INTRODUCTION - Profi Dental Equipment
Contents
1. IOD Annana BOF aa malal EL 30 OPTIONAL OPTIONAL S B S B T2 OPTIONAL S B 3 OPTIONAL Page 5 2 OPTIONAL S B s f ln EC KEE EE WK SE LC CH E Sg CH DE Minen Ze ia se Pleo oo Ces d p jl PEN je INTRODUCTION 9 lt 2 v OH I a St N 1 m q N LI o St N 3 o c 9 6 mid E o 0 o Q o o c o pen 5 m o 9 lt Q 6 Be o e INTRODUCTION c COMINOK References analytical index A M access KEY 06 sso c eed 33 manual tank arain essen 18 access keys Op 8 26 29 84 35 metering funnel 05 ieeeeeereerrernerrnereeeeeeene 8 21 23 adjustable feet 22 sss 21 N air sterilising filter 15 31 37 38 40 B nameplales mm mm 16 elm 17 BOWIE amp DICK est 33 o c ODCIAIOIS M 8 chamber 09 P 9 15 14 15 16 21 27 29 31 32 54 35 36 37 40 chamber probe 27 21 personal protection means eieeeseeeereeeseereersereeeseenee 8 chamber seal 31 Lasse ut bias ot stia riiia 36 37 40 EE EEEE Set 14 20 clean water tank 10 14 18 22 23 24 25 37 40 nrintar2B scisco ties 8 26 28 32 33 35 clean Water tap 24 sss 24 p2. COMINOX GENERAL SUPPLY CONDITIONS COMINOX hereby declares that the unit complies with any standard and regulation in force within the European Union and provides for the hereby enclosed CONFORMITY DECLARATION COMINOX accepts and undertakes to check and repair possible manufacturing defects appearing within 24 months from the unit installation refer back to the guarantee The chamber 09 is guaranteed for 10 years The customer is liable for using original spare parts and for fitting them according to their forecast use and operation Reference manufacturers are liable for any fitted accessory COMINOX is not liable for defects or wrong operation depending on the unit incorrect use changes after transportation or specific environmental conditions missing or incorrect maintenance tapering or incorrect repairing COMINOX is not liable in the case the installation is not compliant with the hereby enclosed instructions or if not be carried out by duly trained and qualified personnel COMINOX IS NOT liable for disposal of the unit transportation or operation or production materials packaging waste water lubricants etc The customer is individually liable according to the specific regulations and standards in force in each single installation country for disposing of any potentially dangerous substance and of any harmful and non ecologic or environmental friendly substance The same apply to the unit dismaniling DOC
3. INSTALLATION age 21 IC COMINOX When installing the unit for the first time or should it be removed from its original installation site follow and repeat the hereby described procedure position and direct the unit where it is to be commissioned and do not move it afterwards open the door 16 and the remove the chamber 09 content remove the coil covering grid 19 loosening any relating screw remove the tray support 08 remove the waste filter 20 and put the supplied evel testing pipe 27 in the hole the filter is not fitted in the middle portion of the chamber use the metering funnel 05 close it with the supplied plug and fill it with what follows according to the unit model Mod Sterilclave 18 60 cc Mod Sterilclave 24 80 cc ONLY USE DISTILLED or demineralised WATER refer back to the Feeding water table slowly pour the funnel content into the chamber the poured water could not drain from the discharge and drain hole and therefore will flow outside the chamber Water should not leave the chamber If the levelling is correct measured water correctly poured in must touch the chamber probe 21 should a similar condition not arrive adjust the adjustable feet 22 after loosening the clamping nuts adjust raising the feet if water tends to outflow or lowering them vice versa after levelling tighten the adjustable feet 22 clamping nuts empty water and dry the c
4. INSTALLATION np COMINOX GENERAL CONDITIONS The unit installation is to be carried out according to the Customer requirements and on the site the unit is to be fitted in It is therefore important that the Customer promptly inform COMINOX on possible special conditions environmental conditions size or built in limits etc In general it is necessary to check that any environmental condition is correct explosion risk excessively aerated areas high humidity Volt ii it Cw to check that the unit is not exposed to any adverse weather conditions such as EE AA EE sun rain wind etc to check that power supply complies with what specified on any nameplate on the unit to check that the power supply is correctly grounded Setting The unit is to be installed inside a laboratory medical cabinet dental cabinet or similar accessed only by trained and authorised personnel IT IS NOT BE INSTALLED next to heat sources in rooms where volatile explosive substances are kept under or above any live equipment within unsuitable built in units without the fitted adjustable feet in unsuitable places easily accessed by unqualified or untrained personnel on soft unstable or wheeled surfaces Position the unit rightly where it has to be installed on a stiff surface perfectly horizontal
5. COMINOX SPECIAL CYCLE It is a unique sterilisation cycle whose temperature and sterilising time drying and number of vacuum pulse peaks parameters can easily programmed by the user Parameters to be programmed STERILISING TEMPERATURE 117 C to 134 C STERILISING TIME MIN refer back to table MAX 30 minutes DRYING 0 EXCLUDED to 30 MINUTES EXCLUDED WITH LIQUIDS N OF VACUUM PULSE PEAKS 1 TO 3 ZERO PEAKS IN THE CASE OF LIQUIDS Table sterilising temperature minimum time Temperature Minimum time Temperature Minimum time C in minutes C in minutes 117 23 126 9 118 22 127 119 19 128 120 17 129 121 15 130 122 14 131 123 12 132 124 11 133 125 10 134 AIA OOO OM ING When programming the SPECIAL cycle LIQUIDS can be sterilised too It is thus demanded to automatically cut drying and enforce a vacuum pulse after pre vacuum thus simply programming sterilising temperature and time Such a feature during sterilising does not allow steam to come out from the chamber 09 until temperature lowers under a Safety value protecting liquids within their containers both open and closed with no risk of boiling or container breaking The SPECIAL cycle can be alternated to standard cycles as in the sterilising cycle material table and can be programmed according to specific sterilising requirements for unique instruments or loads for example liquids As already pointed o
6. COMINOX Replaced fitting N of cycles Maintenance date or fitting or admitted N of cycles when service was enforced to be maximum Seal replaced time Technician signature Air 500 filter 1 year By Pass 1500 solenoid valve 2 years Drain 1500 solenoid valve 2 years Vacuum 1500 pump kit 2 years Tanks level 1500 probes 2 years Door 6000 Seal 6 years Liquid inlet 6000 pump 6 years Internal 6000 coil 6 years Chamber 6000 level probe 6 years Temperature 6000 probe 6 years Safety 6000 thermostat 6 years Pressure 6000 transducer 6 years Safety 6000 valve 6 years Cooling 6000 fan 6 years SERVICE Page 43 COMINOX SCHEDULED SERVICE TABLE Service date N of cycles when the service was enforced Seal Technician signature
7. COMINOX SPECIAL cycle programming asang aaa sadad ana aana na eaaa anga wa di aa anga ag eoi ag aaa awana 29 FIRST CYCLE Stamp ER 30 Sterilising cycle stop 31 SUBSEQUENT sterilising cycle start up 32 Printer OP TIONAL EE 33 SELF AUTOMATIC SHUT OPFF EE 33 CONTROL TEST E 33 Lelleg 33 VACUUM NI E 34 TROUBLESHOOTING ceaiicctceccccceceatccstececeiee sn tac rececieiantacebescextoiesdcedeeeeintiteecsiacies 39 SIGNALLING TB 1 Em 35 le El e Rees MH 35 Alarms and troubleshooting eee esses sienne nee NARA ANANA KAEN NANANG KANAN AAN TAK SS see 36 Alarm list ee EE 38 SERVICE e E 39 GENERAL CONDITIONS iv n 5250455754558859 oa sos eaae niu nada pu uso deeg gu n us ru aan aea deha eE E Pana edd e 39 Cleaning R 40 lgli uEE 40 CONOIS sca P 40 STORAGE Ziele TT 41 Unit storage or long term slop mmmm mmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm rr Nak 41 Disposaland SCrappihg suus rtr rr mm tege Reo nae xeu NEAR mm 41 SCHEDULED SERVICE TABLE 5 3 tire bara Sun aba guna na Dan kaa dE Den EBANG sii rasa ENEE Eegen 42 References numerical index 01 tray handle sssssssssssssen 8 16 02 Waste DID eege hee a Resa 8 24 03 supply cable ena nn anae 8 22 37 04 LAYS
8. Volt 230 Hz 50 60 Admitted maximum voltage changes Volt 10 Maximum absorbed power Watt 2000 2800 2000 2800 2000 2800 Heat emission Joule h 0 3 Weight mass kg 48 7 62 51 63 51 68 Loading support system weight Trays 04 9 150 x 3 335 x 3 Envelope holder 07 optional g 300 430 Tray support 08 g 480 630 Admitted room temperature K 415 C to 4350 Admitted maximum relative humidity 96 85 5 to 40 C Admitted maximum altitude m up to 1500 up to 2000 sea level after with a standard safety valve 12 sea level replacing the safety valve Admitted maximum production time with no stops h 23 5 hours Reference standards The unit was designed in compliance with the following standards 93 42 CE Medical device directive class 2A 89 336 CE Electromagnetic compatibility directive 73 23 CE Low tension directive 97 23 CE Pressure Equipment Directive PED EN 13060 Small steam sterilizers EN 61010 1 Safety instructions for any laboratory device EN 61010 2 041 Instructions for autoclaves destined to the medical sector TECHNICAL SPECIFICATIONS oc d IC COMINOX Identification and marking Technical data in the operating instructions do not replace data on the nameplates fitted onto the unit The data nameplate is fitted to the unit back E General dimensions
