OPERATION MAINTENANCE MANUAL
Contents
1. N i LI o i NS J U Page 13 of 51 OVERALL DIMENSIONS DRAWING FOR 3850 3870 ELV ELVC So dO ELA Note The dimensions A B and C are different for the models 3850 and 3870 as indicated below De AE TO T mas T a T ao T C sw oo ssi 025 364 eso 268 Page 14 of 51 2 9 Water Quality 2 9 1 Water for Steam Generation The distilled or mineral free water supplied to the autoclave should have the physical characteristics and maximum acceptable level of contaminants indicated in the table below Physical Characteristics and Maximum acceptable contaminants levels in steam for sterilizers According to EN 13060 2004 allowable content Ca Appearance Colourless clean without i sediment Hardness Ions of alkaline earth lt 0 02 mmol l The suitability of the water to be used should be verified by testing in accordance with the above table at an authorized laboratory using acknowledged analytical methods Attention We recommend testing the water quality once a month The use of water for autoclaves that does not comply with the table above may have severe impact on the working l2. 3 1 Program 1 Unwrapped Instruments cccccsccssssccsssccssssccsscccsssccssssceescees 20 3 2 Program 2 Unwrapped Delicate INStruments cccccccccssccrsscccssscccsscccessees 21 33 Tropram LA aae entender 22 3 4 Program 4 LIGUid F Coolin Gicstivsienesvaewectenecccwctecsvccmmeiaweriiceseeentneeokevaten 23 KEYBOARD Keys and Display essssssssssssosssssecoseooseesseessecseecsecosecosecosecosecosessseoss 24 4 1 Description and Functions of the Front Panel Keyboard cccsscccsescees 25 4 2 Displayed Error and Operational Messages ccsscccrssccrsscccsssccssscccsscccessees 27 CHECKING AND CHANGING PARAMETERS AND OTHER DATA 29 Dad Man MONU oeira a a a a a a a aa 29 S2 Faramello oa R E a a E a aae 30 Ded SAUNINE CLOCK jeti E E A E i 31 IA MISON EEEE E E A A A AE 32 FRINI ER yanun ede acerca sos tescee ostva cob satsca aa wen set pea iteaes ded omedecsaseecnseteayeleeest 33 GI Printer Operaties a T EA E A 33 6 2 Priner OUI ois E E T TARE ER E 34 This page has been re written sssssssssssssssssssosesose Error Bookmark not defined 63 DPU SO Printer TANGUING aseessa Enn E E E ana eee as 35 PREPARATION BEFORE STERILIZATION ccccssssccsssscccsssscccsssscccsscccssssecsees 36 Vid SISUTUIMNOCUUS oosina deveuaVetsaetesacdvatacutacteoudutubuendceviccceevscstuvacetecas 36 FD MONES was ce eicava waa aetaa cs S E shes seats T se 37 L3 EMP CONIAINETS coiere ri E eaten ant et eae eee 37 LA TUDIN aae O E E settee 38 S LIIAS o
3. C Load number 0017 Param Ver 0031 Ver Lab 1 43 Ser Num 02803304 Time 09 54 56 Date 18 03 2009 POWER ON _ Legend W Water inlet H Heating stage Cycle name Cycle counter Version of parameters setting Software version Autoclave s serial number Time sterilization cycle started Date sterilization cycle started e E C Cooling stage E Exhaust stage S Sterilization stage D Dry stage Page 34 of 51 6 3 DPU 30 Printer Handling 6 3 1 Setting Paper 1 Press the paper cover open button 1 and open the paper cover 6 3 2 3 Handle the paper cutter carefully not to cut your hand 2 Seta paper roll as shown in the figure Close the paper cover 3 by pressing both ends of the cover with the tip end of the paper extending out from the cutter Maintenance 1 Wipe off any soiling on the Printer s external surface with a soft cloth and a weak neutral detergent After that wipe the printer with a dry cloth 2 Caution Never disassemble the printer Failure to follow this instruction may cause electric shock overheating or burning of the printer adapter Or an which may lead to fire 3 The Printer is sensitive to moisture Avoid splashing or spilling liquids on the Printer Doing so can lead to electric shock or create a fire hazard 4 Never touch the thermal head immediately after printing because it becomes very hot Make sure that the thermal head is cool before setting paper or cleaning the thermal h
4. E EN opening the door at the end of the cycle UNDER 60 C C INSTRUMENT TEMPERATURE IS UNDER 100 C The meaning of this symbol is Caution hot surface It is to alert the user that the door may be very hot Page 10 of 51 MARKING ON SIDE VIEW MADE IN ISRAEL BY TUTTNAUER CO LTD BEIT SHEMESH P O Box 170 This sticker provides the Manufacturer s name and address This sticker indicates that the autoclave is UL and CSA approved Page 11 of 51 MARKING ON REAR VIEW TUTTNAUER AuTocLave steamsternizen This sticker provides the following technical data MODEL 25a0ELve we E i Model name Nature of electrical supply e Ja h a Rated value of the supply voltage PROTECTIONCLASS O Maximum rated input current Autoclave s serial number max pr 2 80 bar tosi pr F od bar coNT 23 LYEAR 2007 sin meree This sticker indicates that the pressure vessel of the autoclave is ASME approved The operator has to refer to the user manual This sticker indicated the place of the ground connection to the body of the autoclave This sticker shows the on position and the off position of the circuit breaker Page 12 of 51 BE OVERALL DIMENSIONS DRAWING FOR 2540 ELV ELVC
5. cycle to be completed The forced cooling process shortens the cooling stage significantly e Fast exhaust phase After reaching the end temperature 194 F 90 C the exhaust valve is opened until the pressure in the chamber becomes equal to the atmospheric pressure Ambient Pressure and Temperature Pressure Temperature Page 23 of 51 4 KEYBOARD Keys and Display Keypad Power On Off Switch Page 24 of 51 4 1 Description and Functions of the Front Panel Keyboard The front panel is composed of 2 sections 1 Display screen 2 Keypad 4 1 1 Description of the main screen The graphic screen is used to display the current status of the autoclave along with Operational and Error Messages Cycle information e Cycle symbol e Sterilization temperature e Sterilization time e Dry time Chamber information e Temperature e Pressure Time Sterilizing EHR lt Clock J e Counter Process information e Operational messages e Error messages e Current stage Page 25 of 51 4 1 2 Description of the keypad The keypad which enables operation of the autoclave consists of 3 keys as described below The Up Down keys are used to UP key 1 change program selection DOWN key 2 program the clock 3 adjust sterilization time START STOP key This key commands the following 3 functions e Starting the process Stopping the process e Canceling the ERR
