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- Frank`s Hospital Workshop

1. Al ARM PTI DRAIN MISALIGNMENT ALARM PRESSURE TRANSD ALARM MANUAL STOP gt gt E E gt gt A A lt lt Alarms Indicates that during a cycle there was a drop in the power supply to the unit When power is restored to the unit the display will show a message about the phase in which power dropped Whenever there is a power cut while an alarm is active the display will show the last alarm triggered e Check the power supply at the plug and that the power cord 03 is inserted correctly in the plug and in its connection in the machine e Check the fuses 32 and that the main switch 13 is pressed to the I position e Check the efficiency and cleanliness of the chamber seal 31 as well as the door 16 disk the seal is fitted to Replace if damaged see Ch MAINTENANCE e Contact a technical service center to have the door 16 closure adjusted At the end of the cycle there is still water in the chamber 09 e Check that the drain filter 20 is clean and positioned correctly see Ch MAINTENANCE e Recheck the tilt of the machine see Ch INSTALLATION Drying after the cycle is not satisfactory e Check that the cycle selected is appropriate for the material to be sterilized see Table of cycles sterilizable material e Check that the total maximum load weight has not been exceeded see Table of cycles sterilizable material e Check that the load was correctly prepared see Ch OPERATION PREP
2. CYCLE S2 sterilization cycle for solid instruments porous loads and hollow loads type B packaged or unpackaged CYCLE B sterilization cycle for solid instruments porous loads and hollow loads type A or B packaged or unpackaged double packaging is also permitted TYPE A HOLLOW LOADS Instruments with an open cavity on one side only where the length to cavity diameter ratio is greater than or equal to 1 and less than or equal to 750 1 lt L D lt 750 and where the length of the cavity is no longer than 1500 mm L lt 1500 mm Alternatively instruments with an open cavity on both sides whose length to cavity diameter ratio is greater than or equal to 2 and less than or equal to 1500 2 lt L D lt 1500 and where the length of the cavity is no longer than 3000 mm L lt 3000 mm TYPE B HOLLOW LOADS Instruments with an open cavity on one side only where the length to cavity diameter ratio is greater than or equal to 1 and less than or equal to 5 1 lt L D lt 5 and where the diameter of the cavity is greater than or equal to 5 mm D gt 5 mm Alternatively instruments with an open cavity on both sides whose length to cavity diameter ratio is greater than or equal to 2 and less than or equal to 10 2 lt L D lt 10 and where the diameter of the cavity is greater than or equal to 5mm D gt 5 mm MAXIMUM LOAD WEIGHT the maximum weight permitted for each load category described including the load support system a
3. 134 PRION Nye coe WRAPPED WRAPPED HOLLOW HOLLOW Type according to EN 13060 N N S1 B B B Temperature 121 C 134 C 134 C 121 C 134 C 134 C 134 C Pressure 2 1 bar 3 1 bar 3 1 bar 2 1 bar 3 1 bar 3 1 bar 3 1 bar Ion 15 4 4 15 4 18 3 5 sterilization phase Drying no no 20 20 20 20 no no Pora omiaan 23 30 13 21 37 48 57 77 49 6 63 85 25 20 minimum maximum Load solid yes yes yes yes yes yes porous no no no yes yes yes empty empty hollow A no no no yes yes yes chamber chamber hollow b no no no yes yes yes Packaging not packaged yes yes yes yes yes yes oN amay single pack no no yes yes yes yes chamber chamber double pack no no no yes yes yes Maximum load weight solid hollow porous 5Kg 5Kg 3Kg 2 5 1 5 Kg 2 5 1 5Kg 2 5 1 5Kkg Table of c ycles sterilizable material 18S Introd uction 121 134 121 134 UN UN amarre POROUS POROUS 134 PRION EC ed MAC WRAPPED WRAPPED HOLLOW HOLLOW Type according to EN 13060 N N S1 S2 S2 S2 Temperature 121 C 134 C 134 C 121 C 134 C 134 C 134 C Pressure 2 1 bar 3 1 bar 3 1 bar 2 1 bar 3 1 bar 3 1 bar 3 1 bar Duration of 15 4 4 15 4 18 3 5 E sterilization phase Drying no no 25 25 25 25 no no Ord PUGNON 24 29 14 19 44 54 59 70 50 5 64 74 25 20 minimum maximum Load solid yes yes yes yes ye
4. COMINOX is not liable for defects or malfunctions deriving from improper use of the sterilizer changes that occur during transportation or those caused by specific environmental conditions lack of maintenance or maintenance conducted improperly or problems due to tampering or incorrect repairs COMINOX declines all responsibility if the sterilizer is not installed properly or if it is not installed by duly trained and qualified personnel COMINOX IS NOT responsible for the disposal of the products required for the transport or operation of the sterilizer or for production materials packaging waste water lubricants etc The customer is individually responsible under the specific regulations and standards in force in each installation country for disposing of any substances that are potentially harmful to the environment The same precautions apply to scrapping the sterilizer Introduction PURPOSE OF THE DOCUMENT This Use and Maintenance Manual aims to provide the operator with a useful guide for understanding the correct procedures for installing the sterilizer explaining the various SterilClave functions ensuring optimal use of the sterilizer operating in complete safety conducting the maintenance required for proper upkeep of the sterilizer EQUIPMENT In addition to this Use and Maintenance Manual each sterilizer is supplied with a Guarantee Certificate and the EC Declaration of Conformity The Cominox SterilClav
5. Table of contents Reference index tray handle waste pipe powercable tray metering funnel SterilC a rd pouch holders support for 5 trays or 3 cassettes Chamber Clean water tank waste water recovery tank Safety valve main switch filler air sterilization filter door safety thermostat print door Coil covering grid waste filter chamberprobe adjustable feet lifting straps Clean watertap waste watertap printer level testing pipe grid seal auto water fill direct dra in Chamberseal fuses Table of contents Graphic representation of references Mod 18 OPTIONAL S B OPTIONAL S B Table of contents Graphic representation of references Mod 24 OPTIONAL B 26 OPTIONAL Y 7 OPTIONAL OPTIONAL B B Introduction INTRODUCTION GENERAL SUPPLY CONDITIONS COMINOX declares that the sterilizer complies with the standards and regulations in force in the European Economic Community and issues the attached DECLARATION OF CONFORMITY COMINOX will repair any manufacturing defects that arise within 24 months from the time the sterilizer is installed refer to the Guarantee The chamber 09 is guaranteed for 10 years The customer must use original spare parts only and fit them according to their intended use Responsibility forcommercial components lies with their manufacturers
6. such as sun rain wind etc Check that the power supply complies with the specifications provided on the label plates affixed to the machine check that the power supply is properly grounded Avoid any electro magnetic interference that could affect the proper operation of electronic equipment leading to consequent dangers Arrangement The sterilizer should be installed in a laboratory or medical or dental office where it can be accessed exclusively by authorized personnel ITIS NOT BE INSTALLED near sources of heat in rooms where volatile explosive substances are kept under or above any live equipment in unsuitable built in units without the fitted adjustable feet in domestic environments accessible to untrained personnel on surfaces that are flammable soft unstable or have wheels Position the unit in the area where it will be installed on a sturdy perfectly horizontal surface When installing the unit for the first time and whenever it is removed from its original installation location follow the procedure indicated below position the sterilizer where it will be installed and do not move it thereafter open the door 16 and empty the chamber 09 22 Installation WARNING the door 16 cannot be opened if the unit is switched on see OPERATION remove the grid covering the coil 19 loosening the corresponding screw remove the tray support 08 remove the waste f
7. 121 UNWRAPPED 134 UNWRAPPED 121 HOLLOW POROUS 134 HOLLOW POROUS 134 PRION 67 7 Y COMINOX Cominox S r l via G Vigano 7 20048 Carate B za Mi Italia tel 39 0362 912312 Fax 39 0362 900940 www cominox it UCGO1LCD August 2007 We reserve the right to modify the products without any notice
8. 14 ADVANCED TOOLS SterilCard option O Generate User Delete User E Enable User ENTER This item is only present if the sterilizer is equipped with a SterilCard 06 optional standard on BHD models and if the SterilCard O6 inserted is at Administrator level There are three SterilC ard 06 management functions l Generate User 2 Delete User 3 Enable User 3 4b 1 Create User Press ENTER to access the screen for entering the name of the new user 10 04 07 14 87 55 ENTER NEW USER NAME ey gt COMINOX se ABTS GGOONEQA ao ej e e DUO gt MBE lt gt JENTER Using the lt gt keys scroll through the keyboard to select a letter Press ENTER to confirm each letter Once you have finished composing the name in this way select END and press ENTER to confirm the name of the user and move to the next screen to choose the cycles 37 Operation 38 10 04 07 14 88 10 SELECT CYCLE 121 UNWRAPPED N 134 UNWRAPPED N 134 WRAPPED Si 121 HOLL POROUS B 134 HOLL POROUS B 134 PRIONS B SPECIAL USER ON ON N N N ON ON ENTER The ON OFF value for the first cycle is displayed and can be changed using the arrows Tl Cycles set to ON will be entered in the new user profile Press ENTER to confirm the selection and move on to the next cycle If the SPECIAL cycle is set fo ON you will be shown the screen for setting the values for the SPECIAL cycle parameters 10 04
9. 73 23 CEE Low voltage and subsequent updates Standards EN 13060 Small steam sterilizers EN 61010 1 Safety regulations for laboratory devices Part 1 General regulations EN 61010 2 040 Safety regulations specific to sterilizers used in the processing of medical material EN 61326 1 Electromagnetic compatibility regulations for laboratory devices DIMENSIONS General dimensions Technical specifications StenilClave 18 SterilC lave 24 A Width 445 445 B Height 390 470 C Depth 640 700 D Unit depth with door 880 940 open Dimensions required when the unitis to be built in SterilC lave 18 SterilC lave 24 E Width 450 450 F Height 395 475 G Depth 560 620 NEVER place the machine on soft surfaces such as cloth or foam and never remove the adjustable feet Leave approximately 20 mm of space for rear ventilation Built in units require an additional 20 mm between the unit and the wall In this case the unit must have a rearopening for ventilation as illustrated Usable space dimensions SterilC lave 18 SterilClave 24 H Width 185 185 Height 150 150 L Depth 285 420 General safety conditions GENERAL SAFETY CONDITIONS e Switch off the sterilizer at the main switch 13 and disconnect the power cable 03 before conducting any operations apart from those in the normal operations cycle e The main power supply must be p