9. a cycle is to be started within a short distance from the previous cycle and temperature is still higher than 90 C 80 C in the case of the Model 18B after pressing the key START the following message will be displayed on the display It is possible to a Wait for the unit to automatically lower temperature before starting the cycle b Press the key STOP to stop the cycle Open the door 16 to aerate the chamber removing the load for a few minutes thus speeding the entire cooling procedure up Rinse the load close the door and start the cycle pressing the key START If temperature in the chamber is higher than 80 C 60 C for the Model 18B before And the autoclave will stop any possible cycle setting Keep the door 16 opened to aerate the chamber 09 and simply start the cycle when the message COOLING PAUSE is no longer displayed on the display t lt 80 C COOLING PAUSE COOLING PAUSE OPERATION Page 33 IC COMINOX Printer OPTIONAL If present and set refer back to SETTING the printer 26 fitted to the control panel during the started cycle prints any information relating to the selected cycle and to the following phase throughout the cycle until its end With the access key fitted in the printer 26 prints data relating to pressure tempera ture and time at any phase change If the white access key is used the printer prints
10. at any minute of elapsed time To fit in or replace a printer 26 paper roller it is enough to open the printing door 18 and then the printer internal door They are both tilted downward Fit it or replace the paper roller with a compatible roller thermal paper and fit it with a paper portion coming out from the upper slide Close the printer door and door 18 on the control panel and press the key V to move paper into the door slide SELF AUTOMATIC SHUTOFF The autoclave is fitted with a self automatic shutoff system Under STAND BY conditions no operator can use the unit for more than 30 minutes otherwise it automatically shuts off If no operator presses the key STOP after a concluded cycle for more than 30 minutes the autoclave automatically shifts to the POWER SAVING mode The cycle comple te procedure and any displayed information is saved while the READY LED remains on Display back lighting and any power is stopped The two described operations can be set by means of the self automatic shutoff setting refer back to SETTING on the control panel CONTROL TEST BOWIE amp DICK Test The BOWIE amp DICK test is used to check the correct steam penetration into porous loads for example gauzes and fabrics and the air drain system efficiency The test mainly consists of packaging holding a process chemical indicator To correctly carry out the test it is necessary to follow the same procedure enforced in the case o
11. c General dimensions Sterilclave 18 Sterilclave 24 A 640 mm A 700 mm B 445 mm B 445 mm C 390 mm C 470mm Dimensions of the chamber 09 Sterilclave 18 Sterilclave 24 Mod 18 440 x 350 mm D 251 mm D 2 251mm Mod 24 440 x 500 mm E 330mm E2451 mm Dimensions required when the unit is to be built in Sterilclave 18 Sterilclave 24 F 520 mm F 580 mm G 450 mm G 450 mm H 395 mm H 475 mm Dimensions of the trays 04 Sterilclave 18 Sterilclave 24 X 185 mm X 185 mm Y 285 mm Y 420 mm Z 3x50 mm Z 3x50 mm Useful loading dimensions with an empty chamber 09 Sterilclave 18 Sterilclave 24 O 226 mm O 226 mm P 305 mm P 425 mm ATTENTION under any conditions the unit charge should never lean against the chamber 09 walls ACCIDENT PREVENTION COMINOX GENERAL SAFETY CONDITIONS Any operation different from the operating cycle is to be carried out when the unit is cut from the main power supply The main power supply is to be fitted with the required grounding Avoid any unsafe repairing Any repairing is to be carried out with original spare parts only to be fitted according to their specific use Never remove any part from the unit Only authorised and previously trained personnel by COMINOX can remove the exterior protection cover and access the interior parts Nameplates on the unit are not to be removed damaged or
12. many time as required to allow the VACUUM TEST LED to be switched on Press the key START and wait for the TEST conclusion when the following message is displayed on the display VACUUM TEST COMPLIANT Press the key STOP wait for pressure to move back to 0 bar and then open the door Should the message REPEAT TEST be displayed the test will be automatically interrupted Before repeating the test open the door 16 let the chamber 09 completely cool and check that it is perfectly dry Should the VACUUM test be started when the chamber temperature is still higher than 40 C the message COOLING PAUSE is displayed and no cycle can be started To be able to press the key START or to start the TEST wait for the chamber 09 cooling under 40 C TROUBLESHOOTING Page 39 COMINOX SIGNALLING ALARMS Signals and signalling are messages which in the majority of cases ask for a simple correction or control operation by the user Alarms ask for maintenance or inform about the presence of a possible failure When enabled they are displayed on the display followed by a sound running for 30 seconds To reset the signalling or the alarm it is necessary to use one of the access keys 06 and then press the key STOP The COOLING PAUSE and CHECK WATER QUALITY signals are followed by a sound and do not need any reset through the key STOP Signalling It signa
13. na anaa anana nana nana anan an anana asas IER uana Rasa aa ananas aan nas nawan anane 16 Thermal Ee TEE 16 DOS eege EERSTEN tease 17 Environmental conditions and risks eese esee enne eene innen nnn nnne ener nnne enhn ntn en nnns 17 FeSidUal E 17 TRANSPORTATION and PACKAGING sscccccccccsssnnssencceceseesannnnsssessseneennaneenees 18 GENERAL CONDITIONS tee 18 UNPACKING and unit SISANING TT 19 5118 f2 18 TEE 19 INSTALLA Eeer 20 GENERALGONDIHIONS eege 20 SWING EE 20 CONNECTIONS pu ERE 22 EIOCIICAl CONIO CONS ET 22 Walor GOMMOCHON E 22 1 Ee WEE 22 RE EE 22 Waler supply TEE 23 CLEAN WATER TANK MANUAL CHARGE cssanenann eaaa nan nawan nnnnan anana ewan hana usan ananas aa ewan nenen anana eaaa enananene 23 TANK MANUAL DRAIN empero rot a a aaa NE Ng HL want aga Ka cas Na ga ah aa BANG ENEG HING EN Ha ba pan as Gaga naga aa dan ekan 24 INE E RE 24 Ee 29 CONTROL PANEL ski 25 i ee 27 ci izpiMse no lm iaa 27 START UP D 27 epo C gana 27 SENIE sasasi M 28 Preparation of the load to be sterilised esses seien nnns nnn tnnt 29 Selection of the sterilisation cycle eese siiis eene tnnt nennt nna 29 INTRODUCTION es W
14. packed and 75 80 unpacked Delicate hollow loads for example fabrics packed or 75 82 unpacked Unspecific solid and type B hollow instruments infected by 79 85 BSE infectious agents packed or unpacked Unspecific hollow loads for example fabrics infected by BSE infectious agents packed 79 85 or unpacked Solid instruments in stainless 19 19 metal only unpacked Stainless metal type B hollow instruments packed or 64 72 unpacked Hollow loads for example fabrics packed or unpacked 64 71 Solid stainless metal instruments packed or unpacked 59 61 length is lower than 3000 mm L x 3000 mm TYPE B HOLLOW LOADS instruments fitted with an open cavity one side only whose length to cavity diameter ratio accounts for or it is higher than 1 or it accounts for or it is lower than 5 1 lt L D x 5 and whose cavity diameter accounts for or is higher than 5 mm D gt 5 mm or instruments fitted with a cavity on both sides whose length to cavity diameter ration accounts for or it is higher than 1 or it accounts for or itis lower than 10 2 x L D 10 and whose cavity diameter accounts for or is higher than 10 mm D 2 5 mm MAXIMUM TOTAL LOAD WEIGHT the maximum admitted weight for each load described category including the loading support system and its packaging CYCLE TOTAL MAXIMUM TIME the total time an autoclave requires to carry out a complete cycle including cold unit start up room tem