6. 6 3 1 Printing Paper not print Contact your dealer to solve the problem When the machine is switched on the printer feeds paper all the time Contact your dealer to solve the problem Make sure the door is tightened enough The machine is leaking at the door Replace the door gasket see para 10 3 Replacing the Door Gasket Water does not exit chamber due to 1 Clean strainer according to instructions see sec clogged outlet 10 5 strainer If the above recommendations did not correct the malfunction or if any problems not discussed in this section were encountered please contact your dealer for further assistance You may also contact the distributor at the address on the front cover of this manual Page 49 of 51 BASKETS AND CONTAINERS Container for waste products Large Basket Small Basket Stainless steel container for waste products with vent holes i Dia x Height mm Dia x Height mm 227 x 350 236 x 350 so 2278350 Lt Type Stainless steel wire baskets 357 x 330 l 366 x 330 l 357 x 330 2 366 x 330 2 Page 50 of 51 12 SPARE PARTS LIST Cat No Description 2540 3850 3870 3850 3870 Cable Electric Plug 02819996 Cap for 4 strainer FIL175 0027 FIL175 0027 Teflon gasket 4 mm GAS082 0008 GAS082 0008 IS ACCESSORIES Description 2540 3850 3870 Paper Roll Printer DPU 30 pack of 5 01610406 01610406 BSK254 0001 BSK387 0001 Stainless steel wire b
7. a shallow pan under the strainer or water will spill on the floor 1 Open the left service door 2 Open the strainer cap 3 Remove the strainer element 4 Rinse the strainer with water using a brush if necessary 5 Reinstall the strainer element 6 Close the strainer cap 7 Close the left service door Attention Ensure the silicon gasket is in place A missing gasket will cause the strainer to leak Strainer Cap Silicon Strainer Strainer gasket element housing Page 48 of 51 TROUBLESHOOTING This troubleshooting chart enables the user to solve minor malfunctions prior to requesting service Only technical personnel having proper qualifications and holding technical documentation including a technician manual and adequate information are authorized to service the apparatus 1 1 Check the power source and verify that it is according to specifications 1 2 Verify that the ON OFF switch is in the On position Display is not 1 3 Make sure the power cord is properly connected to activated the machine and the mains see rear view drawing 1 4 Check the reset button on the cut out thermostat Reset if necessary 1 5 Make sure the circuit breaker has not tripped Reset if necessary The printer prints but nothing is printed on the paper Verify that the printing paper is inserted correctly see para 6 3 1 Printing Paper Make sure the paper is inserted in the printer see The printer does para
8. to set the time and date 1 Enter the MENU see sec 5 1 2 Using the UP DOWN keys select the set clock option 3 Press the START STOP key to enter that option 4 The SET CLOCK screen 1s displayed SET CLOCK Time 1 50 29 Date 25 05 2009 EXIT mm dd year Upon entering the set clock display the time and date are shown The curser is blinking on the digits for the hour The time is displayed in a 24 hour format in the upper row in the form hh mm ss The date is displayed in the lower row in the form MM DD Y Y 1 To increase or decrease the time or the date use the UP and DOWN keys 2 To move the curser from one digit to another press the START STOP key 3 After setting the time and date use the START STOP key to go to SAVE Save the new time and date by pressing UP key 4 Use the START STOP key to advance to EXIT and press the UP key to leave this section Page 31 of 51 5 4 History This directory enables you to print the 10 previous cycles oe a aS Enter the MENU see sec 5 1 Using the UP DOWN keys select the history option Press the START STOP key to enter that option The HISTORY screen is displayed HISTORY Wrote mam Fot Yo ma 1b E 0011 Log Load Nu 0012 Log Load Nu 0013 Choose the cycle that you want according to its number using the UP and DOWN keys Select it by pressing the START STOP key The cycle is printed In order to leave this sc
9. to the basket s top These baskets are intended for waste cycles to avoid clogging of the vessel s drainage pipe by overflowing liquids ia AAAI Page 38 of 51 8 OPERATION 8 1 8 2 8 3 8 4 Turning on the Autoclave To start the system turn on the main power switch located at the bottom right corner of the keyboard panel see sec 4 The software name and version number are displayed briefly then the main screen is displayed as shown 166 9 Lire h 10 15 54 Verification Before Operating the Autoclave Verify that the mineral free water supply is connected to the mineral free water inlet NOTE the electrical conductivity of the water must not exceed 15 micro siemens Verify that the date and the time are correct see SETTING THE CLOCK sec 5 2 Loading Correct loading of the autoclave is essential to successful sterilizing for several reasons Efficient air removal from the chamber and the load will permit effective steam penetration and saturation and allow proper drainage of condensate Additionally correct loading will prevent damage to packs and their contents and maximize efficient use of the steriliz
10. 1 2 and 3 Caution This gasket is designed with a trapezoidal cross section The gasket should be placed with the widest side towards the door Page 46 of 51 10 4 Checking the Safety Valve The safety valve is located on the rear side of the autoclave In order to prevent the safety valve from becoming blocked it is necessary to manually operate it once a month as follows 1 Select the 1 Unwrapped Instrument sterilization cycle and run it according to the manual making sure there are no instruments in the chamber 2 Allow a pressure of approximately 29 psi 200 kPa to build up in the chamber 4 Operate the safety valve by pulling the ring of the safety valve using a tool 1 e screwdriver hook etc and lift the safety valve ring for 2 seconds Be careful not to burn your hands 5 Press the STOP key to abort the cycle and exhaust steam from chamber 6 Wait until pressure goes down to zero only then can the door be opened CAUTION To avoid being burned by the hot steam stand away from the Safety Valve r ATTENTION Use protective gloves in order not to burn your hands with the hot steam Safety valve ring Page 47 of 51 10 5 Cleaning Water Outlet Strainer gt gt gt Caution Before proceeding Make sure that the electric cord is disconnected and there is no pressure in the autoclave Warning The strainer cover may be HOT Use heat resistant gloves to avoid being burned Caution Place
