Elara 11 Operator`s Manual
Contents
1. lt m U A A JL P Caution Under no circumstance should water be filled above the level of 1 below the safety valve holder 8 In case more water is added accidentally above the top red section on the sight gauge decrease the water level by draining the reservoir before starting a cycle see para 11 2 Ni Page 44 of 57 10 2 Turning on the autoclave e When the power is off the door is locked e To start the system press the main white switch 1 on the right side of the autoclave i VT Y Wax em e When the unit is turned on heating begins The chamber is preheated and the symboli is displayed until the process is completed The steam generator 1s also heated and the symbol eg is displayed until the generator is ready Sterilization cycles cannot be started until the unit is ready NOTE If the unit is in the Vacuum Test mode the heaters are turned off e When the unit is ready the pre heating symbol is replaced by the next load number see picture below 2492 F 106 90 F Xx E i2 HA PSI c rU A e ONSE 10 3 Opening the door e Place your thumb on the plastic door cover right above the locking mechanism 1 and the other fingers in the handle 3 e Pull the handle 2 until the door lock is released e Open the door 10 4 Loading e Load the autoclave2. e Two safety pressure valves to prevent over pressurizing the steam generator or the chamber e A digital display is used for monitoring and control purposes This device displays the pressure in kPa psia or psig according to the operators needs The pressure is displayed for both the pressure in the chamber and the pressure in the steam generator e Temperature can be displayed in either F or C according to the operators needs The advantages of the prevacuum sterilizer are as follows e Removal of residual air from packs and porous load and most kinds of tubes rubber plastic etc by vacuum at the first stage of the cycle e More efficient steam penetration into the load assuring effective sterilization e Improved temperature uniformity throughout the chamber e Better drying of materials due to the vacuum achieved in the chamber during the drying cycle The printer prints the preset and actual parameters of the cycle temperature time and pressure vacuum This Manual is intended for the user and gives the user a general understanding of the instrument and the best ways to operate and take care of it in order to obtain effective results Before operating this autoclave read carefully the Operation Manual After reading this Manual operating the autoclave will be easy However since this instrument 1s built with high technology sensitive components no attempt should be made by the user or any other unauthorized p
3. 997 cm 39 257 452 mm 17 8 315 mm 12 4 400 mm 15 7 0 5 kg 1 1 Ib 2 0 kg 4 4 Ib Distance between supporting legs F Frontlegs F1 Rear legs Ti Maximum load per item Maximum load per tray Maximum solid load 8 0 kg 17 6 Ib Maximum textile load 2 0 kg 4 4 Ib 170 mm 6 7 Tray dimensions 2 mm 0 8 415 mm 16 3 No of trays 5 Page 12 of 57 4 5 4 6 4 7 Note Property Value Weight 148 Ib 67 1 kg 1 71 N m2 Weight per support area max load 0 036 Ib ft2 Shipping weight 184 Ib 83 4 kg Width 63 cm 24 8 m l Height 71 cm 28 0 Shipping dimensions Length 80 cm 35 8 Volume 0 36 m3 14 5 ft3 WEE EE Seal volume Mineral free water reservoir EE j 2 6 lit 0 68 US gal volume Used waste water reservoir E 5 2 lit 1 37 US gal volume Utilities Utility Value Mineral free water See table in para 4 10 TIENE phase 230 5 Vac o 50 60Hz Recommended circuit breaker ISA According to the local network Attention The electrical net must be protected with a current leakage safety relay The electrical network must comply with local rules or regulations Environment Emission Information 1 The peak sound level generated by the autoclave is 65dBa with background noise of 48 dBa 2 The total heat per hour transmitted by the autoclave is lt 200Wh Electrical Data Property Value Total Power 2300W Voltage 1 ph 230 Vac Amperage 10A Protec
4. The autoclave has unique characteristics Please read and understand the operation instructions before first operation of the autoclave This manual includes instructions guidance provided by the manufacturer how to operate the autoclave the door safety mechanism and the hazards involved in circumventing safety means and how to select an adequate sterilization program Make sure that you know where the main power switch 1s located Autoclave maintenance is crucial for the safe and effective function of the device The daily B amp D test at the beginning of the working day is part of the preventive maintenance plan along with the annual validation of the sterilization processes that ensures appropriate sterilization conditions Never use the autoclave to sterilize liquids since it is not designed for that purpose Below are the operating instructions safety instructions 1 All autoclave users must receive training in proper usage from an experienced employee Every new employee must undergo a training period under an experienced employee 2 Before use check inside the autoclave chamber to ensure that no items have been left from the previous cycle 3 Load trays in such a way as to allow steam to move freely among all items 4 When sterilizing plastic materials make sure that the item can withstand sterilization temperature Plastic that melts in the chamber is liable to cause a great deal of damage 5 Individual glass b
5. 6 F above sterilization temperature during the sterilization stage for 10 seconds This error is displayed when Perform a new the Generator pressure 1s cycle more than 40kPa 6psi above If the problem the required pressure persists call the technician This error is displayed if Perform a new Chamber Pressure raises 20kPa cycle 3psi above sterilization If the problem pressure for 5 seconds during persists call the the sterilization stage technician Err 005 High Gen Press Err 007 High Pressure Err 008 Low This error is displayed if Check for leakage Pressure Chamber Pressure drops from the door bellow the sterilization Perform a new pressure for 5 seconds during cycle the sterilization stage If the problem persists call the technician real time clock is faulty Err 011 Door is This error is displayed when Open and close the Open the door 1s open during the door then run a cycle new cycle If the problem persists Call the technician Page 22 of 57 Error Error m Err 012 Manual This error is displayed and Stop cycle is aborted after the STOP key is pressed Err 013 Air Valve This error is displayed after Replace air filter Error the air valve has been open for 3 minutes and the chamber is unable to reach atmospheric pressure Err 014 Low The error is displayed if the Verify that the door Vacuum chamber cannot reach
6. PIG TER ee 4466406000244460 6C a 50 11 4 REPLACING THE DOOR GASKET EE 51 11 5 CHECKING THE SAFETY TER 52 11 6 CLEANING WATER STRAINER eege eege Ee 53 11 7 EMERGENCY OPENING OF THE DOOR ccssscccsssscccssscccssscccessscccssscocsssces 54 12 TROUBLESHOOTING wissiaicecensssctvesssadiensatceseavascivasvatscsesvadsdsenbadcoseasasctseevasseveerssss 55 13 SPARE PAR ES LIST E 57 14 ACCESSORIES ee 57 Page 2 of 57 TABLE OF ILLUSTRATIONS FRONT KEEN e 17 REAR EE 18 ERAY TRAN DUB 3727270222792022 NI tu tsi T 56 FOUEN RACE EE 56 TRAV nueini E AAA P E EEE 56 ERA HOLDER deo 56 Page 3 of 57 1 GENERAL Read the Operating Instructions carefully before beginning any operation on the autoclave 1 1 LZ 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 1s 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 shipme
7. current process Cancels the ERROR message displayed on the screen and opens the electric door lock e Inthe menu directories o When the cursor is blinking on a number the START STOP LU key enables moving to the next position When the cursor is blinking on a menu selection the START STOP key activates that selection 5 1 3 Printer The printer prints the detailed history of each cycle performed by the autoclave The printing is made on thermal paper with 24 characters per line and contains the record information for subsequent consideration Page 21 of 57 5 2 Displayed Error and Operational Messages Error Error j l Ptl out This error and symbol are Call the technician displayed when the Chamber Temperature sensor Pt is disconnected or out of range Low This error 1s displayed when Check that the Temperature the temperature drops for more autoclave is not than second below the overloaded or check sterilization temperature for leakage from the door If the problem Err 002 persists call the technician Err 003 This error is displayed in one Check that the Temperature of the following cases autoclave is not During Pre vacuum Heating overloaded or or Sterilization Stages perform a new If Chamber Temperature is cycle greater than Limit Temperature If the problem for more than 10 seconds persists call the Sterilization Stage technician If temperature rises 3 C
