. Use the key +/-then confirm by the key -. 3 LONG DRY +7 SHORT DRY u Choice LONG 10 dry in property way the porous andlor wrapped instruments or SHORT in case of load with unwrapped (or hollow) instruments, Use the key +/=then confirm by the key prompted: 2) Mode LONG ‘The following options are available: S STANDARD LIGENT ‘ L EXTRA ‘Select STANDARD option for a long preset time drying (about 10 minutes). . 25SE 6 — SETTING THE EQUIPMENT fiocom GG iris o16 Lovo on SPEoIAL MATERIAL, THE STANDARD OPTION wiGkT NOT (GUARANTEE SOMETIMES A CORRECT RESULT. IN THIS CASE, EXTEND THE DRYING PHASE WITH THE EXTRA OPTION. ‘Select INTELLIGENT to enable an automatic crying characterized with a duration {higher or lower the standard one) depending on the load volume, quantity and typology. (wins comptex Lap (6.6. WRAPPED INSTRUMENTS IN STERLZATION CONTAINER”) THE "INTELLIGENT" OPTION MIGHT NOT CORRECTLY OPERATE, WITH RESULTS LOWER THE EXPECTATION. Int THIS CASE USE THE STANDARD. OR EXTRA OPTIONS AS NECESSARY, Select EXTRA option for extending the drying phase of a selectable time period (¢.g. for particularly dificult ioad). Enabling this option, the following choice will be prompted: E J allowing to set the time period of the extra drying. ‘The exlended time ranges from 1 to 15 minutes, b) Mode SHORT. ‘The following options are displayed: > STANDARD +T FAST +t 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 ofthe residual humicity Use the key +/+ then confiem by the key 8. Confirm the choices by the key .1. The program is stored at the selected position, WW lc tue 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: (WP The ceLECTION CAN BE WHENEVER MODIFIABLE BY PERFORMING AGAIN THE PROCEDURE: ‘ABOVE DESORBED. (@ Treust oF te AvALABLE PROGRAMS, THER DIAGRAMS ANO THE CHARACTERISTIOS OF THE [AUTOCLAVASLE MATERIAL (DEPENDING ON THE PROGRAMS) CAN BE FOUND IN APPEND B. (Prooras), Extroma Plus fiocom Sotting the STAND- BY modes (STAND-BY option of the ADVANCED menu) Setting the Drying Options (ORYING OPTions of the ADVANCED menu) Extrema Plus 6 ~ SETTING THE EQUIPMENT ‘The heating slage in STAND-BY status (pre-heating) can be set according to the high- or tow-uso of the unit and others possible considerations, ‘As selected the STAND-BY option by the key .J the following menu will appears: HIGH +T Low it ° ‘Select HIGH (hiah preheating stage) for infensive use and to reduce however the waiting time between one cycle and the other. Select LOW (low preheating stage) for normal use, maintaining an accoptable 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 cconsiton).. Use the key + / then confirm by the key «1 §@® Te STAND-BY oPeRATING NoDE (HIGH O% LOW) 5 THVED IN ORDER TO AVOIO HIGH POWER CONSUMPTION OF THE HEATER. SO, AFTER 30 MINUTES WITH THE UNIT NOT HANDLED, THE HEATER WILL BE DISABLED (EQUWALENT TO THE ODE STAND-BY OFF}. OPERATING ANY CYCLE KEY (STERLUATION OR TEST KEY), OR SWITCHING OFF/ON THE UNIT Vi THE MANS SWITCH, THE ORIGINAL STAND-BY Mobs (HIGH oR LOW) WL BE RESTOR. To allow the offective drying for the different typos of load and in all the conditions, the drying modes must be correctly selected. Operates as follows: 4. Select DRYING OPT. and confirm by the key -1 fo access the following menu: SLONG ° +t RT at Choice LONG (long drying, typical in eyes foc WRAPPED and POROUS materials) or SHORT (short drying, typical in cycles for SOLID, UNWRAPPED and HOLLOW materials) Use the key + / - then confirm by the koy 4 2, Depending on the choice (LONG or SHORT) two different menus are displayed: a) LONG ootion 3 STANDARD +t INTELLIGENT =u EXTRA Select STANDARD to enable, for WRAPPED and POROUS cycles, a fixed time drying. (Wim neavy Lonps on PECUUAR MATERIALS THE STANDARD OPTION MIGHT SOMETINES NOT GUARANTEE A PERFECT RESULT. IN THIS CASE EXTEND THE DRYING PHASE BY USING ‘THE EXTRA MODE,6 — SETTING THE EQUIPMENT Setting the Printer Options (PRINT OP Tons of the ADVANCED menu) (Wirt comtex toro (6.6. WRAPFED INSTRUMENTS IN STEF fiocom 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. ZATION “CONTAINER") THE MWTELLIGENT’ OPTION MIGHT NOT CORRECTLY OPERATE, WITH RESULTS LOWER THE EXPECTATION. IN THIS CASE USE THs STANDARD on EXTRA OPTIONS AS NECESSARY. Select EXTRA option for extending the drying phase of a selectable time period (e.g. or particulary dificult load). Enabling this option, the following choice will be prompted: RA:X EXT xX min +? J=OK feEse 4 where the duration of the extra drying can be set in the range of 1 +45 minutes. ») SHORT option DARD +7 aid Select STANDARD lo enablo, for SOLID and HOLLOW eycles, a fixod-time drying. Select FAST to minimize the drying time, forgoing however a porfact removal of the residual humidity. ‘Scroll the options through the key + J - then confirm by the kay «1 It the sterlizer is connected to a printer for the recording of the sterlization data, set the necessary parameters in order to guarantee the correct operation, Proceed as follows: By selecting the item PRINT OPT. and confirming it by the key =, appear the following SPRINTER REPORT oo The item PRINTER opens a next menu for selecting the line feed mode sccordingly with the printer used, whereas the item REPORT is used to set the number of the printouts and to enable the reprint ofthe last performed program, @) PRINTER menu By selocting the item PRINTER the following screen is proposed: CR +t CR+LF ot OFF Choice ER if you are using printers that carry out the form feed through @ CR command (Canfage Refum), choice CR+LF for printers needing a OR+LF command (Carriage Retum + Line Feed) or OFF to disable the data printout. Extrema Plus Extrema Plus 6 - SETTING THE EQUIPMENT (Fook uF i THE PRINTER MANUAL FOR RNONG THE COMMANDS USED (GR OR CRLF). TF ‘TH INFORMATION ARE NOT AVALABLE, CARRY OUT A TEST PRINTOUT WITH BOTH THE (OPTIONS 70 INDIOUALIZE THE CORRECT OPERATING SETTING. b) REPORT menu By selecting REPORT the following choice Is proposed: SNR, COPIES +t PRINT LAST +t Select NR. COPIES to set the number ofthe printout copies of the data at the end ‘of the steriization process (fhe printer is connected) ‘Appears the following screen: COPIES:X +? s=OK Teese 4 Use the key + / - to set the desired number of copies (inaximum §). Confirm through the key 1. ‘he item PRINT LAST allows to reprint the roport ofthe last performed cycle (both correctly terminated or intorupted due to an alarm). The following choice is proposed: 3 NORMAL +t EXTENDED 4 ‘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 cycte interrupted by an alarm). (@ ic THE LAST CYCLE HAS BEEN CORRECTLY COMPLETED (OR INTERRUPTED THROUGH AMA- NUAL Stor) THE REPRINT IN NORMAL on EXTENDED MOOE CAN BE PERFORMED. IF THE LAST GYCLE HAS BEEN INTERRUPTED DUE TO AN OCCURED ALARM (EXCLUDED A MANUAL Sto®) onLy THE EXTENDED NODE WILL BE AVALABLE, By entering the reprint command, the display will show the following message: NOW PRINTING PLEASE WAIT... ‘hat vil remain on until the end of the print. Use the key + /- to move through the menu and confiim by the key J. ” 296 — SETTING THE EQUIPMENT Setting the tank ling