15. the filter from upward check and clean the filter with a compressed air jet or replace it position the new filter Yearly Controls To extend its life it is better to leave the door 16 half opened and not locked through the handle when the unit is not being used Daily check that there are no breaks or dripping inside the workplace which could lead to dangerous slipping Daily At least manually check the chamber seal 31 efficacy and if damaged replace it H Monthly SERVICE page 41 COMINOX STORAGE AND DISPOSAL Unit storage or long term stop Storage only in closed well ventilated rooms under consistent conditions to avoid damaging the unit components especially the electronic components If necessary cover the unit with a plastic layer and fit dehydrated salts NEVER lean any different unit on the packaging and in any case do not pile up more than 4 cases or crates In the case the unit is not used for a long time period it needs to be specifically controlled Ask for the specific instructions to COMINOX or to an AUTHORISED TECHNICAL SERVICE CENTRE When the unit is not used for a long time period completely empty the tanks Disposal and Scrapping ATTENTION COMINOX is not liable at all in the case of damages to the systems used for the unit disposal or used for its operation SERVICE page a 9 SCHEDULED SERVICE TABLE
16. wear any required personal protection means gloves to be protected against cutting or pointed objects or from heat Itis not possible to check training and or train operators working on each single unit according to the operator role within the company each single operator is to be qualified enough and he is liable for any risk depending on his specific activity and job INTRODUCTION COMINOX OPERATING USE It is absolutely forbidden to use the unit or its parts for different reasons and operations from what hereby detailed described It is absolutely forbidden to incorrectly operate the unit or to operate the unit differently from what specified in the operating use chapter The unit was designed to STERILISE SURGICAL DIAGNOSTIC OR MEDICAL INSTRUMENTS IN AN AUTOCLAVE SUCH AS SCISSORS CUTTERS KNIVES GAUZES ETC The material and composition of any product to be sterilised in an autoclave can be varied stainless steel glass rubber plastics cotton pads fabrics in general Products to be sterilised in an autoclave are divided into solid instruments for example knives hollow instruments for example surgical suction cannula and porous loads for example fabrics and gauzes The most suitable sterilising cycle is to be chosen following instructions in the Cycle sterilising material Table It is also possible to sterilise LIQUIDS for example culture soils through the cycle SPECI
17. 16 internal disk the seal is fitted to Possibly if damaged replace it refer back to CLEANING and CONTROLS in the chapter MAINTENANCE e Carry out a VACUUM test to check a possible pressure loss e Check the machine positioning once more refer back to INSTALLATION e Check that total maximum load weight refer back to OPERATION was not overcome INSUFFICIENT STEAM It informs that a small steam loss or unsaturated steam prevented a correct tempe rature increase within the chamber 09 during pressurising BEES MAEN e follow the instructions specified in the case of the alarm INSUFFICIENT STEAM e If the alarm is still repeatedly on it could depend on a failure of the heating electric circuit address a service centre It informs that temperature inside the chamber 09 overcame 150 C ALARM e if the alarm is still on address a service centre OVER TEMPERATURE It informs that during a vacuum peak in the vacuum pulse phase pressure was not reduced to the programmed value e follow the instructions specified in the case of the alarm INSUFFICIENT VACUUM e check that the total maximum load weight refer back to OPERATION was not overcome ALARM FRACT VACUUM TROUBLESHOOTING Page 37 COMINOX It informs that during pre vacuum pressure did not reach the correct programmed value e check the chamber seal 31 ef
18. AL Taking into account that the SPECIAL cycle is not covered by technical information and requirements in the EN13060 standard as well as that LIQUIDS are not considered within the standard scope of the standard such a cycle is protected by an access key both in case of selection and operating parameter change Always check that the thermal resistance value of the product to be sterilised is higher than the programmed cycle temperature value mainly taking into account that COMINOX is liable for the maximum temperature to be measured in chamber 09 under consistent operating conditions which accounts for PROGRAMMED STERILISING TEMPERATURE 3 C in compliance with pr EN13060 instructions Minimum temperature sterilising temperature 0 C maximum tem perature sterilising temperature 4 C Strictly comply with instructions and information relating to sterilisation specified by the manufacturer of any material to be sterilised Instruments and fabrics to be sterilised MUST be accurately washed rinsed with water with no additives and dried The loading support too is to be perfectly dry Comply with the maximum total load weight Use the loading support system supplied by COMINOX refer back to Preparation of the load to be sterilised Should different loading supports be used from the standard supplied loading support steam penetration and drying performances validated during certification tests are not
19. BY OPERATION race 28 f IC COMINOX From the STAND BY conditions it is possible to press the key DISPLAY thus consecutively displaying Temperature temperature ll C relative pressure TOTAL CYCLE N aborted cycles included PRESSURE date and hour REL bar From such a condition it is possible to move to sterilisation refer back to the TOTAL CYCLE N sterilisation cycle start up DATE TIME Settings xxlyylzz hh mm Keep the key DISPLAY pressed for 5 seconds the following message will be displayed as far as the programmed language is concerned LANGUAGE Press the key A or when the language is to be modified ENGLISH Press the key START to confirm the choice and the following message will be SETTING Press the key A or to increase or reduce the blinking value Press the key START to confirm the chosen value and automatically a different value starts blinking Continue and confirm all the different values until once confirmed the minute value xxlyy zz hh mm the following message will be displayed SELF CHARGE 0 Press the key START to confirm the water self charge exclusion OPTIONAL in the case of B and S models if available or if manual load is required or press the key Z to change the information in SELF ER and finally confirm pressing the key START to set the water
20. EEN 8 14 15 16 29 33 05 metering funnel esses 8 21 23 06 access keys ssssssssssl 8 26 29 34 35 07 envelope holder 14 29 08 tray support ssssssssssssseeeeeeene 8 14 21 29 09 chamber9 13 14 15 16 21 27 29 31 32 34 35 36 37 40 10 clean water tank 14 18 22 23 24 25 37 40 11 waste water recovery tank14 18 22 23 24 35 40 12 safely valve ssssseee eee 14 38 13 cut out switch eese 27 33 34 37 TNI E n 23 15 air sterilising lier 31 37 38 40 16 door16 18 21 24 25 27 29 32 33 34 35 36 37 40 17 safety thermostat essere 16 18 printing door 32 33 19 coil covering Org 21 20 waste ter 21 37 40 21 chamber Grofe 21 22 adjustable feet 21 23 lifting belts sssssssssssssssees 18 19 24 clean water op 24 25 waste water Ian 24 26 Drinfer anana sagara naiona 8 26 28 32 33 35 27 level testing pipe 400rrssanraanananaannnnanaae anana 8 21 28 grid EE 8 21 29 water self charge 8 14 22 35 38 30 direct waste dran 8 14 22 31 chamber seg 36 37 40 G27 DT EE 37 T2 23 Page 4 26 OPTIONAL INTRODUCTION 9 lt o o Graphical reference representation Mod 18S 18B 18BHD 12 11 07 OPTIONAL
21. EST B amp D VACUUM TEST wr KEYS to switch on and off the cycle The START cycle is sometimes used as an ENTER key The STOP key is also used as an emergency stop key START STOP KEYS to increase or reduce a data to be programmed on the display or to scroll up and down the menu The key is used to stop a displayed message on the display during sterilising or drying on the specific time at the end or on temperature and pressure The key is used to move paper onward in STAND BY on the printer 26 OPTIONAL if enabled JACK plug for the access keys 06 Supplied keys are used to enforce the programme selection on each single unit WHITE KEY it allows to select any cycle and access the SPECIAL cycle data selection and programming What is more if a printer 26 is fitted OPTIONAL such a key allows to print data any time and minutes and not only at any cycle phase change BLACK KEY it is used to select any cycle with the exception of SPECIAL cycle Both keys can be used to stop any ALARM during the cycle The alarm is stopped pressing the key STOP OPERATION Page 27 f COMINOX GENERAL CONDITIONS It would be extremely important to extensively know the available INSTRUMENTS to avoid damages to the unit and to the operator Therefore itis suggested to carefully read instructions in the operating instructions and in case of doubts or non compliance among the different instr
