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19.7. STERILIZATION PROGRAM DIAGRAM

PROGRAM
134°C UNIVERSAL
134°C

– 4’ 00’’

PROGRAM
134°C PRION
134°C

– 18’ 00’’

PRESSURE (BAR)

PROCESS

TIME (MIN)

FRACTIONATED VACUUM

VACUUM DRYING

PROGRAM
121°C UNIVERSAL
121°C

– 20’ 00’’

PRESSURE (BAR)

PROCESS

TIME (MIN)

FRACTIONATED PRE-VACUUM

LONG DRYING

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Summary of Contents for MOCOM Supreme-17

Page 1: ...97055023 Rev 00 2019 03 Supreme 17 Supreme 22 Supreme 28 EN https stomshop pro...

Page 2: ...1 4 5 ELECTRICAL CONNECTIONS 22 4 6 DIRECT CONNECTION TO A CENTRALIZED DRAINING POINT 22 5 FIRST START UP 23 5 1 STARTING 23 5 2 MAIN MENU 24 5 3 UPPER DOOR OPENING 24 5 4 DISCHARGE WATER RECOVERY AND...

Page 3: ...0 V CYCLES 73 19 5 SUMMARY TABLE OF 28 220 V 240 V CYCLES 75 19 6 SUMMARY TABLE OF 28 120 V CYCLES 77 19 7 STERILIZATION PROGRAM DIAGRAM 80 19 8 DIAGRAMS OF THE TEST PROGRAMMES 82 20 APPENDIX MAINTENA...

Page 4: ...5 1 ERRORS CATEGORY E 99 24 5 2 ALARMS CATEGORY A 102 24 5 3 HAZARDS CATEGORY H 105 24 5 4 SYSTEM ERRORS CATEGORY S 106 25 USER PIN RESET 108 26 APPENDIX ACCESSORIES 108 27 LOCAL PRINTER CONNECTION 11...

Page 5: ...to high temperature Disposal symbol in accordance with Directive 2012 19 EU Device in compliance with essential requirements of Directive 93 42 EU and subsequent modifications Notified body IMQ spa Re...

Page 6: ...responsible for any breakage malfunction property damage or injury to people in the event that the product is not installed or used correctly or proper maintenance is not carried out Please observe th...

Page 7: ...tely separate the materials to be sterilized from those that must not be subjected to such process or are not able to withstand it Contamination due to unsterilised material caused by wrong final asse...

Page 8: ...atches the specifications of the order see the delivery note There is no visible damage to the product Dimensions and weight A Height 600 mm B Width 600 mm C Depth 700 mm Total weight 68 kg In case of...

Page 9: ...s EC Declaration of Conformity 11 Rear spacers 4 Lubricant for door locking mechanism 12 USB key containing User manual and DataSter Software 5 Tray extractor 13 Filling tank demineralisation filter...

Page 10: ...similar means We recommend to transport and store the device at a temperature not below 5 C Extended exposure to low temperatures may damage the product Store the original package and use it for any...

Page 11: ...and a perfect result The device offers users 6 sterilization programs one of which completely programmable all equipped with customisable optimised drying for the fast effective sterilization of the v...

Page 12: ...100 m max 3000 m a s l Pressure min 980 hPA max 1045 hPA a s l External dimensions HxWxD rear connections excluded 500 x 480 x 600 mm Net weight unladen unladen with tray holder support and trays unla...

Page 13: ...0V 60Hz Main power cord Plug NEMA 6 15P 250V 15A SJT 14 AWG 3C 300V 60 C Connector C19 acc to IEC 60320 Ethernet connection RJ45 max cable length 29 m Wi Fi 802 11 b g n 2 4 Ghz WEP WPA WPA2 PSK encry...

Page 14: ...ction cut off of the electricity to the chamber heating element Door position safety microswitch Confirmation of the correct closing position of the door of the container under pressure Action signall...

Page 15: ...D 0 05 mg l 0 05 mg l HEAVY METAL RESIDUES iron cadmium and lead excluded 0 1 mg l 0 1 mg l CHLORIDES 2 mg l 0 1 mg l PHOSPHATES 0 5 mg l 0 1 mg l CONDUCTIVITY AT 20 C 15 S cm 3 S cm pH VALUE 5 7 5 7...

