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Smeg B-One, User Manual

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Smeg B-One User Manual Download Page 11

 
 

Revision n.1 

User Manual B-One 

Edition: 04/2009 

Page 11 of 52 

 

 
 
REFERENCE NORMS 
 
Product norm 

UNI EN 13060 
 
Safety norm 

UNI EN 61010-1; UNI EN 61010-2-041 
 
Directives 

DIRECTIVE 93/42/CE “MEDICAL DEVICES” 

DIRECTIVE 2004/108/CE “ELECTROMAGNETIC COMPATIBILITY” 
 

Summary of Contents for B-One

Page 1: ...B One STEAM STERILIZER English user manual ...

Page 2: ......

Page 3: ...nual must be read carefully before any equipment use to ensure proper autoclave use Our products comply with current general safety norms and do not create hazards for operators if used according to provided instructions Finally we wish you success with your work and remind you that the reproduction of this manual is strictly prohibited and that due to our continued research and technological deve...

Page 4: ...sponsibility for any use of this equipment differing from uses described within this manual Any installation maintenance and repair operations must be performed solely by authorised Smeg personnel The warranty shall be forfeited any time the machine is employed in a manner which has not be authorised by the manufacturer The machine must only be used by specifically trained person It is Smeg task t...

Page 5: ...equipment use continued and regular maintenance Dimensions indicated in this manual are not binding All drawings and any other document contained in this manual are property of the manufacturer who reserves all rights its rights Said drawings and documents cannot be conferred to third parties Partial or complete reproduction of text or illustrations is strictly prohibited ...

Page 6: ...NAGEMENT 21 5 8 1 LOADING TANK FILLING DEMI 22 5 8 2 DEMINERALISED WATER QUALITY CONTROL 24 5 8 3 SUPPLY WATER QUALITY 24 5 8 4 MANUAL DRAINING OF LOADING TANK WATER 25 5 8 5 WATER SUPPLY TANK DRAINING 25 5 8 6 AUTOMATIC DRAINING 26 5 8 7 WATER PURIFIER WATER SUPPLY 26 5 8 8 AUTOMATIC SUPPLY FROM AN EXTERNAL CAN 27 5 9 DOOR CLOSING 27 5 10 CYCLE INTERRUPTION 28 5 11 CYCLE COMPLETED 29 5 12 PRINTER...

Page 7: ...ON MONITORING B D AND HELIX TESTS 38 7 3 PREPARATION OF OBJECTS FOR STERILIZATION 39 8 ERRORS AND ALARMS 41 9 MAINTENANCE 45 9 1 BACTERIOLOGICAL FILTER REPLACEMENT PROCEDURES 45 9 2 MECHANICAL PARTS LUBRICATION 46 9 3 MAINTENANCE OPERATIONS SUMMARY TABLE 46 10 ACCESSORIES 47 10 1 PROVIDED ACCESSORIES 47 10 2 OPTIONAL ACCESSORIES UPON REQUEST 47 ...

Page 8: ...ions related to correct installation and operation Smeg S p A declines all responsibility for any failure or damage to third parties derived from erred installation improper use or lack of maintenance PACKAGING DIMENSIONS AND WEIGHT The autoclave is delivered in packaging with the indicated dimensions and weight fig 1 autoclave packaging open bottom box which extraction from top Approx 52 x 60 x 7...

Page 9: ... Inner architecture B One has been designed with an innovative inner architecture the sterilization chamber is wound by an external chamber The compartment between the two form a jacket in which steam is present This jacket is the essential element for autoclave performance and efficiency B One is also equipped with a steam generator connected directly to the jacket A heating element is housed in ...

Page 10: ...test Air filter Bacteriologic porosity 0 3µm Sterilization chamber dimensions 240 x 340 mm External dimensions 48 x 44 x 60 cm L x A x P Electrical resistance 1300W Chamber capacity 4 standard trays 284x183x17 Net weight 52 kg Max weight filled reservoirs and maximum load in chamber 62 5 kg Net weight Max weight N feet 128 153 N feet Temperature range from 10 C to 40 C Humidity 80 for temperatures...

Page 11: ...al B One Edition 04 2009 Page 11 of 52 REFERENCE NORMS Product norm UNI EN 13060 Safety norm UNI EN 61010 1 UNI EN 61010 2 041 Directives DIRECTIVE 93 42 CE MEDICAL DEVICES DIRECTIVE 2004 108 CE ELECTROMAGNETIC COMPATIBILITY ...