mode (FILLING option of the ADVANCED menu) Acquisition of the environment pressure (SET 0 bar option of the ‘SPECIAL menu) fpocom Extrema Plus allows to perform both manually and automatically the topping up of the Internal distiled water reservoir, in automatic mode the water will be drawn from an ‘external tank properly connected to the equipment (see Chapter “Installation"), ‘As solocted the option FILLING tho following choice is proposed: SAUTOMATIC vT MANUAL 4 ‘Solect the item AUTOMATIC to enable the automatic filing. In this operation mode, as the ‘minimum water lovol of the internal reservoir is reached {red Led MIN tums on), the system will provide to supply the reservoir with water for a preset time. However, ifthe maximum level is reached (green Led MAX turns on) before the expiration of the preset time the automatic filing will be disabled in advance. SF Actiware THE AUTOMATIC FILLING OPTION ONLY AFTER THE EXTERNAL TANK HAS BEEN FILLED WITH HIGH QUALITY DISTILLED WATER. PLEASE ALSO REMENBER TO OPEN THE TAP PUT ON THE TANK. In MANUAL mode the topping up have to be made manually. Uso the key +/- to move through the option and confirm by the key « ‘At the first set-up and after each new Installation of the sterlzer, the user must activate the acquisition of the environment prossure value, This operation is necessary for the correct operation ofthe intemal auxilary systems of the equipment, By selecting the option SET 0 bar the following screen will show SET VALUE 2 u=0K Teese (MF Veriry THAT THE DOOR OF THE STERILZER 18 COMPLETELY OPEN. ON THE CONTRARY, IF ‘YOU ATTEMPT TO PERFORM THE PRESSURE ACQUISITION WITH THE DOOR CLOSED, THE FOLLOWING MESSAGE WILL BE PRODUCED AND MAINTAINED UNTIL THE DOOR IS NOT OPEN: OPEN THE DOOR TO CONTINUE Confirm the command by the key J fo acquire data. The following message will appear: CURRENT VALUE SET INTO MEMORY followed by an acoustic signal, (To RENDER EFFECTIVE THE ACQUIRED AMBIENT PRESSURE VALUE IT Is NECESSARY 10 {©0T THE SETUP MODE, SWITCH OFF AND THEN ON THE DEVICE BY USING THE MANS SwiTcH. Extrema Plus fiocom Manual activation of the door-locking mechanism (POOR LOCK option of the SPECIAL menu). Adjusting the LCD contrast {LCD CONTRAST option of the SPECIAL monu) EXIT THE SETUP MODE Extrema Plus 6 - SETTING THE EQUIPMENT This option may be used to manually activate the doorocking mechanism, for Instance to ‘chack its correct operation or to uniock, at the end of the cycle, the door ofthe sterilization ‘chambor remained blocked for the failure of the electromagnet. By selecting the option DOOR LOCK the following choice Is proposed: LocK UNLOCK By tho option LOGK (key +) a command pulse is generated to disable the doorock, whereas by the option UNLOCK (key -) a reverse command is generated, thal is to enable the door-lock mechanism, Use the key 1! to ext the option as the item EXIT is not available inthis screen. §@ on exmne the SETUP move THE 000R-LOCKING SYSTEM WILL BE AUTOMATICALLY RELEASED. ‘Adjust the contrast of the LCD dlepley to compeneate diferent environmental lighting conditions. By selecting the option LOD CONTRAST the following chajce is proposed: 5 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 neatnoss of the writings. Use the key fl to exit the option as the iter EXIT is not available in this screen. ‘After having properly set all the options of the sterilizer, proceed as follows to retum in the normal operation mode: = Move to main menu (see Flowchart of the SETUP menu). (@ Toreruaw ar tHe MAN MENU, FROM WHATEVER PART OF THE PROGRAM YOU ARE, SIMPLY SELECT ONE OR MORE TIVES THE ITEM EXIT (CONFIRMING THROUGH THE KEY ..)) DISPLAYED INTHE CURRENT NENUS. ALTERNATIVELY PUSH ON THE KEY 21 (ESC) ONE OR MORE "WES. — Select the item EXIT and confirm by the key J, The display will show the message: REMA PLUS xT SETUP COMPLETE ‘After a few seconds the equipment returns to the normal operation mode and in STAND- BY state, “” 347 — PREPARING THE MATERIAL TO BE STERILIZED PREPARING THE MATERIAL TO BE STERILIZED INTRODUCTION HANDLING THE MATERIAL ! BEFORE : STERILIZING 32 focom ‘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 sterilization chamber. We notice that the organic residues or deposits of substances used in the medical practice are obviously recoptacias 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 andior 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 conceming this aspects, leaving the user to Material and instruments Cycle duration city |e |e | or | ras | ue na. | MSteceng otto "| _copanding onthe 121 | #10 | 20> contpured eye cating uP wauxrest Jw lawlas] eo] = lem] ata, VACUUMTEST] - [0.90] - - =F] 18 : Empty chamber rome Plus stAPPENDIX B —- PROGRAMS DIAGRAMS OF THE STERILIZATION PROGRAMS fijocom rescue om PROCESS 240 FRACTIONATED VACUUM PROGRAM ‘34e POROUS 134°C - 4°00" PROGRAM 134¢ PRION 134°C - 18°00" EXTENDED ORYING PROGRAM 1210 POROUS sare-2000" Extrema Plus fJocom APPENDIX B - PROGRAMS PROGRAM 134 HOLLOW oon 434°C - 400" or) {soos 4 | sr tan, paoceAn 42%¢ HOLLOW 12t*c - 2000" Extrema Plus 53.Fees | fiocom APPENDIX B - PROGRAMS. rene PROGRAM = ‘34¢ SOLID ‘t94e WRAPPED 134°C 400" oe 1340-400" i tein) resin | it +++ + t fete eee ttt tt ttt { | : | | Pete PROGRAM 1216 WRAPPED esas) PROGRAM t2i"o-2000" 121¢ 8000, 121°C 2000" The tet Ht Pott ween or) Extrema Plus Extrema Plus : 55APPENDIX B —- PROGRAMS fiocom 0 = : Pen bat PROGRAM ‘ade EMERGENCY 1340-900" inser) +++ ttt 44+ nen PROGRAM iad ove CUSTOM me fase 60) er mrg 134°C. rom 400" to 3000" 121°C from 2000" to. 30'00" “ia 86 Extrema Plus fiocom DIAGRAM OF THE TEST PROGRAMS APPENDIX B — PROGRAMS Pree PROGRAM HELIXTEST (HT) rnoctse 134°C 300" s nef) jee, sf rath PROGRAM VACUUM TEST (VT) 70.90 bar esonemeosr (ween costar _ ensiae oo How os EF ttt At Extrema Plus 67APPENDIX B - PROGRAMS: EXAMPLES OF PRINTING REPORTS focom Normal program report Extended program report Report following a Manual Stop (required by operator) a sgt Sense ae s gorenres | ae Eyre rr eoceuae x oe oat eee eee See eee Se, He, «= [Ee Pome tiie eee ieee Be fee Be ee a ih ee te Srey acces SRIOLE ‘Vacuum pulses FRACTIONATED Yomuum Pulses FRACTIONATED. oa = oe Sas a a eee ae crcneswat amen creiceramT aoe i prin Wiese ae ae wise ae ae a eae ee ae a ane eae ati lae a oe Be Sea tatiaiee eeeseae, me ge eae ee = as ae Bae Sasa teeta a 8g = oe eee ae shoe de ieee ee = 2h 6 mi as eet ee Eee ee BF oe eta eetlies ees #2 gp ae 8 tere yaaa | ovum ee ec eee fore 081.1 0.49 4421 1046 0366 fetta ; HEecHoreate ict ena fee DBAS OFS 0684-076 151.8 1047 1023 ptaes WS GE BE | Accor me a bia 06:92 10F 097.4 +0.01 154.7 104.0 1005 | DESCRIPTION MANUAL STOP- a ce ee deaeeoe frente eee ee overaron ee ro eyraares i ores ee ae ce, | BEE. me RE fe (Eire zouren oe ses Be ee ie jane ea he 158 es hie Bese ss ks Es stots Yt00 ise be | a8 Gar See cE 58 “O08 4420 mx 1359 jon IN ea Puss 05 Bre NS Poces jour STERILIZATION: POSITIVE OPERATOR 68 Me 8s 1359-217 1499 11 S23 He 353 1248 tess Hh se19 se Hiss 215 1974 1205 1594 12 saa st07 to70 1208 fees 1 TAS Took Tees ee TES OS Toia lato feet Hees $904 12E 9912-050 1551 1259 $9) Woe Ge3 Ove tear Saas tage 12 Goo2 ost tes Tend tao Be Gee Ger fs12 20 Ybor So G434.090 1509 1227 2265 EPO 49-00 1688 t2U7 1 ME soa-o6r 1960 1217 4 B25 de tosaDer ser 1215 4 248s 0& Hi26.047 woe 1181 112 2528 G5 152.050 1430 N84 1107 GE Mea cos tera tat Hor pepe mete sremsaro_ ret orsren EXTENDED REPORT REQUESTED BY THE OPERATOR Report following a Black-Out BTREMA PLUS Scam mesos ecusrom pac Biker Girne fiat EexerionareD Fast 2an99 fear 249790 js STERILISATION NEGATIVE (OPERATOR. ALARMCODE: £000 DESCRIPTION BLACKOUT Exirema Plus Report following an Alarm Medal EXTREMA PLUS oa 23% 0000 Corner Soor-dots Solocton SgaePoRoUS Tempero fae 0207 oF 9765-057 499 1052 Geir 8F Oat. oa 1424 O48 i BRUNET 034s 9&3 Gia 078 1518 1047 402, Osa Spy Opt 079 tase 043 101 3 7 oss2 196 974 sa01 1537 040 1008 saa ior Sous S024 Yas 4037 foro sot er Yss.216 uaa tin7 1947 $8 19592217 was 1195 1328 Mas Tir 137210 thse ise 10 tsa 96 Yis5216 1974 t295 1 34 oF 1344 107 t5rO j238 ise 8 teas ibe Wea4 20 toss O8 foed taco ted i238 STERLBATION NEGATIVE ALARMCODE: ANZ DESCRIPTION PTC SHORTCRCUIT caution PLEASEREFER TO USER MANUAL Extrema Plus : HELIX TEST program report Yc ExrReMA PLUS PR Bx m0 Serer Soiaie Selection Ftest Fempertre one prosur Pid ow Prowesotine 35min CrOLESTART 20990 ase ‘Time ct coor CS crea 3000 Go fy tes a Gas ys Sie Be ae fost ws iy GH te fio er fas8 as a $8 Maso Bar Ba tgs i2t ra fee ts a tes iia as cease ae ao Bs t's 30.0 eu Seo ows 0 iz) Epo tes Ba i271 be oma ao CE Or? OF tes wx eg sae HS Dyieapuees ot QELS — Loase ‘ese HeLncTesT coveteTE Peas toda ewan erect ‘OPERATOR APPENDIX B - PROGRAMS: VACUUM TEST program report Nodal exTREMA PLUS Pa xP 0060 Counter Sarvnote Selection Yacuuw rest ovcesTaRT — 2an600 Tine ce bar ooo 6s eas oe 0199 IF ark 090 os 6 Fame 000 1699 EF oD 090 Wh CE tS 030 CYCLE END iat VACUYMATEST: POSITIVE OPERATOR,MAINTENANCE INTRODUCTION ORDINARY SCHEDULED MAINTENANCE APPENDIX C - MAINTENANCE fpocom In order to guarantee a sure and efficient operation for the whole life of the equipment, @ regular maintenance by the usor as well as the corract use are necessary. (@ For a BETTER QUALITY OF THE MAINTENANCE, IT 16 NECESSARY TO INTEGRATE THE ORDINARY CONTROLS WITH PERIODIC CHECK-UP BY THE SERVICE (REFER TO APFENDIXZ), In addition, @ pettodie validation of the sterilizer, ic. the check of the thermodynamic process paramators compering them to the reference values measured by tools suitably adjusted, is fundamental. Refer to the paragraph Valldation 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. IW CASE OF REPLACEMENT OF COMPONENTS OR EQUPHENT PARTS REQUIRE FOR AND/OR USE ONLY ORIGINAL SPARE PARTS. ‘The following table reports an overview of the maintenance actions and frequency to be performed on the sterlizer 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. DAILY Cleaning of the external surfaces Cleaning of the sterilization chamber and accessories WEEKLY Desinfection of the extemal surfaces Lubrication of the door locking mechanism Maintonance of the safety valve MONTLY. Cleaning (or replacement) of the draining filter Storilization of the bactertologic filter EVERY 3/6 MOTHS lacemer riologic filter [lopenting on tne [Replacement of the bacterologicfite tose frequency) YEARLY Validation of the sterilizer (see proper paragraph) ‘Always refer to the folk | 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 sterlization chamber; = Do not use chemical products or disinfectant substances for cleaning the sterilization ‘chamber, These products could provoke possible damages, sometimes kremediable, to the sterilization chamber; = Do not let the caloarcous or dirty residues accumulate on the sterlization chamber, ‘door and gasket, but provide for their periodic removal, n the course of the time thse residues could cause damages to the elements, and jeopardize the operation of the ‘components installed on the hydraulic circuit. Exrema Plus MAINTENANCE OPERATIONS Cleaning the gasket and parabola Cleaning the external surfaces Cleaning the sterilization chamber and accessories Disinfecting the external surfaces Lubricating the door locking mechanism Extrema Plus APPENDIX C — MAINTENANCE (The PRESENCE OF WHITE SPOTS AT THE BASE OF THE INSIDE WALL OF THE CHAMBER MEANS THE USE OF POOR GUALITY DEMINERALIZED WATER. sae eG Miata ora CEE le QS Itiisbrator coroners OF osmon eaten Toko) tre DoccmncT or Ne Eno rowan Soret ere QUEM HOT ‘stu met See wen esvcn's tan en YonEveR Mor aE So 8 cee car or te antenee, tie nenice WORN PROGRESS wer EE re With reference to the previous table, the operations conceming the different maintenance actions are here synthetically described, . In order fo oliminate 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 extornal parts by using a clean cotton cloth dampened with water, eventually ‘added with some neutral detergent. Diy 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 water, eventually added with a bland neutral detergent. Rinso carefully with distived water, paying attention do not let any residue remain on the ‘chamber or accessories, (@® _Donotuse POINTED OR SHARP TOOLS To REMOVE THE CALCAREOUS SPOTS FROM THE STERILZATION CHAPIBER. INGASE OF EVIOENT RESIDUES, IMMEDIATELY VERIFY THE QUALITY OF THE DISTILLED WATER YOU ARE USING (SEE APPENDIX A., TECHNICAL CHARACTERISTICS) For the desultory disinfection of the extemal surfaces both methylated spirit and detergents with @ minimum percentage of sodium hypochlorite (or equivalent) can be used. For a good maintenance of the equipment periodically perform the cleaning of all the ‘oxtemal 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 oll or analogous spray product. ay attention do not sprinkle the lubricant on sterilization chamber, gasket and the inside part of the parabola, "Do nor Use GREASE OR OTHERS SOLID PRODUCTS, AS THEY COULD PRODUCE IN THE (COURSE OF THE TIME INCRUSTATIONS AND CONSEQUENT JAMS OF THE MECHANSHL ae etAPPENDIX C — MAINTENANCE | Maintenance of the | safety valve 8 “oo i Cleaning (or | replacement) the draining filter Sterilization of the bacteriological filter Replacement of the bacteriological filter fiocom ‘Access the safety valve on the back side of the storiizer. Loosen the grained ferrule with the fingers (or with a proper too! 