11. 7 1 0 21 19 8 0 56 19 8 a Shipping weight lb kg 125 57 222 101 255 116 2 5 3 Electrical Data MODEL Mone Ampere wales EY ae 8 ET Ea ae Power Watts 2400 W W 6000 W W 6000 W W Protection against electrical shock Class I IEC 60601 1 Page 8 of 51 2 6 Lei Loading Capacities liquid instrument 2 6 1 2 6 2 Utility Erlenmeyer Flasks 250 500i Medium Flasks Schott SIZE 2540 3850 3870 1000 ml 4 2x8 2x8 2000 ml 4 2x4 oom Pp 10000 ml I I Utility 1Ph 208V 60Hz Recommended 20A Electrical Circuit Breaker data 3 Ph 208V 60Hz Recommended on Circuit Breaker IANA 1 2 60 120psi 4 1 8 3 Bar 60 I min 1 2 30 45 psi 2 1 3 1 Bar 1 2 30 45 psi 2 1 3 1 Bar Must be able to withstand a minimum temp of 190 F 88 C min Attention The electrical net must be protected with a current leakage safety relay The electrical network must comply with local rules or regulations Page 9 of 51 2 8 Marking MARKING ON TOP VIEW ENSURE DOOR This sticker provides a safety instruction for k TIGHTNESS closing the door before beginning the cycle CAUTION DOOR SHOULD BE OPENED ONLY WHEN tana WEENIE This sticker provides safety instructions for ON POSITION
12. CLE END is displayed on the screen and the buzzer sounds one beep continuously during 3 seconds In case the cycle has failed the message CYCLE FAIL 1s displayed on the screen the buzzer sounds intermittently 3 beeps and an Error Message is displayed on the screen For corrective action see Displayed Error and Operational Messages sec 4 2 Pressing the START STOP key will erase the fail message Unloading On completion of the cycle open the door to remove the sterilized material from the autoclave Rotate the handle of the tightening bolt counter clockwise to the end then lower the bolt at a right angle parallel to the front cover Lift the door to a vertical position Caution Before opening the door verify that there is no pressure in the chamber a chamber pressure gauge is located on the autoclave s side cover Open the door slowly to allow steam to escape DO NOT put your head or any other part of your body above the chamber Doing so can cause injury from hot steam Take the load out of the sterilizer immediately upon completion of the cycle Do not remove the load from the basket until its temperature has returned to room temperature Let the load cool down in an area without air movement air conditioning etc and with minimum people passing by to avoid the possibility of touching the hot load Do not touch the hot load since a hot load will absorb moisture and therefore may absorb bacteria from your hand Perf
13. OR message from the command panel and opening the electric door locking Page 26 of 51 4 2 Displayed Error and Operational Messages Message Message Description Ptl out Low Temperature High Temperature High Pressure Low Pressure Manual Stop Press Sensor Cutout This message is displayed when the Chamber Temperature sensor Pt1 is disconnected or out of range This message is displayed when the Chamber Temperature sensor Pt2 additional safety feature is disconnected or out of range This message is displayed when the sterilization temperature wasn t reached This message is displayed if temperature rises 3 C above sterilization temperature during the sterilization stage for 10 seconds This message is displayed if during any cycles there is no water in the chamber This message is displayed if the Chamber Pressure rises 20kPa above sterilization pressure for 5 seconds during the sterilization Stage This message is displayed if Chamber Pressure drops bellow the sterilization pressure for 5 seconds during the sterilization stage This message is displayed if the STOP key is pressed and the cycle is aborted This message is displayed during the heating stage if the system cannot reach the required chamber temperature within 20 minutes This message 1s displayed if pressure sensor 1 of the chamber is disconnected or if the pressure 1s out of range during Air Removal and Hea
14. Tuttnauer Your Sterilization amp Infection Control Partners OPERATION amp MAINTENANCE MANUAL Laboratory Vertical Steam Sterilizers with cooling option models 2540 3850 3870 ELV and 2540 3850 3870 ELVC Cat No MAN205 0350001EN Rev G Heidolph Brinkmann LLC 1241 Jarvis Avenue Elk Grove Village IL 60007 Q 856 786 1448 Toll Free 866 650 9604 LI Fax 856 949 1167 Brinkmann Instruments Canada Ltd 4160 Sladeview Crescent 6 Mississauga Ontario L5N 2L8 905 569 0664 Toll Free 866 260 6069 Fax 905 569 0665 TABLE OF CONTENTS Paragraph Page No OE NE TAL rears cers sates has sca tedion So ecracesaaaiie O 4 FL INCOMING TASPCCHON sssri ai AEA 4 L2 VaraniVo osea E R E A 4 TS Ordering Information sssrin aa SEEE ASEO AE tenet 4 TECHNICAL DATA ar E a EE aat 6 25 Aniroduclion snsorsie e e E E E 6 22 Oneranns CONGHONS osen nai eee 4 23 Directives and Standards wisicestisacatisasts cieeets cae cceecaaiocaeasasiecce as oianeeaca suse 7 2 4 Environment Emission Information cccccccsscccsssccssscccssscsscccsssccssscssssceeses 7 23 SPEC CANONS aaa sais vous euacusucacancevsonca E Gone eee aae ea 8 20 LOADING CAPACITIES wiles ioraeiceesctee E T 9 Lede MOTI cosa scsi sas cessed Sone a ee eee 9 28 MAINO tee ie ares eucesinone cosas coc adaee anna A E 10 29 Water Qualls T N 15 Zed WO Safely F eaire S on E sep ane eae 16 STERILIZATION PROGRAMS rset eet ie es 19
15. asket BSK254 0004 BSK387 0002 Stainless steel container for waste BSK254 0005 BSK387 0005 products with vents holes BSK254 0003 BSK387 0003 Page 51 of 51