8. exposed to non sterile environment Temperature ENNNNNNE Pressure ee ee ee ee ee 7242244342442 4 7 mm mm mm mm mm mm mm mm mm em em e em em e em em em mm em em em e em em em em e em wf em e em mm e em mm em em e e em em em em em em e em epee em e em em e em em em al o om wb em wm wm em wm dl em em em e em mm e mm em em mm e em em em em e em em e mm Be em mm e em em em mm e em mm e em e em em e em em em em dee em e mm em em e em e e em mm em em e em e em mm e em wll e em e em em e em e em em e em em em em e em em e em wll vm at em e cl e e wb wm d em wm em e em em e d e e em e em mm e em e em em e em em e em em em em e e bs em em e em em em mm e em em e em em em em e em em em em d om mm wm e em wm o e e mm e o wm d o o o e wm om mm e mm mm o mm e mm mm o e e e wm wl wm wm mm wm om mm e mm mm om mm e mm mm om mm e mm wm wm d o wm mm o mm em em e em em e em em wm em dl em wm wm em e em mm e em e em em e em em em em e em em wl wm wm mm wm em em wm em e em em e wm e em em e wm em wm dl o wm mm wm em wm wm Time min D I I I 9 18 27 36 45 I I I I 54 Cycle start Cycle end gt Page 28 of 57 6 4 Cycle start Program 4 WDry 121 Program 4 1s recommended for sterilizing double wrapped instruments porous loads and Hollow A e g dental hand pieces suction pipes loads at temperatures of 121 C 250 F with 20 minutes drying stage which its manufacturer declares their compliance to be sterilized in the fol
9. filter from the filter cover Replace the filter with a new one Connect the filter 3 to the flexible tubing 5 and tightening it with a tie wrap 4 Connect the filter to the filter cover by screwing the filter 3 into the hole in the cover 1 Insert the filter into the autoclave and secure the filter cover by turning it a 1 4 turn clockwise Verify that the tube has not been kinked and that the cover is fastened well in its place Page 50 of 57 11 4 Replacing the Door Gasket To avoid injuries replace the gasket while the autoclave is cold Pull off the gasket from the door groove and install the new gasket referring to the drawings as above points 1 2 and 3 Apply a mild and diluted soapy solution to the door gasket to ease its installation CAUTION See drawing below for the correct orientation of the gasket Autoclave s door Door gasket Page 51 of 57 11 5 Checking the Safety Valve See front view In order to prevent the safety valve from becoming blocked it is necessary to open the valve under pressure This
10. the autoclave 2 Insert part 5 into valve 3 and press it until you hear a click The drain valve opens immediately drain into a bucket 3 When the water reservoir is empty press part 4 Item 5 will pop out approx 3mm and the drain valve will be closed Remove item 5 with the plastic tube 4 If the drained reservoir is the clean water reservoir fill reservoir with distilled water until it reaches the full level approximately 6 5 liters 1 72 gallons The autoclave is now ready for use Clean water drain Waste water drain Press in this direction to engage the drain hose Press in the up direction to release the drain valve Page 49 of 57 11 3 Replacing the Air Filter In order to break the vacuum at the end of the dry phase filtered atmospheric air enters the chamber via a solenoid valve The filtration of the air 1s performed by the bacteriological filter that is placed at the inlet of the solenoid valve The filter is mounted near an opening on the rear wall of the autoclave enclosure to allow easy access for replacing it To replace the filter proceed as follows l Remove the filter cover 2 by turning the cover counterclockwise until it 1s released Remove the filter 3 from the filter cover by unscrewing the
11. the is properly closed required vacuum conditions Perform a new after 20 minutes cycle If the problem persists call the technician Err 015 Low Heat This error 1s displayed during Check that the the Pre Vacuum and Heating autoclave is not stages if the system can t reach overloaded the required pressure or If the problem temperature conditions after 20 persists call the minutes technician Err 016 Press This error and symbol are Call the technician Sensor displayed if the chamber pressure sensor 1s disconnected or out of range Pt2 out This error and symbol are Call the technician displayed when the Jacket Temperature sensor Pt2 1s disconnected or out of range Press This error and symbol are Call the technician Sensor displayed if steam generator Cutout pressure sensor is disconnected or out of range This error is displayed if the Make sure the generator electrode has no mineral free water for a specific time reservoir is full This error may appear the Perform a new first time the autoclave 1s cycle used and in this case does If the problem not indicate any malfunction persists call the technician Err 021 Test Fail This error is displayed if Check for leakage one of the test programs fails from the door Dry the chamber and try a second time Page 23 of 57 Cutout Symbol Message Description Corrective Action This symbol is displayed if Pour water in the there
12. the unit on momentarily to allow the door to be opened Then turn the unit off to stop the chamber from preheating 2 Remove the trays and the tray holder Remove the strainer element mounted on the bottom rear of the chamber 4 Clean the strainer with water using a nylon or brass bristle brush if necessary Reinstall the strainer element 6 Reinstall the tray holder and the tray Strainer element The strainer element is located on the back of the chamber Page 53 of 57 11 7 Emergency opening of the door If there is no power to the autoclave and the door is closed the lock will be engaged If you need to open the door follow this procedure 1 Turn the power switch off 2 Wait at least one hour until the autoclave cools down 3 Verify that there is no pressure in the autoclave chamber by pulling the ring of the chamber safety valve see sec 11 5 4 Insert a pin 1 into the hole 2 in the handle pressing down the locking pin 5 Open the door Page 54 of 57 12 TROUBLESHOOTING technical documentation including a technician manual and adequate information are authorized to service the apparatus Display is not Verify that the main switch is in the On position activated Only technical personnel having proper qualifications and holding Make sure the power cord is properly connected to the machine and the power source Verify that there 1s electrical power in the main source I
13. 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 3 Launder textile wraps prior to reuse but do not use bleach 4 Follow the instrument manufacturer 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 directly on stainless steel trays 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 on the tray or rack 7 When using a paper plastic bag the plastic side should always be down 8 Items must be sterilized in an open position Surfaces that are hidden because the item is in a closed position will not be exposed to the steam and will not be sterilized a o Pb m po pid gt SS o iu Se eg 2 ete Fe EH SE e a p 9 Check the instructions of the item manufacturer as to the proper procedure for sterilizing each item 10 Place a sterilization indicator in each tray or inside each wrapped pack Page 41 of 57 11 12 13 14 15 16 17 18 19 20 At least once a week use a biological spore test Bacillus Stearothermophilus in any load to insure prop