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 ieast for a couple of times. ‘Althe end tighten the ferruie definitively. ‘Ts oreRATO 1s MECESEANY To OUARAYTEE THE CORRECT OPRATON OFTHE VALE AY, ve course or erm ‘At the end of the maintenance verify that the ferrule ‘and locked. completely tighton During the use, the accumulation of residuos within the filter could graduelly obstruct the lower draining duct. For cleaning (or replace) the fier, open the door of the sterilizer and remove the nut 1 with a hexagonal wrench n. 14, Then remove the water stopper 2 and tho relative gasket and, by the same wrench, ‘unscrew the fiting 3 for accessing the fier 4. Remove the filer from the support and carefully clean it under a throw of running water, Using if necessary # pointed tool to remove possible extraneous bodies of greater dimensions. Ifthe fiter cannot be recovered provide for the replacement with a new one. Plug the fitarin the support blocking It with a drop of pipe-fiting sealing (if available). Reassemble all the parts following In opposite order the procedure, paying attention to let the draining holes § remain at the level of the chamber wall. Periodically eliminate the bacterial charge of the bacteriological fiter by means of @ sterilization process at 121°C for porous material (program 121¢ POROUS). ‘At the end of the program screw it completely on the support. (@ Tucprocess STERILIZATION DOESN'T RENOVE THE O3STRUCTION OF THE FILTER, NETHER. ROLONGS IN ANY WAY ITS LIFE, THGREFORE 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 fiter Is noticed (signaled by a color markedly tending towards the grey) unscrew the bacteriologic fiter from the suppor, replace It with a new one that must be screwed completely on the fitting. (1 sane BACTERIOLOGIOAL FILTER 15 SUPPLIED WITH THE EQUIPMENT, To REQUIRE ‘ADDITIONAL FRTERS REFER TO THE APPENDZ, SERVICE. 7 Extrema Plus fiocom PERIODIC VALIDATION OF THE STERILIZER Extrema Plus Tee APPENDIX C - MAINTENANCE ‘As for every equipment, a decadence of the performances and components during the life, depending on the utiization type and frequency, is inevitable, In order to guarantee a constant process safely it is necessary to verify, at periadle ‘expiration (possibly yearly), the process thermodynamic parameters (pressure end temperature), checking If these are remaining within admitted limits or not ‘The performance validation of the stetlizer is al care and responsibility of the user. ‘The reference European standards EN 84 (Storlzation of tho modical devices - Method for tho validation and systematic contro! of the steam storiization) and EN 656 {Storlzation 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 speciic experience and knowledge, the use of a ‘special tools (high accuracy’ sensors and probes, data logger, dedicated software, etc properly verified and adjusted, itis necessary to address to companies specialized i this activity. ‘Tho M.0.COM, Customer Service (see Appendix Z) is at your disposal to supply every possible information concerning the periodic validation of the sterilizers. 63APPENDIX D - GENERAL PROBLEMS fijocom GENERAL PROBLEMS OVERVIEW if during the equipment use a problem or an alarm signaling occurs, itis not the cage to immodiatoly wory. ‘This could nol bo ‘caused by a broakdown, but more probably by an abnormal situation, often only transitory (for instance @ black-out), or by an incorrect use, In any caso, itis important to individuelize 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 actions for their solution are supplied in the following, | ANALYSIS AND RESOLUTION OF THE PROBLEMS If Your sterlizer doesn't work correctly, please perform the followings verifications before contacting the Customer Service: PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION “The plug of the power supply cable | Plug in correctly the power supply cable, Is not comectly plugged in the socket. Voltage lack at the output socket. Verify the cause of the voltage lacking and try to recovery tt ‘Set the switch in ON position. “The malns switch andor the automatic circuit breaker are in OFF state. ‘The mains fuses are bummed. Roplace the fuses with others of the same type and value. (See Appendix A, Technical characteristics). ‘After the START The equipment is performing the | Wait for the steilzer reaches the correct thermal ‘commend, the pre-heating phase (WARMUP), conditions for the start of the sterilization cycie. sterilization cycle Hue fag a Scan etat | NOTE: Under normal operating condions, the proheating average time is about 12 minutes, “Topping up the reservoir with distilled water until the The red Led MIN tums | The distilled water level of the m Tees ecrte — |igkpsolve goss ted wer stoaa te rin minimum ‘evel. off of the red Led MIN). ‘The red Led Alarm An alarm signaling has been Verify the alarm code and operate consequently. tase Soars ee oes, Ca ee (Seong pagans, alr sonata, Alarm MER diy adresse 0 | Oe shooting Tarttayvave [Arent rrr ras | Vay oreo okra of We sey intervenes. the chamber. valve. | NOTE: Let the equipment cool or use gloves to avoid from burring oneself when you are touching the valve, a Extrema Plus i Gijocom APPENDIX D - GENERAL PROBLEMS PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION tthe end of the program (CYCLE COMPLETE) itis impossible to open the door. Residual pressure inside the chamber. NOTE: LCD displays the Wait for some minutes until the pressure return to the 0.00 bar, and retry to open the door. Verify that the bacteriologic filter is not obstructed and, message: I mecessary, replace it. NOW LEVELLING “The procedure for storing the environment pressure PLEASE WAIT... value (function SET 0 bar) has not been correctly performed. {Call for the Customer Service (see Appendix Z), “The safety ction ofthe Randle is | Push on the handle (pay attention to not damage it) loosen, ‘against the equipment until to set it in the position parallel with the door. Retry to open the door. “The door-locking system is remained engaged at the ond of the oycle. After having reset the alarm (code £021), verify that {the handle is in the correct closing position. Call the SETUP program and the DOOR LOCK option in the monu SPECIAL for the manual command of the mechanism. (see Chapter “Setting the equipment”), NOTE: In case of unsuccessful, cary out the manual ‘unlocking through the supplied tool {see note at tho end of this appendix). Presence of water on the table of the sterlizer. Fitings or draining pipetines not ‘correctly connected. ‘Verify the locking of the filings; necessary perform the assembly with greater attention to the sealing (see ‘Chapter - Installation) Check that the pipotines towards the draining tank are completely fied; very that the proper clamps ere postioned on th pipes. Feeding water pipe coming from the extomal reservoir not correctly connected, Verify the locking of the pipe: if necessary perform the assembly with greater attention to the sealing (see Chapter - Installation). ‘Check that te pipelines coming from the external tank is completely ited; vel that the propor 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 verity the condition. Presence of water around the draining tank, Draining pipes not correctly ‘connected fo the tank. ‘Chock that the pipelines towards the draining tank is completely ited; 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, Difficulty for reaching the correct vacuum in the chamber (problems, of drying, presence of ‘Sterlization chamber draining fter obstructed. Provide for the cleaning or replacement of the draining filter. (see Appendix ¢ * Maintenance”). water inthe stenlization | Draining circuit obstructed or Verify the draining pipes (and the fittings on which they chamber at the end of | graining pipes obstructed. aro fitted) are without obstructions and runs freely