16. ator To be filled in manually by operator Time 09 17 34 Time sterilization cycle ended Date 10 03 2006 Date sterilization cycle ended Bre a nro ne eer 085 7 082 9 017 4 Status of the autoclave during exhaust stage E 00 40 03 Temp and pressure reading time in HH MM SS 122 6 122 6 016 5 Status of the autoclave during cooling stage C 00 34 51 Temp and pressure reading time in HH MM SS 122 6 122 6 016 5 Status of the autoclave during sterilization stage S 00 35 08 Temp and pressure reading time in HH MM SS X Prints sterilization data every 60 seconds X 121 2 121 1 016 2 Status of the autoclave during sterilization stage S 00 14 51 Temp and pressure reading time in HH MM SS 108 9 108 9 006 5 Status of the autoclave during heating stage H 00 12 29 Temp and pressure reading time in HH MM SS X Prints heating data every 3 minutes X 023 2 023 0 000 2 Status of the autoclave during heating stage H 00 00 29 Temp and pressure reading time in HH MM SS 022 7 022 3 000 5 Status of the autoclave during water inlet stage W 00 00 00 Temp and pressure reading time in HH MM SS C C i Temperature sensor 1 Temperature Chamber press nen NE End Temp 090 0min End temperature for selected program Dry Time 000 0min Drying time for selected program N A on this unit Ster Time 020 0min Sterilization time for selected program Ster Temp 121 1 C Sterilization temperature in chamber for selected program Cycle Liquid amp
17. boiling point 1 3 2 Accessories e Baskets Different size baskets are available for these units see pages 49 amp 50 The baskets are made of stainless steel wire and have a handle The basket allows the operator to load a large quantity of materials into the chamber e Stainless steel containers Different size containers are available for these units see pages 49 amp 50 The containers are designed for sterilizing waste material The containers have vent holes along the upper rim Page 5 of 51 2 TECHNICAL DATA 2 1 Introduction Models 2540 3850 3870 ELV ELVC are vertical sterilizers designed especially for sterilization of instruments liquids and other materials in laboratories research institutes food laboratories and pharmaceutical facilities A special feature of the ELVC sterilizer is the ability is to rapidly cool down a liquid load at the end of the sterilizing portion of the cycle The sterilizer provides four fully automatic programs eliminating any need for operator intervention during a cycle A computerized control unit enables precise control and monitoring of physical parameters and clear documentation of the sterilization cycles A safety valve mounted at the back top of the autoclave is set to 40psig and protects the system from excessive pressure The autoclave is equipped with a pressure gauge for reference only that can be used in case there is any problem with the electricity supp
18. e two temperature sensors 1 into the sensors holder 2 attached to the autoclave s door 3 see picture below 2 Clean instruments immediately after use to remove any residue It is recommended that all instruments be ultrasonically cleaned using Tuttnauer s CLEAN AND SIMPLE enzymatic cleaning tablets or other suitable solution 3 After cleaning rinse instrument under tap water for 30 second and pat or air dry to remove residual minerals If your tap water has a high mineral content rinse a second time in a bath of distilled water to remove minerals 4 Follow the instrument manufacture s instructions on the use of products for cleaning and lubricating instruments that have been ultrasonically cleaned 5 Be sure that instruments of dissimilar metals stainless steel carbon steel etc are separated Carbon steel instruments should be bagged or placed on autoclavable towels and not be allowed to come in contact with the stainless steel baskets mixing will result in the oxidation of these metals 6 Do not place materials to be sterilized against the chamber s wall Place the material only in the basket 7 When using a paper plastic bag the plastic side should always be down Page 36 of 51 Toke 7 3 8 Check the instructions of the item manufacturer as to the proper procedure for sterilizing each item 9 Items must be sterilized in an open position Surfaces that are hidden because the item is in a closed po
19. ead 5 Power OFF the autoclave in any of the following cases e The printer does not recover from an error e Smoke strange noise or smells erupt from the printer e A piece of metal or any liquid touches the internal parts or slot of the printer 6 Notes on treatment of thermal papers e Store the papers in a dry cool and dark place e Do not rub the papers with hard substance e Keep the papers away from organic solvent Page 35 of 51 PREPARATION BEFORE STERILIZATION The purpose of packaging and wrapping of items for sterilization is to provide a protective barrier against recontamination after items are removed from the sterilizer Packaging and wrapping materials should permit the removal of air from the pack penetration of the sterilizing water vapor into the pack and removal of the sterilizing vapor The basic principle determining the size mass and contents of instrument and hollowware packs is that the contents are sterile and dry immediately on completion of the drying cycle and removal of the pack from the sterilizer chamber Instruments to be sterilized must be free from all residual matter such as blood or organic tissue Instruments must also be dry and free from mineral deposits Such substances may cause damage to the to instruments themselves or the sterilizer If the unit is equipped with a printer check if a new roll of paper is needed 7 1 Instruments 1 For all loads not containing liquids insert th
20. edere eee 5I Page 2 of 51 TABLE OF CONTENT Drawings Page No Overall Dimensions Drawing for 2540 ELV EL VC ccsscccsssccsssccsssccsssccsssscessccssssceees 13 Overall Dimensions Drawing for 3850 3870 ELV ELV C ssssssssssssesoosscsosseosesooseesoeses 14 Top VUCW SAD CUA S cienie a E NE E A E A wena 17 Rear y iewe Details oor a a cack Sean E a E a a 18 Baskets and Containers srian a aE a a 50 Page 3 of 51 I GENERAL 1 1 EZ 1 3 Incoming Inspection Upon receiving your Tuttnauer Autoclave carefully inspect the outside of the shipping carton for signs of damage If any damage to the carton is found note the location with respect to the autoclave and check that area of the autoclave carefully once it is fully unpacked Observe packing method and retain packing materials until the unit has been inspected Mechanical inspection involves checking for signs of physical damage such as scratched panel surfaces broken knobs etc If any damage is found contact your dealer as soon as possible so that they can file a claim with the shipping carrier and also notify Tuttnauer All Tuttnauer products are carefully inspected prior to shipment and all reasonable precautions are taken in preparing them for shipment to assure safe arrival at their destination Note Lifting and carrying should always be done by two people Warranty To activate your warranty or for warranty information on this unit please contact your dealer or Heidolph B