Page 12: ...ce performed by unauthorised personnel Set B One on a flat surface In addition to the external autoclave dimensions consider an extra bulk in depth for connections located on the rear side approx 6cm In the event of built in installation leave a suitable space on the sides and rear to allow for equipment aeration if possible leaving the rear part of the cabinet open Do not set equipment in areas w...

Page 13: ...ensitivity 0 03A EN 61010 1 installation category Class II Degree of pollution 2 3 2 SAFETY WARNINGS Do not use B One in the presence of potentially explosive gas or vapours Do not pour water or other liquids on the equipment except in special connections for demineralised water filling B One carries out sterilization cycles during function bringing B One metal parts near the chamber to high tempe...

Page 14: ... Turn and push knob to select and confirm selections 3 Bacteriologic filter from input air replaceable 4 Analog gauge signals pressure present in the jacket winding around the chamber 5 Memory card housing if the memory card SD type is present information related to sterilization cycles is registered on it 6 Main switch equipment power supply 4 2 FRONT HYDRAULIC CONNECTIONS The three front hydraul...

Page 15: ...ot suitable for sterilization 4 3 DEVICES ON THE REAR PANEL fig 6 Rear view of the autoclave lower right corner In order from top to bottom 1 RS 232 port printer or PC connection 2 Switch for water purifier supply manual supply standard automatic can be set only by authorised technical personnel 3 Power supply input cable 4 Quick connect for tank loading demineralised water from can can only be se...

Page 16: ...hem from those which have not been selected fig 8 Stop icon for a forced cycle stop selected and unselected The turn and push knob is the means by which the user communicates with the machine turn the knob to select items shown on the display press to confirm selection A lit ring is housed on the knob It shows different colours for different status off flashing fixed depending on the current machi...

Page 17: ...n will appear on the display see the following preheating paragraph for further details fig 10 Main screen cycle selection It is also possible to select and confirm sterilization cycles during the preheating phase The machine will automatically manage the initial wait approx 15 min and cycle start up The vacuum test cycle does not need to wait until the end of the preheating phase to be turned on ...

Page 18: ...creen It is still possible at this point to return to the main screen by selecting the escape icon fig 14 escape icon on the lower right of the display this allows the user to return to the previous screen If the door is set for closing B One proceeds with automatic closing The display will read cycle in progress In the event that the machine has not completed its preheating phase the same screen ...

Page 19: ...on 5 4 AVAILABLE CYCLES STERILIZATION AND TESTS Available sterilization cycles Class B 134 C Class B 121 C Fast 134 C Prion 134 C 2 test cycles Vacuum test auto vacuum seal test B D helix test class B auto test The following table summarises sterilization cycle features Cycle Number of vacuums Sterilization temperature Sterilization time Drying time Description 121 C 16 00 CLASS B 4 134 C 4 00 9 0...

Page 20: ...mediately active upon machine turn on the turn on time or wake can also be programmed see the SETTINGS WAKE paragraph It is possible to turn on a sterilization cycle or test even if preheating has not been completed In this case sterilization will require additional preheating time managing the wait time automatically fig 16 preheating icon The preheating icon appears on the lower right side of th...

Page 21: ... a sterilization process in progress is necessary we recommend proceeding with a forced interruption see the following cycle interruption paragraph 5 7 RECOVERY AFTER A SUDDEN BLACK OUT In the event of a power failure during any sterilization cycle phase when the machine is turned back on it will complete the end of the preceding cycle in progress discharging the pressure in the chamber and drying...

Page 22: ...ust be added fig 18 LOADING TANK EMPTY warning screen Use the supplied tube to refill the tank 1 Enter the tube into the end connection in the corresponding outlet blue found on the lower left front of the machine 2 Properly plunge the other end of the tube in a demineralised water can The end must be positioned so that it is completed immersed in water Any tube blockages must be prevented these c...

Page 23: ...em malfunction to Smeg technical assistance before carrying out the procedure described below 1 Switch off the machine and disconnect the power supply cable connected at the rear of the equipment 2 Remove the sheet metal cover holding it at the rear and pulling upward The cover is fastened with inserts which lock and unlock when pressed Two tanks are housed under the cover These tanks have blue ru...

Page 24: ... also located over the front outlet which allows loading tank draining When this icon appears the user should empty the tank and top up with suitable quality demineralised water The user can decide at his her own risk to proceed with sterilization 5 8 3 SUPPLY WATER QUALITY Only optimal quality demineralised water should be used The use of municipal water line water compromises B One function caus...