14. tray They should not be touching each other or the Chamber walls There should be about 1 between packs for proper steam circulation Page 42 of 57 2l 22 25 If spotting is detected on the instruments the first step would be to use an ordinary eraser to remove the spot If there is no pitting under the spot then the spot was only dirt Dirt spots on an instrument may be an indication that the autoclave needs to be cleaned or that the instruments were not adequately cleaned or dried If removal of the spot reveals pitting the spot was most likely rust Rust spots on an instrument are not uncommon on inexpensive instruments It may also be an indication that the instruments were rinsed in tap water with a high content of minerals These minerals when exposed to high temperature and steam will accelerate the oxidation of the metal One suggestion would be to final rinse the instruments in a distilled water bath If the instruments exhibit a discoloration this can be due to the mixing of carbon steel and stainless steel When these two metals come into contact with each other an electrolysis occurs that breaks down the metal The best solution is to separately wrap the carbon steel to insulate it from other instruments or the trays Items should not be allowed to touch the walls of the Chamber as the hot metal can damage the item Page 43 of 57 10 OPERATING INSTRUCTIONS It is recommended to perform a B amp D test cycl
15. will allow the steam to escape clearing the valve this needs to be done monthly There are two safety valves located in the mineral free water reservoir CAUTION You can be burned by hot steam Do not place your face or hands N directly over the safety valve 1 Operate the sterilization cycle according to the manual but with no instruments 2 Allow a pressure of approximately 300 kPa 29 psig to build up in the generator and the chamber Remove water reservoir cover 1 4 Pull the ring 4 of each safety valve in turn using a tool i e screwdriver hook etc 3 Pull the safety valve ring for 2 seconds Be careful not to burn your hands 5 Press the STOP key to stop operation and exhaust steam from chamber 6 Wait until pressure decreases to zero only then can the door be opened GL 3718 fa Mu ISd Ob LAS Safety valve Pulling device Pressure relief ring Page 52 of 57 11 6 Cleaning water strainer CAUTION Before proceeding make sure that there is no pressure in the chamber gt CAUTION Do not touch the strainer shortly after operation Touching the hot strainer s cover may cause severe injuries If maintenance operation is performed while strainer cover is hot use heat resistant gloves to avoid injuries gt 1 Turn
16. 2 Use the UP and DOWN keys to increase or decrease the current digit 3 After changing the parameter to the required value confirm the new value Do this by pressing START STOP a few times until SET is blinking and then press UP or DOWN 4 If before confirmation you decided not to change the parameter press START STOP a few times until EXIT is blinking Press UP or DOWN The display will return to the previous menu and the parameter will not be changed 5 If by mistake the curser skipped the SET and reached EXIT continue to press START STOP until the curser returns to SET Page 34 of 57 Zi Setting the Clock This directory enables the operator to set the time and date The SET CLOCK screen is displayed when entering the SET CLOCK directory SET CLOCK Time M1 50 29 Date 25 05 2007 SAVE EXIT When entering the directory the curser will be blinking on the hour digit The time is displayed in the upper row in the form hh mm ss The hour range is 24 hour 1 e from 0 to 24 The date is displayed in the lower row in the form DD MM Y YYY l 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 After changing the time and the date move the curser to SAVE 4 Confirm the new time and date by pressing the UP key While the new time and date are being saved the following screen is displ
17. 4 41 Date 04 29 2010 POWER ON V Vacuum stage H Heating stage S Sterilization stage DESCRIPTION To be filled in manually by operator Time sterilization cycle ended Date sterilization cycle ended The time temperature and pressure during drying Prints drying data every 3 minutes The time temperature and pressure during drying The time temperature and pressure during exhaust The time temperature and pressure during exhaust The time temperature and pressure during sterilization Prints sterilization data every minute The time temperature and pressure during sterilization The time temperature and pressure during heating The time temperature and pressure during heating The time temperature and pressure during air removal Prints sterilization data every 3 minute or on upper and lower peak the shorter time The time temperature and pressure during air removal Time temperature and pressure psig columns Drying time for selected program Sterilization time for selected program Sterilization temperature in chamber for selected program Cycle name with dry Cycle counter Version of parameters setting Software version Autoclave s serial number Time sterilization cycle started Date sterilization cycle started The device is turned on Exhaust stage Drying stage Test J P Page 38 of 57 8 2 Printer Handling 8 2 1 Maintenance Wipe off any soiling on the printer surface
18. Tuttnauer Your Sterilization amp Infection Control Partners OPERATION amp MAINTENANCE MANUAL Pre Post vacuum Class B Table top Autoclave Model ELARA 11 Cat No MAN205 0342001EN Rev Q C Manufactured by l2 Tuttnauer Co Ltd Har Tuv Industrial zone B P O Box 170 Beit Shemesh 99000 Israel Tel 972 2 9904611 Fax 972 2 9904730 Tuttnauer U S A Co Ltd 25 Power Drive Hauppauge NY 11788 USA Tel 631 737 4850 800 624 5836 L 7377 0720 Fax 631 TABLE OF CONTENT Be OPENER S WEE 4 1 1 INCOMING INSPECTION WEE 4 1 2 EE EN EE 4 1 3 WARRANTY STATEMENT WEE 5 2 SAFETY INSTRUCTION ee 4246 e A CI Eee o VE PELO HUI eri 6 3 2 INSTAELATION e 7 3 1 e e e E 7 GENERAL INFORMATION eccccccecccccccccccccccoccccco00eeoooo0000eoooo0u000eeoooue0eeoooueuesocoues 10 4 1 INTENDED lege 10 4 2 INTRODUCTION orree Diete e oas E E debana 10 4 3 OPERATING CHILE EIERE EE 11 4 4 EE 12 4 5 UTILIT S 142443420 22210504 EE 13 4 6 ENVIRONMENT EMISSION INFORMATION ccccccocccco0000000000000000000000000000 13 4 7 ELECTRICAL DATA E 13 4 8 EENS 14 4 9 SYMBOL DESCRIPTION egen 14 4 10 WATER QUALITY EE 15 4 11 DIRECTIVES ECKE 16 2 KEYBOARD SEN 19 5 1 DESCRIPTION AND FUNCTIONS OF THE FRONT PANEL KEYBOARD 20 9 2 DISPLAYED ERROR AND OPERATIONAL MESSAGES eee eee eee eene ooue 22 v NTERILIZATION PROGRAMS 52246 6266204866 606 eege Vua near
19. age which its manufacturer declares their compliance to be sterilized in the following conditions The solid load shall not exceed 8kg 17 6 Ib Nominal Parameters e Sterilization temperature 134 C 273 F e Sterilization time 4 minutes e Dry time minute e Max cycle time 25 minutes e Average cycle time 15 minutes Operation Sequence e Air removal phase two vacuum pulses as described in the diagram below Saturated steam is introduced into the chamber until the sterilization temperature is reached e Sterilization phase temperature and pressure are maintained constant at the pre set level for the sterilization time e Fast exhaust phase steam is rapidly exhausted from the chamber followed by a 1 minute vacuum pulse for drying followed by a vacuum break air inlet until the chamber pressure equalizes to atmospheric pressure Note The sterility of instruments processed in unwrapped cycles cannot be maintained if exposed to non sterile environment gt Temperature H Pressure ega amMmssaiq GEL susp asmgesadura T ee ee mm mm GA vn Er ee ee ee ee mm mm mm mm mm mm mm mm mm mm mm mm mm mm mm PLE af o hb o wm em wm wm ET TT e n wm wm mm wm em em e em em em ELE em elle wm wm em wm wm dl em wm wm mm wm em em wm mm A wm wm em wm dl wm wm em wm wm 661 _ _ cococcocococococcccoccocodcocococococococcococpbocrococ
20. ayed 5 After saving is completed the SET CLOCK screen is displayed again move the cursor to EXIT and press UP to return to the previous MENU screen 6 The printer will print the date in the format DD MM Y Y YY if the chamber temperature is being displayed in C It will print the date in the format MM DD Y Y Y Y if the chamber temperature is being displayed in F Page 35 of 57 7 4 History This directory enables you to print the 40 previous cycles The HISTORY screen is displayed when entering the HISTORY directory Log Load Nu Log Load Nu Log Load Nu Log Load Nu Log Load Nu EXIT 1 Choose the required cycle according to its number Log Load Nu with the UP and DOWN key 2 The words Log Load Nu are replaced by printing and the required cycle data is printed by the built in printer 3 In order to leave this screen go to the EXIT option by using the DOWN key and select it by pressing the START STOP key Page 36 of 57 8 PRINTER 8 1 Printer Operation The autoclave is equipped with a character printer which prints a detailed history of each cycle performed by the instrument This can be useful for record keeping or subsequent consideration The printing is made on thermal paper with 24 characters per line and contains the following information Date started Time started Serial number of unit Software version Parameter version Load number Selected program Sterili