from the cycle, etc). the equipmont to the condensation recovery tank. ‘Air slots on the sides andlor on the | Remove every possible obstruction from the air slots rear obstructed or heat exchanger | and from the heat exchanger. meee ated Very the equipment is not on direct contact with walls or surfaces (s00 Chapter “instalation’). Extrema Plus 65APPENDIX D — GENERAL PROBLEMS, fiocom | PROBLEM POSSIBLE CAUSE PROPOSED SOLUTION Excessive damp on the ‘material andlor tho tools E at the end of the rogram. Excess of material inside the chamber. Verify the quantity of sterlized material and mako sure do not overcome the maximum admilled quantities, ‘according to the typology of the load, (See overview fable in Appendix A, “Technical characteristics”). Load not correctly arranged. [Arrange tho load, particularly the wrapped one, according fo the indications, (See Chaptor ‘Preparing the material to be sterilized”), Wrong selection of the sterilization program ‘Choose the proper sterilization program for tho type of material to be sterilized. (Gee Table in Appendix B, “Programs'). ‘Obstruction on the sterilization ‘chamber draining filer. Provide for cleaning or replacing the draining filter, (S00 Appendix G, “Maintenance”. (Oxidation traces or spots on the tools Poor qualty ofthe tools. ‘Check the quality ofthe tools showing the problem, ‘make gure thet the material of the tools is, autoclavable. Poor quality ofthe distiled water. Emply the reservoir and fit with high quality dstiled water (possibly obtained by inverse osmosis}. (See Characteristics of the feeding water in Appendix A. “Technical characteristics”) ‘Organic or inorganic residues on the tools Carefully clean the material boforo the sterilization oye. {See Chapter ‘Preparing the material to be sterilized”) Contact among tools of different metal. Separate the tools of different metal with proper ‘expedients. (See Chapter ‘Preparing the material to bo sterilized”). Presence of calcareous residues ‘on the wall ofthe sterilization chamber andlor accessories, Perform the cleaning of the equipment and parts as Indicated. (See Appendix ¢ ‘Maintenance”) BBluing oF blackening of ‘the materials. ‘Wrong selection of the sterilization rogram. Verify the adequacy of the temperature of the sterlization program selected according to the material tobe treated. (See Table in Appendix B, “Programs”). ‘The printer (i installed) doesnit print the report. Printor not switched on. ‘Switch on the printer, Parallel cable not correctly connected or wrong model. ‘Verify that the cable used Is sultablo for the printer and correctly connected. ‘Sterlizer not correctly configured for the use of the printer. Provide for setting the equipment according to the used printer. (See Chapter "Setting the equipment’). OG irre pRooem PERSIOTS, CALL FOR THE CUSTOMER SERVICE (SEE APPENOKKZ) BY COMMUNICATING THE MODEL AND THE [SERIES NUVBER OF THE STERLZER. THESE DATA MAY BE FOUNO ON THE NANUFACTURING PLATE ON THE REAR SIDE OF THE EQUIPMENT AND ON THE GUARANTEE CERTIFCATE. Extroma Plus 7 Pallett fiocom 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. 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; 2. Firmly hold the equipment, pay attention do not fall it down avoiding damages or injures to property andior people; Insort the special supplied tool (Ref. 16 — see page 3) into the hole below the frame; ‘Screw the fool on threaded shaft of the electromagnet without tightening; ‘5. Pull downward the tool until the mechanism is unlocked; 6. Unscrew the tool and remove 7, Arrange the equipment on the support plane; 8. Open the door and recover the load. PESEEEL EE FAUT E Extrema Plus . a orAPPENDIX E - ALARM SIGNALING ALARM SIGNALING | OVERVIEW ALARM PROCEDURE Alarm occurring during the sterilization cycle focom 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= ERROR Wrong action andlor use, or extemal equipment cause. Problem generally recoverable by the user. Code format — Exxx (xxx = identification number 000 + 999) * A= ALARM Failure of ft level, not concerning the safety. Problem generally recoverable on site by a specialized tochnician. Code format; Axxx (xxx = identification number 000 + 989) * H= HAZARD allure of second level, involving the safety. Problem generally recoverable by the Customer Service. Code format: Hxxx (xxx = identification number 000 + 998) ‘The Intervention of the alarm procedure causes the interruption of the program (or the ‘normal operation), associated withthe alarm code displaying, a message on LCD cispiay (se0 table below), an acoustic signaling and the lighting of the alarm red led (steady or intermittent). O@ unive rie ALARM PROCEDURE THE TEMPERATURE (°C) AND PRESSURE (BAR) DISPLAYS LL SHOW ALWAYS THE CURRENT VALUES OF THE STERLIZATION CiAMBER, 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 tunintentior f the not s a. ‘The performing of the alarm procedure differs according to whether i cours during or out the program execution, and is structured for driving the user until the final RESET of the sterilize. {the alarm occurs during the sterilization of tast program the LCD will show: Alarm message LEVELLING. Reached the safely conditions, the equipment enables @ special procedure, on the first ‘asking the user for manually unlocking the door with the following message: PRESS f TO UNLOCK THE DOOR Press the key f to unlook the door locking mechanism, The following message appears Alarm message OPEN THE DOOR : ‘Opened the door, the user is required fo reset the equipment: Alarm message RESET SYSTE Extrema Plus | fifocom Alarm occurring out the sterilization cycle RESET OF THE SYSTEM >3s Extrema Plus APPENDIX E — ALARM SIGNALING ‘or, according to the prosot RESET modes: Alarm message ALARM IF APRINTER SS INSTALLED, ON OPENING THE DOOR AT THE END OF THE CYCLE THE REPORT (NORMAL OR EXTENDED ACCORDING TO THE TYPE OF THE OCCURRED ALARM) RELATIVE TO ‘THE STERIUZATION 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 oF test program the following message will be shown: Alarm message ALARM! ‘, according to the foreseen RESET modes, * Alarm me N ssage WARNINGE ‘which wil automatically change with the message: Alarm message RESET SYSTEM (@ Tie sans occunneo Our OF THe PROGRAM WIL 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) = By pressing for about 3 seconds the PROGRAM SELECTION key. ‘An acoustic signal will be generated as RESET confirmation; - Bysuitchi i jough the mains switch. (On turning on the sterilizer the normel inital autotest willbe performed. x Ie THE EQUIPMENT HAS SWITCHED OFF (MANS SWITCH IN OFF) BEFORE THE RESET ‘THROUGH THE PROPER KEY WILL CAUSE A FURTHER ALARM (BLAGK-OUT, coDe E000) [AT THE NEXT SWITCHING ON, IN FACT, THE ALARM PROCEDURE WIL BE CONSIDERED NOT COMPLETED IF MISSED THE CORRECT AND COMPLETE RESTORATION. After the RESET, and the possible technical service, the equipment will go in STAND-BY status, ready to perform a new program, (@® ir 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 LCI 134¢ POROUS CIRCUIT CLEANING ‘Over the cleaning procedure, the sterlzation