22. LAYED ON THE DISPLAY ss 0000000 o mmm hene e Check that the plug is live the correct connection of the supply cable 03 socket and its connection to the unit e Check fuses 32 and that the cut out switch 13 is pressed on the I position e Check the chamber seal 31 efficiency and cleaning as well the door 16 disk STEAM LOSS where the seal is fitted to and possibly if damaged replace it refer back to the FROM DOOR MAINTENANCE chapter e Address a technical service centre to ask for the door 16 closing adjusting At the end of the cycle there is still water inside the chamber 09 e check cleaning as well as the correct waste filter 20 positioning refer back to the chapter MAINTENANCE e control the machine positioning once more refer back to chapter INSTALLATION WATER IN THE CHAMBER AFTER THE CYCLE Drying after a cycle is not satisfactory e check that the selected cycle complies with the material type to be sterilised refer back to OPERATION e check that the total maximum load weight was not overcome refer back to OPERATION e check that the load was correctly prepared refer to chapter OPERATION PREPARATION OF THE LOAD TO BE STERILISED e check the air sterilising filter 15 and possibly replace it refer back to the chapter MAINTENANCE e Follow the instructions in the case of the previous problem INSATISFACTORY DRYING TROUBLESHOOTING Page 38 o COMINOX Pres
23. RT to confirm the selection the following message will be automatically displayed press the key A or 7 if the sterilising time is to be modified Press the key START to confirm the selection Automatically it will be possible to leave the previously chosen programming if LIQUIDS sterilisation setting was selected But if such a setting was excluded the following message will be Press the key A or 7 if the vacuum pulse number is to be modified Press the key START to confirm the selection the following message will be automatically displayed Press the key A or 7 if the drying lasting time is to be modified or to cut it off setting the value 0 Press the key START to confirm the selection Automatically it will be possible to leave the previously chosen programming and it will be possible to move back to the message Such a programmed SPECIAL cycle will be saved and used with the same information until itis newly programmed FIRST CYCLE Start up In stand by the following message is displayed on the display alternating every 2 seconds with the message relating to the selected cycle name Check that The selected cycle is the required cycle The load was correctly fit in The MIN LED on the control panel is off The door 16 is perfectly closed The printer if present and correctly set refer back to OPERATION Settings holds paper and its door and the external inspection door 18 ar
24. The present document belongs to COMINOK It can not be copied or sold to anybody without COMINOX informed approval INTRODUCTION Page _ COMINOX COMINOX Via Vigano 7 20048 CARATE BRIANZA Milano Italy OPERATING AND Phone 39 0362 91 23 12 MAINTENANCE INSTRUCTIONS Fax 39 0362 90 09 40 e mail comm cominox it AUTOCLAVE Sterilizer STERILCLAVE 18 24 Document code UCG08824 FOREWORD The present operating instructions are integral to the unit They are to be kept within reach and constantly used by people profiting and operating the unit itself The operating instructions are always to come with the unit when the unit is sold to a different user too Any operator is liable to read the operating instructions and strictly comply with its instructions and information as COMINOX is not liable at all for any damage to people or things or to the unit should the operator not comply with the hereby described general operating conditions Such instructions are confidential and the customer is liable not to disclose any information to third parties What is more such operating instructions and its annexes can not be changed tampered modified violated copied or sold to anybody without COMINOX approval INTRODUCTION ea COMINOK INDEK INTRODUCTION E 1 FOREWORD E 1 INDENK E 2 Fieferences numerical E E 3 Graphical reference represen
25. UMENT SCOPE The operating instructions OPERATING AND MAINTENANCE INSTRUCTIONS are only to be considered a reference to safely operate the unit or to carry out any maintenance as to keep the unit under consistent general conditions Any professional working on the unit is liable for reading the operating and maintenance instructions they are to be informed on residual risks depending on the unit operation or sterilised products INTRODUCTION ea W IC COMINOX Annexe list STANDARD Supply Besides the operating and maintenance instructions the unit comes with MODEL N 18S 18B 18BHD 24S 24B 24BHD Guarantee certificate 1 e e e EC Conformity declaration 1 o e Tray handle 01 1 e e e Waste pipe 02 1 e o e Level testing pipe 27 1 e o 6 Grid seal 28 1 e e amp Supply cable 03 1 e o o Trays 04 3 o e e Tray support 08 1 e e e Metering funnel 05 with cover 1 e e e Access keys 06 2 e o o Printer 26 1 Optional Optional Optional Water self charge 29 1 Optional Optional d Direct waste drain 30 1 Optional Optional e PERSONNEL DEMANDED QUALIFICATIONS Operators in charge of the unit operation and maintenance are to be trained aware and informed of any activity and skilled enough to correctly interpret what specified in the present operating instructions and to provide for safe and accurate controls Operators directly working on the unit are to
26. ank 10 until the MAX LED switches on refer back to CLEAN WATER TANK MANUAL LOADING The clean water tap 24 is used to empty the clean water tank in case of maintenance or transportation refer back to chapters TRANSPORTATION and MAINTENANCE and it is only used under such conditions BUILT IN SETTING Should the unit be fitted to a built in unit or with a different rack it is necessary to comply with ANY previously specified instructions in the case of the normal installation what is more comply with any built in distances refer back to general sizes comply with the correct unit aeration take the unit heat emissions into account refer back to the technical feature table provide for the door 16 opening provide for any routine maintenance never damage the unit provide for any demanded room to fit in any water supply connection fitting D INSTRUMENTS zs COMINOX CONTROL PANEL A 134 Bo 3 m S DOO Maximum clean water tank 10 LED MAX Minimum clean water tank 10 LED MIN a COMPLETE CYCLE LED it switches on at the CYCLE COMPLETE together with READY the message on the display Unit drying LED the led blinks during the drying process DRYING E Locked door LED the led can be switched on when the unit is ON or OFF In both DOOR LOCKED cased the door 16 is closed and locked Heating unit LED when the led is
27. blem be still not solved address a COMINOX AUTHORISED SERVICE CENTRE The load in the autoclave during the cycle interrupted by the alarm is to be considered NON STERILE Description e Remedy It informs that distilled or demineralised water is missing in the clean water tank 10 ALARM TROUBLE INSUFFICIENT T WATER LEVEL e l the alarm is triggered when the cycle is started up fill the tank refer back to SELF CHARGE and CLEAN WATER TANK chapter SETTING e if the alarm was displayed during the cycle fill the tank and move forward according to the instructions given in the case of INSUFFICIENT STEAM It is enabled in STAND BY refer back to CHECK WATER QUALITY chapter INSUFFICIENT SIGNALLING WATER QUALITY It informs that water conductivity value overcame an acceptable value e Change the cartridge of the fitting for mains water demineralisation SPEEDY WATER It informs that the necessary time was overcome to recover the correct water level ALARM within the chamber 09 e Check once more the machine position refer back to the INSTALLATION chapter CHAMBER LEVEL It informs that the chamber 09 is overheated with the consequent safety thermostat operation 17 e Address a technical service centre ALARM TRIAC It informs that steam or over heated steam is coming out from the chamber 09 e Check the efficiency and cleaning of the chamber seal 31 as well as the door
28. d NOTES CYCLE N sterilising cycle targeted to unpacked solid instruments only CYCLE S1 sterilising cycle targeted to packed and unpacked solid instruments CYCLE S2 sterilising cycle targeted to packed or unpacked solid instruments type B hollow or porous loads CYCLE B sterilising cycle targeted to packed and unpacked solid instruments type A typeB hollow or porous loads Double packaging too TYPE A HOLLOW LOADS instruments fitted with an open cavity on one side only whose length to cavity diameter ratio accounts for or it is higher than 1 and it accounts for or it is lower than 750 1 lt L D lt 750 whose cavity length is lower than 1500 mm L lt 1500 mm Instruments fitted with an open cavity on both sides whose length to cavity diameter ratio account for or it is higher than 2 and it accounts for or it is lower than 1500 2 lt L D x 1500 whose cavity INTRODUCTION rt W IC COMINOX Cycle sterilising material table Mod 18S 24S CYCLE Max weight Minimum time Maximum time Total load Total cycle Total cycle Material to be N S2 S2 N S2 S1 kg Minutes Minutes sterilised in an 121 C 121 C 134 C 134 C 134 C 134 C Models Models Models autoclave 18 24 18 24 18 24 QD pes Qe Qs sls s s s Solid instruments in rubber plastics glass only unpacked 29 29 Type B hollow instruments in rubber plastics
