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Operating instructions

classic

Family of Steam sterilizers B28 series -

 

B 

CLASSIC

 models:

B 

Classic

-28

Summary of Contents for B Classic-28

Page 1: ...Operating instructions classic Family of Steam sterilizers B28 series B CLASSIC models B Classic 28...

Page 2: ...ON OF THE CONTENTS 3 HANDLING THE PRODUCT 4 PRODUCT INTRODUCTION 5 Introduction 5 General Characteristics 5 FRONT 6 REAR 7 LCD ICONS 8 Operating cycle example 9 INSTALLATION 10 Introduction 10 Compart...

Page 3: ...NING 42 USED WATER DRAIN 43 Detaching the pipe 43 MANUAL INTERRUPTION 44 DATA MANAGEMENT 45 APPendix Technical Characteristics 49 SUMMARY TABLE 49 Safety Devices 50 Water supply characteristics 51 APP...

Page 4: ...filter 69 Water tank cleaning 69 Boiler gasket replacement 69 Periodic sterilizer validation 70 DISPOSAL at end of life 70 APPENDIX GENERAL PROBLEMS 71 Introduction 71 Analysis and resolution of prob...

Page 5: ......

Page 6: ...o low vol tage equipment 2004 108 CE for the approximation to the legislation of the Members States related to the elec tromagnetic compatibility 93 42CEE and subsequent changes concerning the medical...

Page 7: ...l not be responsible for any breakage malfunctions property damage or injury in the event that the product is not installed or used correctly Please observe the following precautions in order to avoid...

Page 8: ...on to the steriliser the package contains 1 No 6 stainless steel wire instrument tray 2 Stainless steel wire tray support 3 Operating documentation with CD ROM 4 Lubricant for door lock mechanism 5 Tr...

Page 9: ...ged exposure to low temperature an damage the product NOTE KEEP THE ORIGINAL PACKAGING AND USE IT WHENEVER THE DEVICE IS TO BE TRANSPORTED THE USE OF DIFFERENT PACKAGING COULD DA MAGE THE PRODUCT DURI...

Page 10: ...uum system for the complete removal of air even from hollow porous materials and an effective final vacuum drying phase capable of elimi nating all traces of humidity from any load Its exclusive steam...

Page 11: ...ystem Bacteriological filter Water drain filter On Off switch Used water drain quick connector Door Distilled water top up quick cou pling ONLY FOR B VERSIONS Dust filter ONLY FOR B VERSIONS distilled...

Page 12: ...ction ONLY FOR B VERSIONS Serial cable connection Data label Rear spacer fastening slots Connection for automatic distilled water filling only for PURE 100 500 and the automatic filling accessory kit...

Page 13: ...nt 11 04 13 10 54 Sterilization cycle selection Selection of the test cycles NOTE OTHER PARTICULAR SYMBOLS RELATING TO THE VARIOUS CONDITIONS OF USE WILL BE DESCRIBED IN THE RELATIVE PARAGRAPHS 11 04...

Page 14: ...le 134 C 4 stabilizing the pressure and temperature 5 sterilizing for the required time in the example 4 minutes 6 depressurizing the sterilization chamber 7 vacuum drying phase 8 ventilating the load...

Page 15: ...device to pro vide effective ventilation as well as a large enough opening in the back that in addition to allowing the passage of the power cord will also provide an ade quate air flow and the conseq...

Page 16: ...ventilated Do not install the machine were there is gas or inflammable and or explosive vapors Install the device so that the power cord is not bent or crushed It must run freely all the way to the so...

Page 17: ...gram provides an indicative arrangement of the components NOTE THE CONNECTION POINT TO THE CENTRAL DRAIN MUST BE LOWER THAN THE STERILIZER S SUPPORT SURFACE OTHERWISE THE TANK MAY NOT EMPTY CORRECTLY...

Page 18: ...installed turn it on with the main switch on the right hand side of the machine FIRST START UP Turning on the equipment WARNING DO NOT TURN ON THE STERILIZER IF USB KEY IS INSERTED When the sterilize...