cycle solectod will start automaticaly, 69APPENDIX E — ALARM SIGNALING LIST OF THE ALARM CODES ‘The alarm codes, LCD messages and consequont RESET modes are listed in the following fiocom | cope ALARM DESCRIPTION. LCD MESSAGE RESET MODE ERRORS (category E) E000 | Black-out BLACK-OUT _ E010 [Door opon DOOR OPEN 020 | Door unlocked DOOR UNLOGKES £021 _| Door locked DOOR LOCKED E030. | Minimum water level inthe filing tank (MIN) WATERMIN | E031 | Maximum water lovel inthe filing tank (MAX) EXHAUST MAX E041 | Too much frequent ling up ofthe tank FILLING PROBLEM | PROGRAM SELECTION it (automatic filling) key £900 | Unsuecesstul Vacuum Test TEST FAILED (during tho LEAKAGE phase) fe E901 | Unsuccossful Vacuum Tost TEST FAILED (during the WAITING phase) E902 | Unsuccessful Vacuum Test TEST FAILED (timeout vacuum pulses exceeded) 1999 [ Manual interruption ofthe cycle WANUAL STOP. ALARMS (catogory A) ‘K022__[ Problem of the door locking mechanism LOCKING PROBLEM ‘A032 _ | Problom ofthe level probes LEVEL PROBLEM "A040 | Unsuccessful reservoir filing FILLING PROBLEM {automatic filing) A101 | Failure of the thermo-resistor PT1 PTC BROKEN bs (Gteriizaton chambor) ‘A102 | Failure of the thermo-esisior PT2 PTC BROKEN (steam generator) "M103 _ | Failure of tho thormo-resisior PTS PTC BROKEN (heating resistor) ‘A104 | Falure ofthe thermo-resistor PT4 PTO BROKEN {on the wall of the steriization chamber) Switching eff the equipment TAIT | Shor-circult ofthe thermo-esistor PTA PTC SHORTOIRCUT (OFF) (Gtenitation chamber) "AH12 | Shor-crcuit ofthe thermo-resistor PT2 PTC SHORTOIROUIT (steam generator) 'A113 | Shor-creult ofthe thermno-resistor PTO PTC SHORTCIRCUIT (heating resisior) ‘AIt4 | Shor-circut ofthe thormo-resistor PT4 PTC SHORTOIRCUIT (on the wail of the sterilization chamber) ‘A121 | Instability of the thermo-resistor PT1 PTC FLICKERING (sterilization chamber) "A200 Pre-heating not performed within the imeout| HEATING PROBLEM (heating resistor problem), : ‘A250 [1° vacuum pulse not performed within the| | PV1 TIMEOUT timeout PROGRAM SELECTION "A261 |" raising towards the atmospheric prossure| ATM TIMEOUT key ‘ot performed within the timeout 70 Extrema Plus fiocom APPENDIX E - ALARM SIGNALING CODE ALARM DESCRIPTION LCD MESSAGE _ RESET MODE ‘A252, [7° vacuum pulse not performed within the| PP TINEOUT timeout roma Frac piso 91 prermed WI el mya rycouT 284 |" raising towards the amoaphera pressure] ATMA TIMEOUT hot performed witin the timeout ‘A266 |2° vacuum pulse not poriormed within tho] PP2 TIMEOUT eee PROGRAM SELECTION A266 [3° vacuum pulse not performed within the’ ‘PV3 TIMEOUT key tinoout A257 | 3° raising towards the atmospheric pressure ATMS TIMEOUT tot performed win the tneout ‘A268 |3* vacuum pulse not performed within the| PPP TNEOUT timeout ‘Aas [PROCESS phase nol eared wit te imoout |” PROCESS TIMEOUT HAZARDS (category H) 180 _| Failure of the pressure probe MPX MPX BROKEN = iH H160 | Short-circuit/disconnection of the pressure| MPXSHORTCIRCUIT | Switching off the equipment probe MEX. (orm T1170” | netabiliy of the prosoure probe MPX PX FLIOKERING H400 | Ratio PoefT unbalanced (Pon>T) rr PROBLEM (PROCESS pase) F401 | Ratio TPiaw unbalanced (Poon) iP PROBLEM (PROCESS phase) 402 | Temperature ovor the MAX iit TOVvER UwiT (PROCESS phase) Faas | Tomporatro under MINT FUNDER LIMIT (PROCESS phase) THao4 | Temporeture thictucting over te it PTH FLUCTUATING (PROCESS phase) a08 [Pressure over the MAX im POVERLMIT —] PROGRAM SELECTION {PROCESS phase) key 408 | Pressure under the MIN it PUNDER LMT (eROGESS phase) 860 | Overproseure OVERPRESSURE (steritization chamber, MPX) H81 | Overheating OVERHEATING PTT (sterilization chamber, PT1) 992 | Over-heating OVERHEATING PT2 (steam generator, PT2) W893 | Overheating ‘OVERHEATING PTS (band heating resistor, PT3) Extrema Plus nAPPENDIX E — ALARM SIGNALING. fpocom 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: CODE POSSIBLE CAUSE ‘SUGGESTED SOLUTION ERRORS (category E) E000 _ | Seddon intorupton ofthe electe | Wal forthe rtum af tro electi power supply and perform he power supply (black-out). RESET according fo the instructions, erly the correct sterilization ofthe load bofore using tho treated mate Accidental swiching off the main | Rezonnect the plug endfor witch onthe equipment, end perform the Sulich andor clsconnection ofthe | RESET according othe Instructions Pen eee eeeerert Verity the correct sterization ofthe load bofore using the treated mati Wane fuses burned. Replace the fuses of same iype and value (@oe Tabi in Appendix A, "Technical characteristics”) Switch on the equipment and perform the RESET according tothe Inatuctions, ‘Verity the correct sterilization of he load before using the treated matt E010 | Door open (or nt corecty close) Perform tho RESET aovording othe instructions. onthe start ofthe cyte (START). | corey cose the door and estat the cyl. Faire ofthe door micro-evtch, | Call for the Customer Service (see Aapendie 2. E020 | Door ocking mecharvem not | Perform the RESET according tothe instructions. Feeney cat n° S21 | coracty close the dor, pushing complatly te handle, and try to ; feslart aga the program Failure ofthe door locking Call for the Gustomer Service (see Anpendix 2). mechanism. E021 | Door locking system noteleased | Perform the RESET according tote instructions. eitgtBesce (CVC lestpecerur ora en son D008 LOK een he menu SPECIAL In otder lo operate manvaly the mechanism {Gee Chaptor "Setting the equlpmont’). NOTE: In case of unsuccessful sul, manually perform the releasing of he mechanism tough the supplied too. Fallure ofthe door locking Call forthe Customer Service (see Appendix 2}. mecherism E030 _ | Intomal reser wator lovel under | Perform the RESET according tothe instructions. the mina (aN) ; Provide for filing up the water unl the turing on ofthe Lod MAX (or turing off toast of tre Lod MIN), Fallure ofthe MIN evel signaling. [Call forthe Customer Service (s00 Appendix Z). E031 | Dreining tank watorlevel overtho | Perforn the RESET according tothe instructions. betateties Provide fr draining the tan, ating a minimum level of water a8 mmarkod to remain, a Cable ofthe draining tank level | Perform the RESET according to the inatustons. Slanaling isconnected from the | connect the jack of he level signaling cable tothe inlet on the back of eee tho seriizer, Fale of the MAX tovel signaling, [all for the Customer Service (see Appendix 2). 