21. er For detailed loading instructions see para 2 6 Loading Capacities and para 7 Preparation before sterilization Operations To seal the chamber close the door then lift the handle of the tightening bolt in vertical position and then rotate it clockwise until the bolt is hand tight The operational message Door is open disappears indicating the door is closed Once the sterilization cycle is in progress a safety device locks the door and makes it impossible to open it until completion of the cycle or a manual stop is executed NOTE Due to the inherent elasticity of the door gasket the operational message Door is open may disappear before a complete seal is made between the door and the chamber In order to ensure the chamber is fully sealed when the operational message and symbol Door is open disappears continue to tighten the door bolt until it is hand tight Do not over tighten the bolt as this may result in damage to the gasket Should the autoclave fail to reach sterilizing temperature pressure always check first that the door is fully sealed If not tighten the door bolt further as described above until a complete seal is made Page 39 of 51 8 5 8 6 ZN Select the required program by means of the keys UPA DOWN and START STOP UP key next program DOWN key previous program START STOP key start the selected program End of the Cycle At the end of the cycle the message CY
22. g any parameters needs to be done by a qualified technician Sterilization Programs Fahrenheit Celsius Program 1 Unwrapped instruments 273 134 C Program 2 Unwrapped delicate instruments 250 F 121 C Program 3 Liquid 250 F BRIC Program 4 Liquid Cooling 250 F 121 C Page 19 of 51 3 1 Program I Unwrapped Instruments Program 1 is recommended for sterilizing unwrapped instruments and materials where the materials manufacturer recommends autoclaving at a temperature of 273 F 134 C for 4 minutes The cycle ends with a rapid exhaust and no drying is available Lg 58 oe Nominal Parameters e Sterilization temperature 273 F 134 C e Sterilization time 4 min e Dry time None Operations Sequence e Water Inlet phase Water enters the chamber to the required level e Heating phase Water heats up until steam reaches the preset sterilization temperature e Sterilization phase Temperature is maintained constant at the preset value for the preset sterilization time e Exhaust phase Condensate is rapidly exhausted from the chamber until the pressure equalizes to atmospheric pressure Ambient Pressure and Temperature Pressure Temperature Page 20 of 51 3 2 Program 2 Unwrapped Delicate Instruments Program 2 is recommended for sterilizing unwrapped instruments and materials where the materials manufacturer recommends autoclaving at a temperature of 250 F 121 C for 20 minutes The cycle ends w
23. hese operations The owner of the autoclave is responsible to have an authorized technician perform the periodical tests and preventive maintenance operations as specified in the technician manual Use only mineral free water as detailed in para 2 9 water quality Warning Before carrying out any preventive maintenance operation ensure that the electrical cord is disconnected and there is no pressure in the autoclave 10 1 1 Daily Clean the door gasket with a soft cloth using water and a mild soapy solution The gasket should be clean and smooth 10 1 2 Weekly 1 Remove the baskets if applicable Clean the chamber and baskets with a cleaning agent amp water and with a cloth sponge You may use diluted lemon acid 25 50 CC lemon acid in 1 liter of water as cleaning agent If detergent is used rinse baskets immediately with water to avoid stains on the metal Caution Do not use steel wool or steel brush as this can damage the chamber To remove the used water open the water outlet strainer see para 10 5 Caution Place a shallow pan under the strainer or water will spill on the floor Z 3 Put a few drops of oil on the two door pins and door tightening bolts Clean outer parts of the autoclave with a soft cloth 4 Clean the electrode with a soft cloth 10 1 3 Periodically 1 Every 6 months replace the air filter if installed according to para 10 2 2 Every 6 months clean the electronic box with compre
24. ife of the sterilizer and can invalidate the manufacturer s warranty Page 15 of 51 2 10 Safety Features This autoclave includes built in safety features such as Error message display to alert the operator of problems with the sterilization cycle Electronic pressure and temperature measurement Safety valve to prevent build up of excessive pressure Door switch to enable operation only when the door is closed Water level safety device Excess temperature protection Electronic door interlock to permit door opening only when l The sterilized liquid temperature as measured by the two temperature sensors is below the boiling point 2 The chamber pressure is the same as the ambient pressure 3 The electrical power is switched ON Page 16 of 51 TOP VIEW DETAILS Pgh oe Na J uy NON alas a v7 12540 Door switch behind the door Cs Primer e onori oo EA a 2 Locking screw assembly 73 l 2 3 4 5 Display Electrical cord Page 17 of 51 REAR VIEW DETAILS Compressed air Pressure regulator on ELVC only 7 Drain Drain outlet S a 9 Feed waterinlet SSS Page 18 of 51 3 STERILIZATION PROGRAMS The autoclave offers 4 sterilization programs Changin