Page 16: ...st filter 5 USB port 6 NFC reader 1 Sterilization chamber 2 Bacteriological filter 3 Door locking system 4 Steam diffuser 5 Water drainage filter 6 Water top up quick connector 7 Water drainage quick...

Page 17: ...PURE 100 500 and automatic filling accessory kit AUX EV Kit 5 Data plate SERIAL NUMBER LABEL See image 6 Ethernet cable connection max length 29 m 7 Serial cable connection 8 Automatic filling electri...

Page 18: ...the same as shown on the sterilizer display A Door opening B Settings C Sterilizer information D Performed cycle list E Sterilization cycles F Test cycles G Custom cycle customisable Other particular...

Page 19: ...ization in the example 134 C 4 Stabilizing the pressure and temperature 5 Sterilizing for the required time in the example 4 minutes 6 Depressurizing the sterilization chamber 7 Vacuum drying phase 8...

Page 20: ...ions contained hereafter in this chapter Technical service department see appendix is available for any doubt or further information The sterilizer is placed on the marked only after having passed all...

Page 21: ...echnical characteristics for complete technical data 4 3 GENERAL PRECAUTIONS FOR INSTALLATION To ensure a correct operation of the device and or avoid risk situations respect the following warnings In...

Page 22: ...ter Remove the cap holding clip and the cap on the rear of the autoclave Fit the plastic tube on the elbow union supplied Fit the union and then refit the clip Fasten the clamp supplied to the drain s...

Page 23: ...he main switch on the right hand side of the machine Do not turn on the sterilizer if USB key is inserted When the device is first turned on the display shows the selection of LANGUAGE DATE and TIME s...

Page 24: ...24 EN 5 2 MAIN MENU At the end of starting procedure the main menu is displayed on the side 5 3 UPPER DOOR OPENING Remove the upper panel by lifting it and sliding it forward https stomshop pro...

Page 25: ...reused to generate steam This new feature allows saving up to 90 water as compared with a standard class B autoclave All this with the objective of offering a product suitable for the daily needs in...

Page 26: ...The sterilizer is ready to reuse the discharge water Both tanks must be emptied from water before leaving the sterilizer off for a long period of time Failure to empty them will cause the degradation...

Page 27: ...l a clack is heard indicating that the filter is correctly fitted inside the tank 4 Fill the tank with water from the mains 5 The sterilizer is ready for use 5 4 3 SAFETY PRECAUTIONS Below are the ind...

Page 28: ...O conductivity at filter outlet B Litres of treated water 5 5 MAINTENANCE OF THE INTEGRATED DEMINERALISATION FILTER The integrated demineralisation filter is a consumable part a message is displayed w...

Page 29: ...l CHLORIDES 2 mg l 0 1 mg l PHOSPHATES 0 5 mg l 0 1 mg l CONDUCTIVITY AT 20 C 15 S cm 3 S cm pH VALUE 5 7 5 7 ASPECT colourless transparent without sediment colourless transparent without sediment HAR...

Page 30: ...le in user friendly menus Use the configuration program whenever necessary A correct customisation of the device provides the best performance and the most satisfactory use The technical service depar...

Page 31: ...EN 31 6 1 2 DATE AND TIME Select DATE AND TIME option Select the field to edit Set DATE and TIME and confirm by pressing the CONFIRM icon https stomshop pro...

Page 32: ...f temperature and pressure values Confirm by pressing the CONFIRM icon 6 1 4 SCREEN AND AUDIO Select SCREEN AND AUDIO to set the parameters of screensaver audio volume and brightness of screen and LED...

Page 33: ...screensavers provided or to load an image from an USB memory support to be connected to the front USB port Use the AUDIO control to set the volume of notifications Use the BRIGHTNESS control to set th...

Page 34: ...brightness value is set to 00 both bars remain off 6 1 5 PREHEATING Select PREHEATING to activate the PREHEATING of the sterilization chamber Select ACTIVE to activate the PREHEATING OFF to disable i...

Page 35: ...e actually connected by pressing the corresponding key If connecting the filling system when the sterilizer is off access the menu via the configuration program and manually select the correct option...