21. ccocococorboooooboooboocoocooco boooooo 00ooocooc00c00000009000c004900000c00c0c0c00000004q0r00r00 Ch 8 ee ee ee eee zm zm eda 2C 16 20 24 C Cycle end 5 Page 26 of 57 Time min 6 2 eqop amssa1q GEL enen auqeaadura T CEL PEL GGC LLE 9 0 Of 69 Ec 8 Cycle start F P Program 2 WDry 134 Program 2 is recommended for sterilizing double wrapped instruments porous loads and Hollow A e g dental hand pieces suction pipes loads at temperatures of 134 C 273 F with 20 minutes drying stage which its manufacturer declares their compliance to be sterilized in the following conditions The solid load shall not exceed 8kg 17 6 Ib The porous load shall not exceed 2kg 4 4 Ib Nominal Parameters e Sterilization temperature 134 C 273 F e Sterilization time 4 minutes e Dry time 20 minutes e Max cycle time 50 minutes e Average cycle time 42 minutes Operation Sequence e Air removal phase three vacuum pulses as described in the diagram below Saturated steam is introduced into the chamber until the sterilization temperature is reached e Sterilization phase temperature and pressure are maintained constant at the pre set level for the sterilization time e Fast exhaust phase steam is rapidly exhausted from the chamber followed by a continuous vacuum pulse for the drying stage followed by vacuum break air inlet until the chamber pressure equalize
22. cles which ever comes first according to para 11 3 11 1 3 2 4 Check the door gasket every 12 months and replace it 1f required see para 11 4 By a qualified technician Every 6 months Tighten the bolts of the heater bands and the electrical connections of the heaters valves and connectors 1n the control box Dram the generator and refill with mineral free water Once a year Check the grounding continuity Calibrate the temperature and pressure Perform validation of the autoclave Check the precise operation of the earth leakage relay Check the safety elements safety valve cut off thermostat door locking mechanisms Check the operation sequences the sterilization parameters etc Check the water reservoir piping plastic parts and electric wires Check and tightening the piping joints to avoid leakage Check and tighten all screw connections in the control box heaters and valves and instrumentation 5 years Check the door closing system for excessive wear Performing safety tests pressure vessel efficiency electrical according to local rules or regulations safety tests shall be perform only by an authorized inspector Page 48 of 57 11 2 Draining the Reservoirs Applies to the clean water reservoir and to the waste water reservoir 1 To drain the reservoir use item 5 with the plastic hose 6 attached to it supplied with
23. e at the beginning of each working day 10 1 AN Filling the Mineral Free Water Reservoir Attention Only use water having the characteristics outlined in section 4 10 Water Quality Using Tap water will clog the system and invalidate the manufacturer s guarantee 1 Open the door 3 2 Pour water gently into the front funnel 7 until it reaches the required level 4 on the sight gauge Please note that the sight gauge is divided into three sections The bottom red section 6 indicates that the water level in the reservoir is too low The middle blue section 4 shows that there is sufficient amount of water The upper red section 2 indicates that the water level in the reservoir is too high To assist the operator to detect the water level the sight gauge is equipped with a yellow float 5 Caution Under no circumstance should water be filled above the top red section on the sight gauge ENU d d j 1 A 1 j ri z l E j e 3 Ifthe reservoir is empty it is recommended to add water directly into the reservoir as follows Remove the water reservoir cover to reveal the water reservoir 1 Pour water having the characteristics outlined in section 4 10 Water Quality into the reservoir through the opening on top of the autoclave until it reaches the blue level on the sight gauge 4 3 A ES Ba ES X H H H V e V H
24. e chamber from preheating and proceed with cleaning l Clean the door gasket with a soft cloth using water and a mild soapy solution The gasket should be clean and smooth Check the interior of the autoclave If the autoclave is dirty it requires cleaning as follows Remove the tray holder and trays Clean the tray holder and trays 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 the tray holder and trays immediately with water to avoid stains on the metal CAUTION Do not use steel wool or steel brush as this can damage the chamber and trays 11 1 2 Weekly by the operator l 2 Clean the outer parts of the autoclave with a soft cloth Replace mineral free water in the reservoir If the autoclave is only used occasionally drain the water from the mineral free water reservoir once a week and refill with fresh mineral free water or distilled water see para 11 2 Once a week or when symbol Ej is displayed which ever comes first drain the water from the waste water reservoir see para 11 2 Page 47 of 57 11 1 3 Periodically 11 1 3 1 By the operator 1 Oncea month check the safety valve see para 11 5 2 Once a month clean the strainer as per para 11 6 Cleaning frequency may be reduced according to experience 3 Replace the air filter every 6 months or after 1000 cy
25. eep the back and the sides of the autoclave approximately 2 5 cm away from the wall to allow ventilation and facilitate the device disconnection 4 f placed in a cabinet verify that the rear of the cabinet 1s open to allow ventilation Insufficient space for ventilation may result 1n an increase of the autoclave s temperature that may cause a malfunction or damage the instrument Page 7 of 57 It is recommended that enough space be left around the autoclave to give a technician access for servicing the machine Check and verify that the room ventilation is 10 cycles per hour minimum Check and verify that the ambient temperature range is 41 F 104 F 5 C 40 C it is preferable not to exceed 86 F 30 C Check and verify that the ambient relative humidity does not exceed 85 3 1 4 Connections to Utility Supplies l Check and verify that the power supply is a 1 phase 230Vac 5 50 60Hz as appropriate 15A supply Check and verify grounding of the autoclave Check and verify that the electrical net is protected with a current leakage safety relay 3 1 5 Final adjustments Once the autoclave is installed the following operations have to be performed before operating any cycle 3 1 6 l Setting clock and date See instruction in the user manual sec 7 3 Adjust parameter ATMPressure according to the altitude of the autoclave See instruction for adjusting parameters ATMPressure sec 7 2 6 in the Techn
26. er sterilization Be aware testing standards may vary Always follow the spore test manufacturer s instructions Make sure that all instruments remain apart during the sterilization cycle Surfaces that are hidden because items are covering other items will not be exposed to the steam and will not be sterilized Verify that packaging methods are in accordance with the good practice approach and the packaging materials used are in agreement with applicable standards Empty canisters should be placed upsidedown in order to prevent the accumulation of water Do not overload the Sterilizer trays Overloading will cause inadequate sterilization amp drying Allow a distance of approximately 1 between trays to permit steam circulation Wrapped instruments should be placed in material which will allow steam penetration and promote drying such as autoclave bag autoclave paper or muslin towels Do not stack pouches It is recommended that a pouch rack such as the Tuttnauer POUCH RACK be used to insure proper steam penetration and adequate drying Surfaces that are hidden because the items are being stacked will not be exposed to the steam and will not be sterilized a Ux lt RNJ A SMK SA L A RY SV gt X X P WN zi Tubing should be rinsed after cleaning When placed in the tray make sure that both ends of the tubing are open and there are no sharp bends or twists Packs should be placed upright on the