2 Extrema Plus | fijocom APPENDIX E - ALARM SIGNALING cope POSSIBLE CAUSE ‘SUGGESTED SOLUTION E041 _ | Connecting pipe between exiemal_| Perform the RESET according fo the intructions, tank and sterizer not comectly | Very the connection ofthe water filing pipe, tighten both ends on the 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 Grout. | Call for the Customer Service (see Appendix Z). E900 |_| Alrtoakage on the gasket Perform the RESET according fo the instructions. Carefully ‘clean the gasket with a clean cloth of cotton dampened with walter. Restart the program, Sterilization chamber too much | Porform the RESET according tothe instructions. See Carry out the test with the sterilization chamber at moderate temperature (for instance in tho moming, at tho frst switching on of the equiomen). Problem on the hydraulic circuit. Call for the Customer Service (see Appendix 2). £901 _ | Excose of damp inside tho Perform the RESET according tothe instructions. Liieeemeiinaliainail Carefully dry the sterilization chamber and restart the program. ‘ir leakage on the gasket Perforh the RESET according tothe instructions. Caaty oan ne gasket wth clean ct of ton dampened with Restart the program. Problem on the hydraulle crcult. | Gall for the Customer Service (see Appendix 2). E902 _| Excess of damp in the steriization | Perform the RESET according to the instructions. ‘chamber. Carefully dry the inside of the sterilization chamber and again restart the program. ‘Ar teakage on tho gasket Perform the RESET according fo the instructions, ‘Carefully clean the gasket with a clean cloth of cotton dampened with water. Restart the program re of the vacuum pump. Call for the Customer Service (see Appendix 2). Problem on the hydraulie circu, £999 _ | Manual interruption ofthe Perform the RESET according othe netrctons, seriiztion or test program. sae lization before using the treated materi (see also Chapter "Running the sterilization program’) ALARMS (category A) ‘A022 _| Door not completely open during | Open completely the door, verifying the closing hook doesnt provent the lial automatic seltest, | the acvallon of the mechanism, ‘Switch off (RESET) and switch on again the equipment. Fours of the door locking Call for the Customer Service (see Appendix Z). mechanism Door locking mechanism released | Perform the RESET according fo the instuctions. (erroneously) during thecycle | cau forthe Customer Service (s00 Appendix 2). Extrema Plus 3APPENDIX E — ALARM SIGNALING fiocom ‘CODE POSSIBLE CAUSE ‘SUGGESTED SOLUTION. A032 ‘Water level signaling connector not plugged in. Failure of the level signaling(s) Call for the Customer Service (see Appendix Z). A040 Lacking of wator in the extemal tank (automatic filing) orform the RESET according to the instructions. Fill the tank with sufficient cistiled water, and remember to periodically vorify the level. ‘Connecting pipe between the ‘extemal tank and sterlizer not correctly connected. Perform the RESET according to the instructions. Verify the connection of the water filing pipe, tighten both ends on the filing through the supplied plastic clips. Eliminate possible obstructions on the pipe route. Failure of water pump, Gall for the Customer Service (see Appendix Z). A101 Failure of the temperature probe of the storifzation chamber (PT?) A102 Failure of the temperature probe of the steam gonerator (PT2). A103 Failure of the temperature probe of the heating resistor (PT3). A104 Failure of the temperature probe of the chamber wall (PT4). A111 ‘Wrong connection of the temperature probe (sterilization ‘chamber to the pcb connector, ‘Short-crcult of the temperature probe (sterilzation chamber), AN12 Wrong connection of the temperature probe (steam ‘generator) to the pcb connector. Short-circuit of the temperature probe (steam generator). Call for the Customer Service (see Appendix 2). A113, Wrong connection of the temperature probe (heating reelton to the pob connector. Short-rcui ofthe temperature probe (heating resistor A114 Wrong connection of the temperature probe (chamber wall) to the peb connector. ‘Short-circuit of the temperature probe (chamber wall). A121 Instable operation of the temperature probe (sterlization chamber) Extrema Plus fiocom APPENDIX E - ALARM SIGNALING CODE POSSIBLE CAUSE SUGGESTED SOLUTION "A200 | Release of the steam generator | Provide for the manual reset of the thermostat installed on the rear Safely honmostat, 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. Swich off (RESET) and sith on again th equipment Feoase ofthe heating resistor Ssannunalapia Call for the Customer Service i all for tho Customer Service (see Apnanuie 2) ‘Wrong operation of the steam ‘ generator or heating resistor, "A250 | Presence of water or condensation | Perform the RESET according fo ho inarucons: inside the sterization chamber. | carefully cry the sterzation chambor and restart the program. Bo not introduce material soaked by water or liquid int the chamber. ‘Obstruction on the sterilization | Provide for cleaning or replacing the draining fier. een (See Appendix “Maintenance”. Tirleakage onthe gasket, Perform the RESET aocording othe instuctons Carefully tan the gasket wih a clean coh of cotion dampened with water Restart the program Fate tio vecusnPum | scanty Soin low Anna 2 all forthe Customer Service (soe Append: 2) Probiom on the hycraufe cut (A251. | Wrong operation of the water pump. Call for the Customer Service (see Appendix Z). Problem on the hydraulic ciroult. Reloaco of tho steam gonortor | Provdo for he manval reset of th ihomooal onthe rear aide of the safety thermostat, equipment (see Chapter “Product description”). Unscrew the protection plastic cap, push on the red button until a tick and replace the cop, Switch off (RESET) and evtch onthe equipment Foose of tho heating resistor feet Call for the Customor Service (soe Appendix 2) ‘Wrong operation of the steam: : generator or heating resistor "A252 | Ar leakago onthe goskot Pororm iho RESET according to the instucone, Carefully clean the gasket with a clean cloth of cotton dampened with water Restart the program, Too much bed, Perform the RESET according fo tho tuations, erty the quenity of material into the steiizaton chamber end pay tenfon tonal exceed the maximum adimitied quant according fo the oad typology. (see Table in Appendix A, Technical characteristics). Problem of the hydraulic circuit. Cail for the Customer Service (see Appendix Z). Extema Plus 75EE EES CS ECeH _ APPENDIX E — ALARM SIGNALING focom cope POSSIBLE CAUSE ‘SUGGESTED SOLUTION "A252 | Release of tho stoam generator | Provide fr the manuel resot ofthe tharmosiaton the rear sie of the safety thermostat. equipment (see Chapter ‘Product description’). isetaad 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 he heating resistor safely thermostat 7 Call for the Customer Service (see Appendix 2). ‘Wrong operation ofthe steam Generator oF heating resistor. "A253 | Presence of water or condensation | Perform the RESET according othe instructions. info the eterlization chamber. | efit dry the steriization chamber and restart the program. Do not inroduce material soaked with water or Iquid into the chamb ‘Ar leakage on the gasket Perform the RESET according to the instructions. Carefully clean tho gasket with clean cloth of cotton dampened with wales. Rostart the program. Faliure ofthe vacuum pump. pure Call for the Customer Service (see Appendix 2) Problem on the hyraulie cout ‘A254 | Wrong operation of the water pump. Call for the Customer Service (see Appendix 2). Problem on the hydraulic cult Release ofthe steam gonerator | Provide forthe manuel reset ofthe thermostat on the rear cide ofthe safety thermostat. ‘equipment (see