Page 36: ...end of the cycle LABELS label printing activated including barecodes cycle data and device data REPORT printing of a compact version of the cycle summary report activated EXTENDED REPORT printing of...

Page 37: ...ls option is selected the dedicated menu is displayed when the door opens at the end of the cycle to allow setting Number of labels Package validity interval in days The date that will be printed is i...

Page 38: ...e screen From CYCLE LIST it is possible to download the reports stored in the device on a USB memory support inserted in the front USB port The download can be customised by using the selection boxes...

Page 39: ...control activates the download of reports based on the filters enabled Reports are downloaded in PDF format The control activates the printing of cycle reports according to the mode selected https sto...

Page 40: ...WIFI Select Wi Fi to connect the sterilizer to a local Wi Fi network DHCP can be set as automatic or manual In automatic mode the network configuration parameters are assigned automatically in manual...

Page 41: ...it is possible to set DHCP as automatic or manual If automatic mode is selected the network configuration parameters are assigned automatically whereas in manual mode they must be manually set 8 4 NF...

Page 42: ...SET After you have entered the PIN you can access the reserved administrator menu The ADMIN user can decide whether the sterilizer will request the PIN to the generic user at the cycle start PIN Start...

Page 43: ...possible to enter up to 30 users in the list 9 2 CHANGE This function reserved to ADMIN allows associating one or more sterilization cycles with each user choosing them among the six available ones Ea...

Page 44: ...44 EN 9 3 CHANGE PIN This function allows each single user to change the identification PIN originally entered https stomshop pro...

Page 45: ...llows activating the user identification request Only at CYCLE START Only at CYCLE END At CYCLE START and END If the PIN is requested at CYCLE START and END the system accepts the identification of tw...

Page 46: ...on is not reversible The name of the deleted user will still be shown in any cycle reports associated with the removed account Select ADMIN user to view the summary data on the user The ADMIN user can...

Page 47: ...sonal PIN You will access the screen containing data of the selected user Once entered a NON ADMIN user can see only a summary of his her data or change his her PIN see entering PIN the following is r...

Page 48: ...ons and video tutorials for the user Press on the video of your interest to show the selected tutorial on the sterilizer display 11 SERVICE This menu is intended for the technical service department I...

Page 49: ...must only be applied when it is strictly necessary Solutions containing phenols or quaternary ammonia compounds can cause corrosion on instruments and on the metal parts of the ultrasound device 4 Af...

Page 50: ...bes etc resting on their side or upended thus avoiding pooling water Do not load trays beyond the limit indicated see Appendix Do not stack trays one on top of the other and do not put them in direct...

Page 51: ...if necessary If possible using a suitable support position bags at right angles with tray Never stack bags one on top of the other Always pack instruments if they have to be stored for a long time Ref...

Page 52: ...6 compartments based on the sterilizer model Or if tray holder support is extracted and turned by 90 it can be used to house special boxes 3 4 compartments based on sterilizer model In any case it is...

Page 53: ...he nature of the problem With this type of control when you select a suitable sterilization program you are guaranteed an effective sterilization under any conditions After inserting the load in the s...

Page 54: ...allows accessing the start delay setting expressed in hours The delayed start date and time are indicated at the centre The cycle start screen and the set delay value will be displayed when confirmin...

Page 55: ...4 C UNIVERSAL program characterised by fractionated pre vacuum the cycle sequence is as follows WARMING UP FIRST VACUUM PHASE FIRST PRESSURE RISE SECOND VACUUM PHASE SECOND PRESSURE RISE THIRD VACUUM...

Page 56: ...o open the sterilizer door press the icon indicated in the figure User identification is required in this phase if enabled If enabled the label printing management screen will be displayed once the do...

Page 57: ...of pre vacuum the process temperature the exposure time and extra drying if necessary Once selections have been made save the settings with CONFIRM key Press INFO to display the information on the cyc...

Page 58: ...before any transport and subsequent storage If necessary for transport transfer the material using dry clean and disinfected containers The containers must be closed or if open covered with clean clo...

Page 59: ...the sterilization chamber tubes and the various interception devices is To select VACUUM TEST cycle press the corresponding icon The cycle must be run with the sterilization chamber empty and only the...