27. er the MENU of the autoclave The following screen is displayed 6 d MENU Parameters Set Clock History EXIT To browse through the sub directories use the UP and DOWN keys When the appropriate directory is blinking press the START STOP key The required screen see the following paragraphs will be displayed 8 To exit the MENU screen press the DOWN key to move the curser to EXIT and press START STOP Page 33 of 57 Tze Parameters This directory enables the operator to see and change the cycle s parameters Therefore it is necessary to choose the required cycle before entering the MENU directory see 10 6 Selecting a program For seeing or changing the parameters proceed as follows The CYCLE PARAMETERS screen is displayed when entering the PARAMETERS directory CYCLE PARAMETERS DryTime Exit The following parameters of the current cycle are displayed 1 Ster Time sterilization exposure time in minutes 2 Dry Time drying time in minutes To select the desired parameter use the UP and DOWN keys When the desired parameter is blinking press START STOP The default SterTime value is the minimum allowable value It is possible to increase the time value up to a maximum of 99 minutes However cycles of this length have not been tested and there is no guaranty that they will be successful l To move the curser from one digit to another press the START STOP key
28. erson to repair or recalibrate it Only technical personnel having proper qualifications and holding technical documentation including a Technician Manual and adequate information are authorized to install and service the apparatus Page 10 of 57 4 3 Operating Conditions This device is for indoor use only The sterilizer should be loaded only with autoclavable material Minimum room ventilation shall be10 cycles per hour The environment shall not exceed an ambient temperature range of 41 F 104 F 5 C 40 C and a relative humidity of 85 respectively The operation altitude shall not be over 6500 feet 2000 meters ambient pressure shall not be lower than 80 kPa 11 6 psia CAUTION Waste water should be brought into the public net in accordance with the local rules or requirements ONLY NON HAZARDOUS LIQUIDS SHALL BE DISPOSED IN PUBLIC SEWAGE Page 11 of 57 4 4 Specifications Overall Dimensions Front View Top View E p Property Value Max Allowable Working Pressure MAWP 2 8 bar 40 psi Diameter 280 mm 11 Chamber Depth 504 mm 19 8 28 5 lit 7 5 gal Width A 530 mm 20 8 Height B 444 mm 17 4 External dimensions Length C 645 mm 25 4 Length with open door D Chamber volume
29. eters e Sterilization temperature e Sterilization time e Dry time S A ap E e Te LP Chamber temperature Chamber pressure Steam generator pressure Time display Clock Time countdown Load number Or Error and operational messages Page 20 of 57 5 1 2 Keypad The keypad consists of 3 keys as described below UP key This key has the following functions e Inthe menu directories o This key enables the operator to browse through the cycles e In the directories available o When the cursor is blinking on a number the UP A key increases its value o When the cursor is blinking on a menu selection the UP A key allows browsing backward through the menu When adjusting a parameter and the cursor is blinking on SET or EXIT the UP A key activates that procedure DOWN key This key has the following functions e Inthe menu directories o This key enables the operator to browse through the cycles e In the directories available o When the cursor is blinking on a number the DOWN V key decreases its value When the cursor is blinking on menu selection the DOWN V key allows browsing forward through the menu When adjusting a parameter and the cursor is blinking on SET or EXIT the DOWN V key activates that procedure START STOP key This key has the following functions e Inthe main screen Starts the process when the required program was chosen Stops the
30. f the problem persists contact your dealer or Tuttnauer USA for further assistance The printer Make sure the paper is inserted in the printer correctly does not print See section 8 2 Switch the machine off then back on If the printer prints the date and time the printer 1s O K If the printer does not print the date and time contact your dealer or Tuttnauer USA for service Page 55 of 57 TRAY HANDLE CT530020 POUCH RACK AR910 TRAY CT520010 TRAY HOLDER TRH411 0004 Page 56 of 57 13 SPARE PARTS LIST PART NUMBER FIL175 0016 01610406 14 ACCESSORIES PART NUMBER AR910 CT530020 CT520010 GAS084 0007 THEO002 0022 TRH41 1 0004 02819996 DESCRIPTION Filter Air 0 2 Micron Model 50mm D Paper Roll Printer DPU30 DESCRIPTION Pouch rack Handle Tray Tray Drain P V C Tube 13mm OD x 10mm ID Printer DPU 30 Seiko Holder Tray 11 Power Cord Quick Disconnect 220 V Page 57 of 57
31. he operation 10 9 Canceling the ERROR message e At the end of an aborted process the error number CYCLE FAIL and a blinking warning symbol N are displayed on the screen Refer to Displayed Error and Operational Messages see sec 5 2 e Pressing the START STOP key cancels the displayed message number and enables opening the door Warning The load has not completed a sterilization cycle therefore it is not sterile Handle it as a contaminated load 10 10 Sleep Mode The autoclave has a sleep mode If the autoclave has not been used for 4 hours and no key has been pressed during this period the unit will go to sleep In this mode all outputs including the heaters are turned off To exit the Sleep mode press any key Page 46 of 57 11 MAINTENANCE INSTRUCTIONS 11 1 Preventive and Scheduled 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 these 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 4 10 water quality 11 1 1 Daily by the operator Turn the unit on momentarily to allow the door to be opened Then turn the unit off to stop th
32. icians Manual Operating the autoclave l 2 3 Plug the power cord into the power socket Turn on the Main Switch Circuit Breaker see front view Select Vacuum Test cycle to keep the steam generator and heating elements from heating up See Selecting a program sec 10 6 Open the door of the autoclave and remove the trays and the packaging material Fill the Mineral Free Water Reservoir with water meeting the quality specs in section 4 10 as follows 5 1 Fill with 4 liters of mineral free water by pouring it into the front reservoir fill opening at the top of the machine see front view 5 2 Fill the remaining quantity by pouring water gently into the front funnel until it reaches the required level on the water level sight gauge See Front View Insert a paper roll in the printer see printer handling sec 8 2 Close the door and perform a Vacuum Test If the test fails perform another test since the fail may be a result of moisture in the air If the second test fails it may be necessary to run Program 2 with the long drying cycle to remove any excess moisture that 1s causing the test to fail Page 8 of 57 8 10 11 If the Vacuum Test is successful then select the B amp D Test cycle At this stage the chamber and steam generator will be heating up It will take approximately 15 minutes from selecting the B amp D Test While waiting for the unit to heat up explain and instruct the operator as follo
33. is insufficient water in front funnel until the mineral free water the water level reservoir sight gauge reaches the full level This symbol is displayed if the Drain the reservoir waste water reservoir is full This symbol is displayed Wait for the while the chamber is autoclave to reach preheating the proper operating conditions before staring a new cycle This symbol is displayed Close the door to when the autoclave door is perform a new open cycle This symbol is displayed Wait for the when the steam generator is generator to create heating and not ready to run a steam cycle Page 24 of 57 6 STERILIZATION PROGRAMS The autoclave offers 5 sterilization programs and 2 test programs as follows Sterilization Programs Program Flash 134 Program 2 Wdry 134 Program 3 No Dry 121 Program 4 Wdry 121 Program 5 Delicate 121 Tests programs Test 1 B amp D Test Test 2 VacTest During the process the graph of the E will be displayed on the screen This graph shows the different steps of the process V Vacuum stage V1 first pulse V2 second pulse V3 third pulse H Heating stage S Sterilization stage E Exhaust stage D Drystage T Test program The circle 1 shows the current point of the cycle Page 25 of 57 ON 6 1 Program 1 Flash 134 X Program 1 is recommended for sterilizing unwrapped instruments at temperatures of 134 C 273 F with 1 minute drying st