25. is not powered 2 If power failed or has been turned off while the autoclave is in operation even if power has been restored 3 If operation was stopped before completion of the cycle as a result of a failure or a manual stop 4 The autoclave is equipped with two temperature sensors If one of them senses that the temperature inside the autoclave chamber is higher than the end of cycle temperature preset by the operator the opening of the door is prevented Opening the door is possible only when the temperature has dropped below preset End Temp value For cases described at points 2 and 3 press START STOP key to cancel the door locking at the end of the operation Emergency Release An access hole is provided in the closing device to allow release of the locking pin when the power is off SOLENOID ELECTRICA SOLENOID ie eee XQ A A Sg X U VE po ma l p T PW NSS SSN Se toa J N i NY OPENING FOR THE RELEASE KA Jae OF THE LOCKING DEVICE in q lt lt 1 NS Page 42 of 51 10 SERVICE AND MAINTENANCE 10 1 Preventive Maintenance The maintenance operations described in this chapter must be fulfilled periodically in order to keep the autoclave in good working condition and to keep any breakdown time to a minimum The user s maintenance personnel can easily perform t
26. ith a rapid exhaust and no drying is available Nominal parameters READY Not bbe e Sterilization temperature 250 F 121 C e Sterilization time 20 min e Dry time None Operations Sequence e Water Inlet phase Water enters the chamber to the required level e Heating phase Water heats up until steam reaches the preset sterilization temperature e Sterilization phase Temperature is maintained constant at the preset value for the preset sterilization time e Exhaust phase Condensate is rapidly exhausted from the chamber until the pressure equalizes to atmospheric pressure _ e ees am owe ow Ambient Pressure and Temperature Time Pressure Temperature Page 21 of 51 3 3 Program 3 Liquid Program 3 is intended to sterilize liquids The sterilization temperature is 250 F 121 C with no cooling The cycle ends with slow exhaust to prevent bursting of the bottles Average cycle time 2h15min for two containers holding 700ml each Nominal Parameters e Sterilization temperature 250 F 121 C e Sterilization time 20 min e Dry time None Operations Sequence e Water Inlet phase Water enters the chamber to the required level e Heating phase Water heats up until steam reaches the preset sterilization temperature e Sterilization phase Temperature is maintained constant at the preset value for the preset sterilization time e Exhaust phase Condensate is slowl
27. l Caution Waste water should be brought into the public net in accordance with the local rules or requirements i e only non hazardous liquids shall be disposed in public sewage 253 2 4 Directives and Standards Every autoclave meets the following Standards 2 3 1 Technical Standards 1 The pressure vessel is an integral part of the equipment and complies with the ASME code Section VIII div 1 for unfired pressure vessels 2 UL 61010 2 041 amp UL 61010 1 Safety requirements for medical device 3 UL 1998 Software in Programmable Components 2 3 2 Quality standards The manufacturing plant meets the following quality standards 1 EN ISO 9001 2000 Quality System 2 ISO 13485 2003 Quality systems Medical devices Environment Emission Information A Peak sound level generated by the sterilizer is less than 70 dBA with a back sound level of 60 dBA B Total heat transmitted by the sterilizer is less than 300 W h Page 7 of 51 2 5 Specifications 20 4 Dimensions DIMENSIONS diameter Chamber volume overly 2 9 2 Technical Data St St St St St St 1 4571 1 4571 1 4571 304L 304L 304L after pressure reducer psi Bar 3 1 4 0 3 1 4 0 3 1 4 0 after pressure reducer psi Bar 1 2 1 8 1 2 1 8 1 2 1 8 pressure reducer psi Bar 1 2 l ETA 1 2 l 8 1 2 l 9 Net Net weight 1b k Net weight 1b k kg 105 105 48 Shipping volume ft m
28. ly during the sterilization cycle The pressure gauge can verify if there is pressure in the chamber before an attempt is made to open the door According to the standard for laboratory autoclaves these units are equipped with two temperature sensors that control the cycle and prevent the opening of the door if the temperature is too high This manual is intended to give the user a general understanding of how the autoclave works and indicates best ways to operate and maintain it in order to obtain optimum results and a trouble free operation After reading this manual operating the autoclave should be straight forward However since the autoclave is built using high technology sensitive components no attempt should be made by the user or any other unauthorized person to repair or re calibrate it Only technical personnel having proper qualifications holding technical documentation and having adequate test instrumentation are authorized to install or undertake repair or service Page 6 of 51 2 2 Operating Conditions e The autoclave is for Indoor use only e Only autoclavable materials shall be used e The ambient temperature shall be in the range of 50 F 104 F 10 C 40 C and a relative humidity up to 85 e The operation altitude of this autoclave is restricted to 6600ft 2000m The ambient pressure shall not be lower than 11 6psi 80kPa e The autoclave shall not be used in a manner not specified in this manua
29. ons nE E A 38 PO LOUINO rpa hte E T A E E 38 Page of 51 10 Il 12 13 OFER TLIO N ann E E E TEA eeveusscsaess 39 Of Turning on the AutoclaVve sssssssssssssssssecssecsscosecosecoseeosecosecosecssecsseossessseooe 39 8 2 Verification Before Operating the AuUtoclave iccrrccccrsccsrssccssscccsscccsssccceees 39 Oe OCIS E E A E eaavauaueas cus aaae uaa ence eneaaeseneen ecneronee 39 OM Operati ONS Kasstssacerasetese E A A EET 39 I Lnd of h l Velle a NE A E uns eetianecs 40 6 0 OF LAI LS O ai E A O E E T Er reer 40 6 7 SOPPNZ Ihe T IOCS S eiia a E Ei 4 C DA E caste selec canis wade sas ahs Su estactn sles wis A eres ees 4 DOOR SAFETY SYSTEM oiia E E E ds 42 9 1 Solenoid Locking Safety Device cccsscccsssccsssccssscccsscccsssccssscccsssccsssccsesccssces 42 92 Emeroene y RECASENS 42 SERVICE AND MAINTE NANCE cecina E 43 10 1 Preventive Maintenance ssssssssssessosesossssosesoossccseecossccosseossesossscossecosssesseeos 43 10 2 Replacing the Air Filter ELVC only ssssssssssssessssessecoseooseosseoseeosseoseeoseeseee 45 10 3 Replacing the Door GASKe ccsccccsssccsssccssscccsssccssscssscccsssccsssccsscsssssscsescees 46 10 4 Checking the Safety Valve sssssssesssssssosesoosescosseosescossscossecssesossseosssossesosessoos 47 10 5 Cleaning Water Outlet Strainer ccrccccrscccrssccrssscssssccssccccsssccssccccsscccsscossssees 48 TROUBLESHOOTING srroraisr o a E EE 49 OPARE TARIS LEIST onn ENa 5I ACCESSORIE Sirois raa E A EA a O E v