10. ALARM CHAMBER LEVEL ALARM MANUAL STOP ALARM INSUFFICIENT VACUUM ALARM FRAC VACUUM ALARM PROBE LEVEL ALARM PRESSURIZATION ALARM OVERTEMP BAND ALARM UNDERTEMP BAND ALARM POWER MISSING ALARM DRAIN ALARM MISALIGNMENT ALARM PRESSURE TRANSD ALARM TEMP SENSOR ALARM PT Alarms 61 Maintenance MAINTENANCE GENERAL CONDITIONS All maintenance must be performed by qualified and trained technical personnel only Maintenance must be performed when the unit is idle and unplugged from the power source unless otherwise specified Wait until the machine has cooled completely and has NO heated surfaces In any case proceed with caution Avoid any temporary repairs repairs must exclusively use original replacement parts Always use personal means of protection e The operator must provide prompt notice of any problem dripping wear fraying etc DO NOT allow the unit to be used if a problem of any kind has been detected and anange for proper restoration of nomal operating conditions or make sure that steps are taken in this regard COMINOX declines all responsibility if the maintenance plan indicated in this manual is not followed see Scheduled Maintenance table Cominox also declines all responsibility if maintenance is entrusted to untrained personnel or if the procedures suggested by our installation technicians are not respected For any defect or problem that cannot be resolved using this manual
11. Indicates that the waste water recovery tank 1Lis full e Empty the tank see MANUALLY DRAIN TANKS in the INSTALLATION chapter If the direct drain 30 is installed see CONNECTIONS check the correct connection and that the pipe is not bent or clogged Indicates that the temperature in the chamber 09 is not suitable to start or continue a cycle Machine preheating the indicator notifies you that the external coil is operating During the cycle this indicates that the device that locks the door 16is active it means that the door is closed and locked 54 SCHEDULED MAINTENANCE PROGRAMMED START MAX WATER LEVEL MIN WATER LEVEL CHECK WATER QUALITY DRAIN WASTE WATER COOLING PAUSE PREHEATING DOOR LOCKED Indicators Activates at the end of a cycle or immediately after turning the sterilizer on and indicates that the door 16 release is underway To access the chamber 09 wait until the indicator disappears without attempting to open the door Indicates that the cycle has completed and that the machine is ready to begin a new cycle WAIT DOOR UNLOCK COMPLETED CYCLE 55 Alarms ALARMS The alarms indicate a need to conduct maintenance or that some defect has been found If a defect is encountered during a cycle the cycle is interrupted immediately and a 15 second beep indicates an alarm The description of the alarm appears on the display including the cycle and phase in which
12. Press ENTER to access the menu selected 29 Operation L Cycle Menu 10 04 67 14 82 42 CYCLE 121 UNWRAPPED YyPe Solid umpacked 5 kg 134 UNWRAPPED Tyre N Solids unracked 5 Kg ENTER Use the ft arrows to highlight the various cycles E 2 3 4 5 6 For each cycle the display shows the type of cycle according to standard EN 13060 the 121 UNWRAPPED cycle at 121 C for delicate solid products unpackaged only 134 UNWRAPPED cycle at 134 C for solid products unpackaged only 134 WRAPPED cycle at 134 C for solid products packaged or unpackaged 121 HOLLOW POROUS cycle at 121 C for delicate porous and hollow products packaged or unpackaged 134 HOLLOW POROUS cycle at 134 C for solid porous and hollow products packaged or unpackaged 134 PRION cycle at 134 C for solid porous and hollow products that have come in contact with BSE infective agents packaged or unpackaged BOWIE amp DICK TEST 7 SPECIAL USER user programmable cycle 8 9 VACUUM TEST loads allowed the maximum weight and the type of packaging Press ENTER to return to STAND BY where you can run the cycle you have just selected by pressing START 2 30 Main Settings Menu 10 04 07 14 83 08 MAIN SETTINGS o Language ENGLISH Date and Time 10 04 87 14 83 E Button sound ON 4 Self storP 6 Self filling ON e y ENTER OFF 10 04 07 14 83 22 MAIN SETTING
13. cycle and maintenance operations have been saved to a file on the computer they can be deleted from the SterlCard 06 to create space for the new cycles Otherwise Cycle recording can be disabled in the Main Settings Menu see sec 2 7 and then the cycle can be run However in this case information about the cycle will NOT be saved to the SterilCard 06 so another system must be enabled for saving the data e g printer or CominoxWizard monitor program 53 Indicators INDICATORS Indicators are messages containing notices or warnings that in most cases require a simple corrective action or check from the user The indicators are shown on the display with the corresponding icon and a brief description Description e Solution Indicates that a scheduled maintenance procedure is needed for one or more components e contact a technical service center Indicates that a start has been programmed for the cycle on the display The cycle will begin automatically at the date and time displayed Maximum level reached in Clean water tank 10 Minimum level reached in Clean watertank 10 e Fill the tank Activates when the auto water fill 29 is set Indicates that the conductivity value of the water introduced has exceed the optimum level but is still acceptable the sterilizer allows a cycle to begin but it is advisable to proceed according to instructions given for the WATER QUALITY INSUFFICIENT alarm see sec ALARMS
14. data in the electronic devices The unit is not equipped as standard for operation in environments that present a particular risk of fire or explosion COMINOX is not liable for the disposal of materials required for the operation or production of the sterilizer e g plastic packaging or potentially contaminated waste water The client must personally provide for the removal of any substances that are potentially harmful to the environment in compliance with regulations in force in the country of installation The same precautions apply to scrapping the sterilizer The sterilizer was designed in compliance with best practices concerning energy conservation preventing needless waste Residual risks table RISK ANALYSIS AND DESC RIPTION SUGGESTED REMEDY Losses or leaks with risks of slipping short circuit or pollution Carefully clean the workplace Drainage of waste water contaminated by viruses bacteria or pathogenic micro organisms Dispose of according to the regulations in force Escaping steam and or gas fumes when opening the door 16 Excessively hot surfaces especially in the sterilization chamber 09 and on certain solenoid valves or internal components Always carefully check whether the load complies with cycle temperatures and open the door with caution Wear protective gloves and or never touch any internal components unless duly AUTHORIZED The chamber seal is herm
15. during the cycle and using the lt gt keys you can scroll through the entire graph at 5 minute intervals Press the button to exit Press STOP to interrupt the cycle 48 Operation The upper part of the display shows the icons corresponding to the Door Locked indicator and the Cycle Completed indicator when the cycle ends CONTROL TESTIS All SterilClave models provide two control test cycles the Bowie amp Dick test and the Vacuum test air leakage test In addition SterilClave B and BHD models allow tests with hollow A loads according to EN 13060 Helix Test Bowie amp Dick test The Bowie amp Dick test is used to check the proper steam penetration into porous loads e g gauzes and fabrics and the efficiency of the air drain system The Cominox Bowie amp Dick Test Pack consists of a package containing a chemical process indicator and its even color change ensures that the steam has penetrated properly The Bowie amp Dick test must always be run when the machine is HOT after having run another cycle 0 To run the test correctly proceed as you would for any other sterilization cycle but without loading the machine turn the machine on with the main switch 13 open the door 16 insert a Cominox Bowie amp Dick test package on the lower tray Close the door 16 enter the access code or the SterilCard 06 press the MENU key from STAND BY select the Menu Cycle number 1 and pr
16. it occurred To reset the alarm either enter the security code or insert the SterilCard 06 and press SILENCE ALARM Once the alarm has been reset and the cause behind it has been resolved if possible begin a new cycle If the problem persists contact an AUTHORIZED COMINOX TECHNICAL SERVICE CENTER The load in the sterilizer during an interrupted cycle should be considered NON STERILE Description Solution Activates in STAND BY see CHECK WATER QUALITY Ch INSUFFICIENT INDICATORS This indicates that the water conductivity WATER QUALITY value has exceeded the acceptable level e If a Cominox Speedy Water or Osmosis water demineralization system is installed change the cartridge e lf the water is filled from an external can check that water Indicates that distilled or demineralized water is lacking in INSUFF the clean watertank 10 WATER LEVEL e lf the alarm is triggered at the beginning of a cycle fill the tank see MANUALLY FILL CLEAN WATER TANK Ch INSTALLATION e lf the alarm is triggered during a cycle fill the tank or follow the instructions provided for the INSUFFICIENT STEAM ALARM Indicates that the necessary time was exceeded for the CHAMBER correct water level to be reset in the chamber 09 LEVEL ALARM e Recheck the tilt of the machine see Ch INSTALLATION Indicates that there is a leak of steam or overheated INSUFFICIENT steam in the chamber 09 STEAM e Check the efficiency and cleanliness of the c
17. the MAX WATER LEVEL indicator appears and completely empty the waste water recovery tank 11 see MANUALLY DRAIN TANKS MANUALLY DRAIN TANKS When there is no DIRECT DRAIN see WATER CONNECTION or it is not connected the waste water recovery tank 11 must be drained manually whenever the DRAIN WASTE WATER indicator appears on the display see SIGNALS AND ALARMS Connect the waste pipe 02 provided to the waste watertap 25 after placing a container of sufficient size under the other end see Technical specifications table to collect the water Open the tap to allow any water left in the waste water recovery tank 11 to drain contaminated The liquid should be disposed of according to the legislation in force WARNING the temperature of the liquid can reach 80 C and the liquid may be e For maximum operating time before refilling empty the tank completely and completely fill the clean water tank 10 until the MAX WATER LEVER indicator appears see MANUALLY FILL CLEAN WATER TANK The clean water drainage tap 24 is used to empty the clean water tank 10 for maintenance or transport see Chap TRANSPORTATION and MAINTENANCE and it is only used under these conditions PREPARING FOR BUILT IN INSTALLATION If the sterilizer will be built into a furniture item or another storage rack you must follow ALL the instructions provided for normal installation plus you must comply with the built in distances see Chap DIMENSIONS pro