Page 19: ...menu shown below appears on the display The device waits for selection of the desired program see section Program Selection DANGER To prevent burns be careful not to touch the steriliza tion chamber...

Page 20: ...to exceed the maximum level MAX indicated inside the tank Close the door Be carefulnot to spill any water on the machine and if so immediately dry it off WARNING THE TANK MUST BE FILLED BEFORE THE CY...

Page 21: ...GRam To access the configuration program select the icon below and press OK 11 04 13 10 54 OK SETTINGS LANGUAGE Select the LANGUAGE option and confirm by pressing the OK button Select the desired lang...

Page 22: ...34 15 hh 1 DD MM YYYY 12 04 2013 OK hh mm ss 11 34 15 hh 1 DD MM YYYY 12 04 2013 Select the field to be modified using the arrows and confirm with OK Act on the and buttons to change the value Confirm...

Page 23: ...f the system administrator Admin selecting a 4 digit numerical code After entering the PIN you access the menu reserved for the administrator To create a new user select the USER LIST option from the...

Page 24: ...confirming with OK until complete When the PIN is requested the first field is activated Enter the value using the and buttons numbers from 0 to 9 Pressing OK you go to the next value until the last o...

Page 25: ...ry requested in sequence is current PIN new PIN confirmation of new PIN USER DATA ADMIN users on the other hand have the following rights PIN change they can change its PIN User list PIN request User...

Page 26: ...rrent PIN User 1 OK OK Enter the current PIN Enter the new PIN NOTE IF THE ADMIN USER ENTERS THE PIN INCORRECTLY THREE TIMES THE NEXT TIME THE PIN IS REQUESTED THE SPECIFIC UNLOCKING CODE NEEDS TO BE...

Page 27: ...OK Cycle start Cycle End X Select the desired user Pressing OK you access the page with the data relating to the user selected You can activate only one of the two options or both Activating Cycle Sta...

Page 28: ...ssing the START button you are asked to select the user and the relative PIN OK User 3 User 2 PIN User 1 OK User 1 134 C Univ 4 134 C 2 12 Bar Warming up 39 00 134 C Universal B 4 49 134 C 2 12 Bar On...

Page 29: ...shown OK User 3 User 2 PIN User 1 OK User 1 134 C Univ 4 max 134 7 C min 134 3 C max 2 12 Bar min 2 01 Bar OK 134 C Univ 0 60 C 1 12 Bar Completed 00 00 Once the PIN has been confirmed the autoclave...

Page 30: ...you confirm deletion OK The ADMIN user can delete one or more users Select the option in the list and press OK to access the user list Select the user you want to delete and press OK to confirm or to...

Page 31: ...option and confirm by pressing the OK button Select ON to activate heating in STANDBY or OFF to deactivate it Confirm by pressing OK OK Standby 10 ON OK Standby Status Interval 10 ON OK Users Water fi...

Page 32: ...tem is connected the steri lizer asks you to identify the type of device actually con nected by pressing the corresponding button If the filling system is connected when the sterilizer is off access t...

Page 33: ...ption to adjust the screen brightness and contrast and confirm with OK Select the field to be modified using the arrows and confirm with OK Act on the and buttons to change the value Confirm with OK a...

Page 34: ...ofwaterandgermicidesolution carefully following the manufacturer s recommendations or use a heat disinfector 4 For best results use a detergent specifically designed for ultrasound washing with a neut...

Page 35: ...etween the two different materials In any case arrange the objects sufficiently distant from each other that they will remain so for the entire sterilization cycle Make sure that all instruments are s...

Page 36: ...other fasteners since they can compromise the maintenance of sterility Arrange the envelopes so as to avoid forming air pockets that obstruct the correct penetration and removal of the steam Orient th...

Page 37: ...e program is immediately interrupted generating an alarm identified by a code with a relative mes sage explaining the nature of the problem With this type of control when you select a suitable sterili...

Page 38: ...ontinue with modifying the other fields Press the EXIT button to save all the settings and go back to the previous page Press to start the user defined cycle OK DryingTime ProcessTime Temperature Frac...