Page 60: ...r Close the door and start the cycle The test cycle takes place with a succession of phases similar to those described for a normal sterilization cycle At the end of the cycle remove the test device f...

Page 61: ...ick Test Vacuum Helix Bowie Dick Test based on the available options Once the fields have been set activate the reminder with CONFIRM Reminders activate at 8 a m of the selected day or upon switching...

Page 62: ...62 EN 15 5 H2O TEST Select this option to test the water quality The water conductivity is automatically measured at each sterilization or test cycle start https stomshop pro...

Page 63: ...ince the cycle could not finish correctly In certain phases of the cycle the manual interruption activates an automatic cleaning procedure of the internal hydraulic circuit that can last some minutes...

Page 64: ...free end of the drain tube provided in the basin 2 Insert the other end of the tube in the female union beneath the chamber inlet connector on the left pushing down until you hear a click 3 Completely...

Page 65: ...ta about the cycles carried out stored in the inner memory of the sterilizer on a USB key To download the files of sterilization cycles tests select the following button USB key has to be formatted ac...

Page 66: ...gauze pads etc Other generic material suitable for autoclave treatment Depending on the material conformation solid hollow or porous on any package containing it paper plastic bag paper for sterilizat...

Page 67: ...60 0 20 0 20 Solid and hollow materials in single pack 3 00 1 00 0 50 Unwrapped solid and hollow materials 6 00 1 20 0 25 Solid and hollow instruments in double pack 1 50 0 50 0 25 134 C PRION 134 2...

Page 68: ...0 1 20 0 50 Unwrapped solid instruments 6 00 1 20 0 50 134 C SOLID WRAPPED 134 2 1 4 S S 13 31 350 0 55 Solid and hollow instruments B in single pack 3 00 1 00 0 25 It is advisable to use the 3 tray c...

Page 69: ...00 1 20 0 25 Solid and hollow instruments in double pack 1 50 0 50 0 25 135 C SOLID UNWRAPPED 135 2 2 4 S S 4 26 350 0 55 Unwrapped solid and hollow materials B 6 00 1 20 0 50 121 C RUBBER PLASTIC 121...

Page 70: ...nergy consumption kWh cycle TYPE MAX TOTAL MASS kg MAX MASS PER TRAY kg MAX MASS PER ITEM kg XXX C USER see note 135 121 2 2 1 1 4 30 20 30 n a F 5 30 n a n a n a Unwrapped solid instruments other loa...

Page 71: ...0 75 0 25 0 20 Solid and hollow materials in single pack 4 00 1 25 0 50 Unwrapped solid and hollow materials 7 50 1 20 0 25 Solid and hollow instruments in double pack 2 00 0 60 0 25 134 C PRION 134 2...

Page 72: ...0 1 50 0 50 Unwrapped solid instruments 7 50 1 50 0 50 134 C SOLID WRAPPED 134 2 1 4 S S 15 37 400 0 6 Solid and hollow instruments B in single pack 4 00 1 00 0 25 It is advisable to use the 3 tray co...

Page 73: ...50 1 20 0 25 Solid and hollow instruments in double pack 2 00 0 60 0 25 135 C SOLID UNWRAPPED 135 2 2 4 S S 5 32 400 0 6 Unwrapped solid and hollow materials B 7 50 1 50 0 50 121 C RUBBER PLASTIC 121...

Page 74: ...nergy consumption kWh cycle TYPE MAX TOTAL MASS kg MAX MASS PER TRAY kg MAX MASS PER ITEM kg XXX C USER see note 135 121 2 2 1 1 4 30 20 30 n a F 5 30 n a n a n a Unwrapped solid instruments other loa...

Page 75: ...0 90 0 30 0 30 Solid and hollow materials in single pack 5 00 1 50 0 75 Unwrapped solid and hollow materials 9 00 1 40 0 25 Solid and hollow instruments in double pack 2 50 0 70 0 25 134 C PRION 134...

Page 76: ...0 1 50 0 50 Unwrapped solid instruments 9 00 1 50 0 50 134 C SOLID WRAPPED 134 2 1 4 S S 17 43 500 0 7 Solid and hollow instruments B in single pack 5 00 1 00 0 25 It is advisable to use the 3 tray co...