18. the list of cycles saved on the SterilC ard 06 or in the internal memory for sterilizers not equipped with SterilC ard 06 will appear in chronological order starting with the most recent Use the t arrows to scroll through the list and press ENTER to access the cycle selected 044 CYCLE RECORDS 121 UNWRAPPED N For each cycle the following are displayed the serial number the user who launched it the cycle number and the date and time it was initiated Press EVENT to access a screen that describes the phases of the cycle If the cycle was interrupted by an alarm a description of the alarm will be shown with the values for cycle duration temperature and pressure when the alarm was triggered PRINT is only enabled if the machine features a printer 26 optional It will print the parameters of the cycle in the mode in which the cycle was saved When printing the screen will read PRINTING when complete the machine returns to the cycle screen Press PLOT TO access the absolute pressure diagram for the cycle selected Press to return to the Cycle records 42 Operation 5 Maintenance Menu 10 04 67 14 13 06 MAINTENANCE o Items Save maintenance ENTER Two options are available under this menu 1 Items 2 Save Maintenance 5 1 Items Press ENTER to view the list of components subject to scheduled maintenance 10 04 07 14 13 13 MAINTENANCE 1469 c r Vacuum PumP kit 7s 99 969 c r
19. there is water in the can If there is water and the CHECK AUTO FILL ALARM is active check that the extraction tube is properly positioned so that it touches the bottom of the can Check that the tube is not kinked or twisted Check that the height difference between the sterilizer and the bottom of the can is not more than 1 meter see CONNECTIONS Ch INSTALLATION e f configuration B from the water mains is installed and enabled check that the water mains tap is open If the tap is open and the CHECK AUTO FILL ALARM is active check that water is flowing downstream from the Cominox demineralization system e f none of the solutions provided here solves the problem contact a technical service center and in the meantime disable the WATER AUTO FILL setting see SETTINGS Ch OPERATION and use MANUAL CLEAN WATER REFILL see Ch INSTALLATION to continue using the sterilizer Steam loss from the safety valve 12 STEAM LOSS e lf the sterilizer is installed at more than 1500 meters FROM THE SAFETY above sea level contact a technical service VALVE centre to have a suitable safety valve installed see Ch TECHNICAL FEATURES e f the altitude is below 1500 meters asl but the problem persists contact a technical service center to check the efficiency of the valve 60 List of alam codes Code Type of alarm COILS ALARM PT OVERTEMPERATURE ALARM INSUFFICIENT STEAM ALARM INSUFF WATER LEVEL ALARM MAX WATER LEVEL ALARM DOOR
20. to 1 by default 10 04 07 14 81 06 INSERT SECURITY CODE B gt Pressing the key deletes the last number entered or if no numbers are shown on the display it returns to OFF mode The CODE button is only present when the machine is switched on from the Main switch 13 Thereafter the INSERT STERILCARD screen will not feature the CODE button 10 04 07 14 81 27 INSERT STERILCARD 27 Operation After the SterilCard 06 or Security Code is inserted the sterilizer displays a WELCOME message and switches to STAND BY mode STAND BY Current date gt 10 04 087 14 82 14 Current Time STAND BY Cvcle selected gt 121 UNWRAPPED N eens a E 8 981 bar lt Pressure D Preheating Messages ifany gt Max water level OFF MENU l INFO ISTART The display will show the current date and time the cycle selected the temperature and pressure of the sterilization chamber and any messages A Scheduled maintenance indicates that a scheduled maintenance procedure is needed for one or more components Contact a technical service center Programmed start indicates that a start has been programmed for the cycle on the display The cycle will begin automatically at the date and time displayed Qu Check water qual activates when the auto water fill 29 is set Indicates that the conductivity value of the water introduced has exceed the optimum level but is still acceptable the sterilizer allows a cycl
21. 07 14 88 25 SET UP CYCLE SPECIAL USER Temper Time Peaks No Drying User set ur ENTER If user programming is ON the new user will be allowed to change the parameters of the SPECIAL cycle If it is set to OFF the new user will be allowed to launch the SPECIAL cycle but will not be allowed to change its parameters Once the new profile is complete the machine will request that the new user SterilC ard 06 be inserted for programming 10 04 07 14 88 47 INSERT NEW USER STERILCARD PROGRAM CANCEL Operation Press CANCEL to return to the SterilCard option menu Press PROGRAM to save the profile just created on the SterilCard 06 inserted in the machine If the operation finishes successfully the following message will appear 10 04 07 14 89 41 OPERATION ENDED WITH SUCCESS STAND BY Otherwise if errors occurred the screen will read 10 04 07 14 16 18 OPERATION FAILED STAND BY In both cases press one of the 4 multi function buttons to return to STAND BY If the User SterilC ard 06 that was inserted has already been programmed the following message appears 10 04 07 14 89 20 STERILCARD ALREADY PROGRAMMED REWRITE CANCEL 39 Operation Press REWRITE to overwrite the new profile onto the SterilCard 06 inserted and then view the results of the operation Press CANCEL to return to the SterilCard option menu Only User SterilCards 06 can be programmed If an Adm
22. 26 VACUUM TEST CONSISTENT 48 5 C 4 977 bar Cycle duration 19 23 Pressure variation 13 mbar Leakage rate f 1 3 mbar min STOP lEuEnTI INFO PLOT press STOP wait for the Wait door unlock indication to turn off and then open the door If REPEAT TEST appears on the display the test will be interrupted automatically Before repeating the test open the door 16 let the chamber 09 cool completely and check that it is perfectly dry Whenever you want to run the VACUUM TEST with a chamber temperature above 40 C the display will show a message reading Cooling pause and the cycle will begin only when the temperature drops below 40 C WARNING for this reason selecting the Vacuum test disables preheating when the doorisclosed and the handle clicks If the message VACUUM TEST NOT CONSISTENT ever appears after running the vacuum test contact a TECHNICAL SERVICE CENTER 50 Operation Helix test The purpose of the test with hollow A load according to standard EN 13060 is to check that steam penetrates correctly into hollow A loads and to check the efficiency of the air removal system This test should be run on B type cycles The Cominox Helix test consists of a metal capsule containing a chemical process indicator and a Teflon tube that is 1 5 m long with an internal diameter of 2 mm The even color change of the chemical indicator ensures that the steam has properly penetrated thro
23. AMANTE a E E E E 22 Table of contents CONNECTIONS sce aa a e e A A SSS 2 23 EFIECTCAI CONTES CNA sil e hts i oh ad ee 23 Walter coneccion a o e do RIN Ie SY Oa Ea IMS UO TADS ME eS 23 Water SUD DIY TODS a ETE a eee sa Tee RES 24 MANUALE Y FILE GLEAN WATER TANK ci ici 25 MANUALLY DRAINITANKS a e a cea states alii ad e Sos 25 PREPARING FOR BUILT IN INSTALLATION cccoconcnnonononnnnononnnnncconananononanananononnnnnononnnnnononanunonacinnnnnaninnos 25 OPERATION aiaiai araia naana aa raonada n ka da ma Manawa aa araara aawa A aain aiaa a daian A Aa aiaia aaa aaar naaa aiaa akian 26 SWITCHEON ad E 26 STAND BA ido 28 MENU a aaa 29 li KEV EIS Men aaa teta adds aaa 30 25 MIA SSTHMOS MN i nennen a a aE aa a aa arara E eaea 30 2 1 koine Uee A E ESA 31 2 2 Date a a IME ua it E a a a a as a ao eaS 31 2 3 BUTION S o AAPP E aa ee ee 31 2 4 SCIPS TO Di IA E EE E TAE A E SE 31 2 5 A EE A ee 32 2 6 A OP oP eG Ce 32 2 7 Cycle REC ONGC sae a aaa a a aa oa aE E Goa E EEE O A da 32 2 8 Data Logo ennen T I E 32 3 Advanced MENU FUNCTIONS Sects eects A t as 33 3 1 PROG SPECIA bonera a e T E EI E 33 3 2 Programmed SAN ut A A A 34 3 3 Hollow loadan traca 35 CWO EE le EEN ode ca E E T 36 SAD STEMME OA OHO ee nia 37 SAD E K210 SE AE naaa 37 SAB Delete Usera to o E TR Rit teases a e eai 40 El OEG AERE E OS AE AE EE E AAE E E A E A AA 4 A CYCIO RECOMAS Mel eseon di AA ii aiii da 42 S Malntenance MenVl td tae 43 5 1 EA A TE E
24. ARATION OF THE LOAD TO BE STERILIZED e Check the air sterilization filter 15 and replace if needed see Ch MAINTENANCE e Follow the instructions provided for the previous problem At the end of the cycle pressure rises very slowly e Check the air sterilization filter 15 and replace if needed see Ch MAINTENANCE The printer 26 optional does not print e Check that the printer has been enabled in the Main Settings Menu see Ch OPERATION If the printer 26 is installed and enabled but the printout is not available at the end of the cycle check that the paper roll is positioned correctly and that the printer door POWER MISSING ALARM NO MESSAGE IS SHOWN ON THE DISPLAY STEAM LOSS FROM THE DOOR WATER IN THE CHAMBER AFTER THE CYCLE DRYING UNSATISFACTORY PRESSURE INCREASES SLOWLY PRINTER DOES NOT PRINT 59 Alarms is properly closed If the printer is out of paper or the door is open the ERROR light will flash on the printer e Consult the PRINTER chapter and follow the instructions provided If the POWER light on the printer 26 is off the printer is not correctly powered e contact a qualified technical service center The auto water fill 29 optional standard on BHD models AUTOMATIC WATER AOK o o FILL DOES NOT WORK e Check that the Self filling option is set to ON in the Main Settings menu see Ch OPERATION e f configuration A with external can is installed and enabled check whether
25. Card 06 inserted The information on time pressure and temperature are saved each time the phase changes or after each minute in the cycle has passed depending on the value of the Data logging parameter selected in the Main Settings menu see sec 2 8 If no SterilCard 06 s inserted at the end of the cycle the display will request one However if a programmed and enabled SterilCard 06 is inserted the display will read Cycle recording in progress If the operation concluded successfully the machine will display a message indicating that recording ended successfully If there were errors it will tell you that recording failed In both cases pressing one of the 4 multi function buttons will return the machine to STAND BY mode If the memory available on the SterilCard 06 is nearly full when you press START to begin a cycle the display will show this message 52 Operation 10 04 07 16 15 16 MEMORY SPACE STERILCARD J CYCLES REMAINING In this case you are advised to transfer the files saved on the SterilCard 06 to a PC If the memory is entirely full when you press START the screen will read 10 0407 16 28 89 STERILCARD INSUFFICIENT MEMORY TRANSFER CYCLES ON PC or DISABLE CYCLE RECORDING STAND BY The saved data can be transferred to a computer with the CominoxReader kit optional which allows you to download and save the cycles and maintenance performed using dedicated software Once the