34. lowing conditions The solid load shall not exceed 8kg 17 6 Ib The porous load shall not exceed 2kg 4 4 Ib Nominal Parameters Sterilization temperature 121 C 250 F Sterilization time 20 minutes Dry time 20 minutes Max cycle time 70 minutes Average cycle time 60 minutes Operation Sequence eq aimssaig Ec suso amqejadura T LE c6 FEL 9 1 901 EZ LS 9S Eg OL Air removal phase three vacuum pulses as described in the diagram below Saturated steam is introduced into the chamber until the sterilization temperature is reached Sterilization phase temperature and pressure are maintained constant at the pre set level for the sterilization time Fast exhaust phase steam is rapidly exhausted from the chamber and drying stage is performed with a continuous vacuum pulse followed by vacuum break air inlet until the chamber pressure equalizes to atmospheric pressure Temperature Pressure te re ee eee eee eee ee mm mm zm zm zi dl zm zm zm zm zm zm zs ee ees ee eee eee ep EE E E EE E TE E E E E RA E E E SE E SE S _ M ha GA C J J cn Let lll2zcdulosesssesesc ucsescsuuesucdasdadcecczadqpedu sSuszeua es Cn em Zl a gt aw Cn Cycle end gt Page 29 of 57 Program 5 is recommended for sterilizing delicate instruments at temperatures of 121 C 250 F with slow exhaust which its manufacturer declares their c
35. m mm wm mm wm mm wm wm n wm wm mm wm wm e eee mm wm mm wm mm wm mm wm em wm wm d o wm wm wm e e e wm olf o wb eee wm e wm mm wm wb a mm mm m mm mm mm mm mm H mm mm mm mm m mm mm mm mm mm mm zm am mm zm zm zm zm ss bs a sm ss bk e zm zm zm mm mm em em e em e em e em e em e em e em em em em em em wm Dell o e e eck wm wm em e em e em e em e em em wm gt t wm wm mm e em e em e em e em em em em em em em em em mm d e wm em e em e em e em e em em em mm em em em wm em wm e ln wm wm wm em e em e em e em e em mm em e em e em em wm dl om wm wm em em em wm mm d wm wm em wm em dl em wm wm wm wm wm Jab ss he d ll mm mm mm _ _ ee ee eee a mm mess mm mm mm zm eee zm 24 fR ca N PEE MEM gum Cc 20 Page 32 of 57 Time min MODIFYING PARAMETERS AND OTHER DATA In order to modify sterilization parameters change the system clock or print out previous cycles the operator has access to three sub directories from the main menu 7 1 Menu 1 Enter the MENU screen by pressing simultaneously for 2 3 U seconds the UP and DOWN keys To exit this screen use the START STOP key to move the curser to EXIT then press the UP key 0000 is displayed on the screen with the cursor blinking under the right digit ENTER CODE OOON To increase the right digit press the UP key After changing the code to 0001 move the cursor to SET by pressing the START STOP key four times When SET is blinking press the UP key to ent
36. nt 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 We certify that this instrument is guaranteed to be free from defects in material and workmanship for one year against faulty components and assembly This warranty does not include routine cleaning and preventive maintenance which needs to be performed according to instructions in section 11 Preventive and Scheduled Maintenance Tuttnauer warrantees all new autoclaves for a period of one full year covering both parts and labor This one year warranty covers defects in materials and workmanship on every part in the autoclave except the HEPA filter and the door gasket This warranty does not apply to any instrument that has been subjected to misuse neglect accident or improper installation or application nor shall it extend to autoclaves that have been repaired or altered outside the factory without prior authorization from Tuttnauer Tuttnauer s obligation is limited to the repair or replacement of parts for the autoclave This warranty will be void if the unit is not purchased from an authorized Tuttnauer dealer No other warranties or obligations are expressed or implied Warning Sterilization programs 1 5 are not considered by the Food and Drug Administration to be standard sterilization cycles In the United States use only sterilize
37. oclaves that does not comply with the table above may have severe impact on the working life of the sterilizer and can invalidate the manufacturer s guarantee Page 15 of 57 4 11 Directives and Standards Every autoclave meets the provisions of the following Directives and is in compliance with the following Standards 4 11 1 4 11 2 Technical Standards 1 ANSI AAMI ST55 Small Steam Sterilizers 2 ASME Code section VIII division 1 for pressure vessels 3 UL 61010 1 electrical equipment for laboratory use general requirements 4 IEC 61010 2 040 particular requirements for sterilizers and washer disinfectors used to treat medical materials The following standards were taken in consideration 5 ANSI AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities 6 ISO 17665 1 2006 specifies requirements for the development validation and routine control of a moist heat sterilization process for medical devices Quality standards The manufacturing plant meets the following quality standards l ENISO 9001 2008 Quality System 2 ISO 13485 2003 Quality systems Medical devices 3 21 CFR 820 Quality System Page 16 of 57 FRONT VIEW No Description No Description 1 Water reservoir funnel 10 Operating keypad 2 Autoclave cove
38. ompliance to be sterilized in the following conditions The solid load shall not exceed 8kg 17 6 Ib Nominal Parameters e Sterilization temperature 121 C 250 F 6 5 Program 5 Delicate 121 e Sterilization time 20 minutes e Max cycle time 55 minutes e Average cycle time 45 minutes Operation Sequence e Air removal phase two vacuum pulses as described in the diagram below Saturated steam is introduced into the chamber until the sterilization temperature is reached e Sterilization phase temperature and pressure are maintained constant at the pre set level for the sterilization time e Slow exhaust phase steam is slowly exhausted from the chamber by pulses of the exhaust valve until the chamber pressure equals atmospheric pressure Temperature Pressure eqop amssa1q ECL stusja amer Sig Z 201 BEL C O01 2 C CH Time min Edy vc 15 26 39 Cycle end 5 Cycle Start Page 30 of 57 LOOCO Us Loo000 LOCOO0 gt LOOOO0 gt L00000 uw LOOO 0 gt Eq 3455344 GE spp amptdwa PEL GGC 9LE GLI etl CL edi LI 6 6 Test 1 B amp D Test Test 1 is the Bowie amp Dick test program with fixed sterilization parameters 134 C and 3 5mins which cannot be modified by the operator or the technician Nominal parameters e Sterilization temperature 134 C e Sterilization time 3 5 minutes e Dry time minute e Max cycle time 30 minu
39. ottles shall be placed on a tray 6 On closing the device door make sure it is properly locked before activating Verify that DOOR OPEN symbol is replaced by the load number 7 Verify once again that you have chosen the appropriate sterilization program 8 Open the door slowly to allow steam to escape and wait 1 minute before you remove the load 9 When removing the trays it is recommended to use the tray handle or wear heat resistant gloves 10 Once a month ensure that the safety valve is operating 11 A certified inspector must perform a periodic pressure chamber safety test according to the local regulations 12 Once annually or more frequently effectiveness tests must be performed 1 e calibration and validation 13 Make sure there are no leaks breaks blockages whistles or strange noises 14 Perform maintenance operations as instructed The owner of the autoclave is responsible to perform the maintenance operations 15 Notify the person in charge immediately of any deviation from the normal functioning of the device 16 Protective equipment and clothes and other safety instructions should be implemented in accordance with local and national regulations and or rules Page 6 of 57 3 INSTALLATION 3 1 Placing CAUTION The installation and all operations described in this chapter must be done only by an authorized technician 3 1 1 Lifting and carrying CAUTION Before moving the autoclave Make sure tha