Chapter "Product description”). Unscrew the protection plestc cap, push on the red button untia click and replace the cap. Switch of (RESET) and switoh on egein the equipment. Release of the heating resistor safety thermostat ee Call for the Customer Service (see Appendix 2). Wrong operation ofthe steam ‘generator of heating resistor. ‘A266 | Airleakage on the gosket Perform the RESET according tothe insvucions. Carefully cloan the gasket witha clean cloth of cotton dampened with wator. Restart the program, Excess of oad Perform the RESET according tothe Instructions. Verify the quantity of materia inthe steriization chamber and pay aitention to not excaed the maximum admited quantity according to the load typology. (see Table in Appendiy A, Technical characteristics). Problem of the hycrauile rout. _ | Call for the Customer Service (see Appendix 2). Release of the steam generator __| Provide for the manual reset of the thermostat on the rear sid6 of the safely thermostat. equipment (see Chapter “Product description”) Unscrew the protection plastic cap, push on the red button until a llok and replace the cap ‘Switch off (RESET) and switch on again the equipment. 7 Extrema Plus fiJocom APPENDIX E - ALARM SIGNALING CODE POSSIBLE CAUSE SUGGESTED SOLUTION ‘A255 | Release ofthe heating resistor SS ely hermosa See a eae (corte (or the Customer Service (see Appendix {cort’®) | Wrong operation of the steam : 7 generator or heating relator "A256 | Presence of water or condensation | Perform the RESET according to the Instrucions in th strltzation chamber. Carefuly dry the sterization chamber and restart the program. ‘Do not introduce materia soakod with water o qu nt the chamber. ‘Nr leakogo on tho gaakot Perform the RESET aocording tothe instructions. Caretuy clean the gasket witha clean loth of cotton dampened with water. Again start tho program. Foie ofthe vaaumm pump. | Customer sane all for the Customer Service (see Appendix 2). Problem onthe hycrautc creat : "A257 | Wrong operation of the water pump. Call for the Customer Service (see Appendix 2). Problom onthe hydra cult Release ofthe steam generator | Provide for the manual resol of ho thermostat on to rar eido of the safely thermostat. equipment (see Chapter Product description”. Unscrew the protection plastic cap, push onthe red button una ellek and replace the cap Switch off (RESET) and switch on again tho equipment Release ofthe healing resistor Sete Call for the Customer Service (see Appendix 2. all forthe Customer Service (see Appendix 2) Wrong cperation of the steam generator or heating resistor "A258 | Ar leakage onthe gasket Perform the RESET according othe Insruelione. Carefully clean the gasket wth a clean cloth of eaton dampened wth water Restart the program. Broess offoad Perform the RESET according othe Insrullons. Verity the quantity of materia inthe storlization chamber and pay attention to not exceed the maximum admited quently according to the load ypology. (00 Table n Append A, Technical characteristics). Problem onthe hydraui Grout | Call fr the Customer Service (seo Appendix 2) Reloaee ofthe steam generator | Provide for the manual eset ofthe thermostal onthe rear side ofthe safely thommosta. equipment (see Chapter Product description”) Unscrew the protection plastic cap, puch on the red button uni a alle and replace the cap. Switch off (RESET) and svitch on again the equipment Release ofthe heating resistor eee Call for the Customer Service (see Appendix all for the Customer Service (see, . Wrong operation ofthe steam generator or heating resistor. Extrema Plus 7| APPENDIX E - ALARM SIGNALING figocom APPENDIX F - DRAWINGS ELECTRICAL DRAWING CODE POSSIBLE CAUSE ‘SUGGESTED SOLUTION "A259 | Ex0288 of oad. Perform the RESET according tthe Instructions. : i Very the quantity of material inthe striization chamber and pay a set Se a earth masa nite any aceadty & : the load ypaogy. { 2) b (cee Tabio in Appendix A, Technical characteristics). i \< ic o>” i! Tr oakage fom tho gaakat | Perform the RESET according tothe instructions. = I om Careflly clean the gasket with a clean cloth of otten dempened with i water. 5 Restat the program. Problem on the hydraulic circuit. | Call for the Customer Servics (500 Appendix 2). f HAZARDS (category H) H450_ | Break ofthe pressure probe (MPX). 11160 | Wrong connection of the pressure probe cable (MPX) to the p.c.b. connector. Short-crcult of the pressure probe (NPR. 1170 |Insteble operation ofthe temperature probe (sterilization chamber) H400 | Protiem of the hydraulic circuit. — H401 | Problem of the hydraulic circut. H402 [Wrong operation of the steam generator. Problem of the hydraulic circuit, H403 [Wrong operation of the steam generator. Problem of the hydraulic circuit. H404 | Wrong operation of the steam ‘generator, Problem of the hydraulic circu, H408 |Wrong operation of the steam generator. Problom of the hydraulle circuit, H406 [Wrong operation of the steam generator. Problem of the hydraulle circuit, H990_| General operation problem, Call for the Customer Service (see Appendix Z). bi H991_ | General operation problem. H992_ | General operation problem. H993 | General operation problem. IH 7B Extrema Pius Extrema Plus . 79APPENDIX F - DRAWINGS Giocom fijocom APPENDIX G ~ DECLARATION OF CONFORMITY HYDRAULIC DRAWING (MJ0COM ___ DECLARATION OF CONFORMITY pai Application of the EEC Directives 93/42 - 89/336 - 73123 Name of the Manufacturer: M.0.COM. S.t1. « Manifattura Odontoiatrica Complementare ‘Address of the Manufacturer: Via delle Azalee, 1 - 20090 Buccinasco (Ml) - ITALY : ri dae ICI ano et a lal exrRewapLus Made in: TTALY ‘The undersigned hereby declares that the above mentioned goods entirely conform to the EEC Directives 93/42 - 80/336 - 73/23 (and following updates). Reference standards: EN61010-1 EN 61010-1-A2_ EN 61010-2.041 CEIEN 50081-1 CEI EN 50082-1 EN 55014 EN 55022 EN 6055-2 (CEI 77-3) EN 60555-3 (CEI 77-4) EN 61000-4-2 EN 61000-4-3 EN 61000-4.4 ASME VIII Div. 4 (Add. 1999) DIN 6894875 TRD 421 TRD 511 1/01/2000 ate Signature Alfio VILLA Name and Sumamo egal Agent Function 80 Extrema Plus Extrema Plus : ie 81APPENDIX H — OPERATOR’S NOTES Extrema Plus fiocom APPENDIX Z ~ CUSTOMER SERVICE CUSTOMER SERVICE ‘Tho Customer Servico by M.0.COM, Ltd. Co. is at comploto disposal of the Customers for any request or technical Information conceming the product, as well as for any suggestions on the steam sterilization procedures. Please contact at the following address: M.O.COM. Srl Customer Service Via delle Azalee, 1 20090 Buccinasco (MI) ITALY Tel. (+39) 02 4570 1505. Fax (+39) 02 4570 1258 For Improving the quality of the product and service, please send Your comments and/or suggestions to the followings e-mail addresses: at@mocom.it {customer service and production) yo@mocom.it (marketing and sales) ut@mocom.it (search & development, planning and insurance quality) Besides, You can send comments andor suggestions by letter or fax to the above indicated address. ‘Thanks in advance for the valuable assistance thel you would supply to us. Extrema Plus 83,