26. EST VACUUM TEST VACUUM B amp D TEST The VACUUM B8 D TEST cycle calls for the Vacuum Test followed by the Bowie amp Dick Test with a 5 minute pause between the two cycles and a preheating period to prepare the machine for the Bowie amp Dick Test 34 Operation Press the key to exit without programming any cycle to begin After you have selected the cycle press ENTER to view the day This value can be changed using the 7 arrows Press ENTER to confirm the information and move on to the next setting Once you have set the current date and time check that the door 16 is closed and the clean watertank 10 is full and check whether the waste water recovery tank 11 needs to be emptied If any one of these operations has not been performed the sterilizer will indicate this with a message on the display Press ENTER to return to STAND BY mode The display will indicate which start is programmed 10 04 07 14 85 15 STAND BY 121 UNWRAPPED N Y START 10 04 16 05 Max water level CANCEL At the set time the machine will automatically run the chosen cycle Press CANCEL to cancel the programmed start and return to STAND BY 3 3 Hollow Loads This function allows for automatic recognition of the load type HOLLOW A HOLLOW B or SOLID entering the length and diameter of the cavity in millimetres and the number of open ends Press ENTER to display the value of the first item 10 04 07 14 85 41 ADVANCED TOOLS q Holl
27. F If the Self stop is set and no button is pressed to select a time the sterilizer will automatically turn OFF thus reducing energy consumption to a minimum Press ENTER to confirm the information or press to exit without changing the value of the setting 31 Operation 2 5 2 6 2 7 2 8 32 Self filling This item is only available if the auto water fill 29 is installed optional standard on BHD models Press ENTER to show the value of the automatic fill setting ON OFF Change the setting with the 7 arrows if required Press ENTER to confirm the information or press to exit without changing the value of the setting Printer This item is only available if the sterilizer is equipped with a printer 26 optional Press ENTER to show the value of the Printer setting OFF 1 copy 2 copies 3 copies Use the f arrows to set the printer and the number of copies Press ENTER to confirm the information or press to exit without changing the value of the setting Cycle Recording This item is only available if the sterilizer is equipped with a SterilCard 06 optional standard on BHD models Press ENTER to show the value of the Cycle Recording setting ON OFF use the 7 arrows to change the value if required Press ENTER to confirm the information or press to exit without changing the value of the setting Data Logging Press ENTER to show the value of the Data logging setting Use the ft arrows to se
28. ING US E e a a e edad dd 11 Table of cycles sterilizable material 18B 18BHD ooccnonccccnconannnononnnnnnononannnnnnonnnonononnnanononnnoss 12 Table of cycles sterilizable material 188 ooooooccononacaccnononanonononanonononannnonnonnnonocnnnnanocononnnanononnns 13 Table of cycles sterilizable material 24B 24BHD oooocccconaccnonononanononnnnanocnonanononnonnnanononnnnnononnnnos 13 TEC FINIC AL SPEC IFIC AMONG a vsiseentiecsnsnnecannscsrsseasusdesnsasvensssenapennedesnssadadeassiecacisessussiutsstvasasecnanucaniae 15 Technical specifications table 18 occocococcnonanacononanannnnonnn cnc conan ano nonnononnonannn nro nono nan connn anno connnnss 15 TECHNICA specificghons table AAA sdiuetacdeslecdeasiesdecesesyeegevebaasese 16 REFERENC ESTANDARD S is 16 DIMENSIONS oirnne a a E A EA E A a A EA Sen ty 17 General CUINTSINSIOMNS sisan a a A E a EEE a a aeey 17 Dimensions required when the unit is to be built in o ooconnoconcnnonanncnonananononananononanannnononos 17 GENERAL SAFETY CONDITIONS ciiiiociiani nanc ninnacin naar inanici n 18 Thermal CANE A ann heme 18 A A O 18 Environmental CONCITIONS ARO MK unn 19 Residual TISKS OE a A n a a a 19 TRANSPORTATION AND PACKAGING usnsssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn 20 Unpacking and cleaning the COMPONEN Sii A A ios 20 SOON 21 INSTALLATION Socia dad al IRA a O AA ERAS DARA ela laa a cada ali 22 GENERAL CONDINON S e el e o a e 22
29. JENTER For each component the remaining days and cycles are shown along with the last three replacements the date of the operations and the total number of cycles at that point Use the f arrows to scroll through the entire list For some items Air filter and Door gasket the ENTER key is activated to record a replacement Press ENTER to display 43 Operation 10 04 07 14 13 30 MAINTENANCE REPLACED ITEM Air filter Pressing YES will record the replacement pressing NO will take you back to the list of items Only authorized technicians can replace and record the other items 5 2 Save Maintenance Press ENTER to access this screen 10 04 07 14 13 45 SAVE MAINTENANCE ON STERILCARD Press NO to return to the Maintenance menu Press YES to save the maintenance record on the SterilCard 06 inserted This record is overwritten each time The record is only saved if the SterilC ard 06 inserted is programmed and activated 44 Operation INFORMATION in STAND BY When in STAND BY mode pressing INFO will bring up a screen containing information about the machine 10 04 07 14 14 02 INFORMATION Relative pressure 6 665 bar Theor steam E A E Total cycle number ae 242 Water conductivity O mS cm User connected ADMINISTRATOR Serial number 60611 Firmware Version gt Use the t arrows to scroll through the information and view Relative pressure Theoretical steam temperatur
30. S Self stoP OFF Self filling ON 6 Printer OFF Q Cycle recording ON Data logging Every minute ENTER Operation The main settings that can be changed are Language Date and Time Button sound Self stop Self filling Printer Cycle recording Data logging OOS OS Oe ES Use the f arrows to scroll through the list of settings press ENTER to change the value of the setting selected Press the key to move back a screen without changing the setting values 2 1 Language Press ENTER to show the language 10 0407 14 83 38 MAIN SETTINGS o Language ENGLISH Date and Time 10 04 07 14 6 Button sound ON Q Self storP OFF 6 Self filling ON t JENTER Use the t arrows to change the language and press ENTER to confirm the selection Press the key to exit without changing the setting value 2 2 Date and Time Press ENTER to show the day Use the 1 arrows to change the value Press ENTER to confirm the information and move on to the next setting Press the key to exit without changing the setting value 2 3 Button Sound Press ENTER to show the value of the Button Sound setting ON OFF Use the arrows to change the setting Press ENTER to confirm the information or press to exit without changing the value of the setting 24 Self stop Press ENTER to show the Self stop value which can be set using the 1 arrows to 30 minutes 1 hour 2 hours 3 hours or OF
31. SEA yee A octets hats EE ce Ae 43 5 2 SAVE MIME MAC tai 44 INFORMATION IA STAND BY usina iaa 45 STARTING The GY CLE a O RAE Saa 45 STORING CYCLE ao ea alee e ae 46 EVENTS IN Te CYCLE reana o RO oo a Lana 47 INFORMATION about the CYCLE wie cccccccccccsssssscessssssecsessssscsessssssscesssssscessssscessssssesseseseacs 48 PLOMO Tme EEE a O A EE RSet BS 48 EONTROLTESTS 3 a A dd at codo 49 BOWIE Se Dick TOS A A A a eats 49 NO cod U8 tk Sc ee era a O A A AN ne A ad 49 Heller ties e is IA lion dad em date tt 51 Table of contents SA GARE A O E E OEA 51 CGy le Recording O ASIS A 52 INDICADO Bici dadasdaveddanesntacassaduanicuundcauiiudaaiienduandnanssadaasts 54 ALARMS AP un O 56 LISE OT alamni COGS ssc eau aialanian ele ae et Meas 61 MAINTENANCE Sii A A ada 62 GENERAL CONDIT O N S tia 62 A EN 62 A AAA A RN A O A E AN A EN EA 63 A E atid opbadeareenayleSohalicl tints Asa ebolovece tuatch aabiel E AA E E kadietdinin ene 63 PUSE used dchsnadiaanca EEE AAAA E T ikaoaaidieapseastacaboas O OT 63 To calibrate the fuses 32 refer to the label plate inside the door 18 cooccnoccccconancconnnccnos 63 STORAGE AND DISPOSA Derennes a a e e cen dE E aL Cod N 64 Machine storage or long term GISUSE cnica ibi tata 64 DEPOsal ana Scrapping di IEA ai a i 64 Sseneauls dd sEV e TODS o A naa AEE 65 APPENDIX 1 GRAPHICS 18 B 18 BHD 24B 24 BHD nsssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnna 66 APPENDIX 2 GRAPHICS 18 Sii a 67
32. USE and MAINTENANCE MANUAL dterilCiawve 13 24 Seam stenlizer FOREWORD This manual must be considered an integral part of the sterilizer and must always be available to users The manual must always accompany the sterilizer even if it is sold to another user All operators are responsible for reading this manual and for strictly complying with the instructions and information it provides COMINOX is not liable for any damage to people things or the sterilizer itself in the event that the operator fails to comply with the conditions described in the manual These instructions are confidential and the customer may not disclose any information to third parties Further this documentation and its attachments may not be tampered with or modified copied or ceded to third parties without authorization from COMINOX Table of contents TABLE OF CONTENTS TABLE OF CONTEN Bis fasts caitinsisensnncastiinnescadccsneseasuieecuvcususasseanpansssnseacdsaddassnseussecackseiutsstiessdaanessdausnsia 3 Nado psa e IA A A II A A E OT te 6 Graphic representation of references Mod 18 ccccccccssscccssesseccesssssececessnseeceessseesesesseseeecessaeeees 7 Graphic representation of references MO 24 ccccccsssccccssesseccesesssccecessneeeceessseesesesseceeeceseaeeees 8 DINO DUC THO Nis A A Rae 9 GENERAL SUPPLY CONDITONS rerent rE E ENE ap asic pobre ove ei uu eaves 9 PURPOSE OFTHE DOCUMENT a A a Oia 10 EQUIPMENT us dada A AS A A Si 10 OPERAT
33. aged and run through a new sterilization cycle If installed and enabled the printer 26 optional produces a full report on the cycle conducted When the cycle is complete press STOP to return to STAND BY or only for cycles that end with drying open the door 16 EVENTS in the CYCLE Press EVENT to access the cycle events screen 10 04 67 15 51 08 134 HOLL POROUS B EVENTS START 14 57 18 PREVACLILIM 40 64 22 5 C 0 985 bar STEAM PEAK 1 03 32 26 6 C 6 148 bar VACUUM PULSE 1 10 48 132 4 C 3 100 bar STOP 10 04 07 15 51 56 134 HOLL POROUS B EVENTS STERILIZATION 22 44 134 6 C 3 089 bar Temperature 134 6 C 135 4 C Pressure 3 079 bar 3 152 bar Theor steam temp 134 5 C STOP t 19 04 07 15 51 32 134 HOLL POROUS B EVENTS STEAM PEAK 2 13 80 67 3 C 200 bar VACUUM PULSE 2 16 34 134 4 C 3 166 bar PRESSURIZATION 18 51 r1i 5 C 9 204 bar STERILIZATION 22 44 134 6 C 7 089 bar stop Ty Te 10 04 07 15 52 68 134 HOLL POROUS B EVENTS DRYING 28 32 72 6 C 4 200 bar CYCLE END 48 58 120 4 C 0 864 bar The display will show information about the phases of the cycle in progress the phase name the time the phase began the temperature and the pressure of the sterilization chamber at the beginning of the phase For the sterilization phase the display also shows the mininum and maximum values of the temperature pressure a