40. properly according to instructions in section 9 Compatible goods Do not overload Page 45 of 57 10 5 Closing the Door e Hold the opening handle in an open position while pushing the door to a closed position then release the handle The open door symbol is replaced by the next load number 10 6 Selecting a Program e Select the program UP key next program DOWN key previous program e Verify that you have chosen the correct cycle e Start the cycle by pressing the START STOP key 10 7 Unloading e When the cycle ends the buzzer sounds continuously for 10 seconds and the message CYCLE END is displayed on the screen e Open the autoclave as follows e Open the door the minimum required to let any residual steam escape from the chamber Only after there is no more vapor open the door fully Warning To avoid sever injuries from hot steam when opening the door tis strictly forbidden to lean on the autoclave Itis strictly forbidden to place your hand or any part of your body over the door e Wear heat resistant gloves or use the tray handle to remove the load from the autoclave e On completion of the cycle the load shall be visually inspected to ascertain that the load 1s dry and that sterilization indicators have made the required color change 10 8 Stopping the process e It is possible to stop the program while the autoclave is operating Pressing the START STOP key at any stage of process stops t
41. r 11 Printer cover 3 Water level sight gauge 12 Printer standard 4 Mineral free water reservoir cover 13 Legs 5 Chamber and steam generator safety 14 Mineral free water reservoir drain valves valve 6 Waste water reservoir cover 15 Waste water reservoir drain valve 7 Display 16 Door cover 8 Ventilation grill 17 Door switch 9 Main switch circuit breaker 18 Door closing device Page 17 of 57 REAR VIEW NONO NN NAO VN XE R o Description VDP DP 1r COVCT Mineral free water reservoi l 2 3 4 1r COVCT Waste water reservo lls ion gri Ventilat Aur filter service cover Opening for calibration 5 Main power electric cable socket 6 Page 18 of 57 3 KEYBOARD 0 0 0 No Description 1 Display 2 Keypad 3 Printer Page 19 of 57 5 1 Description and Functions of the Front Panel Keyboard The front panel is composed of 3 sections 1 Display screen 2 Keypad 3 Printer 5 1 1 Display screen The display is a graphical screen used to display the current status of the autoclave and any Operational Messages or Error Messages e Program icon Program param
42. r accessories that have been cleared by the Food and Drug Administration for the selected sterilization cycle parameters time and temperature Users should only use sterilizer accessories such as sterilization wraps sterilization pouches chemical indicators biological indicators and sterilization cassettes that have been cleared for use in their markets The Autoclave should not be used in a manner not described in this manual Page 4 of 57 1 3 Warranty Statement To activate the warranty the registration card must be completed and returned to Tuttnauer within fourteen 14 days of purchase or you may call our customer service department at the number listed below No product will be received or accepted for repair without prior return authorization from Tuttnauer All transportation charges to and from Tuttnauer must be paid by the owner of the autoclave During the first 90 days after purchase of an autoclave Tuttnauer will pay shipping costs on an individually evaluated basis and ONLY with pre approval 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 Tuttnauer USA Co Do not attempt to service this instrument yourself 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 Page 5 of 57 SAFETY INSTRUCTIONS
43. rinting because it becomes very hot Make sure that the thermal head is cool before setting papers or cleaning the thermal head Page 40 of 57 PREPARATION BEFORE STERILIZATION The purpose of packaging and wrapping of items for sterilization is to provide an effective barrier against sources of potential recontamination This is in order to maintain sterility and to permit aseptic removal the pack contents at the time of the procedure 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 Instruments to be sterilized must be clean free from any residual matter such as debris blood pads or any other material Such substances may cause damage to the contents being sterilized and to the sterilizer Correct loading of the autoclave is essential for successful sterilization for several reasons Efficient air removal from the chamber and the load will permit total steam penetration and saturation Additionally correct loading will reduce damage to packs and their contents and maximize efficient use of the sterilizer 1 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 2 After cleaning rinse instruments under tap water for 30 seconds and pat or air dry
44. s to atmospheric pressure Temperature H Pressure 6 12 16 24 30 Cycle end 5 Page 27 of 57 6 3 gt gt gt e qx 9nssa1q BEL 9 1 vic Gol stusjay ampetradura T 001 Ed EZ x Program 3 NoDry 121 Program 3 is recommended for sterilizing unwrapped instruments at a temperature of 121 C 250 F without drying stage which its manufacturer declares their compliance to be sterilized in the conditions specified below Warning This program is intended for tubing and other temperature sensitive material and is not intended for patient use devices The United States Food and Drug Administration does not evaluate sterilization cycles for non patient use devices The solid load shall not exceed 8kg 17 6 Ib Nominal Parameters e Sterilization temperature 121 9C 250 F e Sterilization time 20 minutes e Max cycle time 40 minutes e Average cycle time 35 minutes Operation Sequence e Air removal phase two vacuum pulses as described in the diagram below Saturated steam is introduced into the chamber until the sterilization temperature is reached e Sterilization phase temperature and pressure are maintained constant at the pre set level for the sterilization time e Fast exhaust phase steam is rapidly exhausted from the chamber until the chamber pressure equalizes to atmospheric pressure Note The sterility of instruments processed in unwrapped cycles cannot be maintained if
45. t the electric cord is disconnected from the power and there is no pressure in the chamber and in the generator Attention The pressure of the generator does not decrease N immediately when the equipment is turned off Wait approx 1 2 an hour to verify that the pressure has decreased to atmospheric pressure 1 Disconnect the power supply cord 2 Drain the water from both reservoirs To avoid injuries lifting and carrying should be done with at least two persons or by using a fork lift or any other mechanical aid Do not drop the device 3 1 2 Unpacking the autoclave Unpack the autoclave and inspect for mechanical damage upon receipt 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 To avoid injuries lifting and carrying of the autoclave should be done with at least two persons or by using a fork lift or any other mechanical aid 3 1 3 Installation preparations 1 Check and verify that the counter carrying the autoclave is a rigid and leveled surface and can carry a load of 225 lbs 102kg Attention The Elarall is not designed for use on any standard slide out shelf If it is necessary to use a slide out shelf it must be tested and or rated for 225 lbs or more 2 Check and verify that the counter dimensions are at least 22 wide x 24 deep 55cm x 63 5cm 3 K
46. tes e Average cycle time 25 minutes Operations Sequence e Air removal phase three vacuum pulses as described in the diagram below Saturated steam is introduced into the chamber until the sterilization temperature is reached e Sterilization phase temperature and pressure are maintained constant at the pre set level 134 C for sterilization time 3 5 minutes e Fast exhaust phase steam is rapidly exhausted from chamber until the pressure is reduced to 10 above atmospheric pressure absolute This is followed by 1 minute of drying without vacuum and then by the operation of the air inlet until the chamber pressure equalizes to atmospheric pressure Temperature Pressure Se ee ee mm mm a mm mm mm zm mm zm mm zm mm zm wm d e wm e wm o om om e mm wm om om e mm wm om om e wm wm wm Ja e wm wm wm om om wm mm wm om om af wn vm om vm e e wm wm d o ss d om wm e e wm om om em wm wm e om em wm wm wm om wm n we wm wm ele ses wm zm zm e mm om om e wm e wm wm wm d o wm om om e e mm om om e e mm om om mm wm mm wm om mm mi co is C 16 35 00 16 40 14 16 45 27 16 50 41 16 55 55 17 01 08 17 06 22 23 03 2010 23 03 2010 23 03 2010 23 03 2010 23 03 2010 23 03 2010 23 03 2010 joes I Time min 9 i Cycle start Cycle end Page 31 of 57 6 7 GE Bt 99 28 66 6 DE Eg G gt eqop amssaiq 62h suso aunqe1aduiaT J 546 Cycle start Cycle end 5 0 Test 2 VacTest