30. orm a visual inspection to ascertain that sterilizing indicators have made the required color change and that the load is dry The load shall be rejected if a The package has been compressed b The package is torn c The load is suspected to be wet d The load fell on the floor e Condensed drops can be detected on the load To avoid injuries use heat resistant gloves while unloading the autoclave Page 40 of 51 8 7 Stopping the Process e It is possible to stop the program while the autoclave is in process Pressing the START STOP key at any stage of process stops the operation 8 8 Safety e Protective equipment and clothes and other safety instructions should be implemented in accordance with local and national regulations and or rules e For proper sterilization Do not overload the chamber Only autoclavable products shall be used please refer to the manufacturer instructions for sterilization of unknown materials or instruments Page 41 of 51 DOOR SAFETY SYSTEM The door opening is secured by two safety means le 9 1 9 2 A screw type mechanical closing device that tightens the door and prevents an accidental door opening A pull type locking solenoid that in the inactivated position locks the door and must be electrically powered to release the lock and enable opening of the door Solenoid Locking Safety Device The solenoid locks the door in the following situations 1 When the control unit
31. reen go to the EXIT option using the UP and DOWN keys and select it by pressing the START STOP key Page 32 of 51 6 PRINTER 6 1 Printer Operation The autoclave is equipped with a character printer which prints a detailed history of each cycle performed by the instrument for the record or for subsequent consideration The printing is made on thermal paper with 24 characters per line and contains the following information e Date started e Time started e Serial number of unit e Software version e Parameter version e Load number e Selected program e Programmed Sterilization temperature e Programmed Sterilization time e Dry time N A on this unit e Programmed End temperature e Summary of performed cycle e Date finished e Time finished e Operator initials When the sterilization cycle begins the printer starts printing the above data After the preliminary cycle information is printed the autoclave starts the cycle operation The measured values from the two temperature probes and the pressure sensor are printed at fixed time intervals according to the phase of the process as shown in the sample print out see sec 6 2 The data is printed from the bottom up beginning with the date and ending with CYCLE ENDED for a complete cycle or CYCLE FAIL for an aborted cycle For an example of a typical printout see next page Page 33 of 51 6 2 Printer Output PRINTER OUTPUT DESCRIPTION Oper
32. rinkmann at one of the s listed below Heidolph Brinkmann LLC 1241 Jarvis Avenue Elk Grove Village IL 60007 856 786 1448 Toll Free 866 650 9604 Fax 856 949 1167 Brinkmann Instruments Canada Ltd 4160 Sladeview Crescent 6 Mississauga Ontario L5N 2L8 Ph 905 569 0664 Toll Free 866 260 6069 Fax 905 569 0665 Tuttnauer USA Co Ltd 25 Power Drive Hauppauge NY 11788 USA 800 624 5836 631 737 4850 Fax 631 737 0720 e mail info tuttnauerUSA com Note If you have any questions or there are any difficulties with this instrument and the solution is not covered in this manual please contact your dealer or Heidolph Brinkmann Do not attempt to service this instrument yourself Ordering Information Several items must be specified when ordering the unit from your dealer The chamber diameter and chamber depth required Please specify the supply voltage available 1 e 115v 208v 1Ph 3Ph The temperature scale needed Celsius or Fahrenheit The pressure scale needed kPa or psi Page 4 of 51 1 3 1 Options e Printer An optional built in thermal printer is available e Rapid Cooling these units are available with or without Rapid Cooling for liquid cycles o The cooling option requires an additional water and compressed air connection o While cooling water is circulated around the outside of the chamber compressed air is used inside the chamber to maintain the liquid at a high
33. sition will not be exposed to the steam and will not be sterilized 10 Use single use wraps once only and discard after use 11 Materials used for wrapping and packing including materials used for inner wraps shall be compatible with the item being packed and the sterilizing method selected 12 Wrapped instrument should be placed in material which will allow steam penetration and promote drying such as autoclave bags autoclave paper or muslin towels 13 If necessary disassemble or loosen multi part instrument prior to packaging to permit the sterilizing agent to come into contact with all parts of the instrument 14 Tilt items on edge that are prone to entrap air and moisture e g hollowware so that only minimal resistance to air removal passage of steam and condensate will be met 15 Load the basket loosely to capacity 16 Place a sterilization indicator strip in each basket 17 Once a week use a biological spore test indicator in any load to make sure sterilization is performed 18 Make sure that all instruments remain apart during the sterilization cycle Textiles 1 For all loads not containing liquids insert the two temperature sensors 1 into the sensor holder 2 attached to the autoclave s door 3 see picture 7 1 1 2 Launder textile wraps prior to sterilization but DO NOT use bleach 3 Tilt textile packs on edge to provide minimal resistance to the removal of entrapped air 4 Wrapped textiles sho