34. ain WARNING liquid temperature can reach 80 C and the liquid may be contaminated The liquid should be disposed of according to the legislation in force Water supply table Water supply Residue from evaporation lt 10 mg l Silicon Dioxide SiO2 lt 1 mg l Iron lt 0 2 mg l Cadmium lt 0 005 mg l Lead lt 0 05 mg l Remaining heavy metals excluding iron lt 0 1 mg l cadmium lead Chlorides lt 2 mg l Phosphates lt 0 5 mg l Conductivity at 20 C lt 15 uS cm Acidity value pH From 5 to 7 Appearance Colorless clean without sediment Hardness lt 0 02 mmol l 24 Installation MANUALLY ALL CLEAN WATER TANK If AUTO WATER FILL is not available or not selected see WATER CONNECTION fill the tank manually Unscrew and remove the cap from the filler 14 insert the metering funnel 05 provided and pour in distilled or suitably demineralised water see Water supply table and Technical specifications table for the quantity If you fill the machine when it is switched on and in STAND BY mode the MIN WATER LEVEL and MAX WATER LEVEL indications on the display will allow you to check the level An audible signal lasting three seconds will go off when the MAX WATER LEVEL indication appears indicating that the tank is full Top up with water whenever the MIN WATER LEVEL indicator appears on the display For maximum operating time before refilling fill the tank completely until
35. contact a E COMINOX TEC HNIC AL SERVICE CENTER Cleaning Clean the sterilization chamber 09 and the internal disk on the door 16 each day Use a cotton cloth soaked in alcohol or distilled water During cleaning it is advisable to wear protective gloves If any scale is found use stainless steel polishing products Then remove any product residue with a degreasing product and rinse thoroughly with distilled water NEVER use chlorine based detergents bleach which could lead to oxidation in the sterilization chamber DO NOT use abrasive sponges orwools Clean the workplace every day checking that there are no clogs or blockages to prevent proper ventilation of the machine 62 Maintenance Clean the clean water tank 10 and the waste water recovery tank 11 Empty them completely at least every six months and refill the clean water tank with clean water see the Water supply table If the machine will not be used for a long period leave the tanks empty Filters Replace the air sterilization filter 15 at least every six months remove the filter and screw in the new one Annually check the efficiency of the waste filter 20 as follows open the door 16 remove the filter by pulling upward check it and clean with a jet of compressed air or replace it replace the filter Checks At least once a month check the efficiency of the chamber seal 31 and replace it if there is damage To extend the life o
36. d the Technical specifications table Water connection This option comes standard on BHD and can be requested for other models This option makes it possible to avoid stopping the unit to fill the clean water tank 10 and to empty the waste waterrecovery tank 11 1 Auto water fill This is an alternative configuration to manually refilling the clean water tank 10 see MANUALLY FILL CLEAN WATER TANK A FROM EXTERNAL CAN maximum height differential 1 m the auto water fill 29 tube can be connected directly to a can of demineralized or distilled water purchased on the market or to a can of distilled water produced by a Cominox water demineralization system Discom 23 Installation B FROM WATER MAIN the auto water fill 29 tube can be connected directly to a water demineralization system by Cominox Speedy Water or Osmosis For both the A and Bconfigurations the Autofill setting must be ON in the Main Settings menu Configuration Brequires installation by a qualified technician Check that the water quality complies with the water supply table 2 Direct drain This is an alternative configuration to manually draining the waste water recovery tank 11 see MANUALLY DRAIN TANKS Connect the tube fitted with a male quick connector to the female fitting on the direct drain 30 after placing the other end of the tube at a suitable drain Once the pipe is connected any water in the waste water recovery tank 11 will start to dr
37. e Total number of cycles Water conductivity of last load only if automatic fill is available and enabled User connected only if the sterilizer has a SterilC ard 06 Serial number Firmware version Programming file Press the key to return to STAND BY STARTING the CYCLE From STAND BY press START to launch the cycle shown on the display 16 64 67 14 57 59 10 04 67 15 28 48 10 04 67 15 58 42 134 HOLL POROUS B PREVACUUM 21 6 C Cycle duration 6 673 bar ab 41 Door locked STOP IEVENTI INFO PLOT e The cycle in progress 134 HOLL POROUS B STERILIZATION 135 1 C 3 120 bar Cycle duration 28 56 Time remaining 63 14 Door locked STOP EVENT INFO PLOT During the cycle the display will show e The current date and time 134 HOLL POROUS B CYCLE END 117 4 C 4 998 bar Cycle duration 48 58 Cycle completed STOP IEVENTI INFO PLOT 45 Operation The phase of the cycle in progress The temperature in the sterilization chamber The pressure in the sterilization chamber The cycle duration The end phase time for sterilization and drying phases The Door locked indicator A Cooling pause message if applicable e The Cycle completed message at the end of the cycle During the cycle the multi function buttons correspond to STOP EVENT INFO PLOT STOP the CYCLE The STOP button will halt the cycle in progress You can intemupt the cycle at any time by press
38. e sterilizer also includes the following accessories 18S 18B 24B 18BHD 24BHD Tray handle 01 1 e Waste pipe 02 1 e Level testing pipe27 1 e e e Grid seal 28 Powercable 03 1 e Trays 04 3 e Pouch holders 07 1 optional optional optional Support for 5 trays or 3 cassettes 08 1 s e Metering funnel 05 with cap e Administrator and User SterilC ards 06 2 optional optional Printer 26 1 optional optional optional Auto water fill 29 1 optional optional Direct drain 30 1 optional optional e Supplied as standard Introduction OPERATING USE Under no circumstances should the sterilizer or its parts be used for any purpose other than those described below The sterilizer was designed to STERILIZE AUTOCLAVABLE SURGICAL DIAGNOSTIC OR MEDICAL INSTRUMENTS for example SCISSORS SCALPEL GAUZE FABRICS Various types of materials can be sterilized such as stainless steel glass rubber plastic cotton fabrics in general Check that that the product to be sterilized can withstand a temperature higher than the temperature ofthe programmed cycle Observe the normal usage conditions described COMINOX guarantees that the maximum measurable temperature in chamber 09 will be PROGRAMMED STERIUZATION TEMPERATURE 3 C standard EN 13060 minimum temperature sterilization temperature 0 C maximum temperature sterilization temperatu
39. e to begin but it is advisable to follow the instructions provided for the WATER QUALITY INSUFFICIENT alarm see the section on ALARMS 6 Min water level minimum level reached in the Clean water tank 10 Preheating in progress sterilizer heating Indicates that the exterior coil is working Preheating is activated when the door is closed and the handle clicks Door release act activates at the end of a cycle or directly after turning the sterilizer on and indicates that the door 16 release is underway To access the 28 Operation chamber 09 wait until the indicator disappears without attempting to open the door 63 Cooling pause indicates that the temperature in the chamber 09 is not suitable to start or continue a cycle Max water level maximum level Clean water tank10 Drain waste water indicates that the waste water recovery tank 11 s full Empty the tank see MANUALLY DRAIN TANKS If the direct drain 30 is installed see CONNECTIONS check that the connection is correct and that the pipe is not bent or clogged MENU From STAND BY using the four multi function buttons you can navigate the menu and program the various SterilClave functions When you select MENU from STAND BY the options available are Cycle Main settings Advanced tools Cycle records Maintenance rl ee 10 04 07 14 82 20 JENTER Use the f arrows to scroll through the list until the item you want is highlighted
40. ed comply with the regulations in force in each PN individual country for the disposal of the varous parts In any event avoid creating any sort of pollution N B COMINOX declines all responsibility for damage to the environment or for systems used in the disposal of the materials that comprise the machine or that are used in its operation Dispose of the various types of materials used in the machine in landfills that are suitable foreach materal 64 Maintenance Sc heduled service table Hofcycles or maximum Date of fe yclesat Technician s tem g h the time of the 3 time operation operation signature pemitted P Air Filter 200 l year Water Filter TORO 2 years 1500 Vacuum pump kit 2 years SV2 drain hoes 2 years 1500 SV6 by pass 2 years 1500 Drain tank probe 2 years gt 6000 Water fill pump years Internal coil 5900 6 years Door gasket a0 6 years Chamber level probe e000 6 years 6000 Pana 6 years 6000 Temperature sensor 1 6 years Temperature sensor 2 Cone p 6 years Temperature sensor 3 as P 6 years Chamber safety thermostat 2000 6 years 6000 Pressure Transducer 6 years Chamber safety valve 5000 6 years 65 Appendix 1 APPENDIX 1 GRAPHICS 18 B 18 BHD 24B 24 BHD 121 UNWRAPPED 134 UNWRAPPED 121 HOLLOW POROUS 134 HOLLOW POROUS 134 PRION 134 WRAPPED 66 Appendix 2 APPENDIX 2 GRAPHICS 18 S
41. ems or equipment heavier than 30 kg must only be moved or lifted using appropriate lifting devices At least two people are required for manual lifting using the special lifting straps 23 provided and following the correct procedures as specified by current regulations Never lift or move the sterilizer using the door 16 or holding onto other plastic e Parts Unpacking and cleaning the components Remember that packaging wood nails paper cellophane metal staples adhesive tape straps ropes etc can cut and or injure if not carefully handled a They should be removed using appropriate means and not left within reach of unauthorized persons especially children The same applies to any device used to remove packaging scissors hammers tongs knives etc Packaging Components must be removed and disposed of according to the regulations in force in each country You are advised to retain the packaging and the lifting straps 23 for possible moves in the future When opening the package the first thing to do is check all the pieces and parts of the sterilizer Check that all components required are present and in perfect condition see SUPPLY CONDITIONS Remove the supplied parts by opening the door 16 see OPERATION In the event of defects or wear and tear immediately interrupt any operation contact the shipping orforwarding agent and promptly infonm COMINOX 20 Transportation and packaging T