Page 77: ...38 500 0 6 Unwrapped solid and hollow materials B 9 00 1 50 0 50 121 C RUBBER PLASTIC 121 1 1 20 B F 17 80 950 0 8 Unwrapped porous materials 1 50 0 50 0 50 For wrapped materials and instruments singl...

Page 78: ...ad VACUUM TEST 0 8 18 Empty chamber VACUUM HELIX BD TEST executable in sequence 50 To set a sterilization time of 5 5 minutes contact the Technical Service Single Pre Vacuum 1 pre vacuum 0 8 bar see f...

Page 79: ...81 0 79 t4 2PP 0 97 1 03 t5 3PV 0 81 0 79 t6 SS 4 5 5 134 138 2 04 2 40 t7 SE 4 5 5 134 138 2 04 2 40 t8 DS 0 81 0 79 t9 DE 2 CE 0 02 0 02 121 C cycles EN 13060 2014 Time minutes Min temperature Max t...

Page 80: ...NIVERSAL 134 C 4 00 PROGRAM 134 C PRION 134 C 18 00 A PRESSURE BAR B PROCESS C TIME MIN D FRACTIONATED VACUUM E VACUUM DRYING PROGRAM 121 C UNIVERSAL 121 C 20 00 A PRESSURE BAR B PROCESS C TIME MIN F...

Page 81: ...UNWRAPPED 134 C 4 00 A PRESSURE BAR B PROCESS C TIME MIN F FRACTIONATED PRE VACUUM H SHORT DRYING PROGRAM 134 C SOLID WRAPPED 134 C 4 00 A PRESSURE BAR B PROCESS C TIME MIN I SINGLE PRE VACUUM G LONG...

Page 82: ...A PRESSURE BAR B PROCESS C TIME MIN F FRACTIONATED PRE VACUUM H SHORT DRYING PROGRAM VACUUM TEST 0 80 bar A PRESSURE BAR C TIME MIN L INTERMEDIATE CONDITION TO CONTINUE THE TEST M FINAL CONDITION TO P...

Page 83: ...x The ordinary maintenance described below consists in easy manual operations and preventive interventions involving simple instruments In the event of replacement of components or parts of the device...

Page 84: ...ollowing general warnings Do not wash the sterilizer with direct jets of water neither under pressure nor sprinkled Seepage into electrical and electronic components could damage the functioning of th...

Page 85: ...d with 50 water Apply product with a soaked cloth then dry As an alternative we recommend using products containing the following at no more than the given concentration Ethanol Concentration maximum...

Page 86: ...n filter maintenance is due or every time you notice visible clogging of the filter indicated by the filter markedly turning grey unscrew the bacteriological filter B from its support and replace it w...

Page 87: ...lifting the rear part then the front part Replace the cartridge following the initial installation procedure see INTEGRATED DEMINERALISATION SYSTEM 20 3 10 RECIRCULATION SYSTEM CARTRIDGE REPLACEMENT R...

Page 88: ...y information relative to the periodic validation of steam sterilizers 20 5 DEVICE USEFUL LIFE Water steam sterilizer service life is of 10 years average use 5 cycles day for 220 days year For normal...

Page 89: ...e sterilizer to reach the proper operating conditions for starting the program Under standard conditions the Average Preheating Time is about 10 15 Minutes The safety valve has triggered Locking ring...

Page 90: ...s on the instruments Carefully clean the material before subjecting it to the sterilization cycle See Chapter Preparing the material Contact between instruments made of different metals Separate instr...

Page 91: ...a specialised technician Code format Axxx xxx identification number 000 999 H HAZARD Second level fault The problem can normally be solved by the Technical Service Centre Code format Hxxx xxx identif...

Page 92: ...e OK button 2 Following the instructions displayed and holding down the RESET button for about 3 seconds Press the RESET button for approx 3 seconds to go back to the main menu After the RESET and any...

Page 93: ...QUALITY H2O BAD CHANGE FILTERS CHANGE WATER 2 E012 The cycle threshold for the periodic replacement of integrated water filters has been reached CHANGING FILTERS 1 E013 Water conductivity threshold 2...