Page 25: ...free end of the supplied tube in a large container for the water to be drained into set underneath the autoclave 2 Connect the end with the tube connection on the corresponding quick couple gray on the front part of the equipment the second quick couple from the right Position the tube in such a way to prevent any blockages The quick connect is indicated with an icon similar to the unsuitable qual...

Page 26: ...eg technical personnel can configure discharge in such a way that it is carried out automatically without the user needing to manually manage operations The hydraulic system connection for used water discharge must be set at a height which is lower than the autoclave support level and must not allow for any water reflux to the machine The maximum allowed distance from the hydraulic connection to t...

Page 27: ...n two modes automatic and semi automatic Automatic mode autoclave tank top up is managed completely automatically by the equipment itself Semi automatic mode the user is requested confirmation for tank top up via the display Simply press the knob for top up Note The connection tube between the can and water purifier must not be longer than 1 5 metres The can should be positioned on the same level ...

Page 28: ...ating phase by selecting the lock icon and confirming the selection by means of the knob The door icon flashes during the door opening phase The icon is not visible when the door is open 5 10 CYCLE INTERRUPTION The stop icon appears on the lower right of the display during the cycle select this icon to interrupt the cycle in progress fig 24 STOP icon for forced cycle interruption Once the icon has...

Page 29: ...ED If the cycle has been completed successfully the screen will read CYCLE COMPLETED SUCCESSFULLY The door will open automatically after the knob is pressed once Once the door has been opened the display will return to the start up screen from where a new process can be turned on If the SD memory card is connected to the cycle report all information will be saved on the card The total number of co...

Page 30: ... at forced interruption and resetting will take place quickly During later phases fractioned vacuums increased pressure temperature sterilization The autoclave has entered steam in pressure and temperature in the chamber and must be brought to safe conditions Pressure present is discharged drying takes place and then resetting of the atmospheric pressure These operations will last for a few minute...

Page 31: ...up Only one correct password can be used to access machine use 5 15 PASSWORD ENTRY PROCEDURE fig 28 administrator password request screen The procedure for password entry is the same both for regular users and the administrator Procedure 1 Rotate the knob and position the cursor on the first space of the password line space at the far left 2 Press the knob to enter into modify character mode 3 Tur...

Page 32: ...number Date on which cycle was carried out Start time Outcome The autoclave is equipped with a non volatile internal memory which contains information relative to the last 200 sterilizations The internal memory capacity is limited and cycles will eventually be overwritten when memory is full In addition to this internal memory the B One is equipped with a data back up system on the SD type memory ...

Page 33: ...a archived on the SD can then be archived on the PC in 2 ways 1 using the same SD card if the PC is equipped with the correct inlet 2 using the supplied card reader connecting the reader to the USB inlet on the PC Data on the memory card is already sub divided in folders directory on the basis of sterilization cycle data Simply copy these folders into a single folder to create a more ordered archi...

Page 34: ...t for use The icon located at the lower right corner of the display on the main menu signals the WAKE function fig 31 wake icon Leave the master switch inserted to activate programmed preheating fig 32 The master switch is found on the compartment protected by the openable door 6 3 LANGUAGE Selectable languages are Italian English French German Spanish 6 4 DATE AND TIME DATE and HOUR display scree...

Page 35: ...if desired by the administrator Administrator level deals with machine manager operations manager chemical engineer etc this level allows access to all user level menus plus the SPECIAL FUNCTIONS menu The administrator can enable disable password request on the user level Superior technical assistance and manufacturer password levels also exist The machine is configured with the following base pas...

Page 36: ...essive cycle number file name with information related to cycle 6 9 PRODUCT INFO Read only display of product information 1 model name 2 machine serial number 3 software version 6 10 MAINTENANCE Read only display of last commands for basic user operations ex i Lining Weekly cleaning with a clean wet cloth ii Sterilization chamber Cleaning with a clean cloth and hot water every 30 cycles approximat...

Page 37: ...the autoclave door must be closed without the equipment in operation fig 33 Settings screen When the door closing heading is selected the user will be asked to set the door for closing fig 34 Screen with door closing request select the return icon to return to the previous screen Once the door has been set for closing B One will proceed with automatic closing The door can be unlocked by returning ...

Page 38: ...h a standard test pack ref Norm EN 867 5 Non biological systems for use in sterilizers to be set inside the empty autoclave according to test manufacturer instructions The B D test pack contains an indicator sheet which changes colour generally from yellow to black to demonstrate sterilization efficiency Read the indicator sheet at the end of the test cycle Steam uniformly penetrates the pack and ...