Page 39: ...2 12 Bar OK DryingTime 0 min Select the EXTRA DRYING option by tapping the button indicated Act on the and buttons to set the time and confirm After confirmation the extra drying time will appear next...

Page 40: ...e time and confirm After confirmation the time set is shown on the display To activate delayed starting press the OK button PROGRAMMED STARTING OK Delay Start 00 00 16 04 13 12 58 OK Delay Start 15 30...

Page 41: ...ING VENTILATION CYCLE COMPLETION If the message COMPLETED appears it means that the cycle has completed correctly without any interruptions for alarms and that complete asepsis of the material is guar...

Page 42: ...damage the wrappings 4 Lettheinstrumentscoolbeforeanytransport andsubsequentstorage Ifnecessaryfortransport transfer the material using dry clean and disinfected containers The containers must be clos...

Page 43: ...FOR B VERSIONS Helix BD Test is a cycle run at 134 C characterised by a sterilization phase that lasts a specific time 3 5 minutes the cycle comprises the fractionated vacuum phases similar to those...

Page 44: ...e sterilizer For information in this regard contact Customer Service see Ap pendix Place the device roughly in the middle of the central tray Do not insert other material in the cham ber Close the doo...

Page 45: ...it with pre established limit values you can determine how good the seal of the sterilization chamber tubes and the various interception devices is To select the Vacuum Test cycle select Vacuum Test...

Page 46: ...alarm message generated For a complete description of the alarms refer to the Appendix Selecting this option you can run a VACUUM TEST cycle and a Helix Test B D cycle in sequence To this end place t...

Page 47: ...42 11 04 13 10 54 OK To open the autoclave door hold down the button shown in the figure The door opens and stays ajar You can now manually open the door DOOR OPENING...

Page 48: ...end of the drain tube provided in the basin 2 Insert the other end of the tube in the female union beneath the chamber inlet connector on the right pushing down until you hear a click 3 Completely em...

Page 49: ...ycle could not be completed correctly NOTE If the cycle is interrupted during certain phases an auto matic cleaning procedure of the internal hydraulic circuit starts For a complete description of the...

Page 50: ...mpe Informazioni di sistema Gestione USB PRINT MANAGEMENT To set the parameters select the following option and confirm with OK OK Report Labels OK Print last cycle Paper setting OK USB management Pri...

Page 51: ...toma tically print the summary report at the end of the cycle Selecting the Print last cycleoption with the REPORT option set the summary report of the last cycle is printed otherwise you go back to t...

Page 52: ...file system Insert key Download in progress Download completed Remove key OK New All Last 10 OK Print management System information USB management OK Download technical report Downl cycle data You can...

Page 53: ...NFORMATION Selecting SYSTEM INFORMATION all the information relating to the sterilizer settings is displa yed OK USB management System information FW version Serial number Language Standby mode Print...

Page 54: ...cluding rear connections 480 x 500 x 600 mm Net weight empty empty with trays and supporti empty with trays and supports and water at MAX level about 58 kg about 60 kg about 64 kg Sterilization chambe...

Page 55: ...ff of the electricity to the chamber heating element Door position safety microswitch Confirmation of the correct closing position of the door of the container under pressure Action signals wrong door...

Page 56: ...APPEARANCE colorless transparent without sediments colorless transparent without sediments HARDNESS 0 02 mmol l 0 02 mmol l NOTE WHEN PURCHASING DISTILLED WATER ALWAYS CHECK THAT THE QUALITY AND CHAR...

Page 57: ...iven by compressed air turbines or mechanical transmission counter angles tooth scalers Mineral based articles Articles made of heat resistant plastic Heat resistant textiles Medication materials gauz...

Page 58: ...single package porous and fabric textiles 0 6kg double package porous and fabric textiles C4 SOLID 134 PREVACUUM 1 step 0 8 bar 134 C 273 F 4 minutes 14 5 min 43 46 477 0 7 5 kg unwrapped metal or po...