Page 94: ...TACT TECH SERVICE 2 E901 Vacuum test failed during STAND BY PHASE TEST FAILED FIRST STEP CONTACT TECH SERVICE 2 E902 Vacuum test failed vacuum pulse time out exceeded TEST FAILED VACUUM NOT ACHIEVED C...

Page 95: ...ed sterilization chamber CHAMBER PROBE PT1 SHORT CIRCUIT CONTACT TECH SERVICE 1 A112 Temperature sensor PT2 short circuited steam generator GENERATOR PROBE PT2 SHORT CIRCUIT CONTACT TECH SERVICE 1 A11...

Page 96: ...2 A254 2nd rise back up to atmospheric pressure not reached within the time out ATM2 UPSTROKE TIMEOUT CONTACT TECH SERVICE 2 A255 2nd pressure pulse not reached within the time out 2PP UPSTROKE TIMEOU...

Page 97: ...OW MINIMUM LIMIT CONTACT TECH SERVICE 2 H404 Floating temperature over the limit STERILIZATION phase ERRATIC TEMPERATURE CONTACT TECH SERVICE 2 H405 Pressure over the MAX limit STERILIZATION phase PRE...

Page 98: ...AD NEW CYCLES 2 S021 Cycle storage limit exceeded CYCLE MEMORY FULL START OVERWRITING 2 S030 Check using a watchdog that one of main tasks is not in crash condition SYSTEM ERROR CONTACT TECH SERVICE 2...

Page 99: ...t Technical Service see Appendix Disturbance on the electrical mains RESET according to the instructions If the problem occurs again have the electrical mains checked by a technician If the electrical...

Page 100: ...ice see Appendix E031 Water level in the drain tank over the MAX level RESET according to the instructions and empty the tank Completely drain the drain tank MAX water level sensor failure Contact Tec...

Page 101: ...tructions Thoroughly clean the gasket with a clean cotton cloth moistened with water Restart the program Vacuum pump failure Contact Technical Service see Appendix Problem in the hydraulic circuit E99...

Page 102: ...5 failed conductivity measurement compensation A111 Incorrect temperature sensor connection sterilization chamber Temperature sensor short circuit sterilization chamber A112 Incorrect temperature sens...

Page 103: ...ed with water or in general with liquids into the chamber Air seepage through the gasket RESET according to the instructions Thoroughly clean the gasket with a clean cotton cloth moistened with water...

Page 104: ...ilter obstructed Clean the drain filter see Maintenance Appendix Problem in the hydraulic circuit Contact Technical Service see Appendix A262 Bacteriological filter obstructed Clean the drain filter s...

Page 105: ...aulic circuit H402 Steam generator malfunction Problem in the hydraulic circuit H403 Steam generator malfunction Problem in the hydraulic circuit H404 Problem in the hydraulic circuit Steam generator...

Page 106: ...ake sure that printer lid is correctly closed Check printer cable correct connection If the problem persists contact Technical Service see Appendix S012 Printer not ready for use Make sure that paper...

Page 107: ...trol board or software Contact Technical Service see Appendix S099 Malfunction of control board or control software Try restarting the program a second time Try replacing the USB key If the problem pe...

Page 108: ...eet the manufacturer s specifications DEMINERALIZER PURE 100 DEMINERALIZER PURE 500 TWIN PURE 500 AUTOMATIC FILLING FRONT FILLING H2O AUXILIARY SOLENOID VALVE Additional SV kit including 1 2 way water...

Page 109: ...EN 109 EXTERNAL PRINTER BARCODE READER NETWORK PRINTER DATA STER SOFTWARE MY TRACE SOFTWARE https stomshop pro...

Page 110: ...tivated only if the NETWORK PRINTER and the sterilizers are connected to the same LAN Local Area Network through a Wi Fi connection or an Ethernet cable For a correct installation and configuration of...

Page 111: ...meet the manufacturer s specifications Description Code bacteriological filter 97290160 door gasket 17 22 l 97400145 door gasket 28 l only 97467176 demineralised water tank chamber filter 97290210 dis...

Page 112: ...water steam sterilization procedures In this regard please refer to the following address Cefla S c Plant Via Bicocca 14 C 40026 Imola BO IT Tel 39 0542 653441 Fax 39 0542 653555 Headquarters Via Sel...

Page 113: ...www cefla com https stomshop pro...

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