Page 39: ...omposed of avoiding any direct contact between different material instruments All instruments must be set in an open position to facilitate steam flow Arrange objects spacing them out from one another PACKED Instruments can be bagged to preserve their sterility according to indications from the autoclave paper and bag material manufacturers Instruments to be sterilized must be set inside the bag m...

Page 40: ... of 52 Empty containers should be turned upside down Place a chemical indicator test in each tray Do not overload or overlap trays Always use supplied tray supports Max recommended naked instruments load 3 5kg Max recommended bagged instruments load 1 5kg ...

Page 41: ...ised autoclave operations and preserve its components over time spaces recommended for positioning must be respected The alarm is presented on the display as a phrase expressed by 3 groups of alphanumeric characters as with the following screen a FIRST GROUP identification of seriousness b SECOND GROUP alarm type c THIRD GROUP indication of the programme phase during which alarm was set off For ex...

Page 42: ... 8 Heating resistance problem electronic feedback not compliant with command given E1 16 Vacuum test cycle failed E1 32 Timeout during machine operations said alarm is better specified in the THIRD GROUP of characters see following table E1 64 Steam generator water level too low E1 128 Pressure probe generating a value outside of allowed limits E2 1 Temperature probe generating a value outside of ...

Page 43: ...um level of water has not been reached in the expected time Check to see if the demineralised water can is empty and check that the withdrawal tube end is still immersed in the water Check that loading tube is not blocked 13 Water draining phase from discharge tank Check that discharge tube is not blocked 14 Water load phase into steam generator 15 Vacuum application phase for B D helix test cycle...

Page 44: ... 21 Setpoint application sterilization phase 22 Sterilization phase 27 Problems during the hydraulic circuit cleaning phase 28 Drying decompression phase 31 Atmospheric balance recovery phase before door opening Error may involve function of the machine solenoid valve Keep in mind that solenoid valve malfunction is generally caused by unsuitable water or water whose parameters are not optimal See ...

Page 45: ...nd stainless steel trays can be cleaned with water and normal detergents for stainless steel Do not use disinfectants or alcohol inside the chamber Disconnect the power supply cable before any maintenance operations Allow heated parts to cool down before carrying out maintenance operations inside door chamber supports 9 1 BACTERIOLOGICAL FILTER REPLACEMENT PROCEDURES Unscrew the filter found under...

Page 46: ...nel replacements with non original components can all result in the forfeiture of the official warranty issued by the manufacturer and releases Smeg S p A of any responsibility 9 3 MAINTENANCE OPERATIONS SUMMARY TABLE DAILY MAINTENANCE Clean external and internal surfaces WEEKLY MAINTENANCE Clean sterilization chamber Clean trays and support clean and disinfect external surfaces MONTHLY MAINTENANC...

Page 47: ...liers 4 N 2 tubes with quick couple in plastic for water loading discharge 5 N 1 bacteriological filter already mounted in the autoclave 6 N 1 power supply cable schuko plug 7 N 1 user manual 10 2 OPTIONAL ACCESSORIES UPON REQUEST a Wire tray in stainless steel dimensions 288 x 188 x 18 mm square mesh 12x12 mm b Bacteriological filter refill c PRINT One countertop thermal printer RS 232 serial por...

Page 48: ...n 1 User Manual B One Edition 04 2009 Page 48 of 52 PRESENT ERROR REPORT TABLE DATE ERROR TYPE ex E1 16 16 CONDITIONS AT TIME OF ERROR type of cycle in progress number of completed cycles surrounding conditions ...

Page 49: ...Revision n 1 User Manual B One Edition 04 2009 Page 49 of 52 DATE ERROR TYPE ex E1 16 16 CONDITIONS AT TIME OF ERROR type of cycle in progress number of completed cycles surrounding conditions ...

Page 50: ...rices and offers Our Technical Assistance Office can provide you with information for proper equipment operation and put you in contact with a nearby authorised Assistance Office It is important to include the equipment serial number instruments smeg it Fax 39 0522 821592 See our entire product range at www smeg instruments com SERIAL NUMBER SHOWN ON THE LABEL IN THIS SPACE AT THE REAR ...

Page 51: ...Revision n 1 User Manual B One Edition 04 2009 Page 51 of 52 ...

Page 52: ...Smeg SpA Via L da Vinci 4 Instruments Division Via Circonvallazione Nord 36 42016 Guastalla RE Tel 39 0522 8211 Fax 39 0522 821 592 E mail instruments smeg it www smeg instruments com ...

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