42. ess ENTER use the f arrows to select the Bowie amp Dick test cycle Press ENTER to return to STAND BY Press START in STAND BY mode and wait for the test to finish the words CYCLE END and the corresponding icon will appear on the screen press STOP and wait for the machine pressure to return to O bar Then open the door 16 remove the tray holding the test and check the results of the test according to the manufacturer s instructions Vacuum test The Vacuum test is used to check the efficacy of the vacuum pump and the full correct seal of the hydraulic circuit The Vacuum test must be carried out when the unit is COLD room temperature In order to carry out the test correctly follow the same procedures as for a normal sterilization cycle but do not load the machine and proceed as follows turn the machine on with the main switch 13 close the door 16 enter the access code or insert the SterilC ard 06 press MENU from STAND BY mode select Menu Cycle number 1 and press ENTER 49 Operation use the f arrows to select the Vacuum test cycle and press ENTER to return to STAND BY press START from STAND BY 10 0407 16 41 11 VACUUM TEST MAINTENANCE 45 5 C A 147 bar Cycle duration 12 39 Time remaining 05 44 Pressure variation ar Door locked STOP EVENT INFO PLOT wait for the test to finish shown on the display by the words VACUUM TEST CONSISTENT 10 04 07 16 47
43. etic even when the unit is switched off plants and animals cannot survive inside the machine Do not place plants or animals inside the chamber Poor cleaning or scratching of label plates and or instrumentation can lead to mistakes Poor training of personnel Clean instruments and label plates carefully with the appropriate products and consequent dangers Request an additional training course from COMINOX Transportation and packaging TRANSPORTATION AND PACKAGING During transport the sterilizer is protected by a cardboard box Lifting and transportation are to be carried out by qualified personnel only Weights and dimensions of occupied space are provided in the DIMENSIONS chapter and in the Technical specifications table Lifting means should not damage orcompromise the operation of the sterilizer The packed sterilizer must be lifted after being fitted onto the special pallet and e only using forklifts Transportation of the sterilizer particularly by road must be conducted using means of transportation that can adequately protect the components especially electronic components against violent knocks humidity vibrations and so on The sterilizer ma y be transported only after fully emptying the clean watertank 10 and the waste water recovery tank 11 e COMINOX does not accept sterilizers for repair if they have full tanks see Chap MANUALLY DRAIN TANKS Very heavy it
44. f the filter it is best to leave the door 16 ajar but not locked with the handle when the unit is not being used Every day check that there are no drips or seepage in the work area since they can cause a slipping danger The probes check must be performed strictly by specialized personnel or at a COMINOX TEC HNICAL SERVICE CENTER At least annually check the calibration of the pressure and temperature probes Oo Fuses To calibrate the fuses 32 refer to the label plate inside the door 18 63 Maintenance STORAGE AND DISPOSAL Machine storage or long term disuse If the machine will NOTbe used immediately or if it will be stored forlong periods check that it ispackaged correctly The sterilizer must be stored only in closed but well ventilated locations that have no special characteristics that might be harmful to the machine components especially electronic components If necessary cover the unit with cellophane and use desiccant salts DO NOT place other loads different from machines of the same type on top of the packaging and in any case do not stack more than 4 crates In any event after long periods of disuse the machine will require checks and tests that cannot be fully described here Ask COMINOX or an AUTHORIZED TECHNICAL SERVICE CENTER for more information When the unit will not be used for a long time empty the tanks completely Disposal and Scrapping Should the machine be dismantl
45. finished successfully the message Operation ended with success will appear If there were errors the display will read Operation failed In both cases pressing one of the 4 multi function buttons will return the machine to STAND BY mode Each User SterilCard 06 can be enabled to use 10 different serial numbers If a User SterilCard 06 is already enabled for 10 serial numbers and you want to enable a new serial number the machine will ask you to delete one number from the list to make room for the new number and complete the operation 16 64 87 15 46 22 16 64 87 15 46 39 16 64 87 15 46 46 INSUFFICIENT MEMORY S No IN USE DELETE S No YES NO After you select a serial number from the list and press ENTER the machine will ask you to confirm the deletion Choose YES to delete the serial number from the list Then enable the User SterilCard 06 for the current serial number It is only possible to enable User SterilCards 06 that are already programmed If the SterilCard 06 inserted is an Administrator level card the following message appears STERILCARD LEVEL NOT COMPLYING If it is empty it will read STERILCARD NOT PROGRAMMED 41 Operation 4 Cycle Records Menu 10 04 07 14 12 34 CYCLE RECORDS YPe B S No 00011 10 04 07 10 19 29 134 HOLL POROUS Type N S No 00611 10 0467 69 19 21 121 UNWRAPPED Tyre N S No 00011 10 04 87 07 19 13 JENTER After you press ENTER
46. hamber seal 31 as well as the internal door 16 disk the seal is fitted to Replace if damaged see CLEANING and CONTROLS in Ch MAINTENANCE e Runa VACUUM test to check for pressure leaks e Recheck the tilt of the machine see Ch INSTALLATION e Check that the total maximum load weight see Table of cycles sterilizable material has not been exceeded 56 Alarms Indicates that small steam leaks or an unsaturation of steam has prevented the correct rise in temperature in the chamber 09 during the pressurization phase e Follow the instructions specified in the case of the INSUFFICIENT STEAM ALARM e lf the alarm persists this could be due to a problem in the electric heating circuit contact a technical service center Indicates that the temperature inside the chamber 09 has exceed 150 C e If the alarm persists contact a technical service center Indicates that during a vacuum peak in the vacuum pulse phase the pressure failed to drop to the preset value e Follow the instructions specified in the case of the INSUFFICIENT VACUUM ALARM e Check that the total maximum load weight see Table of cycles sterilizable material has not been exceeded Indicates that during the pre vacuum the pressure failed to drop to the preset value e Check the efficiency and cleanliness of the chamber seal 31 as well as the internal door 16 disk the seal is fitted to Replace if damaged see Ch MAINTENANCE e Check t
47. hase with start time and the temperature and pressure values e in sterilization the minimum and maximum pressure temperature and theoretical steam temperature values will also be printed e the total cycle duration with the date and time the cycle ended e the load e the operator The information on time pressure and temperature is printed each time the phase changes or after each minute in the cycle has passed depending on the option selected in the Main Settings menu for the Data logging parameter see sec 2 8 In the case of an ALARM the printout will show the code for the alarm that was triggered When printing the screen will read 51 Operation 10 04 07 15 54 31 PRINTING The machine then changes to STAND BY mode To insert or replace a printer 26 paper roll simply open the print door 18 and then the interior printer door Both of these tilt downward Insert or replace the paper roll with a compatible replacement thermal paper and thread one end through the upper slot Press the FEED button on the printer to advance the paper through the slot in the door Then close the door on the printer 26 and the door 18 of the control panel Cycle Recording on SterilCard If the machine is equipped with a SterilCard 06 optional standard on BHD models and the Cycle Recording option has been enabled in the Main Settings menu see sec 2 7 at the end of the cycle the information will be saved automatically to the Steril
48. hat the drain filter 20 is clean and positioned correctly see Ch MAINTENANCE e Runa VACUUM test to check for pressure leaks e Check that ventilation air vents are clear see PREP FOR BUILT IN Ch INSTALLATION and ask a technician to check the efficiency of the internal fan s STERILIZATION TEMPERATURE BAND OVERTEMP Indicates that during sterilization the temperature or theoretical steam temperature has exceeded the maximum temperature anticipated for the sterilization temperature range e lf the alarm persists contact a technical service center to check the calibration of the temperature and pressure sensors STERILIZATION TEMPERATURE BAND UNDERTEMP Indicates that during sterilization the temperature or theoretical temperature of the steam has dropped below the minimum value anticipated for the sterilization temperature range e Check that the total maximum load weight see Table of cycles sterilizable material has not been exceeded PRESSURIZATION ALARM PT OVERTEMPERATURE ALARM FRAC VACUUM ALARM INSUFFICIENT VACUUM ALARM STERIL TEMP BAND OVERTEMP STERIL TEMP BAND UNDERTEMP 57 Alarms Indicates a problem with the level probes e Empty and refill the clean water tank 10 when the unit is off and idle Indicates that the chamber 09 is overheated and the safety thermostat 17 has been triggered e Contact a technical service center Activates in STAND BY when the auto water fi
49. he load support system and the external surface of the sterilizer are sometimes protected by a plastic film it must be removed before using the machine Storage If the sterilizer will not be used immediately or if will be removed from the installation site it must be stored in a dry protected location If you wish to cover the machine with plastic sheeting you must first insert silica gel or other desiccant systems inside the packaging Never place any objects on top of the machine packaging especially with loads concentrated on protruding feet or screws Ideal ambient storage conditions are temperature with empty systems 25 C 40 C maximum relative humidity 90 21 Installation INSTALLATION GENERAL CONDITIONS Installation of the sterilizer is to be carried out according to Customer requirements and those of the site where the machine is to be installed Therefore it is important that the Customer promptly informs COMINOX of any special situations such as ambient conditions size or built in limits The operation must be performed by trained qualified personnel only it is important to comply with the specifications in this manual and follow the technicaldiagramsand documents In general it is necessary to check that any ambient conditions are acceptable explosion risk excessive ventilation or high humidity Check that the unit is not exposed to any adverse weather conditions