29. dirtied They are to be kept clean and perfectly readable Information in the present operating instructions do not replace any safety instructions or technical data to be followed during installation and operation on the unit itself nor any safety standards in force in the installation country as well as any other common sense rule The unit is to be cleaned using suitable means and detergents which are not affecting the unit parts It is absolutely forbidden to clean or wash the unit with water jets Never lean liquid containers onto the unit upper portion or in the above shelves A possible leakage or spillage inside the electric installation can lead to a short circuit Never lean onto the door 16 Thermal danger Interior parts of the door 16 and of the chamber 09 can reach extremely high temperatures Never touch the heated surfaces if not already cooled and always wear the supplied protection gloves The same applies when a load is to be removed from the sterilisation chamber To remove trays 04 holding the load always use the tray handle 01 Never leave the tray handle inside the sterilisation chamber Within the sterilisation chamber temperature is controlled through a thermostat which switches on in case of overheating The safety thermostat 17 is to be manually reset ACCIDENT PREVENTION Page 17 IC COMINOX Noise The sound pressure level noise detected within suitabl
30. dress a technical service centre and meanwhile set the SELF AUTOMATIC CHARGE refer to SETTINGS OPERATION chapter and enforce a CLEAN WATER MANUAL CHARGE refer to chapter INSTALLATION to keep on using the autoclave Steam loss from the safety valve 12 e if the autoclave is installed in a place whose altitude is higher than 1500 meters on the sea level address a technical service centre to fit a suitable safety valve refer to chapter TECHNICAL FEATURES e if the altitude is lower than 1500 meters on the sea level and the problem can not repeatedly be solved address a technical service centre to check the valve efficiency Alarm list codes Code Alarm type 00 TRIAC ALARM 01 OVER TEMPERATURE ALARM 02 HEATING ALARM 03 INSUFFICIENT STEAM 04 INSUFFICIENT WATER LEVEL 05 free 06 MAXIMUM USED WATER LEVEL 07 OPEN DOOR OR NOT LOCKED 08 CHAMBER LEVEL ALARM 09 MANUAL STOP 10 INSUFFICIENT VACUUM 11 FRACTIONED VACUUM ALARM 12 free 13 LEVEL PROBE ALARM 14 PRESSURISATION ALARM 15 STERILISATION TEMPERATURE RANGE OVER ALARM 16 STERILISATION TEMPERATURE RANGE UNDER ALARM 17 PRINTER NOT READY 18 POWER FAILURE STEAM LOSS FROM SAFETY VALVE SE R VI CE Page 39 LJ COMINOX GENERAL CONDITIONS Maintenance is to be carried out when the unit is not working duly cut from the main power supply if not differently specified Avoid any unsafe repair Repairs are to be carried out with orig
31. e area on the workplace is to be lower than 70dB A Environmental conditions and risks The unit can not be installed outside or under unfavourable weather conditions sun rain snow wind COMINOX is not liable for any material disposal required for the unit operation and production such as plastic packaging or waste water which could be bacterially infected and the customer is personally liable according to any regulation in force in the different countries for disposing of such substances which are potentially harmful for the environment The same applies in the case of the unit scrapping The unit was designed in compliance with good practice and standards relating to energy saving avoiding wastes and useless dispersions Residual risk table RISK ANALYSIS AND DESCRIPTION Losses leakages or blow up leading to further risks such as slipping short circuit or pollution SUGGESTED REMEDY Accurately clean the workplace Waste water drain which is infected by virus bacteria pathogenic micro organisms Dispose according to the regulations in force Water and or gas steam fumes when opening the door 16 Always carefully check whether the load complies with cycle temperatures and pay due attention when opening the door Surfaces excessively hot mainly in the sterilisation chamber 09 and at the solenoid valve or interior part level Wear protection gloves and or never touch any interio
32. e well closed Press the key START and on the display the following messages will be sequentially displayed relating to the selected cycle The DOOR LOCKED LED will be switched on signalling until the end of the cycle that the safety door locked block is set The LED HEATING ON LED will be switched on during heating The pre vacuum phase is started during which air is removed from the chamber until reaching the programmed vacuum pressure Then the vacuum pulse phase follows during which one or more steam peaks will follow one another followed by the same number of vacuum pulse peaks according to the demanded steam penetration for the specific load to be sterilised during the selected cycle Then the pressurisation phase follows during which pressure and temperature values are increased until they reach the required sterilisation temperature Finally sterilisation starts the relating message is displayed alternating every 2 seconds with the message relating to the required time until the end of sterilisation f TEMPERATURE C STAND BY CC bar STAND BY WITH WITHOUT DRYING PRE VACUUM OPERATION Page 31 f IC COMINOX During such a phase it is possible when pressing the key A to stop displaying information relating to temperature and
33. f any other sterilising cycle without loading the unit and follow the hereby specified instructions Switch the unit on by means of the cut out switch 13 and follow the same procedu re described in the case of the START UP Open the door 16 Fitin a BOWIE amp DICK test packaging to the first trays 04 the lower tray Close the door Fit in the supplied access key 06 in the specific socket Press the key CYCLES as many time as required to switch the BOWIE amp DICK TEST LED on Press the key START and wait for the test conclusion as specified on the display with the information CYCLE COMPLETE N OPERATION Page 34 COMINOX Press the key STOP and wait for the unit pressure to move back to 0 bar then open the door 16 Remove the tray holding the TEST and check the result following the manufacturer s information VACUUM Test The VACUUM TEST is used to check the efficacy of the vacuum pump and the correct and perfect tightness and operation of the hydraulic circuit As to correctly carry out the test it is necessary to follow the same procedure as a normal sterilising cycle without charging and loading the unit as follows Switch the unit on by means of the cut out switch 13 and follow the same procedu re described in the case of START UP Close the door 16 Fit in one of the supplied access keys 06 in the special socket Press the key CYCLES as
34. ficiency and cleaning as well as the internal door 16 disk the seal is fitted to and possibly if damaged replace it refer back to the chapter MAINTENANCE e check the waste filter 20 cleaning and correct positioning refer back to the chapter MAINTENANCE ecarry out a VACUUM test to check the presence of possible pressure losses e check that ventilation air vents are clear refer back to BUILT IN SETTING INSTALLATION chapter and ask a technician to check the efficiency of internal fans ALARM INSUFFICIENT VACUUM STERILISATION TEMPERATURE RANGE OVER TEMPERATURE It informs that during sterilisation temperature within the chamber 09 overcame the forecast value by the sterilisation temperature range e if the alarm is repeatedly on address a technical service centre and ask to check the temperature sensor and pressure adjusting ALARM STERIL TEMP RANGE UNDER STERILISATION TEMPERATURE RANGE UNDER TEMPERATURE It informs that during sterilisation temperature within the chamber 09 is under the minimum forecast value by the sterilisation temperature range e check that the total maximum load weight refer back to OPERATION was not overcome ALARM STERIL TEMP RANGE OVER It informs about a possible problem at the levelling probe level ALARM e Empty and fill the clean water tank 10 when the unit is off and idle LEVEL PROBES NO MESSAGE IS DISP
35. guaranteed Follow instructions as far as correct packaging is concerned and only use packaging materials compliant with EN868 standard The unit can NOT be operated or installed in specific areas at the presence of gas or any other explosive volatile substance INTRODUCTION rave 10 _ IC COMINOX Cycle sterilising material table Mod 18B BHD e 24B BHD CYCLE Max weight Minimum time Maximum time Total load Total cycle Total cycle Material to be N B B N B S1 kg Minutes Minutes terilisad inan gt Models Models Models 0 OJ 0 sterilise a 121 C 121 C 134 C 134 C 134 C 134 C 18 24 18 24 18 24 autoclave B B B BHD B BHD B BHD B BHD a so o Solid instruments in rubber plastics glass only 30 29 28 unpacked Type A hollow instruments in rubber plastics packed and 68 77 71 unpacked Delicate hollow loads for example fabrics packed or 77 87 79 unpacked Unspecific solid and type A hollow instruments infected by BSE infectious agents packed or unpacked 75 85 80 Unspecific hollow loads for example fabrics infected by BSE infectious agents packed or unpacked 85 95 88 Solid instruments in stainless metal only unpacked 21 20 19 Stainless metal type A hollow instruments packed or unpacked i 60 71 66 Hollow loads for example fabrics packed or unpacked 69 81 73 Solid stainless metal instruments packed or 48 54 49 unpacke