47. tion against electrical shock Class I IEC 60601 1 Mains supply fluctuation 5 In order to avoid any injury by electrical hazard it is recommended that a ground fault protection device be installed in the electrical panel feeding the autoclave local codes may make this mandatory Page 13 of 57 4 8 Construction The main parts of the autoclave are made of materials as indicated below Chamber is built of stainless steel 316 L Door is made of stainless steel 316 Trays are made of stainless steel 304 Water reservoir is made of polyethylene Door handle is made of hard plastic material which is safe to touch and thermo insulated 4 9 Symbol Description pp Caution Consult accompanying documents Caution Hot surface Caution Hot steam Protective earth Ground Page 14 of 57 4 10 Water Quality Physical characteristics and contaminants levels 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 water for sterlizers According to ANSI AAMI ST79 2006 Rest of heavy metals Compliance with the above data should be tested in accordance with acknowledged analytical methods by an authorized laboratory Attention We recommend testing the water quality once a month The use of N water for aut
48. veas 25 6 1 PROGRAM 1 FLASH keete eege eege eg Eege 26 6 2 PROGRAM 2 WDRY E34 E 27 6 3 PROGRAM 3 NODRY 121 WE 28 6 4 PROGRAM 4 W DRY 121 i eeu verde ea tta Eo ava P ERE Ea aevo eae Egon 29 6 5 PROGRAM 5 DELICATE 12L iiniiee eee eben eege ee eo ae Re Eee ees ENEE 30 6 6 TEST EBD KC KEE 31 6 7 TEST E e KR WE 32 MODIFYING PARAMETERS AND OTHER DATA cccccecccccccccccccccocccccccooes 33 Ti MEN ee 33 TD EIERE 34 7 3 SETTING THE CLOCK E 35 7 4 USCH 36 z ERUN 37 8 1 GESETZ ee 37 8 2 PRINTER HANDLING areni vba ev eee et vues evo biete 64000446 bee aee vds 39 PREPARATION BEFORE STERILIZATION ccccccccccccccccccccoooeecoco00ees 41 Page 1 of 57 10 OPERATING INSTRUCTIONS eceeeececcccccccccccooooooooooooooococseseoossessssssssssssesesesessees 44 10 1 FILLING THE MINERAL FREE WATER RESERVOIR ccccsssscccssccsscoeees 44 10 2 TURNING ON THE AUTOCLAVE Seege eege 45 10 3 ECKER 45 10 4 Bet RE 45 10 5 CLOSING THE DOOR tee 46 10 6 SELECTING A PROGRAM e EE 46 10 7 IB Ee e E 46 10 8 STOPPING THE PROCESS 4er NEUE tei I ees Lee teorie 46 10 9 CANCELING THE ERROR MESSAGE e eee ee e eene eene eene rete nee eooo 46 10 10 SLEEP IVIODE ope P DT 46 11 MAINTENANCE INSERUC TIONS 3 en I vvEE e eei Ya aea 23 Eae abd 2 aeo ea saepe eius Ges 47 11 1 PREVENTIVE AND SCHEDULED MAINTENANCE ccccossssccssscccsscccsscoeecs 47 11 2 DRAINING THE RESERVOIRS eege 49 11 3 REPLACING THE AIR
49. with a soft cloth and a weak neutral detergent After that wipe the printer with a dry cloth 8 2 2 Setting paper 1 Open the printer s cover door 3 by pulling it at the left bottom corner 2 as shown on Fig 1 2 Press the paper cover open button 4 and open the printer s paper cover Handle the paper cutter 8 carefully not to cut your hand as shown on Fig 2 3 Set a paper roll 5 as shown on Fig 2 The loose end of the paper roll must roll off the top of the paper roll as shown in Fig 2 4 Close the paper cover 7 by pressing both ends of the cover 6 with the tip end of the paper 9 emerging from the cutter 8 Fig 2 5 Close the printer s cover door 3 by pressing corner 2 with the tip end of the paper emerging from the slot 1 as shown on Fig 1 Page 39 of 57 Notes on treatment of the 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 Cautions Never disassemble the printer Failure to follow this instruction may N cause electric shock overheating or burning of the printer which may lead to fire Never use the printer in a place of extreme humidity more than 85 or any place where it can possibly be splashed by any liquids If any liquids X get into the printer it could lead to fire electric shock or other serious accidents Never touch the thermal head immediately after p
50. ws use the operation manual as reference 9 1 92 9 3 9 4 9 5 9 6 9 7 9 8 9 9 Operation principals of the autoclave Preparation for sterilizing instruction including loading instructions Intended use of each cycle Selecting a cycle Water filling method Displayed error and operational messages Monitoring and changing parameters Printer handling Maintenance instructions Perform a B amp D test with a chemical indicator The operator shall perform a cycle under supervision of the technician Page 9 of 57 4 GENERAL INFORMATION 4 1 4 2 Intended Use This table top autoclave is designed for sterilization of medical and surgical goods such as unwrapped and wrapped solid hollow porous products and tubes in ophthalmic dental and medical clinics first aid rooms small laboratories etc Introduction This autoclave model is an electrically heated sterilizer using steam as a sterilizing agent The autoclave is designed as Type B in accordance with EN13060 This model is a prevacuum sterilizer having the following features e An air removal stage prevacuum before starting the sterilizing stage e A post sterilization drying phase based on the combined operation of heat and vacuum with air inlet pulses There are the following safety devices installed in the autoclave to optimize its safe operation e Two safety thermostats to prevent over heating of the steam generator and the chamber
51. y Note Before performing this test verify that the autoclave is cold and that the autoclave is dry not humid and no water drops Vacuum is produced in the chamber down to P 17 kPa At this stage all the valves are close The autoclave remains in this stage for 5 minutes This period enables the condition in the chamber to reach equilibrium After the 5 minutes have elapsed the printer records the pressure that is referred to as P2 At this point the test begins and lasts 10 minutes At the end of the test the printer records the results The pressure at the end of the test is referred to as P3 The rate of change of P5 P5 shall not exceed 0 13 kPa min If P3 P2 exceed 1 3 kPa the printer will print TEST FAIL If P3 P2 1s within the required value the cycle will end successfully and the printer will print TEST ENDED Nominal parameters e Cycle time 20 minutes Operations Sequence e Vacuum is produced into the chamber down to 17 kPa e The vacuum pump stops Notes 1 During the test period the autoclave is not heated 2 If the Vac Test fails on an initial test it may be due to moisture in the system It is recommended to run program 2 with 20 minutes of drying to clear moisture from the system then rerun the Vac Test Temperature H Pressure PPP em em wm mm wm em mm em mm wm e wm wm wm e wm e e eel wm wm wm wm wm wm mm wm mm wm mm wm mm wm mm wm mm em mm wm dl o mm wm em wm wm wm wm mm wm mm wm mm w
52. zation temperature Sterilization time Dry time Summary of performed cycle including cycle run time chamber temperature and chamber pressure Date finished Time finished Operator Initials When the sterilization cycle begins the printer starts printing the cycle details for the program that was selected After the preliminary printing the autoclave starts performing the sequence of operations of the cycle The measured values of temperature and pressure are printed at fixed time intervals according to the phase of the process as shown in the table on the next page The data is printed from the bottom up beginning with the date and ending with CYCLE ENDED for a sterilization cycle or TEST ENDED for a test cycle For an aborted cycle CYCLE FAIL and the Error number are printed refer to sec 5 2 Displayed Error and Operational Messages For an example of a typical printout see next page Page 37 of 57 PRINTER OUTPUT Operator Time 15 01 48 Date 04 29 2010 CYCLE ENDED D 00 57 07 191 7 002 8 D 00 36 49 215 3 000 6 E 00 36 32 220 1 001 6 E 00 35 32 232 2 016 8 S 00 35 32 252 2 016 8 KR S 00 15 32 250 7 016 9 H 00 15 28 250 2 016 5 H 00 12 28 158 4 014 7 V 00 12 28 156 6 014 7 V 00 00 00 108 0 009 9 Time F PSI Dry Time 020 0min ster Time 020 0min Ster Temp 250 F Cycle WDry 121 Load number 0033 Param Ver 0032 Ver ELARA 1 21 Ser Num 02903190 Time 14 0
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