50. ilter 20 and place the supplied level testing pipe 27 in the hole The filter is located in the middle at the bottom of the chamber get the metering funnel 05 insert the plug provided and fill it based on the model with SterilClave 18 60 cc SterilClave 24 80 cc Use ONLY distilled or demineralized water see Water supply table slowly pour the contents of the funnel into the bottom of the chamber the water cannot descend through the drainage hole so it will flow toward the outside of the chamber The water must not spill out of the chamber If the leveling is correct when the full quantity of water measured is poured into the chamber it must touch the chamber probe 21 if the leveling is not correct loosen the clamping nuts and adjust the adjustable feet 22 raise the feet if the water tends to exit Otherwise lower them after leveling tighten the clamping nuts on the adjustable feet 22 remove the water and dry the chamber with a cloth WARNING NEVER REMOVE THE FEET COMPLETELY r Do not block the space underthe sterilizer remove the level testing pipe 27 and replace the waste filter 20 insert the tray support 08 and the coil covering grid 19 Fasten with the corresponding screw paying attention to the grid seal 28 CONNECTIONS Electrical connections To connect to the power supply simply plug in the sterilizer by inserting the power cable 03 plug into a suitable socket see GENERAL CONDITIONS an
51. ing STOP but you are advised to d sop the cycle only in an emergency If a cycle is interrupted with a load of packaged instruments even when the sterilization phase is complete sterility is not guaranteed because the load has not dried Unless they are reused immediately the instruments should be run through another sterilization cycle When the STOP button is pressed the machine shows a MANUAL STOP ALARM describing the cycle and the phase in which the alarm was triggered The alarm can be silenced by pressing any one of the four multi function buttons 10 04 07 15 53 43 ALARM MANUAL STOP 124 HOLL POROUS B PREVACUUM SILENCE ALARM The machine will then switch to STAND BY mode When the STOP button is pressed if the pressure inside the chamber 09 is greater than 0 2 bar the door locking device will still be engaged The display will show e the message Wait doorunlock and the doorcannot be opened Wait for the pressure to return to O bar checking the relative pressure by pressing the INFO button and then open the door 16 WARNING Beware of the steam that exits from the door and do not touch the load its support system or any hot surface unless you are wearing suitable protective glovesorusing the special tray handle 01 46 Operation Pull out the load and if it is packaged check that the packaging has not been damaged e g open seals Material in damaged packages must be repack
52. inistrator SterilCard 06 is inserted the screen will read STERILCARD LEVEL NOT COMPLYING and a User SterilC ard 06 must be inserted to proceed with programming 3 4b 2 Delete User 40 Press ENTER The machine will ask you to insert the User SterilCard 06 to be deleted 10 04 07 14 18 35 INSERT USER STERILCARD DELETE CANCEL Press CANCEL to return to the SterilCard option menu Press DELETE to remove the profile on the SterilC ard 06 inserted in the machine and the cycles and maintenance records along with it If the operation finished successfully the message Operation ended with success will appear If there were errors the display will read Operation failed In both cases pressing one of the 4 multi function buttons will return the machine to STAND BY mode You can delete just one User SterilCard 06 enabled for the current machine If the SterilCard 06 inserted is an Administrator level card the following message appears STERILCARD LEVEL NOT COMPLYING If the card is not enabled the screen will read STERILCARD NOT ENABLED Operation 3 4b 3 Enable User Press ENTER to display the request to enter the User SterilCard 06 that you want to enable 10 04 07 14 16 48 INSERT USER STERILCARD ENABLE CANCEL Press CANCEL to return to the SterilCard option menu Press ENABLE and the User SterilCard 06 inserted will be enabled to use the current serial number If the operation
53. ions Q 0 139 j0 087 maximum impedance Technical specifications Technical specifications table 24 U M B BHD Steam generation in chamber in chamber Chamber capacity l 23 15 Clean water tank capacity l 3 1 Waste water recovery tank capacity l 3 1 Water consumption per cycle minimum maximum cm 420 1040 420 1190 Minimum water load cm 1040 1190 Maximum flow discharge rate direct cm s 30 Maximum discharge temperature direct amp C 83 Absolute operating pressure maximum kPa 331 Electrical voltage and frequency V Hz 230 50 60 single phase AC Maximum allowed voltage fluctuations 10 Absorbed maximum power W 2800 Heat emission J h 0 3 Detected noise level in work areas under suitable conditions medium peak Bra Pie panes Weight mass kg 63 68 Weight per support area with full tank and kg cm 1 53 1 63 maximum load Room temperature allowed C from 15 to 40 Maximum relative humidity allowed 85 ae Glin allowe devil slanclarcsarety m asl 1500 2000 with replacement of the valve Conditional connections Q 0 153 j00 096 maximum impedance REFERENC E STANDARDS SterilClave sterilizers were conceived and designed in conformity with the following directives and standards Directives 97 23 CE Pressure equipment 93 42 EEC Medical devices class Il a 89 336 CEE Electromagnetic compatibility and subsequent updates
54. ll 29 is installed see Ch CONNECTIONS e If configuration A is set the distilled or demineralized water tank must be refilled or replaced e f configuration B is set check that the water main tap is open and that the mains pressure is compliant Indicates that the door 16 was not closed correctly e Close the door firmly before starting a cycle This alarm triggers when the temperature sensor in the machine is disconnected or broken e Contact a technical service center to check the temperature sensor Indicates that during draining pressure did not drop to the correct preset value e Follow the instructions provided for the INSUFFICIENT VACUUM ALARM e Check that the total maximum load weight see Table of cycles sterilizable material has not been exceeded Indicates that the temperature in the chamber 09 does not correspond to the theoretical steam temperature e If the alarm persists contact a technical service center to check the calibration of the temperature and pressure sensors This alarm triggers when the pressure sensor in the machine is disconnected or broken e Contact a technical service center to check the pressure sensor Indicates the while the cycle was underway the STOP button was pressed before the natural completion of the cycle e Consider the load to be NON STERILE and run a new sterilization cycle 58 LEVEL PROBES ALARM COILS ALARM SELF FILLING ALARM DOOR ALARM TEMP SENSOR
55. nd its packaging TOTAL MAXIMUM DURATION the total time the sterilizer requires to run a complete cycle calculated from cold startup room temperature and maximum load TOTAL MINIMUM DURATION the total time the sterilizer requires to run a complete cycle including hot startup one cycle after the other and minimum load load support only TECHNICAL SPECIACATIONS Technical specifications table 18 Technical specifications U M S B BHD Steam generation in chamber in chamber in chamber Chamber capacity l 17 15 Clean water tank capacity l 2 1 Waste water recovery tank capacity 2 1 Water consumption per cycle minimum maximum cm 180 500 210 700 210 700 Minimum water load cms 500 700 700 Maximum flow discharge rate direct cm s 30 Maximum discharge temperature direct e 83 Absolute operating pressure maximum kPa 331 Electrical voltage and frequency V Hz 230 50 60 single phase AC Maximum allowed voltage fluctuations 10 Absorbed maximum power W 2000 Heat emission J h 0 3 Detected noise level in work areas under suitable conditions medium peak ORIN CPN al Weight mass kg 48 7 51 51 Weight per support area with full tank and kg cm 1 16 12 12 maximum load Room temperature allowed ze from 15 to 40 Maximum relative humidity allowed 85 eas oie Allowed MMs nord SEE m asl 1500 2000 with replacement of the valve Conditional connect
56. nd theoretical steam temperature Use the arrows to scroll through the full list or press the button to exit Press STOP to interrupt the cycle The upper part of the display shows the icons corresponding to the Door Locked indicator and the Cycle Completed indicator when the cycle ends 47 Operation INFORMATION about the CYCLE Press INFO to access the screen containing information about the cycle in progress 10 04 07 15 52 46 134 HOLL POROUS B INFORMATION Relative pressure 6 665 bar Theor steam TEDE 4 C Total cycle number Water conductivity SA HS cm User connected ADMINISTRATOR Serial number 60611 STOP Use the t arrows to scroll through the information and view Relative pressure Theoretical steam temperature Total number of cycles Water conductivity of last load only if automatic fill is available and enabled User connected only if the machine has a SterilC a rd 06 Serial number Firmware version Programming file Use the 1 arrows to scroll through the full list or press to exit Press STOP to interrupt the cycle The upper part of the display shows the icons corresponding to the Door Locked indicator and the Cycle Completed indicator when the cycle ends PLOTof the CYCLE Pressing PLOT accesses a screen that displays a graph of the pressure of the cycle in progress 10 04 07 15 53 03 134 HOLL POROUS B GRAPHIC The graph is updated in real time
57. ot use the sterilizer to process containers that hold fluids whether they are sealed or not e Never lean on the door 16 The information in this manual does not replace any safety instructions or technical data for installation and operation on the unit itself nor any safety standards in force in the installation country or the rules of common sense Thermal danger Interior parts of the door 16 and of the chamber 09 can reach extremely high temperatures Never touch the heated surfaces until they have cooled and always use the appropriate protective gloves The same applies when a load is to be removed from the sterilization chamber To remove the trays 04 holding the load always use the tray handle 01 Never leave the tray handle inside the sterilization chamber When opening the door 16 seam may escape which could cause bums Never gt stand in front of or above the door The temperature in the sterilization chamber is controlled by a safety thermostat 17 that intervenes if overheating occurs The safety thermostat must be reset manually Noise The sound pressure level noise detected in suitable work spaces must be lower than 7OCB A 18 General safety conditions Environmental conditions and risks The sterilizer may not be installed in the open or be exposed to unfavourable weather conditions sun rain snow wind In addition make sure that there is no electromagnetic interference that could affect the