Page 59: ...ROGRAM 134 C UNIVERSAL 134 C 4 00 Pressure bar 0 00 1 00 2 00 2 10 0 80 Time min LONG DRYING PROCESS PRE VACUUM 0 00 1 00 1 10 Pressure bar Time min LONG DRYING PROCESS FRACTIONATED PRE VACUUM PROGRAM...

Page 60: ...4 C 4 00 Pressure bar 0 00 1 00 2 00 2 10 1 00 Time min SHORT DRYING PROCESS FRACTIONATED PRE VACUUM 0 80 PROGRAM 134 C WRAPPED 134 C 4 00 Pressure bar 0 00 1 00 2 00 2 10 1 00 Time min LONG DRYING PR...

Page 61: ...D PRE VACUUM 0 00 0 00 PROGRAM VACUUM TEST VT 0 80 bar Pressure bar P 0 1 00 0 00 Time min 0 80 t1 P1 P2 P3 t2 t1 300 s 5 minutes 16 minutes WAITING LEAKAGE End condition for positive test result Inte...

Page 62: ...64 EXAMPLES OF PRINTED REPORTS WITH OPTIONAL PRINTER...

Page 63: ...intenance intervals DAILY Clean the gasket on the porthole Clean external surfaces WEEKLY Clean the sterilization chamber and relative accessories Disinfect external surfaces MONTHLY Clean the interna...

Page 64: ...ter either under pressure or sprinkled Seepage into electrical and electronic components could damage the functioning of the device or its internal parts even irreparably Do not use abrasive cloths me...

Page 65: ...tton cloth dampened with water and possibly the addition of a neutral detergent Dry the surfaces and remove any residue before using the device Clean the sterilization chamber support and trays and in...

Page 66: ...reverse order from removal and making sure that you screw the union on in such a way that the drain holes are positioned at the level of the boiler wall NOTE Properly fit the filter in its housing fit...

Page 67: ...technician therefore contact Technical Service see APPENDIX TECHNICAL SERVICE Replace the bacteriological filter Dust filter cleaning ONLY FOR B VERSIONS Remove the dust filter A from the lower part...

Page 68: ...ied and calibrated it is necessary to contact a company specializing in these activities Customer support department see Appendix is available to provide any information relative to the periodic valid...

Page 69: ...and fix it The main switch and or differential switch are OFF Turn the switch ON The mains fuses are blown Replace with good fuses of equal nominal value See the Summary Table in Appendix Technical C...

Page 70: ...ents Quality of the instruments is not adequate Check the quality of the instruments with the problem checking whether the material they are made of can tolerate steam sterilization Quality of the dis...

Page 71: ...ed technician Code format Axxx xxx identification number 000 999 H HAZARD Second level fault The problem can normally be solved by the Technical Service Centre Code format Hxxx xxx identification numb...

Page 72: ...tton for about 3 seconds Pressing the padlock button for 3 seconds the sterilizer door opens Pressing the RESET button for about 3 seconds you go back to the initial menu After the RESET and any techn...

Page 73: ...Door lock system activation timeout excee ded opening DOOR LOCK TIMEOUT 1 then reattempt or turn off E030 The water in the feed tank is at minimum level MIN MIN WATER LEVEL 1 E031 The water in the dr...

Page 74: ...conductivity measurement compensation PTx SHORT CIRCUITED 1 A116 ADC error ADC error 1 A120 Reference heating element acquisition chain fault Reference heating element fault 1 A121 Reference heating e...

Page 75: ...within the timeout PP2 TIMEOUT 2 A256 3rd vacuum pulse not reached within the ti meout PV3 TIMEOUT 2 A257 3rd rise back up to atmospheric pressure not reached within the timeout ATM3 TIMEOUT 2 A258 3r...

Page 76: ...MIN LIMIT 2 H410 Retention time incorrect PROCESS phase TIMER PROBLEM 2 H990 Excessive pressure sterilization chamber MPX EXCESSIVE PRESSURE 2 H991 Overheating sterilization chamber PT1 PT1 OVERHEATIN...