36. hamber with a cloth fit the tray support 08 and at the same time the coil covering grid 19 to be tighten thanks to the opposite screw Pay attention to the grid sea 28 INSTALLATION COMINOX CONNECTIONS Electrical connections When connecting the unit to the power supply the power supply cable 03 is fitted into a suitable socket refer back to the GENERAL CONDITIONS and technical feature Table Water connection An option available on BHD models and to be fitted on demand OPTIONAL to all the other units When such an option is fitted it is possible to avoid stopping the unit to fill the clean water tank 10 and to empty the waste water recovery tank 11 1 Water self charge It is an alternative configuration to clean water tank 10 manual charge refer back to CLEAN WATER TANK MANUAL CHARGE A FROM AN EXTERNAL TANK maximum height different from 1 meter the water self charge 29 pipe can be directly fitted to a demineralised or distilled water tank easily found on the market or a tank of distilled water produced for example by means of the COMINOX DISCOM accessory for the tap water distillation B FROM WATER MAIN It can be connected to the mains water demineralisation system COMINOX SPEEDY WATER In the case of both configurations A and B it is necessary to set Self charge 1 through the control panel The B configuration is only to be fitted in by an authorised and qualified tech
37. he door 16 Possible sterilising chemical indicators are to be fitted in the load on the trays 04 or inside any packaging Selection of the sterilisation cycle As to select one of the sterilisation cycles available and described in chapter OPERATION it is enough to use one of the two access keys 06 To select the SPECIAL cycle or to re program such a cycle refer back to the chapter OPERATION it is necessary to use the WHITE key Fit the access key referring to the selected cycle into the JACK plug press the key CYCLES to select it SPECIAL cycle programming After carefully reading any information relating to the SPECIAL CYCLE in the chapter OPERATION and fitting the WHITE access key into the JACK plug press the key CYCLES as many time as required until the SPECIAL CYCLE LED switches on Once the LED is on press the keys A and x7 and keep them pressed for 5 seconds until the following message appears on the display Press the key START to confirm excluding the sterilisation LIQUID setting refer back to the chapter OPERATION or press the key A to change the information in And confirm simply pressing the START key LIQUIDS 1 SI 0 LIQUIDS 1 SI 1 OPERATION Page 30 m COMINOX Once the information confirmed the following message will be automatically displayed press the key A or x7 if the sterilising temperature is to be modified Press the key STA
38. inal spare parts only The operator must timely inform about any possible failure dripping wear breaking and so on COMINOX is not liable at all in the case the specified maintenance plan is not correctly enforced refer to the SCHEDULED MAINTENANCE table as well as if maintenance is carried out by unskilled personnel or procedures suggested by the company own personnel are not enforced SERVICE rage 40 IC COMINOX Cleaning Daily clean the sterilisation chamber 09 and the internal door 16 disk N Daily Use a cotton cloth soaked with alcohol or distilled water During cleaning it is advisable to wear protection gloves In case of scales use stainless steel polishing products then remove any product residue with a degreaser and rinse with plenty distilled water Daily clean the workplace checking that there is no clogging at the unit ventilation NN Daily and aeration level Clean the clean water tank 10 and waste water recovery tank 11 Empty them at AN Every Six least every six months and then recharge the tank with clean water refer back to the d months supply water table Should the unit not be used for a longer time period leave the tanks empty Filters Every Six Replace the air sterilising filter 15 at least every six months months At last yearly check the waste filter 20 efficacy following the hereby described pro cedure open the door 16 remove
39. ineralised water refer back to the Water supply table and technical feature table as far as quantity is concerned If charge is carried out when the unit is off or in STAND BY MIN and MAX LEDS on the control panel allow to check the water level a sound signal lasting for 2 seconds is heard followed by the MAX LED switching on it means that the tank is full Top up any time the MIN LED is on before starting any cycle As to provide for the best operating range in any case fill in the tank until the MAX LED switches on and completely empty the waste water recovery tank 11 refer back to the TANK MANUAL DRAIN INSTALLATION Page 24 COMINOX TANK MANUAL DRAIN When the DIRECT DRAIN refer back to the WATER SUPPLY is not present or it is not connected it is necessary to connect the waste water recovery tank 11 manual drain any time when starting a cycle the message MAX WASTER WATER LEVEL is displayed on the display refer back to ALARM SIGNALLING Connect the supplied waste pipe 02 to the waste water tap 25 after placing a sufficiently big container under the other end refer back to the Technical feature table to recover water Once the water tap is opened possibly present water in the waste water recovery tank 11 will start to outflow As to be self sufficient and provide for an automatic operating range it is necessary to completely empty the tank and completely fill the clean water t
40. ls that the chamber 09 temperature is not suitable to start the unit up or to COOLING keep the cycle running refer back to chapters START UP FOLLOWING PAUSE STERILISATION CYCLES and VACUUM TEST The STAND BY is enabled when the water self charge 29 is programmed in the B CHECK WATER configuration from the water supply refer back to chapter CONNECTIONS QUALITY It signals that the water conductivity value inlet through the demineralisation external system overcame the optimum level but it is still acceptable a cycle can be started but it is advisable to follow instructions in the INSUFFICIENT WATER QUALITY alarm refer back to chapter ALARMS AND TROUBLESHOOTING The STAND BY is enabled when the water self charge 29 is programmed refer CHECK back to chapter CONNECTIONS If the A configuration is set it is necessary to fill or replace the distilled or demineralised water tank If B configuration has been installed check whether the mains water tap is open and the mains pressure ranges between 1 and 4 5 bar SELF CHARGE It signals that the waste water recovery tank 11 is full The signal enables the cycle start up Empty the tank refer back to chapter TANK SELF DRAIN in the chapter INSTALLATION If the direct waste discharge 30 is programmed refer to chapter CONNECTIONS check the correct connection and that the pipe is not bent or clogged MAX USED WATER LEVEL It signals that the door 16 was not co
41. nician Check that the water quality complies with water supply table 2 Direct drain An alternative configuration to the waste water recovery tank 11 manual drain refer back to TANK MANUAL DRAIN Connect the tube fitted with a male rapid connection to the female connection of the direct waste drain 30 after fitting the other end of the tube to a suitable drain Once the pipe connected water present in the waste water recovery tank 11 will start to outflow Mod 18 16 03 Min 3 bar Max A 4 bar 30 INSTALLATION zm IC COMINOX Water supply table water supply Evaporation residues lt 10 mg l Silicon dioxide SiO 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 with the exception of iron cadmium lead lt 0 1mg l 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 colourless clean with no sediments Hardness lt 0 02 mmol l CLEAN WATER TANK MANUAL CHARGE When not present or programmed the WATER SELF CHARGE refer back to WATER SUPPLY or in any case the first charge of the clean water tank 10 is manual only Loosen and remove the plug from the filler 14 fit in the supplied metering funnel 05 and pour in suitable distilled or dem