58. ow loads Cavity length gia mm Cavity diameter 14 Orpen edges Q SterilCard option t JENTER Use the f arrows to change this value Press ENTER to confirm the information and move to the next item After you enter the number of open ends and press ENTER the type of load will appear on the display 35 Operation 10 04 07 14 85 50 ADVANCED TOOLS q Hollow loads Cavity length 1666 mm Cavity cdi ues mm Oren edges 1 HOLLOW A 4 SterilCard option t JENTER Press the button to exit 3 4a Change sec Code If the sterilizer is equipped with a SterilCard 06 this item is not available This function allows the user to change the sterilizer access code Pressing ENTER takes you to a new screen that asks you to enter the current security code Press ENTER to move on to entry of the new binary security code maximum 6 digits 10 04 07 14 06 38 ENTER NEW SECURITY CODE amp gt Press the button to delete the last number entered or if there are no numbers on the display to exit without changing the code Once you have finished your entry press ENTER to bring up the screen to confirm the code you have just entered Enter the new code and press ENTER to save it If the printer 26 Optional is installed you can print this new security code Press the button to exit without changing the security code 36 3 4b SterilCard Option Operation 10 04 07 14 87
59. r my C Time 4 min Peaks No 2 Drying 15 min Programmed start 121 UNWRAPPED 19 04 07 14 04 ENTER 33 Operation e the number of peaks in the vacuum pulse phase from 0 to 3 e the drying duration from O to 30 minutes Use the ft arrows to change the value of the parameter and press ENTER again to confirm the input and move to the next parameter Press the button to exit without changing the value of the parameters The SPECIAL cycle is an alternative to the standard cycles listed in the Table of cycles sterilizable material and can be programmed based on specific sterilization needs for special instruments or other loads The SPECIAL cycle is not covered by the technical requirements of the EN 13060 standard with which the COMINOX autoclaves comply for this reason only qualified laboratory personnel are permitted to use the SPECIAL cycle These people authorized by the Administrator must execute a confirmation for example in line with standard EN554 for each special programmed cycle with a specific reference load 3 2 Programmed start 10 04 07 14 04 57 ADVANCED TOOLS Programmed start 10 04 07 14 64 E Hollow loads Cavity teneti Cavity diameter 10 A mm mm 1 ENTER Oren edges Press ENTER to select the cycle to run Use the 1 arrows to select from among e 121 UNWRAPPED 134 UNWRAPPED 134 WRAPPED 121 HOLL POROUS 134 HOLL POROUS 134 PRION SPECIAL USER BOWIE amp DICK T
60. re 4 C The EN 13060 standard distinguishes various types of load depending on the material to be sterilized solid tools e g scalpels hollow tools of type A or type B e g surgical extraction cannula and porous loads e g fabrics and gauzes This division should guide the operator in selecting the sterilization cycle see Table of cycles sterilizable material Strictly comply with the sterilization instructions and information specified by the manufacturer for any material to be sterilized Instruments and fabrics to be sterilized MUST be carefully washed rinsed with additive free water and dried The support for the load must also be perfectly dry Comply with the maximum total load weight see Table of cycles sterilizable material Use the load support system supplied by COMINOX see Preparation of the load to be sterilized Use of load supports other than the standard support provided may compromise the steam penetration and drying performance confirmed during approval tests Follow instructions concerning correct packaging and only use packaging materials compliant with standard EN868 The sterilizer may NOTbe operated or installed in areas in which gas or any other explosive volatile substance is present O Introduction Table of c ycles sterilizable material 18B 18BHD 121 134 121 134 UN UN amarren POROUS POROUS
61. roperly grounded e Itis essential that operators are properly educated lt is therefore compulsory for them to read and comply with the technical information provided in the manual and attached documentation The use of unqualified personnel is strictly prohibited e Personnel who operate the sterilizer must always use the appropriate individual protective devices gloves for sharp or pointed objects and heated elements and the special tray handle for emptying the chamber e Avoid any temporary repairs repairs must be performed exclusively with original spare parts and these must be installed by an authorized technician e Never remove or dismantle any part from the sterilizer Only authorized personnel trained in advance by COMINOX may remove the exterior protective cover and access the interior parts e Labeling plates on the unit should not be removed damaged or dirtied They must be kept clean and clearly visible e Do not use the sterilizer if there are possible defects in its operation e The sterilizer should be cleaned using suitable means and detergents that will not damage or corrode any machine components It is strictly forbidden to clean or wash the sterilizer with jets of water e Never place containers of liquids on the sterilizer or the shelves above it Leakage or spillage on the electric system can cause a short circuit e Do not place flammable or toxic materials and products for sterilization in the chamber 09 e Do n
62. s yes porous no no no yes yes yes empty empty hollow A no no no no no no chamber chamber hollow b no no no yes yes yes Packaging not packaged yes yes yes yes yes yes SEES SeN single pack no no yes yes yes yes chamber chamber double pack no no no no no no Maximum load weight g 5 i i solid hollow porous 5Kg 5Kg 3 Kg 2 5 1 K9 2 5 1 Kg 2 5 1 K9 Table of cycley sterilizable material 24B 24BHD 121 134 121 134 UN UN ennrep POROUS POROUS 134 PRION po VACA WRAPPED WRAPPED HOLLOW HOLLOW Type according to EN 13060 N N S1 B B B Temperature 121 C 134 C 134 C 121 C 134 C 134 C 134 C Pressure 2 1 bar 3 1 bar 3 1 bar 2 1 bar 3 1 bar 3 1 bar 3 1 bar Duration of 15 4 4 15 4 18 3 5 sterilization phase Drying no no 20 20 20 20 no no rea 21 28 11 19 37 49 60 79 49 73 66 88 25 20 minimum maximum Load solid yes yes yes yes yes yes porous no no no yes yes yes empty empty hollow A no no no yes yes yes chamber chamber hollow b no no no yes yes yes Packaging not packaged yes yes yes yes yes yes Pere thot single pack no no yes yes yes yes hamber chamber double pack no no no yes yes yes Maximum load weight A i i solid hollow porous 7 5Kg 7 5 Kg 4Kg 3 7 2 2 Kg 3 7 2 2 Kg 3 7 2 2 Kg Introduction NOTE CYCLEN sterilization cycle for solid instruments unpackaged only CYCLE SI sterilization cycle for solid instruments packaged or unpackaged
63. t the data logging mode Each Minute or Phase Change a mode that is valid both for printing the data and for recording the cycles on a SterilCard 06 or in the internal memory of the sterilizer Press ENTER to confirm the information or press to exit without changing the value of the setting Advanced Menu Functions Operation 10 04 07 14 83 55 ADUANCED TODLS Prog SPECIAL Temper 184 6 C Time 4 min Peaks No 2 Drying 15 min Programmed start 121 UNWRAPPED 10 04 07 14 63 ENTER This menu gives you access to the Advanced Tools RA Prog SPECIAL Programmed start Change sec code SterilCard option Use the 1 arrows to scroll through the list of advanced tools and press ENTER to access the item selected Press the key to exit 3 1 Prog SPECIAL To access this item you need a security code However if the machine is equipped with a SterilCard 06 optional standard on BHD models no code is required the item is only available if the SterilCard 06 inserted is an Administrator level card or if the User SterilCard 06 is authorized to access the programming of the SPECIAL cycle Press ENTER to change the values of the SPECIAL cycle parameters In particular the sterilization temperature from 117 C to 134 C the sterilization duration The maximum value is 30 minutes and the minimum depends on the temperature setting 10 04 07 14 04 36 ADVANCED TOOLS Prog SPECIAL Tempe
64. ugh the hollow body To run the test correctly proceed as you would for any other sterilization cycle but without loading the machine turn the machine on with the main switch 13 open the door 16 insert the Cominox Helix Test device on the lower tray close the door 16 enter the access code or insert the SterilCard 06 press the MENU key from STAND BY select the Menu Cycle number 1 and press ENTER use the arrows 1 to select the B cycle to be tested Press ENTER to return to STAND BY press START from STAND BY and wait for the cycle to finish The words CYCLE END and the corresponding icon will appear on the screen press STOP and wait for the machine pressure to return to 0 bar Then open the door 16 remove the tray holding the test and check the results of the test according to the manufacturer s instructions Printer If installed and enabled see Main settings sec 2 6 at the end of each cycle the printer 26 optional will produce a report containing information about the cycle that just ended Printing starts when STOP is pressed or for cycles that end with drying phases also when the door is opened The printout provides all the information needed to document the cycle the date and time the SterilClave model the serial number the cycle in progress the sterilization time the sterilization temperature the cycle number whether or not drying is scheduled the description of each p
65. vide adequate ventilation for the components take into account heat emissions produced by the machine see Technical specifications table allow for the door 16to open allow for routine maintenance prevent damage to the sterilizer provide for the room necessary for installing the accessories for a water supply fitting 25 Operation OPERATION SVWITCH ON To turn on the sterilizer press the main switch 13 located behind the door 18 The sterilizer switches to OFF 10 04 07 14 08 12 OFF ES COMINOX ON Press ON using one of the four multi function buttons below the display the screen displays a welcome message and the sterilizer switches to STAND BY mode If the machine is equipped with a SterilCard 06 optional standard on BHD models pressing ON will display a request for the SterilCard O6 to be inserted 10 04 07 14 00 40 INSERT STERILCARD The SterilCard 06 should be inserted with the chip facing upward and forward When the card is inserted the sterilizer will beep If the SterlCard 06 cannot be read the CODE button will initiate an emergency procedure that allows the user to operate the sterilizer 26 Operation Pressing CODE will display the message 10 04 67 14 08 52 DISABLE STERILCARD AND ENABLE CODE Pressing YES causes the sterilizer to deactivate the SterilCard 06 for the next usage section and it proceeds to another screen that asks for a security code set

- Frank`s Hospital Workshop

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