Page 77: ...water of very poor quality Do a RESET following the instructions IMMEDIATELY empty the feed tank and refill it with distilled water of adequate quality 15 s cm If an automatic filling system is presen...

Page 78: ...ion along the tube path Automatic filling system failure Contact Technical Service see Appendix Problem in the hydraulic circuit E260 Drain filter obstructed Clean the drain filter see the Appendix MA...

Page 79: ...ection heating element Temperature sensor short circuit heating element A115 Temperature sensor PT5 short circuited conductivity measurement compensation A116 ADC error Contact Technical Service see A...

Page 80: ...Do a RESET following the instructions Thoroughly dry the inside of the sterilization chamber and restart the cycle Do not insert material impregnated with water or liquids in general into the chamber...

Page 81: ...ppendix MAINTENANCE Problem in the hydraulic circuit Contact Technical Service see Appendix A 253 Water or condensate in the sterilization chamber Do a RESET following the instructions Thoroughly dry...

Page 82: ...side of the sterilization chamber and restart the pro gram Do not insert material soaked with water or liquids in general into the chamber Air seepage through the gasket Do a RESET following the instr...

Page 83: ...ee the Appendix MAINTENANCE Problem in the hydraulic circuit Contact Technical Service see Appendix A 261 Bacteriological filter obstructed Clean the drain filter see the Appendix MAINTENANCE Problem...

Page 84: ...2 Steam generator malfunction Problem in the hydraulic circuit H 403 Steam generator malfunction Problem in the hydraulic circuit H 404 Problem in the hydraulic circuit Steam generator malfunction H 4...

Page 85: ...h Memory Failure Contact Technical Service see Appendix S002 Flash Full S005 USB Key Failure S006 USB Stick not accessible S007 USB stick full S009 NO PRINTER S010 PRINTER NO PAPER S011 PRINTER DOOR O...

Page 86: ...88 APPENDIX ADMIN USER PIN RESET IF THE ADMIN USER ENTERS THE PIN INCORRECTLY THREE TIMES THE NEXT TIME THE PIN IS REQUESTED THE FOLLOWING UNLOCKING CODE NEEDS TO BE ENTERED 9999...

Page 87: ...Position refer to the red circle Label content note this is the back of the autoclave manufacturer name and address manufacturer model reference number serial number power information pressure chamber...

Page 88: ...e red circle Label content note this is the back of the autoclave Indication for water inlet connector connection for automatic distilled water filling Indication for water drain connector Connection...

Page 89: ...Label Position refer to the red circle Label content note this is the back of the autoclave Indication for WI FI only for B FUTURA 28 model...

Page 90: ...ontent Note this is the side of the autoclave Label of pressure vessel This label contains the following information Manufacturer Serial Number of the vessel Reference to ASME standard Min Max Pressur...

Page 91: ...Label Position refer to the red circle Label content Note this is the front of the autoclave with the door opened Caution about hot surface laser marked label...

Page 92: ...to the red circle Label content Note this is the front of the autoclave with the door opened Distilled water tank drain quick coupling Quick connector Service only laser marked label Distilled water t...

Page 93: ...Label Position refer to the red circle Label content Note this is the front of the autoclave with the door opened Used water drain quick connector laser marked label...

Page 94: ...e with the door opened Caution about read the instruction for use laser marked label Caution about lubrication of door lock Label Position refer to the red circle Label content Note this is the water...

Page 95: ...INTER For management of the automatic filling accessories refer to the previous section WATER FILLING and to the Accessory Manual THE ABOVE MENTIONED ACCESSORIES ARE AVAILABLE FOR B VERSIONS ONLY For...

Page 96: ...2 serial port located on the rear of the autoclave see figure Load the desired type of paper and turn on the printer Set the type of paper loaded see the paragraph PRINT MANAGEMENT NOTE REFER TO THE P...

Page 97: ...IRECTLY CONTACT THE TECHNICAL SUPPORT DEPARTMENT OF THE DEALER OR RESELLER THAT SUPPLIED THE PRODUCT We will gladly provide any information you may need on the product as well as give you suggestions...

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