42. on one of the heating coils is on HEATING ON Am KEY for the display back lighting OFF the same key in the STAND BY condition DISPLAY allows to visually display data referring to temperature relative pressure number of completed cycles date and hour When the key is kept pressed for 5 seconds it is possible to set in a series of parameters such as language hour and date self charge printer operation self stop D INSTRUMENTS raoe 26 COMINOK Unit STAND BY KEY it is off during any cycle ON OFF Cycle shift KEY When pressing the key it is possible to choose the demanded cycle refer back to the cycle sterilised material table CYCLES 121 C cycle LED for delicate solid products UNPACKED only 121 C UNWRAPPED Qo 121 C cycle LED for porous and hollow delicate products packed and 121 C unpacked POROUS HOLLOW 134 C cycle LED for porous and hollow solid products which enter in contact 134 C PRIONS with infective BSE agents PACKED or UNPACKED POROUS HOLLOW no 134 C cycle LED for SOLID products only UNPACKED 134 C UNWRAPPED 134 C cycle LED for porous or hollow solid products packed or unpacked 134 C POROUS HOLLOW 134 C cycle LED for solid products packed and unpacked 134 C WRAPPED x SPECIAL LED cycle to be programmed by the user by means of the special SPECIAL access key Em Bowie amp Dick TEST cycle LED VACUUM TEST cycle LED BOWIE amp DICK T
43. perature and maximum load CYCLE TOTAL MINIMUM TIME the total time an autoclave requires to carry out a complete cycle including hot start up one cycle after the other and minimum load load support only INTRODUCTION Page 12 B m COMINOX UNWRAPPED NON IMBUSTATO P mbar Absolute Mad d mm 134 C 4 188 245 121 C 15 A N Room pressure HOLLOW POROUS CAVI POROSI P mbar Absolute Mod 134 C 4 18S 3100 248 121 C 15 1000 300 PRIONS P mbar Absolute Mad 134 C 18 188 3100 p 248 Room pri ri 1000 oom pressure 300 WRAPPED IMBUSTATO P mbar Absolute Mod 134 C 4 185 30 I 245 Room pressure 1000 300 UNWRAPPED NON IMBUSTATO P mbar Absolute Mod El ham 134 c 4 18 B 18 BHD 24 B 24 BHD 2300 2100 121 C 15 TUN 1200 1000 Room pressure 200 HOLLOW POROUS CAVI POROSI P mbar Absolute Mod 134 c 4 18B 3100 2100 1000 200 180 150 PRIONS P mbar Absolute Mod 134 C 18 18 B asma ima pan 18 BHD 24B 24 BHD Room pressur 3000 oom pressure 200 180 150 WRAPPED IMBUSTATO P mbar Absolute Mod 134 C 4 18B Eve ree 18 BHD 24B 24 BHD Room pressure 1000 300 20 pDw INTRODUCTION page 13 W
44. pressure or to time required to come to the end of sterilisation When finally pressing the key A once more it is possible to start alternating displaying the different information TIME TO THE END At the end of sterilisation drain follows where steam outflows from the chamber 09 depending on the pressure difference If the cycle is set to a drying time 0 when pressure reaches a value lower than 0 2 relative bar the following message will be displayed CYCLE COMPLETE If the selected cycle is a SPECIAL cycle programmed for LIQUIDS at the end of sterilisation the following message will be displayed refer back to SPECIAL CYCLE Pressure will start dropping to the natural cooling until a value lower than 0 relative bar is reached and then on the display the message CYCLE COMPLETE will be displayed f drying is set after draining vacuum drying starts The DRYING led starts blinking and the following two messages are displayed on the display alternatively every two seconds In such a phase too it is possible to stop displaying any information refer back to the sterilisation phase The vacuum pump keeps on working throughout all the scheduled time Under such conditions sterile air is let in through the air sterilising filter 15 At the end of drying the vacuum pump stops pressure moves back to 0 bar and the led READY switches on On the display the following mes
45. r part if not duly AUTHORISED Chamber tightness when the unit is off no animal or vegetal micro organisms can survive inside the chamber Never allow vegetal or animal micro organisms to enter the chamber Poor cleaning or nameplates and or instrument abrasion can lead to mistakes and consequent dangers Accurately clean with suitable products instruments and nameplates Poor personnel training Ask for an additional training course to COMINOX TRANSPORTATION and PACKAGING page 18 COMINOX GENERAL CONDITIONS The unit is generally protected by a packaging consisting of a small pallet and a cardboard box Lifting and transportation are to be carried out by qualified personnel only Weights and sizes are specified in the chapter TECHNICAL SPECIFICATIONS Mod 18 Mod 24 The unit transportation mainly on road is to be carried out profiting from suitable transportation means and paying due attention to protect the different parts mainly electronic from bumps crashes moist vibrations and so on COMINOX refuses any unit to be repaired with full tanks Refer back to the OPERATION chapter manual tank drain Heavy part and equipment handling and or lifting more than 30 Kg is to be carried out only with suitable lifts In the case of manual lifting at least two people are required using the special supplied ifting belts 23 and following the co
46. rinting door 18 eier 32 33 coil covering grid 19 sssranananaannnanneeennnnnanannnnnnne een 21 cut out Switch 13 27 33 34 87 S D safety thermostat 17 s sssasarasan sengara aga agi ga rawana ana sangang 16 safety valve 17 14 38 direct waste drain 30 iiseerereeeeeererereeerse 8 ET 13 dismantling EE 7 sterilise EEN 9 door 16 Supply cable E 8 22 37 16 18 21 24 25 27 29 32 33 34 35 36 37 40 T E tray handle 0 8 16 use c 26 tray support 08 ENEE 8 14 21 29 envelope holder 07 sss 14 29 tfayS OF teen ege 8 14 15 16 29 33 environmental conditions 7 V F VACUUM TEST RE 34 TE aa aan ga E E ada A Ka 23 Tele EE a W KI 37 waste filler 20 ees 21 37 40 G waste pipe mmimimmiimnm mi i mas 8 24 f waste water recovery tank 1114 18 22 23 24 35 40 ao hais E 8 21 waste water tap 28 24 H water self charge 29 8 14 22 35 38 weather conditions esse 17 heat emission essssssssssssssses seinen ith anane AR TEE 14 heat emissions nenen ea naen nenen a anane eee 24 heated surfaces seeerarenenen areren en eene 16 l incorrectly operate essere 9 K key 90665506 saeka ineasa nad gegaen kajana as aha gan aa nnn 33 L level testing pipe 27 asirsrauauwanee anane nnne nane en anae 8 21 lifting belts 27 18 19 INTRODUCTION
47. rrect procedure as specified in the regulations in force TRANSPORTATION and PACKAGING rage 19 IC COMINOX Unpacking and unit cleaning They are to be removed by special means and not left within reach especially children The same applies to any device used to remove packaging scissors hammers tongs knives etc Any packaging part is to be removed and disposed according to the regulations in force in each single country It is advisable to keep both the packaging and the ifting belts 23 within reach for any possible future unit handling First of all once opened the packaging thoroughly check pieces and parts the unit consists of Check that any demanded part is present as well as its general conditions refer back to SUPPLY CONDITIONS Remove any supplied part opening the door 16 refer back to OPERATION The load supporting system and the autoclave external surface are sometimes protected by a plastic layer remove it before any operation Storage Should the unit not immediately used or removed from the installation site it is to be stored in a dry place and duly protected When the unit is to be covered with plastic layers fit in silica get or any dehydrating system inside the packaging Ideal environmental conditions for storage are temperature with empty installations 25 C 40 C maximum relative humidity 9096
48. rrectly closed DOOR OPEN OR Well close the door before starting a cycle up NOT LOCKED It signals that during the cycle start up the STOP key was pressed before the natural ALARM cycle conclusion Taking into account that the load IS NOT STERILE re start a new MANUAL STOP sterilisation cycle It signals that during a cycle the unit was cut from the main power supply On the display when the unit is connected to the power supply the message relating to the missing voltage is displayed Should the unit be cut from the main power supply when the alarms are on the last alarm will be displayed on the display POWER FAILURE A cycle is started up when the printer 26 OPTIONAL is fitted and set It signals that paper is missing or that the printer door is not perfectly closed Refer back to the PRINTER chapter and follow the specified instructions PRINTER NOT READY It is activated in STAND BY mode at the end of a cycle or soon after the autoclave switching on and signalises that the door lock release operation is in progress Wait until the LED DOOR LOCKED switches off without trying to open the door WAIT FOR DOOR LOCK RELEASE TROUBLESHOOTING Page 36 o IC COMINOX Alarms and troubleshooting Once the alarm reset pressing the key STOP and if possible the problem which triggered the alarm solved start a new cycle Should the pro