34. ssed air from inside outward 3 Check the door gasket every 12 months and replace it if required see para 10 3 4 Oncea year check and tighten the piping joints to avoid leakage 5 Once a year check and tighten all screw connections in the control box heaters valves and instrumentation Page 43 of 51 6 Once a month clean the strainer as per para 10 5 Cleaning frequency may be reduced according to experience 10 1 4 Periodical Tests 1 Once every month activate the safety valve see para 10 4 Page 44 of 51 10 2 Replacing the Air Filter ELVC only During the cooling phase of the Liquid w cooling cycle compressed air is uses to maintain pressure inside the chamber The air filter ensures that the compressed air 1s pure and free from contaminants before entering the chamber The air filtration is performed by a high quality bacteriological filter The filter is mounted at the right side of the autoclave To replace the filter proceed as follows 1 Open the right service door of the autoclave 2 Unscrew the fittings upper and lower fitting connecting the filter to the piping Replace the filter with a new one and reconnect the fittings 4 Close the service door Air filter Page 45 of 51 10 3 Replacing the Door Gasket Pull off the gasket from the door groove and install the new gasket referring to the drawings as above points
35. the machine must be on but not running a cycle 1 Press the UP and DOWN keys at the same time 2 Using the UP key enter code 0001 3 Press the START STOP key to advance to the Set option 4 Press the UP key to enter the code and access the menu ENTER CODE Ofetont 5 The following will be displayed Page 29 of 51 5 2 Parameters This directory enables you to see and modify sterilization time parameter Dry time is not available on this unit 1 Enter the MENU see sec 5 1 2 Using the UP DOWN keys select the parameters option 3 Press the START STOP key to enter that option 4 The CYCLE PARAMETERS screen is displayed CYCLE PARAMETERS Ster Time Dry Time Exit You can see the parameters of the current cycle l Ster Time sterilization time 2 Dry Time the time of drying stage N A for this model You can increase or decrease the value of each parameter to reach the desired value NOTE You can only change the values in the range from the default value up to 99 1 To increase or decrease the sterilization time use the UP and DOWN keys 2 To move the curse from one digit to another press the START STOP key 3 After setting the sterilization time use the START STOP key to go to SAVE Save the new time by pressing the UP key 4 Use the START STOP key to advance to EXIT and press the UP key to leave this section Page 30 of 51 5 3 Setting the Clock This directory enables you
36. ting stages Page 27 of 51 Corrective Action Call for service Call for service e Check that the autoclave is not overloaded see sec 2 6 e Check for steam leakage from the door e If the problem persist call the technician for service Call for service e Check the mineral free water supply is on e If the problem persist call for service Call for service Call for service N A e Check that the autoclave is not overloaded see sec 2 6 e Check for steam leakage from the door e If the problem persists call for service Call the technician Message Message Description Corrective Action This message is displayed if there Check the connections to No Res Src is no water supply the water supply This massage is displayed and Wait until the autoclave door opening is prevented if cools to end temp Temp2 High temperature sensor 2 senses a higher temperature than the pre set end temperature Door is Open Close the door to operate the autoclave You can run a new cycle only when the door is close and the icon disappears Page 28 of 51 CHECKING AND CHANGING PARAMETERS AND OTHER DATA In order to set the autoclave s date and time or change the sterilization time or to print the 10 previous cycles you need to access one of these sub directories in the main menu 1 Parameters 2 Set Clock 3 History 5 1 Main Menu To enter the menu screen
37. uld be placed in material which will allow steam penetration and promote drying such as autoclave bags autoclave paper or muslin towels 5 Materials used for wrapping and packing including materials used for inner wraps shall be compatible with the item being packed and the sterilizing method selected 6 Load the basket loosely to capacity 7 Place a sterilization indicator strip in each basket Empty containers l 2 For all loads not containing liquids insert the two temperature sensors 1 into the sensor holder 2 attached to the autoclave s door 3 see picture 7 1 1 Place empty containers upside down to prevent accumulation of water Page 37 of 51 7 4 Tubing Clean tubing and rinse with pyrogen free water Ensure both ends of the tube are open and free of any sharp bends twists or kinks eae Wrong a aa Right 7 5 Liquids Use only heat proof glass containers filled to 2 3 capacity 2 Place the two temperature sensors located on the door into two separate liquid containers These are used to control the program temperature and ensure the the safety of the operating cycle p 7 6 Loading The loading of goods and instruments is done by means of two stacked baskets The baskets are provided with handles for the convenience of the operator There are 2 types of baskets 1 Baskets that are fully perforated 2 Baskets that are not perforated except one row of holes adjacent
38. y exhausted from the chamber until the pressure equalizes to atmospheric pressure Ambient Pressure and Temperature Time Pressure Temperature Page 22 of 51 3 4 Program 4 Liquid Cooling Program 4 is intended to sterilize liquids The sterilization temperature is 250 F 121 C with cooling The cycle ends with cooling water circulated around the outside of the chamber while compressed air is used inside the chamber to maintain the liquid at a high boiling point e Average cycle time 1h30min for two containers holding 700ml each e Average cooling stage time 30min LaNa Nominal Parameters e Sterilization temperature 250 F 121 C e Sterilization time 20 min e Dry time None Operations Sequence e Water Inlet phase Water enters the chamber to the required level e Heating phase Water heats up until steam reaches the preset sterilization temperature e Sterilization phase Temperature is maintained constant at the preset value for the preset sterilization time e Cooling phase During the cooling phase tap water is circulated around the outside of the chamber to lower the temperature Compressed air is used to maintain pressure in the chamber which in turn maintains a high boiling point for the liquid just sterilized This prevents bursting and spillover of the vessels containing the liquid as the temperature is reduced The temperature of the liquid needs to decrease to 90 C for the
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