49. sage is deplaved 1011 Sterilising cycle stop CYCLE COMPLETE Should a cycle be stopped with a packed instrument load in even when sterilisation is concluded sterility is not guaranteed as the load is not dry If not immediately re used instruments are to be sterilised once more OPERATION COMINOX Press the key STOP READY and DOOR LOCKED LEDS switch off and it is possible to move back to the STAND BY mode Wait for pressure to be reduced to 0 bar checking relating pressure through the DISPLAY key and open the door 16 Remove the load and check in the case of a packed load if packaging was not damaged for example open sealing The material inside damaged packages is to be repacked and sterilised once more If present and set refer back to the chapter SETTING the printer 26 OPTIONAL prints a complete report on the entire cycle press the key as to scroll up paper until it is possible to cut it on the cutting edge at the inspection printing door 18 level Incase the STOP key is pressed within 10 seconds from the READY LED switching on the vacuum pump starts operating to avoid building up condensation Such a procedure can be stopped at any time simply pressing the key STOP SUBSEQUENT sterilising cycle start up The procedure and specific rules to be followed in the case of the following cycles are similar to the cycle first START UP but if
50. self charge refer back to chapter CONNECTIONS Once the information confirmed the following message will be automatically If an integrated printer 26 is available press the key to change the information in And confirm pressing the key START to start the cycle information printing for any available cycle refer back to the PRINTER chapter PRINTER 1 ON 0 PRINTER 1 ON 1 PRINTER 1 ON as it is and confirm pressing the key START 0 Once confirmed the information the following message will be automatically displayed A UTO SHUTOFF If the unit auto shutoff is to be set press the key to move the information to 1 and 0 confirm pressing the key START otherwise confirm 0 refer back to the chapter AUTO SHUTOFF Once confirmed the information pressing the key START it will be possible to exit STAND BY the setting menu back and return to the previous message SO uuu bar OPERATION Page 29 IC COMINOX Preparation of the load to be sterilised As already specified in the chapter OPERATION instruments or fabrics to be sterilised are to be perfectly washed rinsed with water with no additives and dried In case of manual instrument cleaning to avoid any infection risk it is suggested to wear suitable protection gloves It is suggested to automatically wash the instruments in an OMNIWASH instrument wa
51. shing unit or with an ultrasound SONICLEAN unit At the end of washing cycle rinse the instruments with a spongy cotton cloth to perfectly remove any rinsing water residue Uniformly position the material to be sterilised in the supply trays 04 complying with instruction in the chapter OPERATION pay attention that the total maximum weight specified in the Sterilised material cycle table includes the loading and charge support and the packaging material Only use the load supporting system supplied by COMINOX and never remove the tray support 08 Never mix solid or hollow instruments with porous loads in the same load during the same sterilisation cycle for example metal instruments and fabrics If the material is to be packed for a sterile storage for example paper polythene envelopes comply with what specified in standard EN868 and seal envelopes with a 8 mm wide sealing In this connection it is recommended to use a COMINOX sealer with built in cutting and roll support which carries out a 10 mm wide sealing for a max length of 250 mm Envelopes are preferably to be fit in vertically to improve drying by means of the envelope holder 07 optional or flat on the trays 04 the paper side downward and not piled up one on the other Alternatively it is possible to pack and seal the tray 04 directly inclusive of its content paper side downward The load and any part of its content or its packaging are never to touch the chamber 09 walls or t
52. sure at the end of the cycle rises very slowly SLOW INCREASING e check the air air sterilising filter 15 and possibly replace it refer back to the PRESSURE MAINTENANCE chapter The printer optional does not print PRINTER e check the PRINTER 1 programming information on the SETTING menu NOT WORKING refer back to the OPERATION chapter e check that there is enough paper and that the roller is correctly fitted refer to the paragraph PRINTER in the OPERATION chapter and that the door is closed The water self charge 29 OPTIONAL does not work SELF WATER CHARGE NOT WORKING e check the SELF CHARGE 1 programming information on the SETTING menu refer back to the OPERATION chapter e if configuration A from the external tank is set and programmed check that there is enough water in the tank If there is water and the alarm CHECK SELF CHARGE is on check that the suction pipe is correctly positioned until the bottom ofthe tank check that the pipe is not bent or twisted check that the height difference between the autoclave and the tank bottom is no more than 1 meter refer back to CONNECTIONS chapter INSTALLATION e If configuration B from the water supply is set check that the water supply tap is opened if the tap is open and the alarm CHECK SELF FILLING is activated check that the water flow is present downstream the SPEEDY WATER demineralisation system e l none of the suggested remedies is effective ad
53. tation Mod 18S 18B 18BHD seen 4 Graphical reference representation Mod 24S 24B 24BHD sse 5 References analytical index eaae a eese KARANA nnne ninth nna na ninh nna sa ninth nna na ntn nh nnn nnn 6 GENERAL SUPPLY CONDITIONS 7212 etie eae asada nio EE 7 DOCUMENT SGOPE 754 E 7 PINON OUST m T 8 PERSONNEL DEMANDED QUALIFICATIONS ee eaaa eene ee nana nana anana ewan awanan nnann eaaa ewan nawan nass nana SE 8 OPERATING USE aana aa a a a aa WKE Ah KANGEN a ea a cesses sa c E IM P EDT UL BEN Na DIM EIC D E naa RIDE 9 Cycle sterilising material table Mod 18B BHD e 24B BHD sss sesenta 10 Cycle sterilising material table Mod 18S 245 11 SPECIAL CY CEE EE 13 Parameters to be programmed hmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmH 13 TEST CY CLES sip aces cts EET 13 TECHNICAL SPECIFICA TIONG 0sssseccccccecnennnsnsceessseeennnnnnssesseseeeenanansnssesseees 14 Technical specifications table sakarani tte tie ee i ee ei 14 Reference standards aei ee go an aga a na Da bae naka an ag b aa eX ned am gais EE aa ue dad de 14 Identification ANG marking E 19 General enee 15 ACCIDENT PREVENTION E 16 GENERAL SAFETY CONDITIONS sesanan 90 n ane nane
54. uctions ask for more detailed information Carry out any operation described before such a chapter and then move to the START UP START UP When the unit is to be started up press the cut out switch 13 and the following message is displayed on the display Stand by When pressing the ON OFF key the following message is displayed alternating every 2 seconds with the message relating to the selected cycle name On the control panel the led relating to such cycle is switched of If the door was previously closed and blocked now if the DOOR LOCKED is off the door itself can be opened When the unit is in STAND BY and when the door 16 is closed using the handle pre heating starts Remove any heavy object which do not belong to any cycle from the chamber refer back to the unit unpacking Pre heating will stop any time the door 16 is opened Under such conditions the sterilisation chamber 09 will start slightly cooling to room temperature The chamber pre heating is not compulsory for the first sterilisation cycle with a cold unit No time therefore is programmed for the unit setting However after pre heating the unit simply closing the door by means of the handle when the HEATING ON LED switches on on the control panel the cycle total required time is cut to the bare minimum thus improving the load drying and avoiding heat dispersions between different cycles OFF xx yy zz hh mm STAND
55. ut the SPECIAL cycle does not comply with any technical requirements in the prEN13060 standard which any other COMINOX autoclave complies with That is the very reason why the SPECIAL cycle can used by qualified laboratory personnel only Such operators authorised by the sterilising manager to get the supplied access key must validate in compliance for example with EN554 standard any programmed cycle on a specific reference load TEST CYCLES BOWIE amp DICK TEST STEAM PENETRATION TEST EMPTY VACUUM TEST HYDRAULIC CIRCUIT TIGHTENING TEST CHAMBER TECHNICAL SPECIFICATIONS rae 14 A STANDARD Supply IC COMINOX Technical specifications table STERILCLAVE Models U M 18S 18B 18BHD 24S 24B 24BHD Thermal printer 40 columns Optional Optional Optional Water self charge 29 Optional Optional E Direct waste drain 30 Optional Optional e Chamber 09 capacity litres 17 15 23 15 17 15 23 15 17 15 23 15 Clean water tank 10 capacity litres 2 1 3 1 2 1 3 1 2 1 8 1 Waste water recovery tank 11 capacity litres 2 1 3 1 2 1 3 1 2 1 8 1 Water consumption per cycle minimum cm 180 420 210 420 210 420 Water consumption per cycle max Minimum water charge cm 500 990 700 1040 700 1190 Absolute operating pressure maximum kPa 330 330 330 Power supply voltage and frequency V Hz
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